Treaty concerning the Accession of the Republic of Croatia - Main contents

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Text
EU Monitor

1. Kerngegevens

Document date	22-09-2011
Publication date	24-09-2011
Reference	14509/1/11 REV 1
From	General Secretariat
To	Delegations
External link	original PDF
Original document in PDF

2. Text

COUNCIL OF Brussels, 22 September 2011

THE EUROPEAN UNION

14509/1/11

REV 1

INF 162

ELARG 95

NOTE

from: General Secretariat

to: Delegations

Subject: Treaty concerning the Accession of the Republic of Croatia

Delegations are informed that documents AC 31/11 and AC 30/11, which are attached to this note

as annexes I and II respectively, were released to the public on 21 September 2011 pursuant to

Regulation (EC) No 1049/2001 i of the European Parliament and of the Council of 30 May 2001

regarding public access to European Parliament, Council and Commission documents.

It should be noted that these documents contain the draft text of the Accession Treaty with Croatia

as negotiated in English and approved by Coreper on 14 September 2011.

These documents are still subject to legal-linguistic revision.

__________________

ANNEX I

COUNCIL OF Brussels, 13 September 2011

THE EUROPEAN UNION

GENERAL SECRETARIAT

AC 31/11

LIMITE

FINAL EUROPEAN UNION AND CANDIDATE COUNTRY AGREED TEXT ON THE

ACCESSION TREATY

Subject: Accession Treaty:

Treaty concerning the accession of the Republic of Croatia

TABLE OF CONTENTS

A. Treaty between the Kingdom of Belgium, the Republic of Bulgaria, the Czech Republic, the

Kingdom of Denmark, the Federal Republic of Germany, the Republic of Estonia, Ireland, the

Hellenic Republic, the Kingdom of Spain, the French Republic, the Italian Republic, the

Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Grand Duchy of

Luxembourg, the Republic of Hungary, the Republic of Malta, the Kingdom of the

Netherlands, the Republic of Austria, the Republic of Poland, the Portuguese Republic,

Romania, the Republic of Slovenia, the Slovak Republic, the Republic of Finland, the

Kingdom of Sweden, the United Kingdom of Great Britain and Northern Ireland (Member

States of the European Union) and the Republic of Croatia, concerning the accession of the

Republic of Croatia to the European Union ........................................................................... ..

B. Act concerning the conditions of accession of the Republic of Croatia and the adjustments to

the Treaty on European Union, the Treaty on the Functioning of the European Union and to

the Treaty establishing the European Atomic Energy Community……………….…...……….

Part One: Principles ……………………………………………………….….………………..……

Part Two: Adjustments to the Treaties ………………………………….…….……………………..

Title I: Institutional provisions ………………………………………………………

Title II: Other adjustments………………………………………………….…………

Part Three: Permanent provisions …………………………………………………………………….

Part Four: Temporary provisions …………………………………………………………………….

Title I: Transitional measures ………………………………………………………..

Title II: Institutional provisions …………………………...………………………….

Title III: Financial provisions ………………………………………………………….

Title IV: Other provisions …………………………..………………………………….

Part Five: Provisions relating to the implementation of this Act.........................................................

Title I: Adaptations to the rules of the institutions and committees ............................

Title II: Applicability of the acts of the institutions ......................................................

Title III: Final provisions ................................................................................................

ANNEXES

Annex I: List of conventions and protocols to which the Republic of Croatia accedes

upon accession (referred to in Article 3(4) of the Act of Accession) ................................

Annex II: List of provisions of the Schengen acquis as integrated into the framework

of the European Union and the acts building upon it or otherwise related to it,

to be binding on and applicable in the Republic of Croatia as from accession

(referred to in Article 4(1) of the Act of Accession) ..........................................................

Annex III: List referred to in Article 15 of the Act of Accession: adaptations to acts adopted

by the institutions ................................................................................................................

1.

Freedom to provide services......................................................................................

2.

Intellectual property law ............................................................................................

I. Community trade mark.....................................................................................

II. Supplementary protection certificates..............................................................

III. Community designs..........................................................................................

3.

Financial services.......................................................................................................

4.

Agriculture.................................................................................................................

5.

Fisheries.....................................................................................................................

6.
Taxation …………………………………….………………………………………
- 7.
  
  Regional policy and coordination of structural instruments ………….……………

8.

Environment…………………………………...…………………………………… Annex IV: List referred to in Article 16 of the Act of Accession: other permanent provisions..........

1.

Intellectual property law ...........................................................................................

2.

Competition policy ....................................................................................................

3.

Agriculture.................................................................................................................

4.

Fisheries.....................................................................................................................

5.

Customs union………………………………………………………………………
Appendix to Annex IV……………………………………………………………………

Annex V: List referred to in Article 18 of the Act of Accession: transitional measures ……………

1.

Freedom of movement of goods ................................................................................

2.

Freedom of movement for persons ............................................................................

3.

Free movement of capital ..........................................................................................

4.

Agriculture.................................................................................................................

5.

Food safety, veterinary and phytosanitary policy......................................................

I. Laying hens……………………………………………………………...……

II. Establishments (meat, milk, fish and animal by-products)……………...……

III. Marketing of seeds…………………………………………………...……….

IV. Neum………………………………………………………...………………..

6.

Fisheries.....................................................................................................................

7.

Transport policy.........................................................................................................

8.

Taxation………………………………………………………….…….……………

9.

Justice, freedom and security…………………………………….………………… 10. Environment ..............................................................................................................

I. Horizontal legislation…………………………………...……………….……

II. Air quality ........................................................................................................

III. Waste management ..........................................................................................

IV. Water quality ....................................................................................................

V. Integrated pollution prevention and control .....................................................

VI. Chemicals…………………………………………………………………….

Appendix to Annex V .........................................................................................................

Annex VI: Rural development (referred to in Article 35(2) of the Act of Accession)…………….…

Annex VII: Specific commitments undertaken by the Republic of Croatia in its accession

negotiations (referred to in Article 36(1), second subparagraph, of the Act of

Accession)……………………………………………………………………...................

Annex VIII: Commitments undertaken by the Republic of Croatia on the restructuring

of the Croatian shipbuilding industry (referred to in Article 36(1),

third subparagraph, of the Act of Accession)………..……………….…………………

Annex IX: Commitments undertaken by the Republic of Croatia on the restructuring of

the steel sector (referred to in Article 36(1), third subparagraph, of the

Act of Accession)………………………………….……………………..………………

PROTOCOL

Protocol on certain arrangements concerning a possible one-off transfer of assigned

amount units issued under the Kyoto Protocol to the Republic of Croatia, as well as the

related compensation……………………………………….………………………………………… FINAL ACT

I. Text of the Final Act.....................................................................................................................

II. Declarations

[A]. Joint Declaration by the present Member States ……………….…………….….…

[1.] Joint Declaration on the full application of the provisions of the Schengen

acquis…………………………………………………………………….…….

[B]. Joint Declaration by various present Member States ……………..………………..

[1.] Joint Declaration by the Federal Republic of Germany and the

Republic of Austria on the free movement of workers: Croatia ..………..……

[C.] Joint Declaration by the present Member States and the Republic of Croatia …......

[1.] Joint Declaration on the European Development Fund ……………………..…

[D.] Declaration by the Republic of Croatia .................................................................. ..

[1.] Declaration by the Republic of Croatia concerning the transitional

arrangement for the liberalisation of the Croatian agricultural land market …..

III. Exchange of Letters between the European Union and the Republic of Croatia

on an information and consultation procedure for the adoption of certain decisions and

other measures to be taken during the period preceding accession……….……….……………

TREATY

BETWEEN

THE KINGDOM OF BELGIUM, THE REPUBLIC OF BULGARIA, THE CZECH

REPUBLIC, THE KINGDOM OF DENMARK, THE FEDERAL REPUBLIC OF

GERMANY, THE REPUBLIC OF ESTONIA, IRELAND, THE HELLENIC REPUBLIC,

THE KINGDOM OF SPAIN, THE FRENCH REPUBLIC, THE ITALIAN REPUBLIC, THE

REPUBLIC OF CYPRUS, THE REPUBLIC OF LATVIA, THE REPUBLIC OF

LITHUANIA, THE GRAND DUCHY OF LUXEMBOURG, THE REPUBLIC OF

HUNGARY, THE REPUBLIC OF MALTA, THE KINGDOM OF THE NETHERLANDS,

THE REPUBLIC OF AUSTRIA, THE REPUBLIC OF POLAND, THE PORTUGUESE

REPUBLIC, ROMANIA, THE REPUBLIC OF SLOVENIA, THE SLOVAK REPUBLIC,

THE REPUBLIC OF FINLAND, THE KINGDOM OF SWEDEN, THE UNITED

KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND

(MEMBER STATES OF THE EUROPEAN UNION)

AND

THE REPUBLIC OF CROATIA,

CONCERNING THE ACCESSION OF THE REPUBLIC OF CROATIA TO THE

EUROPEAN UNION

HIS MAJESTY THE KING OF THE BELGIANS,

THE PRESIDENT OF THE REPUBLIC OF BULGARIA,

THE PRESIDENT OF THE CZECH REPUBLIC,

HER MAJESTY THE QUEEN OF DENMARK,

THE PRESIDENT OF THE FEDERAL REPUBLIC OF GERMANY,

THE PRESIDENT OF THE REPUBLIC OF ESTONIA,

THE PRESIDENT OF IRELAND,

THE PRESIDENT OF THE HELLENIC REPUBLIC,

HIS MAJESTY THE KING OF SPAIN,

THE PRESIDENT OF THE FRENCH REPUBLIC,

[INSERT ENTRY FOR CROATIA,]

THE PRESIDENT OF THE ITALIAN REPUBLIC,

THE PRESIDENT OF THE REPUBLIC OF CYPRUS,

THE PRESIDENT OF THE REPUBLIC OF LATVIA,

THE PRESIDENT OF THE REPUBLIC OF LITHUANIA,

HIS ROYAL HIGHNESS THE GRAND DUKE OF LUXEMBOURG,

THE PRESIDENT OF THE REPUBLIC OF HUNGARY,

THE PRESIDENT OF MALTA,

HER MAJESTY THE QUEEN OF THE NETHERLANDS,

THE FEDERAL PRESIDENT OF THE REPUBLIC OF AUSTRIA,

THE PRESIDENT OF THE REPUBLIC OF POLAND,

THE PRESIDENT OF THE PORTUGUESE REPUBLIC,

THE PRESIDENT OF ROMANIA,

THE PRESIDENT OF THE REPUBLIC OF SLOVENIA,

THE PRESIDENT OF THE SLOVAK REPUBLIC,

THE PRESIDENT OF THE REPUBLIC OF FINLAND,

THE GOVERNMENT OF THE KINGDOM OF SWEDEN,

HER MAJESTY THE QUEEN OF THE UNITED KINGDOM OF GREAT BRITAIN AND

NORTHERN IRELAND,

UNITED in their desire to pursue the attainment of the objectives of the European Union,

DETERMINED to continue the process of creating an ever closer union among the peoples of

Europe on the foundations already laid,

CONSIDERING that Article 49 of the Treaty on European Union affords European States the

opportunity of becoming members of the Union,

CONSIDERING that the Republic of Croatia has applied to become a member of the Union,

CONSIDERING that the Council, after having obtained the opinion of the Commission and the

consent of the European Parliament, has declared itself in favour of the admission of the Republic

of Croatia,

HAVE AGREED on the conditions of admission and the adjustments to be made to the Treaty on

European Union, the Treaty on the Functioning of the European Union and to the Treaty

establishing the European Atomic Energy Community, and to this end have designated as their

Plenipotentiaries:

HIS MAJESTY THE KING OF THE BELGIANS,

[List signatories]

THE PRESIDENT OF THE REPUBLIC OF BULGARIA,

[List signatories]

THE PRESIDENT OF THE CZECH REPUBLIC,

[List signatories]

HER MAJESTY THE QUEEN OF DENMARK,

[List signatories]

THE PRESIDENT OF THE FEDERAL REPUBLIC OF GERMANY,

[List signatories]

THE PRESIDENT OF THE REPUBLIC OF ESTONIA,

[List signatories]

THE PRESIDENT OF IRELAND,

[List signatories]

THE PRESIDENT OF THE HELLENIC REPUBLIC,

[List signatories]

HIS MAJESTY THE KING OF SPAIN,

[List signatories]

THE PRESIDENT OF THE FRENCH REPUBLIC,

[List signatories]

[INSERT ENTRY FOR CROATIA,]

[List signatories]

THE PRESIDENT OF THE ITALIAN REPUBLIC,

[List signatories]

THE PRESIDENT OF THE REPUBLIC OF CYPRUS,

[List signatories]

THE PRESIDENT OF THE REPUBLIC OF LATVIA,

[List signatories]

THE PRESIDENT OF THE REPUBLIC OF LITHUANIA,

[List signatories]

HIS ROYAL HIGHNESS THE GRAND DUKE OF LUXEMBOURG,

[List signatories]

THE PRESIDENT OF THE REPUBLIC OF HUNGARY,

[List signatories]

THE PRESIDENT OF MALTA,

[List signatories]

HER MAJESTY THE QUEEN OF THE NETHERLANDS,

[List signatories]

THE FEDERAL PRESIDENT OF THE REPUBLIC OF AUSTRIA,

[List signatories]

THE PRESIDENT OF THE REPUBLIC OF POLAND,

[List signatories]

THE PRESIDENT OF THE PORTUGUESE REPUBLIC,

[List signatories]

THE PRESIDENT OF ROMANIA,

[List signatories]

THE PRESIDENT OF THE REPUBLIC OF SLOVENIA,

[List signatories]

THE PRESIDENT OF THE SLOVAK REPUBLIC,

[List signatories]

THE PRESIDENT OF THE REPUBLIC OF FINLAND,

[List signatories]

THE GOVERNMENT OF THE KINGDOM OF SWEDEN,

[List signatories]

HER MAJESTY THE QUEEN OF THE UNITED KINGDOM OF GREAT BRITAIN AND

NORTHERN IRELAND,

[List signatories]

WHO, having exchanged their full powers found in good and due form,

HAVE AGREED AS FOLLOWS:

ARTICLE 1

1.

The Republic of Croatia hereby becomes a member of the European Union and of the
European Atomic Energy Community.

2.

The Republic of Croatia becomes a Party to the Treaty on European Union, the Treaty on the

Functioning of the European Union and the Treaty establishing the European Atomic Energy

Community as amended or supplemented.

3.

The conditions of admission and the adjustments to the Treaties referred to in paragraph 2,
entailed by such admission, are set out in the Act annexed to this Treaty. The provisions of

that Act shall form an integral part of this Treaty.

ARTICLE 2

The provisions concerning the rights and obligations of the Member States and the powers and

jurisdiction of the institutions of the Union as set out in the Treaties to which the Republic of

Croatia becomes a Party by virtue of Article 1(2) shall apply in respect of this Treaty.

ARTICLE 3

1.

This Treaty shall be ratified by the High Contracting Parties in accordance with their

respective constitutional requirements. The instruments of ratification shall be deposited with

the Government of the Italian Republic by 30 June 2013.

2.

By ratifying this Treaty, the Republic of Croatia is also deemed to have ratified or approved
any amendments to the Treaties referred to in Article 1(2) open for ratification or approval by

the Member States pursuant to Article 48 of the Treaty on European Union at the moment of

ratification of this Treaty by Croatia, as well as any acts of the institutions, adopted on or

before that same moment and which only enter into force after having been approved by the

Member States in accordance with their respective constitutional requirements.

3.

This Treaty shall enter into force on 1 July 2013 provided that all the instruments of
ratification have been deposited before that date.

4.

Notwithstanding paragraph 3, the institutions of the Union may adopt before accession the
measures referred to in Articles 3(7), 6(2), second subparagraph, 6(3), second subparagraph,

6(6), second and third subparagraphs, 6(7), second subparagraph, 6(8), third subparagraph, 17,

29(1), 30(5), 31(5), 35(3) and (4), 38, 39, 41, 42, 43, 44, 49, 50, 51, and Annexes IV to VI of

the Act referred to in Article 1(3).

These measures shall enter into force only subject to and on the date of the entry into force of

this Treaty.

5.

Notwithstanding paragraph 3, Article 36 of the Act referred to in Article 1(3) applies upon
signature of this Treaty.

ARTICLE 4

This Treaty, drawn up in a single original in the Bulgarian, Croatian, Czech, Danish, Dutch,

English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian,

Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish and Swedish languages, the

texts in each of these languages being equally authentic, shall be deposited in the archives of the

Government of the Italian Republic, which will remit a certified copy to each of the Governments

of the other Signatory States.

В ПОТВЪРЖДЕНИЕ НА КОЕТО, долуподписаните упълномощени представители

подписаха настоящия договор.

EN FE DE LO CUAL, los plenipotenciarios abajo firmantes suscriben el presente Tratado.

NA DŮKAZ ČEHOŽ připojili níže podepsaní zplnomocnění zástupci k této smlouvě své podpisy.

TIL BEKRÆFTELSE HERAF har undertegnede befuldmægtigede underskrevet denne traktat.

ZU URKUND DESSEN haben die unterzeichneten Bevollmächtigten ihre Unterschriften unter

diesen Vertrag gesetzt.

SELLE KINNITUSEKS on nimetatud täievolilised esindajad käesolevale lepingule alla kirjutanud.

ΣΕ ΠΙΣΤΩΣΗ ΤΩΝ ΑΝΩΤΕΡΩ, οι κάτωθι υπογεγραµµένοι πληρεξούσιοι υπέγραψαν την παρούσα

Συνθήκη.

IN WITNESS WHEREOF the undersigned Plenipotentiaries have signed this Treaty.

EN FOI DE QUOI, les plénipotentiaires soussignés ont apposé leurs signatures au bas du présent

traité.

DÁ FHIANÚ SIN, chuir na Lánchumhachtaigh thíos-sínithe a lámh leis an gConradh seo.

U POTVRDU TOGA niže potpisani opunomoćenici potpisali su ovaj Ugovor.

IN FEDE DI CHE, i plenipotenziari sottoscritti hanno apposto le loro firme in calce al presente

trattato.

TO APLIECINOT, Pilnvarotie ir parakstījuši šo Līgumu.

TAI PALIUDYDAMI šią Sutartį pasirašė toliau nurodyti įgaliotieji atstovai.

FENTIEK HITELÉÜL az alulírott meghatalmazottak aláírták ezt a szerződést.

B'XIEHDA TA' DAN il-Plenipotenzjarji sottoskritti iffirmaw dan it-Trattat.

TEN BLIJKE WAARVAN de ondergetekende gevolmachtigden hun handtekening onder dit

Verdrag hebben gesteld.

W DOWÓD CZEGO niżej podpisani pełnomocnicy złożyli swoje podpisy pod niniejszym

Traktatem.

EM FÉ DO QUE, os plenipotenciários abaixo-assinados apuseram as suas assinaturas no final do

presente Tratado.

DREPT CARE subsemnaţii plenipotenţiari au semnat prezentul tratat.

NA DÔKAZ TOHO splnomocnení zástupcovia podpísali túto zmluvu.

V POTRDITEV TEGA so spodaj podpisani pooblaščenci podpisali to pogodbo.

TÄMÄN VAKUUDEKSI ALLA MAINITUT täysivaltaiset edustajat ovat allekirjoittaneet tämän

sopimuksen.

SOM BEKRÄFTELSE PÅ DETTA har undertecknade befullmäktigade ombud undertecknat detta

fördrag.

[To be inserted in all the official languages: 'Done at…on the…in the year.']

Pour Sa Majesté le Roi des Belges

Voor Zijne Majesteit de Koning der Belgen

Für Seine Majestät den König der Belgier

Cette signature engage également la Communauté française, la Communauté flamande, la

Communauté germanophone, la Région wallonne, la Région flamande et la Région de Bruxelles

Capitale.

Deze handtekening verbindt eveneens de Vlaamse Gemeenschap, de Franse Gemeenschap, de

Duitstalige Gemeenschap, het Vlaamse Gewest, het Waalse Gewest en het Brussels Hoofdstedelijk

Gewest.

Diese Unterschrift bindet zugleich die Deutschsprachige Gemeinschaft, die Flämische

Gemeinschaft, die Französische Gemeinschaft, die Wallonische Region, die Flämische Region und

die Region Brüssel-Hauptstadt.

За Република България

Za prezidenta České republiky

For Hendes Majestæt Danmarks Dronning

Für den Präsidenten der Bundesrepublik Deutschland

Eesti Vabariigi Presidendi nimel

Thar ceann Uachtarán na hÉireann

For the President of Ireland

Για τον Пρόεδρο της Еλληνικής ∆ηµοκρατίας

Por Su Majestad el Rey de España

Pour le Président de la République française

['Insert entry for Croatia']

Per il Presidente della Repubblica italiana

Για τον Πρόεδρο της Κυπριακής ∆ηµοκρατίας

Latvijas Republikas Valsts prezidenta vārdā

Lietuvos Respublikos Prezidento vardu

Pour Son Altesse Royale le Grand-Duc de Luxembourg

A Magyar Köztársaság Elnöke részéről

Għall-President ta' Malta

Voor Hare Majesteit de Koningin der Nederlanden

Für den Bundespräsidenten der Republik Österreich

Za Prezydenta Rzeczypospolitej Polskiej

Pelo Presidente da República Portuguesa

Pentru Preşedintele României

Za predsednika Republike Slovenije

Za prezidenta Slovenskej republiky

Suomen Tasavallan Presidentin puolesta

För Republiken Finlands President

För Konungariket Sveriges regering

For Her Majesty the Queen of the United Kingdom of Great Britain and Northern Ireland

_________________

ACT

concerning the conditions of accession of the Republic of Croatia and the

adjustments to the Treaty on European Union, the Treaty on the Functioning of the European

Union and the Treaty establishing the European Atomic Energy Community

PART ONE

PRINCIPLES

ARTICLE 1

For the purposes of this Act:

– the expression 'original Treaties' means:

(a) the Treaty on European Union ('TEU') and the Treaty on the Functioning of the

European Union ('TFEU'), as amended or supplemented by treaties or other acts which

entered into force before the accession of the Republic of Croatia,

(b) the Treaty establishing the European Atomic Energy Community ('EAEC Treaty'), as

amended or supplemented by treaties or other acts which entered into force before this

accession;

– the expression 'present Member States' means the Kingdom of Belgium, the Republic of

Bulgaria, the Czech Republic, the Kingdom of Denmark, the Federal Republic of Germany,

the Republic of Estonia, Ireland, the Hellenic Republic, the Kingdom of Spain, the French

Republic, the Italian Republic, the Republic of Cyprus, the Republic of Latvia, the Republic

of Lithuania, the Grand Duchy of Luxembourg, the Republic of Hungary, the Republic of

Malta, the Kingdom of the Netherlands, the Republic of Austria, the Republic of Poland, the

Portuguese Republic, Romania, the Republic of Slovenia, the Slovak Republic, the Republic

of Finland, the Kingdom of Sweden and the United Kingdom of Great Britain and

Northern Ireland;

– the expression 'the Union' means the European Union founded on the TEU and on the TFEU

and/or, as the case may be, the European Atomic Energy Community;

– the expression 'the institutions' means the institutions established by the TEU.

ARTICLE 2

From the date of accession, the provisions of the original Treaties and the acts adopted by the

institutions before accession shall be binding on Croatia and shall apply in Croatia under the

conditions laid down in those Treaties and in this Act.

Where amendments to the original Treaties have been agreed by the representatives of the

governments of the Member States pursuant to Article 48(4) TEU after the ratification of the

Accession Treaty by Croatia and where those amendments have not entered into force by the date of

accession, Croatia shall ratify those amendments in accordance with its constitutional requirements.

ARTICLE 3

1.

Croatia accedes to the decisions and agreements of the Heads of State or Government of the
Member States meeting within the European Council.

2.

Croatia accedes to the decisions and agreements adopted by the Representatives of the
Governments of the Member States meeting within the Council.

3.

Croatia is in the same situation as the present Member States in respect of declarations or

resolutions of, or other positions taken up by, the European Council or the Council and in

respect of those concerning the Union adopted by common agreement of the Member States.

Croatia will accordingly observe the principles and guidelines deriving from those

declarations, resolutions or other positions and will take such measures as may be necessary to

ensure their implementation.

4.

Croatia accedes to the conventions and protocols listed in Annex I. Those conventions and
protocols shall enter into force in relation to Croatia on the date determined by the Council in

the decisions referred to in paragraph 5.

5.

The Council, acting unanimously on a recommendation by the Commission and after
consulting the European Parliament, shall make all adjustments required by reason of

accession to the conventions and protocols referred to in paragraph 4 and publish the adapted

texts in the Official Journal of the European Union.

6.

Croatia undertakes in respect of the conventions and protocols referred to in paragraph 4 to
introduce administrative and other arrangements, such as those adopted by the date of

accession by the present Member States or by the Council, and to facilitate practical

cooperation between the Member States' institutions and organisations.

7.

The Council, acting unanimously on a proposal from the Commission, may supplement

Annex I with the relevant conventions, agreements and protocols signed before the date of

accession.

ARTICLE 4

1.

The provisions of the Schengen acquis as referred to in the Protocol on the Schengen acquis

integrated into the framework of the European Union (hereinafter referred to as the 'Schengen

Protocol'), annexed to the TEU and the TFEU, and the acts building upon it or otherwise

related to it, listed in Annex II, as well as any further such acts adopted before the date of

accession, shall be binding on and applicable in Croatia from the date of accession.

2.

Those provisions of the Schengen acquis as integrated into the framework of the European

Union and the acts building upon it or otherwise related to it not referred to in paragraph 1,

while binding on Croatia from the date of accession, shall only apply in Croatia pursuant to a

Council decision to that effect, after verification, in accordance with the applicable Schengen

evaluation procedures, that the necessary conditions for the application of all parts of the

relevant acquis concerned have been met in Croatia, including the effective application of all

Schengen rules in accordance with the agreed common standards and with fundamental

principles. This decision shall be taken by the Council, in accordance with the applicable

Schengen procedures and while taking into account a Commission report confirming that

Croatia continues to fulfil the commitments undertaken in its accession negotiations that are

relevant for the Schengen acquis.

The Council shall take its decision, after consulting the European Parliament, acting with the

unanimity of its members representing the Governments of the Member States in respect of

which the provisions referred to in this paragraph have already been put into effect and of the

representative of the Government of the Republic of Croatia. The members of the Council

representing the Governments of Ireland and of the United Kingdom of Great Britain and

Northern Ireland shall take part in such a decision insofar as it relates to the provisions of the

Schengen acquis and the acts building upon it or otherwise related to it in which these

Member States participate.

ARTICLE 5

Croatia shall participate in the Economic and Monetary Union from the date of accession as a

Member State with a derogation within the meaning of Article 139 of the TFEU.

ARTICLE 6

1.

The agreements concluded or provisionally applied by the Union with one or more third
countries, with an international organisation or with a national of a third country shall, under

the conditions laid down in the original Treaties and in this Act, be binding on Croatia.

2.

Croatia undertakes to accede, under the conditions laid down in this Act, to the agreements

concluded or signed by the present Member States and the Union with one or more third

countries or with an international organisation.

Unless otherwise provided for in specific agreements referred to in the first subparagraph, the

accession of Croatia to such agreements shall be agreed by the conclusion of a protocol to

such agreements between the Council, acting unanimously on behalf of the Member States,

and the third country or countries or international organisation concerned. The Commission,

or the High Representative of the Union for Foreign Affairs and Security Policy where the

agreement relates exclusively or principally to the common foreign and security policy, shall

negotiate these protocols on behalf of the Member States on the basis of negotiating directives

approved by the Council, acting unanimously, and in consultation with a committee

comprised of the representatives of the Member States. It shall submit a draft of the protocols

for conclusion to the Council.

This procedure is without prejudice to the exercise of the Union's own competences and does

not affect the allocation of powers between the Union and the Member States as regards the

conclusion of such agreements in the future or any other amendments not related to accession.

3.

As from the date of accession, and pending the entry into force of the necessary protocols

referred to in the second subparagraph of paragraph 2, Croatia shall apply the provisions of

the agreements referred to in the first subparagraph of paragraph 2 concluded or provisionally

applied before the date of accession, with the exception of the Agreement between the

European Community and its Member States, of the one part, and the Swiss Confederation, of

the other, on the free movement of persons 1 .

Pending the entry into force of the protocols referred to in the second subparagraph of

paragraph 2, the Union and the Member States, acting jointly as appropriate in the framework

of their respective competences, shall take any appropriate measure.

4.

Croatia accedes to the Partnership Agreement between the members of the African, Caribbean

and Pacific Group of States of the one part, and the European Community and its Member

States, of the other part, signed in Cotonou on 23 June 2000 2 , as well as to the agreements

amending that Agreement, signed in Luxembourg on 25 June 2005 3 and opened for signature

in Ouagadougou on 22 June 2010 4 .

5.

Croatia undertakes to accede, under the conditions laid down in this Act, to the Agreement on
the European Economic Area 5 , in accordance with Article 128 of that Agreement.

6.

As from the date of accession, Croatia shall apply the bilateral textile agreements and
arrangements concluded by the Union with third countries.

The quantitative restrictions applied by the Union on imports of textile and clothing products

shall be adjusted to take account of the accession of Croatia to the Union. To that effect,

amendments to the bilateral agreements and arrangements referred to in the first subparagraph

may be negotiated by the Union with the third countries concerned prior to the date of

accession.

1 OJ L 114, 30.4.2002, p. 6

2 OJ L 317, 15.12.2000, p. 3.

3 OJ L 209, 11.8.2005, p. 27, OJ L 287, 28.10.2005, p. 4 and OJ L 168M, 21.6.2006, p. 33.

4 OJ L 287, 4.11.2010, p. 3.

5 OJ L 1, 3.1.1994, p. 3.

Should the amendments to the bilateral textile agreements and arrangements not have entered

into force by the date of accession, the Union shall make the necessary adjustments to its rules

for the import of textile and clothing products from third countries to take into account the

accession of Croatia.

7.

The quantitative restrictions applied by the Union on imports of steel and steel products shall

be adjusted on the basis of imports of Croatia over recent years of steel products originating in

the supplier countries concerned.

To that effect, the necessary amendments to the bilateral steel agreements and arrangements

concluded by the Union with third countries shall be negotiated prior to the date of accession.

Should the amendments to the bilateral agreements and arrangements not have entered into

force by the date of accession, the provisions of the first subparagraph shall apply.

8.

As from the date of accession, fisheries agreements concluded before accession by Croatia
with third countries shall be managed by the Union.

The rights and obligations resulting for Croatia from those agreements shall not be affected

during the period in which the provisions of those agreements are provisionally maintained.

As soon as possible, and in any event before the expiry of the agreements referred to in the

first subparagraph, appropriate decisions for the continuation of fishing activities resulting

from those agreements shall be adopted in each case by the Council acting by qualified

majority on a proposal from the Commission, including the possibility of extending certain

agreements for periods not exceeding one year.

9.

Croatia shall withdraw from any free trade agreements with third countries, including the
Central European Free Trade Agreement as amended.

To the extent that agreements between Croatia on the one hand, and one or more third

countries on the other, are not compatible with the obligations arising from this Act, Croatia

shall take all appropriate steps to eliminate the incompatibilities established. If Croatia

encounters difficulties in adjusting an agreement concluded with one or more third countries,

it shall withdraw from that agreement.

Croatia shall take all the necessary measures to ensure compliance with the obligations of this

paragraph as from the date of accession.

10.

Croatia accedes under the conditions laid down in this Act to the internal agreements

concluded by the present Member States for the purpose of implementing the agreements

referred to in paragraphs 2 and 4.

11.

Croatia shall take appropriate measures, where necessary, to adjust its position in relation to

international organisations, and to those international agreements to which the Union or to

which other Member States are also parties, to the rights and obligations arising from Croatia's

accession to the Union.

Croatia shall in particular withdraw from international fisheries agreements and organisations

to which the Union is also a party, unless its membership relates to matters other than

fisheries.

Croatia shall take all necessary measures to ensure compliance with the obligations of this

paragraph as from the date of accession.

ARTICLE 7

1.

The provisions of this Act may not, unless otherwise provided herein, be suspended, amended
or repealed other than by means of the procedure laid down in the original Treaties enabling

those Treaties to be revised.

2.

Acts adopted by the institutions to which the transitional provisions laid down in this Act

relate shall retain their status in law; in particular, the procedures for amending those acts shall

continue to apply.

3.

Provisions of this Act the purpose or effect of which is to repeal or amend acts adopted by the
institutions, otherwise than as a transitional measure, shall have the same status in law as the

provisions which they repeal or amend and shall be subject to the same rules as those

provisions.

ARTICLE 8

The application of the original Treaties and acts adopted by the institutions shall, as a transitional

measure, be subject to the derogations provided for in this Act.

PART TWO

ADJUSTMENTS TO THE TREATIES

TITLE I

INSTITUTIONAL PROVISIONS

ARTICLE 9

The Protocol on the Statute of the Court of Justice of the European Union, annexed to the TFEU

and the EAEC Treaty, shall be amended as follows:

1.

In Article 9, the first paragraph shall be replaced by the following:
'When, every three years, the Judges are partially replaced, 14 Judges shall be replaced.'

2.

Article 48 shall be replaced by the following:
'The General Court shall consist of 28 Judges.'.

ARTICLE 10

The Protocol on the Statute of the European Investment Bank, annexed to the TEU, the TFEU and

the EAEC Treaty shall be amended as follows:

1.

In Article 4(1), first subparagraph:
(a) the introductory sentence shall be replaced by the following:

'1. The capital of the Bank shall be EUR 233 247 390 000, subscribed by the Member

States as follows:'

(b) the following shall be inserted between the entries for Romania and Slovakia:

'Croatia EUR 854 400 000 '.

2.

In Article 9(2), the first, second and third subparagraphs shall be replaced by the following:

'2. The Board of Directors shall consist of twenty-nine directors and nineteen alternate

directors.

The directors shall be appointed by the Board of Governors for five years, one nominated by

each Member State, and one nominated by the Commission.

The alternate directors shall be appointed by the Board of Governors for five years as shown

below:

– two alternates nominated by the Federal Republic of Germany,

– two alternates nominated by the French Republic, – two alternates nominated by the Italian Republic,

– two alternates nominated by the United Kingdom of Great Britain and Northern Ireland,

– one alternate nominated by common accord of the Kingdom of Spain and the

Portuguese Republic,

– one alternate nominated by common accord of the Kingdom of Belgium, the

Grand Duchy of Luxembourg and the Kingdom of the Netherlands,

– two alternates nominated by common accord of the Kingdom of Denmark, the

Hellenic Republic, Ireland and Romania,

– two alternates nominated by common accord of the Republic of Estonia, the Republic of

Latvia, the Republic of Lithuania, the Republic of Austria, the Republic of Finland and

the Kingdom of Sweden,

– four alternates nominated by common accord of the Republic of Bulgaria, the Czech

Republic, the Republic of Croatia, the Republic of Cyprus, the Republic of Hungary, the

Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak

Republic,

– one alternate nominated by the Commission.'.

ARTICLE 11

Article 134(2), first subparagraph, of the EAEC Treaty on the composition of the Scientific and

Technical Committee shall be replaced by the following:

'2. The Committee shall consist of forty-two members, appointed by the Council after

consultation with the Commission.'.

TITLE II

OTHER ADJUSTMENTS

ARTICLE 12

In Article 64(1) of the TFEU, the following sentence is added:

'In respect of restrictions existing under national law in Croatia, the relevant date shall be

31 December 2002.'.

ARTICLE 13

Article 52(1) of the TEU shall be replaced by the following:

'1. The Treaties shall apply to the Kingdom of Belgium, the Republic of Bulgaria, the

Czech Republic, the Kingdom of Denmark, the Federal Republic of Germany, the Republic of

Estonia, Ireland, the Hellenic Republic, the Kingdom of Spain, the French Republic, the

Republic of Croatia, the Italian Republic, the Republic of Cyprus, the Republic of Latvia, the

Republic of Lithuania, the Grand Duchy of Luxembourg, the Republic of Hungary, the

Republic of Malta, the Kingdom of the Netherlands, the Republic of Austria, the Republic of

Poland, the Portuguese Republic, Romania, the Republic of Slovenia, the Slovak Republic,

the Republic of Finland, the Kingdom of Sweden and the United Kingdom of Great Britain

and Northern Ireland.'.

ARTICLE 14

1.

Article 55(1) of the TEU shall be replaced by the following:

'1. This Treaty, drawn up in a single original in the Bulgarian, Croatian, Czech, Danish,

Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian,

Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish and Swedish

languages, the texts in each of these languages being equally authentic, shall be deposited in

the archives of the Government of the Italian Republic, which will transmit a certified copy to

each of the governments of the other signatory States.'.

2.

Article 225, second paragraph, of the EAEC Treaty shall be replaced by the following:
'Pursuant to the Accession Treaties, the Bulgarian, Croatian, Czech, Danish, English,

Estonian, Finnish, Greek, Hungarian, Irish, Latvian, Lithuanian, Maltese, Polish, Portuguese,

Romanian, Slovak, Slovenian, Spanish and Swedish versions of this Treaty shall also be

authentic.'.

PART THREE

PERMANENT PROVISIONS

ARTICLE 15

The acts listed in Annex III to this Act shall be adapted as specified in that Annex.

ARTICLE 16

The measures listed in Annex IV to this Act shall be applied under the conditions laid down in that

Annex.

ARTICLE 17

The Council, acting unanimously on a proposal from the Commission and after consulting the

European Parliament, may make the adaptations to the provisions of this Act relating to the

common agricultural policy which may prove necessary as a result of a modification in Union rules.

PART FOUR

TEMPORARY PROVISIONS

TITLE I

TRANSITIONAL MEASURES

ARTICLE 18

The measures listed in Annex V to this Act shall apply in respect of Croatia under the conditions

laid down in that Annex.

TITLE II

INSTITUTIONAL PROVISIONS

ARTICLE 19

1.

By way of derogation from Article 2 of the Protocol on transitional provisions annexed to the
TEU, the TFEU and the EAEC Treaty and by way of derogation from the maximum number

of seats provided for in the first subparagraph of Article 14(2) of the TEU, the number of

members of the European Parliament shall be increased to take account of the accession of

Croatia with the following number of members from Croatia for the period running from the

date of accession until the end of the 2009-2014 term of the European Parliament:

Croatia 12.

2.

By way of derogation from Article 14(3) of the TEU, Croatia shall, before the date of

accession, hold ad hoc elections to the European Parliament, by direct universal suffrage of its

people, for the number of members fixed in paragraph 1, I n accordance with the provisions of

the acquis. However, if the date of accession is less than six months before the next elections

to the European Parliament, the members of the European Parliament representing the citizens

of Croatia may be designated by the national Parliament of Croatia, from its midst, provided

that the persons in question have been elected by direct universal suffrage.

ARTICLE 20

Article 3(3) of the Protocol on transitional provisions annexed to the TEU, the TFEU and the EAEC

Treaty shall be replaced by the following:

'3. Until 31 October 2014, the following provisions shall remain in force, without prejudice

to the second subparagraph of Article 235(1) of the Treaty on the Functioning of the European

Union.

For acts of the European Council and of the Council requiring a qualified majority, members'

votes shall be weighted as follows:

Belgium 12

Bulgaria 10

Czech Republic 12

Denmark 7

Germany 29

Estonia 4

Ireland 7

Greece 12

Spain 27

France 29

Croatia 7

Italy 29

Cyprus 4

Latvia 4

Lithuania 7

Luxembourg 4

Hungary 12

Malta 3

Netherlands 13

Austria 10

Poland 27

Portugal 12

Romania 14

Slovenia 4

Slovakia 7

Finland 7

Sweden 10

14509/1/11 REV 1 WS/jj 40 Acts shall be adopted if there are at least 260 votes in favour representing a majority of the

members where, under the Treaties, they must be adopted on a proposal from the

Commission. In other cases decisions shall be adopted if there are at least 260 votes in favour

representing at least two thirds of the members.

A member of the European Council or the Council may request that, where an act is adopted

by the European Council or the Council by a qualified majority, a check is made to ensure

that the Member States comprising the qualified majority represent at least 62% of the total

population of the Union. If that proves not to be the case, the act shall not be adopted.'

ARTICLE 21

1.

With effect for the period running from the date of accession until 31 October 2014, a national

of Croatia shall be appointed to the Commission as from the date of accession. The new

Member of the Commission shall be appointed by the Council, acting by qualified majority

and by common accord with the President of the Commission, after consulting the European

Parliament and in accordance with the criteria set out in the second subparagraph of Article

17(3) of the TEU.

2.

The term of office of the Member appointed in accordance with paragraph 1 shall expire at the
same time as those of the Members in office at the time of accession.

ARTICLE 22

1.

The term of office of the Judge of the Court of Justice and the Judge of the General Court

appointed from Croatia upon its accession in accordance with the third subparagraph of

Article 19(2) of the TEU shall expire, respectively, on 6 October 2015 and 31 August 2013.

2.

For the purpose of judging cases pending before the Courts on the date of accession in respect
of which oral proceedings have started before that date, the full Courts or the Chambers shall

be composed as before accession and shall apply the Rules of Procedure in force on the day

preceding the date of accession.

ARTICLE 23

1.

By way of derogation from the maximum number of members of the Economic and Social

Committee provided for in Article 301, first paragraph, of the TFEU, Article 7 of the Protocol

on transitional provisions annexed to the TEU, the TFEU and the EAEC Treaty, on the

composition of the Economic and Social Committee, shall be replaced by the following:

'Article 7

Until the entry into force of the decision referred to in Article 301 of the Treaty on the Functioning

of the European Union, the allocation of members of the Economic and Social Committee shall be

as follows:

Belgium 12

Bulgaria 12

Czech Republic 12

Denmark 9

Germany 24

Estonia 7

Ireland 9

Greece 12

Spain 21

France 24

Croatia 9

Italy 24

Cyprus 6

Latvia 7

Lithuania 9

Luxembourg 6

Hungary 12

Malta 5

Netherlands 12

Austria 12

Poland 21

Portugal 12

Romania 15

Slovenia 7

Slovakia 9

Finland 9

United Kingdom 24'

14509/1/11 REV 1 WS/jj 43 2. The number of members of the Economic and Social Committee shall be temporarily

increased to 353 to take account of the accession of Croatia for the period running from the

date of accession until the end of the term of office during which Croatia accedes to the

European Union or until the entry into force of the decision referred to in Article 301, second

paragraph, of the TFEU, whichever comes first.

3.

If the decision referred to in Article 301, second paragraph, of the TFEU has already been
adopted by the date of accession, by way of derogation from the maximum number of

members of the Economic and Social Committee provided for in Article 301, first paragraph,

of the TFEU, Croatia shall be temporarily allocated an appropriate number of members until

the end of the term of office during which it accedes to the Union.

ARTICLE 24

1.

By way of derogation from the maximum number of members of the Committee of the
Regions provided for in Article 305, first paragraph, of the TFEU, Article 8 of the Protocol on

transitional provisions, annexed to the TEU, the TFEU and the EAEC Treaty, on the

composition of the Committee of the Regions, shall be replaced by the following:

'Article 8

Until the entry into force of the decision referred to in Article 305 of the Treaty on the Functioning

of the European Union, the allocation of members of the Committee of the Regions shall be as

follows:

Belgium 12

Bulgaria 12

Czech Republic 12

Denmark 9

Germany 24

Estonia 7

Ireland 9

Greece 12

Spain 21

France 24

Croatia 9

Italy 24

Cyprus 6

Latvia 7

Lithuania 9

Luxembourg 6

Hungary 12

Malta 5

Netherlands 12

Austria 12

Poland 21

Portugal 12

Romania 15

Slovenia 7

Slovakia 9

Finland 9

United Kingdom 24'

14509/1/11 REV 1 WS/jj 45 2. The number of members of the Committee of the Regions shall be temporarily increased to

353 to take account of the accession of Croatia for the period running from the date of

accession until the end of the term of office during which Croatia accedes to the Union or until

the entry into force of the decision referred to in Article 305, second paragraph, of the TFEU,

whichever comes first.

3.

If the decision referred to in Article 305, second paragraph, of the TFEU has already been
adopted by the date of accession, by way of derogation from the maximum number of

members of the Committee of the Regions provided for in Article 305, first paragraph, of the

TFEU, Croatia shall be temporarily allocated an appropriate number of members until the end

of the term of office during which it accedes to the Union.

ARTICLE 25

The term of office of the director of the Board of Directors of the European Investment Bank,

nominated by Croatia and appointed upon accession as provided for in the second subparagraph of

Article 9(2) of the Protocol on the statute of the European Investment Bank shall expire at the end

of the annual meeting of the Board of Governors during which the annual report for the 2017

financial year is examined.

ARTICLE 26

1.

New members of the committees, groups, agencies or other bodies created by the original
Treaties or by an act of the institutions shall be appointed under the conditions and according

to the procedures laid down for the appointment of members of these committees, groups,

agencies or other bodies. The terms of office of the newly appointed members shall expire at

the same time as those of the members in office at the time of accession.

2.

The membership of the committees, groups, agencies or other bodies created by the original

Treaties or by an act of the institutions with a number of members fixed irrespective of the

number of Member States shall be completely renewed upon accession, unless the terms of

office of the present members expire within 12 months following accession.

TITLE III

FINANCIAL PROVISIONS

ARTICLE 27

1.

From the date of accession, Croatia shall pay the following amount corresponding to its share

of the capital paid in for the subscribed capital as defined in Article 4 of the Statute of the

European Investment Bank:

Croatia EUR 42 720 000

The contribution shall be paid in eight equal instalments falling due on 30 November 2013, 30

November 2014, 30 November 2015, 31 May 2016, 30 November 2016, 31 May 2017, 30

November 2017 and 31 May 2018.

2.

Croatia shall contribute, in eight equal instalments falling due on the dates provided for in

paragraph 1, to the reserves and provisions equivalent to reserves, as well as to the amount

still to be appropriated to the reserves and provisions, comprising the balance of the profit and

loss account, established at the end of the month preceding accession, as entered on the

balance sheet of the Bank, in amounts corresponding to the following percentage of the

reserves and provisions:

Croatia 0.368 %

3.

The capital and payments provided for in paragraphs 1 and 2 shall be paid in by Croatia in

cash in euro, save by way of derogation decided unanimously by the Board of Governors.

4.

The figures for Croatia referred to in paragraph 1 as well as in Article 10, point 1, may be

adapted by decision of the European Investment Bank governing bodies on the basis of the

latest final data of GDP published by Eurostat before accession.

ARTICLE 28

1.

Croatia shall pay the following amount to the Research Fund for Coal and Steel referred to in
Decision 2002/234/ECSC of the Representatives of the Governments of the Member States,

meeting within the Council, of 27 February 2002 on the financial consequences of the expiry

of the ECSC Treaty and on the Research Fund for Coal and Steel 1

(EUR, current prices )

Croatia 494 000

2.

The contribution to the Research Fund for Coal and Steel shall be made in four instalments

starting in 2015 and paid as follows, in each case on the first working day of the first month of

each year:

2015: 15%

2016: 20%

2017: 30%

2018: 35%.

1 OJ L 79, 22.3.2002, p. 42.

ARTICLE 29

1.

Procurement, grant awards and payments for pre-accession financial assistance under the IPA
Transition Assistance and Institution Building Component and the IPA Cross-Border

Cooperation Component of the Instrument for Pre-Accession Assistance (IPA) 1 , for funds

committed before accession, with the exclusion of the cross-border programmes Croatia

Hungary and Croatia-Slovenia, and for assistance under the Transition Facility referred to in

Article 30, shall be managed by Croatian implementing agencies as of the date of accession.

The ex ante control by the Commission over procurement and grant awards shall be waived

by a Commission decision to that effect, after the Commission has satisfied itself of the

effective functioning of the management and control system concerned in accordance with the

criteria and conditions laid down in Article 56(2) of the Financial Regulation applicable to the

general budget of the European Union 2 and in Article 18 of the IPA Implementing

Regulation 3 .

If this Commission decision to waive ex ante control has not been taken before the date of

accession, any contracts signed between the date of accession and the date on which the

Commission decision is taken shall not be eligible under the pre-accession financial assistance

and the Transition Facility referred to in the first subparagraph.

2.

Budgetary commitments made before the date of accession under the pre-accession financial
assistance and the Transition Facility referred to in paragraph 1, including the conclusion and

registration of subsequent individual legal commitments and payments made after accession,

shall continue to be governed by the rules applying to the pre-accession financial instruments

and be charged to the corresponding budget chapters until closure of the programmes and

projects concerned.

1 Council Regulation (EC) No 1085/2006 i of 17 July 2006 establishing an Instrument for Pre

Accession Assistance (IPA) (OJ L 210, 31.7.2006, p. 82).

2 Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation

applicable to the general budget of the European Communities (OJ L 248, 19.9.2002, p. 1).

3 Commission Regulation (EC) No 718/2007 of 12 June 2007 implementing Council Regulation

(EC) No 1085/2006 establishing an instrument for pre–accession assistance (IPA) (OJ L 170,

29.6.2007, p.1).

3.

The provisions on the implementation of budgetary commitments of financing agreements
concerning the pre-accession financial assistance referred to in paragraph 1, first

subparagraph, and the IPA Rural Development component, relating to financing decisions

taken before accession, shall continue to be applicable after the date of accession. They shall

be governed by the rules applying to the pre-accession financial instruments. Notwithstanding

this, public procurement procedures initiated after accession shall be carried out in accordance

with the relevant European Union Directives.

4.

Pre-accession funds to cover administrative costs, as defined in Article 44, may be committed
in the first two years after accession. For audit and evaluation costs, pre-accession funds may

be committed up to five years after accession.

ARTICLE 30

1.

For the first year after accession, the Union shall provide temporary financial assistance,

hereinafter referred to as the "Transition Facility", to Croatia to develop and strengthen its

administrative and judicial capacity to implement and enforce Union legislation and to foster

exchange of best practice among peers. This assistance shall fund institution-building projects

and limited small-scale investments ancillary thereto.

2.

Assistance shall address the continued need for strengthening institutional capacity in certain
areas through action which cannot be financed by the Structural Funds or by the Rural

Development funds.

3.

For twinning projects between public administrations for the purpose of institution building,

the procedure for call for proposals through the network of contact points in the Member

States shall continue to apply.

4.

The commitment appropriations for the Transition Facility, at current prices, for Croatia shall
be EUR 29 million in total in 2013 to address national and horizontal priorities.

5.

Assistance under the Transition Facility shall be decided and implemented in accordance with

Council Regulation (EC) No 1085/2006 i or on the basis of other technical provisions necessary

for the operation of the Transition Facility, to be adopted by the Commission.

6.

Particular attention shall be paid to ensuring appropriate complementarity with the envisaged
European Social Fund support for administrative reform and institutional capacity.

ARTICLE 31

1.

A Schengen Facility (hereinafter referred to as "the temporary Schengen Facility") is hereby

created as a temporary instrument to help Croatia between the date of accession and the end of

2014 to finance actions at the new external borders of the Union for the implementation of the

Schengen acquis and external border control.

2.

For the period 1 July 2013 to 2014, the following amounts (current prices) shall be made
available to Croatia in the form of lump-sum payments under the temporary Schengen

Facility:

(EUR million, current prices)

• • 2013 • 2014

• Croatia • 40 • 80

3.

The annual amount for 2013 shall be payable to Croatia on 1 July 2013 and the annual amount
for 2014 shall be made available on the first working day after 1 January 2014.

4.

The lump-sum payments shall be used within three years from the first payment. Croatia shall
submit, no later than six months after expiry of this three-year period, a comprehensive report

on the final execution of the payments under the temporary Schengen Facility with a

statement justifying the expenditure. Any unused or unjustifiably spent funds shall be

recovered by the Commission.

5.

The Commission may adopt any technical provisions necessary for the operation of the
temporary Schengen Facility.

ARTICLE 32

1.

A Cash-flow Facility (hereinafter referred to as "the temporary Cash-flow Facility") is hereby

created as a temporary instrument to help Croatia between the date of accession and the end of

2014 to improve the cash-flow in the national budget.

2.

For the period 1 July 2013 to 31 December 2014, the following amounts (current prices) shall

be made available to Croatia in the form of lump-sum payments under the temporary Cashflow

Facility:

(EUR million, current prices)

2013 2014

Croatia 75 28,6

3.

Each annual amount shall be divided into equal monthly instalments, payable on the first
working day of each month.

ARTICLE 33

1.

An allocation of EUR 449,4 million (current prices) in commitment appropriations will be
reserved for Croatia under the Structural and Cohesion Funds in 2013.

2.

One third of the allocation referred to in paragraph 1 shall be reserved for the Cohesion Fund.

3.
For the period covered by the next financial framework, Croatia's allocations under Structural
and Cohesion funding shall be calculated based on the then applicable acquis. These amounts

shall be adjusted in accordance with the following phasing-in schedule:
- -
  
  70% in 2014
- -
  
  90% in 2015
- -
  
  100% as of 2016.

4.

Insofar as the limits of the new acquis allow, an adjustment shall be made to ensure an

increase of funds for Croatia in 2014 of 2.33 times the 2013 allocation, and in 2015 of 3 times

the 2013 allocation.

ARTICLE 34

1.

The total allocation to be made available to Croatia under the European Fisheries Fund in
2013 shall be EUR 8,7 million (current prices) in commitment appropriations.

2.

Pre-financing under the European Fisheries Fund shall amount to 25 % of the total allocation
referred to in paragraph 1. This amount shall be paid in one instalment.

3.

For the period covered by the next financial framework, Croatia's allocations shall be

calculated based on the then applicable acquis. These amounts shall be adjusted in accordance

with the following phasing-in schedule:

-

70% in 2014

-

90% in 2015

-

100% as of 2016.

4.

Insofar as the limits of the new acquis allow, an adjustment shall be made to ensure an

increase of funds for Croatia in 2014 of 2.33 times the 2013 allocation, and in 2015 of 3 times

the 2013 allocation.

ARTICLE 35

1.

Council Regulation (EC) No 1698/2005 i of 20 September 2005 on support for rural
development by the European Agricultural Fund for Rural Development (EAFRD) 1 shall not

apply to Croatia for the whole programming period 2007-2013.

In the year 2013, Croatia shall be allocated EUR 27,7 million under the Rural Development

Component referred to in Article 12 of Council Regulation (EC) No 1085/2006 i.

2.

Temporary additional rural development measures for Croatia are laid out in Annex VI.

3.

The Commission may, by means of implementing acts, adopt rules necessary for the

application of the provisions of Annex VI. Those implementing acts shall be adopted in

accordance with the procedure laid down in Article 90(2) of Council Regulation (EC) No

1698/2005 in conjunction with Article 13(1)(b) of Regulation (EU) No 182/2011 i of the

European Parliament and of the Council of 16 February 2011 laying down the rules and

general principles concerning mechanisms for control by Member States of the Commission's

exercise of implementing powers 2 or the relevant procedure as determined in the applicable

legislation.

4.

The Council, acting on a proposal from the Commission, and after consulting the European

Parliament, shall make any adaptations to the provisions of Annex VI, where necessary, to

ensure coherence with the regulations concerning rural development.

1 OJ L 277, 21.10.2005, p. 1 and OJ L 286M, 4.11.2010, p. 26.

2 OJ L 55, 28.2.2011, p. 13.

TITLE IV

OTHER PROVISIONS

ARTICLE 36

1.

The Commission shall closely monitor all commitments undertaken by Croatia in the

accession negotiations, including those which must be achieved before or by the date of

accession. The Commission’s monitoring shall consist of regularly updated monitoring tables,

the dialogue under the Stabilisation and Association Agreement (SAA) 1 , peer assessment

missions, the pre-accession economic programme, fiscal notifications and, when necessary,

early warning letters to the Croatian authorities. A Progress Report and a Comprehensive

Monitoring Report shall be presented to the Council and the European Parliament in the

autumn of 2011 and 2012, respectively. The Commission shall also draw on input from

Member States and take into consideration input from international and civil society

organisations as appropriate, throughout the monitoring process.

The Commission’s monitoring shall focus in particular on commitments undertaken by

Croatia in the area of the judiciary and fundamental rights (Annex VII), including the

continued development of track records on judicial reform and efficiency, impartial handling

of war crimes cases, and the fight against corruption.

In addition, the Commission's monitoring shall focus on the area of justice, freedom and

security, including the implementation and enforcement of Union requirements with respect to

external border management, police cooperation, the fight against organised crime, and

judicial cooperation in civil and criminal matters, as well as on commitments in the area of

competition policy including the restructuring of the shipbuilding industry (Annex VIII) and

the restructuring of the steel sector (Annex IX).

1 [OJ reference to be inserted]

The Commission shall issue six-monthly assessments up to the accession of Croatia on the

commitments undertaken by Croatia in these areas as an integral part of its regular monitoring

tables and reports.

2.

The Council, acting by qualified majority on a proposal from the Commission, may take all

appropriate measures if issues of concern are identified during the monitoring process. The

measures shall be maintained no longer than strictly necessary and, in any case, shall be lifted

by the Council, acting in accordance with the same procedure, when the relevant issues of

concern have been effectively addressed.

ARTICLE 37

1.

If, until the end of a period of up to three years after accession, difficulties arise which are
serious and liable to persist in any sector of the economy or which could bring about serious

deterioration in the economic situation of a given area, Croatia may apply for authorisation to

take protective measures in order to rectify the situation and adjust the sector concerned to the

economy of the internal market.

In the same circumstances, any present Member State may apply for authorisation to take

protective measures with regard to Croatia.

2.

Upon request by the State concerned, the Commission shall, by emergency procedure,

determine the protective measures which it considers necessary, specifying the conditions and

modalities in which they are to be put into effect.

In the event of serious economic difficulties and at the express request of the Member State

concerned, the Commission shall act within five working days of the receipt of the request

accompanied by the relevant background information. The measures thus decided on shall be

applicable forthwith, shall take into account the interest of all parties concerned and shall not

entail frontier controls.

3.

The measures authorised under this article may involve derogations from the rules of the TEU,
the TFEU and this Act to such an extent and for such periods as are strictly necessary in order

to attain the objectives of this safeguard. Priority shall be given to such measures as will least

disturb the functioning of the internal market.

ARTICLE 38

If Croatia has failed to implement commitments undertaken in the context of the accession

negotiations, including commitments in any sectoral policy which concerns economic activities

with cross-border effect, causing a serious breach of the functioning of the internal market or a

threat to the Union's financial interests or an imminent risk of such a breach or threat, the

Commission may, until the end of a period of up to three years after accession, upon reasoned

request of a Member State or on its own initiative, take appropriate measures.

These measures shall be proportional and priority shall be given to measures which least disturb the

functioning of the internal market and, where appropriate, to the application of the existing sectoral

safeguard mechanisms. The safeguard measures under this article shall not be invoked as a means

of arbitrary discrimination or a disguised restriction on trade between Member States. The

safeguard clause may be invoked even before accession on the basis of the monitoring findings and

the measures adopted shall enter into force as of the date of accession unless they provide for a later

date. The measures shall be maintained no longer than strictly necessary and, in any case, shall be

lifted when the relevant commitment is implemented. They may however be applied beyond the

period specified in the first paragraph as long as the relevant commitments have not been fulfilled.

In response to progress made by Croatia in fulfilling its commitments, the Commission may adapt

the measures as appropriate. The Commission shall inform the Council in good time before

revoking the safeguard measures, and it shall take duly into account any observations of the Council

in this respect.

ARTICLE 39

If there are serious shortcomings or any imminent risks of such shortcomings in Croatia in the

transposition or state of implementation of acts adopted by the institutions pursuant to Part Three,

Title V of the TFEU as well as of acts adopted by the institutions before the entry into force of the

Treaty of Lisbon pursuant to Title VI of the TEU or pursuant to Part Three, Title IV of the Treaty

establishing the European Community, the Commission may, until the end of a period of up to three

years after accession, upon the reasoned request of a Member State or on its own initiative and after

consulting the Member States, adopt appropriate measures and specify the conditions and

modalities under which these measures are put into effect.

These measures may take the form of temporary suspension of the application of relevant

provisions and decisions in the relations between Croatia and any other Member State or Member

States, without prejudice to the continuation of close judicial cooperation. The safeguard clause

may be invoked even before accession on the basis of the monitoring findings and the measures

adopted shall enter into force as of the date of accession unless they provide for a later date. The

measures shall be maintained no longer than strictly necessary and, in any case, shall be lifted when

the shortcomings are remedied. They may however be applied beyond the period specified in the

first paragraph as long as these shortcomings persist. In response to progress made by Croatia in

rectifying the identified shortcomings, the Commission may adapt the measures as appropriate after

consulting the Member States. The Commission shall inform the Council in good time before

revoking the safeguard measures, and it shall take duly into account any observations of the Council

in this respect.

ARTICLE 40

In order not to hamper the proper functioning of the internal market, the enforcement of Croatia's

national rules during the transitional periods referred to in Annex V shall not lead to border controls

between Member States.

ARTICLE 41

If transitional measures are necessary to facilitate the transition from the existing regime in Croatia

to that resulting from the application of the common agricultural policy under the conditions set out

in this Act, they shall be adopted by the Commission in accordance with the procedure referred to in

Article 195(2) of Council Regulation (EC) No 1234/2007 i of 22 October 2007 establishing a

common organisation of agricultural markets and on specific provisions for certain agricultural

products (Single CMO Regulation) in conjunction with Article 13(1)(b) of European Parliament

and Council Regulation (EU) No 182/2011 i 2 or the relevant procedure as determined in the

applicable legislation. They may be adopted during a period of three years following the date of

accession and their application shall be limited to that period. The Council, acting unanimously on a

proposal from the Commission and after consulting the European Parliament, may extend this

period.

Transitional measures referred to in the first subparagraph may also be adopted prior to the date of

accession, if necessary. Such measures shall be adopted by the Council acting by qualified majority

on a proposal from the Commission or, where they affect instruments initially adopted by the

Commission, they shall be adopted by the Commission in accordance with the procedures required

for adopting the instruments in question.

ARTICLE 42

If transitional measures are necessary to facilitate the transition from the existing regime in Croatia

to that resulting from the application of the European Union veterinary, phytosanitary and food

safety rules, such measures shall be adopted by the Commission in accordance with the relevant

procedure as determined in the applicable legislation. These measures shall be taken during a period

of three years following the date of accession and their application shall be limited to that period.

1 OJ L 299, 16.11.2007, p. 1.

2 OJ L 55, 28.2.2011, p. 13.

ARTICLE 43

The Council, acting by a qualified majority on a proposal from the Commission, shall define the

terms under which:

(a) the requirement for an exit summary declaration may be waived for the products

referred to in Article 28(2) of the TFEU leaving Croatia to cross the territory of Bosnia

and Herzegovina at Neum ('Neum corridor');

(b) the requirement for an entry summary declaration may be waived for the products in

the situation under point (a) when they re-enter the territory of Croatia after having

crossed the territory of Bosnia and Herzegovina at Neum.

ARTICLE 44

The Commission may take all appropriate measures to ensure that the necessary statutory staff is

maintained in Croatia for a maximum of 18 months following accession. During this period,

officials, temporary staff and contract staff assigned to posts in Croatia before accession and who

are required to remain in service in Croatia after the date of accession shall benefit from the same

financial and material conditions as were applied before accession in accordance with the Staff

Regulations of officials of the European Communities and the Conditions of Employment of other

servants of the European Communities laid down in Council Regulation (EEC, Euratom, ECSC) No

259/68 1 . The administrative expenditure, including salaries for other necessary staff, shall be

covered by the general budget of the European Union.

1 OJ L 56, 4.3.1968, p. 1.

PART FIVE

PROVISIONS RELATING TO THE IMPLEMENTATION OF THIS ACT

TITLE I

ADAPTATIONS TO THE RULES OF THE INSTITUTIONS AND COMMITTEES

ARTICLE 45

The Union's institutions shall, in accordance with the respective procedures provided for in the

original Treaties, make such adaptations to their Rules of Procedure as are rendered necessary by

accession.

Adaptations to the rules of the Committees established by the original Treaties and to their Rules of

Procedure as are rendered necessary by accession shall be made as soon as possible after accession.

TITLE II

APPLICABILITY OF THE ACTS OF THE INSTITUTIONS

ARTICLE 46

Upon accession, Croatia shall be considered as being an addressee, in accordance with the original

Treaties, of directives and decisions within the meaning of Article 288 of the TFEU. Except with

regard to directives and decisions which have entered into force pursuant to the third subparagraph

of Article 297(1) and the second subparagraph of Article 297(2) of the TFEU, Croatia shall be

considered as having received notification of such directives and decisions upon accession.

ARTICLE 47

1.

Croatia shall put into effect the measures necessary for it to comply, from the date of

accession, with the provisions of directives and decisions within the meaning of Article 288 of

the TFEU, unless another time limit is provided for in this Act. Croatia shall communicate

those measures to the Commission at the latest by the date of accession or, where later, by the

time limit provided for in this Act.

2.

To the extent that amendments to directives within the meaning of Article 288 of the TFEU
introduced by this Act require modification of the laws, regulations or administrative

provisions of the present Member States, the present Member States shall put into effect the

measures necessary to comply, from the date of accession of Croatia, with the amended

directives, unless another time limit is provided for in this Act. They shall communicate those

measures to the Commission by the date of accession or, where later, by the time limit

provided for in this Act.

ARTICLE 48

Provisions laid down by legislation, regulation or administrative action designed to ensure the

protection of the health of workers and the general public in the territory of Croatia against the

dangers arising from ionising radiations shall, in accordance with Article 33 of the EAEC Treaty, be

communicated by Croatia to the Commission within three months of accession.

ARTICLE 49

At the duly substantiated request of Croatia submitted to the Commission no later than the date of

accession, the Council acting on a proposal from the Commission, or the Commission, if the

original act was adopted by the Commission, may take measures consisting of temporary

derogations from acts adopted by the institutions between 1 July 2011 and the date of accession.

The measures shall be adopted according to the voting rules governing the adoption of the act from

which a temporary derogation is sought. Where these derogations are adopted after accession they

may be applied as from the date of accession.

ARTICLE 50

Where acts of the institutions adopted prior to accession require adaptation by reason of accession,

and the necessary adaptations have not been provided for in this Act or its Annexes, the Council,

acting by a qualified majority on a proposal from the Commission, or the Commission, if the

original act was adopted by the Commission, shall to this end adopt the necessary acts. Where

these adaptations are adopted after accession they may be applied as from the date of accession.

ARTICLE 51

Unless otherwise stipulated in this Act, the Council, acting by a qualified majority on a proposal

from the Commission, shall adopt the necessary measures to implement the provisions of this Act.

ARTICLE 52

The texts of the acts of the institutions adopted before accession and drawn up by these institutions

in the Croatian language shall, from the date of accession, be authentic under the same conditions as

the texts drawn up in the present official languages. They shall be published in the Official Journal

of the European Union if the texts in the present languages were so published.

TITLE III

FINAL PROVISIONS

ARTICLE 53

Annexes I to IX, the Appendices thereto and the Protocol shall form an integral part of this Act.

ARTICLE 54

The Government of the Italian Republic shall remit to the Government of the Republic of Croatia a

certified copy of the Treaty on European Union, the Treaty on the Functioning of the European

Union and the Treaty establishing the European Atomic Energy Community, and the Treaties

amending or supplementing them, including the Treaty concerning the accession of the Kingdom of

Denmark, Ireland and the United Kingdom of Great Britain and Northern Ireland, the Treaty

concerning the accession of the Hellenic Republic, the Treaty concerning the accession of the

Kingdom of Spain and the Portuguese Republic, the Treaty concerning the accession of the

Republic of Austria, the Republic of Finland and the Kingdom of Sweden, the Treaty concerning

the accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic

of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic

of Poland, the Republic of Slovenia and the Slovak Republic and the Treaty concerning the

accession of the Republic of Bulgaria and Romania, in the Bulgarian, Czech, Danish, Dutch,

English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian,

Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish and Swedish languages.

The texts of those Treaties, drawn up in the Croatian language, shall be annexed to this Act. Those

texts shall be authentic under the same conditions as the texts of the Treaties referred to in the first

paragraph, drawn up in the present languages.

ARTICLE 55

A certified copy of the international agreements deposited in the archives of the General Secretariat

of the Council of the European Union shall be remitted to the Government of the Republic of

Croatia by the Secretary General.

__________________

A EX I

List of conventions and protocols to which the Republic of Croatia accedes

upon accession (referred to in Article 3(4) of the Act of Accession)

1.

Convention of 23 July 1990 on the elimination of double taxation in connection with the
adjustment of profits of associated enterprises (OJ L 225, 20.8.1990, p. 10)

– Convention of 21 December 1995 on the accession of the Republic of Austria, the

Republic of Finland and the Kingdom of Sweden to the Convention on the elimination

of double taxation in connection with the adjustment of profits of associated enterprises

(OJ C 26, 31.1.1996, p. 1)

– Protocol of 25 May 1999 amending the Convention of 23 July 1990 on the elimination

of double taxation in connection with the adjustment of profits of associated enterprises

(OJ C 202, 16.7.1999, p. 1)

– Convention of 8 December 2004 on the accession of the Czech Republic, the Republic

of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania,

the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic

of Slovenia and the Slovak Republic to the Convention on the elimination of double

taxation in connection with the adjustment of profits of associated enterprises (OJ C

160, 30.6.2005, p. 1)

2.

Convention of 26 July 1995, drawn up on the basis of Article K.3 of the Treaty on
European Union, on the protection of the European Communities' financial interests

(OJ C 316, 27.11.1995, p. 49)

– Protocol of 27 September 1996, drawn up on the basis of Article K.3 of the Treaty on

European Union, to the Convention on the protection of the European Communities'

financial interests (OJ C 313, 23.10.1996, p. 2)

– Protocol of 29 November 1996, drawn up on the basis of Article K.3 of the Treaty on

European Union, on the interpretation, by way of preliminary rulings, by the Court of

Justice of the European Communities of the Convention on the protection of the

European Communities' financial interests (OJ C 151, 20.5.1997, p. 2)

– Second Protocol of 19 June 1997, drawn up on the basis of Article K.3 of the Treaty on

European Union, to the Convention on the protection of the European Communities'

financial interests (OJ C 221, 19.7.1997, p. 12)

3.

Convention of 26 May 1997, drawn up on the basis of Article K.3(2)(c) of the Treaty on
European Union, on the fight against corruption involving officials of the European

Communities or officials of Member States of the European Union (OJ C 195, 25.6.1997,

p.

2)

4.

Convention of 18 December 1997, drawn up on the basis of Article K.3 of the Treaty on

European Union, on mutual assistance and cooperation between customs administrations

(OJ C 24, 23.1.1998, p. 2)

5.

Convention of 17 June 1998, drawn up on the basis of Article K.3 of the Treaty on
European Union, on driving disqualifications (OJ C 216, 10.7.1998, p. 2)

6.

Convention of 29 May 2000, established by the Council in accordance with Article 34 of

the Treaty on European Union, on Mutual Assistance in Criminal Matters between the

Member States of the European Union (OJ C 197, 12.7.2000, p. 3)

– Protocol of 16 October 2001, established by the Council in accordance with Article 34

of the Treaty on European Union, to the Convention on Mutual Assistance in Criminal

Matters between the Member States of the European Union (OJ C 326, 21.11.2001,

p.

2)

________________

A EX II

List of provisions of the Schengen acquis as integrated into the framework of the European

Union and the acts building upon it or otherwise related to it, to be binding on and applicable

in the Republic of Croatia as from accession (referred to in Article 4(1) of the Act of

Accession)

1.

The Agreement between the Governments of the States of the Benelux Economic Union, the

Federal Republic of Germany and the French Republic on the gradual abolition of checks at

their common borders dated 14 June 1985 1 .

2.

The following provisions of the Convention signed in Schengen on 19 June 1990
implementing the Schengen Agreement of 14 June 1985 on the gradual abolition of checks at

their common borders, its related Final Act and Joint Declarations 2 , as amended by certain of

the acts listed in paragraph 8 below:

Article 1 to the extent that it relates to the provisions of this paragraph; Article 26; Article 39;

Articles 44 to 49 (with the exception of Article 47(4) and Article 49(a)), Article 51, Articles

54 to 58; Article 62(3); Articles 67 to 69; Articles 71 and 72; Articles 75 and 76; Article 82;

Article 91; Articles 126 to 130 to the extent that they relate to the provisions of this paragraph;

and Article 136; Joint Declarations 1 and 3 of the Final Act.

3.

The following provisions of the Agreements on Accession to the Convention signed in

Schengen on 19 June 1990 implementing the Schengen Agreement of 14 June 1985 on the

gradual abolition of checks at their common borders, their Final Acts and the related

Declarations, as amended by certain of the acts listed in paragraph 8 below:

1 OJ L 239, 22.9.2000, p. 13.

14509/1/11 REV 1 WS/jj 67 (a) the Agreement signed on 19 December 1996 on the Accession of the Kingdom of Denmark:

– Articles 5(2) and 6,

(b) the Agreement signed on 19 December 1996 on the Accession of the Republic of Finland:

– Article 5,

– Declaration by the Government of the Republic of Finland on the Åland islands in

Part III of the Final Act;

– Article 5.

4.

The following agreements and arrangements which build upon the Schengen acquis or
otherwise relate to it:

– the Agreement of 18 May 1999 concluded by the Council of the European Union and the

Republic of Iceland and the Kingdom of Norway concerning the latters' association with the

implementation, application and development of the Schengen acquis, including the Annexes,

its Final Act, Declarations and the Exchanges of Letters annexed thereto, approved by

Council Decision 1999/439/EC (OJ L 176, 10.7.1999, p. 35)

– the Agreement of 30 June 1999 concluded by the Council of the European Union and the

Republic of Iceland and the Kingdom of Norway on the establishment of rights and

obligations between Ireland and the United Kingdom of Great Britain and Northern Ireland,

on the one hand, and the Republic of Iceland and the Kingdom of Norway, on the other, in

areas of the Schengen acquis which apply to these States, approved by Council Decision

2000/29/EC (OJ L 15, 20.1.2000, p. 1)

– the Agreement between the European Union, the European Community and the Swiss

Confederation on the Swiss Confederation's association with the implementation, application

and development of the Schengen acquis signed on 26 October 2004 and approved by

Council Decision 2008/146/EC i and Council Decision 2008/149 i/JHA (OJ L 53, 27.2.2008, p.

1 and p. 50)

– the Protocol between the European Union, the European Community, the Swiss

Confederation and the Principality of Liechtenstein on the accession of the Principality of

Liechtenstein to the Agreement between the European Union, the European Community and

the Swiss Confederation on the Swiss Confederation's association with the implementation,

application and development of the Schengen acquis signed on 28 February 2008 1

– the Arrangement between the European Community and the Republic of Iceland and the

Kingdom of Norway on the modalities of the participation by those States in the European

Agency for the Management of Operational Cooperation at the External Borders of the

Member States of the European Union, including the Joint Declaration annexed thereto,

signed on 1 February 2007 and approved by Council Decision 2007/511/EC i (OJ L 188,

20.7.2007, p. 15)

– the Arrangement between the European Community, of the one part, and the Swiss

Confederation and the Principality of Liechtenstein, of the other part, on the modalities of the

participation by those States in the European Agency for the Management of Operational

Cooperation at the External Borders of the Member States of the European Union, including

the Annex and Joint Declarations annexed thereto, signed on 30 September 2009 and

approved by Council Decision 2010/490/EU (OJ L 243, 16.9.2010, p. 2)

1 As long as this Protocol is not yet concluded, insofar as it applies only provisionally. Council

Decisions on the signature have been published in OJ L 83 of 26.3.2008, p.3 and p.5.

– the Agreement between the European Community and the Republic of Iceland, the Kingdom

of Norway, the Swiss Confederation and the Principality of Liechtenstein on supplementary

rules in relation to the External Borders Fund for the period 2007 to 2013, including the

Declarations annexed thereto, signed on 19 March 2010 and provisionally applied pursuant to

Council Decision 2010/374/EC (OJ L 169, 3.7.2010, p. 22) 1 .

5.

The provisions of the following Decisions of the Executive Committee established by the

Convention signed in Schengen on 19 June 1990 implementing the Schengen Agreement of

14 June 1985 on the gradual abolition of checks at their common borders, as amended by

certain of the acts listed in paragraph 8 below:

SCH/Com-ex (93) 10 Decision of the Executive Committee of 14 December 1993 concerning

the declarations by the Ministers and State Secretaries

SCH/Com-ex (93) 14 Decision of the Executive Committee of 14 December 1993 on

improving practical judicial cooperation for combating drug trafficking

SCH/Com-ex (94) 16 rev Decision of the Executive Committee of 21 November 1994 on the

acquisition of common entry and exit stamps

SCH/Com-ex (94) 28 rev Decision of the Executive Committee of 22 December 1994 on the

certificate provided for in Article 75 to carry narcotic drugs and psychotropic substances

SCH/Com-ex (94) 29 rev 2 Decision of the Executive Committee of 22 December 1994 on

bringing into force the Convention implementing the Schengen Agreement of 19 June 1990

SCH/Com-ex (95) 21 Decision of the Executive Committee of 20 December 1995 on the swift

exchange between the Schengen States of statistical and specific data on possible

malfunctions at the external borders

14509/1/11 REV 1 WS/jj 70

SCH/Com-ex (98) 1 rev 2 Decision of the Executive Committee of 21 April 1998 on the

activities of the Task Force, insofar as it relates to the provisions in paragraph 2 above

SCH/Com-ex (98) 26 def Decision of the Executive Committee of 16 September 1998 setting

up a Standing Committee on the evaluation and implementation of Schengen

SCH/Com-ex (98) 37 def 2 Decision of the Executive Committee of 27 October 1998 on the

adoption of measures to fight illegal immigration, insofar as it relates to the provisions in

paragraph 2 above

SCH/Com-ex (98) 52 Decision of the Executive Committee of 16 December 1998 on the

Handbook on cross-border police-cooperation, insofar as it relates to the provisions in

paragraph 2 above

SCH/Com-ex (98) 59 rev Decision of the Executive Committee of 16 December 1998 on

coordinated deployment of document advisers

SCH/Com-ex (99) 1 rev 2 Decision of the Executive Committee of 28 April 1999 on the drugs

situation

SCH/Com-ex (99) 6 Decision of the Executive Committee of 28 April 1999 on the Schengen

acquis relating to telecommunications

SCH/Com-ex (99) 7 rev 2 Decision of the Executive Committee of 28 April 1999 on liaison

officers

SCH/Com-ex (99) 8 rev 2 Decision of the Executive Committee of 28 April 1999 on general

principles governing the payment of informers

SCH/Com-ex (99) 10 Decision of the Executive Committee of 28 April 1999 on the illegal

trade in firearms.

6.

The following Declarations of the Executive Committee established by the Convention signed
in Schengen on 19 June 1990 implementing the Schengen Agreement of 14 June 1985 on the

gradual abolition of checks at their common borders, to the extent that they relate to the

provisions in paragraph 2 above:

SCH/Com-ex (96) decl 6 rev 2 Declaration of the Executive Committee of 26 June 1996 on

extradition

SCH/Com-ex (97) decl 13 rev 2 Declaration of the Executive Committee of 9 February 1998

on the abduction of minors.

7.

The following Decisions of the Central Group established by the Convention signed in

Schengen on 19 June 1990 implementing the Schengen Agreement of 14 June 1985 on the

gradual abolition of checks at their common borders, to the extent that they relate to the

provisions in paragraph 2 above:

SCH/C (98) 117 Decision of the Central Group of 27 October 1998 on the adoption of

measures to fight illegal immigration

SCH/C (99) 25 Decision of the Central Group of 22 March 1999 on general principles

governing the payment of informers.

8.

The following acts which build upon the Schengen acquis or otherwise relate to it:

Council Regulation (EC) No 1683/95 i of 29 May 1995 laying down a uniform format for visas

(OJ L 164, 14.7.1995, p. 1)

Council Decision 1999/307/EC of 1 May 1999 laying down the detailed arrangements for the

integration of the Schengen Secretariat into the General Secretariat of the Council

(OJ L 119, 7.5.1999, p. 49) Council Decision 1999/435/EC of 20 May 1999 concerning the definition of the Schengen

acquis for the purpose of determining, in conformity with the relevant provisions of the Treaty

establishing the European Community and the Treaty on European Union, the legal basis for

each of the provisions or decisions which constitute the acquis (OJ L 176, 10.7.1999, p. 1)

Council Decision 1999/436/EC of 20 May 1999 determining, in conformity with the relevant

provisions of the Treaty establishing the European Community and the Treaty on European

Union, the legal basis for each of the provisions or decisions which constitute the Schengen

acquis (OJ L 176, 10.7.1999, p. 17)

Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of

the Agreement concluded by the Council of the European Union and the Republic of Iceland

and the Kingdom of Norway concerning the association of those two states with the

implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999,

p.

31)

Council Decision 1999/848/EC of 13 December 1999 on the full application of the Schengen

acquis in Greece (OJ L 327, 21.12.1999, p. 58)

Council Decision 2000/365/EC of 29 May 2000 concerning the request of the

United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions

of the Schengen acquis (OJ L 131, 1.6.2000, p. 43)

Council Decision 2000/586/JHA of 28 September 2000 establishing a procedure for amending

Articles 40(4) and (5), 41(7) and 65(2) of the Convention implementing the Schengen

Agreement of 14 June 1985 on the gradual abolition of checks at common borders (OJ L 248,

3.10.2000, p. 1)

Council Decision 2000/777/EC of 1 December 2000 on the application of the Schengen

acquis in Denmark, Finland and Sweden, and in Iceland and Norway (OJ L 309, 9.12.2000,

p.

24)

Council Regulation (EC) No 539/2001 i of 15 March 2001 listing the third countries whose

nationals must be in possession of visas when crossing the external borders and those whose

nationals are exempt from that requirement (OJ L 81, 21.3.2001, p. 1)

Council Directive 2001/51/EC i of 28 June 2001 supplementing the provisions of Article 26 of

the Convention implementing the Schengen Agreement of 14 June 1985 (OJ L 187,

10.7.2001, p. 45)

Council Regulation (EC) No 333/2002 i of 18 February 2002 on a uniform format for forms for

affixing the visa issued by Member States to persons holding travel documents not recognised

by the Member State drawing up the form (OJ L 53, 23.2.2002, p. 4)

Council Decision 2002/192/EC of 28 February 2002 concerning Ireland's request to take part

in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20)

Council Regulation (EC) No 1030/2002 i of 13 June 2002 laying down a uniform format for

residence permits for third-country nationals (OJ L 157, 15.6.2002, p. 1)

Council Framework Decision 2002/946/JHA of 28 November 2002 on the strengthening of

the penal framework to prevent the facilitation of unauthorised entry, transit and residence

(OJ L 328, 5.12.2002, p. 1)

Council Directive 2002/90/EC i of 28 November 2002 defining the facilitation of unauthorised

entry, transit and residence (OJ L 328, 5.12.2002, p. 17)

Council Decision 2003/170 i/JHA of 27 February 2003 on the common use of liaison officers

posted abroad by the law enforcement agencies of the Member States (OJ L 67, 12.3.2003, p.

27)

Council Decision 2003/725/JHA of 2 October 2003 amending the provisions of Article 40(1)

and (7) of the Convention implementing the Schengen Agreement of 14 June 1985 on the

gradual abolition of checks at common borders (OJ L 260, 11.10.2003, p. 37)

Council Directive 2003/110/EC i of 25 November 2003 on assistance in cases of transit for the

purposes of removal by air (OJ L 321, 6.12.2003, p. 26)

Council Regulation (EC) No 377/2004 i of 19 February 2004 on the creation of an immigration

liaison officers network (OJ L 64, 2.3.2004, p. 1)

Council Directive 2004/82/EC i of 29 April 2004 on the obligation of carriers to communicate

passenger data (OJ L 261, 6.8.2004, p. 24)

Council Decision 2004/573/EC i of 29 April 2004 on the organisation of joint flights for

removals from the territory of two or more Member States, of third-country nationals who are

subjects of individual removal orders (OJ L 261, 6.8.2004, p. 28)

Council Decision 2004/512/EC i of 8 June 2004 establishing the Visa Information System

(VIS) (OJ L 213, 15.6.2004, p. 5 and OJ L 142M, 30.5.2006, p. 60)

Council Regulation (EC) No 2007/2004 i of 26 October 2004 establishing a European Agency

for the Management of Operational Cooperation at the External Borders of the Member States

of the European Union (OJ L 349, 25.11.2004, p. 1 and OJ L 153M, 7.6.2006, p. 136)

Council Regulation (EC) No 2252/2004 i of 13 December 2004 on standards for security

features and biometrics in passports and travel documents issued by Member States

(OJ L 385, 29.12.2004, p. 1 and OJ L 153M, 7.6.2006, p. 375)

Council Decision 2004/926/EC of 22 December 2004 on the putting into effect of parts of the

Schengen acquis by the United Kingdom of Great Britain and Northern Ireland (OJ L 395,

31.12.2004, p. 70)

Council Decision 2005/267/EC i of 16 March 2005 establishing a secure web-based

Information and Coordination Network for Member States’ Migration Management Services

(OJ L 83,1.4.2005, p. 48 and OJ L 159M, 13.6.2006, p. 288)

Regulation (EC) No 562/2006 i of the European Parliament and of the Council of 15 March

2006 establishing a Community Code on the rules governing the movement of persons across

borders (Schengen Borders Code) (OJ L 105, 13.4.2006, p.1), except the first sentence of

Article 1, Article 5(4)(a), Title III and the provisions of Title II and the annexes thereto

referring to the Schengen Information System (SIS)

Council Framework Decision 2006/960/JHA of 18 December 2006 on simplifying the

exchange of information and intelligence between law enforcement authorities of the Member

States of the European Union (OJ L 386, 29.12.2006, p. 89)

Regulation (EC) No 1931/2006 i of the European Parliament and of the Council of 20

December 2006 laying down rules on local border traffic at the external land borders of the

Member States and amending the provisions of the Schengen Convention (OJ L 405,

30.12.2006, p. 1), except Articles 4 (b) and 9 (c)

Council Decision 2007/471/EC of 12 June 2007 on the application of the provisions of the

Schengen acquis relating to the Schengen Information System in the Czech Republic, the

Republic of Estonia, the Republic of Latvia, the Republic of Lithuania, the Republic of

Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the

Slovak Republic (OJ L 179, 7.7.2007, p. 46)

Regulation (EC) No 863/2007 i of the European Parliament and of the Council of 11 July 2007

establishing a mechanism for the creation of Rapid Border Intervention Teams and amending

Council Regulation (EC) No 2007/2004 i as regards that mechanism and regulating the tasks

and powers of guest officers (OJ L 199, 31.7.2007, p. 30), except the provisions of Article

6(8) and (9) to the extent that they refer to access being given to the Schengen Information

System

Council Decision 2007/801/EC of 6 December 2007 on the full application of the provisions

of the Schengen acquis in the Czech Republic, the Republic of Estonia, the Republic of

Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the

Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 323, 8.12.2007,

p.

34)

Council Decision 2008/421/EC of 5 June 2008 on the application of the provisions of the

Schengen acquis relating to the Schengen Information System in the Swiss Confederation (OJ

L 149, 7.6.2008, p. 74)

Article 6 of Council Decision 2008/633 i/JHA of 23 June 2008 concerning access for

consultation of the Visa Information System (VIS) by designated authorities of Member States

and by Europol for the purposes of the prevention, detection and investigation of terrorist

offences and of other serious criminal offences (OJ L 218, 13.8.2008, p. 129)

Council Decision 2008/903/EC of 27 November 2008 on the full application of the provisions of

the Schengen acquis in the Swiss Confederation (OJ L 327, 5.12.2008, p. 15)

Council Framework Decision 2008/977/JHA of 27 November 2008 on the protection of

personal data processed in the framework of police and judicial cooperation in criminal

matters (OJ L 350, 30.12.2008, p. 60)

Directive 2008/115/EC i of the European Parliament and of the Council of 16 December 2008

on common standards and procedures in Member States for returning illegally staying thirdcountry

nationals (OJ L 348, 24.12.2008, p. 98)

Article 3 of Regulation (EC) No 810/2009 i of the European Parliament and of the Council of

p.

1)

14509/1/11 REV 1 WS/jj 77

Council Decision 2010/252/EU of 26 April 2010 supplementing the Schengen Borders Code

as regards the surveillance of the sea external borders in the context of operational cooperation

coordinated by the European Agency for the Management of Operational Cooperation at the

External Borders of the Member States of the European Union (OJ L 111, 4.5.2010, p. 20)

Council Decision 2010/365/EU of 29 June 2010 on the application of the provisions of the

Schengen acquis relating to the Schengen Information System in the Republic of Bulgaria and

Romania (OJ L 166, 1.7.2010, p. 17).

____________________

A EX III

List referred to in Article 15 of the Act of Accession: adaptations to acts adopted by the

institutions

1.

FREEDOM TO PROVIDE SERVICES

32005 L 0036: Directive 2005/36/EC i of the European Parliament and of the Council of 7

September 2005 on the recognition of professional qualifications (OJ L 255, 30.9.2005, p. 22).

(a) Article 23(5) is replaced by the following:

'5. Without prejudice to Article 43(b), each Member State shall recognise evidence of formal

qualifications as doctor giving access to the professional activities of doctor with basic

training and specialised doctor, as nurse responsible for general care, as dental practitioner, as

specialised dental practitioner, as veterinary surgeon, as midwife, as pharmacist and as

architect held by nationals of the Member States and issued by the former Yugoslavia, or

whose training commenced,

(a) for Slovenia, before 25 June 1991, and

(b) for Croatia, before 8 October 1991,

where the authorities of the aforementioned Member States attest that such evidence has the

same legal validity within their territory as the evidence which they issue and, with respect to

architects, as the evidence of formal qualifications specified for those Member States in

Annex VI, point 6, as regards access to the professional activities of doctor with basic

training, specialised doctor, nurse responsible for general care, dental practitioner, specialised

dental practitioner, veterinary surgeon, midwife, pharmacist with respect to the activities

referred to in Article 45(2), and architect with respect to the activities referred to in Article 48,

and the pursuit of such activities.

Such an attestation must be accompanied by a certificate issued by those same authorities

stating that such persons have effectively and lawfully been engaged in the activities in

question within their territory for at least three consecutive years during the five years prior to

the date of issue of the certificate.'

(b) The following Article is inserted:

'Article 43(b)

Acquired rights in midwifery shall not apply to the following qualifications which were

obtained in Croatia before 1 July 2013: viša medicinska sestra ginekološko- opstetričkog

smjera (High Gynaecology-Obstetrical Nurse), medicinska sestra ginekološko-opstetričkog

smjera ( Gynaecology-Obstetrical Nurse), viša medicinska sestra primaljskog smjera (High

Nurse with Midwifery Degree) , medicinska sestra primaljskog smjera (Nurse with Midwifery

Degree), ginekološko-opstetrička primalja (Gynaecology-Obstetrical Midwife) and primalja

(Midwife).'

2.

INTELLECTUAL PROPERTY LAW

I. COMMUNITY TRADE MARK

32009 R 0207: Council Regulation (EC) No 207/2009 i of 27 February 2009 on the Community trade

mark (OJ L 78, 24.3.2009, p. 1).

Article 165(1) is replaced by the following:

'1. As from the date of accession of Bulgaria, the Czech Republic, Estonia, Croatia, Cyprus,

Latvia, Lithuania, Hungary, Malta, Poland, Romania, Slovenia and Slovakia (hereinafter

referred to as "new Member State(s)"), a Community trade mark registered or applied for

pursuant to this Regulation before the respective dates of accession shall be extended to the

territory of those Member States in order to have equal effect throughout the Community.'

II. SUPPLEMENTARY PROTECTION CERTIFICATES

1.

31996 R 1610: Regulation (EC) No 1610/96 i of the European Parliament and of the Council of

23 July 1996 concerning the creation of a supplementary protection certificate for plant

protection products (OJ L 198, 8.8.1996, p. 30).

(a) The following point is added to Article 19a:

'(m) any plant protection product protected by a valid basic patent and for which the first

authorisation to place it on the market as a plant protection product was obtained after

1 January 2003 may be granted a certificate in Croatia, provided that the application for

a certificate is lodged within six months of the date of accession.'

(b) Article 20(2) is replaced by the following:

'2. This Regulation shall apply to supplementary protection certificates granted in accordance

with the national legislation of the Czech Republic, Estonia, Croatia, Cyprus, Latvia,

Lithuania, Malta, Poland, Romania, Slovenia and Slovakia prior to their respective date of

accession.'

2.

32009 R 0469: Regulation (EC) No 469/2009 i of the European Parliament and of the

Council of 6 May 2009 concerning the supplementary protection certificate for medicinal

products (OJ L 152, 16.6.2009, p. 1).

(a) The following point is added to Article 20:

'(m) any medicinal product protected by a valid basic patent and for which the first

authorisation to place it on the market as a medicinal product was obtained after 1

January 2003 may be granted a certificate in Croatia, provided that the application for a

certificate is lodged within six months of the date of accession.'

(b) Article 21(2) is replaced by the following:

'2. This Regulation shall apply to supplementary protection certificates granted in accordance

with the national legislation of the Czech Republic, Estonia, Croatia, Cyprus, Latvia,

Lithuania, Malta, Poland, Romania, Slovenia and Slovakia prior to their respective date of

accession.'

III. COMMUNITY DESIGNS

32002 R 0006: Council Regulation (EC) No 6/2002 i of 12 December 2001 on Community designs

(OJ L 3, 5.1.2002, p. 1).

Article 110a(1) is replaced by the following:

'1. As from the date of accession of Bulgaria, the Czech Republic, Estonia, Croatia, Cyprus,

Latvia, Lithuania, Hungary, Malta, Poland, Romania, Slovenia and Slovakia (hereinafter referred to

as "new Member State(s)"), a Community design protected or applied for pursuant to this

Regulation before the respective date of accession shall be extended to the territory of those

Member States in order to have equal effect throughout the Community.'

3.

FINANCIAL SERVICES

32006 L 0048: Directive 2006/48/EC i of the European Parliament and of the Council of 14 June

2006 relating to the taking up and pursuit of the business of credit institutions (OJ L 177, 30.6.2006,

p.

1).

In Article 2, the following is inserted after the entry for France:

'– in Croatia, the 'kreditne unije' and the 'Hrvatska banka za obnovu i razvitak','

4.

AGRICULTURE

1.

31991 R 1601: Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general

rules on the definition, description and presentation of aromatized wines, aromatized winebased

drinks and aromatized wine-product cocktails (OJ L 149, 14.6.1991, p. 1).

In Annex II, the following is inserted after the geographical designation "Nürnberger

Glühwein":

'Samoborski bermet'

2.

32007 R 1234: Council Regulation (EC) No 1234/2007 i of 22 October 2007 establishing a
common organisation of agricultural markets and on specific provisions for certain

agricultural products (Single CMO Regulation) (OJ L 299, 16.11.2007, p. 1).

(a) In Article 66, the following paragraph is inserted:

'4a. For Croatia a special restructuring reserve shall be established as set out in point 2 of

Annex IX. This reserve shall be released as from 1 April of the first quota year after accession

to the extent that the on-farm consumption of milk and milk products in Croatia has decreased

in the period 2008-2012.

The decision on releasing the reserve and of its distribution to the deliveries and direct sales

quota shall be taken by the Commission in accordance with the procedure referred to in

Article 195(2) on the basis of an assessment of a report to be submitted by Croatia by 31

December 2013. This report shall detail the results and trends of the actual restructuring

process in Croatia's dairy sector, and in particular the shift from production for on-farm

consumption to production for the market.'

(b) In Article 103k(1), the following subparagraph is added:

'This paragraph shall not apply to Croatia for the financial year 2013. Croatia shall submit to

the Commission a draft five-year support programme for the 2014-2018 programme period.'

'13. "full-time refiner" means a production unit:

– of which the sole activity consists of refining imported raw cane sugar,

– which refined in the marketing year 2004/2005 a quantity of at least 15 000 tonnes of

imported raw cane sugar. For the purpose of this indent, in the case of Croatia the

marketing year shall be that of 2007/2008.'

(d) Annex VI is replaced by the following:

'ANNEX VI

NATIONAL AND REGIONAL QUOTAS

from the 2010/2011 marketing year onwards

(in tonnes)

Member States or

regions Sugar Isoglucose Inulin syrup

(1) (2) (3) (4)

Belgium 676 235,0 114 580, 2 0

Bulgaria 0 89 198,0

Czech Republic 372 459,3

Denmark 372 383,0

Germany 2 898 255,7 56 638,2

Ireland 0

Greece 158 702,0 0

Spain 498 480,2 53 810,2

France 3 004 811, 15

(metropolitan) 0

French overseas 432 220, 05

departments

Croatia 192 877,0

Italy 508 379,0 32 492,5

Latvia 0

Lithuania 90 252,0

Hungary 105 420,0 220 265,8

Netherlands 804 888,0 0 0

Austria 351 027,4

Poland 1 405 608,1 42 861,4

Portugal 0 12 500,0

(mainland)

Autonomous 9 953,0

Region of the

Azores

Romania 104 688,8 0

Slovenia 0

Slovakia 112 319,5 68 094,5

Finland 80 999,0 0

Sweden 293 186,0

United Kingdom 1 056 474,0 0

TOTAL 13 529 618,20 690 440,8 0

(e) In Annex IX, point 1, the following is inserted after the entry for France in the columns

relating to the production years 2013/14 and 2014/15:

Member 2008/09 2009/10 2010/11 2011/12 2012/13 2013/14 2014/15

State

Croatia 765 000 765 000

(f) In Annex IX, point 2, the table is replaced by the following:

Member State Tonnes

Bulgaria 39 180

Croatia 15 000

Romania 188 400

(g) In Annex X, the following is inserted after the entry for France:

Croatia 40,70

(h) In Annex Xb, the following table is added:

' in 1 000 EUR

Budget 2013 2014 2015 2016 from

year 2017

onwards

14509/1/11 REV 1 WS/jj 86 (i) In paragraph 2 of the Appendix to Annex XIb, the following point is added:

'(h) in Croatia, the areas planted with vines in the following sub-regions: Moslavina,

Prigorje-Bilogora, Plešivica, Pokuplje and Zagorje-Međimurje.'

(j) In paragraph 3 of the Appendix to Annex XIb, the following point is added:

'(h) in Croatia, areas planted with vines in the following sub-regions: Hrvatsko Podunavlje

and Slavonija.'

(k) In paragraph 4 of the Appendix to Annex XIb, the following point is added:

'(g) in Croatia, areas planted with vines in the following sub-regions: Hrvatska Istra,

Hrvatsko primorje, Dalmatinska zagora, Sjeverna Dalmacija and Srednja i Južna Dalmacija.'

3.

32008 R 0110: Regulation (EC) No 110/2008 i of the European Parliament and of the Council
of 15 January 2008 on the definition, description, presentation, labelling and the protection of

geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89 i

(OJ L 39, 13.2.2008, p. 16).

(a) In Article 20, the following paragraph is added:

'4. The deadline referred to in paragraph 1 for submission of technical files shall also apply

to the geographical indications of Croatia listed in Annex III.'

(b) In Annex III, point 9, the following geographical indications are added:

Hrvatska loza Croatia

Hrvatska stara šljivovica Croatia

Slavonska šljivovica Croatia

Hrvatski pelinkovac Croatia

(d) In Annex III, the following point is inserted:

39.

Maraschino/ Zadarski maraschino Croatia

Marrasquino/

Maraskino

(e) In Annex III, under product category "Other spirit drinks", the following geographical

indication is added:

Hrvatska travarica Croatia

4.

32009 R 0073: Council Regulation (EC) No 73/2009 i of 19 January 2009 establishing

common rules for direct support schemes for farmers under the common agricultural policy

and establishing certain support schemes for farmers, amending Regulations (EC)

No 1290/2005, (EC) No 247/2006, (EC) No 378/2007 and repealing Regulation (EC) No

1782/2003 (OJ L 30, 31.1.2009, p. 16).

(a) Article 2(g) is replaced by the following:

'(g) "new Member States" means Bulgaria, the Czech Republic, Estonia, Croatia, Cyprus,

Latvia, Lithuania, Hungary, Malta, Poland, Romania, Slovenia and Slovakia;'

(b) In Article 6(2), the first subparagraph is replaced by the following:

'2. The Member States other than the new Member States shall ensure that land which was

under permanent pasture at the date provided for the area aid applications for 2003 is

maintained under permanent pasture. The new Member States other than Bulgaria, Croatia

and Romania shall ensure that land which was under permanent pasture on 1 May 2004 is

maintained under permanent pasture. Bulgaria and Romania shall ensure that land which was

under permanent pasture on 1 January 2007 is maintained under permanent pasture. Croatia

shall ensure that land which was under permanent pasture on 1 July 2013 is maintained under

permanent pasture.'

'(iv) pursuant to Article 47(2), Article 57a, Article 59, the third subparagraph of Article 64(2),

Article 65 and Article 68(4)(c).'

(d) In Article 51(1), the following subparagraph is added:

'Croatia may decide to make use of the options provided for in Article 52 and Article 53(1) of

this Regulation. This decision shall be notified to the Commission by 15 July 2013.'

(e) In Article 51(2), the following subparagraph is added:

'By way of derogation from the second subparagraph, in the case of Croatia, this ceiling is

determined on the basis of the national ceilings set out in Articles 104(4) and 112(5) of this

Regulation as regards respectively sheepmeat and goatmeat payments and beef and veal

payments referred to in Articles 52 and 53, taking into account the schedule of introduction of

direct payments laid down in Article 121.'

(f) In Article 52, the following subparagraph is inserted after the first subparagraph:

'By way of derogation from the first subparagraph, Croatia may retain up to 50 % of the

amount resulting from the ceiling referred to in the third subparagraph of Article 51(2) in

order to make, on a yearly basis, an additional payment to farmers.'

(g) In Article 53(1), the following subparagraph is inserted after the first subparagraph:

'By way of derogation from the first subparagraph, Croatia may retain all or part of the

amount resulting from the ceiling referred to in the third subparagraph of Article 51(2) in

order to make, on a yearly basis, an additional payment to farmers.'

(h) The title of Chapter 3 is replaced by the following:

'Implementation in the new Member States having applied the single area payment scheme

and in Croatia'

(i) The title of Article 55 is replaced by the following:

'Introduction of the single payment scheme in the Members States having applied the single

area payment scheme and in Croatia'

(j) In Article 55(1), the first subparagraph is replaced by the following:

'1. Save as otherwise provided for in this Chapter, this Title shall apply to the new Member

States having applied the single area payment scheme provided for in Chapter 2 of Title V

and to Croatia.'

(k) In Article 57(1), the following sentence is added:

'For Croatia this reduction shall not be higher than 20 % of the annual ceiling as indicated in

table 3 of Annex VIII.'

(l) In Article 57(3), the following sentence is added:

'In Croatia, the use of the national reserve shall be subject to authorisation by the Commission

by means of an implementing act without the assistance of the Committee referred to in

Article 141. The Commission shall examine, in particular, the establishment of any national

direct payment scheme applicable prior to the date of accession and the conditions under

which it applied. The request to authorise the national reserve shall be sent by Croatia to the

Commission by 15 July 2013.'

(m) The following Article is inserted:

'Article 57a

Special national de-mining reserve in Croatia

1.

Croatia shall create a special national de-mining reserve which shall be used for the
purpose of allocating, during a period of ten years after accession and in accordance

with objective criteria and in such a way as to ensure equal treatment between farmers

and to avoid market and competition distortions, payment entitlements to farmers with

de-mined land returning to use for agricultural activities.

2.
Land eligible for allocation of payment entitlements under this Article shall not be
eligible for allocation of payment entitlements under Articles 59 and 61.
- 3.
  
  The value of the payment entitlements established under this Article shall not be higher
  than the value of the payment entitlements established in accordance with Articles 59
  
  and 61, respectively.
- 4.
  
  The maximum amount allocated to the special national de-mining reserve shall be EUR
  in Article 121. The maximum amounts per year shall be as follows:

14509/1/11 REV 1 WS/jj 91

(EUR 1 000)

Croatia 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

Maximum

amount

for the

specific

national 2 400 2 880 3 360 3 840 4 800 5 760 6 720 7 680 8 640 9 600

de-mining

reserve

5.

In the first year of implementation of the single payment scheme Croatia shall allocate
payment entitlements to the farmers on the basis of the land which has been de-mined

and declared by farmers in the aid applications submitted in the first year of

implementation of the single payment scheme and returned to use for agricultural

activities between 1 January 2005 and 31 December 2012.

6.

For the years 2013 to 2022, payment entitlements shall be allocated to farmers on the
basis of the de-mined land declared by the farmers in the year in question on condition

that such land was returned to use for agricultural activities during the previous calendar

year, and which has been notified to the Commission in accordance with paragraph 9.

7.

In order to ensure an appropriate use of Union funds, the Commission shall, in
accordance with the procedure referred to in Article 141(2), modify the ceiling in table

3 of Annex VIII in order to add thereto the amounts from the special national de-mining

reserve which have been allocated by 31 December 2022.

8.

All land declared for the purpose of this Article shall comply with the definition of
eligible hectare provided for in Article 34(2).

9.

By 15 July 2013, Croatia shall notify the Commission of the area of land eligible
according to paragraph 5, indicating both land eligible for the support levels according

to Article 59, and land eligible for the support levels according to Article 61. This

notification shall also include information on the corresponding budgetary envelopes

and the unused amounts. From 2014 onwards, a communication with the same

information shall be sent to the Commission no later than 31 January every year and

shall cover the previous calendar year, specifying areas returned to use for agricultural

activities and the corresponding budgetary envelopes.

10.

By 31 December 2012, all mined and de-mined land on which farmers might receive
payment entitlement from this special national de-mining reserve shall be identified in

the integrated administration and control system established in accordance with Chapter

4 of Title II.'

(n) In Article 59, the following paragraph is added:

'4. The Commission shall, in accordance with the procedure referred to in Article 141(2),

adopt rules on the initial allocation of payment entitlements in Croatia.'

(o) In Article 61, the following paragraph is added:

"For Croatia, the above mentioned dates shall be 30 June 2011.'

(p) In Article 69(1), the following is added to the first subparagraph:

'Croatia may decide, by the date of accession, to use from the first year of implementation of

the single payment scheme as provided for in Article 59(2) up to 10% of the national ceiling

referred to in Article 40 as indicated in table 3 of Annex VIII.'

(q) In Article 69(9), the following is inserted to the first subparagraph:

'(aa) specified for the year 2022 in the case of Croatia.'

(r) Article 104(4) is replaced by the following:

'4. The following national ceilings shall apply:

Member States National ceiling

Bulgaria 2 058 483

Czech Republic 66 733

Denmark 104 000

Estonia 48 000

Spain 19 580 000

France 7 842 000

Croatia 542 651

Cyprus 472 401

Latvia 18 437

Lithuania 17 304

Hungary 1 146 000

Poland 335 880

Portugal 2 690 000

Romania 5 880 620

Slovenia 84 909

Slovakia 305 756

Finland 80 000

Total 41 273 174

(s) In Article 112(5), the following is inserted after the entry for France:

Croatia 105 270

(t) Article 121 is replaced by the following:

'Article 121

Introduction of direct payments

In the new Member States other than Bulgaria, Croatia and Romania, direct payments shall be

introduced in accordance with the following schedule of increments expressed as a percentage

of the then applicable level of such payments in the Member States other than the new

Member States:

— 60 % in 2009,

— 70 % in 2010,

— 80 % in 2011,

— 90 % in 2012,

— 100 % as from 2013.

In Bulgaria and Romania, direct payments shall be introduced in accordance with the

following schedule of increments expressed as a percentage of the then applicable level of

such payments in the Member States other than the new Member States:

-

35 % in 2009,

-

40 % in 2010,

-

50 % in 2011,

-

60 % in 2012,

-

70 % in 2013,

-

80 % in 2014,

-

90 % in 2015,

-

100 % as from 2016.

In Croatia, direct payments shall be introduced in accordance with the following schedule of

increments expressed as a percentage of the then applicable level of such payments in the

Member States other than the new Member States:

-

25 % in 2013,

-

30 % in 2014,

-

35 % in 2015,

-

40 % in 2016,

-

50 % in 2017,

-

60 % in 2018,

-

70 % in 2019,

-

80 % in 2020,

-

90 % in 2021,

-

100 % as from 2022.'

(u) In Article 132(2), the following point is added:

'(c) By way of derogation from points (a) and (b), Croatia shall have the possibility to

complement direct payments up to 100% of the level applicable in Member States other than

the new Member States,'.

(v) In Annex VII, the following is inserted after the entry for France:

14509/1/11 REV 1 WS/jj 96 (w) In Annex VIII, the following table is added:

'Table 3(*)

Member 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

State

Croatia 93 250 111 900 130 550 149 200 186 500 223 800 261 100 298 400 335 700 373 000

(*) Ceilings calculated taking into account of the schedule of increments provided for in Article 121.'

5.

FISHERIES

1.

32002 R 2371: Council Regulation (EC) No 2371/2002 i of 20 December 2002 on the

conservation and sustainable exploitation of fisheries resources under the Common Fisheries

Policy (OJ L 358, 31.12.2002, p. 59).

(a) In Annex I, the following parts are added:

'11. COASTAL WATERS OF CROATIA*

Geographical area Member State Species Importance or

particular

characteristics

12 miles limited to Slovenia Demersal and small 100 tonnes for a

the sea area under the pelagic species maximum number of

sovereignty of including sardine and 25 fishing vessels

Croatia situated to anchovy which includes 5

the north of the 45 fishing vessels

degrees and 10 equipped with trawl

minutes parallel nets

north latitude along

the west Istrian coast,

from the outer limit

of the territorial sea

of Croatia, where this

parallel touches the

land of the west

Istrian coast (the cape

Grgatov rt Funtana)

*

The above mentioned regime shall apply from the full implementation of the arbitration award

resulting from the Arbitration Agreement between Slovenia and Croatia, signed in Stockholm on 4

November 2009.

12. COASTAL WATERS OF SLOVENIA*

Geographical area Member State Species Importance or

particular

characteristics

12 miles limited to Croatia Demersal and small 100 tonnes for a

the sea area under the pelagic species maximum number of

sovereignty of including sardine and 25 fishing vessels

Slovenia situated to anchovy which includes 5

the north of the 45 fishing vessels

degrees and 10 equipped with trawl

minutes parallel nets

north latitude along

the west Istrian coast,

from the outer limit

of the territorial sea

of Croatia, where this

parallel touches the

land of the west

Istrian coast (the cape

Grgatov rt Funtana)

*

The above mentioned regime shall apply from the full implementation of the arbitration award

resulting from the Arbitration Agreement between Slovenia and Croatia, signed in Stockholm on 4

November 2009.'

2.

32006 R 1198: Council Regulation (EC) No 1198/2006 i of 27 July 2006 on the European
Fisheries Fund (OJ L 223, 15.8.2006, p. 1).

(a) In Article 27, the following paragraph is added:

'5. The EFF may contribute to the financing of a scheme of individual premiums for fishers

who will benefit from the access regime laid down in Part 11 of Annex I of Regulation (EC)

No 2371/2002 as amended by the Act of Accession. The scheme may only apply during the

period 2014 to 2015 or, if this occurs earlier, up until the date of the full implementation of

the arbitration award resulting from the Arbitration Agreement between Slovenia and Croatia,

signed in Stockholm on 4 November 2009.'

(b) Article 29(3) is replaced by the following:

'3. By way of derogation from paragraph 2, in the outermost regions and the outlying Greek

islands as well as in the Croatian islands Dugi otok, Vis, Mljet and Lastovo, aid may be

granted to all enterprises.'

'4. By way of derogation from paragraph 3, in the outermost regions and the outlying Greek

islands as well as in the Croatian islands Dugi otok, Vis, Mljet and Lastovo, aid may be

granted to all enterprises.'

(d) In Article 53(9), the first subparagraph is replaced by the following:

'9. When operations are financed by the EFF in the outlying Greek islands which are under a

handicap due to distant location and in the outermost regions as well as in the Croatian islands

Dugi otok, Vis, Mljet and Lastovo, the ceiling for the contribution from the EFF for each

priority axis shall be increased by up to 10 percentage points in the regions eligible under the

Convergence objective and by up to 35 percentage points for the regions not eligible under the

Convergence objective.'

(e) In Annex II, point (a), the table is replaced by the following:

Group 1 Group 2 Group 3 Group 4

Regions covered A ≤ 100 % A ≤ 40 % A ≤ 80 % A ≤ 60 %

by the B ≥ 0 % B ≥ 60 % (*) (**) B ≥ 20 % B ≥ 40 % (***)

Convergence

objective and

outlying Greek

islands and the

Croatian islands

Dugi otok, Vis,

Mljet and

Lastovo

Regions not A ≤ 100 % A ≤ 40 % A ≤ 60 % A ≤ 40 %

covered by the B ≥ 0 % B ≥ 60 % (*) (**) B ≥ 40 % B ≥ 60 % (***)

Convergence

objective

Outermost A ≤ 100 % A ≤ 50 % A ≤ 80 % A ≤ 75 %

regions B ≥ 0 % B ≥ 50 % (*) (**) B ≥ 20 % B ≥ 25 %

(*) In the case of operations referred to in Article 25(3), the (B) rates for Group 2 are increased by

20 percentage points. The (A) rates are reduced accordingly.

(**) In the case of operations referred to in Article 26(2) (investment on board within the meaning

of Article 25 in small scale coastal fishing vessels), the (B) rates for Group 2 may be reduced by 20

percentage points. The (A) rates are increased accordingly.

(***) In case of operations referred to in Articles 29 and 35 when undertaken by enterprises not

covered by the definition in Article 3(f) with less than 750 employees or with a turnover of less than

EUR 200 million, the (B) rates are increased in the regions covered by the Convergence objective,

with the exception of the outlying Greek islands and the Croatian islands Dugi otok, Vis, Mljet and

Lastovo, by 30 percentage points and in the regions not covered by the Convergence objective by

14509/1/11 REV 1 WS/jj 101 (f) In Annex II, point (a), the second paragraph of sub-title "Group 2" is replaced by the

following:

'Following the application of (*) and (**) where the EFF finances operations referred to in

Article 25(3) in favour of small scale coastal fishing vessels, the (B) rates for Group 2 will be:

— for the regions covered by the Convergence objective, the outlying Greek islands and the

Croatian islands Dugi otok, Vis, Mljet and Lastovo and the regions not covered by the

Convergence objective equal or more than 60 percentage points (B ≥ 60 %),

and

— for the outermost regions equal or more than 50 percentage points (B ≥ 50 %).'

6.

TAXATION

1.

32006 L 0112: Council Directive 2006/112/EC i of 28 November 2006 on the common

system of value added tax (OJ L 347, 11.12.2006, p. 1).

In Article 287, the following is added:

'(19) Croatia: EUR 35 000.'

2.

32008 L 0118: Council Directive 2008/118/EC i of 16 December 2008 concerning the general

arrangements for excise duty and repealing Directive 92/12/EEC i (OJ L 9, 14.1.2009, p. 12).

Article 46(3) is replaced by the following:

'3. Without prejudice to Article 32, Member States not referred to in the third and fourth

subparagraphs of Article 2(2) of Directive 92/79/EEC i may, as regards cigarettes which may

be brought into their territory without further payment of excise duties, apply from 1 January

2014 a quantitative limit of not less than 300 items with respect to cigarettes brought in from a

Member State which applies, in accordance with the third and fourth subparagraphs of Article

2(2) of that Directive, lower excise duties than those resulting from the first subparagraph of

Article 2(2) thereof.

Member States referred to in the third and fourth subparagraphs of Article 2(2) of Directive

92/79/EEC which levy an excise duty of at least EUR 77 per 1 000 cigarettes irrespective of

the weighted average retail selling price, may, from 1 January 2014, apply a quantitative limit

of not less than 300 items as regards cigarettes brought into their territory without further

payment of excise duties from a Member State which applies a lower excise duty in

accordance with the third subparagraph of Article 2(2) of that Directive.

Member States which apply a quantitative limit in accordance with the first and the second

subparagraphs of this paragraph shall inform the Commission thereof. They may carry out the

necessary checks provided that these checks do not affect the proper functioning of the

internal market.'

7.

REGIONAL POLICY AND COORDINATION OF STRUCTURAL INSTRUMENTS

1.

32006 R 1083: Council Regulation (EC) No 1083/2006 i of 11 July 2006 laying down general
provisions on the European Regional Development Fund, the European Social Fund and the

Cohesion Fund and repealing Regulation (EC) No 1260/1999 i (OJ L 210, 31.7.2006, p. 25).

1.

In Article 15 (4), the following subparagraph is inserted after the second subparagraph:

'The Commission shall, in cooperation with Croatia, verify additionality ex post on 31

December 2017.'

2.

In Article 18(1), the first subparagraph is replaced by the following:

'1. The resources available for commitment from the Funds for the period 2007 to 2013 shall

be EUR 308 417 037 817 at 2004 prices in accordance with the annual breakdown shown in

Annex I.'

3.

Article 19 is replaced by the following:
'Article 19

Resources for the Convergence objective

Overall resources for the Convergence objective shall amount to 81,56 % of the resources

referred to in Article 18(1) (i.e. a total of EUR 251 529 800 379) and shall be distributed

between the different components as follows:

(a) 70,50% (i.e. a total of EUR 177 324 921 223) for the financing referred to in Article

5(1), using eligible population, regional prosperity, national prosperity and

unemployment rate as the criteria for calculating the indicative breakdowns by Member

State;

(b) 4,98 % (i.e. a total of EUR 12 521 289 405) for the transitional and specific support

referred to in Article 8(1), using eligible population, regional prosperity, national

prosperity and unemployment rate as the criteria for calculating the indicative

breakdowns by Member State;

5(2), using population, national prosperity, and surface area as the criteria for

calculating the indicative breakdowns by Member State;

(d) 1,29 % (i.e. a total of EUR 3 250 000 000) for the transitional and specific support

referred to in Article 8(3).'

4.

In Article 20, the first subparagraph is replaced by the following:
'Overall resources for the Regional competitiveness and employment objective shall amount

to 15,93 % of the resources referred to in Article 18(1) (i.e. a total of EUR 49 127 784 318)

and shall be distributed between the different components as follows:'

5.

In Article 21, paragraphs 1 and 2 are replaced by the following:
'1. Overall resources for the European territorial cooperation objective shall amount to 2,52 %

of the resources referred to in Article 18(1) (i.e. a total of EUR 7 759 453 120) and, excluding

the amount referred to in paragraph 22 of Annex II, shall be distributed between the different

components as follows:

(a) 73,86 % (i.e. a total of EUR 5 583 386 893) for the financing of cross-border cooperation

referred to in Article 7(1), using eligible population as the criterion for calculating the

indicative breakdowns by Member State; (b) 20,95 % (i.e. a total of EUR 1 583 594 654) for the financing of transnational cooperation

referred to in Article 7(2), using eligible population as the criterion for calculating the

indicative breakdowns by Member State;

cooperation networks and exchange of experience referred to in Article 7(3).

2.

The contribution from the ERDF to the cross-border and sea-basin programmes under the

European Neighbourhood and Partnership Instrument and to the cross-border programmes

under the Instrument for Pre-Accession Assistance pursuant to Regulation (EC) No 1085/2006 i

shall be EUR 817 691 234, as a result of the indication of each Member State concerned,

deducted from their allocations under paragraph 1(a). These ERDF contributions shall not be

subject to reallocation between the Member States concerned.'

6.

In Article 22, the following subparagraph is added:

'By way of derogation from the first subparagraph, Croatia may distribute its financial

allocation under the European territorial cooperation objective among the three components

referred to in Article 21(1)(a) to (c) with a view of a high level of efficiency and

simplification.'

7.

Article 23 is replaced by the following:
'Article 23

Resources for the performance reserve

Three per cent of the resources referred to in Article 19(a) and (b) and Article 20 may be

allocated by the Member States, with the exception of Croatia, in accordance with Article 50.'

8.

Article 28 is amended as follows:

(a) In paragraph 1, the following subparagraph is inserted between the first and second

subparagraphs:

'For Croatia, the national strategic reference framework shall cover the period from the

date of accession to 31 December 2013.'

(b) In paragraph 2, the following subparagraph is inserted between the first and second

subparagraphs:

'Croatia shall transmit its national strategic reference framework to the Commission

within three months following the date of accession.'

9.

In Article 29, the following paragraph is added:
'5. Paragraphs 1 to 4 shall not apply to Croatia.'

10.

In Article 32(3), the following subparagraph is added:
'For Croatia, the Commission shall adopt the Decision approving an Operational Programme

to be financed under the programming period 2007-2013 not later than 31 December

2013. The submission of this operational programme by Croatia shall be made not later than

three months following the date of accession, provided that any observations made by the

Commission have been taken into account.'

11.

In Article 33(1), the following subparagraph is added:

'For Croatia, operational programmes adopted before the date of accession may be revised for

the sole purpose of a better alignment with this Regulation.'

12.

In Article 49(3), the following subparagraph is added:

'For Croatia's operational programmes ex post evaluation shall be completed by 31 December

2016.'

13.

The following Article is inserted:
'Article 51a

Articles 50 and 51 shall not apply to Croatia.'

14.

Article 53(3) is replaced by the following:
'3. For operational programmes under the European territorial cooperation objective in which

at least one participant belongs to a Member State whose average GDP per capita for the

period 2001 to 2003 was below 85 % of the EU-25 average during the same period, or for

such programmes where Croatia is a participating country, the contribution from the ERDF

shall not be higher than 85 % of the eligible expenditure. For all other operational

programmes, the contribution from the ERDF shall not be higher than 75 % of the eligible

expenditure co-financed by the ERDF.'

15.

In Article 56(1), the following subparagraph is added:

'For Croatia, expenditure shall be eligible for a contribution from the Funds between the

starting date of eligibility of expenditure as fixed in accordance with the instruments adopted

under Regulation (EC) No 1085/2006 i and 31 December 2016. However, for operational

programmes adopted after the date of accession, expenditure for a contribution from the Funds

shall be eligible from the date of accession, unless a later date is specified in the Decision on

the operational programme concerned.'

16.

In Article 56(3), the following subparagraph is added:

'Notwithstanding specific provisions on eligibility as laid down in Article 105a, the criteria

fixed by the monitoring committee of operational programmes for Croatia shall not apply to

operations for which the approval decision has been adopted before the date of accession and

which have been part of the instruments adopted under Regulation (EC) No 1085/2006 i.'

17.

Article 62(1) is amended as follows:
(a) In point (c), the following subparagraph is inserted between the first and second

subparagraphs:

'For Croatia, the audit authority of an operational programme shall submit to the

Commission an update of the annual audit work plan as referred to in Article 29(2)(a) of

Commission Regulation (EC) No 718/2007 of 12 June 2007 implementing Council

Regulation (EC) No 1085/2006 i establishing an instrument for pre-accession assistance

(IPA) 1 within three months from the date of accession.'

(b) In point (d) (i), the following subparagraph is added:

'For Croatia, the first annual control report shall be submitted by 31 December 2013

covering the period from 1 October 2012 until 30 June 2013. The following reports

covering the periods from 1 July 2013 to 30 June 2014, from 1 July 2014 to 30 June

2015 and from 1 July 2015 to 30 June 2016 shall be submitted to the Commission by 31

December 2014, 31 December 2015 and 31 December 2016, respectively. The

information concerning the audits carried out after 1 July 2016 shall be included in the

final control report supporting the closure declaration referred to in point (e);'

1 OJ L 170, 29.6.2007, p. 1.

'For Croatia, a closure declaration supported by the final control report, shall be

submitted to the Commission by 31 March 2018.'

18.

In Article 67(1), the following subparagraph is added:

'For Croatia, the managing authority shall send a final report on the implementation of the

operational programme by 31 March 2018.'

19.

Article 71 is amended as follows:
(a) The following paragraph is inserted:

'1a. Notwithstanding paragraph 1, as soon as possible following the date of its accession

or, at the latest, before any payment by the Commission is made, Croatia shall submit to

the Commission a description of the systems, covering the elements set out in points (a)

and (b) of that paragraph.'

(b) The following paragraph is inserted:

'2a. Paragraph 2 shall apply mutatis mutandis to Croatia. The report referred to in the

first subparagraph shall be deemed to be accepted under the same conditions as set out in

the second subparagraph. However, such acceptance shall be a pre-requisite for the prefinancing

amount referred to in Article 82.'

20.

In Article 75, the following paragraph is inserted:
'1a. For Croatia, the respective budget commitments from the ERDF, the Cohesion Fund and

the ESF for 2013 shall be made based on the decision referred to in Article 28(3) before the

Commission takes any decision on the revision of an adopted programme. The decision

referred to in Article 28(3) shall constitute a financing decision in the meaning of Article 75 of

Regulation (EC, Euratom) No 1605/2002 for any budget commitment in favour of Croatia.'

21.

In Article 78(2)(c), the following sentence is added:
'For Croatia, they shall be covered by expenditure paid by beneficiaries in implementing the

project and supported by receipted invoices or accounting documents of equivalent probative

value at the latest three years after the year of the payment of the advance or on 31 December

2016, whichever is the earlier; if they are not, the next statement of expenditure shall be

corrected accordingly.'

22.

In Article 82, the following paragraph 1a is inserted:

'1a. For Croatia, following the acceptance of the report as referred to in Article 71(2a) and

following the respective budget commitments as referred to in Article 75(1a), a single prefinancing

amount for the rest of the 2007 to 2013 period shall be paid in a single instalment

and will represent 30 % of the contribution from the Structural Funds and 40 % of the

contribution from the Cohesion Fund to the operational programme.'

23.

In Article 89(1) the following subparagraph is added:

'For Croatia, an application for payment comprising the documents listed in point (a) (i) to (iii)

shall be sent by 31 March 2018. '

24.

In Article 93, the following paragraph is inserted:

'3a. By way of derogation from paragraphs 1 to 3, for Croatia the Commission shall apply the

de-commitment mechanism set out in paragraph 1 in the following way:

(i) the deadline for any open part of the 2010 commitment shall be 31 December 2013;

(ii) the deadline for any open part of the 2011 commitment shall be 31 December 2014;

(iii) the deadline for any open part of the 2012 commitment shall be 31 December 2015;

(iv) any part of 2013 commitments still open on 31 December 2016 shall be automatically decommitted

if the Commission has not received an acceptable application for payment for it by

31 March 2018.'

25.

In Article 95, the following subparagraph is inserted after the second subparagraph:

'By way of derogation from the first and second subparagraphs, for Croatia the deadlines

referred to in Article 93(3a) shall be interrupted under the conditions set out in the first

subparagraph of this paragraph in respect of the amount relating to the operations concerned.'

26.

In Article 98(2), the following subparagraph is added:
'For Croatia, the resources from the Funds released in this way may be reused by Croatia until

14509/1/11 REV 1 WS/jj 112 27. The following Article is inserted:

'Article 105a

Specific provisions following the accession of Croatia

1.

Programmes and major projects which, on the date of accession of Croatia, have been

approved under Council Regulation (EC) No 1085/2006 i of 17 July 2006 establishing an

Instrument for Pre-Accession Assistance (IPA) 1 and the implementation of which has not

been completed by that date, shall be considered to have been approved by the Commission

under this Regulation, with the exception of programmes approved under the components

referred to in Article 3(1) (a) and (e), of that Regulation.

In addition, the following programmes falling under the component referred to in Article 3 (1)

(b) of Regulation (EC) No 1085/2006 i shall be excluded as well:

a)

the "IPA Adriatic cross-border co-operation programme";

b)

the cross-border programme "Croatia – Bosnia and Herzegovina ";

c)

the cross-border programme "Croatia – Montenegro";

d)

the cross-border programme "Croatia – Serbia".

Without prejudice to paragraphs 2 to 7, the provisions governing the implementation of

operations and major projects approved pursuant to this Regulation shall apply to these

operations and major projects.

1 OJ L 210, 31.7.2006, p. 82.

2.

Any procurement procedure relating to operations within the programmes or relating to
major projects referred to in paragraph 1 which, on the date of accession, has already been the

subject of an invitation to tender published in the Official Journal of the European Union shall

be implemented in accordance with the rules laid down in that invitation to tender. The

provisions contained in Article 165 of Council Regulation (EC, Euratom) No 1605/2002 of 25

June 2002 on the Financial Regulation applicable to the general budget of the European

Communities 1 shall not apply.

Any procurement procedure relating to operations within the programmes or relating to major

projects referred to in paragraph 1 which, on the date of accession, has not yet been the subject

of an invitation to tender published in the Official Journal of the European Union shall be

implemented in compliance with the provisions of the Treaties or of the acts adopted under the

Treaties as well as in compliance with Article 9 of this Regulation.

Other operations than those referred to in the first and second subparagraphs and for which

calls for proposals were launched in accordance with Article 158 of Commission Regulation

(EC) No 718/2007 of 12 June 2007 implementing Council Regulation (EC) No 1085/2006 i or

for which applications had been submitted to the competent authorities before the date of

accession, and for which the contracting could only be finalised after that date, shall be

implemented in accordance with the conditions and eligibility rules published in the relevant

call for proposal or those communicated in advance to potential beneficiaries.

3.

Payments made by the Commission under programmes referred to in paragraph 1 shall be

considered as a contribution from the Funds under this Regulation and shall be posted to the

earliest open commitment including IPA commitments.

Any part of commitments made by the Commission under programmes referred to in

paragraph 1 still open on the date of accession shall be governed by this Regulation from the

date of accession.

1 OJ L 248, 16.9.2002, p.1.

4.

For the operations approved under Council Regulation (EC) No 1085/2006 i for which the

approval was given or for which the respective grant agreements with final beneficiaries were

signed before the date of accession, the rules governing the eligibility of expenditure in

accordance with or based on Commission Regulation (EC) No 718/2007 shall remain

applicable, except in duly justified cases to be decided on by the Commission at the request of

Croatia.

The eligibility rule established in the first subparagraph applies also to major projects referred

to in paragraph 1 for which bilateral project agreements were signed before the date of

accession.

5.

Concerning Croatia, any reference to the Funds as defined in the second subparagraph of

Article 1 shall be construed as also including the Instrument for Pre-accession Assistance

referred to in Council Regulation (EC) No 1085/2006 i.

6.

Specific deadlines applicable to Croatia shall also apply to the following cross-border

programmes falling under the component referred to in Article 3(1) (b) of Regulation (EC) No

1085/2006, where Croatia is a participating country:

a)

the cross-border programme "Hungary – Croatia", and

b)

the cross-border programme "Slovenia – Croatia".

Specific deadlines applicable to Croatia under this Regulation do not apply to operational

programmes under the transnational and interregional components under the European

territorial cooperation objective, where Croatia is a participating country.

7.

If any measures are necessary to facilitate the transition of Croatia from the pre-accession

regime to that resulting from the application of this Article, the Commission

shall adopt the required measures.'

28.

Annex I is replaced by the following:

'A EX I

Annual breakdown of commitment appropriations for 2007 to 2013

(referred to in Article 18)

(EUR, 2004 prices)

2007 2008 2009 2010 2011 2012 2013

42 863 000 43 318 000 43 862 000 43 860 000 44 073 000 44 723 000 45 718 037

000 000 000 000 000 000 817

29.

Annex II is amended as follows:
(a) In paragraph 5, first subparagraph, the following points are added:

'(c) for Croatia, the resources for the financing of cross-border cooperation shall be

EUR 7 028 744 at 2004 prices;

(d) for Croatia, the resources for the financing of transnational cooperation shall be

EUR 1 874 332 at 2004 prices.'

(b) The following paragraph is inserted:

'7a. For Croatia, the maximum level of transfer from the Funds will be 3,5240% of its

GDP.'

'9a. For Croatia, calculations of the GDP by the Commission will be based on

statistics and projections published in May 2011.'

30.

Annex III is replaced by the following:

'A EX III

Ceilings applicable to co-financing rates

(referred to in Article 53)

Criteria Member States ERDF and ESF Cohesion Fund

Percentage of eligible Percentage of eligible

expenditure expenditure

1.

Member States Bulgaria, Czech 85 % for the 85 %

whose average GDP Republic, Estonia, Convergence and

per capita for the Greece, Croatia, Regional

period 2001 to 2003 Cyprus, Latvia, competitiveness

was below 85 % of the Lithuania, Hungary, and employment

EU-25 average during Malta, Poland, objectives

the same period Portugal, Romania,

Slovenia, Slovakia

2.

Member States other Spain 80 % for the 85 %

than those under (1) Convergence

eligible for the and the phasing-in

transitional regions

regime of the under the Regional

Cohesion Fund on competitiveness

1 January 2007 and employment

objective

50 % for the Regional

competitiveness and

employment objective

outside phasing-in

regions

3.

Member States other Belgium, Denmark, 75 % for the

than those referred to Germany, France, Convergence

under (1) and (2) Ireland, Italy, objective

Luxemburg, the

Netherlands, Austria,

Finland, Sweden and

United Kingdom

4.

Member States other Belgium, Denmark, 50 % for the Regional

than those referred to Germany, France, competitiveness and

under (1) and (2) Ireland, Italy, employment objective

Luxemburg, the

Netherlands, Austria,

Finland, Sweden and

United Kingdom

5.

Outermost regions Spain, France and 50 %

referred to in Portugal

Article 349 of the

TFEU benefiting from

the additional

allocation for these

regions provided for in

paragraph 20 of Annex

6.

Outermost Regions Spain, France and 85 % under the

referred to in Portugal Convergence and

Article 349 of the Regional

TFEU competitiveness and

employment

objectives

2.

32006 R 1084: Council Regulation (EC) No 1084/2006 i of 11 July 2006 establishing a

Cohesion Fund and repealing Regulation (EC) No 1164/94 i (OJ L 210, 31.7.2006, p. 79).

The following Article is inserted:

'Article 5a

Specific provisions following the accession of Croatia

1.

Measures which, on the date of accession of Croatia, have been the subject of Commission

decisions on assistance under Council Regulation (EC) No 1267/1999 i of 21 June 1999

establishing an Instrument for Structural Policies for Pre-accession (ISPA) 1 and the

implementation of which has not been completed by that date shall be considered to have been

approved by the Commission under this Regulation.

Without prejudice to paragraphs 2 to 5, the provisions governing the implementation of

actions approved pursuant to this Regulation and to Council Regulation (EC) No 1083/2006 i

shall apply to these measures.

2.

Any procurement procedure relating to measures referred to in paragraph 1 which, on the

date of accession, has already been the subject of an invitation to tender published in the

Official Journal of the European Union shall be implemented in accordance with the rules laid

down in that invitation to tender. The provisions contained in Article 165 of Council

Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation

applicable to the general budget of the European Communities 2 shall not apply.

Any procurement procedure relating to a measure referred to in paragraph 1 which, on the

date of accession, has not yet been the subject of an invitation to tender published in the

Official Journal of the European Union shall be implemented in compliance with the

provisions of the Treaties or of the acts adopted under the Treaties as well as in compliance

with Article 9 of Council Regulation (EC) No 1083/2006 i.

1 OJ L 161, 26.6.1999, p. 73.

2 OJ L 248, 16.9.2002, p. 1.

3.

Payments made by the Commission under a measure referred to in paragraph 1 shall be
considered as a contribution from the Fund under this Regulation.

Payments made by the Commission under a measure referred to in paragraph 1 shall be posted

to the earliest open commitment made in the first instance pursuant to Council Regulation

(EC) No 1267/1999, and then pursuant to this Regulation and to Council Regulation (EC) No

1083/2006.

The conditions for interim payments or for the final balance are those set out in paragraph 2

(b) to (d) and paragraphs 3 to 5 of Article D in Annex II of Council Regulation (EC) No

1164/94.

4.

For the measures referred to in paragraph 1, the rules governing the eligibility of

expenditure pursuant to Council Regulation (EC) No 1267/1999 i or specifically established in

the relevant financing agreements shall remain applicable, except in duly justified cases to be

decided on by the Commission at the request of Croatia.

5.

If any measures are necessary to facilitate the transition of Croatia from the pre-accession

regime to that resulting from the application of this Article, the Commission shall adopt the

required measures.'

8.

ENVIRONMENT

1.

32003 L 0087: Directive 2003/87/EC i of the European Parliament and of the Council of 13

October 2003 establishing a scheme for greenhouse gas emission allowance trading within the

Community and amending Council Directive 96/61/EC i (OJ L 275, 25.10.2003, p. 32).

(a) In Article 9, the following is added to the first subparagraph:

'The Community-wide quantity of allowances will be increased as a result of Croatia's

accession only by the quantity of allowances that Croatia shall auction pursuant to Article

10(1).'

(b) In Annex IIa, the following is inserted before the entry for Italy:

'Croatia 26 %'.

2.

32009 D 0406: Decision No 406/2009/EC of the European Parliament and of the Council of

23 April 2009 on the effort of Member States to reduce their greenhouse gas emissions to

meet the Community’s greenhouse gas emission reduction commitments up to 2020 (OJ L

140, 5.6.2009, p. 136).

In Annex II, the following is inserted before the entry for Italy:

'Croatia 11%'.

_____________________

A EX IV

List referred to in Article 16 of the Act of Accession: other permanent provisions

1.

INTELLECTUAL PROPERTY LAW

Treaty on the Functioning of the European Union, Part Three, Title II, Free Movement of

Goods

SPECIFIC MECHANISM

With regard to Croatia, the holder, or his beneficiary, of a patent or Supplementary Protection

Certificate (SPC) for a pharmaceutical product filed in a Member State at the time when such

protection could not be obtained in Croatia for that product, may rely on the rights granted by that

patent or SPC in order to prevent the import and marketing of that product in the Member State or

States where the product in question enjoys patent or SPC protection, even if this product was put

on the market in Croatia for the first time by him or with his consent.

Any person intending to import or market a pharmaceutical product covered by the first paragraph

in a Member State where the product enjoys patent or SPC protection shall demonstrate to the

competent authorities in the application regarding that import that one month's prior notification has

been given to the holder or beneficiary of such protection.

2.

COMPETITION POLICY

Treaty on the Functioning of European Union, Part Three, Title VII, Chapter 1, Rules on

Competition

1.
The following aid schemes and individual aid put into effect in Croatia before the date of
accession and still applicable after that date shall be regarded upon accession as existing aid

within the meaning of Article 108(1) of the TFEU:
- a)
  
  aid measures put into effect before 1 March 2002;
- b)
  
  aid measures listed in the Appendix to this Annex;
- c)
  
  aid measures which prior to the date of accession were assessed by the Croatian
  Competition Agency and found to be compatible with the acquis, and to which the

Commission did not raise an objection on the ground of serious doubts as to the

compatibility of the measure with the internal market, pursuant to the procedure set out

in paragraph 2.

All measures still applicable after the date of accession which constitute State aid and which

do not fulfil the conditions set out above shall be considered as new aid upon accession for the

purpose of the application of Article 108(3) of the TFEU.

The above provisions do not apply to aid to activities linked to the production, processing

or marketing of products listed in Annex I to the TFEU.

2.

To the extent that Croatia wishes the Commission to examine an aid measure under the

procedure described in paragraph 1(c), it shall provide the Commission regularly with:

a)

a list of existing aid measures which have been assessed by the Croatian Competition
Agency and which that authority has found to be compatible with the acquis; and

b)

any other information which is essential for the assessment of the compatibility of the
aid measure to be examined,

in accordance with the concrete reporting format provided by the Commission.

If the Commission does not object to the existing aid measure on the ground of serious doubts

as to the compatibility of the measure with the internal market, within three months of receipt

of complete information on that measure or of receipt of the statement of Croatia in which it

informs the Commission that it considers the information provided to be complete because the

additional information requested is not available or has been already provided, the

Commission shall be deemed not to have raised an objection.

All aid measures submitted under the procedure described in paragraph 1(c) prior to the date

of accession to the Commission are subject to the above procedure irrespective of the fact that

in the period of examination Croatia has already become member of the Union.

3.

A Commission decision to object to a measure, within the meaning of paragraph 1(c), shall be

regarded as a decision to initiate the formal investigation procedure within the meaning of

Council Regulation (EC) No 659/1999 i of 22 March 1999 laying down detailed rules for the

application of Article 93 of the EC Treaty 1 (now Article 108 of the TFEU).

If such a decision is taken before the date of accession, the decision will only come into effect

upon the date of accession.

1 OJ L 83, 27.3.99, p. 1.

3.

AGRICULTURE

(a) Treaty on the Functioning of the European Union, Part Three, Title III, Agriculture and

Fisheries

1.

Public stocks held at the date of accession by Croatia and resulting from its market-support

policy shall be taken over by the Union at the value resulting from the application of Article

4(1)(d) and Annex VIII of Commission Regulation (EC) No 884/2006 of 21 June 2006 laying

down detailed rules for the application of Council Regulation (EC) No 1290/2005 i as regards

the financing by the European Agricultural Guarantee Fund (EAGF) of intervention measures

in the form of public storage operations and the accounting of public storage operations by the

paying agencies of the Member States 1 . The said stocks shall be taken over only on condition

that public intervention for the products in question is operated in the Union and that the

stocks meet the Union intervention requirements.

2.

For any stocks, private as well as public, in free circulation at the date of accession in Croatia
exceeding the level of what can be considered as normal carry-over of stock Croatia shall be

charged with a payment to the general budget of the European Union.

The amount of the payment shall be fixed at a level which reflects the cost related to the

effects of the surplus stock on the markets of agricultural products.

The level of the surplus stock shall be determined for each product taking into account the

characteristics of each product and the relevant markets as well as the Union legislation

applicable to it.

3.

The stocks referred to in paragraph 1 shall be deducted from the quantity exceeding the
normal carry-over of stocks.

14509/1/11 REV 1 WS/jj 125 4. The Commission shall implement and apply the arrangements outlined in paragraphs 1 to 3 in

accordance with the procedure laid down in Article 41(2) of Council Regulation (EC) No

1290/2005 of 21 June 2005 on the financing of the common agricultural policy 1 or, as

appropriate, in accordance with the procedure referred to in Article 195(2) of Council

Regulation (EC) No 1234/2007 i of 22 October 2007 establishing a common organisation of

agricultural markets and on specific provisions for certain agricultural products (Single CMO

Regulation) 2 or the relevant committee procedure as determined in the applicable legislation.

(b) Treaty on the Functioning of the European Union, Part Three, Title VII, Chapter 1,

Rules on competition

Without prejudice to the procedures concerning existing aid provided for in Article 108 of the

TFEU, aid schemes and individual aid granted to activities linked to the production of and

trade in products listed in Annex I to the TEU and the TFEU with the exception of fisheries

products and products derived therefrom, put into effect in Croatia before the date of

accession and still applicable after that date, shall be regarded as existing aid within the

meaning of Article 108(1) of the TFEU subject to the following conditions:

– the aid measures shall be communicated to the Commission within four months

from the date of accession. This communication shall include information on the

legal basis for each measure. Existing aid measures and plans to grant or alter aids

communicated to the Commission prior to the date of accession shall be deemed to

have been communicated on the date of accession. The Commission shall publish a

list of such aids.

These aid measures shall be regarded as ‘existing’ aid within the meaning of Article 108(1) of

the TFEU during a period of three years from the date of accession.

1 OJ L 209, 11.08.2005, p. 1.

14509/1/11 REV 1 WS/jj 126 Croatia shall, where necessary, amend these aid measures in order to comply with the

guidelines applied by the Commission within three years of the date of accession. After that

period, any aid found to be incompatible with those guidelines shall be considered as new aid.

4.

FISHERIES

Treaty on the Functioning of the European Union, Part Three, Title VII, Chapter 1, Rules on

competition

Without prejudice to the procedures concerning existing aid provided for in Article 108 of the

TFEU, aid schemes and individual aid granted to activities linked to the production of and trade in

fisheries products and products derived therefrom listed in Annex I to the TEU and the TFEU, put

into effect in Croatia before the date of its accession and still applicable after that date, shall be

regarded as existing aid within the meaning of Article 108(1) of the TFEU subject to the following

conditions:

– the aid measures shall be communicated to the Commission within four months from the

date of accession. This communication shall include information on the legal basis for

each measure. Existing aid measures and plans to grant or alter aids communicated to the

Commission prior to the date of accession shall be deemed to have been communicated on

the date of accession. The Commission shall publish a list of such aids.

These aid measures shall be regarded as ‘existing’ aid within the meaning of Article 108(1) of

the TFEU during a period of three years from the date of accession.

Croatia shall, where necessary, amend these aid measures in order to comply with the

guidelines applied by the Commission within three years of the date of accession. After that

period, any aid found to be incompatible with those guidelines shall be considered as new aid.

5.

CUSTOMS UNION

Treaty on the Functioning of the European Union, Part Three, Title II, Free Movement of

Goods, Chapter 1, The Customs union

31992 R 2913: Council Regulation (EEC) No 2913/92 i of 12 October 1992 establishing the

Community Customs Code (OJ L 302, 19.10.1992, p. 1).

31993 R 2454: Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions

for the implementation of Council Regulation (EEC) No 2913/92 i establishing the Community

Customs Code (OJ L 253, 11.10.1993, p. 1).

Regulation (EEC) No 2913/92 i and Regulation (EEC) No 2454/93 shall apply to Croatia subject to

the following specific provisions.

PROOF OF UNION STATUS (TRADE WITHIN THE ENLARGED UNION)

1.

Notwithstanding Article 20 of Regulation (EEC) No 2913/92 i, goods which on the date of

accession are in temporary storage or under one of the customs treatments and procedures

referred to in Article 4(15)(b) and (16)(b) to (h) of that Regulation in the enlarged Union, or

which are in transport after having been the subject of export formalities within the enlarged

Union, shall be free of customs duties and other customs measures when declared for release

for free circulation within the enlarged Union on condition that one of the following is

presented:

(a) proof of preferential origin properly issued or made out prior to the date of accession

under the Stabilisation and Association Agreement between the European Communities

and their Member States, of the one part, and the Republic of Croatia, of the other part

(the Stabilisation and Association Agreement) 1 ;

14509/1/11 REV 1 WS/jj 128 (b) any of the means of proof of Union status referred to in Article 314c of Regulation

(EEC) No 2454/93;

Croatia.

2.

For the purpose of issuing the proofs referred to in paragraph 1(b) above, with reference to the
situation at the date of accession and in addition to the provisions of Article 4(7) of

Regulation (EEC) No 2913/92 i, "Community goods" shall mean goods:

– wholly obtained in the territory of Croatia under conditions identical to those of Article

23 of Regulation (EEC) No 2913/92 i and not incorporating goods imported from other

countries or territories;

– imported from countries or territories other than Croatia, and released for free

circulation in Croatia; or

– obtained or produced in Croatia, either from goods referred to in the second indent of

this paragraph alone or from goods referred to in the first and second indent of this

paragraph.

3.

For the purpose of verifying the proofs referred to in paragraph 1(a) above, the provisions
concerning the definition of the concept of "originating products" and methods of

administrative cooperation under the Stabilisation and Association Agreement shall apply.

Requests for subsequent verification of those proofs shall be accepted by the competent

customs authorities of the present Member States and of Croatia for a period of three years

after the issue or making out of the proof of origin concerned and may be made by those

authorities for a period of three years after acceptance of the proof of origin in support of a

declaration of free circulation.

PROOF OF PREFERENTIAL ORIGIN (TRADE WITH THIRD COUNTRIES, INCLUDING

TURKEY, IN THE FRAMEWORK OF THE PREFERENTIAL AGREEMENTS ON

AGRICULTURE, COAL AND STEEL PRODUCTS)

4.

Without prejudice to the application of any measure deriving from the common commercial

policy, proof of origin properly issued by third countries or made out in the framework of

preferential agreements concluded by Croatia with those countries shall be accepted in

Croatia, provided that:

(a) the acquisition of such origin confers preferential tariff treatment on the basis of the

preferential tariff measures contained in agreements or arrangements which the Union

has concluded with, or adopted in respect of, those third countries or groups of

countries, as referred to in Article 20(3)(d) and (e) of Regulation (EEC) No 2913/92 i;

(b) the proof of origin and the transport documents were issued or made out no later than

the day before the date of accession; and

months from the date of accession.

Where goods were declared for release for free circulation in Croatia prior to the date of accession,

proof of origin issued or made out retrospectively under preferential agreements in force in Croatia

at the date of the release for free circulation may also be accepted in Croatia, provided that it is

submitted to the customs authorities within a period of four months from the date of accession.

5.

Croatia is authorised to retain the authorisations with which the status of "approved exporters"

has been granted in the framework of agreements concluded with third countries, provided

that:

(a) such a provision is also provided for in the agreements concluded prior to the date of

accession by those third countries with the Union; and

(b) the approved exporters apply the rules of origin provided for in those agreements.

These authorisations shall be replaced by Croatia, no later than one year after the date of accession,

by new authorisations issued under the conditions of Union legislation.

6.

For the purpose of verifying the proofs referred to in paragraph 4, the provisions concerning
the definition of the concept of "originating products" and methods of administrative

cooperation of the relevant agreements or arrangements shall apply. Requests for subsequent

verification of those proofs shall be accepted by the competent customs authorities of the

present Member States and of Croatia for a period of three years after the issue or making out

of the proof of origin concerned and may be made by those authorities for a period of three

years after acceptance of the proof of origin in support of a declaration of free circulation.

7.

Without prejudice to the application of any measure deriving from the common commercial
policy, proof of origin issued or made out retrospectively by third countries in the framework

of preferential agreements or arrangements which the Union has concluded with, or adopted

in respect of, these countries shall be accepted in Croatia for the release for free circulation of

goods which on the date of accession are either in transport or in temporary storage, in a

customs warehouse or in a free zone in one of these third countries or in Croatia, provided

that Croatia had no free trade agreement in force with the third country, for the products

concerned, at the moment when the transport documents where issued, and provided that:

(a) the acquisition of such origin confers preferential tariff treatment on the basis of the

preferential tariff measures contained in agreements or arrangements which the Union

has concluded with, or adopted in respect of, third countries or groups of countries, as

referred to in Article 20(3)(d) and (e) of Regulation (EEC) No 2913/92 i;

(b) the transport documents were issued no later than the day before the date of accession;

and

authorities within four months from the date of accession.

8.

For the purpose of verifying the proofs referred to in paragraph 7, the provisions concerning
the definition of the concept of "originating products" and methods of administrative

cooperation of the relevant agreements or arrangements shall apply.

PROOF OF STATUS UNDER THE PROVISIONS ON FREE CIRCULATION FOR

INDUSTRIAL PRODUCTS WITHIN THE EC-TURKEY CUSTOMS UNION

9.

Proofs of origin properly issued by either Turkey or Croatia or made out in the framework of

preferential trade agreements applied between them and providing for a prohibition of

drawback of, or exemption from, customs duties on the goods concerned shall be accepted in

the respective countries as a proof of status under the provisions on free circulation for

industrial products, laid down in Decision No 1/95 of the EC-Turkey Association Council 1 ,

provided that:

(a) the proof of origin and the transport documents were issued or made out no later than

the day before the date of accession; and

1 Decision No 1/95 of the EC-Turkey Association Council of 22.12.1995 on implementing the

final phase of the Customs Union (OJ L 35, 13.2.1996, p. 1).

(b) the proof of origin is submitted to the customs authorities within a period of four

months from the date of accession.

Where goods were declared for release for free circulation in either Turkey or Croatia, prior to

the date of accession, in the framework of preferential trade agreements referred to in the first

subparagraph, proof of origin issued or made out retrospectively under those agreements may

also be accepted provided that it is submitted to the customs authorities within a period of

four months from the date of accession.

10.

For the purpose of verifying the proofs referred to in paragraph 9, the provisions concerning
the definition of the concept of "originating products" and methods of administrative

cooperation of the relevant preferential agreements shall apply. Requests for subsequent

verification of those proofs shall be accepted by the competent customs authorities of the

present Member States and of Croatia for a period of three years after the issue or making out

of the proof of origin concerned and may be made by those authorities for a period of three

years after acceptance of the proof of origin in support of a declaration of free circulation.

11.

Without prejudice to the application of any measure deriving from the common commercial

policy, an A.TR movement certificate issued under the provisions on free circulation for

industrial products, laid down in Decision No 1/95 of the EC-Turkey Association Council of

22 December 1995, shall be accepted in Croatia for the release for free circulation of goods

which on the date of accession are either in transport after having been the subject of export

formalities within the Union or Turkey or are in temporary storage or under a customs

procedure referred to in Article 4(16)(b) to (h) of Regulation (EEC) No 2913/92 i in Turkey or

in Croatia, provided that:

(a) no proof of origin as referred to in paragraph 9 is submitted for the goods concerned;

(b) the goods comply with the conditions for the implementation of the provisions on free

circulation for industrial products;

and

(d) the A.TR movement certificate is submitted to the customs authorities within four

months from the date of accession.

12.

For the purpose of verifying the A.TR movement certificates referred to in paragraph 11, the

provisions concerning the issue of A.TR movement certificates and methods of administrative

cooperation under Decision No 1/2006 of the EC-Turkey Customs Cooperation Committee 1

shall apply.

CUSTOMS PROCEDURES

13.

Temporary storage and customs procedures referred to in Article 4(16) (b) to (h) of
Regulation (EEC) No 2913/92 i which have begun before accession shall be ended or

discharged under the conditions of Union legislation.

Where the end or discharge gives rise to a customs debt, the amount of import duty to be paid

shall be that in force at the time when the customs debt is incurred in accordance with the

Common Customs Tariff and the amount paid shall be considered as own resources of the

Union.

1 Decision No 1/2006 of the EC-Turkey Customs Cooperation Committee of 26 September

2006 laying down detailed rules for the application of Decision No 1/95 of the EC-Turkey

Association Council (OJ L 265, 26.9.2006, p. 18).

14.

The procedures governing customs warehousing laid down in Articles 84 to 90 and 98 to 113

of Regulation (EEC) No 2913/92 i and Articles 496 to 535 of Regulation (EEC) No 2454/93

shall apply to Croatia subject to the following specific provisions:

– where the amount of a customs debt is determined on the basis of the nature of the

import goods and where the declaration placing the goods under the procedure was

accepted prior to the date of accession, the tariff classification, quantity, value for

customs purposes and origin of the import goods at the time they were placed under the

procedure shall result from the legislation applicable in Croatia at the date of acceptance

of the declaration by the customs authorities.

15.

The procedures governing inward processing laid down in Articles 84 to 90 and 114 to 129 of

Regulation (EEC) No 2913/92 i and Articles 496 to 523 and 536 to 550 of Regulation (EEC)

No 2454/93 shall apply to Croatia subject to the following specific provisions:

– where the amount of a customs debt is determined on the basis of the nature of the

import goods and where the declaration placing the goods under the procedure was

accepted prior to the date of accession, the tariff classification, quantity, value for

customs purposes and origin of the import goods at the time they were placed under the

procedure shall result from the legislation applicable in Croatia at the date of acceptance

of the declaration by the customs authorities;

– where the discharge gives rise to a customs debt, in order to maintain the equity

between the holders of authorisations established in the present Member States and

those in Croatia, compensatory interest shall be paid on the import duties due under the

conditions of Union legislation from the date of accession;

– if the declaration for inward processing was accepted under a drawback system, the

drawback shall be effected under the conditions of Union legislation, by and at the

expense of Croatia, where the customs debt in respect of which the drawback is

requested was incurred before the date of accession.

16.

The procedures governing temporary importation laid down in Articles 84 to 90 and 137 to

144 of Regulation (EEC) No 2913/92 i and Articles 496 to 523 and 553 to 584 of

Regulation (EEC) No 2454/93 shall apply to Croatia subject to the following specific

provisions:

– where the amount of a customs debt is determined on the basis of the nature of the

import goods and where the declaration placing the goods under the procedure was

accepted prior to the date of accession, the tariff classification, quantity, value for

customs purposes and origin of the import goods at the time they were placed under the

procedure shall result from the legislation applicable in Croatia at the date of acceptance

of the declaration by the customs authorities;

– where the discharge gives rise to a customs debt, in order to maintain equity between

the holders of authorisations established in the present Member States and those in

Croatia, compensatory interest shall be paid on the import duties due under the

conditions of Union legislation from the date of accession.

17.

The procedures governing outward processing laid down in Articles 84 to 90 and 145 to 160

of Regulation (EEC) No 2913/92 i and Articles 496 to 523 and 585 to 592 of Regulation (EEC)

No 2454/93 shall apply to Croatia subject to the following specific provisions:

– Article 591, second paragraph, of Regulation (EEC) No 2454/93 shall apply mutatis

mutandis to temporary export goods which have been exported temporarily before the

date of accession from Croatia.

OTHER PROVISIONS

18.

Authorisations which have been granted by Croatia before the date of accession for the use of
the customs procedures referred to in Article 4(16)(d), (e) and (g) or the status of Authorised

Economic Operators referred to in Article 5a(2) of Regulation (EEC) No 2913/92 i shall be

valid until the end of their validity or one year after the date of accession, whichever is the

earlier.

19.

The procedures governing incurrence of a customs debt, entry in the accounts and postclearance

recovery laid down in Articles 201 to 232 of Regulation (EEC) No 2913/92 i and

Articles 859 to 876a of Regulation (EEC) No 2454/93 shall apply to Croatia subject to the

following specific provisions:

– recovery shall be effected under the conditions of Union legislation. However, where

the customs debt was incurred before the date of accession, recovery shall be effected

under the conditions in force in Croatia before accession, by it and in its own favour.

20.

The procedures governing repayment and remission of duty laid down in Articles 235 to 242
of Regulation (EEC) No 2913/92 i and Articles 877 to 912 of Regulation (EEC) No 2454/93

shall apply to Croatia subject to the following specific provisions:

– repayment and remission of duties shall be effected under the conditions of Union

legislation. However, where the duties of which repayment or remission is requested

relate to a customs debt which was incurred before the date of accession, the repayment

and remission of duties shall be effected under the conditions in force in Croatia before

accession, by it and at its own expense.

______________________

Appendix to Annex IV

List of existing aid measures referred to in paragraph 1(b) of the existing aid mechanism

provided for in Chapter 2 of Annex IV

Note: The aid measures listed in this Appendix are only to be considered as existing aid for the

purpose of the application of the existing aid mechanism set out in Chapter 2 of Annex IV to

the extent that they do fall within the scope of paragraph 1 thereof.

No. Date of approval

Title (original) by the Croatian Duration

MS Nb Yr Competition

Agency

HR 1 2011 Zakon o slobodnim zonama (NN 17/06/2008 31/12/2016

44/96, 92/05 i 85/08)

HR 3 2011 Zakon o Hrvatskoj radioteleviziji (NN 21/10/2010 Unlimited

137/10)

HR 4 2011 Odluka o otvorenosti Zračne luke 25/05/2009 31/12/2013

Osijek d.o.o. u razdoblju od 2009. do

2013. godine, od 20. veljače 2009. i

24.

travnja 2009

HR 5 2011 Program financiranja nakladništva od 10/02/2011 31/12/2013

2011. do 2013

HR 6 2011 Naknadno odobrenje državnih potpora 30/12/2010 31/12/2015

poduzetniku Rockwool Adriatic d.o.o.

HR 9 2011 Zakon o znanstvenoj djelatnosti i 01/02/2007 31/12/ 2014

visokom obrazovanju

(NN 123/03, 198/03, 105/04, 174/04,

46/07)

HR 10 2011 Odluka o obvezi otvorenosti Zračne 10/03/2011 31/12/ 2014

luke Rijeka d.o.o. za javni zračni

promet u razdoblju od 2010. do 2014.,

od 25. siječnja 2010. i 3. studenoga

2010

_________________________

ANNEX V

List referred to in Article 18 of the Act of Accession: transitional measures

1.

FREE MOVEMENT OF GOODS

32001 L 0083: Directive 2001/83/EC i of the European Parliament and of the Council of 6 November

2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001,

p.

67).

By way of derogation from the requirements of quality, safety and efficacy laid down in Directive

2001/83/EC, marketing authorisations for medicinal products, which are not subject to Article 3(1)

of Regulation (EC) No 726/2004 i and which are on the list (in the Appendix to this Annex as

provided by Croatia in one language) issued under Croatian law prior to the date of accession shall

remain valid until they are renewed in compliance with the acquis or until four years from the date

of accession, whichever is earlier.

The marketing authorisations covered by this derogation shall not benefit from mutual recognition

in the Member States as long as these products have not been authorised according to Directive

2001/83/EC.

The national marketing authorisations granted under the national law before accession and not

covered by this derogation and every new marketing authorisation shall, as from the date of

accession, be in compliance with Directive 2001/83/EC i.

2.

FREEDOM OF MOVEMENT FOR PERSONS

Treaty on the Functioning of the European Union

31996 L 0071: Directive 96/71/EC i of the European Parliament and of the Council of 16 December

1996 concerning the posting of workers in the framework of the provision of services (OJ L 18,

21.1.1997, p. 1);

32004 L 0038: Directive 2004/38/EC i of the European Parliament and of the Council of 29 April

2004 on the right of citizens of the Union and their family members to move and reside freely

within the territory of the Member States amending Regulation (EEC) No 1612/68 and repealing

Directives 64/221/EEC, 68/360/EEC, 72/194/EEC, 73/148/EEC, 75/34/EEC, 75/35/EEC,

90/364/EEC, 90/365/EEC and 93/96/EEC (OJ L 158, 30.4.2004, p. 77);

32011 R 0492: Regulation (EU) No 492/2011 i of the European Parliament and of the Council of 5

April 2011 on freedom of movement for workers within the Union (OJ L 141, 27.5.2011, p. 1).

1.

Article 45 and the first paragraph of Article 56 of the TFEU shall fully apply only, in relation

to the freedom of movement of workers and the freedom to provide services involving

temporary movement of workers as defined in Article 1 of Directive 96/71/EC i, between

Croatia on the one hand and each of the present Member States on the other hand, subject to

the transitional provisions laid down in paragraphs 2 to 13.

2.

By way of derogation from Articles 1 to 6 of Regulation (EU) No 492/2011 i and until the end
of the two year period following the date of accession, the present Member States will apply

national measures, or those resulting from bilateral agreements, regulating access to their

labour markets by Croatian nationals. The present Member States may continue to apply such

measures until the end of the five year period following the date of accession.

Croatian nationals legally working in a present Member State at the date of accession and

admitted to the labour market of that Member State for an uninterrupted period of 12 months

or longer will enjoy access to the labour market of that Member State but not to the labour

market of other Member States applying national measures.

Croatian nationals admitted to the labour market of a present Member State following

accession for an uninterrupted period of 12 months or longer shall also enjoy the same rights.

The Croatian nationals referred to in the second and third subparagraphs shall cease to enjoy

the rights contained in those subparagraphs if they voluntarily leave the labour market of the

present Member State in question.

Croatian nationals legally working in a present Member State at the date of accession, or

during a period when national measures are applied, and who were admitted to the labour

market of that Member State for a period of less than 12 months shall not enjoy these rights.

3.

Before the end of the two year period following the date of accession, the Council shall review

the functioning of the transitional provisions laid down in paragraph 2, on the basis of a report

from the Commission.

On completion of this review, and no later than at the end of the two year period following the

date of accession, the present Member States shall notify the Commission whether they will

continue to apply national measures or measures resulting from bilateral agreements, or

whether they will apply Articles 1 to 6 of Regulation (EU) No 492/2011 i henceforth. In the

absence of such notification, Articles 1 to 6 of Regulation (EU) No 492/2011 i shall apply.

4.

Upon the request of Croatia, one further review may be held. The procedure referred to in

paragraph 3 shall apply and shall be completed within six months of receipt of the request

from Croatia.

5.

A Member State maintaining national measures or measures resulting from bilateral

agreements at the end of the five year period referred to in paragraph 2 may, in case of serious

disturbances of its labour market or threat thereof and after notifying the Commission,

continue to apply these measures until the end of the seven year period following the date of

accession. In the absence of such notification, Articles 1 to 6 of Regulation (EU) No 492/2011 i

shall apply.

6.

During the seven year period following the date of accession, those Member States in which,

by virtue of paragraphs 3, 4 or 5, Articles 1 to 6 of Regulation (EU) No 492/2011 i apply as

regards Croatian nationals, and which are issuing work permits to nationals of Croatia for

monitoring purposes during this period, will do so automatically.

7.

Those Member States in which, by virtue of paragraphs 3, 4 or 5, Articles 1 to 6 of
Regulation (EU) No 492/2011 i apply as regards Croatian nationals, may resort to the

procedures set out in the second and third subparagraphs until the end of the seven year period

following the date of accession.

When a Member State referred to in the first subparagraph undergoes or foresees disturbances

on its labour market which could seriously threaten the standard of living or level of

employment in a given region or occupation, that Member State shall inform the Commission

and the other Member States thereof and shall supply them with all relevant particulars. On

the basis of this information, the Member State may request the Commission to state that the

application of Articles 1 to 6 of Regulation (EU) No 492/2011 i be wholly or partially

suspended in order to restore to normal the situation in that region or occupation. The

Commission shall decide on the suspension and on the duration and scope thereof not later

than two weeks after receiving such a request and shall notify the Council of such a decision.

Any Member State may, within two weeks from the date of the Commission’s Decision,

request the Council to annul or amend the Decision. The Council shall act on such a request

within two weeks, by qualified majority.

A Member State referred to in the first subparagraph may, in urgent and exceptional cases,

suspend the application of Articles 1 to 6 of Regulation (EU) No 492/2011 i, followed by a

reasoned ex-post notification to the Commission.

8.

As long as the application of Articles 1 to 6 of Regulation (EU) No 492/2011 i is suspended by

virtue of paragraphs 2 to 5 and 7 above, Article 23 of Directive 2004/38/EC i shall apply in

Croatia with regard to nationals of the present Member States, and in the present Member

States with regard to Croatian nationals, under the following conditions, so far as the right of

family members of workers to take up employment is concerned:

-

the spouse of a worker and their descendants who are under 21 years of age or are
dependants, legally residing with the worker in the territory of a Member State at the

date of accession, shall have, upon accession, immediate access to the labour market of

that Member State. This does not apply to family members of a worker legally admitted

to the labour market of that Member State for a period of less than 12 months;

-

the spouse of a worker and their descendants who are under 21 years of age or are
dependants, legally residing with the worker in the territory of a Member State from a

date later than the date of accession, but during the period of application of the

transitional provisions laid down above, shall have access to the labour market of the

Member State concerned once they have been resident in the Member State concerned

for at least 18 months or from the third year following the date of accession, whichever

is earlier.

These provisions shall be without prejudice to more favourable measures whether national or

resulting from bilateral agreements.

9.

Insofar as provisions of Directive 2004/38/EC i which take over provisions of Directive

68/360/EEC 1 may not be dissociated from those of Regulation (EU) No 492/2011 i whose

application is deferred pursuant to paragraphs 2 to 5 and 7 and 8, Croatia and the present

Member States may derogate from those provisions to the extent necessary for the application

of paragraphs 2 to 5 and 7 and 8.

10.

Whenever national measures, or those resulting from bilateral agreements, are applied by the
present Member States by virtue of the transitional provisions laid down above, Croatia may

maintain in force equivalent measures with regard to the nationals of the Member State or

States in question.

11.

Any present Member State applying national measures in accordance with paragraphs 2 to 5

and 7 to 9, may introduce, under national law, greater freedom of movement than that existing

at the date of accession, including full labour market access. From the third year following the

date of accession, any present Member State applying national measures may at any time

decide to apply Articles 1 to 6 of Regulation (EU) No 492/2011 i instead. The Commission

shall be informed of any such decision.

12.

In order to address serious disturbances or the threat thereof in specific sensitive service

sectors on their labour markets, which could arise in certain regions from the transnational

provision of services, as defined in Article 1 of Directive 96/71/EC i, and as long as they apply,

by virtue of the transitional provisions laid down above, national measures or those resulting

from bilateral agreements to the free movement of Croatian workers, Germany and Austria

may, after notifying the Commission, derogate from the first paragraph of Article 56 of the

TFEU with a view to limit in the context of the provision of services by companies

established in Croatia, the temporary movement of workers whose right to take up work in

Germany and Austria is subject to national measures.

1 Council Directive 68/360/EEC of 15 October 1968 on the abolition of restrictions on movement

and residence within the Community for workers of Member States and their families (OJ L 257,

19.10.1968, p. 13). Directive as last amended by the 2003 Act of Accession (OJ L 236, 23.9.2003,

p.

33) and repealed with effect from 30 April 2006 by Directive 2004/38/EC i of the European

Parliament and of the Council (OJ L 158, 30.4.2004, p. 77).

The list of service sectors which may be covered by this derogation is as follows:

– in Germany:

Sector (*) NACE code, unless otherwise specified

Construction, including related branches 45.1 to 4;

Activities listed in the Annex to Directive

96/71/EC

Industrial cleaning 74.70 Industrial cleaning

Other Services 74.87 Only activities of interior decorators

(*) NACE: see 31990 R 3037: Council Regulation (EEC) No 3037/90 i of 9 October 1990 on the

statistical classification of economic activities in the European Community (OJ L 293,

24.10.1990, p. 1)

_________________________________________________________________________________________________________________

– in Austria:

Sector NACE (*) code, unless otherwise specified

Horticultural service activities 01.41

Cutting, shaping and finishing of stone 26.7

Manufacture of metal structures and parts of 28.11

structures

Construction, including related branches 45.1 to 4;

Activities listed in the Annex to Directive

96/71/EC

Security activities 74.60

Industrial cleaning 74.70

Home nursing 85.14

Social work and activities without 85.32

accommodations

(*) NACE: see 31990 R 3037: Council Regulation (EEC) No 3037/90 i of 9 October 1990 on the

statistical classification of economic activities in the European Community (OJ L 293,

24.10.1990, p. 1).

_____________________________________________________________________________________________

To the extent that Germany or Austria derogate from the first paragraph of Article 56 of the

TFEU in accordance with the preceding subparagraphs, Croatia may, after notifying the

Commission, take equivalent measures.

The effect of the application of this paragraph shall not result in conditions for the temporary

movement of workers in the context of the transnational provision of services between

Germany or Austria and Croatia which are more restrictive than those prevailing on the date

of signature of the Treaty of Accession.

13.

The effect of the application of paragraphs 2 to 5 and 7 to 11 shall not result in conditions for

access of Croatian nationals to the labour markets of the present Member States which are

more restrictive than those prevailing on the date of signature of the Treaty of Accession.

Notwithstanding the application of the provisions laid down in paragraphs 1 to 12, the present

Member States shall, during any period when national measures or those resulting from

bilateral agreements are applied, give preference to workers who are nationals of the Member

States over workers who are nationals of third countries as regards access to their labour

market.

Croatian migrant workers and their families legally resident and working in another Member

State or migrant workers from other Member States and their families legally resident and

working in Croatia shall not be treated in a more restrictive way than those from third

countries resident and working in that Member State or Croatia respectively. Furthermore, in

application of the principle of Union preference, migrant workers from third countries

resident and working in Croatia shall not be treated more favourably than nationals of Croatia.

3.

FREE MOVEMENT OF CAPITAL

Treaty on European Union,

Treaty on the Functioning of the European Union.

Notwithstanding the obligations under the Treaties on which the European Union is founded,

Croatia may maintain in force for seven years from the date of accession the restrictions laid down

in its Agricultural Land Act (OG 152/08), as in force on the date of signature of the Treaty of

Accession, on the acquisition of agricultural land by nationals of another Member State, by

nationals of the States which are a party to the European Economic Area Agreement (EEAA) and

by legal persons formed in accordance with the laws of another Member State or an EEAA State.

However, a national of a Member State or a legal person formed in accordance with the laws of

another Member State may in no instance be treated less favourably in respect of the acquisition of

agricultural land than such a national or person would have been treated at the date of signature of

the Accession Treaty or be treated in a more restrictive way than a national or a legal person of a

third country.

Self-employed farmers, who are nationals of another Member State and who wish to establish

themselves and reside in Croatia, shall not be subject to the provisions of the preceding paragraph

or to any rules and procedures other than those to which nationals of Croatia are subject.

A general review of this transitional measure shall be held by the end of the third year following the

date of accession. To this effect, the Commission shall submit a report to the Council. The Council

may, acting unanimously on a proposal from the Commission, decide to shorten or terminate the

transitional period indicated in the first paragraph.

If there is sufficient evidence that, upon expiry of the transitional period, there will be serious

disturbances or a threat of serious disturbances on the agricultural land market of Croatia, the

Commission, at the request of Croatia, shall decide upon the extension of the transitional period for

three years. This extension might be limited to selected geographical areas particularly affected.

4.

AGRICULTURE

I.TRANSITIONAL MEASURES FOR CROATIA

1.

32001 L 0113: Council Directive 2001/113/EC i of 20 December 2001 relating to fruit jams,
jellies and marmalades and sweetened chestnut purée intended for human consumption (OJ L

10, 12.1.2002, p. 67).

By way of derogation from the obligation laid down in Article 8, the marketing of products

designated under the names "domaća marmelada" and "ekstra domaća marmelada" shall be

permitted on the Croatian market until clearance of the stock existing at the date of accession.

2.

32006 R 0510: Council Regulation (EC) No 510/2006 i of 20 March 2006 on the protection of

geographical indications and designations of origin for agricultural products and foodstuffs

(OJ L 93, 31.03.2006, p. 12 and OJ L 335M, 13.12.2008, p. 213).

(a) In Article 5(8), the second subparagraph is replaced by the following:

'Bulgaria, Romania and Croatia shall introduce the said laws, regulations or

administrative provisions not later than one year after their respective date of accession.'

(b) In Article 5(11), the first subparagraph is replaced by the following:

'11. In the case of Bulgaria, Romania and Croatia, the national protection of

geographical indications and designations of origin existing on the date of their

accession may continue for twelve months from their respective date of accession.'

3.

32007 R 1234: Council Regulation (EC) No 1234/2007 i of 22 October 2007 establishing a
common organisation of agricultural markets and on specific provisions for certain

agricultural products (Single CMO Regulation) (OJ L 299, 16.11.2007, p. 1).

(a) In Article 118m, the following paragraph is added:

'5. By way of derogation from paragraphs 1 to 4, Croatia shall be allowed to place on the

market in Croatia or export to third countries, wines with the denomination "Mlado vino

portugizac", until clearance of the stocks that were available at the date of accession. Croatia

shall set up a computerised databank with information of the stocks available at the date of

accession, and shall ensure that these stocks are verified and declared to the Commission.'

(b) In Article 118s, the following paragraph is added:

'5. For Croatia, the wine names published in OJ C 116 of 14 April 2011 shall be

protected under this Regulation, subject to a favourable outcome of the objection

procedure. The Commission shall list them in the register provided for in Article 118n.

Paragraphs 2 to 4 of this Article shall apply, subject to the following: The deadline

referred to in paragraph 3 shall be one year from the date of accession of Croatia. The

deadline referred to in paragraph 4 shall be four years from the date of accession of

Croatia. '

4.

32009 R 0073: Council Regulation (EC) No 73/2009 i of 19 January 2009 establishing
common rules for direct support schemes for farmers under the common agricultural policy

and establishing certain support schemes for farmers, amending Regulations (EC)

No 1290/2005, (EC) No 247/2006, (EC) No 378/2007 and repealing Regulation (EC) No

1782/2003 (OJ L 30, 31.1.2009, p. 16).

(a) By way of derogation from the obligation laid down in Article 4(1) of Regulation (EC)

No 73/2009 to respect the statutory management requirements listed in Annex II of that

Regulation, farmers in Croatia receiving direct payments shall include into the scope of

cross compliance the statutory management requirements laid down in Points A, B and

C of Annex II according to the following time schedule: as of 1 January 2014 for Point

A, as of 1 January 2016 for Point B and as of 1 January 2018 for Point C.

(b) After Chapter 1 in title V of Regulation (EC) No 73/2009 i, the following Chapter

heading and Article are inserted:

'CHAPTER 1a

Single payment scheme

Article 121a

Single payment scheme in Croatia

For Croatia, the application of Articles 4, 5, 23, 24 and 25 shall be optional until 31 December 2013

insofar as those provisions relate to statutory management requirements. As from 1 January 2014 a

farmer receiving payments under the single payment scheme in Croatia shall fulfil the statutory

management requirements referred to in Annex II in accordance with the following timetable:

(a) requirements referred to in Point A of Annex II shall apply from 1 January 2014;

(b) requirements referred to in Point B of Annex II shall apply from 1 January 2016;

II. TRANSITIONAL TARIFF QUOTA FOR RAW CANE SUGAR FOR REFINING

An annual autonomous erga omnes import quota of 40 000 tonnes of raw cane sugar for refining

shall be reserved for Croatia for a period of up to three marketing years following its accession at an

import duty of EUR 98,00 per tonne. Should negotiations with other Members of the World Trade

Organisation according to Article XXIV.6 of the General Agreement on Tariffs and Trade on

compensatory adjustment following the accession of Croatia result in the opening of compensatory

sugar quotas before the end of the transitional period, the quota of 40 000 tonnes allocated to

Croatia shall be terminated, wholly or partially, upon the opening of the compensatory sugar quotas.

The Commission shall adopt necessary implementing measures in accordance with the procedure

referred to in Article 195(2) of Council Regulation (EC) No1234/2007 i of 22 October 2007

establishing a common organisation of agricultural markets and on specific provisions for certain

agricultural products (Single CMO Regulation) in conjunction with Article 13(1)(b) of Regulation

(EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down

the rules and general principles concerning mechanisms for control by Member States of the

Commission’s exercise of implementing powers.

III. TEMPORARY DIRECT PAYMENTS MEASURES FOR CROATIA

The reimbursement of direct payments granted to farmers for the year 2013 shall be conditional on

the application by Croatia, before accession, of rules identical to those set out for such direct

payments in Council Regulation (EC) 73/2009 i of 19 January 2009 establishing common rules for

direct support schemes for farmers under the common agricultural policy and establishing certain

support schemes for farmers, amending Regulations (EC) No 1290/2005 i, (EC) No 247/2006, (EC)

No 378/2007 and repealing Regulation (EC) No 1782/2003 i 1 , and in Commission Regulations (EC)

No 1120/2009, (EC) No 1121/2009 and (EC) No 1122/2009 2 .

5.

FOOD SAFETY, VETERINARY AND PHYTOSANITARY POLICY

I. LAYING HENS

31999 L 0074: Council Directive 1999/74/EC i of 19 July 1999 laying down minimum standards for

the protection of laying hens (OJ L 203, 3.8.1999, p. 53).

By way of derogation from Article 6 of Council Directive 1999/74 i//EC, laying hens in lay at the

date of accession may be kept in cages which are not in conformity with the structural requirements

laid down in that Article. Croatia shall ensure that the use of such cages stops at the latest 12

months after accession.

1 OJ L 30, 31.1.2009, p. 16.

2 Commission Regulation (EC) No 1120/2009 of 29 October 2009 laying down detailed rules

for the implementation of the single payment scheme provided for in Title III of Council Regulation

(EC) No 73/2009 establishing common rules for direct support schemes for farmers under the

common agricultural policy and establishing certain support schemes for farmers, Commission

Regulation (EC) No 1121/2009 of 29 October 2009 laying down detailed rules for the application of

Council Regulation (EC) No 73/2009 i as regards the support schemes for farmers provided for in

Titles IV and V thereof and Commission Regulation (EC) No 1122/2009 of 30 November 2009

laying down detailed rules for the implementation of Council Regulation (EC) No 73/2009 i as

regards cross-compliance, modulation and the integrated administration and control system, under

the direct support schemes for farmers provided for that Regulation, as well as for the

implementation of Council Regulation (EC) No 1234/2007 i as regards cross-compliance under the

support scheme provided for the wine sector (OJ L 316, 2.12.2009, p. 1, 27 and 65).

Eggs from those un-enriched cages shall only be placed on the national market of Croatia. Such

eggs and their packs shall be clearly identified with a special mark, which allows for the necessary

controls. A clear description of this special mark shall be communicated to the Commission not

later than one year before the date of accession.

II. ESTABLISHMENTS (MEAT, MILK, FISH AND ANIMAL BY-PRODUCTS)

32004 R 0852: Regulation (EC) No 852/2004 i of the European Parliament and of the Council of 29

April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1);

32004 R 0853: Regulation (EC) No 853/2004 i of the European Parliament and of the Council of 29

April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p.

55).

32009 R 1069: Regulation (EC) No 1069/2009 i of the European Parliament and of the Council of

21 October 2009 laying down health rules as regards animal by-products and derived products not

intended for human consumption and repealing Regulation (EC) No 1774/2002 i (OJ L 300,

14.11.2009, p. 1).

a)
The structural requirements laid down in:
- i)
  
  Regulation (EC) No 852/2004 i:
  
  -
  
  Annex II, Chapter II;
- ii)
  
  Regulation (EC) No 853/2004 i:
  
  -
  
  Annex III, Section I, Chapters II and III,
  
  -
  
  Annex III, Section II, Chapters II and III,
- -
  
  Annex III, Section V, Chapter I;
- iii)
  
  Regulation (EU) No 142/2011:
  
  -
  
  Annex IV, Chapter I,
  
  -
  
  Annex IX, Chapters I, II and III,
  
  -
  
  Annex X, Chapters I and II, and
  
  -
  
  Annex XIII;

shall not apply to certain establishments in the meat, milk, fish and animal by-products sectors

in Croatia until 31 December 2015, subject to the conditions laid down below.

b)

As long as the establishments referred to in paragraph (a) benefit from the provisions of that

paragraph, products originating from those establishments shall only be placed on the national

market of Croatia or on markets of third countries in accordance with relevant Union

legislation, or used for further processing in establishments in Croatia also covered by the

provisions of paragraph (a), irrespective of the date of marketing.

c)

Food from establishments referred to in paragraph (a) above shall bear a different health or
identification mark to that provided for in Article 5 of Regulation (EC) No 853/2004 i. A clear

description of the different health or identification mark shall be communicated to the

Commission not later than one year before the date of accession.

d)

Paragraphs (b) and (c) also apply to all products originating from integrated meat, milk or

fishery establishments where a part of the establishment is subject to the provisions of

paragraph (a).

e)

Croatia shall continuously monitor the implementation of the national programme for

upgrading establishments and shall provide the Commission with an annual plan of progress

in this respect. Croatia shall ensure that an individual upgrading plan for each of these

establishments with deadlines for the correction of the structural requirements is elaborated

and made available to the Commission on request.

f)

The Commission shall in good time before accession establish a list of the establishments

referred to in paragraph (a). This list shall be made public and include the name and address

of each establishment.

Croatia shall ensure that any establishments, which by the time of accession fail fully to comply

with the food safety acquis, except where covered by the provisions of this transitional measure,

terminate their activities.

Implementing rules to ensure the smooth operation of the transitional regime with respect to

Regulations (EC) No 852/2004 i and No 853/2004, may be adopted in accordance with the second

paragraph of Article 12 and the second paragraph of Article 9 respectively thereof.

Implementing rules to ensure the smooth operation of the transitional regime with respect to

Regulation (EC) No 1069/2009 i may be adopted in accordance with Article 52(4) thereof.

III. MARKETING OF SEEDS

32002 L 0053: Council Directive 2002/53/EC i of 13 June 2002 on the common catalogue of

varieties of agricultural plant species (OJ L 193, 20.7.2002, p. 1);

32002 L 0055: Council Directive 2002/55/EC i of 13 June 2002 on the marketing of vegetable seed

(OJ L 193, 20.7.2002, p. 33).

Croatia may postpone until 31 December 2014 the application of Article 4(1) of Directive

2002/53/EC and Article 4(1) of Directive 2002/55/EC i with regard to the marketing in its territory of

seeds of varieties listed in its respective national catalogues of varieties of agricultural plant species

and varieties of vegetable plant species which have not been officially accepted in accordance with

the provisions of those Directives. During that period, such seeds shall not be marketed in the

territory of other Member States.

IV. NEUM

31997 L 0078: Council Directive 97/78/EC i of 18 December 1997 laying down the principles

governing the organisation of veterinary checks on products entering the Community from third

countries (OJ L 24, 30.1.1998, p. 9).

Article 1 is replaced by the following:

"Article 1

1.

Veterinary checks on products from third countries introduced into one of the territories listed
in Annex I shall be carried out by Member States in accordance with this Directive and with

Regulation (EC) No 882/2004 i of the European Parliament and of the Council of 29 April

2004 on official controls performed to ensure the verification of compliance with feed and

food law, animal health and animal welfare rules (1) .

2.

By way of derogation from paragraph 1, consignments of products coming from the territory

of Croatia and transiting through the territory of Bosnia and Herzegovina at Neum ('Neum

corridor') before re-entering the territory of Croatia via the points of entry at Klek or Zaton

Doli, may be exempted from the veterinary checks, subject to compliance with the following

requirements:

(a) Croatia must have in place on or before the date of accession points of entry to the north

and south of the Neum corridor that are equipped, staffed and prepared to ensure

compliance with the requirements of this paragraph;

(b) Croatia must ensure that:

(i) only closed vehicles are used for transporting the consignments;

(ii) vehicles transporting consignments are sealed with uniquely numbered seals before

transiting the Neum corridor;

(iii) a register is made, detailing which numbered seals have been attached to which

vehicles, which allows for the necessary controls;

(iv) the date and time of leaving and re-entering the territory of Croatia of the vehicles

transporting consignments are recorded, so that the total time of transit can be

calculated.

where:

(i) a vehicle's seal has been broken or replaced during transiting the Neum corridor;

and/or

(ii) the total time of transit considerably exceeds the acceptable total time of transit,

given the total distance of transit unless the competent authority has carried out an

assessment of the risks to animal and public health and has adopted effective,

proportionate and targeted measures based on that assessment.

(d) Croatia must regularly and as necessary inform the Commission of any non-compliance

with the requirements of point (b) and of the measures it has taken under point (c).

(e) Where necessary, a decision to suspend or withdraw the derogation from paragraph 1

shall be adopted in accordance with the procedure laid down in Article 29.

(f) Where necessary, detailed rules for the application of this paragraph may be adopted in

accordance with the procedure laid down in Article 29.'

6.

FISHERIES

32006 R 1967: Council Regulation (EC) No 1967/2006 i of 21 December 2006 concerning

management measures for the sustainable exploitation of fishery resources in the Mediterranean

Sea, amending Regulation (EEC) No 2847/93 i and repealing Regulation (EC) No 1626/94 i (OJ L

409, 30.12.2006, p. 11. Corrected version in OJ L 36, 8.2.2007, p. 6).

(a) By way of derogation from Article 13(1) and (2), at depths less than 50 meters vessels

registered and operating only in the Western Istria region shall be temporarily allowed, until

30 June 2014, to use bottom trawls at the minimum distance of 1,5 nautical miles from the

coast.

This derogation shall apply in the area designated as Western Istria, defined from the point

with geographic coordinates φ=44.52135 and λ=14.29244 with a line due north and a line due

west.

For vessels of less than 15 meters length overall, at depths over 50 meters Croatia shall be

temporarily allowed, until 30 June 2014, to use bottom trawls at the minimum distance of 1

nautical mile from the coast, maintaining all other spatial and temporal restrictions applied on

the date of accession.

(b) By way of derogation from Article 17 (1), a limited number of vessels included in the specific

category of non-commercial fisheries "small scale artisanal fishing for personal needs", which

shall not exceed 2 000 vessels, shall be allowed to use maximum 200 meters of gillnets until

31 December 2014, provided that all other restrictions in place on the date of accession

continue to apply. Croatia shall submit to the Commission on the date of accession, at the

latest, the list of vessels covered by this transitional period, including their characteristics and

capacity, expressed in terms of GT and kW.

7.

TRANSPORT POLICY

1.

31992 R 3577: Council Regulation (EEC) No 3577/92 i of 7 December 1992 applying the
principle of freedom to provide services to maritime transport within Member States

(maritime cabotage) (OJ L 364, 12.12.1992, p. 7).

In Article 6, the following paragraphs are added:

'4. By way of derogation from the second subparagraph of Article 4(1), public service

contracts concluded before the date of Croatia's accession may continue to be applied until 31

December 2016.

5.

By way of derogation from Article 1(1), until 31 December 2014 cruise services carried
out between Croatian ports by ships smaller than 650 gross tonnes shall be reserved to ships

registered in, and flying the flag of, Croatia, which are operated by shipping companies,

established in accordance with Croatian law, and whose principal place of business is situated,

and effective control exercised, in Croatia.

6.

By way of derogation from Article 1(1), and for the transitional period until 31 December

2014, the Commission may, upon a substantiated request by a Member State, decide, within

30 working days of receipt of the relevant request, that ships benefiting from the derogation

set out in paragraph 5 of this Article shall not carry out cruise services between ports of

certain areas of a Member State other than Croatia where it is demonstrated that the operation

of these services seriously disturbs or threatens to seriously disturb the internal transport

market in the areas concerned. If after the period of 30 working days the Commission has

taken no decision, the Member State concerned shall be entitled to apply safeguard measures

until the Commission has taken its decision. In the event of an emergency, the Member State

may unilaterally adopt appropriate provisional measures which may remain in force for no

more than three months. The Commission shall be immediately informed. The Commission

may abrogate the measures or confirm them until it takes its final decision. Member States

shall be kept informed.'

2.

32009 R 1072: Regulation (EC) No 1072/2009 i of the European Parliament and of the Council
of 21 October 2009 on common rules for access to the international road haulage market (OJ

L 300, 14.11.2009, p. 72).

By way of derogation from Article 8 of Regulation (EC) No 1072/2009 i, the following shall apply:

– for a period of two years after the date of Croatia's accession, undertakings established in

Croatia shall be excluded from cabotage in the other Member States;

– for a period of two years after the date of Croatia's accession, other Member States may notify

the Commission on whether they intend to prolong the transitional period mentioned in the

first indent for a maximum of two years or whether they intend to apply Article 8 of

Regulation (EC) No 1072/2009 i in relation to undertakings established in Croatia. In the

absence of such notification, Article 8 shall apply;

– any of the present 27 Member States may at any time during a period of two years from the

date of Croatia's accession notify the Commission of its intention to apply Article 8 of

Regulation (EC) No 1072/2009 i in relation to undertakings established in Croatia;

– only carriers established in Member States where Article 8 of Regulation (EC) No 1072/2009 i

applies in relation to undertakings established in Croatia may perform cabotage in Croatia;

– for a period of four years after the date of Croatia's accession, any Member State applying

Article 8 of Regulation (EC) No 1072/2009 i may, in case of serious disturbance of its national

market or parts thereof due to or aggravated by cabotage, such as serious excess of supply

over demand or a threat to the financial stability or survival of a significant number of road

haulage undertakings, request the Commission to suspend in whole or in part the application

of Article 8 of Regulation (EC) No 1072/2009 i in relation to undertakings established in

Croatia. In this case, Article 10 of Regulation (EC) No 1072/2009 i shall apply.

Member States that apply the transitional measure referred to in the first and second indents of

the first paragraph may progressively exchange cabotage authorisations on the basis of

bilateral agreements with Croatia.

The transitional arrangements referred to in the first and second paragraphs shall not lead to

more restrictive access for Croatian carriers to cabotage in any Member State than that

prevailing at the time of the signature of the Accession Treaty.

8.

TAXATION

1.

31992 L 0079: Council Directive 92/79/EEC i of 19 October 1992 on the approximation of
taxes on cigarettes (OJ L 316, 31.10.1992, p. 8).

In Article 2(2), the following subparagraph is added:

'Croatia shall be allowed a transitional period until 31 December 2017 in order to reach the

requirements laid down in the first and second subparagraphs. However, as from 1 January

2014 the excise duty shall not be less than EUR 77 per 1 000 cigarettes irrespective of the

weighted average retail selling price.'

2.

32006 L 0112: Council Directive 2006/112/EC i of 28 November 2006 on the common
system of value added tax (OJ L 347, 11.12.2006, p. 1).

(a) Article 13(2) is replaced by the following:

'2. Member States may regard activities, exempt under Articles 132, 135, 136 and 371,

Articles 374 to 377, Article 378(2), Article 379(2) or Articles 380 to 390c, engaged in by

bodies governed by public law as activities in which those bodies engage as public

authorities.'

(b) Article 80 (1)(b) is replaced by the following:

'(b) where the consideration is lower than the open market value and the supplier does not

have a full right of deduction under Articles 167 to 171 and Articles 173 to 177 and the

supply is subject to an exemption under Articles 132, 135, 136, 371, 375, 376, 377, 378(2),

379(2) or Articles 380 to 390c;'

'(a) the supply of goods used solely for an activity exempted under Articles 132, 135, 371,

375, 376 and 377, Article 378(2), Article 379(2) and Articles 380 to 390c, if those goods have

not given rise to deductibility;'

(d) Article 221(3) is replaced by the following:

'3. Member States may release taxable persons from the obligation laid down in Article 220 to

issue an invoice in respect of supplies of goods or services which they have made in their

territory and which are exempt, with or without deductibility of the VAT paid at the preceding

stage, pursuant to Articles 110 and 111, Article 125(1), Article 127, Article 128(1), Articles

132, 135, 136, 371, 375, 376 and 377, Article 378(2), Article 379(2) and Articles 380 to

390c.'

(e) The following Article is inserted after Article 390b:

'Article 390c

Croatia may, in accordance with the conditions applying in that Member State on the date

of its accession, continue to exempt the following transactions:

(a) the supply of building land, with or without buildings built on it, as referred to in point (j)

of Article 135(1) and in point (9) of Annex X, Part B, non-renewable, until 31 December

2014; (b) the international transport of passengers, as referred to in point (10) of Annex X, Part B,

for as long as the same exemption is applied in any of the Member States which were

members of the Union before the accession of Croatia.'

(f) Article 391 is replaced by the following:

'Article 391

Member States which exempt the transactions referred to in Articles 371, 375, 376 or 377,

Article 378(2), Article 379(2) or Articles 380 to 390c may grant taxable persons the right to

opt for taxation of those transactions.'

(g) The Title of Annex X (also, correspondingly, in the Table of contents) is replaced by the

following:

'LIST OF TRANSACTIONS COVERED BY THE DEROGATIONS REFERRED TO IN

ARTICLES 370 AND 371 AND ARTICLES 375 TO 390c'.

9.

JUSTICE, FREEDOM AND SECURITY

32006 R 0562: Regulation (EC) No 562/2006 i of the European Parliament and of the Council of 15

March 2006 establishing a Community Code on the rules governing the movement of persons

across borders (Schengen Borders Code) (OJ L 105, 13.4.2006, p. 1).

The following Article is inserted after Article 19:

'Article 19a

By derogation from the provisions of this Regulation relating to the establishment of border

crossing points, and until the entry into force of a decision by the Council of the European Union on

the full application of the provisions of the Schengen acquis in Croatia pursuant to Article 4(2) of

the Act of Accession or until this Regulation is amended to include provisions governing border

control at common border crossing points, whichever is the earlier, Croatia may maintain the

common border crossing points at its border with Bosnia and Herzegovina. At these common

border crossing points, border guards of one party shall carry out entry and exit checks on the

territory of the other party. All entry and exit checks by Croatian border guards shall be carried out

in compliance with the acquis of the Union, including Member States' obligations as regards

international protection and non-refoulement. The relevant bilateral agreements establishing the

common border crossing points in question shall, if necessary, be amended to that end.'

10.

ENVIRONMENT

I. HORIZONTAL LEGISLATION

1.

32003 L 0087: Directive 2003/87/EC i of the European Parliament and of the Council of 13

October 2003 establishing a scheme for greenhouse gas emission allowance trading within the

Community and amending Council Directive 96/61/EC i (OJ L 275, 25.10.2003, p. 32).

(a) With regard to all flights between two aerodromes situated in the Croatian territory, and all

flights between an aerodrome situated in the Croatian territory and an aerodrome situated in a

country outside the EEA area (referred to as "additional aviation activities"), the following

shall apply:

(i) By way of derogation from Article 3c(2), the period referred to in Article 13(1) and

beginning on 1 January 2013 shall start on 1 January 2014 for the additional aviation

activities.

(ii) By way of derogation from Article 3c(4), the Commission shall decide, following the

procedure referred to in that same provision, on the historical aviation emissions for the

additional aviation activities within six months from the date of accession.

(iii) By way of derogation from Article 3d(2), from 1 January 2014, the percentage of

allowances to be auctioned for the additional aviation activities shall be the proportion of the

allowances remaining after having calculated the number of allowances to be allocated free of

charge under point (d) of Article 3e(3) and the number of allowances to be set aside in a

special reserve under Article 3f.

(iv) By way of derogation from Article 3d(3), the attributed aviation emissions from

additional aviation activities shall be decided upon by the Commission for the reference year

2010 on the basis of the best available data. The number of allowances to be auctioned by

Member States whose total attributed aviation emissions include those from flights arriving

from a Croatian aerodrome, shall be adjusted from 1 July 2013, in order to reallocate

auctioning rights related to these emissions, to Croatia.

(v) By way of derogation from Article 3e(1), the monitoring year for the additional aviation

activities shall be 2012, and any application for an allocation of allowances shall be made to

the Croatian competent authorities by 31 March 2013.

(vi) By way of derogation from Article 3e(2), Croatia shall submit to the Commission

applications related to the additional aviation activities by 1 July 2013.

(vii) By way of derogation from Article 3e(3), the Commission shall adopt a decision on the

matters referred to in points (a) to (e) thereof, in relation to the additional aviation activities

by 30 September 2013.

(viii) By way of derogation from point (d) of Article 3e(3), for the additional aviation

activities the number of allowances to be allocated free of charge shall be calculated by

multiplying the benchmark specified in point (e) by the sum of the tonne-kilometre data

included in the applications submitted to the Commission in accordance with Article 3e(2)

adjusted to account for the average change in aviation tonne-kilometre activity covered by the

EU ETS relative to 2010 levels. If necessary, the benchmark may be subject to a uniform

correction factor to be applied by the Commission.

(ix) By way of derogation from Article 3e(3), for the additional aviation activities, the

benchmark referred to in point (e) thereof shall be the same as that calculated for aviation

activities covered by the EU ETS from 1 January 2012.

(x) By way of derogation from Article 3e(5), the date of issue of allowances for the

additional aviation activities shall be 28 February 2014.

(xi) By way of derogation from Article 3f, with regard to additional aviation activities, any

reference to the second calendar year of the period starting in 2013 shall be read as a reference

to 2014 and any references to the third calendar year of that period shall be read as a reference

to 2015.

(xii) By way of derogation from Article 14(3), for the additional aviation activities, the date

set therein shall be 1 July 2013.

(xiii) By way of derogation from Article 18a(1), the reattribution of administrative

responsibilities for aircraft operators to Croatia shall take place during the year 2014, after

fulfilment by the operator of its 2013 obligations, unless a different date is agreed between the

former administering authority and Croatia following a request by the aircraft operator within

six months from the date the Commission publishes an update of the list of operators which

takes into account the accession of Croatia. In this case, reallocation shall take place no later

than the year 2020 with regard to the trading period beginning in 2021.

(xiv) By way of derogation from point 6 of Annex I, additional aviation activities shall be

included as from 1 January 2014.

(b) Without prejudice to the above derogations, Croatia shall bring into force the laws, regulations

and administrative provisions necessary to ensure that it can comply with the Directive as of

accession for the whole year 2013.

2.

32010 R 0920: Commission Regulation (EU) No 920/2010 of 7 October 2010 for a

standardised and secured system of registries pursuant to Directive 2003/87/EC i of the

European Parliament and of the Council and Decision No 280/2004/EC of the European

Parliament and of the Council (OJ L 270, 14.10.2010, p. 1).

Articles 16, 29, 41, 46 and 54, and Annex VIII, relating to the aviation activities, shall apply

in Croatia as from 1 January 2014.

II. AIR QUALITY

32008 L 0050: Directive 2008/50/EC i of the European Parliament and of the Council of 21 May

2008 on ambient air quality and cleaner air for Europe (OJ L 152, 11.6.2008, p.1).

(a) By way of derogation from Annex XIV, the reference year of point A, first paragraph shall be

the second year after the end of the year of Croatia's accession. The Average Exposure

Indicator for that reference year shall be the mean concentration of the year of accession and

the first and the second year after the year of accession.

(b) By way of derogation from Annex XIV, point B, the exposure reduction target shall be

calculated in relation to the Average Exposure Indicator in the reference year which is the

second year after the end of the year of Croatia's accession.

III. WASTE MANAGEMENT

31999 L 0031: Council Directive 1999/31/EC i of 26 April 1999 on the landfill of waste (OJ L 182,

16.7.1999, p. 1).

(a) By way of derogation from points (a), (b) and (c) of the first subparagraph of Article 5(2), the

requirement to reduce the amount of biodegradable municipal waste going to landfills to

respectively 75 %, 50 % and 35 % of the total amount (by weight) of biodegradable municipal

waste produced in 1997 shall apply in Croatia in accordance with the deadlines specified

below.

Croatia shall ensure a gradual decrease in the amount of biodegradable municipal waste going to

landfills according to the following scheme:

(i) by 31 December 2013, the share of biodegradable municipal waste deposited on landfills will

be reduced to 75 % of the total amount (by weight) of biodegradable municipal waste

produced in 1997;

(ii) by 31 December 2016, the share of biodegradable municipal waste deposited on landfills will

be reduced to 50 % of the total amount (by weight) of biodegradable municipal waste

produced in 1997;

(iii) by 31 December 2020, the share of biodegradable municipal waste deposited on landfills will

be reduced to 35 % of the total amount (by weight) of biodegradable municipal waste

produced in 1997.

(b) By way of derogation from Article 14 (c), all existing landfills in Croatia shall comply with

the requirements of the Directive by 31 December 2018 with the exception of the

requirements laid down in Annex I, point 1.

Croatia shall ensure a gradual reduction of waste landfilled in existing non-compliant landfills in

accordance with the following annual maximum quantities:

– by 31 December 2013: 1 710 000 tonnes

– by 31 December 2014: 1 410 000 tonnes

– by 31 December 2015: 1 210 000 tonnes

– by 31 December 2016: 1 010 000 tonnes

– by 31 December 2017: 800 000 tonnes

Croatia shall provide the Commission by 31 December of each year starting with the year of

accession a report concerning the gradual implementation of the Directive and compliance with

intermediate targets.

IV. WATER QUALITY

1.

31991 L 0271: Council Directive 91/271/EEC i of 21 May 1991 concerning urban waste water
treatment (OJ L 135, 30.5.1991, p. 40).

By way of derogation from Articles 3, 4, 5, 6 and 7, the requirements for collecting systems and

treatment of urban waste water shall apply in Croatia as from 1 January 2024, in accordance with

the following intermediate targets:

(a) By 31 December 2018, compliance with the Directive shall be achieved in agglomerations

with a population equivalent of more than 15 000, except for the following coastal

agglomerations:

Bibinje - Sukošan,

Biograd,

Jelsa - Vrboska,

Makarska,

Mali Lošinj,

Malinska - Njivice,

Nin,

Pirovac - Tisno - Jezera,

Pula - sjever,

Vela Luka,

Vir.

(b) By 31 December 2020, compliance with the Directive shall be achieved in agglomerations

with a population equivalent of more than 10 000 whose waste water is discharged into

sensitive areas, as well as for treatment plants which are situated in the relevant catchment

areas of the Danube and other sensitive areas and that contribute to the pollution of these

areas, and in the 11 coastal agglomerations listed in point (a) above.

with a population equivalent of more than 2 000.

2.

31998 L 0083: Council Directive 98/83/EC i of 3 November 1998 on the quality of water
intended for human consumption (OJ L 330, 5.12.1998, p.32).

By way of derogation, the microbiological parameters and indicator parameters laid down,

respectively, in Annex I – Parts A and C shall apply to the following water supply zones in Croatia

as from 1 January 2019:

Water Supply Zone Area No. Population Nuts code

DA BJELOVAR 107 51 921 HR02

DA DARUVAR 125 25 608 HR02

DA ĐURĐEVAC 204 30 079 HR01

DA GORSKI KOTAR 306 26 430 HR03

DA HRVATSKO ZAGORJE 101 143 093 HR01

DA ISTOČNA SLAVONIJA - SLAVONSKI BROD 129 124 349 HR02

DA ISTRA 301 97 046 HR03

DA JASTREBARSKO-KLINČA SELA 114 23 213 HR01

DA KARLOVAC-DUGA RESA 116 91 511 HR02

DA KNIN 404 17 187 HR03

DA KOPRIVNICA 203 58 050 HR01

DA KRIŽEVCI 103 36 338 HR01

DA LAPAC 311 1 880 HR03

DA LIČKA JESENICA 118 13 893 HR02

DA NAŠICE 210 37 109 HR02

DA NERETVA-PELJEŠAC-

KORČULA-LASTOVO-MLJET 407 58 246 HR03

DA OGULIN 117 25 192 HR02

DA OPATIJA-RIJEKA-KRK 304 238 088 HR03

DA OTOČAC 309 15 434 HR03

DA OZALJ 113 11 458 HR02

DA PETRINJA-SISAK 121 84 528 HR02

DA PISAROVINA 115 3 910 HR01

14509/1/11 REV 1 WS/jj 171 DA POŽEŠTINE 128 70 302 HR02

DA SVETI IVAN ZELINA 102 17 790 HR01

DA UDBINA-KORENICA 310 6 747 HR03

DA VARAŽDIN 201 184 769 HR01

DA VELIKA GORICA 503 75 506 HR01

DA ZAGREB 501 831 047 HR01

DA ZAPREŠIĆ 502 50 379 HR01

DA ZRMANJA-ZADAR 401 158 122 HR03

DA ŽRNOVNICA 307 20 160 HR03

V. INTEGRATED POLLUTION PREVENTION AND CONTROL

1.

31999 L 0013: Council Directive 1999/13/EC i of 11 March 1999 on the limitation of

emissions of volatile organic compounds due to the use of organic solvents in certain

activities and installations (OJ L 85, 29.3.1999, p. 1).

(a) By way of derogation from Article 5 and Annexes IIA and IIB, the emission limit values of

volatile organic compounds due to the use of organic solvents in certain activities and

installations shall apply to the following installations in Croatia only as from the dates

mentioned below:

(i) As from 1 January 2014:

1.

ČATEKS, dioničko društvo za proizvodnju tkanine, umjetne kože, kućanskog rublja i

proizvoda za šport i rekreaciju (ČATEKS d.d.), Čakovec, Ulica Zrinsko

Frankopanska 25

2.

Drvna industrija KLANA d.d. (DI KLANA d.d.), Klana, Klana 264.

(ii) As from 1 January 2015:

1.

HEMPEL društvo s ograničenom odgovornošću Prerađivačka kemijska industrija
(HEMPEL d.o.o.), Umag, Novigradska ulica 32

2.

ALUFLEXPACK, proizvodno, trgovačko, export-import društvo s ograničenom
odgovornošću (ALUFLEXPACK, d.o.o.), Zadar, Murvica bb - pogon Zadar (Zadar

facility, location: Zadar, Murvica bb)

3.

ALUFLEXPACK, proizvodno, trgovačko, export-import društvo s ograničenom
odgovornošću (ALUFLEXPACK, d.o.o.), Zadar, Murvica bb - pogon Umag (Umag

facility, location: Umag, Ungarija bb).

(iii) As from 1 January 2016:

1.

PALMA društvo s ograničenom odgovornošću za proizvodnju pogrebnih potrepština
(PALMA d.o.o.), Jastrebarsko, Donja Reka 24

2.
FERRO-PREIS društvo s ograničenom odgovornošću za proizvodnju ljevanih,
kovanih i prešanih metalnih proizvoda (FERRO-PREIS d.o.o.), Čakovec, Dr. Tome

Bratkovića 2
- 3.
  
  AD PLASTIK dioničko društvo za proizvodnju dijelova i pribora za motorna vozila i
  proizvoda iz plastičnih masa (AD PLASTIK d.d.), Solin, Matoševa ulica 8 - location:
  
  Zagreb, Jankomir 5
- 4.
  
  REMONT ŽELJEZNIČKIH VOZILA BJELOVAR društvo s ograničenom
  odgovornošću (RŽV d.o.o.), Bjelovar, Trg Kralja Tomislava 2

5.

FEROKOTAO d.o.o. za proizvodnju transformatorskih kotlova i ostalih metalnih
konstrukcija (FEROKOTAO d.o.o.), Kolodvorska bb, Donji Kraljevec

6.

SAME DEUTZ-FAHR Žetelice, društvo s ograničenom odgovornošću za proizvodnju

i usluge (SAME DEUTZ-FAHR Žetelice d.o.o.), Županja, Industrijska 5

7.

CMC Sisak d.o.o. za proizvodnju i usluge (CMC Sisak d.o.o.), Sisak, Braće Kavurića
12

8.

METALSKA INDUSTRIJA VARAŽDIN dioničko društvo (MIV d.d.), Varaždin,

Fabijanska ulica 33

9.

CHROMOS BOJE I LAKOVI, dioničko društvo za proizvodnju boja i lakova
(CHROMOS BOJE I LAKOVI, d.d.), Zagreb, Radnička cesta 173/d

10.

CHROMOS-SVJETLOST, Tvornica boja i lakova, društvo s ograničenom

odgovornošću (CHROMOS-SVJETLOST d.o.o.), Lužani, Mijata Stojanovića 13

11.

MURAPLAST društvo s ograničenom odgovornošću za proizvodnju i preradu
plastičnih masa (MURAPLAST d.o.o.), Kotoriba, Industrijska zona bb

12.

ISTRAPLASTIKA dioničko društvo za proizvodnju ambalaže (ISTRAPLASTIKA
d.d.), Pazin, Dubravica 2/a

13.

GRUDINA društvo s ograničenom odgovornošću za proizvodnju i usluge
(GRUDINA d.o.o.), Županja, Aleja Matice Hrvatske 21

14.

SLAVICA - KEMIJSKA ČISTIONICA, vlasnik Slavica Hinek, Beli Manastir, J. J.
Strossmayera 17

15.

MIDA d.o.o. za usluge i ugostiteljstvo (MIDA d.o.o.), Osijek, Ivana Gundulića 206

16.

EXPRESS KEMIJSKA ČISTIONA, vlasnik Ivanka Drčec, Križevci, Ulica Petra
Preradovića 14

17.

Kemijska čistionica "BISER", vlasnik Gojko Miletić, Dubrovnik, Nikole Tesle 20

18.

Kemijska čistionica "ELEGANT", vlasnik Frane Miletić, Dubrovnik, Andrije
Hebranga 106

19.

KOLAR obrt za kemijsko čišćenje odjeće, vlasnik Svjetlana Kolar, Žakanje, Kamanje
70/a

20.

MM d.o.o. za trgovinu i usluge (MM d.o.o.), Draganić, Lug 112

21.

KEMIJSKA ČISTIONA "AGATA", vlasnik Branko Szabo, Virovitica, S. Radića 66

22.

Obrt za kemijsko čišćenje odjeća "KEKY", vlasnik Jovita Malek-Milovanović, Pula,
Dubrovačke bratovštine 29

23.

LORNA d.o.o. za pranje i kemijsko čišćenje tekstila i krznenih proizvoda (LORNA
d.o.o.), Pula, Valdebečki put 3

24.

KEMIJSKA ČISTIONICA I KOPIRANJE KLJUČEVA "ŠUPER", vlasnik Ivan
Šuper, Virovitica, J.J. Strossmayera 5

25.

KEMIJSKO ČIŠĆENJE ŠTEFANEC kemijsko čišćenje tekstila i krznenih proizvoda,
vlasnik Nadica Štefanec, Koprivnica, Ledinska 1a

26.
ARIES društvo s ograničenom odgovornošću za proizvodnju glazbala i usluge
(ARIES d.o.o.), Varaždin, Creska 3
- 27.
  
  OBRT ZA PRANJE I ČIŠĆENJE TEKSTILA I ODJEĆE ĐORĐEVIĆ, vlasnik
  Javorka Đorđević, Makarska, Ante Starčevića 2
- 28.
  
  OBRT ZA USLUGE PRANJA I KEMIJSKOG ČIŠĆENJA "KORDIĆ", vlasnik Pero
  Kordić, Makarska, Kipara Rendića 2
- 29.
  
  Kemijsko čišćenje tekstila i krznenih proizvoda ČISTIONICA GALEB, vlasnik
  Stipan Radović, Zadar, Varoška 6

30.
KEMIJSKA ČISTIONICA, vlasnik Krešimir Borovec, Varaždin, Juraja Habdelića 2
- 31.
  
  KEMIJSKA ČISTIONICA "VBM", vlasnik Biserka Posavec, Maruševec, Biljevec 47
- 32.
  
  OBRT ZA KEMIJSKO ČIŠĆENJE I PRANJE RUBLJA "PLITVICE", vlasnik
  Momirka Ninić, Pula, Rizzijeva 34
- 33.
  
  "ANA" KEMIJSKA ČISTIONA, vlasnik Saša Dadić, Pula, Zagrebačka 18
- 34.
  
  Kemijska čistionica, vlasnik Gordana Bralić, Trogir, Put Demunta 16
- 35.
  
  "ECONOMATIC" - PRAONICA RUBLJA, vlasnik Marino Bassanese, Umag,
  Savudrijska cesta 9
- 36.
  
  SERVIS ZA ČIŠĆENJE "SJAJ", vlasnik Danijela Brković, Virovitica, Golo Brdo 2A.

(b) By way of derogation from Article 5(3)(b), the obligation for the operator to demonstrate to

the satisfaction of the competent authority that the best available techniques are being used for

coating processes in shipbuilding with regard to the following installations in Croatia shall

apply as from 1 January 2016:

1.

BRODOTROGIR d.d., Trogir, Put Brodograditelja 16

2.

NCP-NAUTIČKI CENTAR PRGIN-REMONTNO BRODOGRADILIŠTE ŠIBENIK
d.o.o. za remont i proizvodnju brodova (NCP - REMONTNO BRODOGRADILIŠTE

ŠIBENIK d.o.o.), Šibenik, Obala Jerka Šižgorića 1

3.
BRODOGRADILIŠTE VIKTOR LENAC dioničko društvo (BRODOGRADILIŠTE
VIKTOR LENAC d.d.), Rijeka, Martinšćica bb
- 4.
  
  3. MAJ BRODOGRADILIŠTE d.d., Rijeka, Liburnijska 3
- 5.
  
  BRODOSPLIT-BRODOGRADILIŠTE društvo s ograničenom odgovornošću
  (BRODOSPLIT-BRODOGRADILIŠTE d.o.o.), Split, Put Supavla 21
- 6.
  
  ULJANIK Brodogradilište, d.d., Pula, Flaciusova 1.

2.

32001 L 0080: Directive 2001/80/EC i of the European Parliament and of the Council of 23

October 2001 on the limitation of emissions of certain pollutants into the air from large

combustion plants (OJ L 309, 27.11.2001, p. 1).

(a) By way of derogation from Article 4(1) and (3), the emission limit values for sulphur dioxide,

nitrogen oxides and dust shall apply to the following plants in Croatia as from 1 January

2018:

1.

BELIŠĆE d.d., Belišće: steam boiler K3 +K4 (240 MW)

2.

DIOKI d.d., Zagreb: steam boiler SG 6401C (86 MW)

3.

HEP-Proizvodnja d.o.o., Zagreb, TE Plomin 1: steam boiler (338 MW)

4.

TE PLOMIN d.o.o., Plomin, TE Plomin 2: steam boiler (544 MW)

5.

HEP-Proizvodnja d.o.o., Zagreb, TE Rijeka: steam boiler (800 MW)

6.

HEP-Proizvodnja d.o.o., Zagreb, TE Sisak - block 1: steam boilers 1A+1B (548 MW)

7.

HEP-Proizvodnja d.o.o., Zagreb, TE Sisak - block 2: steam boilers 2A+2B (548 MW)

8.

HEP-Proizvodnja d.o.o., Zagreb, TE-TO Zagreb: consisting of block C steam boiler K3,
hot water boilers VK 3, VK 4, VK 5, VK 6 and steam boiler PK 3 (total: 828 MW)

9.
HEP-Proizvodnja d.o.o., Zagreb, EL-TO Zagreb: consisting of block 30 MW with steam
boilers K4 (K8) and K5 (K9), block 12 MW with steam boiler K3 (K6), hot water

boilers WK 1 and WK 3, and steam boiler K2 (K7) (total: 510 MW)
- 10.
  
  HEP-Proizvodnja d.o.o, Zagreb, TE-TO Osijek: steam boilers K1+K2 (total: 196 MW).

3.

32008 L 0001: Directive 2008/1/EC i of the European Parliament and of the Council of 15

January 2008 concerning integrated pollution prevention and control (OJ L 24, 29.1.2008,

p.

8).

By way of derogation from Article 5(1), the requirements for the granting of permits for existing

installations shall apply to the following installations in Croatia only as from the date indicated for

each installation, insofar as the obligation to operate these installations in accordance with emission

limit values, equivalent parameters or technical measures, based on the best available techniques

according to Article 2, point 12, is concerned:

(a) As from 1 January 2014:

1.

NAŠICECEMENT Tvornica cementa, dioničko društvo (NAŠICECEMENT d.d.
Našice), Našice, Tajnovac 1, IPPC activity 3.1.

2.

LIPIK GLAS za proizvodnju stakla društvo s ograničenom odgovornošću (LIPIK
GLAS d.o.o.), Lipik, Staklanska b.b., IPPC activity 3.2.

3.

KOKA peradarsko prehrambena industrija dioničko društvo (KOKA d.d.), Varaždin,
Jalkovečka ulica bb – farma br. 18 (Farm No.18, location: Čakovec, Totovec), IPPC

activity 6.6.a.

4.
ŽITO d.o.o. za proizvodnju i trgovinu (ŽITO d.o.o.), Osijek, Đakovština 3 - farma
Forkuševci (Farm Forkuševci), IPPC activity 6.6.c.
- 5.
  
  ŽITO d.o.o. za proizvodnju i trgovinu (ŽITO d.o.o.), Osijek, Đakovština 3 - farma V.
  Branjevina (Farm V. Branjevina), IPPC activity 6.6.c.
- 6.
  
  Drvna industrija KLANA d.d. (DI KLANA d.d.), Klana, Klana 264, IPPC activity 6.7.
- 7.
  
  ČATEKS, dioničko društvo za proizvodnju tkanine, umjetne kože, kućanskog rublja i
  proizvoda za šport i rekreaciju (ČATEKS d.d.), Čakovec, Ulica Zrinsko-Frankopanska
  
  25, IPPC activity 6.7.

(b) As from 1 January 2015:

1.
CIMOS LJEVAONICA ROČ d.o.o. proizvodnja aluminijskih odljevaka (CIMOS
LJEVAONICA ROČ d.o.o.), Roč, Stanica Roč 21, IPPC activity 2.5.b.
- 2.
  
  P. P. C. BUZET društvo s ograničenom odgovornošću za proizvodnju, trgovinu i usluge
  (P. P. C. BUZET d.o.o.), Buzet, Most 24, IPPC activity 2.5.b.

3.

Vetropack Straža tvornica stakla d.d. Hum na Sutli (Vetropack Straža d.d. Hum na
Sutli), Hum na Sutli, Hum na Sutli 203, IPPC activity 3.2.

4.

KOKA peradarsko prehrambena industrija dioničko društvo (KOKA d.d.), Varaždin,
Jalkovečka ulica bb - pogon mesa (meat facility), IPPC activity 6.4.a.

5.

SLADORANA TVORNICA ŠEĆERA dioničko društvo (SLADORANA d.d.), Županja,
Šećerana 63, IPPC activity 6.4.b.

6.

KOKA peradarsko prehrambena industrija dioničko društvo (KOKA d.d.), Varaždin,

Jalkovečka ulica bb – farma br. 19 (Farm No. 19, location: Donji Martijanec,

Vrbanovec), IPPC activity 6.6.a.

7.

ŽITO d.o.o. za proizvodnju i trgovinu (ŽITO d.o.o.), Osijek, Đakovština 3 - farma
Slaščak (Farm Slaščak), IPPC activity 6.6.b.

8.

ŽITO d.o.o. za proizvodnju i trgovinu (ŽITO d.o.o.), Osijek, Đakovština 3 - farma
Magadenovac (Farm Magadenovac), IPPC activity 6.6.c.

9.

ALUFLEXPACK, proizvodno, trgovačko, export-import društvo s ograničenom
odgovornošću (ALUFLEXPACK, d.o.o.), Zadar, Murvica bb - pogon Umag (Umag

facility, location: Umag, Ungarija bb), IPPC activity 6.7.

10.

ALUFLEXPACK, proizvodno, trgovačko, export-import društvo s ograničenom
odgovornošću (ALUFLEXPACK, d.o.o.), Zadar, Murvica bb - pogon Zadar (Zadar

facility, location: Zadar, Murvica bb), IPPC activity 6.7.

11.

HEMPEL društvo s ograničenom odgovornošću Prerađivačka kemijska industrija
(HEMPEL d.o.o.), Umag, Novigradska ulica 32, IPPC activity 6.7.

12.
BELIŠĆE dioničko društvo za proizvodnju papira, kartonske ambalaže, strojeva,
primarnu i finalnu preradu drva i suhu destilaciju drva (BELIŠĆE d.d.), Belišće, Trg

Ante Starčevića 1 - except Steam boilers K3 and K4 (transitional period until 31

December 2017, see below), IPPC activity 6.1.b.
- 13.
  
  MAZIVA-ZAGREB d.o.o. za proizvodnju i trgovinu mazivima i srodnim proizvodima

(MAZIVA-ZAGREB d.o.o.), Zagreb, Radnička cesta 175, IPPC activity 1.2.

1.

GAVRILOVIĆ Prva hrvatska tvornica salame, sušena mesa i masti M. Gavrilovića
potomci, d.o.o. (GAVRILOVIĆ d.o.o.), Petrinja, Gavrilovićev trg 1 - pogon klaonice:

papkari, rezanje i prerada mesa i proizvodnja prerađevina od peradi i papkara, te

skladištenje mesa (facility for animal slaughter: hoof animals, cutting and processing of

meat and production of processed products from poultry and hoof animals, and storage

of meat), IPPC activity 6.4.a.

(d) As from 1 January 2016:

1.

FERRO-PREIS društvo s ograničenom odgovornošću za proizvodnju ljevanih, kovanih
i prešanih metalnih proizvoda (FERRO-PREIS d.o.o.), Čakovec, Dr. Tome Bratkovića

2, IPPC activity 2.4.

2.

CEMEX Hrvatska dioničko društvo za proizvodnju i prodaju cementa i drugih
građevinskih materijala (CEMEX Hrvatska d.d.), Kaštel Sućurac, Cesta dr. Franje

Tuđmana bb - pogon Sv. Kajo (Sv. Kajo facility), IPPC activity 3.1.

3.

CEMEX Hrvatska dioničko društvo za proizvodnju i prodaju cementa i drugih
građevinskih materijala (CEMEX Hrvatska d.d.), Kaštel Sućurac, Cesta dr. Franje

Tuđmana bb - pogon Sv. Juraj (Sv. Juraj facility), IPPC activity 3.1.

4.

CEMEX Hrvatska dioničko društvo za proizvodnju i prodaju cementa i drugih
građevinskih materijala (CEMEX Hrvatska d.d.), Kaštel Sućurac, Cesta dr. Franje

Tuđmana bb - pogon 10. kolovoza (10. kolovoza facility), IPPC activity 3.1.

5.

KIO KERAMIKA d.o.o. za proizvodnju keramičkih pločica - "u stečaju" (KIO

KERAMIKA d.o.o. - "u stečaju"), Orahovica, V. Nazora bb - pogon Orahovica

(Orahovica facility, location: Orahovica, V. Nazora bb), IPPC activity 3.5.

6.

KIO KERAMIKA d.o.o. za proizvodnju keramičkih pločica - "u stečaju" (KIO
KERAMIKA d.o.o. - "u stečaju"), Orahovica, V. Nazora bb - pogon Rujevac (Rujevac

facility, location: Dvor, Rujevac bb), IPPC activity 3.5.

7.

PLIVA HRVATSKA d.o.o. za razvoj, proizvodnju i prodaju lijekova i farmaceutskih
proizvoda (PLIVA HRVATSKA d.o.o.), Zagreb, Prilaz baruna Filipovića 25 - pogon

Savski Marof (Savski Marof facility, location: Prigorje Brdovečko, Prudnička 98), IPPC

activity 4.5.

8.

PURIS, poljoprivredna, prehrambena, trgovačka i ugostiteljska djelatnost, dioničko
društvo (PURIS d.d.), Pazin, Hrvatskog narodnog preporoda 2 - mesna industrija (meat

industry, location: Sv. Petar u Šumi), IPPC activity 6.4 a and b.

9.

KOKA peradarsko prehrambena industrija dioničko društvo (KOKA d.d.), Varaždin,
Jalkovečka ulica bb – farma br. 20 (Farm No. 20, location: Petrijanec-Nova Ves), IPPC

activity 6.6.a.

10.

PURIS, poljoprivredna, prehrambena, trgovačka i ugostiteljska djelatnost, dioničko

društvo (PURIS d.d.), Pazin, Hrvatskog narodnog preporoda 2 - farma Sv. Petar u Šumi

8 (Farm Sv. Petar u Šumi 8, location: Sveti Petar u Šumi), IPPC activity 6.6.a.

11.

PURIS, poljoprivredna, prehrambena, trgovačka i ugostiteljska djelatnost, dioničko

društvo (PURIS d.d.), Pazin, Hrvatskog narodnog preporoda 2 - farma Sv. Petar u Šumi

9 (Farm Sv. Petar u Šumi 9, location: Sveti Petar u Šumi), IPPC activity 6.6.a.

12.

PURIS, poljoprivredna, prehrambena, trgovačka i ugostiteljska djelatnost, dioničko

društvo (PURIS d.d.), Pazin, Hrvatskog narodnog preporoda 2 - farma Barban (Farm

Barban, location: Barban), IPPC activity 6.6.a.

13.

PURIS, poljoprivredna, prehrambena, trgovačka i ugostiteljska djelatnost, dioničko
društvo (PURIS d.d.), Pazin, Hrvatskog narodnog preporoda 2 - farma Muntrilj (Farm

Muntrilj, location: Muntrilj), IPPC activity 6.6.a.

14.

PURIS, poljoprivredna, prehrambena, trgovačka i ugostiteljska djelatnost, dioničko

društvo (PURIS d.d.), Pazin, Hrvatskog narodnog preporoda 2 - farma Šikuti (Farm

Šikuti, location: Svetvinčenat), IPPC activity 6.6.a.

15.

PURIS, poljoprivredna, prehrambena, trgovačka i ugostiteljska djelatnost, dioničko
društvo (PURIS d.d.), Pazin, Hrvatskog narodnog preporoda 2 - farma Žminj 2 (Farm

Žminj 2, location: Žminj), IPPC activity 6.6.a.

16.

PURIS, poljoprivredna, prehrambena, trgovačka i ugostiteljska djelatnost, dioničko
društvo (PURIS d.d.), Pazin, Hrvatskog narodnog preporoda 2 - farma Surani 2 (Farm

Surani 2, location: Tinjani, Surani), IPPC activity 6.6.a.

17.

PURIS, poljoprivredna, prehrambena, trgovačka i ugostiteljska djelatnost, dioničko

društvo (PURIS d.d.), Pazin, Hrvatskog narodnog preporoda 2 - farma Pilati (Farm

Pilati, location: Lovrin, Pilati), IPPC activity 6.6.a.

18.

PURIS, poljoprivredna, prehrambena, trgovačka i ugostiteljska djelatnost, dioničko

društvo (PURIS d.d.), Pazin, Hrvatskog narodnog preporoda 2 - farma Škropeti 2 (Farm

Škropeti 2, location: Škropeti), IPPC activity 6.6.a.

19.

PURIS, poljoprivredna, prehrambena, trgovačka i ugostiteljska djelatnost, dioničko
društvo (PURIS d.d.), Pazin, Hrvatskog narodnog preporoda 2 - farma Katun 2 (Farm

Katun 2, location: Trviz, Katun Trviski), IPPC activity 6.6.a.

20.
PURIS, poljoprivredna, prehrambena, trgovačka i ugostiteljska djelatnost, dioničko
društvo (PURIS d.d.), Pazin, Hrvatskog narodnog preporoda 2 - farma Srbinjak (Farm

Srbinjak, location: Jakovici, Srbinjak), IPPC activity 6.6.a.
- 21.
  
  AD PLASTIK dioničko društvo za proizvodnju dijelova i pribora za motorna vozila i
  proizvoda iz plastičnih masa (AD PLASTIK d.d.), Solin, Matoševa ulica 8 - location:
  
  Zagreb, Jankomir 5, IPPC activity 6.7.
- 22.
  
  BRODOSPLIT-BRODOGRADILIŠTE društvo s ograničenom odgovornošću
  (BRODOSPLIT-BRODOGRADILIŠTE d.o.o.), Split, Put Supavla 21, IPPC activity
  
  6.7.
- 23.
  
  CHROMOS BOJE I LAKOVI, dioničko društvo za proizvodnju boja i lakova

(CHROMOS BOJE I LAKOVI, d.d.), Zagreb, Radnička cesta 173/d, IPPC activity 6.7.

24.

MURAPLAST društvo s ograničenom odgovornošću za proizvodnju i preradu
plastičnih masa (MURAPLAST d.o.o.), Kotoriba, Industrijska zona bb, IPPC activity

6.7.

25.

3. MAJ BRODOGRADILIŠTE d.d., Rijeka, Liburnijska 3, IPPC activity 6.7.

26.

CHROMOS-SVJETLOST, Tvornica boja i lakova, društvo s ograničenom

odgovornošću (CHROMOS-SVJETLOST d.o.o.), Lužani, Mijata Stojanovića 13, IPPC

activity 6.7.

27.

BRODOTROGIR d.d., Trogir, Put Brodograditelja 16, IPPC activity 6.7.

28.

ULJANIK Brodogradilište, d.d., Pula, Flaciusova 1, IPPC activity 6.7.

(e) As from 1 January 2017:

1.

METALSKA INDUSTRIJA VARAŽDIN dioničko društvo (MIV d.d.), Varaždin,
Fabijanska ulica 33, IPPC activity 2.4.

2.
KANDIT PREMIJER d.o.o. za proizvodnju, promet i usluge (KANDIT PREMIJER
d.o.o.), Osijek, Frankopanska 99, IPPC activity 6.4.b.
- 3.
  
  KOKA peradarsko prehrambena industrija dioničko društvo (KOKA d.d.), Varaždin,
  Jalkovečka ulica bb – farma br. 21 (Farm No. 21, location: Čakovec, Totovec), IPPC
  
  activity 6.6.a.

4.

ŽITO d.o.o. za proizvodnju i trgovinu (ŽITO d.o.o.), Osijek, Đakovština 3 – farma
Lužani (Farm Lužani), IPPC activity 6.6.b.

(f) As from 1 January 2018:

1.

BELIŠĆE dioničko društvo za proizvodnju papira, kartonske ambalaže, strojeva,
primarnu i finalnu preradu drva i suhu destilaciju drva (BELIŠĆE d.d.), Belišće, Trg

Ante Starčevića 1 – parni kotao K3, parni kotao K4 (Steam boiler K3, Steam boiler K4),

IPPC activity 1.1 (this only concerns steam boilers K3 and K4).

2.

HEP-Proizvodnja d.o.o. za proizvodnju električne i toplinske energije (HEP-
Proizvodnja d.o.o.), Zagreb, Ulica grada Vukovara 37 – KTE Jertovec (Jertovec

Combined-Cycle Power Plant, location: Konjšćina, Jertovec, Jertovec 151), IPPC

activity 1.1.

3.

HEP-Proizvodnja d.o.o. za proizvodnju električne i toplinske energije (HEP-
Proizvodnja d.o.o.), Zagreb, Ulica grada Vukovara 37 - TE Plomin 1 (Thermal Power

Plant Plomin 1, location: Plomin, Plomin bb), IPPC activity 1.1.

4.

TE PLOMIN društvo s ograničenom odgovornošću za proizvodnju električne energije
(TE PLOMIN d.o.o.), Plomin, Plomin bb - TE Plomin 2 (Thermal Power Plant Plomin

2, location: Plomin, Plomin bb), IPPC activity 1.1.

5.

HEP-Proizvodnja d.o.o. za proizvodnju električne i toplinske energije (HEP-
Proizvodnja d.o.o.), Zagreb, Ulica grada Vukovara 37 - EL-TO Zagreb (Zagreb Power

Plant - Heating Station, location: Zagreb, Zagorska 1), IPPC activity 1.1.

6.

HEP-Proizvodnja d.o.o. za proizvodnju električne i toplinske energije (HEP-

Proizvodnja d.o.o.), Zagreb, Ulica grada Vukovara 37 - TE-TO Zagreb (Zagreb Thermal

Power Plant - Heating Station, location: Zagreb, Kuševačka 10 a), IPPC activity 1.1.

7.

HEP-Proizvodnja d.o.o. za proizvodnju električne i toplinske energije (HEP-

Proizvodnja d.o.o.), Zagreb, Ulica grada Vukovara 37 - TE Sisak (Sisak Thermal Power

Plant, location: Sisak, Čret bb), IPPC activity 1.1.

8.

HEP-Proizvodnja d.o.o. za proizvodnju električne i toplinske energije (HEP-
Proizvodnja d.o.o.), Zagreb, Ulica grada Vukovara 37 - TE-TO Osijek (Osijek Thermal

Power Plant - Heating Station, location: Osijek, Martina Divalta 203), IPPC activity 1.1.

9.

HEP-Proizvodnja d.o.o. za proizvodnju električne i toplinske energije (HEP-
Proizvodnja d.o.o.), Zagreb, Ulica grada Vukovara 37 - TE Rijeka (Rijeka Thermal

Power Plant, location: Kostrena, Urinj bb), IPPC activity 1.1.

10.

DIOKI Organska petrokemija dioničko društvo (DIOKI d.d.), Zagreb, Čulinečka cesta
252, IPPC activity 1.1.

11.

INA-INDUSTRIJA NAFTE, d.d. (INA, d.d.), Zagreb, Avenija V. Holjevca 10 –
Rafinerija nafte Rijeka - Urinj (Rijeka Oil Refinery - Urinj, location: Kostrena, Urinj),

IPPC activity 1.2.

12.
INA-INDUSTRIJA NAFTE, d.d. (INA, d.d.), Zagreb, Avenija V. Holjevca 10 –
Rafinerija nafte Sisak (Sisak Oil Refinery, location: Sisak, Ante Kovačića 1), IPPC

activity 1.2.
- 13.
  
  ŽELJEZARA SPLIT poduzeće za proizvodnju i preradu čelika d.d. "u stečaju"
  (ŽELJEZARA SPLIT d.d. "u stečaju"), Kaštel Sućurac, Cesta dr. F. Tuđmana bb, IPPC
  
  activity 2.2.
- 14.
  
  PETROKEMIJA, d.d. tvornica gnojiva (PETROKEMIJA, d.d.), Kutina, Aleja Vukovar
  4, IPPC activity 4.2.b.

VI. CHEMICALS

32006 R 1907: Regulation (EC) No 1907/2006 i of the European Parliament and of the Council of

18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of

Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC i

and repealing Council Regulation (EEC) No 793/93 i and Commission Regulation (EC) No 1488/94

as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC,

93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

(a) By way of derogation from Article 23(1) and (2) and Article 28 defining the deadline for the

registration and pre-registration of the substances mentioned therein, manufacturers, importers

and producers of articles established in Croatia shall be granted an adaptation period of six

months after the date of accession for pre-registration of phase-in substances. The dates for the

first and second registration deadline set out in Article 23(1) and (2) shall be 12 months after

the date of accession.

(b) Articles 6, 7, 9, 17, 18 and 33 shall not apply in Croatia for a period of six months from the

date of accession.

in Annex XIV, if the latest application date falls before the date of accession or less than six

months after that date, applicants established in Croatia shall be granted an adaptation period

of six months from the date of accession by the end of which applications for authorisations

must be received.

__________________

Appendix to Annex V

List(*) as provided by Croatia in one language of medicinal products for which a marketing

authorisation issued under Croatian law prior to the date of accession shall remain valid until it is

renewed in compliance with the acquis or until 30 June 2017, whichever is earlier.

Mention on this list does not prejudge whether or not the medicinal product in question has a

marketing authorization in compliance with the acquis.

___________________________

______________________

( ∗∗∗∗ ) See OJ C xxx [E], xx.xx.xxxx, p. xxx. [Text as set out in AC 30/11].

ANNEX VI

Rural development (referred to in Article 35(2) of the Act of Accession)

I. RURAL DEVELOPMENT MEASURE FOR CROATIA

32005 R 1698: Council Regulation (EC) No 1698/2005 i of 20 September 2005 on support for rural

development by the European Agricultural Fund for Rural Development (EAFRD) (OJ L 277,

21.10.2005, p. 1 and OJ L 286M, 4.11.2010, p. 26).

Council Regulation (EC) 1698/2005 i shall not apply to Croatia for the whole programming period

2007-2013.

II. TEMPORARY ADDITIONAL RURAL DEVELOPMENT MEASURES FOR CROATIA

A. Support for semi-subsistence farms undergoing restructuring

In the rural development legislative framework for programming period 2014-2020, as regards

Croatia, a special support for semi-subsistence agricultural holdings shall be granted, pursuant to

the principles laid down in Article 34 of Council Regulation (EC) 1698/2005 i, to farmers in respect

of applications approved by 31 December 2017, provided that no similar general measures and/or

support is foreseen in the new rural development regulation for programming period 2014-2020.

B. Producer groups

In the rural development legislative framework for programming period 2014-2020, as regards

Croatia, a special support to facilitate the setting up and administrative operation of producer groups

shall be granted, pursuant to the principles laid down in Article 35 of Council Regulation (EC)

1698/2005, to producer groups which are officially recognised by Croatia’s competent authority by

rural development regulation for programming period 2014-2020.

14509/1/11 REV 1 WS/jj 186 C. Leader

In the rural development legislative framework for programming period 2014-2020, as regards

Croatia, the minimum EAFRD contribution to the rural development programme for Leader shall be

set on average at a level which is at least half of the percentage of the budget that shall be applicable

to the other Member States, if such a requirement is set.

D. Complements to direct payments

1.

Support may be granted to farmers eligible for complementary national direct payments or
aids under Article 132 of Council Regulation (EC) No 73/2009 i 1 .

2.

The support granted to a farmer in respect of the years 2014, 2015 and 2016 shall not exceed
the difference between:

(a) the level of direct payments applicable in Croatia for the year concerned in accordance

with Article 121 of Council Regulation (EC) No 73/2009 i, and

(b) 45 % of the level of direct payments applicable in the Union as constituted on 30 April

2004 in the relevant year.

3.

The Union contribution to support granted under this subsection D in Croatia in respect of the

years 2014, 2015 and 2016 shall not exceed 20 % of its respective total annual EAFRD

allocation.

4.

The Union contribution rate for the complements to direct payments shall not exceed 80 %.

1 Council Regulation (EC) No 73/2009 i of 19 January 2009 establishing common rules for direct

support schemes for farmers under the common agricultural policy and establishing certain

support schemes for farmers, amending Regulations (EC) No 1290/2005 i, (EC) No 247/2006,

(EC) No 378/2007 and repealing Regulation (EC) No 1782/2003 i (OJ L 30, 31.1.2009, p. 16).

E. Instrument for pre-accession – Rural development

1.

Croatia may continue to contract or enter into commitments under the IPARD programme

under Commission Regulation (EC) No 718/2007 of 12 June 2007 implementing Council

Regulation (EC) No 1085/2006 i establishing an instrument for pre-accession assistance (IPA)

until it begins to contract or enter into commitments under the relevant rural development

Regulation 1 . Croatia shall inform the Commission of the date on which it begins contracting

or entering into commitments under the relevant rural development Regulation.

2.

The Commission shall adopt the necessary measures to this end in accordance with the
procedure referred to in Article 5 of Regulation (EU) No 182/2011 i of the European

Parliament and of the Council of 16 February 2011 laying down the rules and general

principles concerning mechanisms for control by Member States of the Commission’s

exercise of implementing powers. To that effect, the Commission shall be assisted by the IPA

Committee referred to in Article 14(1) of Council Regulation (EC) No 1085/2006 i.

F. IPARD ex-post evaluation

In the rural development legislative framework for programming period 2014-2020, as regards the

implementation of the IPARD programme for Croatia, expenditure relating to the ex-post

evaluation of the IPARD programme provided for in Article 191 of Commission Regulation (EC)

No 718/2007 may be eligible under technical assistance.

1 OJ L 170, 29.6.2007, p. 1.

G. Modernisation of agricultural holdings

In the rural development legislative framework for programming period 2014-2020, as regards

Croatia, the maximum intensity of an aid for the modernisation of agricultural holdings shall be

75% of the amount of eligible investment for the implementation of Council Directive 91/676/EEC i

of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from

agricultural sources, within a maximum period of four years from the date of accession pursuant to

Articles 3(2) and 5(1) of that Directive 1 .

H. Respect of standards

In the rural development legislative framework for programming period 2014-2020, as regards

Croatia, the statutory management requirements referred to in Annex II to Council Regulation (EC)

No 73/2009 applicable in that programming period shall be respected according to the following

timetable: requirements referred to in Point A of Annex II shall apply from 1 January 2014;

requirements referred to in Point B of Annex II shall apply from 1 January 2016; and requirements

referred to in Point C of Annex II shall apply from 1 January 2018.

_____________________________________

1 OJ L 375, 31.12.1991, p. 1.

ANNEX VII

Specific commitments undertaken by the Republic of Croatia in its accession negotiations

(referred to in Article 36(1), second subparagraph, of the Act of Accession)

1.

To continue to ensure effective implementation of its Judicial Reform Strategy and Action
Plan.

2.

To continue to strengthen the independence, accountability, impartiality and professionalism
of the judiciary.

3.

To continue to improve the efficiency of the judiciary.

4.

To continue to improve the handling of domestic war crimes cases.

5.

To continue to ensure a sustained track record of substantial results based on efficient,

effective and unbiased investigation, prosecution and court rulings in organised crime and

corruption cases at all levels including high level corruption, and in vulnerable sectors such as

public procurement.

6.

To continue to improve its track record of strengthened prevention measures in the fight
against corruption and conflict of interest.

7.

To continue to strengthen the protection of minorities, including through effective

implementation of the Constitutional Act on the Rights of National Minorities (CARNM).

8.

To continue to address outstanding refugee return issues.

9.

To continue to improve the protection of human rights.

10.

To continue to cooperate fully with the International Criminal Tribunal for the former
Yugoslavia.

ANNEX VIII

Commitments undertaken by the Republic of Croatia on the restructuring of the Croatian

shipbuilding industry (referred to in Article 36(1), third subparagraph, of the Act of

Accession)

The shipbuilding companies to be restructured (hereinafter referred to as "the companies") are the

following:

− Brodograđevna industrija 3 MAJ dioničko društvo, Rijeka (hereinafter referred to as "3.

MAJ")

− BRODOTROGIR d.d., Trogir (hereinafter referred to as "Brodotrogir")

− BRODOGRAĐEVNA INDUSTRIJA SPLIT, dioničko društvo, Split (hereinafter referred to

as "Brodosplit")

− BRODOSPLIT-BRODOGRADILIŠTE SPECIJALNIH OBJEKATA društvo s ograničenom

odgovornošću, Split (hereinafter referred to as "BSO")

− BRODOGRADILIŠTE KRALJEVICA dioničko društvo za izgradnju i popravak brodova,

Kraljevica (hereinafter referred to as "Kraljevica").

Croatia agreed to carry out the restructuring of these companies through their privatisation on the

basis of a competitive tendering process. Restructuring plans for these companies have been

submitted by the bidders and accepted by the Croatian Competition Agency and the Commission.

The restructuring plans will be incorporated in the respective privatisation contracts to be concluded

between Croatia and the buyers of the companies.

The restructuring plans submitted for each of these companies specify the following key conditions

to be respected in the restructuring process:

− All State aid received by these companies since 1 March 2006 must be counted as

restructuring aid. The companies shall provide a contribution to the restructuring plan from

their own resources which must be real, free of State aid and which represents at least 40 % of

the total restructuring costs.

− The overall production capacity of the companies shall be reduced compared to the levels of 1

June 2011 from 471 324 CGT to 372 346 CGT. The companies shall reduce their production

capacities no later than twelve months after the signing of the privatisation contract. Capacity

reduction shall be implemented through the permanent closure of slipways, through the

designation of slipways for exclusive military production within the meaning of Article 346 of

the TFEU and/or through surface area reduction. The CGTs are the units of measurement of

output calculated according to the applicable OECD rules.

− The total annual production of the companies shall be limited to 323 600 CGT for a ten year

period, starting on 1 January 2011. The companies' output will be limited to the following

levels 1 :

− 3 MAJ: 109 570 CGT

− Brodotrogir: 54 955 CGT

− Brodosplit and BSO: 132 078 CGT

− Kraljevica: 26 997 CGT

The companies may agree to review their individual production limits. On the basis of binding

agreements, they can expressly establish which portion of their individual production quota

(expressed in CGTs) they cede to each other. The overall yearly production limit of 323,600

CGT shall be respected.

− The restructuring plans also specify a number of other measures which each company will

implement to ensure a return to long term viability.

1 The annual production of a given company is calculated as follows. The start of production of

a ship is the planned date of steel cutting and the end of production is the date of expected delivery

of the ship as set out in the contract with the buyer (or the anticipated date of delivery of the

incomplete ship when the construction of a ship is shared between two companies). The number of

CGTs corresponding to a ship is linearly allocated to the calendar years covering the production

period. The total output of a company in a given year is calculated by adding the number of CGTs

produced over that year.

Any subsequent change to these plans shall comply with the key conditions to be respected in the

restructuring process listed above and shall be submitted to the Commission for acceptance.

The companies shall not receive any new rescue or restructuring aid until at least ten years have

elapsed since the date of signing of the privatisation contract. Upon Croatia's accession, the

Commission shall order Croatia to recover any rescue or restructuring aid granted in breach of this

provision, with compound interest.

The restructuring plans that have been accepted by the Croatian Competition Agency and by

Commission will be incorporated in the respective privatisation contracts to be concluded between

Croatia and buyers of the companies. The privatisation contracts shall be submitted to the

Commission for acceptance and shall be signed before Croatia's accession.

The Commission shall closely monitor the implementation of the restructuring plans and the respect

of the conditions set out in this Annex regarding the level of State aid, the own contribution, the

capacity reductions, the production limitation and the measures taken to ensure a return to viability.

This monitoring shall be carried out each year of the restructuring period. Croatia shall cooperate

fully with all the arrangements for monitoring. In particular:

− Croatia shall supply the Commission with six-monthly reports concerning the restructuring of

the benefiting companies, no later than 15 January and 15 July each year until the end of the

restructuring period.

− The reports shall contain all the information necessary to monitor the restructuring process,

the own contribution, the reduction of capacity, the production limitation and the measures

taken to ensure a return to viability.

− Croatia shall submit reports on the annual output of the companies under restructuring no later

than 15 July each year, until the end of 2020.

− Croatia shall oblige the companies to disclose all relevant data which might, under other

circumstances, be considered as confidential. The Commission shall ensure that the companyspecific

confidential information is not disclosed.

The Commission may at any time decide to mandate an independent expert to evaluate the

monitoring results, undertake any research necessary and report to the Commission. Croatia will

provide full cooperation to the independent expert appointed by the Commission and ensure that he

has full access to all information he will need to carry out the tasks entrusted to him by the

Commission.

Upon Croatia's accession, the Commission shall order Croatia to recover all rescue or restructuring

aid granted since 1 March 2006 to a particular company, with compound interest if :

− the privatisation contract for this company has not yet been signed or does not fully

incorporate the conditions set out in the restructuring plan accepted by the Croatian

Competition Agency and by the Commission, or

− the company has not provided a real, State aid free contribution from its own resources which

represents at least 40 % of the restructuring costs, or

− the reduction of the overall production capacity has not been implemented within twelve

months after the signing of the privatisation contract. In that case, the recovery of the aid shall

only be required from those companies that have not achieved the following individual

reductions of capacity:

− 3 MAJ: by 46 543 CGT

− Brodotrogir: by 15 101 CGT

− Brodosplit and BSO: by 29 611 CGT

− Kraljevica: by 9 636 CGT

− the overall production limitation for the shipyards (i.e. 323 600 CGT) has been exceeded in

any individual calendar year between 2011 and 2020. In that case, the recovery of the aid shall

be required from those companies that have exceeded their individual production limits (if

applicable, as amended by a legally binding agreement with another shipbuilding company).

_______________________

ANNEX IX

Commitments undertaken by the Republic of Croatia on the restructuring of the steel sector

(referred to in Article 36(1), third subparagraph, of the Act of Accession)

By letter dated 23 May 2011, Croatia informed the Commission that it received recognition of debt

from the steel producer CMC Sisak d.o.o., corresponding to the restructuring aid, received by this

company over the period from 1 March 2002 until 28 February 2007, plus compound interests 1 . The

State aid received, without compound interests, amounts to HRK 19 117 572,36.

Upon Croatia's accession, in case the total amount of this aid plus compound interests has not been

reimbursed by CMC Sisak d.o.o., the Commission shall order Croatia to recover any rescue and

restructuring aid granted to this company since 1 March 2006, with compound interests.

______________________

1 To be calculated according to Articles 9-11 of Commission Regulation (EC) No 794/2004 of

21 April 2004 implementing Council Regulation (EC) No 659/1999 i of 22 March 1999 laying down

detailed rules for the application of Article 93 of the EC Treaty (OJ L 140, 30.04.2004, p. 1), as last

amended by Commission Regulation (EC) No 1125/2009 of 23 November 2009.

PROTOCOL

on certain arrangements concerning a possible one-off transfer of assigned amount units

issued under the Kyoto Protocol to the Republic of Croatia, as well as the related

compensation

THE HIGH CONTRACTING PARTIES,

NOTING that in view of the specific historical circumstances that have affected Croatia, it has been

agreed to express a readiness to provide assistance to Croatia through a one-off transfer of Assigned

Amount Units issued under the Kyoto Protocol,

NOTING that any such transfer would only be made on a single occasion, would not set a precedent

and would reflect the unique and exceptional nature of Croatia's situation,

STRESSING that any such transfer would have to be compensated for by Croatia through an

adjustment of its obligations under Decision No 406/2009/EC so as to ensure environmental

integrity by avoiding an increase in the total amount of allowed emissions of the Union and Croatia

until 2020,

HAVE AGREED ON THE FOLLOWING PROVISIONS:

PART I

TRANSFER

Article 1

This Part shall apply to measures relating to a possible one-off transfer of a quantity of Assigned

Amount Units issued under the Kyoto Protocol (AAUs) to Croatia.

Article 2

No transfer shall take place unless Croatia has withdrawn its appeal against the decision of the

enforcement branch of the Compliance Committee of the Kyoto Protocol in accordance with any

relevant rules and time-limits governing the withdrawal of appeals, before the start of the UNFCCC

Conference in Durban (28 November - 9 December 2011).

Any transfer shall be conditional upon the determination by the UNFCCC Expert Review Team,

after the true-up period, that Croatia has fallen short of its commitments under Article 3 of the

Kyoto Protocol.

No transfer shall take place unless Croatia has made all reasonable efforts to comply with its

commitments under Article 3 of the Kyoto Protocol, including the full use of removal units from

land use, land-use change and forestry.

Article 3

Any decision on the transfer of AAUs shall be adopted in accordance with the examination

procedure referred to in Article 5 of Regulation (EU) No 182/2011 i 1 . The Commission shall be

2

assisted by the Climate Change Committee established by Article 9 of Decision No 280/2004/EC .

That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 i. No such

decision shall be adopted where no opinion is delivered.

1 Regulation (EU) No 182/2011 i of the European Parliament and of the Council of 16 February

2011 laying down the rules and general principles concerning mechanisms for control by

Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p.

13).

2 Decision No 280/2004/EC of the European Parliament and of the Council of 11 February 2004

concerning a mechanism for monitoring Community greenhouse gas emissions and for

implementing the Kyoto Protocol (OJ L 49, 19.2.2004, p. 1).

The AAUs to be transferred shall be drawn from the quantity of AAUs referred to in Article 2 of

Commission Decision 2006/944/EC 1 .

Any transfer shall not exceed a total quantity of seven million AAUs.

PART II

COMPENSATION

Article 4

This Part shall apply to the compensation to be provided by Croatia in the event of a transfer of

AAUs in accordance with the provisions of Part I.

Article 5

1.

Croatia shall compensate for any AAUs transferred to it through an adjustment, pursuant to
this article, of its obligations under Decision No 406/2009/EC 2 .

In particular, the equivalent amount in tonnes of carbon dioxide equivalent of any AAUs

transferred shall, pursuant to this article, be subtracted from Croatia's annual emission

allocations once they have been determined pursuant to Article 3(2) of Decision

406/2009/EC.

2.

The Commission shall publish the figures for Croatia's annual emission allocations resulting
from the subtraction made in accordance with paragraph 1.

1 Commission Decision 2006/944/EC of 14 December 2006 determining the respective emission

levels allocated to the Community and each of its Member States under the Kyoto Protocol

pursuant to Council Decision 2002/358/EC i (OJ L 358, 16.12.2006, p. 87), as amended by

Commission Decision 2010/778/EU of 15 December 2010 (OJ L 332, 16.12.2010, p. 41).

2 Decision No 406/2009/EC of the European Parliament and of the Council of 23 April 2009 on

the effort of Member States to reduce their greenhouse gas emissions to meet the Community’s

greenhouse gas emission reduction commitments up to 2020 (OJ L 140, 5.6.2009, p. 136).

FINAL ACT I. TEXT OF THE FINAL ACT

1.

The Plenipotentiaries of:
HIS MAJESTY THE KING OF THE BELGIANS,

THE PRESIDENT OF THE REPUBLIC OF BULGARIA,

THE PRESIDENT OF THE CZECH REPUBLIC,

HER MAJESTY THE QUEEN OF DENMARK,

THE PRESIDENT OF THE FEDERAL REPUBLIC OF GERMANY,

THE PRESIDENT OF THE REPUBLIC OF ESTONIA,

THE PRESIDENT OF IRELAND,

THE PRESIDENT OF THE HELLENIC REPUBLIC,

HIS MAJESTY THE KING OF SPAIN,

THE PRESIDENT OF THE FRENCH REPUBLIC,

[ENTRY FOR CROATIA TO BE INSERTED AT A LATER STAGE],

THE PRESIDENT OF THE ITALIAN REPUBLIC,

THE PRESIDENT OF THE REPUBLIC OF CYPRUS,

THE PRESIDENT OF THE REPUBLIC OF LATVIA, THE PRESIDENT OF THE REPUBLIC OF LITHUANIA,

HIS ROYAL HIGHNESS THE GRAND DUKE OF LUXEMBOURG,

THE PRESIDENT OF THE REPUBLIC OF HUNGARY,

THE PRESIDENT OF MALTA,

HER MAJESTY THE QUEEN OF THE NETHERLANDS,

THE FEDERAL PRESIDENT OF THE REPUBLIC OF AUSTRIA,

THE PRESIDENT OF THE REPUBLIC OF POLAND,

THE PRESIDENT OF THE PORTUGUESE REPUBLIC,

THE PRESIDENT OF ROMANIA,

THE PRESIDENT OF THE REPUBLIC OF SLOVENIA,

THE PRESIDENT OF THE SLOVAK REPUBLIC,

THE PRESIDENT OF THE REPUBLIC OF FINLAND,

THE GOVERNMENT OF THE KINGDOM OF SWEDEN,

HER MAJESTY THE QUEEN OF THE UNITED KINGDOM OF GREAT BRITAIN

AND NORTHERN IRELAND,

Assembled at [city to be inserted] on the [date to be inserted] on the occasion of the signature

of the Treaty between the Kingdom of Belgium, the Republic of Bulgaria, the Czech

Republic, the Kingdom of Denmark, the Federal Republic of Germany, the Republic of

Estonia, Ireland, the Hellenic Republic, the Kingdom of Spain, the French Republic, the

Italian Republic, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania,

the Grand Duchy of Luxembourg, the Republic of Hungary, the Republic of Malta, the

Kingdom of the Netherlands, the Republic of Austria, the Republic of Poland, the Portuguese

Republic, Romania, the Republic of Slovenia, the Slovak Republic, the Republic of Finland,

the Kingdom of Sweden, the United Kingdom of Great Britain and Northern Ireland (Member

States of the European Union) and the Republic of Croatia concerning the accession of the

Republic of Croatia to the European Union.

Have placed on record the fact that the following texts have been drawn up and adopted

within the Conference between the Member States of the European Union and the Republic of

Croatia concerning the accession of the Republic of Croatia to the European Union:

I. the Treaty between the Kingdom of Belgium, the Republic of Bulgaria, the Czech

Republic, the Kingdom of Denmark, the Federal Republic of Germany, the Republic of

Estonia, Ireland, the Hellenic Republic, the Kingdom of Spain, the French Republic, the

Italian Republic, the Republic of Cyprus, the Republic of Latvia, the Republic of

Lithuania, the Grand Duchy of Luxembourg, the Republic of Hungary, the Republic of

Malta, the Kingdom of the Netherlands, the Republic of Austria, the Republic of

Poland, the Portuguese Republic, Romania, the Republic of Slovenia, the Slovak

Republic, the Republic of Finland, the Kingdom of Sweden, the United Kingdom of

Great Britain and Northern Ireland (Member States of the European Union) and the

Republic of Croatia, concerning the accession of the Republic of Croatia to the

European Union (hereinafter "the Treaty of Accession");

II. the Act concerning the conditions of accession of the Republic of Croatia and the

adjustments to the Treaty on European Union, the Treaty on the Functioning of the

European Union and to the Treaty establishing the European Atomic Energy

Community (hereinafter "the Act of Accession");

III. the texts listed below which are annexed to the Act of Accession:

A. Annex I: List of conventions and protocols to which the Republic of Croatia

accedes upon accession (referred to in Article 3(4) of the Act of

Accession),

Annex II: List of provisions of the Schengen acquis as integrated into the

framework of the European Union and the acts building upon it or

otherwise related to it, to be binding on and applicable in the Republic

of Croatia as from accession (referred to in Article 4(1) of the Act of

Accession),

Annex III: List referred to in Article 15 of the Act of Accession: adaptations to

acts adopted by the institutions,

Annex IV: List referred to in Article 16 of the Act of Accession: other permanent

provisions,

Annex V: List referred to in Article 18 of the Act of Accession: transitional

measures,

Annex VI: Rural development (referred to in Article 35(2) of the Act of

Accession),

Annex VII: Specific commitments undertaken by the Republic of Croatia in its

accession negotiations (referred to in Article 36(1), second

subparagraph, of the Act of Accession),

Annex VIII: Commitments undertaken by the Republic of Croatia on the

restructuring of the Croatian shipbuilding industry (referred to in

Article 36(1), third subparagraph, of the Act of Accession),

Annex IX: Commitments undertaken by the Republic of Croatia on the

restructuring of the steel sector (referred to in Article 36(1), third

subparagraph, of the Act of Accession);

B. Protocol on certain arrangements concerning a possible one-off transfer of

assigned amount units issued under the Kyoto Protocol to the Republic of Croatia,

as well as the related compensation;

C. the texts of the Treaty on European Union, the Treaty on the Functioning of the

European Union and of the Treaty establishing the European Atomic Energy

Community, and the Treaties amending or supplementing them, including the

Treaty concerning the accession of the Kingdom of Denmark, Ireland and the

United Kingdom of Great Britain and Northern Ireland, the Treaty concerning the

accession of the Hellenic Republic, the Treaty concerning the accession of the

Kingdom of Spain and the Portuguese Republic, the Treaty concerning the

accession of the Republic of Austria, the Republic of Finland and the Kingdom of

Sweden, the Treaty concerning the accession of the Czech Republic, the Republic

of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of

Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of

Poland, the Republic of Slovenia and the Slovak Republic and the Treaty

concerning the accession of the Republic of Bulgaria and Romania in the Croatian

language.

2.

The High Contracting Parties have reached political agreement on a set of adaptations to acts

adopted by the institutions required by reason of accession and invite the Council and the

Commission to adopt these adaptations before accession in accordance with Article 50 of the

Act of Accession, as referred to in Article 3(4) of the Treaty of Accession, completed and

updated where necessary to take account of the evolution of the law of the Union.

3.

The High Contracting Parties undertake to communicate to the Commission and to each other
all necessary information required for the application of the Act of Accession.

Where necessary, this information shall be provided in such good time before the date of

accession as to enable the full application of the Act of Accession from the date of accession,

in particular as regards the functioning of the internal market. In this context early notification

under Article 47 of the Act of Accession of the measures adopted by the Republic of Croatia

is of primary importance. The Commission may inform the Republic of Croatia of the time by

which it considers it appropriate to receive or transmit specific information. By this day of

signature, the Contracting Parties were provided with a list setting out the information

obligations in the veterinary domain.

4.

The Plenipotentiaries have taken note of the following Declarations which have been made
and are annexed to this Final Act:

[A.] Joint Declaration by the present Member States

[1.] Joint Declaration on the full application of the provisions of the Schengen

acquis

[B.] Joint Declaration by various present Member States

[1.] Joint Declaration by the Federal Republic of Germany and the

Republic of Austria on the free movement of workers: Croatia

[C.] Joint Declaration by the present Member States and the Republic of Croatia

[1.] Joint Declaration on the European Development Fund

[D.] Declaration by the Republic of Croatia

[1.] Declaration by the Republic of Croatia concerning the transitional

arrangement for the liberalisation of the Croatian agricultural land market

5.

The Plenipotentiaries have taken note of the Exchange of Letters between the European Union
and the Republic of Croatia on an information and consultation procedure for the adoption of

certain decisions and other measures to be taken during the period preceding accession and

which is attached to this Final Act.

["Done at….on"…:to be inserted in all the official languages, including Croatian]

Pour Sa Majesté le Roi des Belges

Voor Zijne Majesteit de Koning der Belgen

Für Seine Majestät den König der Belgier

Cette signature engage également la Communauté française, la Communauté flamande, la

Communauté germanophone, la Région wallonne, la Région flamande et la Région de Bruxelles

Capitale.

Deze handtekening verbindt eveneens de Vlaamse Gemeenschap, de Franse Gemeenschap, de

Duitstalige Gemeenschap, het Vlaamse Gewest, het Waalse Gewest en het Brussels Hoofdstedelijk

Gewest.

Diese Unterschrift bindet zugleich die Deutschsprachige Gemeinschaft, die Flämische

Gemeinschaft, die Französische Gemeinschaft, die Wallonische Region, die Flämische Region und

die Region Brüssel-Hauptstadt.

За Република България

Za prezidenta České republiky

For Hendes Majestæt Danmarks Dronning

Für den Präsidenten der Bundesrepublik Deutschland

Eesti Vabariigi Presidendi nimel

Thar ceann Uachtarán na hÉireann

For the President of Ireland

Για τον Пρόεδρο της Еλληνικής ∆ηµοκρατίας

Por Su Majestad el Rey de España

Pour le Président de la République française

[Insert translation into Croatian: Entry for Croatia to be inserted at a later stage] Per il Presidente della Repubblica italiana

Για τον Πρόεδρο της Κυπριακής ∆ηµοκρατίας

Latvijas Republikas Valsts prezidentas vārdā

Lietuvos Respublikos Prezidento vardu

Pour Son Altesse Royale le Grand-Duc de Luxembourg

A Magyar Köztársaság Elnöke részéről

Għall-President ta' Malta

Voor Hare Majesteit de Koningin der Nederlanden

Für den Bundespräsidenten der Republik Österreich

Za Prezydenta Rzeczypospolitej Polskiej

Pelo Presidente da República Portuguesa

Pentru Preşedintele României

Za predsednika Republike Slovenije

Za prezidenta Slovenskej republiky

Suomen Tasavallan Presidentin puolesta

För Republiken Finlands President

För Konungariket Sveriges regering

For Her Majesty the Queen of the United Kingdom of Great Britain and Northern Ireland

______________________

II. DECLARATIONS

[A.] JOINT DECLARATION BY THE PRESENT MEMBER STATES

[1.] Joint Declaration on the full application of the provisions of the Schengen acquis

It is understood that the agreed procedures for the future full application by Croatia of all provisions

of the Schengen acquis – as they will be included in the Treaty concerning Croatia’s accession to

the Union – are without prejudice to and have no implications for the decision to be taken by the

Council for the full application of the provisions of the Schengen acquis in Bulgaria and Romania.

The decision of the Council on the full application of the provisions of the Schengen acquis in

Bulgaria and Romania shall be taken on the basis of the procedure laid down in that respect in the

2005 Treaty concerning the accession of Bulgaria and Romania to the EU and in line with the

Council Conclusions of 9 June 2011 on the completion of the process of evaluation of the state of

preparedness of Bulgaria and Romania to implement all provisions of the Schengen acquis.

The agreed procedures for the future full application by Croatia of all provisions of the Schengen

acquis - as they will be included in the Treaty concerning Croatia's accession to the Union - do not

create a legal obligation in any other context than that of Croatia's Accession Treaty.

____________________

[B.] JOINT DECLARATION BY VARIOUS PRESENT MEMBER STATES

[1.] Joint Declaration by the Federal Republic of Germany and the Republic of Austria on the

free movement of workers: Croatia

The wording of point 12 of the transitional measures on the free movement of workers under

Directive 96/71/EC i in Annex V to the Act of Accession is understood by the Federal Republic of

Germany and the Republic of Austria in agreement with the Commission as meaning that ‘certain

regions’ may, where appropriate, also comprise the entire national territory.

_____________________

[C.] JOINT DECLARATION BY THE PRESENT MEMBER STATES AND

THE REPUBLIC OF CROATIA

[1.] Joint Declaration on the European Development Fund

The Republic of Croatia will accede to the European Development Fund (EDF) as of the entry into

force of the new Multiannual Financial Framework of Cooperation following its accession to the

Union and will contribute to it as from the 1 January of the second calendar year following the date

of its accession.

__________________________

[D.] DECLARATION BY THE REPUBLIC OF CROATIA

[1.] Declaration by the Republic of Croatia concerning the transitional arrangement for

the liberalisation of the Croatian agricultural land market

Having regard to the transitional arrangement with respect to the acquisition of agricultural land

in the Republic of Croatia by natural and legal persons from the EU/EEA, as provided for in Annex

V of the Act of Accession,

Having regard to the provision which stipulates that the Commission, at the request of the Republic

of Croatia, shall decide upon the extension of the seven-year transitional period for additional 3

years, provided that there is sufficient evidence that, upon expiry of the seven-year transitional

period, there will be serious disturbances or a threat of serious disturbances on the agricultural

land market of the Republic of Croatia,

The Republic of Croatia declares that, should the above-mentioned extension of the transitional

period be granted, it will endeavour to carry out the necessary steps to liberalise the acquisition of

agricultural land in the specified areas before expiry of the fixed three-year period.

___________________

III. EXCHANGE OF LETTERS

between the European Union and the Republic of Croatia on an information and consultation

procedure for the adoption of certain decisions and other measures to be taken during the

period preceding accession

Letter o 1

Sir,

I have the honour to refer to the question concerning an information and consultation procedure for

the adoption of certain decisions and other measures to be taken during the period preceding the

accession of your country to the European Union which was raised in the framework of the

accession negotiations.

I hereby confirm that the European Union is able to agree to such a procedure, in the terms set out

in the Annex to this letter, which could be applied in respect of the Republic of Croatia as from the

date on which the Accession Conference declares that the accession negotiations have been finally

concluded.

I should be obliged if you could confirm that your Government is in agreement with the contents of

this letter.

Yours faithfully,

Letter o 2

Sir,

I have the honour to acknowledge receipt of your letter which reads as follows:

‘I have the honour to refer to the question concerning an information and consultation procedure for

the adoption of certain decisions and other measures to be taken during the period preceding the

accession of your country to the European Union which was raised in the framework of the

accession negotiations.

I hereby confirm that the European Union is able to agree to such a procedure, in the terms set out

in the Annex to this letter, which could be applied in respect of the Republic of Croatia as from the

date on which the Accession Conference declares that the accession negotiations have been finally

concluded.

I should be obliged if you could confirm that your Government is in agreement with the contents of

this letter.’

I have the honour to confirm that my Government is in agreement with the contents of this letter.

Yours faithfully,

_________________

A EX

Information and consultation procedure for the adoption of certain decisions and other

measures to be taken during the period preceding accession

I.

1.

In order to ensure that the Republic of Croatia, hereinafter referred to as 'Croatia', is kept

adequately informed, any proposal, communication, recommendation or initiative which is

intended to lead to the adoption of legal acts of the European Parliament and Council, the

Council, or the European Council shall be brought to the knowledge of Croatia after being

transmitted to the Council or the European Council.

2.

Consultations shall take place pursuant to a reasoned request by Croatia, which shall set out
expressly therein its interests as a future member of the Union and its observations.

3.

Administrative decisions shall not, as a general rule, give rise to consultations.

4.

Consultations shall take place within an Interim Committee composed of representatives of
the Union and of Croatia. Save for a reasoned objection from the Union or Croatia,

consultations may also take place in the form of the exchange of messages by electronic

means, in particular in the common foreign and security policy.

5.

On the Union side, the members of the Interim Committee shall be the members of the

Permanent Representatives Committee or persons designated by them for this purpose. Where

appropriate, the members may be the Members of the Political and Security Committee. The

Commission shall be adequately represented.

6.

The Interim Committee shall be assisted by a Secretariat, which shall be that of the
Conference, continued for this purpose.

7.

Consultations shall take place as soon as the preparatory work carried out at Union level with
a view to the adoption of the acts mentioned in point 1 above has produced common

guidelines enabling such consultations to be usefully arranged.

8.

If serious difficulties remain after consultations, the matter may be raised at ministerial level
at the request of Croatia.

9.

The above provisions shall apply mutatis mutandis to the decisions of the Board of Governors
of the European Investment Bank.

10.

The procedure laid down in the above paragraphs shall also apply to any decision to be taken

by Croatia which might affect the commitments resulting from its position as a future member

of the Union.

II.

11.

The Union and Croatia shall take the necessary measures to ensure that its accession to the
agreements or conventions and protocols referred to in Articles 3(4), 6(2) and 6(5) of the Act

concerning the conditions of accession of the Republic of Croatia and the adjustments to the

Treaties on which the European Union is founded, hereinafter referred to as 'the Act of

Accession', coincides so far as possible with the entry into force of the Treaty of Accession.

12.

With regard to the negotiations with the co-contracting parties of the protocols referred to in

Article 6(2), second subparagraph, of the Act of Accession, the representatives of Croatia

shall be associated with the work as observers, side by side with the representatives of the

present Member States.

13.

Certain non-preferential agreements concluded by the Union, which remain in force after the

date of accession, may be the subject of adaptations or adjustments in order to take account of

the enlargement of the Union. These adaptations or adjustments will be negotiated by the

Union in association with the representatives of Croatia in accordance with the procedure

referred to in the preceding paragraph.

III.

14.

The institutions shall, in due course, draw up the texts referred to in Article 52 of the Act of

Accession. To that end, Croatia shall provide the institutions with translations of those texts in

a timely manner.

_______________________

ANNEX II

COUNCIL OF Brussels, 13 September 2011

THE EUROPEAN UNION

GENERAL SECRETARIAT

AC 30/11

LIMITE

FINAL EUROPEAN UNION AND CANDIDATE COUNTRY AGREED TEXT ON THE

ACCESSION TREATY

Subject: Accession Treaty:

Appendix to Annex V

Candidate country: Croatia

1.
Texts in square brackets [ ] are for information. These could include:
- -
  
  the reference text in English of the adaptation inserted in the relevant candidate country
  language, where necessary,
- -
  
  data which still needs to be confirmed,
- -
  
  reminders for a later date.

2.

The draft provisions included in this text are those that are required in relation to the specific
acquis screened and negotiated under this chapter, within the framework of the list of chapter

headings defined by the EU at the beginning of the negotiations with Croatia.

_____________________

Appendix to Annex V

List(*) as provided by Croatia in one language of medicinal products for which a marketing authorisation issued under Croatian law prior to the date of accession shall remain valid until it is renewed in compliance with the acquis or until 30 June 2017, whichever is the earlier.

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

NAME OF THE MEDICINAL NATURE AND CONTENTS OF Generic PHARMACEUTICAL FORM MANUFACTURER Domestic Imported Proprietary nCADREAC CP MRP OTC Herbal Immunological Blood Orphan

PRODUCT CONTAINER UDMP

50 mL of solution in a glass injection

1M potassium-chloride (7.45%) concentrate for intravenous Hrvatski zavod za transfuzijsku concentrate 50 mL after reconstitution medicinu, Petrova 3, Zagreb, bottle with a chlorobutyl stopper YES YES

Republic of Croatia protected with an aluminium cap (40 bottles per box)

1M sodium hydrogencarbonate 100 mL of solution in a glass infusion (8.4%) solution for intravenous solution for intravenous Hrvatski zavod za transfuzijsku bottle with rubber stopper protected by

infusion, 100 mL infusion

medicinu, Petrova 3, Zagreb,

Republic of Croatia Al cap, 20 bottles with plastic holders

YES YES

in a box

15 mL of solution in an amber glass

A.T. 10 solution oral solution Merck KGaA, Frankfurter Straße 250, Darmstadt, Germany bottle with plastic dropper attachment, YES YES

supplied in a box

Abaktal 400 mg film coated Lek farmacevtska družba d.d., tablets film coated tablets Verovškova 57, Ljubljana, 10 (1x10) tablets in a blister, supplied YES YES Republic of Slovenia in a box

Abaktal 400 mg/5 mL solution for Lek farmacevtska družba d.d., injection solution for injection Verovškova 57, Ljubljana, 10 ampoules each containing 5 mL of YES Republic of Slovenia solution, supplied in a box

YES

Accupro 10 mg tablets film coated tablets Gödecke GmbH, dio Pfizer 30 (3x10) tablets in a blister, supplied grupe, Karlsruhe, Germany in a box YES YES

Accupro 20 mg tablets film coated tablets Gödecke GmbH, dio Pfizer 31 (3x10) tablets in a blister, supplied grupe, Karlsruhe, Germany in a box YES YES

Accupro 5 mg tablets film coated tablets Gödecke GmbH, dio Pfizer 32 (3x10) tablets in a blister, supplied grupe, Karlsruhe, Germany in a box YES YES

Novartis Pharma Stein AG, 100 mL solution in a plastic bottle with

Aclasta 5 mg solution for infusion solution for infusion Schaffhauserstrasse, Stein, rubber stopper, aluminum ring and YES YES YES

Switzerland plastic protective cap, 1 bottle in a box

Bottle with 1 dose of lyophilised

Act HIB, vaccine against lyophilisate and diluent for Haemophilus influenzae type B preparation of injection

Sanofi Pasteur S.A., 2 avenue vaccine and 1 glass syringe with

solution Pont Pasteur, Lyon, France solvent for preparation for injection

YES YES

(0.5 mL), supplied in a box

50 mg of lyophilisate in a bottle, 50 mL

Actilyse lyophilisate for injection lyophilisate and diluent for

Boehringer Ingelheim Pharma

GmbH & Co. KG, Birkendorfer of solvent (water for injection) in a

50 mg preparation of solution for injection Strasse 65, Biberach an der Riss, bottle and a transfer needle, supplied YES YES

Germany in a box

28 tablets in a plastic calendar dial

Activelle film coated tablets Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark pack (dispenser with marked days of YES YES

the week), supplied in a box

Procter & Gamble

Actonel 30 mg tablets film coated tablets Pharmaceuticals Germany 28 (2x14) tablets in a blister, supplied

GmbH, Weiterstadt, Germany in a box

YES YES

Procter & Gamble

Actonel 35 mg tablets film coated tablets Pharmaceuticals Germany 4 (1x4) tablets in a blister, supplied in YES YES

GmbH, Weiterstadt, Germany a box

Procter & Gamble

Actonel 5 mg tablets film coated tablets Pharmaceuticals Germany 28 (2x14) tablets in a blister, supplied

GmbH, Weiterstadt, Germany in a box

YES YES

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Actrapid HM 100 solution for injection (for s.c., Novo Nordisk A/S, Novo Allé, 10 mL of solution in a glass bottle, i.m. and i.v. use) DK-2880 Bagsvaerd, Denmark supplied in a box YES YES

Novo Nordisk A/S, Novo Alle,

Bagsvaerd, Denmark Novo

Actrapid Penfill solution for subcutaneous injection Nordisk Production SAS, 45, 5 glass cartridges with 3 mL of solution YES

Avenue d' Orleans, Chartres, in a blister, supplied in a box

YES

France

SmithKline Beecham

Adartrel 0.25 mg tablets film coated tablets Pharmaceuticals, Crawley, West 12 (1x12) tablets in PVC/PCTFE/Al

Sussex, Great Britain blister, supplied in a box

YES YES YES YES

SmithKline Beecham

Adartrel 0.5 mg tablets film coated tablets Pharmaceuticals, Crawley, West 28 (2x14) tablets in a PVC/PCTFE/Al

Sussex, Great Britain blister, supplied in a box

YES YES YES YES

SmithKline Beecham

Adartrel 2 mg tablets film coated tablets Pharmaceuticals, Crawley, West 28 (2x14) tablets in a PVC/PCTFE/Al YES YES YES YES

Sussex, Great Britain blister, supplied in a box

Adriblastina PFS 10 mg injection

(2 mg/mL) solution for injection Pfizer Italia S.r.I., Milano, Italy

5 mL of solution for injection in a glass

bottle, supplied in a box YES YES

Adriblastina PFS 50 mg injection

(2 mg/mL) solution for injection Pfizer Italia S.r.I., Milano, Italy

25 mL of solution for injection in a

glass bottle, supplied in a box YES YES

Advantan cream cream Intendis Manufacturing S.p.A., 15 g of cream in an aluminum tube, Segrate, Milano, Italy supplied in a box YES YES

Advantan ointment ointment Intendis Manufacturing S.p.A., 15 g of cream in an aluminum tube, Segrate, Milano, Italy supplied in a box YES YES

Schering-Plough Labo N.V. 60 mL of syrup in an amber glass

Aerius syrup of 0.5 mg/mL syrup Industrepark 30, Heist-op-denbottle and a measuring spoon, YES YES

Berg, Belgium supplied in a box

Schering-Plough Labo N.V.

Aerius 5 mg film coated tablets film coated tablets Industrepark 30, Heist-op-den 10 (1x10) tablets in a blister, supplied YES YES

Berg, Belgium in a box

Belupo, lijekovi i kozmetika d.d., 20 grams of cream in an aluminum

Afloderm cream cream Ulica Danica 5, Koprivnica, tube with a plastic cap, supplied in a YES YES

Republic of Croatia box

Belupo, lijekovi i kozmetika d.d., 40 g of cream in an aluminium tube

Afloderm cream cream Ulica Danica 5, Koprivnica, with a plastic stopper, supplied in a YES YES

Republic of Croatia box

Belupo, lijekovi i kozmetika d.d., 20 grams of ointment in an aluminum

Afloderm ointment ointment Ulica Danica 5, Koprivnica, tube with a plastic cap, supplied in a YES YES

Republic of Croatia box

Afluria suspension for injection in CSL Limited, 45 Poplar Road, Box with 1 pre-filled syringe (glass,

pre-filled syringe, influenza suspension for injections Parkville, Melbourne, Victoria type I) with a needle, with 1 dose of YES YES

vaccine (fragmented inactivated) 3052, Australija vaccine (0.5 mL of suspension)

Aggrastat concentrate of solution concentrate of solution for Merck Sharp & Dohme B.V., for infusion infusion Waarderweg 39, Postbus 581, 50 mL of solution concentrate in a YES YES Haarlem, The Nederlands glass bottle, supplied in a box

YES

Aggrenox 200/25 mg modified modified release capsules, Boehringer Ingelheim Pharma

60 capsules in a white plastic (PP)

release capsules hard GmbH&Co.KG, Biberach an der

container with a plastic (PE) temper YES YES

Riss, Germany evident stopper with a desiccant, supplied in a box

60 tablets in a plastic (HDPE) bottle

Aglurab 1000 film coated tablets Weifa AS, Oslo, Norway with a plastic stopper (there is a bag in a bottle or a capsule in a stopper YES YES

containing silicagel to attenuate the

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tablet odor)

Aglurab 850 film coated tablets Weifa AS, Oslo, Norway 36 tablets in a plastic (HDPE) bottle with a desiccant YES YES

Agrippal vaccine against suspension for Pre-filled syringe with a needle

influenza (surface antigen, intramuscular or Chiron S.r.l, Siena, Italy (containing a single 0.5-mL vaccine YES YES

inactivated) subcutaneous administration dose in the form of suspension)

Agrippal suspension for A pre-filled syringe (glass type I) injections in pre-filled syringe, suspension for injections in Novartis Vaccines & Diagnostics containing 0.5 mL of suspension, influenza vaccine (surface a pre-filled syringe S.r.l., Siena, Italy equipped with a needle (23G, 1"; or YES YES

antigens), inactivated 25G, 1"; or 25G, 5/8";) and a rubber plunger stopper, supplied in a box

Ebewe Pharma Ges. m.b.H. Nfg.

Akineton injection solution for injection KG, Mondseestrasse 11, 5 ampoules with 1 mL of solution for

Unterach, Austria injection, supplied in a carton box

YES YES

Laboratorio Farmaceutico S.I.T.

Akineton tablets tablets Srl, Via Cavour 70, Mede (PV), 50 tablets (5x10) in a PVC/Al blister,

Italy supplied in a box

YES YES

Jadran - Galenski laboratorij d.d., 30 mL of solution in an amber glass

Aknet dermal solution Pulac bb, Rijeka, Republic of bottle with a dropper and a plastic YES YES

Croatia stopper, supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Aktivin H capsule capsules Ulica Danica 5, Koprivnica, 30 (2x15) capsules in a PVC/PVDC/Al YES YES YES

Republic of Croatia blister, supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Aktivin H capsules capsules Ulica Danica 5, Koprivnica, 60 capsules in a polypropylene bag, YES

Republic of Croatia supplied in a box

YES YES

Alkaloid AD - Skopje, Skopje, Amber glass bottle with powder for

Alamcin 250 mg/5 mL powder for powder for preparation of FYROM in cooperation with preparation of 100 mL of suspension

oral suspension oral suspension BILIM PHARMACEUTICALS with a polyethylene stopper and a YES YES

A.S., Maslak Istanbul, Turkey plastic spoon, supplied in a box

25 mL of solution in an amber glass

Albothyl solution solution Altana Pharma AG, Byk-Gulden Strasse 2, Konstanz, Germany bottle with black plastic cap, supplied YES YES

in a box

Albothyl pessaries pessaries Altana Pharma AG, Byk-Gulden 6 pessaries in a white non-transparent Strasse 2, Konstanz, Germany plastic foil (PVC/PE), supplied in a box YES YES

Human albumin 20% solution for Imunološki zavod d.d., intravenous use solution for intravenous use Rockefellerova 2, Zagreb,

Glass bottle with 50 mL of solution,

Republic of Croatia supplied in a box

YES YES

Human albumin 20% solution Imunološki zavod d.d., for i.v. use solution for intravenous use Rockefellerova 2, Zagreb, Glass bottle with 100 mL of solution, YES YES Republic of Croatia supplied in a box

Human albumin 20% solution Imunološki zavod d.d.,

for intravenous use (Albumini solution for infusion Rockefellerova 2, Zagreb, Glass bottle with 50 mL of solution, YES humani solutio), 200g/l Republic of Croatia supplied in a box

YES

Human albumin 20% solution for Imunološki zavod d.d.,

intravenous use (Albumini solution for infusion Rockefellerova 2, Zagreb, Glass bottle with 100 mL of solution, YES humani solutio), 200g/l blood Republic of Croatia supplied in a box

YES

Albumin (human) 5% solution for Imunološki zavod d.d., One glass vial with 250 mL of solution,

intravenous use solution for intravenous use Rockefellerova 2, Zagreb, YES YES Republic of Croatia supplied in a box

Aldactone 100 mg capsules capsules Roche Farma S.A., Madrid, Spain 20 (2x10) capsules in PVC/Al blister, supplied in a box YES YES

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Aldactone 25 mg coated tablets coated tablets Roche Farma S.A., Madrid, Spain 50 (5x10) coated tablets in a PVC/Al blister, supplied in a box YES YES

Aldactone 50 mg coated tablets coated tablets Roche Farma S.A., Madrid, Spain 20 (2x10) coated tablets in PVC/Al blister, supplied in a box YES YES

Alkaloid AD - Skopje, Bulevar

Aldizem 60 mg tablets Aleksandar Makedonski 12, 34 (3x10) tablets in a PVC/Al blister, YES YES

Skopje, FYROM supplied in a box

Alkaloid AD - Skopje, Bulevar

Aldizem 90 mg tablets Aleksandar Makedonski 12, 35 (3x10) tablets in a PVC/Al blister,

Skopje, FYROM supplied in a box

YES YES

Aldurazyme 100 U/mL

concentrate for solution for concentrate for solution for

Genzyme Ltd., 37 Hollands One glass vial with 5 mL of solution

infusion infusion

Road, Haverhill, Suffolk CB9 YES

8PU, Great Britain concentrate, supplied in a box

YES YES YES YES

Belupo, lijekovi i kozmetika d.d.,

Aledox 70 mg tablets tablets Ulica Danica 5, Koprivnica, 4 (1x4) tablets in a PA/Al/PVC//Al YES YES

Republic of Croatia blister, supplied in a box

Pliva Croatia Ltd., Ulica grada

Alendor 70 tablets Vukovara 49, Zagreb, Republic of 4 (1x4) tablets in a blister

Croatia (PVC/PE/PVDC//AI), supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Alendor tablets 5 mg tablets Vukovara 49, Zagreb, Republic of 28 (4x7) tablets in a blister, supplied in

Croatia a box

YES YES

Pliva Croatia Ltd., Ulica grada

Alendor tablets10 mg tablets Vukovara 49, Zagreb, Republic of 28 (4x7) tablets in a blister, supplied in

Croatia a box

YES YES

Pliva Croatia Ltd., Ulica grada

Alfuzosin Pliva tablets 10 mg film coated tablets with 33 (3x10) tablets in a PVC/Al blister, prolonged-release Vukovara 49, Zagreb, Republic of YES YES

Croatia supplied in a box

Pliva Croatia Ltd., Ulica grada

Alfuzosin Pliva tablets 5 mg prolonged-release filmcoated tablets Vukovara 49, Zagreb, Republic of 23 (2x10) tablets in a blister (PVC/Al) , YES

Croatia supplied in a box

YES

Alimta 500 mg powder for powder for concentrate for Lilly France S.A.S., Rue du

infusion solution concentrate infusion solution Colonel Lilly, Fegersheim, France Glass bottle, supplied in a box YES YES YES

Alkagin 2.5 g/5 mL solution for Alkaloid AD - Skopje, Bulevar 50 (5x10) ampoules each with 5 mL of

injection solution for injection Aleksandar Makedonski 12, solution in a protective container, YES YES Skopje, FYROM supplied in a box

Alkaloid AD - Skopje, Bulevar

Alkagin 500 mg tablets tablets Aleksandar Makedonski 12, 10 (1x10) tablets in a PVC/Al blister,

Skopje, FYROM supplied in a box

YES YES

Alkaloid AD - Skopje, Skopje,

Almacin 500 mg capsules capsules FYROM in cooperation with 16 capsules in a A/PVC blister, BILIM PHARMACEUTICALS supplied in a box YES YES

A.S., Maslak Istanbul, Turkey

60 mL of solution in a white plastic

Belupo, lijekovi i kozmetika d.d., bottle with a plastic stopper, a

Alomax 2% dermal solution dermal solution Ulica Danica 5, Koprivnica, metering plastic pump and a spray YES YES YES

Republic of Croatia attachment, in a protective bag,

supplied in a box

60 mL of solution in a white plastic

Belupo, lijekovi i kozmetika d.d., bottle with a plastic stopper, a

Alomax 5% dermal solution dermal solution Ulica Danica 5, Koprivnica, metering plastic pump and a spray YES YES YES

Republic of Croatia attachment, in a protective bag,

supplied in a box

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Alomide 1 mg/mL eye drops eye drops Alcon-Couvreur s.a., Rijksweg 5 mL of solution in a plastic bottle with 14, Puurs, Belgium a dropper, supplied in a carton box YES YES

Belupo, lijekovi i kozmetika d.d.,

Alopurinol 100 mg tablets tablets Ulica Danica 5, Koprivnica, 100 tablets in a plastic bottle, supplied

Republic of Croatia in a box

YES YES

Helsinn Birex Pharmaceuticals

Aloxi, solution for injection solution for injection Ltd., Damastown, Mulhuddart, One glass vial with 5 mL of solution, YES YES YES

Dublin 15, Republic of Ireland supplied in a box

Allergan Pharmaceuticals

Alphagan eye drops eye drops Republic of Ireland, Castlebar 5 mL of solution in a plastic bottle with Road, Westport, Co Mayo, a dropper, supplied in a box YES YES

Republic of Ireland

Alvesco 160 Inhaler pressurized inhalant, Altana Pharma AG, Byk-Gulden

Al container with a metering valve,

solution Strasse 2, Konstanz, Germany mouthpiece and stopper, 60 YES YES YES inhalations

Alvesco 40 Inhaler pressurized inhalant, Altana Pharma AG, Byk-Gulden

Al container with a metering valve,

solution Strasse 2, Konstanz, Germany mouthpiece and stopper, 60 YES YES YES inhalations

Alvesco 80 Inhaler pressurized inhalant, Altana Pharma AG, Byk-Gulden

Al container with a metering valve,

solution Strasse 2, Konstanz, Germany mouthpiece and stopper, 60 YES YES YES inhalations

Amaryl 1.0 tablets Aventis Pharma S.p.A., S.S. 17 30 (2x15) tablets in a blister, supplied KM 22, Scoppito, Italy in a box YES YES

Amaryl 2.0 tablets Aventis Pharma S.p.A., S.S. 17 30 (2x15) tablets in a blister, supplied KM 22, Scoppito, Italy in a box YES YES

Amaryl 3.0 tablets Aventis Pharma S.p.A., S.S. 17 30 (2x15) tablets in a blister, supplied KM 22, Scoppito, Italy in a box YES YES

Jadran - Galenski laboratorij d.d.,

Amicor 10 tablets Pulac bb, Rijeka, Republic of 41 (3x10) tablets in a PVC/Al blister, YES

Croatia supplied in a box

YES

Jadran - Galenski laboratorij d.d.,

Amicor 20 tablets Pulac bb, Rijeka, Republic of 42 (3x10) tablets in a PVC/Al blister, YES YES

Croatia supplied in a box

Jadran - Galenski laboratorij d.d.,

Amicor 5 tablets Pulac bb, Rijeka, Republic of 20 (1x20) tablets in a PVC/Al blister,

Croatia supplied in a box

YES YES

Jadran - Galenski laboratorij d.d.,

Amicor H 10 tablets Pulac bb, Rijeka, Republic of 20 (1x20) tablets in a PVC/Al blister, YES

Croatia supplied in a box

YES

Jadran - Galenski laboratorij d.d.,

Amicor H 10 tablets Pulac bb, Rijeka, Republic of 43 (3x10) tablets in a PVC/Al blister,

Croatia supplied in a box

YES YES

Jadran - Galenski laboratorij d.d.,

Amicor H 20 tablets Pulac bb, Rijeka, Republic of 44 (3x10) tablets in a PVC/Al blister, YES YES

Croatia supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Aminfluorid dental gel dental gel Ulica Danica 5, Koprivnica, Tube with 25 g of gel, supplied in a YES

Republic of Croatia box

YES YES

Belupo, lijekovi i kozmetika d.d., 50 mL of solution in a polyethylene

Aminfluorid dental solution dental solution Ulica Danica 5, Koprivnica, bag with a dropper and a screw cap, YES YES YES

Republic of Croatia supplied in a box

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One plastic bag with two

compartments (for solutions A and B),

Aminomix 2 Novum solution for infusion (for Fresenius Kabi Deutschland

peel seam and two attachments

parenteral nutrition) GmbH, Bad Homburg, Germany connected to the compartments (with YES YES solutions for drug delivery and

infusion) in an external protective bag

inserted with bag with agent

One plastic bag with two

compartments (for solutions A and B),

peel seam and two attachments

Aminomix 2 Novum solution for infusion (for Fresenius Kabi Deutschland parenteral nutrition) GmbH, Bad Homburg, Germany connected to the compartments (with YES YES

solutions for drug delivery and

infusion) in an external protective bag

inserted with bag with agent

Aminophyllinum Lek 100 mg Lek farmacevtska družba d.d., tablets tablets Verovškova 57, Ljubljana, 50 (5x10) tablets in a blister (PVC/Al), YES YES Republic of Slovenia supplied in a carton box

Aminophyllinum Lek 250 mg/10 Lek farmacevtska družba d.d., mL solution for injection solution for injection Verovškova 57, Ljubljana, 50 (5x10) ampoules with 10 mL of YES YES Republic of Slovenia solution for injection, supplied in a box

Aminophyllinum Lek 350 mg Lek farmacevtska družba d.d., prolonged-release tablets prolonged-release tablets Verovškova 57, Ljubljana, 20 (2x10) tablets in a blister (PVC/Al) , YES YES Republic of Slovenia supplied in a carton box

B. Braun Melsungen AG, Carl

Aminoplasmal - 10% E solution for infusion Braun-Straße 1, Melsungen, 500 mL of solution for infusion in a YES

Germany glass bottle, 10 bottles in a box

YES

B. Braun Melsungen AG, Carl

Aminoplasmal - 5% E solution for infusion Braun-Straße 1, Melsungen, 500 mL of solution for infusion in a

Germany glass bottle, 10 bottles in a box

YES YES

B. Braun Melsungen AG, Carl

Aminoplasmal Hepa - 10% solution for infusion Braun-Straße 1, Melsungen, 500 mL of solution for infusion in a

Germany glass bottle, 10 bottles in a box

YES YES

Aminoven 10% solution for infusion Fresenius Kabi Austria GmbH, One glass bottle for infusion with 500 Graz, Austria mL of solution YES YES YES

Aminoven 5% solution for infusion Fresenius Kabi Austria GmbH, One glass bottle for infusion with 500 Graz, Austria mL of solution YES YES YES

Aminoven Infant 10% solution for infusion Fresenius Kabi Austria GmbH, 10 glass infusion bottles with 100 mL Graz, Austria of solution, supplied in a carton box YES YES

Aminoven Infant 10% solution for infusion Fresenius Kabi Austria GmbH, 10 glass infusion bottles with 250 mL Graz, Austria of solution, supplied in a carton box YES YES

Belupo, lijekovi i kozmetika d.d.,

Amiodaron 200 mg tablets tablets Ulica Danica 5, Koprivnica, Box with 30 (2x15) tablets in a blister YES YES

Republic of Croatia

AmLodipin Cipla 10 mg tablets Cipla Ltd., Verna Industrial 30 (3x10) tablets in a brown PVC/Al Estate, Verna Goa, India blister, supplied in a box YES YES

AmLodipin Cipla 5 mg tablets Cipla Ltd., Verna Industrial 30 (3x10) tablets in a brown PVC/Al Estate, Verna Goa, India blister, supplied in a box YES YES

Lek farmacevtska družba d.d.,

AmLopin 10 mg tablets tablets Verovškova 57, Ljubljana, 20 (2x10) tablets in a blister, supplied

Republic of Slovenia in a box

YES YES

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Lek farmacevtska družba d.d.,

AmLopin 5 mg tablets tablets Verovškova 57, Ljubljana, 30 (3x10) tablets in a blister, supplied

Republic of Slovenia in a box

YES YES

Lek farmacevtska družba d.d.,

AmLopin 5 mg tablets tablets Verovškova 57, Ljubljana, 20 (2x10) tablets in a blister, supplied YES YES

Republic of Slovenia in a box

Belupo, lijekovi i kozmetika d.d.,

Amoksicilin 375 mg capsules capsules Ulica Danica 5, Koprivnica, 12 capsules in a bottle, supplied in a YES YES

Republic of Croatia box

Belupo, lijekovi i kozmetika d.d.,

Amoksicilin 500 mg capsules capsules Ulica Danica 5, Koprivnica, 16 capsules in a blister, supplied in a YES YES

Republic of Croatia box

Amoksicilin powder for oral Belupo, lijekovi i kozmetika d.d., Bottle with powder for preparation of

suspension 250 mg/5 mL powder for oral suspension Ulica Danica 5, Koprivnica, 100 mL of suspension, supplied in a YES YES Republic of Croatia box

Belupo, lijekovi i kozmetika d.d.,

Amonex 10 mg tablets tablets Ulica Danica 5, Koprivnica, 30 (1x30) tablets in a blister, supplied

Republic of Croatia in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Amonex 5 mg tablets tablets Ulica Danica 5, Koprivnica, 30 (1x30) tablets in a blister, supplied

Republic of Croatia in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Amoxil capsules 500 mg capsules Vukovara 49, Zagreb, Republic of 16 (2x8) tablets in a blister, supplied in YES YES

Croatia a box

Amoxil syrup powder for preparation of

Pliva Croatia Ltd., Ulica grada

oral suspension Vukovara 49, Zagreb, Republic of

Amber glass bottle with powder,

Croatia supplied in a box

YES YES

Torrex Chiesi Pharma GmbH, Turbid glass bottle (with 100 mg of dry

Amphocil 100 mg powder for preparation of solution for infusion Gonzagagasse 16/16, Vienna, matter) with a cap and Al ring, supplied YES YES

Austria in a box

Torrex Chiesi Pharma GmbH, Turbid glass bottle (with 50 mg of dry

Amphocil 50 mg powder for preparation of solution for infusion Gonzagagasse 16/16, Vienna, matter) with a cap and Al ring, supplied YES YES

Austria in a box

Amphotericin B, powder for powder for preparation of Jadran - Galenski laboratorij d.d., One glass vial with powder for injection

preparation of injections injections Pulac bb, Rijeka, Republic of YES Croatia preparation, supplied in a box YES

Krka d.d., Šmarješka cesta 6,

Ampril HD tablets 5 mg/25 mg tablets Novo mesto, Republic of 31 (3x10) tablets in a OPA/Al/PVC//Al

Slovenia blister, supplied in a box

YES YES YES YES

Ampril HL tablets 2.5 mg/12.5 Krka d.d., Šmarješka cesta 6, 32 (3x10) tablets in a OPA/Al/PVC//Al

mg tablets Novo mesto, Republic of Slovenia blister, supplied in a box YES YES YES YES

Krka d.d., Šmarješka cesta 6,

Ampril 1.25 mg tablets tablets Novo mesto, Republic of 33 (3x10) tablets in a OPA/Al/PVC//Al YES YES YES YES

Slovenia blister, supplied in a box

Krka d.d., Šmarješka cesta 6,

Ampril 10 mg tablets tablets Novo mesto, Republic of 34 (3x10) tablets in a OPA/Al/PVC//Al YES YES YES

Slovenia blister, supplied in a box

YES

Krka d.d., Šmarješka cesta 6,

Ampril 2.5 mg tablets tablets Novo mesto, Republic of 35 (3x10) tablets in a OPA/Al/PVC//Al YES YES YES YES

Slovenia blister, supplied in a box

Krka d.d., Šmarješka cesta 6,

Ampril 5 mg tablets tablets Novo mesto, Republic of 36 (3x10) tablets in a OPA/Al/PVC//Al

Slovenia blister, supplied in a box

YES YES YES YES

Lek farmacevtska družba d.d.,

Amyzol 10 mg film coated tablets film coated tablets Verovškova 57, Ljubljana, 100 (4X25) tablets in a blister,

Republic of Slovenia supplied in a box

YES YES

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ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Lek farmacevtska družba d.d.,

Amyzol 25 mg film coated tablets film coated tablets Verovškova 57, Ljubljana, 30 (3X10) tablets in a blister, supplied

Republic of Slovenia in a box

YES YES

Pliva Croatia Ltd., Zagreb,

ANAFRANIL coated tablets coated tablets Republic of Croatia and Novartis 31 (3x10) coated tablets in a PVC/Al Pharma Services Inc., Basel, blister, supplied in a box YES YES

Switzerland

Pliva Croatia Ltd., Ulica grada 5 mL of solution for injection in an

Analgin injections solution for injection Vukovara 49, Zagreb, Republic of amber glass ampoule, 50 ampoules in YES YES

Croatia a box

Pliva Croatia Ltd., Ulica grada

Analgin tablets tablets Vukovara 49, Zagreb, Republic of 10 (1x10) tablets in an orange blister

Croatia (PVC/Al), supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Andol tablets Vukovara 49, Zagreb, Republic of 23 (2x10 tablets in Al/PVC/PVDC

Croatia blister, supplied in a box

YES YES YES

Pliva Croatia Ltd., Ulica grada

Andol 100 tablets Vukovara 49, Zagreb, Republic of 24 (2x10 tablets in Al/PVC/PVDC YES YES YES

Croatia blister, supplied in a box

Pliva Croatia Ltd., Ulica grada

Andol C effervescent tablets Vukovara 49, Zagreb, Republic of 10 tablets in a vial (cap with silicagel

Croatia and protective ring)

YES YES

Schering GmbH und Co.

Androcur-10 tablets tablets Produktions KG, 45 (3x15) tablets in a blister, supplied Doebereinerstrasse 20, Weimar, in a box YES YES

Germany

Delpharm Lille S.A.S., Z.I. De

Androcur-50 tablets tablets Roubaix Est, Rue de Toufflers, 50 (5x10) tablets in a blister (PVC/Al), YES

Lys Lez Lannoy, France supplied in a box

YES

Androgel 50 mg, gel in bags gel Besins International Belgique, 5 g of gel in a bag (PET/Al/PE), 30 Drogenbos, Belgium bags in a carton box YES YES YES

Anexate solution for injection or

F. Hoffmann-La Roche Ltd.,

infusion Grenzacherstrasse 124, Basel,

5 mL of solution in a glass ampoule,

Switzerland 10 ampoules in a box

YES YES

Lek farmacevtska družba d.d.,

Angal lozenges lozenges Verovškova 57, Ljubljana, 20 (2x10) lozenges in PVC/Al blister, YES YES

Republic of Slovenia supplied in a box

YES

Lek farmacevtska družba d.d., 30 mL of solution in an amber glass

Angal S oral spray oromucosal spray Verovškova 57, Ljubljana, bottle with a screw cap and automatic YES YES

Republic of Slovenia sprayer/spraying attachment, supplied

YES

in a box

Angeliq film tablets film coated tablets Schering AG, Muellerstrasse 170-178, Berlin, Germany aluminum YES YES YES

Lek farmacevtska družba d.d.,

Ansilan 10 mg capsules capsules Verovškova 57, Ljubljana, 25 capsules in a glass bottle, supplied YES YES

Republic of Slovenia in a box

Lek farmacevtska družba d.d.,

Ansilan mite 5 mg capsules capsules Verovškova 57, Ljubljana, 30 (3x10) capsules in a PVC/Al blister, YES YES

Republic of Slovenia supplied in a box

lyophilized powder and Vial with 1000 IU antithrombin III, vial

Antithrombin III Immuno 1000 IU diluent for preparation of Baxter AG, Industriestrasse 67,

with diluent, portable needle, filter

solution for injection or A-1220 Vienna, Austria needle, vent needle, disposable YES YES

infusion needle, infusion kit , disposable syringe, supplied in a box

lyophilized powder or diluent Vial with 500 IU antithrombin III, vial

Antithrombin III Immuno 500 IU for preparation of solution Baxter AG, Industriestrasse 67,

for injection or infusion A-1220 Vienna, Austria

with diluent, portable needle, filter YES YES

needle, vent needle, disposable

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ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

needle, infusion kit , disposable

syringe, supplied in a box

Antitoxin (equine) against Imunološki zavod d.d., Box with 1 bottle containing 10 mL of

European viper venom solution for parenteral use Rockefellerova 2, Zagreb, preparation (1 dose), with a sterile YES YES Republic of Croatia needle and a disposable syringe

Apidra 100 IU/mL (10 mL glass solution for injection (for s.c. Aventis Pharma Deutschland vial) use) GmbH, Brunningstrasse 50, One glass vial with 10 mL of solution, YES YES Frankfurt am Main, Germany supplied in a box

YES

Apidra 100 IU/mL (3mL glass Sanofi - Aventis Deutschland

cartridge for use with OptiClik solution for subcutaneous GmbH, Frankfurt am Main, 5 glass cartridges (for OptiClik) with 3 YES injector) injection Germany mL of solution, supplied in a box

YES YES

Apidra 100 IU/mL (3.0 mL glass solution for subcutaneous Aventis Pharma Deutschland 5 glass cartridges with 3 mL of

cartridge) injection GmbH, Brunningstrasse 50, YES YES YES Frankfurt am Main, Germany solution, supplied in a box

Apidra 100 IU/mL OptiSet 5 pens (injectors) with a glass

(injector with glass cartridge of 3 solution for subcutaneous

Aventis Pharma Deutschland

cartridge containing 3 mL of solution, YES YES YES

mL) injection

GmbH, Brunningstrasse 50,

Frankfurt am Main, Germany supplied in a box

Sanofi Winthrop Industrie, 1 rue

Aprovel 150 mg film coated tablets de la Vierge, 33440 Ambares, 28 (2x14) tablets in a blister YES YES YES

France (PC/PVDC/Al), supplied in a box

Sanofi Winthrop Industrie, 1 rue

Aprovel 300 mg film coated tablets de la Vierge, 33440 Ambares, 28 (2x14) tablets in a blister

France (PC/PVDC/Al), supplied in a box

YES YES YES

Sanofi Winthrop Industrie, 1 rue

Aprovel 75 mg film coated tablets de la Vierge, 33440 Ambares, 28 (2x14) tablets in a blister YES YES YES

France (PC/PVDC/Al), supplied in a box

Hrvatski zavod za transfuzijsku

Aqua pro injectione diluent for preparation of parenteral solutions medicinu, Petrova 3, Zagreb, 500 mL of water for injection in a glass

Republic of Croatia infusion bottle

YES YES

Hrvatski zavod za transfuzijsku

Aqua pro injectione solvent for preparation of parenteral solutions medicinu, Petrova 3, Zagreb, 1000 mL of Water for Injection in a

Republic of Croatia glass infusion bottle

YES YES

Hrvatski zavod za transfuzijsku

Aqua pro injectione solvent for preparation of parenteral solutions medicinu, Petrova 3, Zagreb, 100 mL of Water for Injection in a

Republic of Croatia glass infusion bottle

YES YES

Aranesp 10 micrograms of One disposable glass syringe with solution for injection in a presolution for injection Amgen Europe B.V., Minervum needle containing 0.4 mL of solution, filled syringe 7061, Breda, the Netherlands in a protective container, supplied in a

YES YES YES YES

box

Aranesp 100 micrograms of A plastic syringe with fitted glass solution for injection in a presolution for injection Amgen Europe B.V., Minervum syringe containing 0.5 mL of solution in filled syringe 7061, Breda, the Netherlands a protective container, supplied in a

YES YES YES YES

box

Aranesp 100 micrograms of One disposable glass syringe with solution for injection in a presolution for injection Amgen Europe B.V., Minervum needle containing 0.5 mL of solution, YES filled syringe 7061, Breda, the Netherlands in a protective container, supplied in a

YES YES YES

box

Aranesp 15 micrograms of One disposable glass syringe with solution for injection in a presolution for injection Amgen Europe B.V., Minervum needle containing 0.375 mL of YES filled syringe 7061, Breda, the Netherlands solution, in a protective container,

YES YES YES

supplied in a box

A plastic syringe with fitted glass

Aranesp 150 mcg solution for syringe containing 0.3 mL of solution in

injection in a pre-filled syringe solution for injection

Amgen Europe B.V., Minervum

7061, Breda, the Netherlands a protective container, supplied in a YES YES YES YES

box

Aranesp 150 micrograms of One disposable glass syringe with

solution for injection in a presolution for injection Amgen Europe B.V., Minervum needle containing 0.3 mL of solution, YES YES YES YES filled syringe 7061, Breda, the Netherlands in a protective container, supplied in a

14509/1/11 REV 1 WS/jj 229

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

box

Aranesp 20 micrograms of A plastic syringe with fitted glass solution for injection in a presolution for injection Amgen Europe B.V., Minervum syringe containing 0.5 mL of solution in filled syringe 7061, Breda, the Netherlands a protective container, supplied in a

YES YES YES YES

box

Aranesp 20 micrograms of One disposable glass syringe with solution for injection in a presolution for injection Amgen Europe B.V., Minervum needle containing 0.5 mL of solution, filled syringe 7061, Breda, the Netherlands in a protective container, supplied in a

YES YES YES YES

box

Aranesp 30 micrograms of One disposable glass syringe with solution for injection in a presolution for injection Amgen Europe B.V., Minervum needle containing 0.3 mL of solution, filled syringe 7061, Breda, the Netherlands in a protective container, supplied in a

YES YES YES YES

box

Aranesp 300 micrograms of A plastic syringe with fitted glass solution for injection in a presolution for injection Amgen Europe B.V., Minervum syringe containing 0.6 mL of solution in filled syringe 7061, Breda, the Netherlands a protective container, supplied in a

YES YES YES YES

box

Aranesp 300 micrograms of One disposable glass syringe with solution for injection in a presolution for injection Amgen Europe B.V., Minervum needle containing 0.6 mL of solution, filled syringe 7061, Breda, the Netherlands in a protective container, supplied in a

YES YES YES YES

box

Aranesp 40 micrograms of A plastic syringe with fitted glass solution for injection in a presolution for injection Amgen Europe B.V., Minervum syringe containing 0.4 mL of solution in YES filled syringe 7061, Breda, the Netherlands a protective container, supplied in a

YES YES YES

box

Aranesp 40 micrograms of One disposable glass syringe with solution for injection in a presolution for injection Amgen Europe B.V., Minervum needle containing 0.4 mL of solution, YES filled syringe 7061, Breda, the Netherlands in a protective container, supplied in a

YES YES YES

box

Aranesp 50 micrograms of One disposable glass syringe with solution for injection in a presolution for injection Amgen Europe B.V., Minervum needle containing 0.5 mL of solution, YES YES filled syringe 7061, Breda, the Netherlands in a protective container, supplied in a

YES YES

box

Aranesp 500 micrograms of A plastic syringe with fitted glass solution for injection in a presolution for injection Amgen Europe B.V., Minervum syringe containing 1.0 mL of solution in YES YES YES filled syringe 7061, Breda, the Netherlands a protective container, supplied in a

YES

box

Aranesp 500 micrograms of One disposable glass syringe with solution for injection in a presolution for injection Amgen Europe B.V., Minervum needle containing 1.0 mL of solution, YES YES YES YES

filled syringe 7061, Breda, the Netherlands in a protective container, supplied in a box

Aranesp 60 micrograms of A plastic syringe with fitted glass solution for injection in a presolution for injection Amgen Europe B.V., Minervum syringe containing 0.3 mL of solution in YES YES YES YES

filled syringe 7061, Breda, the Netherlands a protective container, supplied in a box

Aranesp 60 micrograms of One disposable glass syringe with solution for injection in a presolution for injection Amgen Europe B.V., Minervum needle containing 0.3 mL of solution, YES YES YES YES

filled syringe 7061, Breda, the Netherlands in a protective container, supplied in a box

Aranesp 80 micrograms of A plastic syringe with fitted glass solution for injection in a presolution for injection Amgen Europe B.V., Minervum syringe containing 0.4 mL of solution in YES YES YES YES

filled syringe 7061, Breda, the Netherlands a protective container, supplied in a box

Aranesp 80 micrograms of One disposable glass syringe with solution for injection in a presolution for injection Amgen Europe B.V., Minervum needle containing 0.4 mL of solution, filled syringe 7061, Breda, the Netherlands in a protective container, supplied in a

YES YES YES YES

box

Aventis Intercontinental, Route

Arava 10 mg tablets film coated tablets de Choisy au Bac, Compiegne, Box with 30 tablets in a plastic bottle YES YES

Cedex, France

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ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Aventis Intercontinental, Route

Arava 100 mg tablets film coated tablets de Choisy au Bac, Compiegne, 3 tablets in an aluminum blister, YES

Cedex, France supplied in a box

YES

Aventis Intercontinental, Route

Arava 20 mg tablets film coated tablets de Choisy au Bac, Compiegne, Box with 30 tablets in a plastic bottle YES YES

Cedex, France

Arcoxia 120 mg film coated Merck Sharp & Dohme B.V., tablets film coated tablets Waarderweg 39, Postbus 581, 7 (1x7) film coated tablets in an Al/Al YES YES YES Haarlem, the Netherlands blister, supplied in a box

YES

Arcoxia 60 mg film coated Merck Sharp & Dohme B.V., tablets film coated tablets Waarderweg 39, Postbus 581, 14 (2x7) film coated tablets in a A/Al YES YES YES Haarlem, the Netherlands blister, supplied in a box

YES

Arcoxia 90 mg film coated Merck Sharp & Dohme B.V., tablets film coated tablets Waarderweg 39, Postbus 581, 14 (2x7) film coated tablets in a A/Al YES YES YES Haarlem, the Netherlands blister, supplied in a box

YES

Novartis Pharma Stein AG, 4 colourless glass bottles with powder

Aredia 15 mg powder and diluent for solution for infusion Schaffhauserstrasse, Stein, and 4 ampoules with 5 mL of solvent YES YES

Switzerland (water for injection), supplied in a box

2 clear glass bottles containing powder

Aredia 30 mg powder and diluent for

Novartis Pharma Stein AG,

solution for infusion Schaffhauserstrasse, Stein, and 2 ampoules with 10 mL of diluent YES YES Switzerland (Water for Injection), supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Arficin 150 mg capsules capsules Ulica Danica 5, Koprivnica, 100 capsules in a brown plastic bottle,

Republic of Croatia supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Arficin 150 mg capsules capsules Ulica Danica 5, Koprivnica, Plastic bottle with 100 capsules, YES

Republic of Croatia supplied in a box

YES

Belupo, lijekovi i kozmetika d.d.,

Arficin 300 mg capsules capsules Ulica Danica 5, Koprivnica, 16 capsules in a white plastic bottle,

Republic of Croatia supplied in a box

YES YES

Arilin rapid pessaries Dr. August Wolff GmbH & Co. 2 pessaries in an Al/Al strip, supplied Arzneimittel, Bielefeld, Germany in a box YES YES

AstraZeneca UK Limited, Silk

Arimidex film coated tablets Road Business Park, 28 (2x14) tablets in a blister (PVC/al), Macclesfield, Cheshire, Great supplied in a box YES YES

Britain

Arixtra 2.5 mg/0.5 mL solution solution for s.c. and i.v. Glaxo Wellcome Production, for injection (pre-filled syringe) Injection Notre Dame de Bondeville,

10 glass syringes with 0.5 mL of

France solution, supplied in a box

YES YES YES YES

Arixtra 7.5 mg/0.6 mL solution solution for s.c. and i.v. Glaxo Wellcome Production, 10 pre-filled glass syringes with 0.6 mL

for injection (pre-filled syringe) Injection Notre Dame de Bondeville, France of solution, supplied in a box YES YES YES YES

Lek farmacevtska družba d.d.,

Artein 20 mg tablets tablets Verovškova 57, Ljubljana, 21 (2x10) tablets in a blister (PVC/Al),

Republic of Slovenia supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Arvind 100 mg tablets tablets Ulica Danica 5, Koprivnica, 30 (1x10) tablets in a blister, supplied

Republic of Croatia in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Arvind 200 mg tablets tablets Ulica Danica 5, Koprivnica, 30 (1x10) tablets in a blister, supplied

Republic of Croatia in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Arvind 25 mg tablets tablets Ulica Danica 5, Koprivnica, 30 (1x10) tablets in a blister, supplied

Republic of Croatia in a box

YES YES

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ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Belupo, lijekovi i kozmetika d.d.,

Arvind 50 mg tablets tablets Ulica Danica 5, Koprivnica, 30 (1x10) tablets in a blister, supplied YES

Republic of Croatia in a box

YES

Lek farmacevtska družba d.d.,

Asacol 400 mg gastric-resistant 100 (10x10) gastro-resistant tablets

tablets gastric-resistant tablets

Ljubljana, Republic of Slovenia in

cooperation with Tillotts Pharma PVC/Al blisters, supplied in a box YES YES

AG, Ziefen, Switzerland

Lek farmacevtska družba d.d.,

Asacol 800 mg gastric-resistant 50 (5x10) gastro-resistant tablets in a

tablets gastric-resistant tablets

Ljubljana, Republic of Slovenia in

cooperation with Tillotts Pharma PVC/Al blister, supplied in a box YES YES

AG, Ziefen, Switzerland

Asentra 100 mg film coated Krka d.d., Šmarješka cesta 6, 28 (4x7) tablets in a blister, supplied in

tablets film coated tablets Novo mesto, Republic of Slovenia a box YES YES

Asentra 50 mg film coated Krka d.d., Šmarješka cesta 6, tablets film coated tablets Novo mesto, Republic of

28 (4x7) tablets in a blister, supplied in

Slovenia a box

YES YES

Aspirin 100 mg tablets tablets Bayer HealthCare AG, 51368 20 (2x10) tablets in a blister, supplied Leverkusen, Germany in a box YES YES YES

Aspirin 500 mg tablets tablets Bayer HealthCare AG, 51368 20 (2x10) tablets in a blister, supplied Leverkusen, Germany in a box YES YES YES

Aspirin direct chewing tablets Bayer HealthCare AG, 51368 10 (5x2) tablets in a strip, supplied in a Leverkusen, Germany box YES YES YES

Aspirin plus C effervescent tablets Bayer HealthCare AG, 51368 10 (5x2) effervescent tablets in a strip, Leverkusen, Germany supplied in a box YES YES YES

Aspirin protect 100 mg gastricresistant

tablets gastric-resistant tablets

Bayer HealthCare AG, 51368 30 (3x10) tablets in a blister, supplied

Leverkusen, Germany in a box YES YES

Aspirin protect 300 mg gastric 30 (3x10) tablets in a blister, supplied

resistant tablets gastric-resistant tablets

Bayer HealthCare AG, 51368

Leverkusen, Germany in a box YES YES

Farmal d.d., Branitelja 20 (2x10) film coated tablets in a

Astax tablets 10 mg film coated tablets domovinskog rata 8, Ludbreg, (PVC/TE/PVDC/Al) blister, supplied in YES YES

Republic of Croatia a box

Farmal d.d., Branitelja 20 (2x10) film coated tablets in a

Astax tablets 20 mg film coated tablets domovinskog rata 8, Ludbreg, (PVC/TE/PVDC/Al) blister, supplied in YES YES

Republic of Croatia a box

Farmal d.d., Branitelja 20 (2x10) film coated tablets in a

Astax tablets 40 mg film coated tablets domovinskog rata 8, Ludbreg, (PVC/TE/PVDC/Al) blister, supplied in YES YES

Republic of Croatia a box

AstraZeneca AB, Södertälje,

Atacand 16 mg tablets tablets Sweden, AstraZeneca AB, Umea, 28 (2x14) tablets in a blister Sweden and AstraZeneca GmbH, (PVC/PVDC//Al), supplied in a box YES YES YES

Plankstadt, Germany

AstraZeneca AB, Södertälje,

Atacand 32 mg tablets tablets Sweden, AstraZeneca AB, Umea, 28 (2x14) tablets in a blister Sweden and AstraZeneca GmbH, (PVC/PVDC//Al), supplied in a box YES YES YES

Plankstadt, Germany

AstraZeneca AB, Södertälje,

Atacand 4 mg tablets tablets Sweden, AstraZeneca AB, Umea, 28 (2x14) tablets in a blister Sweden and AstraZeneca GmbH, (PVC/PVDC//Al), supplied in a box YES YES YES

Plankstadt, Germany

AstraZeneca AB, Södertälje,

Atacand 8 mg tablets tablets Sweden, AstraZeneca AB, Umea, 28 (2x14) tablets in a blister YES YES YES

Sweden and AstraZeneca GmbH, (PVC/PVDC//Al), supplied in a box

14509/1/11 REV 1 WS/jj 232

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Plankstadt, Germany

AstraZeneca AB, Södertälje,

Atacand Plus tablets Sweden, AstraZeneca AB, Umea, 28 (2x14) tablets in a blister Sweden and AstraZeneca GmbH, (PVC/PVDC//Al), supplied in a box YES YES YES

Plankstadt, Germany

ATenativ 1000 IU lyophilisate and diluent for Octapharma AB, Stockholm, Glass bottle with 50 mL of lyophilisate intravenous solution Sweden and a bottle with 20 mL of solvent YES YES

ATenativ 1500 IU lyophilisate and diluent for Octapharma AB, Stockholm, Glass bottle with 100 mL of lyophilisate intravenous solution Sweden and a bottle with 30 mL of solvent YES YES

ATenativ 500 IU lyophilisate and diluent for Octapharma AB, Stockholm, Glass bottle with 50 mL of lyophilisate intravenous solution Sweden and a bottle with 10 mL of solvent YES YES

Pliva Croatia Ltd., Ulica grada

Atenolol Pliva 100 mg tablets Vukovara 49, Zagreb, Republic of 14 (1x14) tablets in a blister

Croatia (PVC/PVDC/Al), supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Atenolol Pliva 50 mg tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in a PVC/PVdC/A1 YES YES

Croatia blister, supplied in a box

ATG-Fresenius concentrate for infusion Fresenius Biotech GmbH, Am One glass bottle with 5 mL of solution Haag 6-7, Gräfelfing, Germany concentrate, supplied in a box YES YES

Jadran - Galenski laboratorij d.d.,

Athyrazol tablets Pulac bb, Rijeka, Republic of 34 (3x10) tablets in a PVC/Al blister,

Croatia supplied in a box

YES YES

Krka, d.d., Novo mesto, Republic

Atoris tablets 10 mg film coated tablets of Slovenia ili Krka-Farma d.o.o., 60 (6x10) tablets in an OPA/Al/PVC//Al YES YES

Zagreb, Republic of Croatia blister, supplied in a box

Krka d.d., Novo Mesto, Republic

Atoris 10 mg tablets film coated tablets of Slovenia; Krka Farma d.o.o., 30 (3x10) tablets in a blister, supplied DPC Jastrebarsko, Republic of in a box YES YES

Croatia

Krka d.d., Novo Mesto, Republic

Atoris 20 mg tablets film coated tablets of Slovenia; Krka Farma d.o.o., 30 (3x10) tablets in a blister, supplied DPC Jastrebarsko, Republic of in a box YES YES

Croatia

Krka, d.d., Novo mesto, Republic

Atoris tablets 20 mg film coated tablets of Slovenia ili Krka-Farma d.o.o., 60 (6x10) tablets in an OPA/Al/PVC//Al

Zagreb, Republic of Croatia blister, supplied in a box

YES YES

Krka d.d., Novo mesto, Republic

Atoris tablets 40 mg film coated tablets of Slovenia or KRKA - FARMA 30 (3x10) tablets in a blister d.o.o., DPC Jastrebarsko, (OPA/Al/PVC-Al), supplied in a box YES YES

Jastrebarsko, Republic of Croatia

Pliva Croatia Ltd., Ulica grada 30 (3x10) film coated tablets in a

Atorvox tablets 10 mg film coated tablets Vukovara 49, Zagreb, Republic of OPA/Al/PVC//Al blister, supplied in a YES YES

Croatia box

Pliva Croatia Ltd., Ulica grada 30 (3x10) film coated tablets in a

Atorvox tablets 20 mg film coated tablets Vukovara 49, Zagreb, Republic of OPA/Al/PVC//Al blister, supplied in a YES YES

Croatia box

Pliva Croatia Ltd., Ulica grada 31 (3x10) film coated tablets in a

Atorvox tablets 40 mg film coated tablets Vukovara 49, Zagreb, Republic of OPA/Al/PVC//Al blister, supplied in a YES YES

Croatia box

Atropini sulfas 0.5 mg/mL solution for s.c., i.m. and i.v. Belupo, lijekovi i kozmetika d.d., injection Injection Ulica Danica 5, Koprivnica,

50 colourless glass ampoules each

Republic of Croatia with 1 mL of solution, supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 233

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Belupo, lijekovi i kozmetika d.d.,

Atropini sulfas 1 mg/mL injection solution for s.c., i.m. and i.v. Injection Ulica Danica 5, Koprivnica, 50 colourless glass ampoules each YES

Republic of Croatia with 1 mL of solution, supplied in a box

YES

Atrovent 0.025% inhalation 20 mL of solution in an amber glass solution inhalation solution

Instituto de Angeli S.r.l., Regello

(Firenca), Italy bottle with a plastic (PE) dropper and a YES YES plastic (PP) cap, supplied in a box

Boehringer Ingelheim Pharma

Atrovent N inhalation aerosol aerosol GmbH & Co. KG, Binger Strasse

200 inhalation doses in a metal

173, Ingelheim am Rhein, container with metering valve and YES YES Germany plastic mouthpiece, supplied in a box

SmithKline Beecham

Augmentin injection 1.2 g powder for solution for injection or infusion Pharmaceuticals, Crawley, West 5 glass bottles each with a dose of

Sussex, Great Britain drug, supplied in a box

YES YES

Augmentin injection 2.2 g powder for solution for SmithKline Beecham S.A., One glass vial containing one dose of injection or infusion Heppignies, Belgium medicinal product, supplied in a box YES YES

SmithKline Beecham Powder for preparation of 70 mL of

Augmentin syrup 457mg/5 mL powder for preparation of oral suspension Pharmaceuticals, Crawley, West suspension (by the addition of 64 mL YES YES

Sussex, Great Britain of water) in a glass bottle (with aluminium stopper), supplied in a box

SmithKline Beecham 14 (2x7) film coated tablets in a

Augmentin tablets 1 g film coated tablets Pharmaceuticals, Crawley, West PVC/PVDC//Al blister inserted in a YES

Sussex, Great Britain protective aluminum bags (with

YES

desiccant), supplied in a box

Helsinn Birex Pharmaceuticals 6 bags each with 2 g of granules for

Aulin 100 mg granules granules Ltd., Damastown, Mulhuddart, preparation of oral suspension, YES YES

Dublin 15, Republic of Ireland supplied in a box

Helsinn Birex Pharmaceuticals

Aulin 100 mg tablets tablets Ltd., Damastown, Mulhuddart, 6 (1x6) tablets in a blister (white non

Dublin 15, Republic of Ireland transparent PVC/Al), supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6,

Auropan film coated tablets 3 mg film coated tablets Novo mesto, Republic of 30 film coated tablets in an amber

Slovenia glass bottle, supplied in a box

YES YES

F. Hoffmann-La Roche Ltd.,

Aurorix film coated tablets Grenzacherstrasse 124, Basel, 38 (3x10) tablets in a PVC/Al blister,

Switzerland supplied in a box

YES YES

Avandamet 2 mg/1000 mg GlaxoWellcome S.A., Avenida de 56 (4x14) film coated tablets in a

tablets film coated tablets Extremadura 3, 9400 Aranda de PVC/PVDC//Al blister, supplied in a YES YES YES YES Duero, Burgos, Spain carton box

Avandamet 4 mg/1000 mg GlaxoWellcome S.A., Avenida de 56 (4x14) film coated tablets in a

tablets film coated tablets Extremadura 3, 9400 Aranda de PVC/PVDC//Al blister, supplied in a YES YES YES YES Duero, Burgos, Spain carton box

Avandia 2 mg film-tablets film coated tablets Glaxo Wellcome Production, 56 (4x14) tablets in a blister, supplied Mayenne, France in a box YES YES YES YES

Avandia 4 mg film-tablets film coated tablets Glaxo Wellcome Production, 28 (2x14) tablets in a blister, supplied Mayenne, France in a box YES YES YES YES

Avandia 8 mg film-tablets film coated tablets Glaxo Wellcome Production, 28 (2x14) tablets in a blister, supplied Mayenne, France in a box YES YES YES YES

Avastin 25 mg/mL concentrate concentrate of solution for F. Hoffmann-La Roche Ltd., 16 mL of infusion solution concentrate

for infusion solution infusion Grenzacherstrasse 124, Basel, Switzerland in a glass bottle, supplied in a box YES YES YES YES

Avastin 25 mg/mL concentrate concentrate for infusion F. Hoffmann-La Roche Ltd., 4 mL of concentrate for solution for

for infusion solution solution Grenzacherstrasse 124, Basel, infusion in a glass bottle, supplied in a YES YES YES YES Switzerland box

14509/1/11 REV 1 WS/jj 234

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Avelox 400 mg film coated

tablets film coated tablets

Bayer HealthCare AG, 51368 5 (1x5) film coated tablets in a blister

Leverkusen, Germany (PP/Al), supplied in a box YES YES YES

Avelox 400 mg/250 mL solution One glass bottle with 250 mL of

for infusion solution for infusion

Bayer HealthCare AG, 51368

Leverkusen, Germany infusion solution, supplied in a box YES YES

AVODART 0.5 mg soft capsules soft capsules RP Scherer S.A., Beinheim, 30 (3x10) capsules in a blister France (for GlaxoSmithKline) (PVC/PVdC/Al), supplied in a box YES YES YES

AVONEX 30 µg powder and powder and diluent for BIOGEN Idec BV, 2132 WX Box with 4 bottles with BIO SET

diluent for injection solution for injection Hoofddorp, the Netherlands reconstitution kit, 4 syringes with YES YES YES solvent and 4 needles (BIO SET kit)

Azilect 1 mg tablets tablets Teva Pharmaceuticals Europe 7 (1x7) tablets in a blister (Al/Al), B.V., the Netherlands supplied in a box YES YES YES YES

Azilect 1 mg tablets tablets Teva Pharmaceuticals Europe

30 tablets in a plastic (HDPE) bottle

B.V., the Netherlands (desiccant in a plastic PP stopper), YES YES YES YES supplied in a box

Pliva Croatia Ltd., Ulica grada

AZIMED capsules 250 mg capsules Vukovara 49, Zagreb, Republic of 6 (1x6) capsules in a PVC/PVDC//Al

Croatia blister, supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

AZIMED tablets 500 mg film coated tablets Vukovara 49, Zagreb, Republic of 3 (1x3) tablets in a PVC/Al blister,

Croatia supplied in a box

YES YES

Azitromicin Lek 250 mg film Sandoz S.R.L., TG. Mures, 6 (1x6) film coated tablets in a blister

coated tablets film coated tablets Mures District, Rumunjska (PVC/PVDC//Al), supplied in a box YES YES

Azitromicin Lek 500 mg film

coated tablets film coated tablets

Sandoz S.R.L., TG. Mures, 3 (1x3) film-coated tablets in a blister

Mures District, Rumunjska (PVC/PVDC//Al), supplied in a box YES YES

Azopt eye drops eye drops Alcon-Couvreur s.a., Rijksweg Box with 5 mL of suspension in a 14, Puurs, Belgium plastic bottle with a dropper YES YES

Baclofen 10 mg tablets Polpharma S.A., Poland 50 tablets in a polypropylene bottle, supplied in a box YES YES

Baclofen 25 mg tablets Polpharma S.A., Poland 50 tablets in a polypropylene bottle, supplied in a box YES YES

4 unit packs (“Stay Safe Balance

Balance 1.5 % glucose, 1.25 solution for peritoneal Fresenius Medical Care system”) each with 2000 mL of

mmol/l calcium dialysis Deutschland GmbH, St. Wendel, solution for peritoneal dialysis in a YES YES YES Germany protective plastic bag, supplied in a

carton box

4 unit packs (“Stay Safe Balance

Balance 1.5 % glucose, 1.25 solution for peritoneal Fresenius Medical Care system”) each with 2500 mL of

mmol/l calcium dialysis Deutschland GmbH, St. Wendel, solution for peritoneal dialysis in a YES YES YES Germany protective plastic bag, supplied in a

carton box

4 unit packs (“Stay Safe Balance

Balance 1.5% glucose, 1.75 solution for peritoneal Fresenius Medical Care system”) each with 2500 mL of

mmol/l calcium dialysis Deutschland GmbH, St. Wendel, solution for peritoneal dialysis in a YES YES YES Germany protective plastic bag, supplied in a

carton box

4 unit packs (“Stay Safe Balance

Balance 1.5% glucose, 1.75 solution for peritoneal Fresenius Medical Care system”) each with 2000 mL of

mmol/l calcium dialysis Deutschland GmbH, St. Wendel, solution for peritoneal dialysis in a YES YES YES Germany protective plastic bag, supplied in a

carton box

14509/1/11 REV 1 WS/jj 235

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

4 unit packs (“Stay Safe Balance

Balance 2.3 % glucose, 1.25 solution for peritoneal Fresenius Medical Care system”) each with 2500 mL of

mmol/l calcium dialysis Deutschland GmbH, St. Wendel, solution for peritoneal dialysis in a YES YES YES Germany protective plastic bag, supplied in a

carton box

4 unit packs (“Stay Safe Balance

Balance 2.3 % glucose, 1.25 solution for peritoneal Fresenius Medical Care system”) each with 2000 mL of

mmol/l calcium dialysis Deutschland GmbH, St. Wendel, solution for peritoneal dialysis in a YES YES YES Germany protective plastic bag, supplied in a

carton box

4 unit packs (“Stay Safe Balance

Balance 2.3% glucose, 1.75 solution for peritoneal Fresenius Medical Care system”) each with 2500 mL of

mmol/l calcium dialysis Deutschland GmbH, St. Wendel, solution for peritoneal dialysis in a YES YES YES Germany protective plastic bag, supplied in a

carton box

4 unit packs (“Stay Safe Balance

Balance 2.3% glucose, 1.75 solution for peritoneal Fresenius Medical Care system”) each with 2000 mL of

mmol/l calcium dialysis Deutschland GmbH, St. Wendel, solution for peritoneal dialysis in a YES YES YES Germany protective plastic bag, supplied in a

carton box

4 unit packs (“Stay Safe Balance

Balance 4.25 % glucose, 1.25 solution for peritoneal Fresenius Medical Care system”) each with 2500 mL of

mmol/l calcium dialysis Deutschland GmbH, St. Wendel, solution for peritoneal dialysis in a YES YES YES Germany protective plastic bag, supplied in a

carton box

4 unit packs (“Stay Safe Balance

Balance 4.25 % glucose, 1.25 solution for peritoneal Fresenius Medical Care system”) each with 2000 mL of

mmol/l calcium dialysis Deutschland GmbH, St. Wendel, solution for peritoneal dialysis in a YES YES YES Germany protective plastic bag, supplied in a

carton box

4 unit packs (“Stay Safe Balance

Balance 4.25% glucose, 1.75 solution for peritoneal Fresenius Medical Care system”) each with 2500 mL of

mmol/l calcium dialysis Deutschland GmbH, St. Wendel, solution for peritoneal dialysis in a YES YES YES Germany protective plastic bag, supplied in a

carton box

4 unit packs (“Stay Safe Balance

Balance 4.25% glucose, 1.75 solution for peritoneal Fresenius Medical Care system”) each with 2000 mL of

mmol/l calcium dialysis Deutschland GmbH, St. Wendel, solution for peritoneal dialysis in a YES YES YES Germany protective plastic bag, supplied in a

carton box

Aventis Pharma Deutschland

Baralgin M film tablets GmbH, Brunningstrasse 50, 20 (2x10) tablets in a blister, supplied YES YES

Frankfurt am Main, Germany in a box

Bazetham capsules 0.4 mg modified release capsules,

Pliva Croatia Ltd., Ulica grada

hard Vukovara 49, Zagreb, Republic of

30 (3x10) capsules in an orange blister

Croatia (PVC/PE/PVDC/Al), supplied in a box

YES YES

BCG VACCINE SSI, vaccine lyophilisate and solvent for Statens Serum Institut, Box with 10 glass bottles each with 10 against tuberculosis - BCG SSI, preparation of suspension Artillerivej, Copenhagen S, doses of lyophilised vaccine (0.75 mg) YES YES

0.75 mg for injection Denmark and a box with 10 glass bottles each with 1 mL of solvent Sauton SSI

Box with 10 glass bottles each

BCG VACCINE SSI, lyophilisate and solvent for Statens Serum Institut, containing 20 doses of lyophilised

tuberculosis vaccine - BCG SSI, preparation of suspension Artillerivej, Copenhagen S, vaccine (1.5 mg) and a box with 10 YES YES

1.5 mg for injection Denmark glass bottles each containing 2 mL of

solvent Sauton SSI

Krka d.d., Šmarješka cesta 6,

B-COMPLEX granules granules Novo mesto, Republic of 70 g of granules in a (PEPT/Al/PE) YES YES YES

Slovenia bag

Krka d.d., Šmarješka cesta 6,

B-COMPLEX coated tablets coated tablets Novo mesto, Republic of 31 (2x15) capsules in a PVC- Al

Slovenia blister, supplied in a box

YES YES YES

14509/1/11 REV 1 WS/jj 236

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Bekunis herbal tea herbal tea Roha Arzneimittel GmbH,

80 g of tea in a round carton box

Bremen, Germany closed with aluminium foil and a plastic YES YES YES lid

Bekunis coated tablets coated tablets Roha Arzneimittel GmbH, 45 coated tablets in a plastic tube with Bremen, Germany a plastic stopper, supplied in a box YES YES YES

Belara film coated tablets Grünenthal GmbH, Stolberg, 21 (1x21) tablets in a blister Germany (PVC/PVDC//Al), supplied in a box YES YES YES

Pliva Croatia Ltd., Ulica grada 63 (3x21) tablets in a transparent

Bellune 35 coated tablets Vukovara 49, Zagreb, Republic of blister (PVC/Al) calendar dial pack, YES YES

Croatia supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Beloderm cream cream Ulica Danica 5, Koprivnica, 15 g of cream in a tube, supplied in a

Republic of Croatia box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Beloderm ointment ointment Ulica Danica 5, Koprivnica, 15 g of cream in a tube, supplied in a

Republic of Croatia box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Belodin tablets Ulica Danica 5, Koprivnica, Box with 7 tablets (blister) YES YES

Republic of Croatia

Belupo, lijekovi i kozmetika d.d.,

Belodin 10mg tablets tablets Ulica Danica 5, Koprivnica, Box with 10 tablets (blister) YES YES

Republic of Croatia

Belupo, lijekovi i kozmetika d.d.,

Belogent cream cream Ulica Danica 5, Koprivnica, 15 g of cream in a tube, supplied in a YES YES

Republic of Croatia box

Belupo, lijekovi i kozmetika d.d.,

Belogent ointment ointment Ulica Danica 5, Koprivnica, 15 g of cream in a tube, supplied in a

Republic of Croatia box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Belomet 200 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 10 (1x10) tablets in a blister, supplied YES

Republic of Croatia in a box

YES YES

solution for injection for Belupo, lijekovi i kozmetika d.d., 10 (2x5) ampoules each containing 2

Belomet 200 mg/2 mL injection intramuscular and Ulica Danica 5, Koprivnica, mL of solution for injection, supplied in YES YES

intravenous use Republic of Croatia a box

Belupo, lijekovi i kozmetika d.d.,

Belosalic lotion lotion Ulica Danica 5, Koprivnica, 50 mL of lotion in a plastic bottle, YES YES

Republic of Croatia supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Belosalic ointment ointment Ulica Danica 5, Koprivnica, 30 g of ointment in a tube, supplied in YES YES

Republic of Croatia a box

Belupo, lijekovi i kozmetika d.d., 200 mL of solution in an amber glass

Belosept solution oromucosal solution Ulica Danica 5, Koprivnica, bottle with aluminum cap and a 10 mL YES YES YES

Republic of Croatia graduated plastic cup, supplied in a box

Krka d.d., Šmarješka cesta 6, 10-mL of solution in a glass bottle with

Benil 0.5 ‰ nasal drops nasal drops Novo mesto, Republic of plastic dropper attachment, supplied in YES YES YES

Slovenia a box

Krka d.d., Šmarješka cesta 6, 10-mL of solution in a glass bottle with

Benil nasal drops 1.0 ‰ nasal drops Novo mesto, Republic of plastic dropper attachment, supplied in YES YES YES

Slovenia a box

Jadran - Galenski laboratorij d.d., 150 mL of emulsion in an amber glass

Benzyl benzoate, Jadran skin emulsion Pulac bb, Rijeka, Republic of bottle with a plastic cap, supplied in a YES YES

Croatia box

14509/1/11 REV 1 WS/jj 237

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Aventis Boehring GmbH, Emil Bottle with a lyophilized drug and a

Beriate P 500 lyophilized preparation and bottle with water for injection in a diluent von-Behring Strasse 76,

Marburg, Germany carton box also containing a leaflet,

YES YES

dissolution kit, and a filter needle

Alkaloid AD-Skopje, Skopje,

Betadine 1 % solution gargling solution FYROM in cooperation with 100 mL of solution in a brown plastic Mundipharma AG, Basel, bottle, supplied in a box YES YES YES

Switzerland

Alkaloid AD-Skopje, Skopje,

Betadine 10 % ointment ointment FYROM in cooperation with 20 grams of cream in an aluminum Mundipharma AG, Basel, tube, supplied in a box YES YES

Switzerland

Alkaloid AD-Skopje, Skopje,

Betadine 10 % solution solution FYROM in cooperation with 100 mL of solution in a brown plastic Mundipharma AG, Basel, bottle, supplied in a box YES YES YES

Switzerland

Alkaloid AD-Skopje, Skopje,

Betadine 200 mg pessaries pessaries FYROM in cooperation with 14 (2x7) pessaries in a PVC/PE foil, Mundipharma AG, Basel, supplied in a box YES YES

Switzerland

Alkaloid AD-Skopje, Skopje,

Betadine 7.5 % solution solution for cleansing and FYROM in cooperation with 1000 mL of solution in a white disinfection of skin Mundipharma AG, Basel, polyethylene bottle YES YES YES

Switzerland

Boehringer Ingelheim Pharma

lyophilisate and diluent for KG, Biberach an der Riss,

Betaferon prepartion of solution for Germany and Chiron 15 3-mL bottles with lyophilisate and YES YES YES

injection Corporation, Emeryville, US for 15 3-mL bottles with 2 mL of diluent

Schering AG, Berlin, Germany

Boehringer Ingelheim Pharma

lyophilisate and diluent for KG, Biberach, Germany and 15 lyophilisate bottles and 15 syringes

Betaferon injection preparation of solution for Chiron Corporation, Emeryville, with 1.2 mL of diluent (0.54% sodium YES YES YES

injection US for Schering AG, Berlin, chloride solution)

Germany

Pliva Croatia Ltd., Ulica grada

Betaglid 1 mg tablets tablets Vukovara 49, Zagreb, Republic of 32 (3x10) tablets in a PVC/PVdC/Al

Croatia blister, supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Betaglid 2 mg tablets tablets Vukovara 49, Zagreb, Republic of 33 (3x10) tablets in a PVC/PVdC/Al YES YES

Croatia blister, supplied in a box

Pliva Croatia Ltd., Ulica grada

Betaglid 3 mg tablets tablets Vukovara 49, Zagreb, Republic of 34 (3x10) tablets in a PVC/PVdC/Al YES YES

Croatia blister, supplied in a box

Krka d.d., Šmarješka cesta 6,

Betaklav duo tablets tablets Novo mesto, Republic of 10 (5x2) tablets in a AL/PE//AL strip, YES YES

Slovenia supplied in a box

Betaklav powder for solution for powder for solution for Krka d.d., Šmarješka cesta 6, 100-mL glass bottle containing 2.2 g

infusion 2.2 infusion Novo mesto, Republic of of powder for solution for infusion, YES YES Slovenia supplied in a box

Betaklav powder for solution for powder for solution for Krka d.d., Šmarješka cesta 6, 20-mL glass bottle containing 1.2 g of

injection 1.2 injection Novo mesto, Republic of powder for solution for injection, YES YES Slovenia supplied in a box

Solvay Pharmaceuticals B.V.,

Weesp, the Netherlands i Solvay

Betaserc 16 mg tablets Pharmaceuticals, Lieu dit 60 (3x20) tablets in a PVC/PVDC/Al YES YES

Maillard, Chatillon sur blister, supplied in a box

Chalaronne, France

Solvay Pharmaceuticals B.V.,

Betaserc 24 mg tablets Weesp, the Netherlands i Solvay 20 (1x20) tablets in a PVC/PVDC Pharmaceuticals, Lieu dit blister, supplied in a box YES YES

Maillard, Chatillon sur

14509/1/11 REV 1 WS/jj 238

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Chalaronne, France

Solvay Pharmaceuticals B.V.,

Weesp, the Netherlands i Solvay

Betaserc 8 mg tablets Pharmaceuticals, Lieu dit 100 (4x25) tablets in a PVC/PVDC/Al

Maillard, Chatillon sur blister, supplied in a box

YES YES

Chalaronne, France

Jadran - Galenski laboratorij d.d.,

Betazon cream cream Pulac bb, Rijeka, Republic of 25 grams of cream in an aluminium

Croatia tube, supplied in a box

YES YES

Jadran - Galenski laboratorij d.d.,

Betazon ointment ointment Pulac bb, Rijeka, Republic of 25 grams of cream in an aluminium

Croatia tube, supplied in a box

YES YES

Betoptic 0.5 % eye drops eye drops Alcon-Couvreur s.a., Rijksweg 5 mL of solution in a plastic bottle, 14, Puurs, Belgium supplied in a box YES YES

Pliva Croatia Ltd., Ulica grada

Betrion ointment Vukovara 49, Zagreb, Republic of Aluminium tube YES YES

Croatia

powder and diluent for

BiCNU injection 100 mg preparation of solution for Bristol Myers-Squibb S.r.I., Vial with powder and vial with 3 mL of YES YES

infusion Sermoneta, Latina, Italy diluent, supplied in a box

Krka d.d., Šmarješka cesta 6,

Bilobil forte capsules 80 mg capsules Novo mesto, Republic of 20 (2x10) capsules in a blister (PVC- YES

Slovenia Al), supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6,

Bilobil capsules capsules Novo mesto, Republic of 20 (2x10) capsules in a blister, YES YES YES

Slovenia supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Bisobel 10 mg tablets tablets Ulica Danica 5, Koprivnica, 30 (1x30) tablets in a blister

Republic of Croatia (PVC/PVDC-Al), supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Bisobel 5 mg tablets tablets Ulica Danica 5, Koprivnica, 30 (1x30) tablets in a blister

Republic of Croatia (PVC/PVDC-Al), supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Bisolex F tablets tablets Vukovara 49, Zagreb, Republic of 20 (2x10) tablets in an orange blister YES YES

Croatia (PVC/Al), supplied in a box

YES

Pliva Croatia Ltd., Ulica grada 30 mL of solution in an amber glass

Bisolex solution oral drops, solution Vukovara 49, Zagreb, Republic of bottle with a dropper and a plastic 6 YES YES YES

Croatia mL measuring cup, supplied in a box

Pliva Croatia Ltd., Ulica grada 200 mL of solution in an amber glass

Bisolex syrup syrup Vukovara 49, Zagreb, Republic of bottle with an aluminum cap and a 5 YES YES YES

Croatia mL plastic measuring spoon, supplied in a box

Pliva Croatia Ltd., Ulica grada

Bisolex tablets tablets Vukovara 49, Zagreb, Republic of 20 (2x10) tablets in an orange blister YES YES YES

Croatia (PVC/Al), supplied in a box

40 mL of solution in an amber glass

Bisolvon 2 mg/mL solution oral and inhalation solution Instituto de Angeli, Regello (FI), bottle with a plastic dropper and a Italy measuring graduated (1-6 mL) cup, YES YES YES

supplied in a box

250-mL of syrup in an amber glass

Boehringer Ingelheim France, 12, bottle, a plastic dispenser glass with

Bisolvon syrup 4 mg/5 mL syrup Rue Andre Huet, Reims, Cedex, 2.5 and 5 mL printed graduation lines

France or plastic dispenser spoon with 2.5 an

YES YES YES

5 mL graduation marks, supplied in a

box

14509/1/11 REV 1 WS/jj 239

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Boehringer Ingelheim France, 12,

Bisolvon 8 mg tablets tablets Rue Andre Huet, Reims, Cedex, 20 (2x10) tablets in a white blister YES YES YES

France (PVC/PVDC//Al), supplied in a box

Bisopromerck 10 film coated tablets Merck KGaA, Frankfurter Straße 30 (3x10) tablets in a PVC/Al blister, 250, Darmstadt, Germany supplied in a box YES YES

Bisopromerck 5 film coated tablets Merck KGaA, Frankfurter Straße 30 (3x10) tablets in a PVC/Al blister, 250, Darmstadt, Germany supplied in a box YES YES

Lek farmacevtska družba d.d., One amber glass bottle with powder,

Bivacyn eye and nasal drops eye and nasal drops Verovškova 57, Ljubljana, one glass bottle with 10 mL of diluent, YES

Republic of Slovenia and a plastic dropper attachment (in a

YES

protective package), supplied in a box

Lek farmacevtska družba d.d.,

Bivacyn ointment ointment Verovškova 57, Ljubljana, 30 g of ointment in an aluminium tube, YES YES

Republic of Slovenia supplied in a box

Lek farmacevtska družba d.d.,

Bivacyn eye ointment eye ointment Verovškova 57, Ljubljana, 3.5 g of ointment in an aluminum tube, YES YES

Republic of Slovenia supplied in a box

Lek farmacevtska družba d.d.,

Bivacyn dermal powder dermal powder Verovškova 57, Ljubljana, 5 g of powder in a plastic bottle,

Republic of Slovenia supplied in a box

YES YES

Bivacyn dermatological spray, dermatological spray, Lek farmacevtska družba d.d., 150 mL of spray (in a Powder form) in

powder powder Verovškova 57, Ljubljana, an aluminum container with nebulizer, YES YES Republic of Slovenia supplied in a box

BLEOCIN - S powder for solution for Euro Nippon Kayaku GmbH, 10-mL clear glass bottle containing injection Frankfurt am Main, Germany powder, supplied in a box YES YES

Krka d.d., Šmarješka cesta 6,

Bloxan 100 mg tablets tablets Novo mesto, Republic of 30 (3x10) tablets in a blister, supplied YES

Slovenia in a box

YES

Bondronat 2 mg concentrate for concentrate for infusion Roche Diagnostics GmbH, solution for infusion solution Sandhofeer Strasse 116, D- One glass vial with 2-mL of YES YES YES 68305 Mannheim, Germany concentrate, supplied in a box

YES

Bondronat 50 mg film coated F. Hoffmann-La Roche Ltd., tablets film coated tablets Grenzacherstrasse 124, Basel, 28 (4x7) tablets in a blister (A1/Al), YES YES YES YES Switzerland supplied in a box

Bondronat 6 mg concentrate for concentrate for solution for Roche Diagnostics GmbH, solution for infusion infusion Sandhofeer Strasse 116, D-

One glass vial with 6 mL of

68305 Mannheim, Germany concentrate, supplied in a box

YES YES YES YES

Bonefos 400 mg capsules capsules Schering Oy, Turku, Finland 100 capsules in a plastic (HDPE) bottle, supplied in a box YES YES

Bonefos 60 mg/mL concentrate concentrate of solution for 5 glass ampoules with 5 mL of solution

of solution for infusion infusion Schering Oy, Turku, Finland concentrate, supplied in a box YES YES

Bonefos 60 mg/mL concentrate concentrate of solution for

of solution for infusion infusion Schering Oy, Turku, Finland

5 glass ampoules with 5 mL of solution

concentrate, supplied in a box YES YES

Bonefos 800 mg tablets film coated tablets Schering Oy, Turku, Finland 60 tablets in a PVC/Al blister, supplied in a box YES YES

Belupo, lijekovi i kozmetika d.d.,

Bonna 35 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 4 (1x4) tablets in a blister

Republic of Croatia (PVC/PE/PVDC//AI), supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 240

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Belupo, lijekovi i kozmetika d.d., 28 (1x28) tablets in a

Bonna 5 mg tablets film coated tablets Ulica Danica 5, Koprivnica, PVC/PE/PVDC//AI blister, supplied in YES YES

Republic of Croatia a box

Bonviva 150 mg film coated F. Hoffmann-La Roche Ltd., tablets film coated tablets Grenzacherstrasse 124, Basel, One film coated tablet in a blister YES YES Switzerland (Al/Al), supplied in a box

YES YES

Bonviva 3 mg solution for solution for injection (in pre Roche Diagnostics GmbH, injection in a pre-filled syringe filled syringe) Sandhofeer Strasse 116, D- Pre-filled syringe containing 3 mL of YES YES YES 68305 Mannheim, Germany solution, supplied in a box

YES

lyophilisate for preparation Allergan Pharmaceuticals

Botox of injection for intramuscular Republic of Ireland, Castlebar Glass bottle of 10 mL containing 1.4

use Road, Westport, Co Mayo, mg of lyophilisate, supplied in a box

YES YES

Republic of Ireland

Krka d.d., Novo Mesto, Republic

Brinerdin coated tablets coated tablets of Slovenia in cooperation with 50 (5x10) tablets in a blister, supplied Novartis Pharma Ltd., in a box YES YES

Switzerland

Berlin-Chemie AG (Menarini

Brivuzost tablets Group), Glienicker Weg 125, 7 tablets in a blister (PVC/Al),

Berlin, Germany supplied in a carton box

YES YES YES

Lek farmacevtska družba d.d.,

Bromergon 2.5 mg tablets tablets Verovškova 57, Ljubljana, 30 tablets in an amber glass bottle, YES YES

Republic of Slovenia supplied in a box

Brufen 400 film coated tablets film coated tablets Abbott GmbH & Co. KG, 30 (3x10) tablets in a PVC/Al or Ludwigshafen, Germany PVC/PVDC/Al blister, supplied in a box YES YES

Brufen 600 film coated tablets film coated tablets Abbott GmbH & Co. KG, 30 (3x10) tablets in a PVC/Al or Ludwigshafen, Germany PVC/PVDC/Al blister, supplied in a box YES YES

60 mL of shampoo in an amber glass

Bubil shampoo shampoo AD JAKA 80 Radoviš, Radoviš, FYROM bottle with an aluminium stopper, YES YES YES

supplied in a box

Pliva Croatia Ltd., Ulica grada

Buscol dragee sugar-coated tablets Vukovara 49, Zagreb, Republic of Box with 20 (2x10) sugar-coated YES

Croatia tablets in a blister

YES

Boehringer Ingelheim France, 12,

Buscopan 10 mg coated tablets coated tablets Rue Andre Huet, Reims, Cedex, 20 (1x20) tablets in PVC/Al blister,

France supplied in a box

YES YES YES

Lek farmacevtska družba d.d., 50 (5x10) tablets in a blister

Byol 10 mg film coated tablets film coated tablets Verovškova 57, Ljubljana, (PVC/PE/PVDC/Al), in an aluminium YES YES

Republic of Slovenia bag, supplied in a carton box

Lek farmacevtska družba d.d.,

Byol 10 mg film coated tablets film coated tablets Verovškova 57, Ljubljana, 30 (3X10) tablets in a blister, in an

Republic of Slovenia aluminium bag, supplied in a box

YES YES

Lek farmacevtska družba d.d., 50 (5x10) tablets in a blister

Byol 5 mg film coated tablets film coated tablets Verovškova 57, Ljubljana, (PVC/PE/PVDC/Al), in an aluminium YES YES

Republic of Slovenia bag, supplied in a carton box

Lek farmacevtska družba d.d.,

Byol 5 mg film coated tablets film coated tablets Verovškova 57, Ljubljana, 30 (3X10) tablets in a blister, in an YES

Republic of Slovenia aluminium bag, supplied in a box

YES

Krka d.d., Novo Mesto, Republic

Ca-C 500 Sandoz effervescent tablets of Slovenia for Novartis 10 effervescent tablets in an Al-foil in a Consumer Health S.A., Nyon, vial, supplied in a box YES YES YES

Switzerland

Pfizer GmbH Arzneimittelwerk 30 (3x10) film coated tablets in a

Caduet 10 mg/10 mg tablets film coated tablets Gödecke, Mooswaldalle 1, blister (polyamide/aluminum/PVC), YES YES YES YES

Freiburg, Germany supplied in a carton box

14509/1/11 REV 1 WS/jj 241

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pfizer GmbH Arzneimittelwerk 31 (3x10) film coated tablets in a

Caduet 5 mg/10 mg tablets film coated tablets Gödecke, Mooswaldalle 1, blister (polyamide/aluminum/PVC), YES YES YES YES

Freiburg, Germany supplied in a carton box

Alkaloid AD - Skopje, Bulevar

Caffetin Cold film coated tablets Aleksandar Makedonski 12, 10 (1x10) tablets in a PVC/TE/PVdc-Al YES YES

Skopje, FYROM blister, supplied in a box

YES

Alkaloid AD - Skopje, Bulevar

Caffetin tablets tablets Aleksandar Makedonski 12, 12 (2x6) tablets in Al/PE strip, YES YES YES

Skopje, FYROM supplied in a box

1.8 g of herbal tea in a filter bag

"Droga" herbal laxative herbal laxative tea Droga Kolinska d.d., Ljubljana, Republic of Slovenia wrapped in paper envelope, 20 filter YES YES YES

bags in a box

solution for injection for Novartis Pharma Stein AG,

Calcium Sandoz 10 % injection intramuscular and Schaffhauserstrasse, Stein, 10 mL of solution in a glass ampoule,

intravenous use Switzerland 5 ampoules in a carton box

YES YES

Calciumvita C effervescent Krka d.d., Šmarješka cesta 6, tablets effervescent tablets Novo mesto, Republic of 10 effervescent tablets wrapped in an YES YES Slovenia Al-foil in a vial, supplied in a box

YES

GlaxoSmithKline

Calgel gum gel gum gel Pharmaceuticals S.A., Ul. 10 g of gel in aluminum tube, supplied Grunwaldzka 189, Poznan, in a box YES YES YES

Poland

Belupo, lijekovi i kozmetika d.d.,

Calixta 15 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 30 (3x10) tablets in a blister, supplied

Republic of Croatia in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Calixta 30 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 30 (3x10) tablets in a blister, supplied YES YES

Republic of Croatia in a box

Belupo, lijekovi i kozmetika d.d.,

Calixta 45 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 30 (3x10) tablets in a blister, supplied YES YES

Republic of Croatia in a box

CAMPTO 100 mg/5 mL concentrate for preparation Aventis Pharma Dagenham, Amber glass bottle containing 5 mL of of solution for infusion Dagenham, Essex, Great Britain solution, supplied in a box YES YES

CAMPTO 40 mg/2 mL concentrate for preparation Aventis Pharma Dagenham, Amber glass bottle containing 2 mL of of solution for infusion Dagenham, Essex, Great Britain solution, supplied in a box YES YES

CANCIDAS 50 mg powder for powder for concentrate for Merck Sharp & Dohme B.V., 10-mL glass bottle with powder,

concentrate for infusion solution infusion solution Waarderweg 39, Postbus 581, Haarlem, The Nederlands supplied in a box YES YES YES

CANCIDAS 70 mg powder for powder for concentrate for Merck Sharp & Dohme B.V., 10-mL glass bottle with powder

concentrate for infusion solution infusion solution Waarderweg 39, Postbus 581, Haarlem, the Netherlands supplied ina box YES YES YES

One vaginal tablet in a PA/Al/PVC/Al

Canesten 1 vaginal tablet 0.5 g vaginal tablets Bayer HealthCare AG, 51368 Leverkusen, Germany blister pack and one applicator, YES YES

supplied in a box

One vaginal tablet in a PA/Al/PVC/Al

Canesten 1 vaginal tablet 0.5 blister pack, 20 g of cream in an

g/Canesten cream vaginal tablets and cream

Bayer HealthCare AG, 51368

Leverkusen, Germany aluminum tube and applicator, YES YES

supplied in a box

Canesten 3 vaginal cream vaginal cream Bayer HealthCare AG, 51368 20 grams of cream and 3 applicators, Leverkusen, Germany supplied in a box YES YES

3 (1x3) vaginal tablets in a blister

Canesten 3 vaginal tablets 0.2 g vaginal tablets Bayer HealthCare AG, 51368 Leverkusen, Germany (PA/Al/PVC/Al) and one applicator, YES YES

supplied in a box

14509/1/11 REV 1 WS/jj 242

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

3 vaginal tablets in a blister

Canesten 3 vaginal tablets 0.2 g Bayer HealthCare AG, 51368 (PA/Al/PVC/Al), 20 g cream in

/ Canesten cream vaginal tablet and cream Leverkusen, Germany aluminum tube and an applicator, YES YES

supplied in a box

Canesten cream cream Bayer HealthCare AG, 51368 20 grams of cream in an aluminum Leverkusen, Germany tube, supplied in a box YES YES

Canesten solution solution (for external use) Bayer HealthCare AG, 51368

20 mL of solution in a plastic bottle

Leverkusen, Germany with dropper attachment, supplied in a YES YES box

Canesten dermal powder dermal powder Bayer HealthCare AG, 51368 30 g of powder in a plastic bottle, Leverkusen, Germany supplied in a box YES YES

Canesten dermatological spray, dermatological spray, Bayer HealthCare AG, 51368 30 mL of solution in a plastic bottle

solution solution Leverkusen, Germany with a spray attachment, supplied in a YES YES box

Canifug 1% solution dermal solution Dr. August Wolff GmbH & Co.

30 mL of solution in an amber glass

Arzneimittel, Bielefeld, Germany bottle with a spray applicator supplied YES YES in a box

One plastic bag with 5000 mL of

solution, a feeding tube, a connector

(with protective cap) to the dialysis

CAPD/DPCA 17 sleep safe solution for peritoneal

Fresenius Medical Care

dialysis Deutschland GmbH, St. Wendel, machine ("sleep safe cycler") and YES YES Germany drug administration attachment, two

plastic bags with 5000 mL of solution,

supplied in a box

One plastic bag with 2500 mL of

solution, an feeding tube, a disc

Fresenius Medical Care connector with housing and solution

CAPD/DPCA 17 stay safe solution for peritoneal dialysis Deutschland GmbH, St. Wendel, drain regulator, a catheter connector YES YES

Germany (with protective cap), a collecting bag

with drain tube and attachments

("Injection Unit")

Fresenius Medical Care 4 plastic bags with 2000 mL of solution

CAPD/DPCA 17 stay safe solution for peritoneal and an empty collection bag, inserted dialysis Deutschland GmbH, St. Wendel,

Germany in a protective plastic bag, supplied in

YES YES YES

a box

One plastic bag with 2000 mL of

solution, an feeding tube, a disc

connector with housing and solution

CAPD/DPCA 17 stay safe solution for peritoneal

Fresenius Medical Care

dialysis Deutschland GmbH, St. Wendel, drain regulator, a catheter connector YES YES Germany (with protective cap), a collecting bag

with drain tube and attachments

("Injection Unit")

Fresenius Medical Care 4 plastic bags with 2500 mL of solution

CAPD/DPCA 17 stay safe solution for peritoneal and an empty collection bag, inserted dialysis Deutschland GmbH, St. Wendel, YES YES YES

Germany in a protective plastic bag, supplied in a box

One plastic bag with 5000 mL of

solution, a feeding tube, a connector

Fresenius Medical Care (with protective cap) to the dialysis

CAPD/DPCA 18 sleep safe solution for peritoneal dialysis Deutschland GmbH, St. Wendel, machine ("sleep safe cycler") and YES YES

Germany drug administration attachment, two

plastic bags with 5000 mL of solution,

supplied in a box

One plastic bag with 2500 mL of

Fresenius Medical Care solution, an feeding tube, a disc

CAPD/DPCA 18 stay safe solution for peritoneal dialysis Deutschland GmbH, St. Wendel, connector with housing and solution

Germany drain regulator, a catheter connector

YES YES

(with protective cap), a collecting bag

with drain tube and attachments

14509/1/11 REV 1 WS/jj 243

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

("Injection Unit")

One plastic bag with 2000 mL of

solution, an feeding tube, a disc

Fresenius Medical Care connector with housing and solution

CAPD/DPCA 18 stay safe solution for peritoneal dialysis Deutschland GmbH, St. Wendel, drain regulator, a catheter connector YES YES

Germany (with protective cap), a collecting bag

with drain tube and attachments

("Injection Unit")

Fresenius Medical Care 4 plastic bags with 2500 mL of solution

CAPD/DPCA 18 stay safe solution for peritoneal and an empty collection bag, inserted dialysis Deutschland GmbH, St. Wendel, YES YES YES

Germany in a protective plastic bag, supplied in a box

Fresenius Medical Care 4 plastic bags with 2000 mL of solution

CAPD/DPCA 18 stay safe solution for peritoneal and an empty collection bag, inserted dialysis Deutschland GmbH, St. Wendel, YES

Germany in a protective plastic bag, supplied in

YES YES

a box

One plastic bag with 5000 mL of

solution, a feeding tube, a connector

(with protective cap) to the dialysis

CAPD/DPCA 19 sleep safe solution for peritoneal

Fresenius Medical Care

dialysis Deutschland GmbH, St. Wendel, machine ("sleep safe cycler") and YES YES Germany drug administration attachment, two

plastic bags with 5000 mL of solution,

supplied in a box

4 plastic bags with 2000 mL of solution

CAPD/DPCA 19 stay safe solution for peritoneal

Fresenius Medical Care

dialysis Deutschland GmbH, St. Wendel,

and an empty collection bag, inserted YES YES YES

Germany in a protective plastic bag, supplied in a box

4 plastic bags with 2500 mL of solution

CAPD/DPCA 19 stay safe solution for peritoneal

Fresenius Medical Care and an empty collection bag, inserted

dialysis Deutschland GmbH, St. Wendel, YES YES Germany in a protective plastic bag, supplied in YES

a box

One plastic bag with 2000 mL of

solution, an feeding tube, a disc

Fresenius Medical Care connector with casing and solution

CAPD/DPCA 19 stay safe solution for peritoneal dialysis Deutschland GmbH, St. Wendel, drain regulator, a catheter connector YES YES

Germany (with protective cap), a collecting bag

with drain tube and attachments

("Injection Unit")

One plastic bag with 2500 mL of

solution, an feeding tube, a disc

Fresenius Medical Care connector with housing and solution

CAPD/DPCA 19 stay safe solution for peritoneal dialysis Deutschland GmbH, St. Wendel, drain regulator, a catheter connector YES YES

Germany (with protective cap), a collecting bag

with drain tube and attachments

("Injection Unit")

One plastic bag with 5000 mL of

solution, a feeding tube, a connector

Fresenius Medical Care (with protective cap) to the dialysis

CAPD/DPCA 2 sleep safe solution for peritoneal dialysis Deutschland GmbH, St. Wendel, machine ("sleep safe cycler") and YES YES

Germany drug administration attachment, two

plastic bags with 5000 mL of solution,

supplied in a box

Fresenius Medical Care 4 plastic bags with 2000 mL of

CAPD/DPCA 2 stay safe solution for peritoneal dialysis Deutschland GmbH, St. Wendel, solution, inserted in a protective plastic YES YES

Germany bag, supplied in a box

One plastic bag with 2000 mL of

Fresenius Medical Care solution, an feeding tube, a disc

CAPD/DPCA 2 stay safe solution for peritoneal dialysis Deutschland GmbH, St. Wendel, connector with housing and solution YES YES

Germany drain regulator, a catheter connector

(with protective cap), a collecting bag

14509/1/11 REV 1 WS/jj 244

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

with drain tube and attachments

("Injection Unit")

One plastic bag with 5000 mL of

solution, a feeding tube, a connector

(with protective cap) to the dialysis

CAPD/DPCA 3 sleep safe solution for peritoneal

Fresenius Medical Care

dialysis Deutschland GmbH, St. Wendel, machine ("sleep safe cycler") and YES YES Germany drug administration attachment, two

plastic bags with 5000 mL of solution,

supplied in a box"

One plastic bag with 2000 mL of

solution, an feeding tube, a disc

Fresenius Medical Care connector with housing and solution

CAPD/DPCA 3 stay safe solution for peritoneal dialysis Deutschland GmbH, St. Wendel, drain regulator, a catheter connector YES YES

Germany (with protective cap), a collecting bag

with drain tube and attachments

("Injection Unit")

CAPD/DPCA 3 stay safe solution for peritoneal

Fresenius Medical Care 4 plastic bags with 2000 mL of

dialysis Deutschland GmbH, St. Wendel, solution, inserted in a protective plastic YES YES Germany bag, supplied in a box

One plastic bag with 5000 mL of

solution, a feeding tube, a connector

Fresenius Medical Care (with protective cap) to the dialysis

CAPD/DPCA 4 sleep safe solution for peritoneal dialysis Deutschland GmbH, St. Wendel, machine ("sleep safe cycler") and YES YES

Germany drug administration attachment, two

plastic bags with 5000 mL of solution,

supplied in a box"

CAPD/DPCA 4 stay safe solution for peritoneal

Fresenius Medical Care 4 plastic bags with 2000 mL of

dialysis Deutschland GmbH, St. Wendel, solution, inserted in a protective plastic YES YES Germany bag

One plastic bag with 2000 mL of

solution, an feeding tube, a disc

connector with housing and solution

CAPD/DPCA 4 stay safe solution for peritoneal

Fresenius Medical Care

dialysis Deutschland GmbH, St. Wendel, drain regulator, a catheter connector YES YES Germany (with protective cap), a collecting bag

with drain tube and attachments

("Injection Unit")

Jadran - Galenski laboratorij d.d.,

Carbomed granules granules Pulac bb, Rijeka, Republic of 50 g of granules in an amber glass YES YES YES

Croatia bottle, supplied in a box

Jadran - Galenski laboratorij d.d.,

Carbomed tablets tablets Pulac bb, Rijeka, Republic of 30 (3x10) tablets in a PVC/Al blister, YES YES

Croatia supplied in a box

YES

CARBOPLATIN EBEWE 150 concentrate of solution for Ebewe Pharma Ges. m.b.H. Nfg. 15 mL of solution concentrate in an

mg/15 mL infusion KG, Mondseestrasse 11, amber glass bottle (with rubber YES YES Unterach, Austria stopper), supplied in a box

CARBOPLATIN EBEWE 50 concentrate of solution for Ebewe Pharma Ges. m.b.H. Nfg. 5 mL of solution concentrate in an

mg/5 mL infusion KG, Mondseestrasse 11, amber glass bottle (with a rubber YES YES Unterach, Austria stopper), supplied in a box

Pliva Croatia Ltd., Ulica grada 15 mL of concentrate in a glass bottle

Carboplatin Pliva 150 concentrate of solution for (amber orclear, with rubber stopper infusion Vukovara 49, Zagreb, Republic of YES

Croatia and aluminum cap with plastic lid),

YES

supplied in a box

5 mL of concentrate in a glass bottle

Carboplatin Pliva 50 concentrate of solution for

Pliva Croatia Ltd., Ulica grada

infusion Vukovara 49, Zagreb, Republic of

(amber or colourless, with a rubber YES YES

Croatia stopper and an Al cap with a plastic lid), supplied in a box

Cardiopirin 100 mg gastric Lannacher Heilmittel GmbH, 30 (3x10) tablets in a blister, supplied

resistant tablets gastric-resistant tablets Lannach, Austria in a box YES YES

14509/1/11 REV 1 WS/jj 245

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Cardiopirin 50 mg gastric Lannacher Heilmittel GmbH, 30 (3x10) tablets in a blister, supplied

resistant tablets gastric-resistant tablets Lannach, Austria in a box YES YES

40 mL of solution in a glass bottle with

CARMOL drops drops, solutiojn Dr. A.&L. Schmidgall, Vienna, Austria a plastic dropper and a plastic stopper, YES YES YES

supplied in a box

Belupo, lijekovi i kozmetika, d.d.,

Carvelol 12.5 mg tablets tablets Koprivnica in cooperation with F. Hoffmann-La Roche Ltd, Basel, 28 tablets in a blister, supplied in a box YES YES

Switzerland

Belupo, lijekovi i kozmetika, d.d.,

Carvelol 25 mg tablets tablets Koprivnica in cooperation with F. Hoffmann-La Roche Ltd, Basel, 28 tablets in a blister, supplied in a box YES YES

Switzerland

Belupo, lijekovi i kozmetika d.d.,

Carvelol 3.125 mg tablets tablets Ulica Danica 5, Koprivnica, 30 (3x10) tablets in transparent YES

Republic of Croatia PVC/PVDC/Al blister, supplied in a box

YES

Belupo, lijekovi i kozmetika, d.d.,

Carvelol 6.25 mg tablets tablets Koprivnica in cooperation with F. Hoffmann-La Roche Ltd, Basel, 28 tablets in a blister, supplied in a box YES YES

Switzerland

CARVETREND tablets 12.5 mg each tablet contains 12.5

Pliva Croatia Ltd., Ulica grada 28 (2x14) tablets in a PVC/PVDC//Al

mg of carvedilolum Vukovara 49, Zagreb, Republic of Croatia blister, supplied in a box YES YES

Pliva Croatia Ltd., Ulica grada

CARVETREND tablets 25 mg each tablet contains 25 mg of carvedilolum Vukovara 49, Zagreb, Republic of 28 (1x28) tablets in a PVC/PVDC//Al

Croatia blister, supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

CARVETREND tablets 3.125 mg each tablet contains 3.125 mg of carvedilolum Vukovara 49, Zagreb, Republic of 28 (2x14) tablets in a PVC/PVDC//Al YES YES

Croatia blister, supplied in a box

Pliva Croatia Ltd., Ulica grada

CARVETREND tablets 6.25 mg each tablet contains 6.25 mg of carvedilolum Vukovara 49, Zagreb, Republic of 28 (2x14) tablets in a PVC/PVDC//Al YES YES

Croatia blister, supplied in a box

AstraZeneca GmbH, Plankstadt,

Casodex tablets 150 mg film coated tablets Germany and AstraZeneca UK 28 (2x14) tablets in a blister (PVC/Al), Limited, Macclesfield, Cheshire, supplied in a box YES YES

Great Britain

AstraZeneca GmbH, Plankstadt,

Casodex tablets 50 mg film coated tablets Germany; AstraZeneca UK 28 (2x14) tablets in a blister (PVC/Alu

Limited, Cheshire, Great Britain foil), supplied in a carton box

YES YES

Cedax capsules 400 mg capsules SIFI S.p.A., Aci S. Antonio, Catania, Italy 5 capsules in a strip, supplied in a box YES YES

Cedax powder for preparation of powder for preparation of SIFI S.p.A., Aci S. Antonio, 15 grams of powder for preparation of

oral suspension 180 mg/5 mL oral suspension Catania, Italy 60 mL oral suspension YES YES

Belupo, lijekovi i kozmetika d.d.,

Cefaleksin 500 mg capsules capsules Ulica Danica 5, Koprivnica, 16 (1x16) capsules in a PVC/Al blister,

Republic of Croatia supplied in a box

YES YES

Cefaleksin 250 mg/5 mL powder powder for preparation of Belupo, lijekovi i kozmetika d.d., for oral suspension oral suspension Ulica Danica 5, Koprivnica,

Amber glass bottle with an aluminium

Republic of Croatia screw cap

YES YES

Amber glass bottle with powder for

Cefalexin Alkaloid 250 mg /5 mL powder for preparation of Alkaloid AD - Skopje, Bulevar preparation of 100 mL of suspension

powder for oral suspension oral suspension Aleksandar Makedonski 12, with an aluminium stopper and a YES YES Skopje, FYROM plastic measuring soon, supplied in a

box

14509/1/11 REV 1 WS/jj 246

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Cefalexin Alkaloid 500 mg Alkaloid AD - Skopje, Bulevar capsules capsules Aleksandar Makedonski 12, 16 (2x8) capsules in a PVC/Al blister, YES Skopje, FYROM supplied in a carton box

YES

Cefalin capsules 500 mg capsules Pliva Krakow, Krakow, Poland 16 capsules (2x8) in a PVC/Al blister, supplied in a box YES YES

Cefalin syrup 250 mg/5 mL powder for preparation of Amber glass bottle of 100 mL with a oral suspension Pliva Krakow, Krakow, Poland plastic stopper and ROPP cap YES YES

Cefalin tablets 1 g film coated tablets Pliva Krakow, Krakow, Poland 16 tablets (2x8) in a PVC/Al blister, supplied in a box YES YES

Cefixim suspension powder for preparation of

Alkaloid AD - Skopje, Bulevar 53 g of powder for preparation of 100

oral suspension Aleksandar Makedonski 12, mL of suspension in an amber glass YES YES Skopje, FYROM bottle, supplied in a box

Alkaloid AD - Skopje, Bulevar

Cefixim tablets film coated tablets Aleksandar Makedonski 12, 10 tablets in an amber glass bottle, YES

Skopje, FYROM supplied in a box

YES

Farmal d.d., Ludbreg, Branitelja

domovinskog rata 8, Republic of

Cefotaksim injection 1 g powder for preparation of injection solution Croatia in cooperation with Lek One glass vial with 1.0 g of powder, YES

d.d., Ljubljana, Verovškova 57, supplied in a box

YES

Republic of Slovenia

Farmal d.d., Ludbreg, Branitelja

domovinskog rata 8, Republic of

Cefotaksim injection 2 g powder for preparation of solution for injection Croatia in cooperation with Lek One glass vial with 2.0 g of powder, YES

d.d., Ljubljana, Verovškova 57, supplied in a box

YES

Republic of Slovenia

Jadran -Galenski laboratorij d.d.,

Cefzil 250 mg/5 mL powder for powder for preparation of Rijeka, Republic of Croatia, in

30 g of powder for oral suspension in a

oral suspension oral suspension cooperation with Bristol-Myers

60 mL plastic (HDPE) bottle with a

Squibb S.p.A., Contrada Fontana plastic measuring spoon, supplied in a

YES YES

del Cerasp. Anagni, Italy box

Jadran -Galenski laboratorij d.d.,

Rijeka, Republic of Croatia, in 10 (2x5) film coated tablets in a

Cefzil 500 mg film-tablets film coated tablets cooperation with Bristol-Myers PVC/PVDC//Al blister, supplied in a YES YES

Squibb S.p.A., Contrada Fontana box

del Cerasp. Anagni, Italy

Pharmacia Limited, Whalton

Celebrex capsules 200 mg capsules Road, Morpeth, Northumberland 10 capsules in a blister, supplied in a YES

NE613YA, Great Britain box

YES

F. Hoffmann-La Roche Ltd.,

CellCept 250 mg capsules capsules Grenzacherstrasse 124, Basel, 100 (10x10) capsules in a PVC/Al

Switzerland blister, supplied in a box

YES YES YES YES

F. Hoffmann-La Roche Ltd.,

CellCept 500 mg tablets film coated tablets Grenzacherstrasse 124, Basel, 50 (5x10) tablets in a blister (PVC/Al),

Switzerland supplied in a box

YES YES YES YES

Cerezyme 200 U powder for Genzyme Ltd., 37 Hollands One glass vial with powder for infusion

concentrate for solution for powder for concentrate for solution concentrate supplied, in a YES YES YES YES infusion solution for infusion

Road, Haverhill, Suffolk CB9

8PU, Great Britain carton box

Cerezyme 400 U powder for Genzyme Ltd., 37 Hollands One glass vial with powder for infusion

concentrate for solution for powder for concentrate for YES YES YES YES infusion solution for infusion

Road, Haverhill, Suffolk CB9 solution concentrate supplied, in a

8PU, Great Britain carton box

Belupo, lijekovi i kozmetika d.d.,

Cerson 5 mg tablets tablets Ulica Danica 5, Koprivnica, 10 (1x10) tablets in a PVC/Al blister, YES YES

Republic of Croatia supplied in a box

Certican 0.1 mg tablets for oral Novartis Pharma Stein AG, suspension tablets for oral susupension Schaffhauserstrasse, Stein,

60 (6x10) tablets in a blister

Switzerland (PA/Al/PVC//Al), supplied in a box

YES YES YES

14509/1/11 REV 1 WS/jj 247

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Novartis Pharma Stein AG,

Certican 0.25 mg tablets tablets Schaffhauserstrasse, Stein, 60 (6x10) tablets in a blister YES

Switzerland (PA/Al/PVC//Al), supplied in a box

YES YES

Certican 0.25 mg tablets for oral Novartis Pharma Stein AG, 60 (6x10) tablets in a blister

suspension tablets for oral susupension Schaffhauserstrasse, Stein, Switzerland (PA/Al/PVC//Al), supplied in a box YES YES YES

Novartis Pharma Stein AG,

Certican 0.5 mg tablets tablets Schaffhauserstrasse, Stein, 60 (6x10) tablets in a blister YES YES YES

Switzerland (PA/Al/PVC//Al), supplied in a box

Novartis Pharma Stein AG,

Certican 0.75 mg tablets tablets Schaffhauserstrasse, Stein, 60 (6x10) tablets in a blister

Switzerland (PA/Al/PVC//Al), supplied in a box

YES YES YES

Novartis Pharma Stein AG,

Certican 1.0 mg tablets tablets Schaffhauserstrasse, Stein, 60 (6x10) tablets in a blister

Switzerland (PA/Al/PVC//Al), supplied in a box

YES YES YES

CETROTIDE 0.25 mg powder and diluent for Baxter Oncology GmbH, Vial with powder and syringe with solution for injection Kantstrasse 2, Halle, Germany diluent, supplied in a box YES YES

CETROTIDE 3 mg powder and diluent for Baxter Oncology GmbH, Vial with powder and syringe with solution for injection Kantstrasse 2, Halle, Germany diluent, supplied in a box YES YES

Eleven 0.5 mL tablets in a blister

Champix tablets 0.5 mg/1 mg film coated tablets Heinrich Mack Nachf. GmbH & (Aclar/PVC//Al) + fourteen1-mg tablets Co., Illertissen, Germany in a blister (Aclar/PVC//Al), supplied in YES YES YES YES

a carton box

Champix tablets 1 mg film coated tablets Heinrich Mack Nachf. GmbH & 28 (2x14) tablets in a blister Co., Illertissen, Germany (Aclar/PVC//Al) in a carton wrapping YES YES YES YES

solution for

Chirocaine 2.5 mg/mL solution injection/concentrate for Abbott S.p.A., Via Pontina 52, I- 10 polypropylene ampoules each for injection preparation of infusion 04010 Campoverde di Aprilia containing 10 mL of solution for YES YES solution (Latina), Italy injection, supplied in a box

solution for

Chirocaine 5 mg/mL solution for injection/concentrate for Abbott S.p.A., Via Pontina 52, I- 10 polypropylene ampoules each injection preparation of infusion 04010 Campoverde di Aprilia containing 10 mL of solution for YES YES solution (Latina), Italy injection, supplied in a box

solution for

Chirocaine 7.5 mg/mL solution injection/concentrate for Abbott S.p.A., Via Pontina 52, I- 10 polypropylene ampoules Each for injection preparation of infusion 04010 Campoverde di Aprilia containing 10 mL of solution for YES YES solution (Latina), Italy injection, supplied in a box

Chloramphenicol Krka eye Krka d.d., Šmarješka cesta 6, ointment eye ointment Novo mesto, Republic of 5 g of ointment in a tube, supplied in a YES YES Slovenia box

Eli Lilly and Company Limited,

Cialis 10 mg tablets film coated tablets Basingstoke, Hampshire, Great 4 tablets in a blister (PVC/PE/Aclar/Al), YES YES YES

Britain supplied in a carton box

Eli Lilly and Company Limited,

Cialis 20 mg tablets film coated tablets Basingstoke, Hampshire, Great 2 tablets in a blister (PVC/PE/Aclar/Al),

Britain supplied in a carton box

YES YES YES

Eli Lilly and Company Limited,

Cialis 20 mg tablets film coated tablets Basingstoke, Hampshire, Great 4 tablets in a blister (PVC/PE/Aclar/Al), YES

Britain supplied in a carton box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Ciflox 250 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 10 (1x10) tablets in a PVC/AI blister,

Republic of Croatia supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Ciflox 500 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 10 (1x10) tablets in a PVC/AI blister,

Republic of Croatia supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 248

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Belupo, lijekovi i kozmetika d.d.,

Ciflox 750 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 10 (1x10) tablets in a PVC/AI blister, YES YES

Republic of Croatia supplied in a box

Pliva Croatia Ltd., Ulica grada

Cilazil 2.5mg film tablets Vukovara 49, Zagreb, Republic of 30 (3x10) film tablets in a blister,

Croatia supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Cilazil 5mg film tablets Vukovara 49, Zagreb, Republic of 30 (3x10) film tablets in a blister,

Croatia supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada 30 (3x10) film coated tablets in a

Cilazil plus film coated tablets Vukovara 49, Zagreb, Republic of blister (OPA/Al/PVC//Al), supplied in a YES YES

Croatia box

Pliva Croatia Ltd., Ulica grada

Cilazil tablets 1 mg film tablets Vukovara 49, Zagreb, Republic of 30 (3x10) film tablets in a blister,

Croatia supplied in a box

YES YES

Cilest tablets tablets Cilag AG, Schaffhausen, 21 (1x21) tablets in a blister (PVC/A1), Switzerland supplied in a box YES YES

Pliva Croatia Ltd., Ulica grada

CIMOLAN capsules capsules Vukovara 49, Zagreb, Republic of 30 (3x10) capsules in a blister YES YES

Croatia (PVC/AI), supplied in a box

YES

Pliva Croatia Ltd., Ulica grada 200 mL of syrup in an amber glass

CIMOLAN P syrup syrup Vukovara 49, Zagreb, Republic of bottle with aluminum cap and a 5-mL YES YES

Croatia plastic measuring spoon, supplied in a

YES

box

Pliva Croatia Ltd., Ulica grada 200 mL of syrup in an amber glass

CIMOLAN syrup syrup Vukovara 49, Zagreb, Republic of bottle with aluminum cap and a 5-mL YES YES YES

Croatia plastic measuring spoon, supplied in a box

Lek farmacevtska družba d.d.,

Cinarizin forte 75mg tablets tablets Verovškova 57, Ljubljana, Box with 50 tablets (blister, 5x10 YES

Republic of Slovenia tablets)

YES

Deutsche Homöopathie - Union,

CINNABSIN tablets DHU - Arzneimittel GmbH & 100 (5x20) tablets in PVC/Al blister,

Co.KG, Karlsruhe, Germany supplied in a box

YES YES YES

Cipralex 10 mg film-tablets film coated tablets H. Lundbeck A/S, Ottilavej 9, 28 (2x14) tablets in a blister, supplied Copenhagen-Valby, Denmark in a box YES YES

Cipralex 5 mg film-tablets film coated tablets H. Lundbeck A/S, Ottilavej 9, 28 (2x14) tablets in a blister, supplied Copenhagen-Valby, Denmark in a box YES YES

Cipralex, 10mg film-tablets film tablets H. Lundbeck A/S, Ottilavej 9, Copenhagen-Valby, Denmark Box with 28 tablets (blister, 2x14 tbl.) YES YES

Cipralex, 5mg film-tablets film tablets H. Lundbeck A/S, Ottilavej 9, Copenhagen-Valby, Denmark Box with 28 tablets (blister, 2x14 tbl.) YES YES

Ciprinol film coated tablets 250 Krka d.d., Šmarješka cesta 6, mg film coated tablets Novo mesto, Republic of 10 (1x10) tablets in a PVC/PVDC//Al YES Slovenia blister, supplied in a box

YES

Ciprinol film coated tablets 500 Krka d.d., Šmarješka cesta 6, mg film coated tablets Novo mesto, Republic of

10 (1x10) tablets in a PVC/PVDC//Al

Slovenia blister, supplied in a box

YES YES

Ciprinol 100 mg/10 mL solution solution concentrate for Krka d.d., Šmarješka cesta 6, 10 mL of infusion solution concentrate

concentrate for infusion infusion Novo mesto, Republic of in a glass ampoule, 5 ampoules on a YES YES Slovenia plastic tray, supplied in a box

14509/1/11 REV 1 WS/jj 249

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Ciprinol solution for infusion 100 Krka d.d., Šmarješka cesta 6,

50 mL of solution for infusion in a glass

mg/50 mL solution for infusion Novo mesto, Republic of

bottle (with a rubber stopper,

Slovenia aluminium ring and a plastic flip off

YES YES

stopper), supplied in a carton box

Ciprinol 200 mg/100 mL solution Krka d.d., Šmarješka cesta 6,

100 mL of infusion solution in a glass

bottle (with rubber stopper and

for infusion solution for infusion Novo mesto, Republic of Slovenia aluminum ring), supplied in a carton YES YES

box

200 mL of solution for infusion in a

Ciprinol solution for infusion 400 Krka d.d., Šmarješka cesta 6, glass bottle (with rubber stopper,

mg/200 mL solution for infusion Novo mesto, Republic of YES Slovenia aluminum ring and plastic cap/flip off), YES

supplied in a carton box

Ciprobay 200 mg/100 mL 100 mL of infusion solution in a

solution for infusion solution for infusion

Bayer HealthCare AG, 51368

Leverkusen, Germany plastic bottle, supplied in a box YES YES

Ciprobay 250 mg film coated Bayer HealthCare AG, 51368 10 (1x10) film coted tablets in a PP/Al

tablets film coated tablets Leverkusen, Germany blister, supplied in a box YES YES

Ciprobay 400 mg/200 mL Bayer HealthCare AG, 51368 200 mL of solution for infusion in a

solution for infusion solution for infusion Leverkusen, Germany glass bottle, supplied in a box YES YES

Ciprobay 500 mg film coated 10 (1x10) film coted tablets in a PP/Al)

tablets film coated tablets

Bayer HealthCare AG, 51368

Leverkusen, Germany blister, supplied in a box YES YES

Pliva Croatia Ltd., Ulica grada

Cipromed tablets 250mg film tablets Vukovara 49, Zagreb, Republic of Box with 10 tablets (blister) YES YES

Croatia

Pliva Croatia Ltd., Ulica grada

Cipromed tablets 500 mg film tablets Vukovara 49, Zagreb, Republic of Box with 10 tablets (blister) YES YES

Croatia

Pliva Croatia Ltd., Ulica grada

Cipromed tablets 750mg film tablets Vukovara 49, Zagreb, Republic of Box with 10 tablets (blister) YES YES

Croatia

Pliva Croatia Ltd., Ulica grada Amber glass bottle with 20 mL of

Cisplatin Pliva 10 concentrate of solution for concentrate (with a rubber stopper, infusion Vukovara 49, Zagreb, Republic of

Croatia and an aluminium cap with a plastic

YES YES

lid), 10 bottles in a box

Pliva Croatia Ltd., Ulica grada

Cisplatin Pliva 10 solution concentrate for 10 amber glass vials each containing infusion Vukovara 49, Zagreb, Republic of YES YES

Croatia 20 mL of solution, u supplied in a box

Cisplatin Pliva 50 concentrate of solution for

Pliva Croatia Ltd., Ulica grada

infusion Vukovara 49, Zagreb, Republic of

100 mL of solution in an amber glass

Croatia bottle, supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada Amber glass bottle with 100 mL of

Cisplatin Pliva 50 concentrate of solution for concentrate (with a rubber stopper, infusion Vukovara 49, Zagreb, Republic of

Croatia and aluminium cap with a plastic lid),

YES YES

supplied in a box

Sandoz Pharmaceuticals GmbH,

Citalon 10 mg film coated tablets film coated tablets Carl-Zeiss-Ring 3, Ismaning, 28 (2x14) tablets in a PVC/PVDC/Alu YES YES YES

Germany blister, supplied in a carton box

Sandoz Pharmaceuticals GmbH,

Citalon 20 mg film coated tablets film coated tablets Carl-Zeiss-Ring 3, Ismaning, 28 (2x14) tablets in a PVC/PVDC/Alu YES YES

Germany blister, supplied in a carton box

YES

Sandoz Pharmaceuticals GmbH,

Citalon 40 mg film coated tablets film coated tablets Carl-Zeiss-Ring 3, Ismaning, 28 (2x14) tablets in a PVC/PVDC/Alu YES YES YES

Germany blister, supplied in a carton box

14509/1/11 REV 1 WS/jj 250

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Citeral 100 mg/10 mL Alkaloid AD - Skopje, Bulevar

concentrate for solution for concentrate for infusion 5 ampoules with 10 mL of solution, infusion solution

Aleksandar Makedonski 12, YES YES

Skopje, FYROM supplied in a carton box

Citeral 250 mg film coated Alkaloid AD - Skopje, Bulevar 10 tablets in an amber glass bottle,

tablets film coated tablets Aleksandar Makedonski 12, YES YES Skopje, FYROM supplied in a carton box

Citeral 500 mg film coated Alkaloid AD - Skopje, Bulevar tablets film coated tablets Aleksandar Makedonski 12, 10 tablets in an amber glass bottle, YES YES Skopje, FYROM supplied in a carton box

Absorbed diphtheria and tetanus Imunološki zavod d.d., Box with 1 glass ampoule containing 1

vaccine for children (above the suspension for injection Rockefellerova 2, Zagreb, dose of vaccine (0.5 mL of YES YES

age of 7) and adults, 1 dose Republic of Croatia suspension)

Absorbed diphtheria and tetanus Imunološki zavod d.d.,

vaccine for children (above the suspension for injection Rockefellerova 2, Zagreb, Box with 1 glass bottle containing 10 age of 7) and adults, 10 doses Republic of Croatia doses of vaccine (5 mL of suspension)

YES YES

Absorbed diphtheria and tetanus Imunološki zavod d.d., Box with 1 glass bottle containing 20

vaccine for children (above the suspension for injection Rockefellerova 2, Zagreb, doses of vaccine (10 mL of YES YES

age of 7) and adults, 20 doses Republic of Croatia suspension)

Absorbed diphtheria and tetanus Imunološki zavod d.d., Box with 1 glass ampoule containing 1

vaccine, 1 dose suspension for injection Rockefellerova 2, Zagreb, dose of vaccine (0.5 mL of YES YES Republic of Croatia suspension)

Absorbed diphtheria and tetanus Imunološki zavod d.d., vaccine 10 doses suspension for injection Rockefellerova 2, Zagreb,

Box with 1 glass bottle containing 10

Republic of Croatia doses of vaccine (5 mL of suspension)

YES YES

Absorbed diphtheria, tetanus Imunološki zavod d.d., and pertussis vaccine, 10 doses suspension for injection Rockefellerova 2, Zagreb,

Box with 50 glass bottles with 10

Republic of Croatia doses of vaccine (5 mL of suspension)

YES YES

Absorbed diphtheria, tetanus Imunološki zavod d.d., Box with 1 glass ampoule containing 1

and pertussis vaccine, 1 dose suspension for injection Rockefellerova 2, Zagreb, dose of vaccine (0.5 mL of YES YES Republic of Croatia suspension)

Absorbed diphtheria, tetanus Imunološki zavod d.d., Box with 1 glass bottle containing 20

and pertussis vaccine, 20 doses suspension for injection Rockefellerova 2, Zagreb, doses of vaccine (10 mL of YES YES Republic of Croatia suspension)

Amber glass lyophilisation bottle,

Meningococcal group A and Imunološki zavod d.d., volume of 3.5 mL with 0.5 mL of group C polysaccharide vaccine, lyophilisate and diluent for lyophilisate for one dose of vaccine + YES YES lyophilized, 1 dose suspension for injection

Rockefellerova 2, Zagreb,

Republic of Croatia ampoule with the volume of 2 mL with 0.5 mL of solvent for one dose of

vaccine

Amber glass lyophilisation bottle,

Meningococcal A and C Imunološki zavod d.d., volume of 5.5 mL with 0.5 mL of

polysaccharide vaccine, lyophilisate and diluent for YES YES lyophilized, 10 doses suspension for injection

Rockefellerova 2, Zagreb, lyophilisate for ten doses of vaccine +

Republic of Croatia ampoule with 5 mL of solvent for ten

doses of vaccine

Box with 1 glass bottle with 1 dose of

Live, lyophilized morbilli and lyophilised vaccine (for 0.5 mL of

rubella vaccine, Edmonstonlyophilisate and diluent for Imunološki zavod d.d., reconstituted vaccine) + 1 ampoule Zagreb, HDS; RA 27/3, HDS, 1 suspension for injection Rockefellerova 2, Zagreb, with 0.5 mL of solvent for vaccine YES YES dose Republic of Croatia against measles and rubella, sterile

water for injection

Box with 50 glass bottles with 10

Live, lyophilzed morbilli and

rubella vaccine, Edmonstonlyophilisate and diluent for Imunološki zavod d.d.,

doses of lyophilised vaccine (for 5 mL

of reconstituted vaccine) + 50

Zagreb, HDS; RA 27/3, HDS, 10 suspension for injection Rockefellerova 2, Zagreb, doses Republic of Croatia ampoules with 5 mL of solvent for YES YES

vaccine against measles and rubella,

sterile water for injection

Live, lyophilzed morbilli and Box with 50 glass bottles with 10

rubella vaccine, Edmonstonlyophilisate and diluent for Imunološki zavod d.d., doses of lyophilised vaccine (for 2.5 Zagreb, HDS; RA 27/3, HDS, 5 suspension for injection Rockefellerova 2, Zagreb, doza Republic of Croatia mL of reconstituted vaccine) + 50 YES YES

ampoules with 2.5 mL of solvent for

14509/1/11 REV 1 WS/jj 251

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

vaccine against measles and rubella,

sterile water for injection

Live, lyophilized vaccine against Box with 1 glass bottle containing 1 morbilli, rubella, parotitis, dose of lyophilised vaccine (for 0.5 mL Edmonston-Zagreb, HDS, RA lyophilisate and diluent for Imunološki zavod d.d., of reconstituted vaccine) and 1

27/3, HDS i L-Zagreb, PF, 1 suspension for injection

Rockefellerova 2, Zagreb,

Republic of Croatia ampoule with 0.5 mL of solvent for

YES YES

doza vaccine against measles, rubella and parotitis, sterile water for injection

Live, lyophilzed morbilli, rubella Box with 50 glass bottles with 10 and parotitis vaccine, doses of lyophilised vaccine (for 5 mL Edmonston-Zagreb, HDS; RA lyophilisate and diluent for

Imunološki zavod d.d.,

Rockefellerova 2, Zagreb, of reconstituted vaccine) + 50 YES YES

27/3, HDS; L-Zagreb, PF, 10 suspension for injection Republic of Croatia ampoules with 5 mL of solvent for

doses vaccine against measles, rubella and parotitis, sterile water for injection

Live, lyophilzed morbilli, rubella Box with 50 glass bottles with 5 doses and parotitis vaccine, Imunološki zavod d.d., of lyophilised vaccine (for 2.5 mL of Edmonston-Zagreb, HDS; RA lyophilisate and diluent for reconstituted vaccine) + 50 ampoules YES 27/3, HDS; L-Zagreb, PF, 5 suspension for injection

Rockefellerova 2, Zagreb,

Republic of Croatia with 2.5 mL of solvent for vaccine

YES

doses against measles, rubella and parotitis, sterile water for injection

One glass vial with singe dose of

Live, lyophilized morbilli vaccine, lyophilisate and diluent for Imunološki zavod d.d.,

lyophilized vaccine (for 0.5 mL of

Edmonston-Zagreb, HDS 1 dose suspension for injection Rockefellerova 2, Zagreb,

reconstituted vaccine) and one

Republic of Croatia ampoule with 0.5 mL of diluent, sterile

YES YES

Water for Injection, supplied in a

carton box

50 glass bottles with 5 doses of

Live, lyophilized morbilli vaccine, lyophilised vaccine (for 2.5 mL of Edmonston-Zagreb, HDS, 5 lyophilisate and diluent for

Imunološki zavod d.d.,

Rockefellerova 2, Zagreb, reconstituted vaccine), supplied in a

doses suspension for injection Republic of Croatia carton box, and 50 ampoules with 2.5

YES YES

mL of solvent, sterile water for

injection, supplied in a carton box

50 glass bottles with 10 doses of

Live, lyophilized morbilli vaccine, Imunološki zavod d.d., lyophilised vaccine (for 5 mL of Edmonston-Zagreb, HDS, 10 lyophilisate and diluent for Rockefellerova 2, Zagreb, reconstituted solvent), supplied in a doses suspension for injection Republic of Croatia carton box, and 50 ampoules with 5

YES YES

mL of solvent, sterile water for

injection, supplied in a carton box

Box with a glass bottle with 1 dose of

lyophilised vaccine against parotitis

Live, lyophilized parotitis lyophilisate and diluent for Imunološki zavod d.d., (for 0.5 mL of reconstituted vaccine) +

vaccine, L-Zagreb, PF, 1 doza suspension for injection Rockefellerova 2, Zagreb, YES YES Republic of Croatia 1 ampoule with 0.5 mL of solvent for

vaccine against parotitis, sterile water

for injection

Box with 50 glass bottles with 10

doses of lyophilised vaccine against

Live, lyophilized parotitis lyophilisate and diluent for Imunološki zavod d.d., parotitis (for 5 mL of reconstituted

vaccine, L-Zagreb, PF, 10 doza suspension for injection Rockefellerova 2, Zagreb, YES YES Republic of Croatia vaccine) + 50 ampoules with 5 mL of

solvent for vaccine against parotitis,

sterile water for injection

Box with 1 glass bottle containing 1

dose of lyophilised vaccine against

Live, lyophilized rubella vaccine lyophilisate and diluent for Imunološki zavod d.d., rubella (for 0.5 mL of reconstituted

RA 27/3, HDS, 1 dose suspension for injection Rockefellerova 2, Zagreb, Republic of Croatia vaccine) + 1 ampoule with 0.5 mL of YES YES

solvent for vaccine against rubella,

sterile water for injection

Box with 50 glass bottles with 10

Live, lyophilized rubella vaccine, lyophilisate and diluent for Imunološki zavod d.d.,

doses of lyophilised vaccine against

RA 27/3, HDS, 10 doses suspension for injection Rockefellerova 2, Zagreb,

rubella (for 5 mL of reconstituted

Republic of Croatia vaccine) + 50 ampoules with 5 mL of

YES YES

solvent for vaccine against rubella,

sterile water for injection

14509/1/11 REV 1 WS/jj 252

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Box with 50 glass bottles with 5 doses

of lyophilised vaccine against rubella

Live, lyophilized rubella vaccine, lyophilisate and diluent for Imunološki zavod d.d., (for 2.5 mL of reconstituted vaccine) +

RA 27/3, HDS, 5 doses suspension for injection Rockefellerova 2, Zagreb, YES YES Republic of Croatia 50 ampoules with 2.5 mL of solvent for

vaccine against rubella, sterile water

for injection

Anti-tetanus vaccine, absorbed, Imunološki zavod d.d., Box with 1 glass ampoule containing 1

1 dose suspension for injections Rockefellerova 2, Zagreb, dose of tetanus vaccine (0.5 mL of YES YES Republic of Croatia suspension)

Anti-tetanus vaccine, absorbed, Imunološki zavod d.d., Box with 1 glass bottle containing 10

1 dose suspension for injections Rockefellerova 2, Zagreb, doses of tetanus vaccine (5 mL of YES YES Republic of Croatia suspension)

Absorbed tetanus vaccine, 20 Imunološki zavod d.d., Box with 1 glass bottle with 20 doses

doses suspension for injection Rockefellerova 2, Zagreb, of tetanus vaccine (5 mL of YES YES Republic of Croatia suspension)

Claccium Folinat Ebewe 100 Ebewe Pharma Ges. m.b.H. Nfg. mg/10 mL solution for injection KG, Mondseestrasse 11, 5 amber glass ampoules with 10 mL of YES Unterach, Austria solution, supplied in a box

YES

Claccium Folinat Ebewe 30 mg/3 Ebewe Pharma Ges. m.b.H. Nfg. mL solution for injection KG, Mondseestrasse 11,

5 amber glass ampoules with 3 mL of

Unterach, Austria solution, supplied in a box

YES YES

Claccium Folinat Ebewe 50 mg/5 Ebewe Pharma Ges. m.b.H. Nfg. 5 amber glass ampoules with 5 mL of

mL solution for injection KG, Mondseestrasse 11, YES YES Unterach, Austria solution, supplied in a box

Pliva Croatia Ltd., Ulica grada

Clarexid tablets 250 mg film coated tablets Vukovara 49, Zagreb, Republic of 14 tablets in PVC/Al blister, supplied in

Croatia a box

YES YES

Pliva Croatia Ltd., Ulica grada

Clarexid tablets 500 mg film coated tablets Vukovara 49, Zagreb, Republic of 14 tablets in PVC/Al blister, supplied in YES

Croatia a box

YES

Clarinase 5 mg/120 mg Schering-Plough Labo N.V. 10 tablets in a PVC/PE/PCTFE//Al or

prolonged-release tablets prolonged release tablets Industrepark 30, Heist-op-den PVC/PCTFE//Al blister, supplied in a YES YES YES Berg, Belgium box

Schering-Plough Labo N.V.

Claritine syrup 1mg/mL syrup Industrepark 30, Heist-op-den 120 mL of solution in an amber glass

Berg, Belgium botlle, supplied in a box

YES YES

Schering-Plough Labo N.V. 10 (1x10) tablets in a PVC/PVDC//AI

Claritine tablets 10 mg tablets Industrepark 30, Heist-op-den OR PVC/PCTFE//AL blister, supplied YES YES YES

Berg, Belgium in a box

White polypropylene tube with

granules for oral suspension, closed

Clarosip 125 mg granules for oral suspension Grünenthal GmbH, Zieglerstrasse with propylene cap on the top and 6, D-52078 Aachen, Germany regulator (porous structure) for the YES YES YES

control of suspension flow at the

bottom, in protective aluminum bag

White polypropylene tube with

granules for oral suspension, closed

Clarosip 187.5 mg granules for oral suspension Grünenthal GmbH, Zieglerstrasse with propylene cap on the top and 6, D-52078 Aachen, Germany regulator (porous structure) for the YES YES YES

control of suspension flow at the

bottom, in protective aluminum bag

White polypropylene tube with

granules for oral suspension, closed

Clarosip 250 mg granules for oral suspension Grünenthal GmbH, Zieglerstrasse with propylene cap on the top and 6, D-52078 Aachen, Germany regulator (porous structure) for the YES YES YES

control of suspension flow at the

bottom, in protective aluminum bag

14509/1/11 REV 1 WS/jj 253

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Clexane 10.000 IU anti-Xa/1.0 solution for injection (for s.c. 2 glass syringes with needles (each mL injections and i.v. use in Aventis Intercontinental, France i YES YES haemodyalisis) Aventis Pharma Le Trait, France

containing 1.0 mL of solution) in a

blister, supplied in a box

Clexane 2000 IU anti-xa/0.2 mL solution for injection (for s.c. Aventis Intercontinental, Maisons 2 glass syringes with needles (each

injection and i.v. use in Alfort, France; Aventis Pharma containing 0.2 mL of solution) in a YES YES haemodyalisis) Le Trait, Le Trait, France blister, supplied in a box

Clexane 4000 IU anti-xa/0.4 mL solution for injection (for s.c. Aventis Intercontinental, Maisons 2 glass syringes with needles (each

injection and i.v. use in Alfort, France; Aventis Pharma containing 0.4 mL of solution) in a YES YES haemodyalisis) Le Trait, Le Trait, France blister, supplied in a box

Clexane 6000 IU anti-Xa/0.6 mL solution for injection (for s.c. injection and i.v. use in

Aventis Intercontinental, France i 2 glass syringes with needles (each containing 0.6 mL of solution) in a YES YES

haemodyalisis) Aventis Pharma Le Trait, France blister, supplied in a box

Clexane 8000 IU anti-Xa/0.8 mL solution for injection (for s.c. injection and i.v. use in

Aventis Intercontinental, France i 2 glass syringes with needles (each containing 0.8 mL of solution) in a YES YES

haemodyalisis) Aventis Pharma Le Trait, France blister, supplied in a box

Climen coated tablets Schering AG, Muellerstrasse 170-178, Berlin, Germany Coated tablets YES YES

10 (2x5) glass syringes (with needle)

Clivarin 1432 solution for subcutaneous Abbott GmbH & Co. KG, each containing 0.25 mLL of solution, injection Ludwigshafen, Germany in a protective container, supplied in a YES YES

carton box

Clivarin 1750 solution for subcutaneous Abbott GmbH & Co. KG,

10 (5x2) syringes with needles each

injection Ludwigshafen, Germany containing 0.25 mL of solution in a YES YES blister, supplied in a box

10 (2x5) glass syringes (with needle)

Clivarin 3436 solution for subcutaneous Abbott GmbH & Co. KG, each containing 0.6 mLL of solution, in injection Ludwigshafen, Germany a protective container, supplied in a YES YES

carton box

10 (2x5) glass syringes (with needle)

Clivarin 5153 solution for injection (for s.c. Abbott GmbH & Co. KG, each containing 0.9 mLL of solution, in use) Ludwigshafen, Germany a protective container, supplied in a YES YES

box

Clopixol acuphase 50 mg/mL solution for intramuscular H. Lundbeck A/S, Ottilavej 9, 5 ampoules each with 1 mL of solution,

solution for injection injection Copenhagen-Valby, Denmark supplied in a box YES YES

Clopixol depot 200 mg/mL solution for injection for H. Lundbeck A/S, Ottilavej 9, 10 ampoules each containing 1 mL of

solution for injection intramuscular use Copenhagen-Valby, Denmark solution, supplied in a box YES YES

Clopixol 10 mg tablets film coated tablets H. Lundbeck A/S, Ottilavej 9,

50 tablets in a polypropylene container

Copenhagen-Valby, Denmark with a specially designed stopper with YES YES a leaflet

50 tablets in a polypropylene container

Clopixol 25 mg tablets film coated tablets H. Lundbeck A/S, Ottilavej 9, Copenhagen-Valby, Denmark with a specially designed stopper with YES YES

a leaflet

Sanofi Winthrop Industrie, 1 rue

Coaprovel 150 mg/12.5 mg film coated tablets de la Vierge, 33440 Ambares, 28 (2x14) tablets in a blister

France (PVC/PVDC/Al), supplied in a box

YES YES YES

Sanofi Winthrop Industrie, 1 rue

Coaprovel 300 mg/12.5 mg film coated tablets de la Vierge, 33440 Ambares, 28 (2x14) tablets in a blister YES

France (PVC/PVDC/Al), supplied in a box

YES YES

Les Laboratories Servier

Coaxil coated tablets Industrie, 905 route de Saran, 30 (1x30) tablets in a PVC/Alu blister ,

45520 Gidy, France supplied in a carton box

YES YES

Les Laboratories Servier

Coaxil coated tablets Industrie, 905 route de Saran, 60 (2x30) tablets in a blister (PVC/Al),

45520 Gidy, France supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 254

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Alkaloid AD - Skopje, Bulevar

Codeini phosphatis Alkaloid tablets Aleksandar Makedonski 12, 10 (1x10) tablets in a Al/PE//PE/Al YES

Skopje, FYROM strip, supplied in a box

YES

CO-Diovan film-tablets 160/12.5 Novartis Pharma Stein AG, 28 (2x14) tablets in a blister, supplied

mg film coated tablets Schaffhauserstrasse, Stein, YES YES YES YES Switzerland in a box

CO-Diovan film-tablets 160/25 Novartis Pharma Stein AG, 28 (2x14) tablets in a blister, supplied

mg film coated tablets Schaffhauserstrasse, Stein, YES YES YES YES Switzerland in a box

CO-Diovan film-tablets 80/12.5 Novartis Pharma Produktions 28 (2x14) tablets in a blister, supplied

mg film coated tablets GmbH, Öflinger Strasse 44, YES YES Wehr, Germany in a box YES YES

Coldrex HotRem Blackcurrant powder for preparation of SmithKline Beecham S.A., 5 bags with 5 g of powder, supplied in oral solution Madrid, Spain a box YES YES YES

Coldrex Junior film coated tablets Famar S.A., Atena, Greece 16 (2x8) tablets in a blister, supplied in a box YES YES YES

Wrafton Laboratories Ltd., 160 mL of oral solution in an amber

COLDREX JUNIOR syrup oral solution Wrafton, Braunton, North Devon, glass bottle with a platic (PP) temper YES YES

Great Britain proof closure and 20-ml measuring

YES

glass, supplied in a box

Coldrex MaxGrip Lemon powder for preparation of SmithKline Beecham S.A., 5 bags with 6.4 g of powder, supplied oral solution Madrid, Spain in a box YES YES YES

GlaxoSmithKline Dungarvan Ltd.,

Coldrex tablets tablets Knockbrack, Dungarvan, Co. 12 tablets in a blister, supplied in a box YES YES YES

Waterford, Republic of Ireland

Glaxo Wellcome Operations,

Combivir tablets film coated tablets Greenford, Great Britain i 60 (6x10) film coated tablets in a GlxoSmithKline Pharmaceuticals blister (PVC/Al), supplied in a box YES YES

S.A., Poznan, Poland

Novartis Pharmaceuticals UK 30 film coated tablets in an amber

COMTAN 200 mg film-tablets film coated tablets Limited, Horsham, West Sussex, glass bottle with a plastic (HDPP) YES YES

Great Britain stopper, supplied in a box

Janssen Pharmaceutica NV, 30 tablets in a plastic (HDPE) bottle

Concerta 18 mg prolonged-release tablets Turnhouseweg 30, Beerse, with a temper-evident stopper and YES YES YES YES

Belgium desiccant, supplied in a box

Janssen Pharmaceutica NV, 30 tablets in a plastic (HDPE) bottle

Concerta 36 mg prolonged-release tablets Turnhouseweg 30, Beerse, with a temper-evident stopper and YES YES YES YES

Belgium desiccant, supplied in a box

Janssen Pharmaceutica NV, 30 tablets in a plastic (HDPE) bottle

Concerta 54 mg prolonged-release tablets Turnhouseweg 30, Beerse, with a temper-evident stopper and YES YES YES YES

Belgium desiccant, supplied in a box

Concor 10 film coated tablets Merck KGaA, Frankfurter Straße 30 (3x10) tablets in a blister, supplied 250, Darmstadt, Germany in a box YES YES

Concor 5 film coated tablets Merck KGaA, Frankfurter Straße 30 (3x10) tablets in a blister, supplied 250, Darmstadt, Germany in a box YES YES

Concor Cor 1.25 mg film tablets Merck KGaA, Frankfurter Straße 250, Darmstadt, Germany Box with 20 tablets (blister, 2x10 tbl.) YES YES

Concor Cor 2.5 mg film tablets Merck KGaA, Frankfurter Straße 250, Darmstadt, Germany Box with 30 tablets (blister, 3x10 tbl.) YES YES

14509/1/11 REV 1 WS/jj 255

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Contractubex gel gel Merz Pharma GmbH & Co KGaA, 10 g of gel in aluminum tube, supplied Frankfurt am Main, Germany in a box YES YES YES

Jadran - Galenski laboratorij d.d.,

Contral tablets Pulac bb, Rijeka, Republic of Box with 10 tablets (blister) YES YES

Croatia

28 (2X14) gastric-resistant tablets in a

Controloc 20 mg tablets gastric-resistant tablets Altana Pharma Oranienburg GmBH, Oranienburg, Germany blister (OPA/Al/PE//Al), supplied in a YES YES

box

14 (1x14) gastric-resistant tablets in a

Controloc 40 mg tablets gastric-resistant tablets Altana Pharma Oranienburg GmbH, Oranienburg, Germany blister (OPA/Al/PE//Al), supplied in a YES YES

box

Controloc intravenous powder for solution for Altana Pharma AG, Byk-Gulden One glasss vial with lyophilisate, injection Strasse 2, Konstanz, Germany supplied in a box YES YES

28 (4x7) amber glass bottles with

Copaxone 20 mg, powder and powder and diluent for Teva Pharmaceutical Industries powder and 28 (4x7) ampoules with

diluent for solution for injection solution for injection Ltd., Kfar Saba, Izrael diluent for solution for injection, YES YES YES YES

supplied in a box

Pre-filled syringe with 1 mL of solution

Copaxone 20 mg/mL solution for solution for injection, pre Teva Pharmaceuticals Europe for injection with a needle, in a blister,

injection filled syringe B.V., Mijadrecht, The Nederlands 28 (4x7) pre-filled syringes supplied in YES YES

a box

F. Hoffmann-La Roche Ltd.,

Copegus 200 mg film coated tablets Grenzacherstrasse 124, Basel, 42 film coated tablets in a polyethylene YES YES YES

Switzerland bag, supplied in a box

YES

Cordarone 150 mg/3 mL Sanofi Winthrop Industrie, 1 rue injection solution for injection de la Vierge, 33440 Ambares,

6 ampoules each with 3 mL of solution

France for injection, supplied in a box

YES YES

Sanofi Winthrop Industrie, 1 rue

Cordarone 200 mg tablets film coated tablets de la Vierge, 33440 Ambares, 30 (3x10) tablets in a blister (PVC/Alu YES YES

France foil) supplied in a box

Krka d.d., Šmarješka cesta 6,

Cordipin XL tablets 40 mg modified release tablets Novo mesto, Republic of 20 (2x10 tablets in PVC/PVD/Al blister, YES

Slovenia supplied in a box

YES

Krka d.d., Šmarješka cesta 6,

Cordipin XL tablets 40 mg modified release tablets Novo mesto, Republic of 30 (3x10) tablets in a PVC/PVD/Al

Slovenia blister , supplied in a box

YES YES

Les Laboratoires Servier

Industrie, 905 route de Saran,

45520 Gidy, France; Servier

(Republic of Ireland) Industries

Corlentor 5 mg film coated Ltd., Gorey Road, Arklow, Co. 28 (2x14) film coated tablets in a

tablets film coated tablets Wicklow, Republic of Ireland; PVC/Al blister, supplied in a carton box YES YES YES YES

Przedsiebiorstwo

Farmaceutyczne Anpharm S.A.,

Ul. Annopol 603-236, Warszava,

Poland

Les Laboratoires Servier

Industrie, 905 route de Saran,

45520 Gidy, France; Servier

(Republic of Ireland) Industries

Corlentor 7.5 mg film coated Ltd., Gorey Road, Arklow, Co. 28 (2x14) film coated tablets in a

tablets film coated tablets Wicklow, Republic of Ireland; PVC/Al blister, supplied in a carton box YES YES YES YES

Przedsiebiorstwo

Farmaceutyczne Anpharm S.A.,

Ul. Annopol 603-236, Warszava,

Poland

14509/1/11 REV 1 WS/jj 256

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pantheon YM Inc., Toronto,

CORTEF tablets 10 mg tablets Canada i Pfizer Manufacturing 100 tablets in an amber glass bottle, YES

Belgium, Puurs, Belgium supplied in a box

YES

Krka d.d., Šmarješka cesta 6,

Coryol tablets 12.5 mg tablets Novo mesto, Republic of 28 (4x7) tablets in a OPA/Al/PVC//Al

Slovenia blister, supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6,

Coryol tablets 25 mg tablets Novo mesto, Republic of 28 (4x7) tablets in a OPA/Al/PVC//Al YES YES

Slovenia blister, supplied in a box

Krka d.d., Šmarješka cesta 6,

Coryol tablets 3.125 mg tablets Novo mesto, Republic of 28 (4x7) tablets in a OPA/Al/PVC//Al YES YES

Slovenia blister, supplied in a box

Krka d.d., Šmarješka cesta 6,

Coryol tablets 6.25 mg tablets Novo mesto, Republic of 28 (4x7) tablets in a OPA/Al/PVC//Al

Slovenia blister, supplied in a box

YES YES

Merck Sharp & Dohme B.V.,

Cosopt eye drops eye drops, solution Waarderweg 39, Postbus 581, 5 mL of solution in a plastic container

Haarlem, The Nederlands OCUMETER PLUS, supplied in a box

YES YES

Cozaar 100 mg filmom obložete Merck Sharp & Dohme B.V., 28 (2x14) tablets in a blister, supplied

tablets film coated tablets Waarderweg 39, Postbus 581, Haarlem, the Netherlands in a box YES YES

Merck Sharp & Dohme B.V.,

Cozaar 50 mg film coated tablets film coated tablets Waarderweg 39, Postbus 581, 28 (2x14) tablets in a blister, supplied

Haarlem, the Netherlands in a box

YES YES

AstraZeneca GmbH, Plankstadt,

Germany; AstraZeneca UK 28 (2x14) film coated tablets in a

Crestor 10 mg film coated tablets Limited, Silk Road Business blister of aluminum laminate and YES YES YES YES

Park, Macclesfield, Cheshire, aluminum foil, supplied in a carton box

Great Britain

AstraZeneca GmbH, Plankstadt,

Germany; AstraZeneca UK 29 (2x14) film coated tablets in a

Crestor 20 mg film coated tablets Limited, Silk Road Business blister of aluminum laminate and YES YES YES YES

Park, Macclesfield, Cheshire, aluminum foil, supplied in a carton box

Great Britain

AstraZeneca GmbH, Plankstadt,

Germany; AstraZeneca UK 28 (4x7) film coated tablets of

Crestor 40 mg film coated tablets Limited, Silk Road Business aluminum laminate and aluminum foil, YES YES YES YES

Park, Macclesfield, Cheshire, supplied in a carton box

Great Britain

AstraZeneca GmbH, Plankstadt,

Germany; AstraZeneca UK 30 (2x14) film coated tablets in a

Crestor 5 mg film coated tablets Limited, Silk Road Business blister of aluminum laminate and YES YES YES YES

Park, Macclesfield, Cheshire, aluminum foil, supplied in a carton box

Great Britain

M.Y. Healthcare Packaging 1.45 g of gel in an applicator for single

CRINONE 8% vaginal gel vaginal gel Limited, Bedfordshire, Great use, inserted in a protective bag YES YES

Britain (paper/Al/PE), 15 bags in a box

Merck Sharp & Dohme B.V.,

CRIXIVAN 100 mg capsules capsules Waarderweg 39, Postbus 581, 180 capsules in a polyethylene YES YES YES

Haarlem, the Netherlands (HDPE) container

Merck Sharp & Dohme B.V.,

Crixivan 200 mg capsules capsules Waarderweg 39, Postbus 581, 360 capsules in a polyethylene

Haarlem, the Netherlands (HDPE) container

YES YES YES

Merck Sharp & Dohme B.V.,

CRIXIVAN 333 mg capsules capsules Waarderweg 39, Postbus 581, 135 capsules in a polyethylene YES YES

Haarlem, the Netherlands (HDPE) container

YES

Merck Sharp & Dohme B.V.,

Crixivan 400 mg capsules capsules Waarderweg 39, Postbus 581, 180 capsules in a polyethylene YES YES YES

Haarlem, the Netherlands (HDPE) container

14509/1/11 REV 1 WS/jj 257

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pliva Croatia Ltd., Ulica grada

Crystacillin powder for solution for injection Vukovara 49, Zagreb, Republic of 50 bottles with powder, supplied in a YES

Croatia box

YES

Cymbalta 30 mg hard gastricgastric-resistant capsules, Lilly, S.A., Avendia de la Industria 28 (2x14) capsules in a blister

resistant capsules hard 30, Alcobendas, Madrid, Spain (PVC/PE/PCTFE//Al), supplied in a YES YES YES box

Cymbalta 60 mg hard gastricgastric-resistant capsules, Lilly, S.A., Avendia de la Industria 28 (2x14) capsules in a blister

resistant capsules hard 30, Alcobendas, Madrid, Spain (PVC/PE/PCTFE//Al), supplied in a YES YES YES box

Cymevene powder for solution powder for solution for F. Hoffmann-La Roche Ltd., for infusion infusion Grenzacherstrasse 124, Basel,

10-mL glass vial with powder (for

Switzerland multiple use) supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Dabroston 10 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 30 tablets in a blister, supplied in a box YES YES

Republic of Croatia

lyophilisate for preparation Pliva Croatia Ltd., Ulica grada Lyophilisate in an amber glass bottle

DACARBAZINE PLIVA 100 of solution for injection or Vukovara 49, Zagreb, Republic of (with a rubber stopper and an YES YES

infusion Croatia aluminium cap with a plastic lid), 10 bottles in a box

lyophilisate for preparation Pliva Croatia Ltd., Ulica grada Lyophilisate in an amber glass bottle

DACARBAZINE PLIVA 200 of solution for injection or Vukovara 49, Zagreb, Republic of (with a rubber stopper and an

infusion Croatia aluminium cap with a plastic lid), 10

YES YES

bottles in a box

Krka d.d., Novo Mesto, R.

Daktarin cream cream Republic of Slovenia in 30 g of cream in a tube, supplied in a cooperation with Janssen box YES YES

Pharmaceutica, Beerse, Belgium

Krka d.d., Novo Mesto, R.

Daktarin oral gel oral gel Republic of Slovenia in 40 g of gel in a tube with a measuring cooperation with Janssen spoon, supplied in a box YES YES

Pharmaceutica, Beerse, Belgium

DALERON C granules for oral Krka d.d., Šmarješka cesta 6, solution granules for oral solution Novo mesto, Republic of

10 bags each containing 5 g of

Slovenia granules, supplied in a box

YES YES YES

DALERON C JUNIOR granules Krka d.d., Šmarješka cesta 6, for oral solution granules for oral solution Novo mesto, Republic of 10 bags each containing 5 g of YES YES YES Slovenia granules, supplied in a box

Abbott S.p.A., Via Pontina 52, I-

Dalsy syrup syrup 04010 Campoverde di Aprilia Brown polyethylene bottle with 100 mL

(Latina), Italy of syrup, supplied in a box

YES YES

Abbott S.p.A., Via Pontina 52, I-

Dalsy syrup syrup 04010 Campoverde di Aprilia Brown polyethylene bottle with 200 mL YES YES

(Latina), Italy of syrup, supplied in a box

Pliva Croatia Ltd., Ulica grada

Danoptin 100 mg tablets tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in a PVC/Aclar/Al YES YES

Croatia blister, supplied in a box

Pliva Croatia Ltd., Ulica grada

Danoptin 25 mg tablets tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in a PVC/Aclar/Al YES YES

Croatia blister, supplied in a box

Pliva Croatia Ltd., Ulica grada

Danoptin tablets 50 mg tablets Vukovara 49, Zagreb, Republic of 31 (3x10) tablets in a PVC/Aclar/Al YES YES

Croatia blister, supplied in a box

Danoptin tablets for oral Pliva Croatia Ltd., Ulica grada suspension 5 mg tablets for oral solution Vukovara 49, Zagreb, Republic of

32 (3x10) tablets in a PVC/Aclar/Al

Croatia blister, supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6, 100 capsules in a brown plastic bottle

Danoval capsules 100 mg capsules Novo mesto, Republic of with aluminum cap, supplied in a YES YES

Slovenia carton box

14509/1/11 REV 1 WS/jj 258

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Darob tablets Abbott GmbH & Co. KG, 50 (5x10) tablets in a blister, supplied Ludwigshafen, Germany in a box YES YES

Darob mite tablets Abbott GmbH & Co. KG, 50 (5x10) tablets in a blister, supplied Ludwigshafen, Germany in a box YES YES

Lek farmacevtska družba d.d.,

Dartelin 400 mg tablets film coated tablets Verovškova 57, Ljubljana, 20 (2x10) tablets in a blister, supplied YES YES

Republic of Slovenia in a box

DaTscan 74 MBq/mL solution for Amersham Health BV, Den injection solution for injection Dolech 2, Eindhoven, NL 5612

10-mL glass vial with 5.0 mL of

AZ, the Netherlands solution, supplied in a box

YES YES YES

DaTscan 74 MBq/mL solution for Amersham Health BV, Den injection solution for injection Dolech 2, Eindhoven, NL 5612

10-mL glass vial with 2.5 mL of

AZ, the Netherlands solution, supplied in a box

YES YES YES

Ferring GmbH, Wittland 1, Kiel,

Decapeptyl 0.1 mg solution for subcutaneous Germany; Ferring International

7 syringes each with 1 mL of solution

injection Center SA, Chemin de la for injection in a blister, supplied in a YES YES

Vergognausaz, Switzerland box

micro-capsules for Ferring GmbH, Wittland 1, Kiel, One syringe with 172 mg

Decapeptyl CR preparation of suspension Germany; Ferring International microcapsules, one syringe with 1 mL for subcutaneous or Center SA, Chemin de la of suspending agent, one adapter and YES YES

intramuscular injection Vergognausaz, Switzerland one needle, supplied in a box

Decortin 20 tablets Merck KGaA, Frankfurter Straße 10 (1x10) tablets in a PVC/Al blister, 250, Darmstadt, Germany supplied in a box YES YES

Decortin 5 tablets Merck KGaA, Frankfurter Straße 24 (2x10) tablets in a blister (PVC/Al), 250, Darmstadt, Germany supplied in a box YES YES

The Mentholatum Company Ltd, 35 g of gel in an alumininum tube with

Deep Freeze Cold gel gel 1 Redwood Avenue, Peel Park Campus, East Kilbride, Great a plastic (HDPE) stopper, supplied in a YES YES YES

Britain box

The Mentholatum Company Ltd, 200 mL (135 g) of spray solution in a

Deep Freeze spray spray, solution 1 Redwood Avenue, Peel Park Campus, East Kilbride, Great metal container (with PE tube and PP YES YES YES

Britain atmizer) with plastic (PP) cap

The Mentholatum Company Ltd, 15 g of cream in an aluminum tube

Deep heat rub cream cream 1 Redwood Avenue, Peel Park Campus, East Kilbride, Great with plastic (HDPE) cap, supplied in a YES YES YES

Britain box

The Mentholatum Company Ltd, 150 mL of sprey solution in a metal

Deep Heat spray spray, solution 1 Redwood Avenue, Peel Park Campus, East Kilbride, Great container (with PE tube and PP YES YES YES

Britain nebulizer) with plastic (HDPE) cap

The Mentholatum Company Ltd,

Deep relief gel gel 1 Redwood Avenue, Peel Park 100 grams of gel in an aluminum tube, Campus, East Kilbride, Great supplied in a box YES YES YES

Britain

Dentinox Gesellschaft für 10 g of solution in an amber glass

Dentinox N drops, oromucosal solution pharmazeutische Präparate Lenk bottle with plastic dropper and cap, YES YES

&

Schuppan, Berlin, Germany supplied in a box

Sanofi Winthrop Industrie, 1 rue

Depakine Chrono 300 mg film coated modified-release 100 tablets (two plastic containers with tablets de la Vierge, 33440 Ambares, YES YES

France 50 tablets each) supplied in a box

Depakine Chrono 500 mg modified release film coated

Sanofi Winthrop Industrie, 1 rue

tablets de la Vierge, 33440 Ambares,

30 tablets in a plastic container,

France supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 259

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

DEPAKINE CHRONOSPHERE Sanofi Winthrop Industrie, 30 bags with granules, supplied in a

100 mg prolonged-release granules AMILLY, France box YES YES

DEPAKINE CHRONOSPHERE Sanofi Winthrop Industrie, 30 bags with granules, supplied in a

1000 mg prolonged-release granules AMILLY, France box YES YES

DEPAKINE CHRONOSPHERE Sanofi Winthrop Industrie, 30 bags with granules, supplied in a

250 mg prolonged-release granules AMILLY, France box YES YES

DEPAKINE CHRONOSPHERE Sanofi Winthrop Industrie, 30 bags with granules, supplied in a

500 mg prolonged-release granules AMILLY, France box YES YES

DEPAKINE CHRONOSPHERE Sanofi Winthrop Industrie, 30 bags with granules, supplied in a

750 mg prolonged-release granules AMILLY, France box YES YES

Pliva Croatia Ltd., Ulica grada

Deprozel tablets 20 mg film coated tablets Vukovara 49, Zagreb, Republic of Box with 30 tablets (blister, 3x10 tbl.) YES YES

Croatia

Pliva Croatia Ltd., Ulica grada

Deprozel tablets 30 mg film coated tablets Vukovara 49, Zagreb, Republic of Box with 30 tablets (blister, 3x10 tbl.) YES YES

Croatia

Dercome Clear suspension for topical Dr. August Wolff GmbH & Co. 100 grams of suspension in a plastic application to the skin Arzneimittel, Bielefeld, Germany tube, supplied in a box YES YES

Les Laboratories Servier

Detralex film coated tablets Industrie, 905 route de Saran, 30 (2x15) film coated tablets in a

45520 Gidy, France PVC/Al blister, supplied in a box

YES YES

Detrunorm coated tablets 15 mg coated tablets Apogepha Arzneimittel GmbH, 30 (3x10) coated tablets in a PVC/A1 Germany blister, supplied in a box YES YES

Dexamethason Krka solution for Krka d.d., Šmarješka cesta 6, 25 ampoules (5x5) each containing 1

injection solution for injection Novo mesto, Republic of mL of solution in a blister, supplied in a YES YES Slovenia box

Krka d.d., Šmarješka cesta 6,

Dexamethason Krka tablets tablets Novo mesto, Republic of 10 tablets in a blister, supplied in a box YES YES

Slovenia

Diane-35 sugar-coated tablets sugar-coated tablets Schering AG, Muellerstrasse 63 (3x21) tablets in a PVC/Al blister, 170-178, Berlin, Germany supplied in a box YES YES

Dianeal PD1 solution for 5x1 plastic bags with 2000 mL of peritoneal dialysis with 1.36% solution for peritoneal BAXTER Healthcare S.A., solution and 5x1 empty bags (for

glucose and electrolytes dialysis

Monreen Road, Castlebar,

County Mayo, Republic of Ireland draining of liquid), in a protective

YES YES

plastic bag; supplied in a carton box

Dianeal PD1 solution for BAXTER Healthcare S.A., 5x1 plastic bags with 2000 mL of peritoneal dialysis with 2.27% solution for peritoneal solution and 5x1 empty bags (for YES glucose and electrolytes dialysis

Monreen Road, Castlebar,

County Mayo, Republic of Ireland draining of liquid), in a protective

YES

plastic bag; supplied in a carton box

Dianeal PD1 solution for BAXTER Healthcare S.A., 5x1 plastic bags with 2000 mL of peritoneal dialysis with 3.86% solution for peritoneal Monreen Road, Castlebar, solution and 5x1 empty bags (for YES YES

glucose and electrolytes dialysis County Mayo, Republic of Ireland draining of liquid), in a protective plastic bag; supplied in a carton box

Dianeal PD4 solution for

peritoneal dialysis with 1.36% solution for peritoneal

BAXTER Healthcare S.A., 2x1 plastic bags containing 5000 mL

glucose and electrolytes dialysis

Monreen Road, Castlebar, of solution in a protective plastic bag, YES YES

County Mayo, Republic of Ireland supplied in a box

5x1 plastic bags with 2000 mL of

Dianeal PD4 solution for

peritoneal dialysis with 1.36% solution for peritoneal

BAXTER Healthcare S.A., solution with attachments and one

Monreen Road, Castlebar, empty bag (for draining of liquid), in a YES YES

glucose and electrolytes dialysis County Mayo, Republic of Ireland protective plastic bag; supplied in a

box

14509/1/11 REV 1 WS/jj 260

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

4x1 plastic bags with 2500 mL of

Dianeal PD4 solution for BAXTER Healthcare S.A., solution with attachments and one

peritoneal dialysis with 1.36% solution for peritoneal glucose and electrolytes dialysis

Monreen Road, Castlebar, empty bag (for draining of liquid), in a YES YES

County Mayo, Republic of Ireland protective plastic bag, supplied in a

box

Dianeal PD4 solution for

peritoneal dialysis with 1.36% solution for peritoneal

BAXTER Healthcare S.A., 5x1 plastic bags with 2000 mL of

Monreen Road, Castlebar, solution in a protective plastic bag, YES YES

glucose and electrolytes dialysis County Mayo, Republic of Ireland supplied in a box

5x1 plastic bags with 2000 mL of

Dianeal PD4 solution for

peritoneal dialysis with 2.27% solution for peritoneal

BAXTER Healthcare S.A., solution with attachments and one

Monreen Road, Castlebar, empty bag (for draining of liquid), in a YES YES

glucose and electrolytes dialysis County Mayo, Republic of Ireland protective plastic bag; supplied in a

box

Dianeal PD4 solution for 5x1 plastic bags with 2000 mL of

peritoneal dialysis with 2.27% solution for peritoneal

BAXTER Healthcare S.A.,

Monreen Road, Castlebar, solution in a protective plastic bag, YES YES

glucose and electrolytes dialysis County Mayo, Republic of Ireland supplied in a box

Dianeal PD4 solution for 2x1 plastic bags containing 5000 mL

peritoneal dialysis with 2.27% solution for peritoneal

BAXTER Healthcare S.A.,

Monreen Road, Castlebar, of solution in a protective plastic bag, YES YES

glucose and electrolytes dialysis County Mayo, Republic of Ireland supplied in a box

4x1 plastic bags with 2500 mL of

Dianeal PD4 solution for solution with attachments and one

peritoneal dialysis with 2.27% solution for peritoneal

BAXTER Healthcare S.A.,

Monreen Road, Castlebar, empty bag (for draining of liquid), in a YES YES

glucose and electrolytes dialysis County Mayo, Republic of Ireland protective plastic bag, supplied in a

box

Dianeal PD4 solution for BAXTER Healthcare S.A., 5x1 plastic bags with 2000 mL of

peritoneal dialysis with 3.86% solution for peritoneal Monreen Road, Castlebar, solution in a protective plastic bag, YES YES glucose and electrolytes dialysis County Mayo, Republic of Ireland supplied in a box

4x1 plastic bags with 2500 mL of

Dianeal PD4 solution for BAXTER Healthcare S.A., solution with attachments and one

peritoneal dialysis with 3.86% solution for peritoneal Monreen Road, Castlebar, empty bag (for draining of liquid), in a YES YES glucose and electrolytes dialysis County Mayo, Republic of Ireland protective plastic bag, supplied in a

box

Dianeal PD4 solution for

peritoneal dialysis with 3.86% solution for peritoneal

BAXTER Healthcare S.A., 2x1 plastic bags containing 5000 mL

YES YES

glucose and electrolytes dialysis

Monreen Road, Castlebar, of solution in a protective plastic bag,

County Mayo, Republic of Ireland supplied in a box

5x1 plastic bags with 2000 mL of

Dianeal PD4 solution for

peritoneal dialysis with 3.86% solution for peritoneal

BAXTER Healthcare S.A., solution with attachments and one

empty bag (for draining of liquid), in a YES YES

glucose and electrolytes dialysis

Monreen Road, Castlebar,

County Mayo, Republic of Ireland protective plastic bag; supplied in a

box

Les Laboratories Servier

Diaprel tablets Industrie, 905 route de Saran, 60 (3x20) tablets in a blister, supplied YES

45520 Gidy, France in a box

YES

Les Laboratoires Servier

Industrie, Gidy, France; Servier

Diaprel MR modified release tablets Republic of Ireland Industries 60 (2x30) tablets in a blister (PVC/Al),

Ltd., Arcklow, Co. Wicklow, supplied in a box

YES YES

Republic of Ireland

Diazepam Alkaloid 10 mg/2 mL Alkaloid AD - Skopje, Bulevar 10 amber glass ampoules each

solution for injection solution for injection Aleksandar Makedonski 12, containing 2 mL of solution, supplied in YES YES Skopje, FYROM a box

Diazepam Alkaloid 2 mg coated Alkaloid AD - Skopje, Bulevar tablets coated tablets Aleksandar Makedonski 12, 30 coated tablets in a 15 mL amber YES Skopje, FYROM glass bottle, supplied in a box

YES

Diazepam Alkaloid 5 mg coated Alkaloid AD - Skopje, Bulevar 30 coated tablets in a 15 mL amber

tablets coated tablets Aleksandar Makedonski 12, Skopje, FYROM glass bottle, supplied in a box YES YES

Diazepam Desitin 10 mg rectal Desitin Arzneimittel GmbH, 5 (5x1) plastic containers each with 2.5

solution rectal solution Hamburg, Germany mL of solution (with applicator for YES YES rectal administration) in a protective

14509/1/11 REV 1 WS/jj 261

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

bag, supplied in a box

5 (5x1) plastic containers each with 2.5

Diazepam Desitin 5 mg rectal Desitin Arzneimittel GmbH, mL of solution (with applicator for

solution rectal solution Hamburg, Germany rectal administration) in a protective YES YES

bag, supplied in a box

Jadran - Galenski laboratorij d.d.,

Diazepam Jadran 10 mg tablets Pulac bb, Rijeka, Republic of 30 (3x10) tablets in a blister, supplied

Croatia in a box

YES YES

Jadran - Galenski laboratorij d.d.,

Diazepam Jadran 2 mg tablets Pulac bb, Rijeka, Republic of 30 (3x10) tablets in a blister, supplied YES

Croatia in a box

YES

Jadran - Galenski laboratorij d.d.,

Diazepam Jadran 5 mg tablets Pulac bb, Rijeka, Republic of Box with 30 (3x10) tablets in a blister YES YES

Croatia

Diclo Duo capsules 75 mg modified release capsules, TemmLer Werke GmbH, 20 (2x10) capsules in a blister hard München, Germany (PVC/PVDC/Al), supplied in a box YES YES

15-mL amber glass bottle containing

Diclo Duo spray 4% dermatological spray,

Pharbil Waltrop GmbH, Im

solution Wirrigen 25, D-45731 Waltrop,

12.5 g solution, with metering pump/ YES YES YES YES YES

Germany spraying attachment and protective cap, supplied in a carton box

DICLORAPID 75 mg gastric-resistant capsules, Astellas Pharma GmbH, 10 (1x10) capsules in a PVC/PVdC/Al hard München, Germany blister, supplied in a box YES YES YES YES

Diclorapid 75 mg gastric-resistant capsules, Astellas Pharma GmbH, 20 (2x10) capsules in a PVC/PVDC/Al hard München, Germany blister, supplied in a box YES YES YES YES

solution for injection for Lek farmacevtska družba d.d., 10 (2x5) ampoules each containing 2

Dicynone 250 mg/2 mL injection intramuscular use and Verovškova 57, Ljubljana, mL of solution in a blister, supplied in a YES YES

intravenus infusion Republic of Slovenia box

Pliva Croatia Ltd., Ulica grada

DIFETOIN tablets Vukovara 49, Zagreb, Republic of 100 (10x10) tablets in OPA/Al/PVC//Al

Croatia blister, supplied in a box

YES YES

DIFLUCAN 100 mg capsules capsules Pfizer PGM, Poce-sur-Cisse, 7 (1x7) capsules in (PVC/Al) blister, France supplied in a box YES YES

DIFLUCAN 150 mg capsules capsules Pfizer PGM, Poce-sur-Cisse, One (1x1) capsule in a blister (PVC/Al) France supplied in a box YES YES

DIFLUCAN 50 mg capsules capsules Pfizer PGM, Poce-sur-Cisse, 7 (1x7) capsules in (PVC/Al) blister, France supplied in a box YES YES

DIFLUCAN solution for infusion solution for infusion Pfizer PGM, Poce-sur-Cisse, 100 mL of solution in a glass bottle for France infusion, supplied in a box YES YES

Plastic (HDPE) bottle of 60 mL (with a

DIFLUCAN powder for Pfizer PGM, Poce-sur-Cisse, plastic, temper-evident stopper) with

suspension 50 mg/7 mL powder for oral suspension France powder for preparation of 35 mL of YES YES suspension and a plastic measuring

spoon (of 5 mL), supplied in a box

Diphtheria antitoxin (equine) Imunološki zavod d.d., 10000 IU solution for parenteral use Rockefellerova 2, Zagreb, Box with 1 bottle containing 10000 IU YES YES Republic of Croatia of preparation

Diphtheria antitoxin (equine) Imunološki zavod d.d., 10000 IU solution for parenteral use Rockefellerova 2, Zagreb,

Box with 50 bottles with 10000 IU of

Republic of Croatia preparation

YES YES

14509/1/11 REV 1 WS/jj 262

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pliva Croatia Ltd., Ulica grada

Diglical tablets 80 mg tablets Vukovara 49, Zagreb, Republic of 60 (6x10) tablets in a blister, supplied YES YES

Croatia in a box

Krka d.d., Novo Mesto, Republic

Dihalar tablets tablets of Slovenia in cooperation with 30 (2x15) tablets in a blister, supplied Novartis Pharma Ltd., in a box YES YES

Switzerland

Farmal d.d., Branitelja

Diklofenak retard 100 mg tablets prolonged-release tablets domovinskog rata 8, Ludbreg, 20 (2x10) tablets in a blister, supplied

Republic of Croatia in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Diklonat P gel gel Vukovara 49, Zagreb, Republic of 60 g of gel in an aluminium tube, YES YES

Croatia supplied in a box

YES

Pliva Croatia Ltd., Ulica grada

Diltiazem Pliva 60 mg tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in a PVC/Al blister,

Croatia supplied in a carton box

YES YES

Pliva Croatia Ltd., Ulica grada

Diltiazem Pliva 90 mg tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in a PVC/Al blister,

Croatia supplied in a carton box

YES YES

Pliva Croatia Ltd., Ulica grada

Dimidril tablets tablets Vukovara 49, Zagreb, Republic of 32 (3x10) tablets in a PVC/Al blister, YES

Croatia supplied in a box

YES

Pliva Croatia Ltd., Ulica grada

Dinamico tablets 100 mg film tablets Vukovara 49, Zagreb, Republic of One (1x1) tablet in a blister supplied in

Croatia a box

YES YES

Pliva Croatia Ltd., Ulica grada

Dinamico tablets 25 mg film tablets Vukovara 49, Zagreb, Republic of One (1x1) tablet in a blister supplied in YES

Croatia a box

YES

Pliva Croatia Ltd., Ulica grada

Dinamico tablets 50 mg film tablets Vukovara 49, Zagreb, Republic of One (1x1) tablet in a blister supplied in YES YES

Croatia a box

Novartis Pharma Produktions

Diovan 160 mg film-tablets film coated tablets GmbH, Öflinger Strasse 44, 28 (2x14) tablets in a blister, supplied

Wehr, Germany in a box

YES YES YES YES

Novartis Pharma Produktions

Diovan 320 mg film-tablets film coated tablets GmbH, Öflinger Strasse 44, 28 (2x14) tablets in a blister

Wehr, Germany (PVC/PVDC//Al), supplied in a box

YES YES YES YES

Novartis Pharma Produktions

Diovan 40 mg film-tablets film coated tablets GmbH, Öflinger Strasse 44, 28 (2x14) tablets in a blister, supplied YES YES YES YES

Wehr, Germany in a box

Novartis Pharma Produktions

Diovan 80 mg flim-tablets film coated tablets GmbH, Öflinger Strasse 44, 28 (2x14) tablets in a blister, supplied YES YES YES YES

Wehr, Germany in a box

Schering-Plough Labo N.V.

Diprogenta cream cream Industrepark 30, Heist-op-den 15 g of cream in an aluminum tube, YES

Berg, Belgium supplied in a box

YES

Schering-Plough Labo N.V.

Diprogenta ointment ointment Industrepark 30, Heist-op-den Aluminium tube with 15 g of ointment,

Berg, Belgium supplied in a box

YES YES

Schering-Plough Labo N.V.,

Diprosalic losion lotion Heist-op-den-Berg, Belgium; 30 mL of lotion in a plastic bottle, Schering-Plough France, supplied in a box YES YES

Herouville-Saint-Clair, France

Schering-Plough Labo N.V.

Diprosalic ointment ointment Industrepark 30, Heist-op-den 15 g of cream in an aluminum tube,

Berg, Belgium supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 263

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Fresenius Kabi AB, Stockholm,

Sweden and AstraZeneca SpA,

Disoprivan 1% propofolum emulsion for infusion Caponago, Italy for AstraZeneca Box with 5 ampoules containing 20 mL

UK Ltd., Macclesfield, Cheshire, of emulsion

YES YES

Great Britain

Jadran - Galenski laboratorij d.d.,

Disopyramide JADRAN capsules Pulac bb, Rijeka, Republic of 50 capsules in an amber glass bottle, YES YES

Croatia supplied in a box

Pliva Croatia Ltd., Ulica grada

Diuver 10 mg tablets tablets Vukovara 49, Zagreb, Republic of 20 (2x10) tablets in a blister, supplied

Croatia in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Diuver 5 mg tablets tablets Vukovara 49, Zagreb, Republic of 20 (2x10) tablets in a blister, supplied

Croatia in a box

YES YES

Dobutamin Admeda 250 solution for infusion Wuelfing Pharma GmbH, 50 mL of solution for infusion in a glass Gronau, Germany ampoule, 1 ampoule in a box YES YES

Belupo, lijekovi i kozmetika d.d., 6 capsules in a white plastic (PP)

DOKSICIKLIN 100 mg capsules capsules, hard Ulica Danica 5, Koprivnica, bottle of 50 mL bag with a temper

Republic of Croatia evident (PP/PE) stopper, supplied in a

YES YES

box

Jadran - Galenski laboratorij d.d., 25 grams of gel in an aluminum tube

Dolokain gel gel Pulac bb, Rijeka, Republic of with plastic cap (in a protective bag), YES YES

Croatia supplied in a carton box

Dopamin Admeda 200 concentrate of solution for

5 glass ampoules each with 10.3 mL of

infusion Wuelfing Pharma GmbH solution for infusion concentrate, YES YES supplied in a box

5 glass ampoules each with 5.3 mL of

Dopamin Admeda 50 concentrate of solution for infusion Wuelfing Pharma GmbH solution for infusion concentrate, YES YES

supplied in a box

F. Hoffmann-La Roche Ltd.,

Dormicum 15 mg tablets film coated tablets Grenzacherstrasse 124, Basel, 10 (1x10) tablets in a blister, supplied

Switzerland in a box

YES YES

F. Hoffmann-La Roche Ltd.,

Dormicum 15 mg/3 mL injection solution for injection Grenzacherstrasse 124, Basel, 5 ampoules with 3 mL of solution, YES

Switzerland supplied in a box

YES

F. Hoffmann-La Roche Ltd.,

Dormicum 5 mg/1 mL injection solution for injection Grenzacherstrasse 124, Basel, 10 ampoules each containing 1 mL of YES YES

Switzerland solution, supplied in a box

F. Hoffmann-La Roche Ltd.,

Dormicum 7.5 mg tablets film coated tablets Grenzacherstrasse 124, Basel, 10 (1x10) tablets in a blister, supplied

Switzerland in a box

YES YES

Dotarem 0.5 mmol/mL solution for injection Guerbet, Roissy CdG Cedex, 20 mL of solution in a glass bottle with France rubber stopper, supplied in a box YES YES YES

Dotarem 0.5 mmol/mL solution for injection Guerbet, Roissy CdG Cedex, 15 mL of solution in a glass bottle with France rubber stopper, supplied in a box YES YES YES

Jadran - Galenski laboratorij d.d.,

Doxazin 2 mg tablets Pulac bb, Rijeka, Republic of 20 (2x10) tablets in a blister, supplied YES YES

Croatia in a box

Jadran - Galenski laboratorij d.d.,

Doxazin 4 mg tablets Pulac bb, Rijeka, Republic of 20 (2x10) tablets in a blister, supplied

Croatia in a box

YES YES

DOXORUBICIN EBEWE 10 mg/ concentrate of solution for Ebewe Pharma Ges. m.b.H. Nfg. 5 mL of solution concentrate in an

5 mg infusion KG, Mondseestrasse 11, amber glass bottle (with a rubber YES YES Unterach, Austria stopper), supplied in a box

14509/1/11 REV 1 WS/jj 264

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

DOXORUBICIN EBEWE 50 mg/ concentrate of solution for Ebewe Pharma Ges. m.b.H. Nfg. 25 mL of solution concentrate in an

25 mg infusion KG, Mondseestrasse 11, amber glass bottle (with rubber YES YES Unterach, Austria stopper), supplied in a box

5-mL bottle containing 10 mg of

Doxorubicin Pliva injection 10 powder for solution for Pliva Lachema, Karasek 1, 62133 powder, with bromobutyl stopper and

mg injection Brno, Czech Republic aluminum cap and ring, supplied in a YES YES

box

25-mL bottle containing 50 mg of

Doxorubicin Pliva injection 50 powder for solution for Pliva Lachema, Karasek 1, 62133 powder, with bromobutyl stopper and

mg injection Brno, Czech Republic aluminum cap and ring, supplied in a YES YES

box

Colourless glass bottle (glass type I)

with a rubber stopper (chlorobutyl)

Doxorubicin-Teva 2 mg/mL solution for injection Pharmachemie B.V., Haarlem, coated with fluoropolymer film, the Netherlands aluminium ring and polypropylene lid YES YES YES YES

containing 5 mL of solution, supplied in

a box

Colourless glass bottle (glass type I)

with a rubber stopper (chlorobutyl)

Doxorubicin-Teva 2 mg/mL solution for injection Pharmachemie B.V., Haarlem, coated with fluoropolymer film, the Netherlands aluminium ring and polypropylene lid YES YES YES YES

containing 25 mL of solution, supplied

in a box

Dr. Theiss Mucoplant eucalyptus 50 g of ointment in an amber glass balm against cold ointment

Dr. Theiss Naturwaren GmbH,

Homburg, Germany bottle with a wide neck, supplied in a YES YES YES box

Jadran - Galenski laboratorij d.d.,

Dramina tablets Pulac bb, Rijeka, Republic of 10 tablets in a A/PVC blister, supplied YES YES YES

Croatia in a carton box

Driptane tablets Laboratories Fournier S.A., 60 (2x30) tablets in a blister (PVC/Al), Fontaine les Dijon, France supplied in a box YES YES

Dulcolax suppositories suppositories Boehringer Ingelheim Italia 6 suppositories in aluminium foil, S.p.A., Firenca, Italy supplied in a box YES YES YES

Boehringer Ingelheim France, 12, 30 (3x10) coated tablets in a

Dulcolax coated tablets coated tablets Rue Andre Huet, Reims, Cedex, PVC/PVDC-Al blister, supplied in a YES YES YES

France box

Solvay Pharmaceuticals GmbH, 100 mL of intestinal gel in a PVC bag

Duodopa intestinal gel intestinal gel Justus-von-Liebig-Strasse 33, with a plastic tube and pump

Neustadt, Germany attachement, inside a hard plastic

YES YES YES YES

cassette, carton with 7 casettes

Duphaston film coated tablets Solvay Pharmaceuticals B.V., 42 (3x14) tablets in a blister (PVC/Al), Weesp, the Netherlands supplied in a box YES YES

Duphaston film coated tablets Solvay Pharmaceuticals B.V., 20 (1x20) tablets in a blister (PVC/Al), Weesp, the Netherlands supplied in a box YES YES

Jadran -Galenski laboratorij d.d.,

Rijeka, Republic of Croatia, in

DURACEF 250 mg capsules capsules cooperation with Bristol-Myers 12 capsules (2x6) in PVC/PVDC//Al

Squibb S.p.A., Contrada Fontana blister, supplied in a box

YES YES

del Cerasp. Anagni, Italy

Jadran -Galenski laboratorij d.d.,

Rijeka, Republic of Croatia, in

DURACEF 500 mg capsules capsules cooperation with Bristol-Myers 12 capsules (2x6) in PVC/PVDC//Al

Squibb S.p.A., Contrada Fontana blister, supplied in a box

YES YES

del Cerasp. Anagni, Italy

14509/1/11 REV 1 WS/jj 265

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Jadran -Galenski laboratorij d.d., 35 g of powder for oral suspension in a

Duracef powder for oral powder for preparation of Rijeka, Republic of Croatia, in 60 mL plastic (HDPE) bottle with a

suspension 250 mg/5 mL oral suspension cooperation with Bristol-Myers YES Squibb S.p.A., Contrada Fontana plastic measuring spoon, supplied in a YES

del Cerasp. Anagni, Italy box

Jadran -Galenski laboratorij d.d.,

Rijeka, Republic of Croatia, in

Duracef 1 g dispersible tablets dispersible tablets cooperation with Bristol-Myers 10 (2x5) tablets in blisters, supplied in

Squibb S.p.A., Contrada Fontana a box

YES YES

del Cerasp. Anagni, Italy

Durogesic transdermal patch Janssen Pharmaceutica NV, 5 transdermal patches (individually

100 ug/h transdermal patch Turnhouseweg 30, Beerse, packed in a protective bag), supplied YES YES Belgium in a box

Durogesic transdermal patch 12 Janssen Pharmaceutica NV, 5 transdermal patches (individually

µg/h transdermal patch Turnhouseweg 30, Beerse, packed in a protective bag), supplied YES YES Belgium in a box

Durogesic transdermal patch 12 Janssen Pharmaceutica NV, 5 transdermal patches (individually

microg/h transdermal patch Turnhouseweg 30, Beerse, packed in a protective bag), supplied YES YES Belgium in a box

Durogesic transdermal patch 25 Janssen Pharmaceutica NV, 5 transdermal patches (individually

ug/h transdermal patch Turnhouseweg 30, Beerse, packed in a protective bag), supplied YES YES Belgium in a box

Durogesic transdermal patch 50 Janssen Pharmaceutica NV, 5 transdermal patches (individually

ug/h transdermal patch Turnhouseweg 30, Beerse, packed in a protective bag), supplied YES YES Belgium in a box

Durogesic transdermal patch 75 Janssen Pharmaceutica NV, 5 transdermal patches (individually

µg/h transdermal patch Turnhouseweg 30, Beerse, packed in a protective bag), supplied YES YES Belgium in a box

10 or 40 l of nitrogen oxidule in

Nitric oxidul medical gas SOL SpA, Cremona, Italy i SOL SpA, Marcianise, Italy stainless steel bottles under pressure YES YES

of 50 bars

Messer Croatia Plin d.o.o., 11 or 40 l of nitrogen oxidule in

Nitric oxidul medical gas Zaprešić, Industrijska 1, Republic stainless steel bottles under pressure YES YES

of Croatia of 50 bars

2 glass bottles of lyophilisate for

Dysport lyophilisate for solution for IPSEN BIOPHARM LIMITED, injection Wrexham, Great Britain preparation of injection, supplied in a YES YES

box

Dysport lyophilisate for preparation IPSEN BIOPHARM LIMITED,

Glass vial with lyophilisate for

of solution for injections Wrexham, Great Britain preparation of injection, supplied in a YES YES box

Ebixa 10 mg tablets film coated tablets H. Lundbeck A/S, Ottilavej 9, 28 (2x14) tablets in a blister, supplied Copenhagen-Valby, Denmark in a box YES YES

50 g of solution in an amber glass

Ebixa 10 mg/g oral drops solution for oral drops H. Lundbeck A/S, Ottilavej 9, Copenhagen-Valby, Denmark bottle with a dropper and a plastic YES YES

stopper, supplied in a box

Ebrantil 25 iv. solution for injection Altana Pharma AG, Byk-Gulden 5 ampoules each with 5 mL of solution, Strasse 2, Konstanz, Germany supplied in a box YES YES

Ebrantil 30 capsules prolonged release capsules Altana Pharma Oranienburg

50 prolonged release capsules in a

GmbH, Oranienburg, Germany plastic bottle with a desiccant, supplied YES YES in a box

Ebrantil 50 iv. solution for injection Altana Pharma AG, Byk-Gulden 5 ampoules each with 10 mL of Strasse 2, Konstanz, Germany solution, supplied in a box YES YES

50 prolonged release capsules in a

Ebrantil 60 capsules prolonged release capsules Altana Pharma Oranienburg GmbH, Oranienburg, Germany plastic bottle with a desiccant, supplied YES YES

in a box

14509/1/11 REV 1 WS/jj 266

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Ebrantil 90 capsules prolonged release capsules Altana Pharma Oranienburg

50 prolonged release capsules in a

GmbH, Oranienburg, Germany plastic bottle with a desiccant, supplied YES YES in a box

Lek farmacevtska družba d.d.,

Edemid forte 500 mg tablets tablets Verovškova 57, Ljubljana, 20 tablets in an amber glass bottle,

Republic of Slovenia supplied in a carton box

YES YES

Edemid forte 250mg/10mL solution for infusion Lek farmacevtska družba d.d., 5 ampoules with 10 mL of solution in a

injection (concentrate) Verovškova 57, Ljubljana, YES YES Republic of Slovenia plastic container, supplied in a box

Edicin 0.5 g injection for Lek farmacevtska družba d.d., intravenous infusion powder for injection Verovškova 57, Ljubljana,

One glass vial with powder for

Republic of Slovenia injection, supplied in a box

YES YES

Edicin 1.0 g injection for Lek farmacevtska družba d.d., intravenous infusion powder for injection Verovškova 57, Ljubljana, One glass vial with powder for YES YES Republic of Slovenia injection, supplied in a box

EDRONAX tablets 4 mg tablets Pfizer Italia S.r.l., Marina De 60 (3x20) tablets in a blister, supplied Tronto, Ascoli Piceno, Italy in a box YES YES

Wyeth Medica Republic of

Efectin ER capsules 150 mg prolonged release capsules Ireland, Newbridge, Republic of Box with 28 capsules (blister, 2x14 YES YES

Ireland capsules)

Wyeth Medica Republic of

Efectin ER capsules 37.5 mg prolonged-release capsules Ireland, Newbridge, Republic of Box with 30 capsules (blister, 3x10 YES YES

Ireland capsules)

Wyeth Medica Republic of

Efectin ER capsules 75 mg prolonged release capsules Ireland, Newbridge, Republic of Box with 28 capsules (blister, 2x14 YES YES

Ireland capsules)

Bristol-Myers Squibb, 304,

Efferalgan 1 g effervescent avenue du Dr. Jean Bru, Agen, tablets effervescent tablets France; Bristol-Myers Squibb,

8 effervescent tablets in a plastic tube,

979 Avenue des Pyrenees, Le supplied in a box

YES YES YES

Passage, France

Bristol-Myers Squibb, 304,

Efferalgan 150 mg suppositories suppositories avenue du Dr Jean Bru, Agen, 10 (2x5) suppositories in a PVC/PE YES YES

France strip, supplied in a box

YES

Bristol-Myers Squibb, 304,

Efferalgan 300 mg suppositories suppositories avenue du Dr Jean Bru, Agen, 10 (2x5) suppositories in a PVC/PE YES

France strip, supplied in a box

YES YES

Bristol-Myers Squibb, 304,

EFFERALGAN 500 mg, avenue du Dr Jean Bru, Agen, effervescent tablets effervescent tablets France i Bristol-Myers Squibb, 16 (4x4) effervescent tablets in a strip YES YES 979 Avenue des Pyrénés, Le (Al/PE), supplied in a box

YES

Passage, France

Bristol-Myers Squibb, 304,

Efferalgan 80 mg suppositories suppositories avenue du Dr Jean Bru, Agen, 10 (2x5) suppositories in a PVC/PE YES

France strip, supplied in a box

YES YES

Bristol-Myers Squibb, 304, 90 mL of solution in a brown plastic

Efferalgan solution for children solution for oral use avenue du Dr Jean Bru, Agen, bottle with a temper-evident stopper, YES YES YES

France supplied in a box

Bristol-Myers Squibb, 304,

EFFERALGAN plus vitamin C, avenue du Dr. Jean Bru, Agen, effervescent tablets effervescent tablets France; Bristol-Myers Squibb, 10 effervescent tablets in a YES YES 979 Avenue des Pyrenees, Le polypropylene tube, supplied in a box

YES

Passage, France

Allergan Pharmaceuticals

Efflumidex Liquifilm eye drops eye drops, suspension Republic of Ireland, Castlebar 5 mL of suspension in a plastic bottle Road, Westport, Co Mayo, with a dropper, supplied in a box YES YES

Republic of Ireland

14509/1/11 REV 1 WS/jj 267

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Farmal d.d., Branitelja

EFOX tablets 250 mg film coated tablets domovinskog rata 8, Ludbreg, 10 (1x10) tablets in a Al/Al blister,

Republic of Croatia supplied in a box

YES YES

Farmal d.d., Branitelja

Efox tablets 500 mg film coated tablets domovinskog rata 8, Ludbreg, 10 (1x10) tablets in a Al/Al blister, YES YES

Republic of Croatia supplied in a box

Eglonyl 100 mg/2 mL solution for Alkaloid AD-Skopje, Skopje, 30 colourless glass ampoules each

injection solution for injection FYROM in cooperation with containing 2 mL of solution, supplied in YES YES Sanofi-Aventis, France a box

Alkaloid AD-Skopje, Skopje,

Eglonyl 25 mg/5 mL oral solution oral solution FYROM in cooperation with 120 mL of solution in an amber glass

Sanofi-Aventis, France botlle with dispenser, supplied in a box

YES YES

Alkaloid AD - Skopje, Bulevar

Eglonyl 50 mg capsules capsules Aleksandar Makedonski 12, 30 capsules in an amber glass bottle, YES YES

Skopje, FYROM supplied in a box

Alkaloid AD-Skopje, Skopje,

Eglonyl forte tablets tablets FYROM in cooperation with 12 tablets in an amber glass bottle, YES YES

Sanofi-Aventis, France supplied in a box

Elaprase 2 mg/mL concentrate concentrate for infusion Shire Human Genetic Therapies 5-mL glass bottle with 3-mL of

for infusion solution solution AB, Danderyd, Sweden concentrate supplied in a box YES YES YES YES

Elaprase 2 mg/mL concentrate concentrate for solution for Shire Human Genetic Therapies 10 5-mL glass bottles with 3 mL of

for infusion solution infusion AB, Danderyd, Sweden concentrate, supplied in a box YES YES YES YES

Elaprase 2 mg/mL concentrate concentrate for solution for Shire Human Genetic Therapies 4 glass bottles (à 5 mL) with 3 mL of

for solution for infusion infusion AB, Danderyd, Sweden concentrate, supplied in a box YES YES YES YES

ELEVIT PRONATAL film coated Rottendorf Pharma GmbH, 30 (3x10) film coated tablets in a

tablets film coated tablets Enningerloh, Germany blister (PVC/PE/PVDC//Al), supplied in YES YES YES a box

Novartis Pharma Produktions

Elidel 1 % cream 15 g cream GmbH, Öflinger Strasse 44, 15 g of cream in an aluminum tube, YES YES

Wehr, Germany supplied in a box

Schering-Plough Labo N.V.

Elocom cream cream Industrepark 30, Heist-op-den 15 g of cream in an aluminum tube,

Berg, Belgium supplied in a box

YES YES

Schering-Plough Labo N.V.

Elocom lotion lotion Industrepark 30, Heist-op-den 20 mL of lotion in a plastic bottle with YES

Berg, Belgium dropper attachment, supplied in a box

YES

Schering-Plough Labo N.V.

Elocom ointment ointment Industrepark 30, Heist-op-den 15 g of cream in an aluminum tube,

Berg, Belgium supplied in a box

YES YES

Emadine eye drops eye drops Alcon-Couvreur s.a., Rijksweg Bottle-dropper with 5 mL of sterile 14, Puurs, Belgium solution, supplied in a box YES YES

Merck Sharp & Dohme B.V.,

Emend 125 mg hard capsules capsules, hard Waarderweg 39, Postbus 581, One (1x1) capsule in a blister back YES YES YES YES

Haarlem, The Nederlands (Al/Al) supplied in a carton box

Emend 125 mg hard capsules / Merck Sharp & Dohme B.V., One 125-mg capsule in a blister (Al/Al)

Emend 80 mg hard capsules hard capsules Waarderweg 39, Postbus 581, and two 80-mg capsules in a blister YES YES YES YES Haarlem, the Netherlands (A/Al), supplied in a box

Merck Sharp & Dohme B.V.,

Emend 40 mg hard capsules capsules, hard Waarderweg 39, Postbus 581, One capsule in a blister (Al/Al), YES YES

Haarlem, the Netherlands supplied in a box

YES YES

Merck Sharp & Dohme B.V.,

Emend 80 mg hard capsules capsules, hard Waarderweg 39, Postbus 581, 2 (1x2) capsules in a blister (Al/Al), YES YES YES YES

Haarlem, the Netherlands supplied in a box

14509/1/11 REV 1 WS/jj 268

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Belupo, lijekovi i kozmetika d.d., 210 tablets in a white plastic (HDPE)

Eminens 0.25 mg tablets film coated tablets Ulica Danica 5, Koprivnica, bottle with temper-proof closure and YES YES

Republic of Croatia desiccant, supplied in a box

Belupo, lijekovi i kozmetika d.d., 21 tablets in a white (HDPE) plastic

Eminens 0.5 mg tablets film coated tablets Ulica Danica 5, Koprivnica, bottle with temper-proof closure and YES YES

Republic of Croatia desiccant, supplied in a box

Belupo, lijekovi i kozmetika d.d., 21 tablets in a white (HDPE) plastic

Eminens 1 mg tablets film coated tablets Ulica Danica 5, Koprivnica, bottle with temper-proof closure and YES YES

Republic of Croatia desiccant, supplied in a box

Belupo, lijekovi i kozmetika d.d., 21 tablets in a white (HDPE) plastic

Eminens 2 mg tablets film coated tablets Ulica Danica 5, Koprivnica, bottle with temper-proof closure and YES YES

Republic of Croatia desiccant, supplied in a box

Belupo, lijekovi i kozmetika d.d., 21 tablets in a white (HDPE) plastic

Eminens 5 mg tablets film coated tablets Ulica Danica 5, Koprivnica, bottle with temper-proof closure and YES YES

Republic of Croatia desiccant, supplied in a box

Novartis Pharma Stein AG,

Emselex 15 mg prolonged-release tablets Schaffhauserstrasse, Stein, 28 (4x7) tablets in a blister YES YES YES

Switzerland (PVC/PVDC//Al), supplied in a box

Novartis Pharma Stein AG,

Emselex 7.5 mg prolonged-release tablets Schaffhauserstrasse, Stein, 28 (4x7) tablets in a blister

Switzerland (PVC/PVDC//Al), supplied in a box

YES YES YES

Krka d.d., Šmarješka cesta 6,

Enap -H tablets tablets Novo mesto, Republic of 20 (2x10) tablets in a blister YES YES

Slovenia (OPA/Al/PVC//Al), supplied in a box

Krka d.d., Šmarješka cesta 6,

Enap HL tablets tablets Novo mesto, Republic of 20 (2x10) tablets in a blister, supplied

Slovenia in a box

YES YES

Krka d.d., Šmarješka cesta 6,

Enap tablets 10 mg tablets Novo mesto, Republic of 20 (2x10) tablets in a blister

Slovenia (OPA/Al/PVC//Al), supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6,

Enap tablets 20 mg tablets Novo mesto, Republic of 20 (2x10) tablets in a blister

Slovenia (OPA/Al/PVC//Al), supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6,

Enap tablets 5 mg tablets Novo mesto, Republic of 20 (2x10) tablets in a blister

Slovenia (OPA/Al/PVC//Al), supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6,

Enap-HL 20 tablets tablets Novo mesto, Republic of 60 (6x10) tablets in a blister, supplied YES

Slovenia in a box

YES

Krka d.d., Šmarješka cesta 6,

Enap-HL 20 tablets tablets Novo mesto, Republic of 20 (2x10) tablets in a blister, supplied

Slovenia in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Enazil 10 tablets Vukovara 49, Zagreb, Republic of 20 (2x10) tablets in a blister YES YES

Croatia (OPA/Al/PVC//Al), supplied in a box

Pliva Croatia Ltd., Ulica grada

Enazil 20 tablets Vukovara 49, Zagreb, Republic of 20 (2x10) tablets in a blister YES YES

Croatia (OPA/Al/PVC//Al), supplied in a box

Pliva Croatia Ltd., Ulica grada

ENAZIL 5 tablets Vukovara 49, Zagreb, Republic of 20 (2x10) tablets in a blister

Croatia (OPA/Al/PVC//Al), supplied in a box

YES YES

Box with 4 glass bottles containing 25

Enbrel 25 mg powder and diluent powder and diluent for Wyeth Pharmaceuticals, New

mg of lyophilised powder, 4 syringes

with needle filled with solvent (water

for solution for injection solution for injection Lane, Havant, Hampshire P092NG, Great Britain for injection), 4 needles with YES YES

protection, 3 bottle adapters and 8

alcohol impregnated pads

14509/1/11 REV 1 WS/jj 269

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Box with 4 glass bottles containing 25

Enbrel 25 mg powder and diluent powder and diluent for Wyeth Pharmaceuticals, New mg of lyophilised powder, 4 syringes

for solution for injection solution for injection Lane, Havant, Hampshire with needle filled with solvent (water YES YES P092NG, Great Britain for injection) and 8 alcohol

impregnated pads

Enbrel 25 mg powder for solution powder for solution for Wyeth Pharmaceuticals, New Box with 4 glass bottles containing 25

for injection injection Lane, Havant, Hampshire mg of lyophilised powder and 8 YES YES P092NG, Great Britain alcohol impregnated pads

ENCEPUR for for children,

vaccine against viral Middle

European tick-borne intramuscular suspension Chiron Behring GmbH & Co,

Box with 1 pre-filled syringe with a

YES

meningoencephalitis Marburg, Germany

needle with 1 dose of vaccine (0.25 YES

mL of suspension)

(inactivated, absorbed)

ENCEPUR Adult, inactivated

absorbed vaccine against viral Chiron Behring GmbH & Co, Box with 1 pre-filled syringe with a Central European tick-born intramuscular suspension Marburg, Germany needle with 1 dose of vaccine (0.5 mL YES YES meningoencephalitis of suspension)

Endoxan coated tablets 50 mg coated tablets Baxter Oncology GmbH, 50 (5x10) coated tablets in a blister Kantstrasse 2, Halle, Germany (PVC/PVDC/Al), supplied in a box YES YES

Endoxan 1 g powder for solution powder for injection solution Baxter Oncology GmbH, Powder for solution for injection in a

for injection (for intravenous use) Kantstrasse 2, Halle, Germany glass bottle, supplied in a box YES YES

Endoxan 200 mg powder for powder for solution for Baxter Oncology GmbH, Powder for solution for injection in a

solution for injection intravenous injection Kantstrasse 2, Halle, Germany glass bottle, supplied in a box YES YES

Endoxan powder for injection powder for solution for Baxter Oncology GmbH, Powder for solution for injection in a

solution 500 mg intravenous injection Kantstrasse 2, Halle, Germany glass bottle, supplied in a box YES YES

Engerix-B Dosis Adulta; GlaxoSmithKline Biologicals s.a., Box with one pre-filled syringe with 1

recombinant hepatitis B vaccine intramuscular suspension Rue de lInstitut 89, Rixensart, mL of vaccine, needle and needle YES YES

for adults Belgium protection

Engerix-B Dosis Adulta; GlaxoSmithKline Biologicals s.a.,

recombinant hepatitis B vaccine intramuscular suspension Rue de lInstitut 89, Rixensart, Box with 25 glass bottles with 1 mL of YES YES for adults Belgium vaccine

Engerix-B Dosis Paediatrica; GlaxoSmithKline Biologicals s.a.,

recombinant hepatitis B vaccine intramuscular suspension Rue de lInstitut 89, Rixensart, Box with 25 glass bottles with 0.5 mL YES for children Belgium of vaccine

YES

Engerix-B Dosis Paediatrica; GlaxoSmithKline Biologicals s.a., Box with one pre-filled syringe with 0.5

recombinant hepatitis B vaccine intramuscular suspension Rue de lInstitut 89, Rixensart, mL of vaccine, needle and needle YES YES

for children Belgium protection

Pliva Croatia Ltd., Ulica grada

Epiramat tablets 100 mg film coated tablets Vukovara 49, Zagreb, Republic of 60 (6x10) tablets in an OPA/Al/PVC//Al

Croatia blister, supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Epiramat tablets 200 mg film coated tablets Vukovara 49, Zagreb, Republic of 60 (6x10) tablets in an OPA/Al/PVC//Al YES

Croatia blister, supplied in a box

YES

Pliva Croatia Ltd., Ulica grada

Epiramat tablets 25 mg film coated tablets Vukovara 49, Zagreb, Republic of 60 (6x10) tablets in an OPA/Al/PVC//Al

Croatia blister, supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Epiramat tablets 50 mg film coated tablets Vukovara 49, Zagreb, Republic of 60 (6x10) tablets in an OPA/Al/PVC//Al YES

Croatia blister, supplied in a box

YES

Ebewe Pharma Ges. m.b.H. Nfg. 5 mL of solution for infusion

Epirubicin Ebewe 10 mg/5 mL concentrate of solution for infusion KG, Mondseestrasse 11, concentrate in a glass bottle (with a YES YES

Unterach, Austria rubber stopper), supplied in a box

14509/1/11 REV 1 WS/jj 270

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Ebewe Pharma Ges. m.b.H. Nfg. 50 mL of solution for infusion

Epirubicin Ebewe 100 mg/50 mL concentrate of solution for infusion KG, Mondseestrasse 11, concentrate in a glass bottle (with a YES YES

Unterach, Austria rubber stopper), supplied in a box

Ebewe Pharma Ges. m.b.H. Nfg. 25 mL of infusion solution concentrate

Epirubicin Ebewe 50 mg/ 25 mL concentrate of solution for infusion KG, Mondseestrasse 11, in a glass bottle (with rubber stopper), YES YES

Unterach, Austria supplied in a box

Epivir tablets 150 mg film coated tablets Glaxo Wellcome Operations, 60 tablets in a polyethylene bottle, Greenford, Great Britain supplied in a box YES YES

Pliva Croatia Ltd., Ulica grada

Epoetal injection 2000 IU/mL solution for injection Vukovara 49, Zagreb, Republic of One ampoule in a box YES YES

Croatia

Pliva Croatia Ltd., Ulica grada

Epoetal injection 4000 IU/mL solution for injection Vukovara 49, Zagreb, Republic of One ampoule in a box YES YES

Croatia

6 bottles with rubber stoppers

Eprex 10 000 injection solution for injection Cilag AG, Schaffhausen, containing 1.0 mL of solution for Switzerland injection, in protective packaging, YES YES YES YES

supplied in a box

Eprex 10 000 injection solution for injection Cilag AG, Schaffhausen,

6 syringes with a needle (disposable)

Switzerland with 1.0 mL of solution, in protective YES YES YES YES packaging, supplied in a box

6 syringes with a needle (disposable)

Eprex 2 000 injection solution for injection Cilag AG, Schaffhausen, Switzerland with 0.5 mL of solution, in protective YES YES YES YES

packaging, supplied in a box

Pre-filled disposable syringe

Eprex 20 000 injection solution for injection Cilag AG, Schaffhausen, containing 0.5 mL of solution for Switzerland injection in a protective container, YES YES YES YES

supplied in a box

6 syringes with a needle (disposable)

Eprex 3 000 injection solution for injection Cilag AG, Schaffhausen, Switzerland with 0.3 mL of solution, in protective YES YES YES YES

packaging, supplied in a box

6 syringes with a needle (disposable)

Eprex 4 000 injection solution for injection Cilag AG, Schaffhausen, Switzerland with 0.4 mL of solution, in protective YES YES YES YES

packaging, supplied in a box

Eprex 40 000 injection solution for injection Cilag AG, Schaffhausen,

Vial containing 1 mL of solution for

Switzerland injection, with rubber stopper, in a YES YES YES YES protective container, supplied in a box

Pre-filled disposable syringe

Eprex 40 000 injection solution for injection Cilag AG, Schaffhausen, containing 1.0 mL of solution for Switzerland injection in a protective container, YES YES YES YES

supplied in a box

IVAX-Pharmaceuticals s.r.o.,

Equoral 100 mg soft capsules Ostravska 29, Opava - Komarov, 50 (5x10) capsules in an Al/Al blister,

Czech Republic supplied in a carton box

YES YES

IVAX-Pharmaceuticals s.r.o.,

Equoral 25 mg soft capsules Ostravska 29, Opava - Komarov, 50 (5x10) capsules in an Al/Al blister, YES

Czech Republic supplied in a carton box

YES

IVAX-Pharmaceuticals s.r.o.,

Equoral 50 mg soft capsules Ostravska 29, Opava - Komarov, 50 (5x10) capsules in an Al/Al blister,

Czech Republic supplied in a carton box

YES YES

50 mL of solution in an amber glass

bottle in a protective container, 1

IVAX-Pharmaceuticals s.r.o., plastic syringe of 4 mL, 1 plastic pipe

Equoral solution oral solution Ostravska 29, Opava - Komarov, for extraction of bottle content in a YES YES

Czech Republic protective plastic container and 1

plastic temper-evident screw cap,

supplied in a carton box

14509/1/11 REV 1 WS/jj 271

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Farmal d.d., Ludbreg, Republic of

ERAZON capsules 10 mg capsules, hard Croatia in cooperation with Krka 20 (2x10) capsules in a blister (PVC - d.d., Novo mesto, Republic of Al), supplied in a box YES YES

Slovenia

Farmal d.d., Ludbreg, Republic of

ERAZON capsules 20 mg capsules, hard Croatia in cooperation with Krka 20 (2x10) capsules in a blister (PVC - d.d., Novo mesto, Republic of Al), supplied in a box YES YES

Slovenia

Farmal d.d., Ludbreg, Republic of

ERAZON suppositories suppositories Croatia in cooperation with Krka 10 (2x5) suppositories in a strip, d.d., Novo mesto, Republic of supplied in a box YES YES

Slovenia

Erbitux 2 mg/mL solution for Merck KGaA, Frankfurter Straße 50 mL of solution in a glass bottle,

infusion solution for infusion 250, Darmstadt, Germany supplied in a box YES YES YES

Ergometrin Lek 0.2 mg film Lek farmacevtska družba d.d., coated tablets film coated tablets Verovškova 57, Ljubljana,

20 film coated tablets in an amber

Republic of Slovenia glass bottle, supplied in a box

YES YES

Ergometrin Lek 0.2 mg/mL Lek farmacevtska družba d.d., solution for injection solution for injection Verovškova 57, Ljubljana, 50 ampoules with 1 mL of solution, YES YES Republic of Slovenia supplied in a carton box

Belupo, lijekovi i kozmetika d.d.,

Eritromicin 250 mg capsules capsules Ulica Danica 5, Koprivnica, 16 (1x16) capsules in a blister,

Republic of Croatia supplied in a box

YES YES

Esberitox N tablets tablets Schaper & Brümmer GmbH & 50 (5x10) tablets in a blister Co. KG, Salzgitter, Germany (PVC/PVDC/Al), supplied in a box YES YES YES

Esmeron solution for injection (for N.V. Organon, Oss, The

10 mL of solution for injection in a

intravenous use) Nederlands glass bottle with rubber stopper, 10 YES YES glass bottles in a box

5 mL of solution for injection in a glass

Esmeron solution for injection (for

N.V. Organon, Oss, the

intravenous use) Netherlands; ORGANON S.A., bottle with a rubber stopper, 12 glass YES YES Usine Saint Charles, France bottles in a box

Berlin-Chemie AG (Menarini

Espumisan capsules, soft Group), Glienicker Weg 125, 25 (1x25) capsules in a PVC/Al blister, YES

Berlin, Germany supplied in a box

YES YES

4 transdermal patches Estraderm TTS

Novartis Pharma Stein AG, 50 and 4 transdermal patches

Estracomb TTS transdermal patch Schaffhauserstrasse, Stein, Estragest TTS 250/50 (individually YES YES

Switzerland packed in a protective Surlyn/Al bag),

supplied in a box

Pliva Croatia Ltd., Zagreb,

Estracyt capsules Republic of Croatia in 40 capsules in an amber glass bottle, cooperation with Pharmacia & supplied in a box YES YES

Upjohn S.p.A., Milano, Italy

Novartis Pharma Stein AG, 6 (3x2) transdermal patches

Estraderm TTS 100 transdermal patch Schaffhauserstrasse, Stein, (individually packed in a protective YES YES

Switzerland Surlyn/Al bag), supplied in a box

Novartis Pharma Stein AG, 6 (3x2) transdermal patches

Estraderm TTS 25 patch Schaffhauserstrasse, Stein, (individually packed in a protective YES YES

Switzerland Surlyn/Al bag), supplied in a box

Novartis Pharma Stein AG, 6 (3x2) transdermal patches

Estraderm TTS 50 transdermal patch Schaffhauserstrasse, Stein, (individually packed in a protective YES YES

Switzerland Surlyn/Al bag), supplied in a box

28 tablets in a plastic calendar pack

Estrofem 1 mg film coated tablets Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark (dispenser with marked days of the YES YES YES

week), supplied in a box

14509/1/11 REV 1 WS/jj 272

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

28 tablets in a plastic calendar dial

Estrofem 2 mg film coated tablets Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark pack (dispenser with marked days of YES YES YES

the week), supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Etambutol 400 mg tablets tablets Ulica Danica 5, Koprivnica, 100 tablets in an amber glass bottle,

Republic of Croatia supplied in a box

YES YES

Alkaloid AD - Skopje, Bulevar

Etambutol Alkaloid tablets Aleksandar Makedonski 12, 100 tablets in an amber glass bottle, YES

Skopje, FYROM supplied in a box

YES

ETOPOSIDE EBEWE 100 mg/5 concentrate of solution for Ebewe Pharma Ges. m.b.H. Nfg. 5 mL of solution concentrate in an

mL infusion KG, Mondseestrasse 11, amber glass bottle (with a rubber YES YES Unterach, Austria stopper), supplied in a carton box

ETOPOSIDE EBEWE 1000 concentrate of solution for Ebewe Pharma Ges. m.b.H. Nfg. 50 mL of solution concentrate in an

mg/50 mL infusion KG, Mondseestrasse 11, amber glass bottle (with a rubber YES YES Unterach, Austria stopper), supplied in a carton box

ETOPOSIDE EBEWE 200 solution concentrate for Ebewe Pharma Ges. m.b.H. Nfg. 10 mL of concentrate in an amber

mg/10 mL infusion KG, Mondseestrasse 11, glass bottle (with rubber stopper), YES YES Unterach, Austria supplied in a carton box

ETOPOSIDE EBEWE 50 mg/2.5 concentrate of solution for Ebewe Pharma Ges. m.b.H. Nfg. 2.5 mL of solution concentrate in an

mL infusion KG, Mondseestrasse 11, amber glass bottle (with rubber YES YES Unterach, Austria stopper), supplied in a carton box

Novartis Consumer Health S.A., 50 mL of emulsion in an amber glass

EURAX emulsion emulsion for application on skin Route de l' Etraz, Nyon, bottle with a plastic measuring insert YES YES YES

Switzerland and a plastic stopper, supplied in a box

Novartis Consumer Health S.A.,

EURAX cream cream Route de l' Etraz, Nyon, 20 grams of cream in an aluminum YES YES YES

Switzerland tube with plastic cap, supplied in a box

Euthyrox 100 tablets tablets Merck KGaA, Frankfurter Straße 100 (4X25) tablets in a blister, 250, Darmstadt, Germany supplied in a box YES YES

Euthyrox 150 tablets tablets Merck KGaA, Frankfurter Straße 100 (4X25) tablets in a blister, 250, Darmstadt, Germany supplied in a box YES YES

Euthyrox 25 tablets tablets Merck KGaA, Frankfurter Straße 100 (4X25) tablets in a blister, 250, Darmstadt, Germany supplied in a box YES YES

Euthyrox 50 tablets tablets Merck KGaA, Frankfurter Straße 100 (4X25) tablets in a blister, 250, Darmstadt, Germany supplied in a box YES YES

28 (2x14) film coated tablets in a

Evista 60 mg film coated tablets film coated tablets Lilly, S.A., Avendia de la Industria 30, Alcobendas, Madrid, Spain blister (PVC/PE/Aclar//Al), supplied in YES YES YES

a box

9 patches individually packaged in

Janssen Pharmaceutica NV, protective sachets (paper/LDPE/Al

Evra transdermal patch transdermal patch Turnhouseweg 30, Beerse, foil/LDPE), wrapped à 3 in a YES YES

Belgium transparent plastic bag, supplied in a

box

3 patches individually packaged in

Janssen Pharmaceutica NV, protective bags (paper/LDPE/Al

Evra transdermal patch transdermal patch Turnhouseweg 30, Beerse, foil/LDPE) inserted in a common YES YES

Belgium transparent plastic bag, supplied in a

box

Exforge 5 mg/160 mg film coated Novartis Pharma Stein AG, 28 (2x14) tablets in a blister

tablets film coated tablets Schaffhauserstrasse, Stein, YES YES YES YES Switzerland (PVC/PVDC//Al), supplied in a box

Exforge 5 mg/80 mg film coated Novartis Pharma Stein AG, 28 (2x14) tablets in a blister

tablets film coated tablets Schaffhauserstrasse, Stein, YES YES YES YES Switzerland (PVC/PVDC//Al), supplied in a box

14509/1/11 REV 1 WS/jj 273

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

EXJADE 125 mg tablets for oral Novartis Pharma Stein AG, suspension tablets for oral suspension Schaffhauserstrasse, Stein,

28 (4x7) tablets in a blister

Switzerland (PVC/PE/PVDC//Al), supplied in a box

YES YES YES YES

EXJADE 250 mg tablets for oral Novartis Pharma Stein AG, 28 (4x7) tablets in a blister

suspension tablets for oral suspension Schaffhauserstrasse, Stein, Switzerland (PVC/PE/PVDC//Al), supplied in a box YES YES YES YES

EXJADE 500 mg tablets for oral Novartis Pharma Stein AG, 28 (4x7) tablets in a blister

suspension tablets for oral suspension Schaffhauserstrasse, Stein, YES YES YES YES Switzerland (PVC/PE/PVDC//Al), supplied in a box

4 plastic (PVC) Viaflex bags with 2500

mL of solution, a supply/drain pipe

(PVC), a connector with a protective

Extraneal solution for peritoneal

BAXTER Healthcare S.A.,

dialysis Monreen Road, Castlebar,

cap, an attachment for drug

County Mayo, Republic of Ireland administration, and a collective plastic

YES YES YES

Viaflex bag (individual packaging in a

protective plastic bag), supplied in a

box

5 plastic (PVC) Viaflex bags with 2000

mL of solution, a supply/drain pipe

(PVC), a connector with a safety cap,

Extraneal solution for peritoneal

BAXTER Healthcare S.A.,

dialysis Monreen Road, Castlebar, a dispensing unit and a collective YES YES YES County Mayo, Republic of Ireland plastic Viaflex bag (individual

packaging in a protective plastic bag),

supplied in a box

5 plastic (PVC) Viaflex bags with 2000

BAXTER Healthcare S.A., mL of solution, with a connector with a

Extraneal solution for peritoneal dialysis Monreen Road, Castlebar, safety cap and a dispensing unit YES YES YES

County Mayo, Republic of Ireland (individual packaging in a protective

plastic bag), supplied in a box

Merck Sharp & Dohme B.V.,

Ezetrol 10 mg tablets Waarderweg 39, Postbus 581, 28 (2x14) tablets in an Aclar/PVC/Al YES YES

Haarlem, the Netherlands blister, supplied in a box

YES

Genzyme Ltd., 37 Hollands

Fabrazyme 35 mg powder for concentrate for solution for infusion Road, Haverhill, Suffolk CB9 One glass vial containing powder for YES YES YES

8PU, Great Britain concentrate, supplied in a box

YES

Genzyme Ltd., 37 Hollands

Fabrazyme 5 mg powder for concentrate for One glass vial containing powder for solution for infusion Road, Haverhill, Suffolk CB9 YES YES YES YES

8PU, Great Britain concentrate, supplied in a box

Faktu suppositories suppositories Altana Pharma AG, Byk-Gulden 10 (2x5) suppositories in a PVC/PE Strasse 2, Konstanz, Germany strip, supplied in a box YES YES

Faktu ointment ointment Altana Pharma AG, Byk-Gulden

20 grams of ointment in an aluminum

Strasse 2, Konstanz, Germany tube and an applicator for rectal use, YES YES supplied in a box

Alkaloid AD - Skopje, Bulevar

Famosan 20 mg film coated tablets Aleksandar Makedonski 12, 20 (1x20) tablets in a blister, supplied YES YES

Skopje, FYROM in a box

Alkaloid AD - Skopje, Bulevar

Famosan 40 mg film coated tablets Aleksandar Makedonski 12, 10 (1x10) tablets in a blister, supplied

Skopje, FYROM in a box

YES YES

Farmorubicin PFS 10 mg solution for intravenus and Pfizer Italia s.r.l., Viale Pasteur

injection (2 mg/mL) intravesical use 10, Nerviano Plant, Milano, Italy Box with a bottle with 5 mL of solution YES YES

Farmorubicin PFS 50 mg solution for intravenus and Pfizer Italia s.r.l., Viale Pasteur

injection (2 mg/mL) intravesical use 10, Nerviano Plant, Milano, Italy Box with a bottle with 25 mL of solution YES YES

14509/1/11 REV 1 WS/jj 274

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

AstraZeneca UK Limited, Silk

Faslodex 250 mg/5 mL solution solution for injection (in a Road Business Park, One glass syringe with 5 mL of for injection pre-filled syringe) Macclesfield, Cheshire, Great solution, with child resistant closure, in YES YES YES YES Britain a plastic container, supplied in a box

A. Menarini Manufacturing

Fastum Gel gel Logistic and Services S.r.l., 20 grams of gel in an aluminum tube

Firenca, Italy with plastic cap, supplied in a box

YES YES YES

Belupo, lijekovi i kozmetika d.d., Amber glass bottle (10 mL) with a

Favora Eusin drops drops, solution Ulica Danica 5, Koprivnica, plastic screw cap and a dropper, YES YES YES

Republic of Croatia supplied in a box

Belupo, lijekovi i kozmetika d.d., 200 grams of powder in a PP vessel

Favora Fitolax powder powder Ulica Danica 5, Koprivnica, with PE cap and measuring spoon, YES YES YES

Republic of Croatia supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Favora Orasept lozenges lozenges Ulica Danica 5, Koprivnica, 30 (3x10) lozenges in a blister, YES YES

Republic of Croatia supplied in a box

YES

Belupo, lijekovi i kozmetika d.d.,

Favora Urosal capsules capsules Ulica Danica 5, Koprivnica, 50 (2x25) capsules in a blister, YES YES YES

Republic of Croatia supplied in a box

Feiba TIM 4 immuno 1000 FJ lyophilisate for preparation Baxter AG, Industriestrasse 67,

Box with a bottle with lyophilisate,

of intravenous solutions A-1220 Vienna, Austria bottle with 20 mL of water for injection YES YES and dissolution and injection kit

Feiba TIM 4 immuno 500 FJ lyophilisate for preparation Baxter AG, Industriestrasse 67,

Box with a bottle with lyophilisate,

of intravenous solutions A-1220 Vienna, Austria bottle with 20 mL of water for injection YES YES and dissolution and injection kit

Novartis Pharma Stein AG, 30 (3x10) tablets in a

Femara 2.5 mg film-tablets film coated tablets Schaffhauserstrasse, Stein, PVC/PE/PVDC/Al blister, supplied in a YES YES YES

Switzerland box

Solvay Pharmaceuticals B.V.,

Femoston 1/10 film coated tablets Veerweg 12, 8121 AA Olst, the 28 (1x28) tablets (14 white and 14 YES YES

Netherlands grey) in a blister, supplied in a box

Solvay Pharmaceuticals B.V.,

Femoston 2/10 film coated tablets Veerweg 12, 8121 AA Olst, the 28 (1x28) tablets (14 pink and 14 YES YES

Netherlands yellow) in a blister, supplied in a box

Solvay Pharmaceuticals B.V.,

Femoston Conti 1/5 film coated tablets Veerweg 12, 8121 AA Olst, the 28 (1x28) tablets in a blister, supplied YES YES

Netherlands in a box

Novartis Consumer Health S.A., 20 mL of solution in an amber glass

Fenistil 0.1% oral drops oral drops (solution) Route de l' Etraz, Nyon, bottle with a polyethylene dropper and YES YES

Switzerland a polypropylene cap, supplied in a box

Novartis Consumer Health S.A.,

Fenistil gel gel Route de l' Etraz, Nyon, Al tube with 30 g of gel with a

Switzerland polyethylene cap, supplied in a box

YES YES

Fentanil M Lek 100 transdermal One transdermal patch in a protective

patch transdermal patch Hexal AG, Holzkirchen, Germany bag (PE/Al/PE/paper foil), 5 patches in YES YES a box

Fentanil M Lek 25 transdermal One transdermal patch in a protective

patch transdermal patch Hexal AG, Holzkirchen, Germany bag (PE/Al/PE/paper foil), 5 patches in YES YES a box

Fentanil M Lek 50 transdermal One transdermal patch in a protective

patch transdermal patch Hexal AG, Holzkirchen, Germany bag (PE/Al/PE/paper foil), 5 patches in YES YES a box

Fentanil R Lek 100 transdermal One transdermal patch in a protective

patch transdermal patch Hexal AG, Holzkirchen, Germany bag (PE/Al/PE/paper foil), 5 patches in YES YES a box

14509/1/11 REV 1 WS/jj 275

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Fentanil R Lek 25 transdermal One transdermal patch in a protective

patch transdermal patch Hexal AG, Holzkirchen, Germany bag (PE/Al/PE/paper foil), 5 patches in YES YES a box

Fentanil R Lek 50 transdermal One transdermal patch in a protective

patch transdermal patch Hexal AG, Holzkirchen, Germany bag (PE/Al/PE/paper foil), 5 patches in YES YES a box

FENTANYL injection solution for intravenous

Janssen Pharmaceutica NV,

injection Turnhouseweg 30, Beerse,

50 ampoules with 10 mL of solution for YES

Belgium injection, supplied in a box

YES

Janssen Pharmaceutica NV,

FENTANYL injection solution for intravenous 50 ampoules with 2 mL of solution for injection Turnhouseweg 30, Beerse,

Belgium injection, supplied in a box

YES YES

Ferrum Lek 100 mg chewing Lek farmacevtska družba d.d., 30 (3x10) chewable tablets in a strip,

tablets chewing tablets Verovškova 57, Ljubljana, Republic of Slovenia supplied in a box YES YES

Lek farmacevtska družba d.d., 100 mL of syrup in an amber glass

Ferrum Lek 50 mg/5 mL syrup syrup Verovškova 57, Ljubljana, bottle and a measuring spoon, YES YES

Republic of Slovenia supplied in a box

Bristol-Myers Squibb, 304,

avenue du Dr Jean Bru, Agen,

FERVEX granules for oral solution France; Bristol-Myers Squibb, 8 bags each with 13.100 g of granules,

979 Avenue des Pyrénées, Le supplied in a box

YES YES YES

Passage, France

Bristol-Myers Squibb, 304,

avenue du Dr Jean Bru, Agen,

FERVEX sugar-free granules for oral solution France; Bristol-Myers Squibb, 8 bags each with 4.950 g of granules,

979 Avenue des Pyrénées, Le supplied in a box

YES YES YES

Passage, France

Bristol-Myers Squibb, 304,

avenue du Dr Jean Bru, Agen,

FERVEX for children granules for oral solution France; Bristol-Myers Squibb, 8 bags each with 3.0 g of granules, YES YES YES

979 Avenue des Pyrénées, Le supplied in a box

Passage, France

Solvay Pharmaceuticals B.V.,

Fevarin film coated tablets Weesp, the Netherlands Solvay 15 (1x15) film coated tablets in Pharmaceuticals S.A.S., Châtillon PVC/PVDC/Al blister, supplied in a box YES YES

sur Chalaronne, France

FINCAR 5 mg film coated tablets Cipla Ltd, Bangalore, India 28 (2x14) tablets in a blister (PVC/PVDC/Al), supplied in a box YES YES

Flixonase nasal spray water suspension Glaxo Wellcome S.A., Aranda de

120 doses of suspension in a glass

Duero, Burgos, Spain bottle with plastic dispenser, supplied YES YES in a box

Glaxo Wellcome Operations, 60 doses of powder in an aluminium

Flixotide 100 Diskus inhalation powder Greenford, Vel. Britanija; Glaxo Wellcome Production, Evreux, blister, in a plastic housing, supplied in YES YES

France a box

GlaxoSmithKline

Flixotide 125 Inhaler inhalation aerosol Pharmaceuticals SA, poznan, Aluminium container with a plastic Poland; Glaxo Wellcome mouthpiece containing 60 doses YES YES

Production, Evreux, France

Glaxo Wellcome Operations, 60 doses of powder in an aluminium

Flixotide 250 Diskus inhalation powder Greenford, Vel. Britanija; Glaxo Wellcome Production, Evreux, blister, in a plastic housing, supplied in YES YES

France a box

GlaxoSmithKline

Flixotide 250 Inhaler inhalation aerosol Pharmaceuticals SA, Poznan, Aluminium container with a plastic Poland; Glaxo Wellcome mouthpiece containing 60 doses YES YES

Production, Evreux, France

14509/1/11 REV 1 WS/jj 276

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

GlaxoSmithKline 120 doses (not less than 10.0 g of

Flixotide 50 Inhaler inhalation aerosol Pharmaceuticals S.A., Ul. suspension) in an aluminum container Grunwaldzka 189, Poznan, with metering valve in a plastic YES YES

Poland nebulizer, supplied in a box

Glaxo Wellcome Operations,

Flixotide 500 Diskus inhalation powder Greenford, Vel. Britanija; Glaxo

60 doses of powder in an aluminium

Wellcome Production, Evreux, blister, in a plastic housing, supplied in YES YES France a box

Lek farmacevtska družba d.d.,

Flonidan 10 mg tablets tablets Verovškova 57, Ljubljana, 10 (1x10 ) tablets in a blister, suplied YES YES

Republic of Slovenia in a box

Lek farmacevtska družba d.d., 120 mL of solution in an amber glass

Flonidan 5mg/5mL suspension oral suspension Verovškova 57, Ljubljana, botlle and plastic spoon, supplied in a YES YES

Republic of Slovenia box

Flosteron suspension for Krka d.d., Šmarješka cesta 6, injections suspension for injection Novo mesto, Republic of

5 ampoules each with 1 mL of

Slovenia suspension, supplied in a box

YES YES

Jadran - Galenski laboratorij d.d.,

Fluacet gel gel Pulac bb, Rijeka, Republic of 30 g of gel in an aluminium tube,

Croatia supplied in a box

YES YES

Fluad MF59C.1 adjuvanted Novartis Vaccines & Diagnostics

vaccine against influenza in suspension for injection in S.r.l., Siena, Italy and Imunološki Pre-filled syringe with a needle ready-to-use syringe, inactivated pre-filled syringe zavod d.d., Zagreb, Republic of containing 0.5 mL of suspension, YES YES (surface antigens) Croatia supplied in a box

Fluarix vaccine against Sächsisches Serumwerk

influenza, inactivated, Box with 1 glass syringe with a needle

fragmented (without suspension for injections

Dresden NL der SmithKline

Beecham Pharma GmbH & Co. containing 1 dose of vaccine of 0.5 mL YES YES

preservative) KG, Germany

Schering-Plough Labo N.V.

Flucinom tablets 250 mg tablets Industrepark 30, Heist-op-den 100 (10x10) tablets in an orange YES YES

Berg, Belgium (PVC/Al) blister, supplied in a box

Jadran - Galenski laboratorij d.d.,

Fluconax 100 mg capsules capsules Pulac bb, Rijeka, Republic of 7 (1x7) capsules in (PVC/PVDC/Al) YES YES

Croatia blister, supplied in a box

Jadran - Galenski laboratorij d.d.,

Fluconax 150 mg capsules capsules Pulac bb, Rijeka, Republic of One capsule in a PVC/PVDC/Al blister, YES YES

Croatia supplied in a box

Jadran - Galenski laboratorij d.d.,

Fluconax 200 mg capsules capsules Pulac bb, Rijeka, Republic of 7 (1x7) capsules in (PVC/PVDC/Al) YES YES

Croatia blister, supplied in a box

Fluconax 2mg/1mL solution for solution for intravenous Jadran - Galenski laboratorij d.d., 100 mL of solution in a glass bottle for

intravenous infusion infusion Pulac bb, Rijeka, Republic of infusion and a plastic bottle holder, YES YES Croatia supplied in a box

Jadran - Galenski laboratorij d.d.,

Fluconax 50 mg capsules capsules Pulac bb, Rijeka, Republic of 7 (1x7) capsules in (PVC/PVDC/Al) YES

Croatia blister, supplied in a box

YES

Fludara powder for solution for Schering AG, Muellerstrasse 5 glass bottles with powder, supplied injection or infusion 170-178, Berlin, Germany in a box YES YES

20 (4x5) tablets in a blister

Fludara oral 10 mg film coated

tablets film coated tablets

Schering AG, Muellerstrasse (PA/Al/PP//Al) in a 150 mL plastic

170-178, Berlin, Germany (HDPE) bottle with a plastic child YES YES YES

resistant closure

Fluimukan 100 mg granules for Lek farmacevtska družba d.d., oral solution granules for oral solution Verovškova 57, Ljubljana, 30 bags each containing 5 g of YES YES Republic of Slovenia granules, supplied in a box

YES

Fluimukan 200 mg granules for Lek farmacevtska družba d.d., oral solution granules for oral solution Verovškova 57, Ljubljana,

20 bags with à 5 grams of granules,

Republic of Slovenia supplied in a box

YES YES YES

14509/1/11 REV 1 WS/jj 277

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Glass vial containing 0.5 mL of

suspension for injection, plastic

FLUIMUN, vaccine against Imunološki zavod d.d., syringe, needle for drawing influenza (surface antigen, suspension for injection Rockefellerova 2, Zagreb, suspension from the bottle (21Gx1"; YES YES

inactivated) Republic of Croatia inch) and one needle for drug administration (23Gx1 inch or 25Gx1

inch or 25Gx5/8 inch), supplied in a

box

Belupo, lijekovi i kozmetika d.d.,

FLUONATRIL 0.25 mg tablets tablets Ulica Danica 5, Koprivnica, 400 tablets in a plastic (PP) bottle with YES YES

Republic of Croatia a stopper, supplied in a box

Belupo, lijekovi i kozmetika d.d.,

FLUONATRIL 1 mg tablets tablets Ulica Danica 5, Koprivnica, 250 tablets in a plastic (PP) bottle with

Republic of Croatia a cap, supplied in a box

YES YES

Fluorouracil Pliva injection 250 Pliva Croatia Ltd., Ulica grada 10 glass vials each containing 5 mL of

mg/5 mL solution for injection Vukovara 49, Zagreb, Republic of YES YES Croatia solution, supplied in a box

Fluorouracil Pliva injection 500 Pliva Croatia Ltd., Ulica grada One glass vial with 10 mL of solution,

mg/10 mL solution for injection Vukovara 49, Zagreb, Republic of Croatia supplied in a box YES YES

Krka d.d., Šmarješka cesta 6,

Fluval capsules 20 mg capsules Novo mesto, Republic of 14 (2x7) capsules in a blister YES YES

Slovenia (PVC/PVDC//Al), supplied in a box

Krka d.d., Šmarješka cesta 6,

Fluzepam capsules 15 mg capsules Novo mesto, Republic of 10 (1x10) capsules in a blister,

Slovenia supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6,

Fluzepam capsules 30 mg capsules Novo mesto, Republic of 10 (1x10) capsules in a blister,

Slovenia supplied in a box

YES YES

Jadran - Galenski laboratorij d.d.,

Folacin tablets Pulac bb, Rijeka, Republic of 20 tablets in a PE vial, supplied in a YES

Croatia carton box

YES

Forane inhalation liquid Abbott Laboratories Ltd, Box with 100 mL of liquid in an amber Queenborough, Great Britain glass bottle YES YES

Forteo 20 micrograms/80

microliters, solution for injection solution for injection Lilly France S.A.S., Rue du

Pen-injector containing 3 mL of

solution (750 µg teriparatide) in a YES YES

in a pre-filled pen-injector Colonel Lilly, Fegersheim, France glass cartridge

Fortral solution for injection 30 Krka d.d., Novo mesto, Republic mg/1 mL solution for injection of Slovenia in cooperation with

10 ampoules each containing 1 mL of

Sanofi, France solution, supplied in a box

YES YES

Krka d.d., Novo mesto, Republic

Fortral tablets 50 mg tablets of Slovenia in cooperation with 100 tablets in an amber glass bottle, YES

Sanofi, France supplied in a box

YES

Fortrans powder for oral solution powder for oral solution Beaufor Ipsen Industrie, Dreux,

4 bags (LDPE/Al/paper) each with

France 73.69 g of powder for oral solution, YES YES supplied in a box

Merck Sharp & Dohme B.V.,

Fortzaar film coated tablets Waarderweg 39, Postbus 581, 31 (2x14) film coated tablets in a YES YES

Haarlem, the Netherlands blister, supplied in a carton box

Merck Sharp & Dohme B.V.,

Fosamax T tablets Waarderweg 39, Postbus 581, Box with 4 tablets (blister, 1 x 4 tbl.) YES YES YES

Haarlem, the Netherlands

Merck Sharp & Dohme B.V., 4 (1x4) tablets in a blister (Al/Al) in a

Fosavance tablets tablets Waarderweg 39, Postbus 581, carton casing (with a leaflet), supplied YES YES YES

Haarlem, the Netherlands in a box

14509/1/11 REV 1 WS/jj 278

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Fraxiparine 2850 IU AXa/0.3 mL Glaxo Wellcome Production, injection subcutaneous injection Notre Dame de Bondeville, Box with 10 syringes with a needle YES YES France containing 0.3 mL of solution

Fraxiparine 3800 IU AXa/0.4 mL Glaxo Wellcome Production, injection subcutaneous injection Notre Dame de Bondeville, Box with 10 syringes with a needle YES France containing 0.4 mL of solution

YES

Fraxiparine 5700 IU AXa/0.6 mL Glaxo Wellcome Production, Box with 10 syringes with a needle

injection subcutaneous injection Notre Dame de Bondeville, YES YES France containing 0.6 mL of solution

Fraxiparine 7600 IU AXa/0.8 mL Glaxo Wellcome Production, injection subcutaneous injection Notre Dame de Bondeville,

Box with 10 syringes with a needle

France containing 0.8 mL of solution

YES YES

Fraxiparine 9500 IU AXa/1 mL Glaxo Wellcome Production, injection subcutaneous injection Notre Dame de Bondeville, Box with 10 syringes with a needle YES YES France containing 1 mL of solution

Krka d.d., Šmarješka cesta 6,

Fromilid 250 tablets film coated tablets Novo mesto, Republic of 14 tablets (2x7) in A/PVC/PVDC YES YES

Slovenia blister, supplied in a box

Krka d.d., Šmarješka cesta 6,

Fromilid 500 tablets film coated tablets Novo mesto, Republic of 14 tablets (2x7) in A/PVC/PVDC

Slovenia blister, supplied in a box

YES YES

25 grams of granules for the

Fromilid 125 mg/5 mL granules Krka d.d., Šmarješka cesta 6, preparation of 60 mL of oral

for oral suspension granules for oral suspension Novo mesto, Republic of suspension in a glass bottle and a 5 YES YES Slovenia mL plastic syringe for oral dose

delivery, supplied in a box

Fromilid uno prolonged-release Krka d.d., Šmarješka cesta 6, tablets 500 mg prolonged-release tablets Novo mesto, Republic of

14 (2x7) tablets in a PVC/PVDC//Al

Slovenia blister, supplied in a box

YES YES

Fromilid uno 500 mg tablets with Krka d.d., Šmarješka cesta 6, prolonged release prolonged release tablets Novo mesto, Republic of 5 (1x5) tablets in a PVC/PVDC//Al YES Slovenia blister, supplied in a box

YES

FSME Immun inject, inactivated Box with 1 pre-filled syringe with 1

vaccine against viral tick-borne intramuscular suspension Baxter AG, Industriestrasse 67, meningoencephalitis A-1220 Vienna, Austria

dose of vaccine (0.5 mL susp), with a YES YES

needle

FSME-IMMUN 0.25 mL Junior suspension for injection Baxter AG, Industriestrasse 67,

Pre-filled syringe with needle

A-1220 Vienna, Austria containing one 0.25 mL of vaccine YES YES dose, supplied in a box

Bosnalijek d.d., Jukićeva 53,

Funzol capsules 100 mg capsules Sarajevo, Bosnia and 7 (1x7) capsules in (PVC/PVDC/Al) YES

Herzegovina blister, supplied in a box

YES

Bosnalijek d.d., Jukićeva 53,

Funzol capsules 150 mg capsules Sarajevo, Bosnia and One (1x1) capsule in a PVC/PVDC/Al YES YES

Herzegovina blister supplied in a box

Bosnalijek d.d., Jukićeva 53,

Funzol capsules 50 mg capsules Sarajevo, Bosnia and 7 (1x7) capsules in (PVC/PVDC/Al) YES YES

Herzegovina blister, supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Fursemid 20 mg/2 mL injection solution for injection Ulica Danica 5, Koprivnica, 5 ampoules each with 2 mL of solution

Republic of Croatia in a plastic holder, supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Fursemid 40 mg tablets tablets Ulica Danica 5, Koprivnica, 12 (1x12) tablets in a blister, supplied

Republic of Croatia in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Fursemid 40 mg tablets tablets Ulica Danica 5, Koprivnica, 20 (1x20) tablets in a blister, supplied

Republic of Croatia in a box

YES YES

14509/1/11 REV 1 WS/jj 279

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Belupo, lijekovi i kozmetika d.d.,

Fursemid forte 500 mg tablets tablets Ulica Danica 5, Koprivnica, 20 (2x10) tablets in PVC/Al blister ,

Republic of Croatia supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Gabalept capsules 100 mg capsules Vukovara 49, Zagreb, Republic of 20 (2x10) capsules in a blister,

Croatia supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Gabalept capsules 300 mg capsules Vukovara 49, Zagreb, Republic of 50 (5x10) capsules in a blister,

Croatia supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Gabalept capsules 400 mg capsules Vukovara 49, Zagreb, Republic of 50 (5x10) capsules in a blister,

Croatia supplied in a box

YES YES

7.5 mL of solution in a glass syringe, 5

Gadovist 1.0 mmol/mL injection solution for injection Schering AG, Muellerstrasse 170-178, Berlin, Germany syringes individually packed in a YES YES YES

blister, supplied in a box

Gadovist 1.0 mmol/mL solution Schering AG, Muellerstrasse 15 mL of solution in a glass bottle, 10

for injection solution for injection 170-178, Berlin, Germany bottles in a box YES YES YES

Bottle with lyophilisate, bottle with 192

lyophilisate and solvent for mL of diluent, sterile set for

Gammagard S/D 10 g preparation of solution for Baxter S.A, Hyland Immuno, lyophilisate dissolution, and sterile YES YES

intravenous infusion Lessines, Belgium application kit used with a filter,

supplied in a box

lyophilisate and diluent for Bottle with lyophilisate, bottle with 50

Gammagard S/D 2.5 g preparation of solution for Baxter S.A, Hyland Immuno, mL of diluent, sterile kit for lyophilisate

intravenous infusion Lessines, Belgium reconstitution, and one sterile kit for

YES YES

use with filter, supplied in a box

lyophilisate and diluent for Botle with lyophilisate, bottle with 96

Gammagard S/D 5 g preparation of solution for Baxter S.A, Hyland Immuno, mL of diluent, sterile kit for lyophilisate

intravenous infusion Lessines, Belgium reconstitution, and sterile kit for use

YES YES

with filter, supplied in a box

Allergan Pharmaceuticals 3 mL of solution in a 5 mL plastic

GANFORT eye drops eye drops, solution Republic of Ireland, Castlebar (LDPE) bottle with dropper attachment Road, Westport, Co Mayo, and plastic (HDPE) temper-proof YES YES YES

Republic of Ireland closure, 1 bottle in a box

Schering-Plough Labo N.V.

Garasone eye/nasal drops eye/nasal drops Industrepark 30, Heist-op-den 5 mL of solution in a plastic (10 mL) YES YES

Berg, Belgium bottle with a dropper

GARDASIL, suspension for

injections in a pre-filled syringe, Pre-filled glass syringe (glass type I) vaccine against human suspension for injections in Merck Sharp & Dohme B.V., with 0.5 mL of suspension for injection,

papillomavirus [type 6, 11, 16, a pre-filled syringe

Waarderweg 39, Postbus 581,

Haarlem, the Netherlands a needle with protective mechanism,

YES YES YES YES YES

18] (recombinant, absorbed) and two needles, supplied in a box

GARDASIL, suspension for

injection, human papillomavirus Merck Sharp & Dohme B.V., vaccine [types 6, 11, 16, 18] suspension for injection Waarderweg 39, Postbus 581, Tyle 1 glass ampoule containing 0.5 YES YES YES YES YES

(recombinant, absorbed) Haarlem, the Netherlands

mL of suspension, supplied in a box

Pliva Croatia Ltd., Ulica grada

Gastal tablets peppermint tablets Vukovara 49, Zagreb, Republic of 24 (4x6) tablets in a blister, supplied in YES YES YES

Croatia a box

Pliva Croatia Ltd., Ulica grada

Gastal tablets spearmint tablets Vukovara 49, Zagreb, Republic of 24 (4x6) tablets in a blister, supplied in YES

Croatia a box

YES YES

Pliva Croatia Ltd., Ulica grada

Gastal tablets, sour cherry tablets Vukovara 49, Zagreb, Republic of 24 (4x6) tablets in a blister, supplied in

Croatia a box

YES YES YES

100 mL of solution in an amber glass

Gastrografin solution solution Berlimed S.A., Madrid, Spain bottle with plastic cap, supplied in a YES YES

box

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ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Gemzar 1 g powder for solution powder for solution for Lilly France S.A.S., Rue du One glasss vial with lyophilisate,

for infusion infusion Colonel Lilly, Fegersheim, France supplied in a box YES YES

Gemzar 200 mg powder for powder for solution for Lilly France S.A.S., Rue du One glasss vial with lyophilisate,

solution for infusion infusion Colonel Lilly, Fegersheim, France supplied in a box YES YES

powder and diluent for 5 two-part glass cartridges with

Genotropin 5.3 mg solution for subcutaneous Pfizer Health AB, Stockholm, lyophilisate (front part (I) and solvent

injection Sweden (rear part (II)) in a plastic container,

YES YES

supplied in a box

Gentamicin 120 mg/2 mL Belupo, lijekovi i kozmetika d.d., injection solution for injection Ulica Danica 5, Koprivnica,

10 ampoules each containing 2 mL of

Republic of Croatia solution, supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Gentamicin 20 mg/2 mL injection solution for injection Ulica Danica 5, Koprivnica, 10 ampoules each containing 2 mL of YES

Republic of Croatia solution, supplied in a box

YES

Belupo, lijekovi i kozmetika d.d.,

Gentamicin 40 mg/2 mL injection solution for injection Ulica Danica 5, Koprivnica, 10 ampoules each containing 2 mL of

Republic of Croatia solution, supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Gentamicin 80 mg/2 mL injection solution for injection Ulica Danica 5, Koprivnica, 10 ampoules each containing 2 mL of YES YES

Republic of Croatia solution, supplied in a box

Bosnalijek d.d., Jukićeva 53,

Gentamicin injection 120 mg solution for injection Sarajevo, Bosnia and 50 amber glass ampoules each with 2

Herzegovina mL of solution, supplied in a box

YES YES

Farmal d.d., Ludbreg, Republic of

Gentamicin injection 120 mg/2 10 ampoules each containing 2 mL of

mL solution for injection

Croatia in cooperation with Lek

d.d., Ljubljana, Republic of solution, supplied in a box YES YES

Slovenia

Bosnalijek d.d., Jukićeva 53,

Gentamicin injection 40 mg solution for injection Sarajevo, Bosnia and 50 amber glass ampoules each with 2

Herzegovina mL of solution, supplied in a box

YES YES

Farmal d.d., Ludbreg, Republic of

Gentamicin injection 40 mg/2 mL solution for injection Croatia in cooperation with Lek 10 ampoules each containing 2 mL of d.d., Ljubljana, Republic of solution, supplied in a box YES YES

Slovenia

Bosnalijek d.d., Jukićeva 53,

Gentamicin injection 80 mg solution for injection Sarajevo, Bosnia and 50 amber glass ampoules each with 2 YES

Herzegovina mL of solution, supplied in a box

YES

Farmal d.d., Ludbreg, Republic of

Gentamicin injection 80 mg/2 mL solution for injection Croatia in cooperation with Lek 10 ampoules each containing 2 mL of d.d., Ljubljana, Republic of solution, supplied in a box YES YES

Slovenia

Jadran - Galenski laboratorij d.d., 10 amber glass ampoules each

Gentamicin Jadran 120 solution for injection Pulac bb, Rijeka, Republic of containing 2 mL of solution, supplied YES YES

Croatia in a box

Jadran - Galenski laboratorij d.d., 10 amber glass ampoules each

Gentamicin Jadran 40 solution for injection Pulac bb, Rijeka, Republic of containing 2 mL of solution, supplied YES YES

Croatia in a box

Jadran - Galenski laboratorij d.d., 10 amber glass ampoules each

Gentamicin Jadran 80 solution for injection Pulac bb, Rijeka, Republic of containing 2 mL of solution, supplied YES YES

Croatia in a box

Pliva Croatia Ltd., Ulica grada

Geokorton ointment 20 g ointment Vukovara 49, Zagreb, Republic of Aluminium tube with 20 g of ointment,

Croatia supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 281

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pliva Croatia Ltd., Ulica grada

Geomycin capsules Vukovara 49, Zagreb, Republic of 16 (2x8) capsules in a PVC/Al blister, YES

Croatia supplied in a box

YES

Pliva Croatia Ltd., Ulica grada

Geonistin vaginal tablets Vukovara 49, Zagreb, Republic of 6 (2x3) tablets in a blister (PVC/Al),

Croatia supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Ginkgo film-tablets film coated tablets Ulica Danica 5, Koprivnica, 30 (1x30) tablets in a blister, supplied YES YES YES

Republic of Croatia in a box

Glibenclamid Genericon 3.5 mg Genericon Pharma Ges.m.b.H, 30 (3x10) tablets in a PVC/Al blister ,

tablets tablets Lannach, Austria supplied in a box YES YES

Glibenclamid Genericon 3.5 mg 120 (12x10) tablets in a blister

tablets tablets

Genericon Pharma Ges.m.b.H,

Lannach, Austria (PVC/Al), supplied in a box YES YES

Glivec 100 mg film coated

tablets film coated tablets

Novartis Pharma GmbH, 60 (6x10) tablets in a blister (PVC/Al),

Nurnberg, Germany supplied in a box YES YES YES YES

Novartis Pharma Stein AG,

Glivec 100 mg capsules hard capsules Schaffhauserstrasse, Stein, 120 (10x12) capsules in a blister YES YES

Switzerland (PVC/Al), supplied in a box

YES YES

Glivec 100 mg capsules capsules Novartis Pharma A.G., Basel, 120 (10x12) capsules in a blister, Switzerland supplied in a box YES YES YES YES

Glivec 400 mg film coated Novartis Pharma GmbH, 30 (3x10) tablets in a

tablets film coated tablets Nurnberg, Germany PVC/PE/PVDC/Al blister, supplied in a YES YES YES YES box

Glivec 50 mg capsules capsules Novartis Pharma A.G., Basel, 30 (3x10) capsules in a blister, Switzerland supplied in a box YES YES YES YES

Novartis Pharma Stein AG,

Glivec 50 mg capsules hard capsules Schaffhauserstrasse, Stein, 30 (3x10) capsules in a blister YES YES YES YES

Switzerland (PVC/Al), supplied in a box

GlucaGen HypoKit powder and diluent for Novo Nordisk A/S, Novo Allé,

One glass vial with lyophilisate and

solution for injection DK-2880 Bagsvaerd, Denmark one glass syringe with needle (1 mL YES YES of diluent), in a plastic container

Glucobay 100 mg tablets tablets Bayer HealthCare AG, 51368 30 tablets (2x15) in a blister Leverkusen, Germany (polypropylene/Al), supplied in a box YES YES

Glucobay 50 mg tablets tablets Bayer HealthCare AG, 51368 32 (2x15) capsules in a PVC/Al blister, Leverkusen, Germany supplied in a box YES YES

Merck SANTE s.a.s., Centere de

Production de Semoy, 2 Rue du

Glucomerck 1000 mg film coated Pressior Vert - 45400 Semoy, 60 (4x15) film coated tablets in a tablets film coated tablets France; Merck KGcA, Frankfurt transparent blister (PVC/Al), supplied YES YES Strasse 250, 64293 Darmstadt, in a box

Germany

Merck SANTE s.a.s., Centere de

Production de Semoy, 2 Rue du

Glucomerck 500 mg film coated 100 (5x20) film coated tablets in tablets film coated tablets

Pressior Vert - 45400 Semoy,

France; Merck KGcA, Frankfurt transparent blister (PVC/Al), supplied YES YES Strasse 250, 64293 Darmstadt, in a box

Germany

Merck SANTE s.a.s., Centere de

Glucomerck 850 mg film coated Production de Semoy, 2 Rue du 30 (2x15) film coated tablets in a tablets film coated tablets Pressior Vert - 45400 Semoy, transparent PVC/Al blister, supplied in YES YES France; Merck KGcA, Frankfurt a box

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ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Strasse 250, 64293 Darmstadt,

Germany

Glucophage 1000 mg film coated Merck SANTE s.a.s./Centre de 30 (3x10) film coated tablets in a

tablets film coated tablets Production de Semoy, France transparent blister (PVC/A1), supplied YES YES YES YES Merck KGaA, Germany in a box

Glucophage 500 mg film coated Merck SANTE s.a.s./Centre de 50 (5x10) film coated tablets in a

tablets film coated tablets Production de Semoy, France transparent blister (PVC/Al), supplied YES YES YES YES Merck KGaA, Germany in a box

Glucophage 850 mg tablets film coated tablets Merck Sante s.a.s., Lyon CEDEX 30 (2x15) tablets in a blister, supplied 08, France in a box YES YES YES YES

Glucovance 500 mg/ 2.5 mg Merck SANTE s.a.s., 2 Rue du tablets film coated tablets Pressoir Vert - 45400 Semoy, 30 (2x15) tablets in a blister (PVC/Al), YES France supplied in a box

YES

Glucovance 500 mg/ 5 mg Merck SANTE s.a.s., 2 Rue du 30 (2x15) tablets in a PVC/Al blister,

tablets film coated tablets Pressoir Vert - 45400 Semoy, YES YES France supplied in a box

Pliva Croatia Ltd., Ulica grada

Gluformin 850 mg tablets film coated tablets Vukovara 49, Zagreb, Republic of 35 (3x10) tablets in a PVC/PVdC/Al

Croatia blister, supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Gluformin tablets1g film coated tablets Vukovara 49, Zagreb, Republic of 30 (2x15) tablets in a PVC/Al blister,

Croatia supplied in a box

YES YES

Hrvatski zavod za transfuzijsku 100 mL of solution in an infusion

Glukosalina I solution , 100mL solution for intravenous bottle with rubber stopper protected by infusion medicinu, Petrova 3, Zagreb,

Republic of Croatia Al cap and plastic lid, 10 bottles with

YES YES

holders in a carton box

250-mL of solution in an infusion bottle

Glukosalina I solution for solution for intravenous Hrvatski zavod za transfuzijsku intravenous infusion, 250mL infusion medicinu, Petrova 3, Zagreb, with rubber stopper and protective Al YES YES

Republic of Croatia cap with plastic lid (10 bottles with holders, supplied in a carton box)

500 mL of solution in an infusion bottle

Glukosalina I solution for solution for intravenous Hrvatski zavod za transfuzijsku with a rubber stopper and an

intravenous infusion, 500mL infusion medicinu, Petrova 3, Zagreb, aluminium cap with a plastic lid (10 YES YES Republic of Croatia bottles with holders, supplied in a

carton box)

500 mL of solution in an infusion

Glukosalina III solution for solution for intravenous Hrvatski zavod za transfuzijsku bottle with a rubber stopper and an

intravenous infusion infusion medicinu, Petrova 3, Zagreb, aluminium cap with a plastic lid (10 YES YES Republic of Croatia bottles with holders, supplied in a

carton box)

B. Braun Melsungen AG, Carl

Glucose 10% Braun solution for infusion Braun-Straße 1, Melsungen, 500 mL of solution for infusion in a YES YES

Germany plastic bottle (10 bottles in a box)

B. Braun Melsungen AG, Carl

Glucose 10% Braun solution for infusion Braun-Straße 1, Melsungen, 1000 mL of infusion solution in a YES YES

Germany plastic bottle (10 bottles in a box)

Glucose 10% solution for Hrvatski zavod za transfuzijsku

intravenous infusion, 100 mL solution for infusion medicinu, Petrova 3, Zagreb, 100 mL of solution in a glass bottle YES YES Republic of Croatia

Glucose 10% solution for Hrvatski zavod za transfuzijsku

intravenous infusion, 250 mL solution for infusion medicinu, Petrova 3, Zagreb, 250-mL of solution in a glass bottle YES YES Republic of Croatia

Glucose 10% solution for Hrvatski zavod za transfuzijsku

intravenous infusion, 500 mL solution for infusion medicinu, Petrova 3, Zagreb, 500 mL of solution in a glass bottle YES YES Republic of Croatia

14509/1/11 REV 1 WS/jj 283

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Glucose 10% Pliva solution for solution for intravenous Pliva Croatia Ltd., Ulica grada 12 PVC bags with 500 mL of solution,

infusion infusion Vukovara 49, Zagreb, Republic of YES YES Croatia supplied in a box

250-mL of solution in a glass infusion

Glucose 10% Pliva solution for solution for intravenous Pliva Croatia Ltd., Ulica grada bottle with rubber stopper and combiinfusion

250 mL infusion Vukovara 49, Zagreb, Republic of YES Croatia cap (10 bottles with polyethylene YES

holder supplied in a box)

Glucose 10% Pliva solution for solution for intravenous Pliva Croatia Ltd., Ulica grada infusion 500mL infusion Vukovara 49, Zagreb, Republic of 10 glass vials with 500 mL of solution, YES Croatia supplied in a box

YES

Baxter S.A., Belgium; Baxter

Healthcare Ltd, Great Britain; 30 plastic Viaflo bags with 250 mL of

Glucose 5 %, Viaflo solution for infusion Bieffe Medital Sabinanigo, Spain; solution for infusion in a protective YES YES

Baxter Healthcare S.A., Republic bag, supplied in a box

of Ireland

Baxter S.A., Belgium; Baxter

Healthcare Ltd, Great Britain; 10 plastic Viaflo bags with sa 1000 mL

Glucose 5 % Viaflo solution for infusion Bieffe Medital Sabinanigo, Spain; of infusion solution, in a protective bag, YES YES

Baxter Healthcare S.A., Republic supplied in a box

of Ireland

Baxter S.A., Belgium; Baxter

Healthcare Ltd, Great Britain; 50 plastic Viaflo bags with 50 mL of

Glukose 5 %, Viaflo solution for infusion Bieffe Medital Sabinanigo, Spain; solution for infusion in a protective YES YES

Baxter Healthcare S.A., Republic bag, supplied in a box

of Ireland

Baxter S.A., Belgium; Baxter

Healthcare Ltd, Great Britain; 50 plastic bags Viaflo with 100 mL of

Glucose 5 %, Viaflo solution for infusion Bieffe Medital Sabinanigo, Spain; solution for infusion, in a protective YES YES

Baxter Healthcare S.A., Republic bag, supplied in a box

of Ireland

Baxter S.A., Belgium; Baxter

Healthcare Ltd, Great Britain; 20 plastic Viaflo bags with 500 mL of

Glucose 5 % Viaflo solution for infusion Bieffe Medital Sabinanigo, Spain; infusion solution, in a protective bag, YES YES

Baxter Healthcare S.A., Republic supplied in a box

of Ireland

Hrvatski zavod za transfuzijsku

Glucose 5% solution for infusion medicinu, Petrova 3, Zagreb, 500 mL of solution in a glass bottle YES YES

Republic of Croatia

Hrvatski zavod za transfuzijsku

Glucose 5% solution for infusion medicinu, Petrova 3, Zagreb, 100 mL of solution in a glass bottle YES YES

Republic of Croatia

Hrvatski zavod za transfuzijsku

Glucose 5% solution for infusion medicinu, Petrova 3, Zagreb, 250-mL of solution in a glass bottle YES YES

Republic of Croatia

B. Braun Melsungen AG, Carl

Glucose 5% Braun solution for infusion Braun-Straße 1, Melsungen, 1000 mL of infusion solution in a YES

Germany plastic bottle (10 bottles in a box)

YES

B. Braun Melsungen AG, Carl

Glucose 5% Braun solution for infusion Braun-Straße 1, Melsungen, 250-mL of solution for infusion in a

Germany plastic bottle (10 bottles in a box)

YES YES

B. Braun Melsungen AG, Carl

Glucose 5% Braun solution for infusion Braun-Straße 1, Melsungen, 500 mL of solution for infusion in a YES YES

Germany plastic bottle (10 bottles in a box)

B. Braun Melsungen AG, Carl

Glucose 5% Braun solution for infusion Braun-Straße 1, Melsungen, 100 mL of infusion solution in a plastic

Germany bottle (20 bottles in a box)

YES YES

Pliva Croatia Ltd., Ulica grada 500 mL of solution in a PVC bag, with

Glucose 5% Pliva solution for infusion Vukovara 49, Zagreb, Republic of a draining attachment (closed with

Croatia combiflack stopper) and an application

YES YES

attachment, 12 bags in a box

14509/1/11 REV 1 WS/jj 284

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pliva Croatia Ltd., Ulica grada 500 mL of solution in a glass infusion

Glucose 5% Pliva solution for infusion Vukovara 49, Zagreb, Republic of bottle with a rubber stopper and a YES YES

Croatia protective cap, 10 bottles in a box

Glurenorm 30 mg tablets tablets Boehringer Ingelheim Ellas A.E., 60 (6x10) tablets in a white blister Atena, Greece (PVC/PVDC//Al), supplied in a box YES YES

powder and diluent (in a

GONAL-f 1050 IU/1.75 mL syringe) for solution for Industria Farmaceutica Serono Vial with powder and syringe with 2 mL

injection S.p.A., Bari, Italy of diluent, supplied in a box

YES YES YES

Pen-syringe with 0.5 mL of solution (in

GONAL-f 300 IU/0.5 mL solution for injection in pen Industria Farmaceutica Serono a 3-mL glass cartridge) and 5 needles syringe S.p.A., Bari, Italy in a plastic container, supplied in a YES YES YES

box

powder and diluent (in a

GONAL-f 450 IU/0.75 mL syringe) for solution for Industria Farmaceutica Serono Vial with powder and syringe with 1 mL

injection S.p.A., Bari, Italy of diluent, supplied in a box

YES YES YES

Pen-syringe with 0.75 mL of solution

GONAL-f 450 IU/0.75 mL solution for injection in pen Industria Farmaceutica Serono (in a 3-mL glass cartridge) and 7 syringe S.p.A., Bari, Italy needles in a plastic container, YES YES YES

supplied in a box

powder and diluent (in a Vial with powder and syringe with 1

GONAL-f 75 IU syringe) for solution for Industria Farmaceutica Serono YES YES YES

injection S.p.A., Bari, Italy

mL of diluent in a plastic container,

supplied in a box

Pen syringe with 1.5 mL of solution (in

GONAL-f 900 IU/1.5 mL solution for injection in pen Industria Farmaceutica Serono a 3-mL glass cartridge) and 14 syringe S.p.A., Bari, Italy needles in a plastic container, supplied YES YES YES

in a box

Gopten 0.5 mg capsules capsules Abbott GmbH & Co. KG, 50 (5x10) capsules in a blister, Ludwigshafen, Germany supplied in a box YES YES

Gopten 2 mg capsules capsules Abbott GmbH & Co. KG, 28 (2x14) capsules in a blister, Ludwigshafen, Germany supplied in a box YES YES

Gopten 4 mg capsules capsules Abbott GmbH & Co. KG, 28 (2x14) capsules in a blister, Ludwigshafen, Germany supplied in a box YES YES

STADA Arzneimittel AG,

Grippostad C capsules Stadtstraße 2-18, Bad Vilbel, 20 (2x10) capsules in a blister

Germany (PVC/PVDC-Al), supplied in a box

YES YES YES

STADA Arzneimittel AG, 90 mL of syrup in a glass bottle with a

Grippostad Good Night syrup syrup Stadtstraße 2-18, Bad Vilbel, plastic temper-evident stopper (white YES YES YES

Germany PP/PE), supplied in a box

STADA Arzneimittel AG,

Grippostad hot drink effervescent powder Stadtstraße 2-18, Bad Vilbel, 10 bags (Al/paper/PE) each containing YES YES

Germany 5.0 g of powder, supplied in a box

YES

Glass vial with powder, glass vial with

Haemate P 500 powder and diluent for

ZLB Behring GmbH, Emil-vonsolution

for injection/infusion Behring Str. 76, Marburg,

10 mL of Water for Injection, transfer YES YES

Germany kit, and disposable filter, supplied in a box

Krka d.d., Novo mesto, R.

Haldol depo solution for injection oily solution for Republic of Slovenia in 5 brown ampoules (in a blister) each

50 mg/1 mL intramuscular injection cooperation with Janssen with 1 mL of solution, supplied in a box YES YES

Pharmaceutica, Beerse, Belgium

Krka d.d. , Novo mesto, Republic

Haldol 10 mg/1 mL oral drops oral drops of Slovenia in cooperation with 30 mL of solution in an amber glass Janssen Pharmaceutica, Beerse, bottle, supplied in a box YES YES

Belgium

14509/1/11 REV 1 WS/jj 285

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Krka d.d. , Novo mesto, Republic

Haldol oral drops 2 mg/1 mL oral drops of Slovenia in cooperation with 10 mL of solution in an amber glass Janssen Pharmaceutica, Beerse, bottle, supplied in a box YES YES

Belgium

Haldol solution for injection 5 solution for injection for

Krka d.d., Novo mesto, R. 10 (2x5) ampoules each containing 1

mg/1 mL intramuscular and

Republic of Slovenia in YES

intravenous use cooperation with Janssen

mL solution in a blister, supplied in a YES

Pharmaceutica, Beerse, Belgium box

Krka d.d., Novo mesto, R.

Haldol 10 mg tablets tablets Republic of Slovenia in 30 tablets in an amber glass bottle, cooperation with Janssen supplied in a box YES YES

Pharmaceutica, Beerse, Belgium

Krka d.d. , Novo Mesto, R.

Haldol tablets 2 mg tablets Republic of Slovenia in 25 tablets in an amber glass bottle, cooperation with Janssen supplied in a carton box YES YES

Pharmaceutica, Beerse, Belgium

Belupo, lijekovi i kozmetika d.d.,

Halea 100 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 30 (2x15) tablets in a blister, supplied

Republic of Croatia in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Halea 50 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 30 (2x15) tablets in a blister, supplied YES

Republic of Croatia in a box

YES

Alkaloid AD - Skopje, Bulevar

Heferol capsules Aleksandar Makedonski 12, 30 capsules in a bottle, supplied in a

Skopje, FYROM box

YES YES

75 mg of 13 C-urea in a polystyrene

container with a closed polyethylene

Helicobacter test INFAI for INFAI Institut für Biomedizinische "snap" stopper; equipment for

infrared spectroscopy oral powder Analytik & NMR Imaging GmbH, sampling and transfer of samples of YES YES YES Bochum, Germany expired air (4 glass "vacutainer" test

tubes or plastic"vacuette" of 10 mL

and 1 flexible straw), inserted in a box

50 polystyrene jars with polyethylene

snap cap containing 75 mg 13C-urea

Helicobacter test INFAI for powder for preparation of INFAI Institut für Biomedizinische powder for oral solution, with a kit for

infrared spectroscopy oral solution Analytik & NMR Imaging GmbH, sampling and transporting of breath YES YES YES Bochum, Germany samples, 50x2 bags with plastic

attachments, and 50x1 bendable

plastic straws, supplied in a box

75 mg of 13 C-urea in a polystyrene

container with a closed polyethylene

Helicobacter test INFAI for mass INFAI Institut für Biomedizinische "snap" stopper; equipment for

spectrometry powder for oral solution Analytik & NMR Imaging GmbH, sampling and transfer of samples of YES YES YES Bochum, Germany expired air (4 glass "vacutainer" test

tubes or plastic"vacuette" of 10 mL

and 1 flexible straw), inserted in a box

Glass bottle with lyophilisate and a

Hemofil M 250 IU human lyophilisate and solvent for glass bottle with 10 m of solvent, coagulation factor VIII, preparation of intravenous Baxter S.A., Hyland Immuno, sterile double dissolution needle, YES YES

monoclonally purified solution (injection/infusion) Lessines, Belgium sterile filter needle, sterile mini infusion kit, sterile disposable syringe of 10 mL,

supplied in a box

Glass bottle with lyophilisate and a

Hemofil M 500 IU human lyophilisate and solvent for glass bottle with 10 m of solvent, coagulation factor VIII, preparation of intravenous Baxter S.A., Hyland Immuno, sterile double dissolution needle, monoclonally purified solution (injection/infusion) Lessines, Belgium sterile filter needle, sterile mini infusion

YES YES

kit, sterile disposable syringe of 10 mL,

supplied in a box

Hemofil M 500 IU human lyophilisate and solvent for Glass bottle with lyophilisate and a coagulation factor VIII, preparation of intravenous Baxter S.A., Hyland Immuno, glass bottle with 10 m of solvent, monoclonally purified solution (injection/infusion) Lessines, Belgium sterile double dissolution needle,

YES YES

sterile filter needle, sterile mini infusion

14509/1/11 REV 1 WS/jj 286

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

kit, sterile disposable syringe of 10 mL,

supplied in a box

Jadran - Galenski laboratorij d.d.,

Hepan gel gel Pulac bb, Rijeka, Republic of Box with 50 g of gel in an Al tube YES YES YES

Croatia

Jadran - Galenski laboratorij d.d.,

Hepan cream cream Pulac bb, Rijeka, Republic of Box with 50 g of cream in an Al tube YES YES YES

Croatia

Belupo, lijekovi i kozmetika d.d., 5 mL of solution in a glass bottle (with

HEPARIN injection solution for injection (for s.c. and i.v. use) Ulica Danica 5, Koprivnica, a rubber stopper and an Al cap), 10 YES YES

Republic of Croatia bottles in a box

Heptanon injection solution for intramuscular

Pliva Croatia Ltd., Ulica grada

and subcutaneous injection Vukovara 49, Zagreb, Republic of

50 ampoules with 1 mL of solution,

Croatia supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada 10 mL of solution in an amber glass

Heptanon drops oral drops, solution Vukovara 49, Zagreb, Republic of bottle with plastic dropper attachment, YES YES

Croatia supplied in a box

Pliva Croatia Ltd., Ulica grada 100 mL of solution in a 125-mL brown

Heptanon solution oral solution Vukovara 49, Zagreb, Republic of plastic bottle with aluminum cap, YES YES

Croatia supplied in a box

Pliva Croatia Ltd., Ulica grada

Heptanon tablets tablets Vukovara 49, Zagreb, Republic of 20 (2x10) tablets in a blister, supplied YES YES

Croatia in a box

HERCEPTIN 150 mg powder for F. Hoffmann-La Roche Ltd.,

concentrate for solution for powder for concentrate for One glass vial with powder, supplied in infusion solution for infusion

Grenzacherstrasse 124, Basel, YES YES YES YES

Switzerland a box

Hermes Cevitt lemon effervescent powder Hermes Arzneimittel GmbH, 20 effervescent tablets in a München, Germany polypropylene tube YES YES YES

Hermes Cevitt naranca effervescent powder Hermes Arzneimittel GmbH, 20 effervescent tablets in a München, Germany polypropylene tube YES YES YES

Belupo, lijekovi i kozmetika d.d.,

Herplex 400 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 35 (7x5) tablets in a PVC/Al blister, YES YES

Republic of Croatia supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Herplex 400 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 35 (7x5) tablets in a PVC/Al blister, YES YES

Republic of Croatia supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Herplex cream cream Ulica Danica 5, Koprivnica, 2 grams of cream in a tube, supplied in YES YES YES

Republic of Croatia a box

Hiberix vaccine against GlaxoSmithKline Biologicals s.a., Box with one bottle wtih 1 dose of

Haemophilus influenzae type B, lyophilisate Rue de lInstitut 89, Rixensart, lyophilised vaccine and 1 syringe with YES YES

glycoconjugated Belgium solvent and 2 needles

Pliva Croatia Ltd., Ulica grada

Hiramicin capsules Vukovara 49, Zagreb, Republic of 5 (1x5) capsules in a blister, supplied

Croatia in a box

YES YES

Jadran - Galenski laboratorij d.d.,

Holyplant Purgal tablets tablets Pulac bb, Rijeka, Republic of 20 (2x10) tablets in a blister, supplied

Croatia in a box

YES YES YES

Jadran - Galenski laboratorij d.d.,

Holyplant Sena tea herbal tea Pulac bb, Rijeka, Republic of 50 g of tea in a polypropylene YES YES

Croatia transparent bag, supplied in a box

YES

Jadran - Galenski laboratorij d.d.,

Holyplant Septogal oriblettes oriblettes Pulac bb, Rijeka, Republic of 30 (3x10) oriblettes in a PVC/Al blister, YES YES YES

Croatia supplied in a box

14509/1/11 REV 1 WS/jj 287

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Humaject M3 (30/70) 100 IU/mL suspension for subcutanous Lilly France S.A.S., Rue du 5 disposable injectors with glass

(3.0 mL) injection Colonel Lilly, Fegersheim, France cartridges each with 3 mL of solution, YES YES supplied in a box

5 disposable injectors with glass

Humaject N 100 IU/mL (3.0 mL) suspension for subcutanous Lilly France S.A.S., Rue du injection Colonel Lilly, Fegersheim, France cartridges each with 3 mL of solution, YES YES

supplied in a box

Humaject R 100 IU/mL (3.0 mL) suspension for Lilly France S.A.S., Rue du

5 disposable injectors with glass

subcutaneous injection Colonel Lilly, Fegersheim, France cartridges each with 3 mL of solution, YES YES supplied in a box

Humalog 100 IU/mL cartridge

(3.0 mL) solution for injection

Lilly France S.A.S., Rue du 5 cartridges with 3 mL of solution in a

Colonel Lilly, Fegersheim, France blister, supplied in a box YES YES

5 glass cartridges with 3.0 mL of

Humalog Mix25 100 IU/mL Lilly France S.A.S., Fegersheim, suspension to be administered with a

(suspension in cartridge 3.0 mL) suspension for injection France i Lilly S.A., Alcobendas YES YES Madrid, Spain pen injector, in protective packaging, YES

supplied in a box

5 injectors with a glass cartridge with

Humalog Mix25 Pen 100 IU/mL suspension for injection Lilly France S.A.S., Rue du Colonel Lilly, Fegersheim, France 3.0 mL of suspension, supplied in a YES YES YES

box

5 glass cartridges with 3.0 mL of

Humalog Mix50 100 IU/mL Lilly France S.A.S., Fegersheim, sspension to be administered with a

(suspension in cartridge 3.0 mL) suspension for injection France i Lilly S.A., Alcobendas YES Madrid, Spain pen injector, in protective packaging, YES YES

supplied in a box

Humalog Mix50 Pen 100 IU/mL suspension for injections Lilly France S.A.S., Rue du

5 injectors with a glass cartridge each

Colonel Lilly, Fegersheim, France with 3.0 mL of suspension, supplied in YES YES YES a box

Humalog Pen 100 IU/mL (3 mL) solution for injection Lilly France S.A.S., Rue du

5 injectors with a glass cartridge with 3

Colonel Lilly, Fegersheim, France mL of solution, supplied in a carton YES YES YES box

Human albumin 20% immuno 50 Box with 1 bottle containing 50 mL of

mL solution for intravenous use

Baxter AG, Industriestrasse 67,

A-1220 Vienna, Austria solution YES YES

Octapharma Pharmazeutika

HUMAN ALBUMIN 20% Produktionsges.m.b.H., Vienna, One glass vial with 100 mL of solution

OCTAPHARMA 100 mL solution for infusion Austria and Octapharma SA, for infusion, supplied in a box YES YES

Lingolsheim, France

Human Albumin 20% Octapharma Pharmazeutika Octapharma 100 mL intravenous solution Produktionsges.m.b.H., Vienna, Paper box with 1 glass bottle with YES YES Austria human albumin solution à 100 mL

Octapharma Pharmazeutika

HUMAN ALBUMIN 20% Produktionsges.m.b.H., Vienna, One glass vial containing 50 mL of

OCTAPHARMA 50 mL solution for infusion Austria and Octapharma SA, solution for infusion, supplied in a box YES YES

Lingolsheim, France

Human Albumin 20% Octapharma Pharmazeutika Paper box with 1 glass bottle with

Octapharma 50 mL intravenous solution Produktionsges.m.b.H., Vienna, Austria human albumin solution à 50 mL YES YES

Human albumin 5% immuno 250

mL solution for intravenous use

Baxter AG, Industriestrasse 67, Box with 1 bottle containing 250 mL of

A-1220 Vienna, Austria solution YES YES

Human Albumin 5% Octapharma Octapharma Pharmazeutika Paper box with 1 glass bottle with

100 mL intravenous solution Produktionsges.m.b.H., Vienna, YES YES Austria human albumin solution à 100 mL

HUMAN ALBUMIN 5% Octapharma Pharmazeutika OCTAPHARMA 100 mL solution for infusion Produktionsges.m.b.H., Vienna,

One glass vial with 100 mL of solution

Austria for infusion, supplied in a box

YES YES

Human Albumin 5% Octapharma Octapharma Pharmazeutika 250 mL intravenous solution Produktionsges.m.b.H., Vienna,

Paper box with 1 glass bottle with

Austria human albumin solution à 250 mL

YES YES

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ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

HUMAN ALBUMIN 5% Octapharma Pharmazeutika OCTAPHARMA 250 mL solution for infusion Produktionsges.m.b.H., Vienna, One glass vial with 250 mL of solution YES YES Austria for infusion, supplied in a box

One cartridge with lyophilisate, a

Humatrope 12 mg lyophilisate for injection Lilly France S.A.S., Rue du Colonel Lilly, Fegersheim, France syringe with 3.15 mL of diluent and a YES YES

diluent feed line, supplied in a box

One cartridge with lyophilisate, a

Humatrope 6 mg lyophilisate and diluent for Lilly France S.A.S., Rue du syringe with diluent, and a needle with solution for injection Colonel Lilly, Fegersheim, France protective plastic cap, supplied in a YES YES

box

Abbott Biotehnology Deutschland Pre-filled glass syringe containing 0.8

Humira solution for injection solution for injection GmbH, Max-Planck-Ring 2, mL of solution and one alcohol YES YES

Wiesbaden, Germany drenched cotton wool roll in a blister

Humulin M3 (30/70) 100 IU/mL suspension for subcutanous Lilly France S.A.S., Rue du 5 (1x5) cartridges with 3 mL of

(3.0 mLcartridge) injection Colonel Lilly, Fegersheim, France suspension per blister, supplied in a YES YES box

5 injectors with a glass cartridge each

Humulin M3 Pen 100 IU/mL suspension for Lilly France S.A.S., Rue du subcutaneous injection Colonel Lilly, Fegersheim, France with 3 mL of suspension, supplied in a YES YES YES

carton box

Humulin N 100 IU/mL (3.0 mL suspension for subcutanous Lilly France S.A.S., Rue du 5 (1x5) cartridges with 3 mL of

cartridge) injection Colonel Lilly, Fegersheim, France suspension per blister, supplied in a YES YES box

Humulin N Pen 100 IU/mL solution for subcutaneous Lilly France S.A.S., Rue du

5 injectors with a glass cartridge each

injection Colonel Lilly, Fegersheim, France with 3 mL of suspension, supplied in a YES YES YES carton box

Humulin R 100 IU/mL (cartridge solution for subcutaneous Lilly France S.A.S., Rue du 5 (1x5) cartridges with 3 mL of solution

3.0 mL) injection Colonel Lilly, Fegersheim, France per blister, supplied in a box YES YES

Dentinox Gesellschaft für

HUSTAGIL oral solution pharmazeutische Präparate Lenk 150 mL of solution an amber glass YES YES

&

Schuppan, Berlin, Germany bottle with Alu cap, supplied in a box
YES

SmithKline Beecham

Pharmaceuticals, West Sussex,

Hycamtin lyophilisate for preparation of infusion Great Britain i GlaxoSmithKline 5 glass bottles of 5 mL with YES YES

Manufacturing S.p.A., Parma, lyophilisate, supplied in a box

Italy

Hydrocyclin ointment Galenika a.d., Beograd - Zemun, 5 g of ointment in an aluminium tube, Srbija supplied in a box YES YES

Hyperici Aktiv granules granules Cedevita d.o.o., Zagreb, Republic 15 bags (paper/Al/PE) containing 5 g , of Croatia supplied in a box YES YES YES

Janssen Pharmaceutica NV,

HYPNOMIDATE solution for injection Turnhouseweg 30, Beerse, 5 ampoules with 10 mL of solution, YES YES

Belgium supplied in a box

Merck Sharp & Dohme B.V.,

Hyzaar film coated tablets Waarderweg 39, Postbus 581, 32 (2x14) film coated tablets in a YES YES

Haarlem, the Netherlands blister, supplied in a carton box

Ibuprofen 100 mg/5 mL oral Belupo, lijekovi i kozmetika d.d., suspension oral suspension Ulica Danica 5, Koprivnica,

100 mL of suspension in an amber

Republic of Croatia glass bottle, supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Ibuprofen 400 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 30 (3x10) tablets in a PVC/Al blister,

Republic of Croatia supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Ibuprofen 600 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 31 (3x10) tablets in a PVC/Al blister,

Republic of Croatia supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 289

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Belupo, lijekovi i kozmetika d.d., 30 tablets in a white polyethylene (PE)

Ibuprofen 800 mg tablets film coated tablets Ulica Danica 5, Koprivnica, bottle, with a PE screw cap, supplied YES YES

Republic of Croatia in a box

The Mentholatum Company Ltd,

Ibuprofen gel gel 1 Redwood Avenue, Peel Park 50 g of gel in an aluminium tube with a Campus, East Kilbride, Great plastic stopper, supplied in a box YES YES YES

Britain

Farmal d.d., Ludbreg, Republic of

Ibuprofen 200 mg coated tablets coated tablets Croatia in cooperation with Lek 30 (3x10) tablets in a blister, supplied d.d., Ljubljana, Republic of in a box YES YES

Slovenia

Farmal d.d., Ludbreg, Republic of

Ibuprofen 400 mg coated tablets coated tablets Croatia in cooperation with Lek 30 (3x10) tablets in a blister, supplied d.d., Ljubljana, Republic of in a box YES YES

Slovenia

Farmal d.d., Ludbreg, Republic of

Ibuprofen retard 800 mg tablets prolonged release tablets Croatia, in cooperation with Box with 30 tablets (blister, 3x10 tbl.) YES YES

Valpharma Int. s.a., San Marino

Imacort cream cream Spirig Pharma AG, Egerkingen, 20 grams of cream in an aluminum Switzerland tube, supplied in a box YES YES

Imazol cream-paste paste Spirig Pharma AG, Egerkingen, Switzerland 30 g of paste in an aluminium tube YES YES

Imazol Plus cream Spirig Pharma AG, Egerkingen, 30 g of cream in an aluminium tube, Switzerland supplied in a box YES YES

Two plastic measuring devices (for

Imigran nasal spray of 20 mg nasal spray GlaxoSmithKline S.p.A., Parma, Italy nasal spray) in a blister ,supplied in a YES YES

box

Glaxo Wellcome Operations,

Greenford, Middlesex, Great

Imigran tablets 50 mg film coated tablets Britain i GlaxoSmithKline 2 tablets in aluminum blister (Al/Al), Pharmaceuticals S.A., Ul. supplied in a carton box YES YES

Grunwaldzka 189, Poznan,

Poland

ImmuCyst, BCG lyophilisate and diluent for Sanofi Pasteur Limited, Toronto, One glass vial with BCG 81g

Immunotherapeutic agent intravesical instillation Ontario, Canada (lyophilisate) and one glass bottle with YES YES 3 mL of diluent, supplied in a box

lyophilisate and diluent for Bottle with lyophilisate, bottle with 5

Immunate 1000 IU preparation of solution for Baxter AG, Industriestrasse 67, mL of diluent, and set for dissolution

intravenous use A-1220 Vienna, Austria and injection of medicinal product,

YES YES

supplied in a box

lyophilisate and diluent for Bottle with lyophilisate, bottle with 5

Immunate 250 IU preparation of solution for Baxter AG, Industriestrasse 67, mL of diluent, and set for dissolution

intravenous use A-1220 Vienna, Austria and injection of medicinal product,

YES YES

supplied in a box

lyophilisate and diluent for Bottle with lyophilisate, bottle with 5

Immunate 500 IU preparation of solution for Baxter AG, Industriestrasse 67, mL of diluent, and set for dissolution

intravenous use A-1220 Vienna, Austria and injection of medicinal product,

YES YES

supplied in a box

lyophilisate and solvent for Lyophilisate in a glass bottle, 10 mL of

Immunine 1200 IU preparation of solution for Baxter AG, Industriestrasse 67, solvent in a glass bottle and

i.v. injection/infusion A-1220 Vienna, Austria dissolution and injection kit, supplied in

YES YES

a box

lyophilisate and solvent for Lyophilisate in a glass bottle, 5 mL of

Immunine 200 IU preparation of solution for Baxter AG, Industriestrasse 67, solvent in a glass bottle and

i.v. injection/infusion A-1220 Vienna, Austria dissolution and injection kit, supplied in

YES YES

a box

14509/1/11 REV 1 WS/jj 290

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

lyophilisate and solvent for Lyophilisate in a glass bottle, 5 mL of

Immunine 600 IU preparation of solution for Baxter AG, Industriestrasse 67, solvent in a glass bottle and

i.v. injection/infusion A-1220 Vienna, Austria dissolution and injection kit, supplied in

YES YES

a box

IMOVAX POLIO inactivated suspension for poliomyelitis vaccine intramuscular or

Sanofi Pasteur S.A., 2 avenue 0.5-mL of suspension in a glass syring,

subcutaneous injection Pont Pasteur, Lyon, France supplied in a box

YES YES

Imunološki zavod d.d.,

Human rabies immunoglobulin solution for intramuscular Bottle with 5 mL of preparation (not use Rockefellerova 2, Zagreb, YES YES

Republic of Croatia less than 500 IU), supplied in a box

Human rabies immunoglobulin solution for intramuscular

Imunološki zavod d.d.,

use Rockefellerova 2, Zagreb,

Bottle with 2 mL of preparation (not YES

Republic of Croatia less than 200 IU), supplied in a box

YES

Human hepatitis B Imunološki zavod d.d., One glass vial with 250 IU of

immunoglobulin , 250 IU solution for injection Rockefellerova 2, Zagreb, immunoglobulin, supplied in a carton YES YES Republic of Croatia box

Human hepatitis B Imunološki zavod d.d., One glass vial with 500 IU of

immunoglobulin, 500 IU solution for injection Rockefellerova 2, Zagreb, immunoglobulin, supplied in a carton YES YES Republic of Croatia box

Imunološki zavod d.d.,

Human tetanus immunoglobulin solution for intramuscular Box containing 1 ampoule of use Rockefellerova 2, Zagreb,

Republic of Croatia preparation - 250 IU/ampoule

YES YES

Human immunoglobulin for Imunološki zavod d.d., intravenous use solution for intravenous use Rockefellerova 2, Zagreb, Glass bottle with 50 mL of solution and YES YES Republic of Croatia an infusion kit, supplied in a box

Human immunoglobulin for Imunološki zavod d.d., intravenous use solution for intravenous use Rockefellerova 2, Zagreb, Glass bottle with 100 mL of solution YES Republic of Croatia and an infusion kit, supplied in a box

YES

Human immunoglobulin for Imunološki zavod d.d., Glass bottle with 10 mL of solution with

intravenous use solution for intravenous use Rockefellerova 2, Zagreb, YES YES Republic of Croatia a needle and a filter, supplied in a box

Imuran tablets film coated tablets Heumann PCS GmbH, Feucht, 100 (4 x 25) tablets in PVC/Al blister, Germany supplied in a box YES YES

Belupo, lijekovi i kozmetika d.d.,

Indamid SR tablets prolonged-release tablets Ulica Danica 5, Koprivnica, 30 (1x30) tablets in a white PVC/Al YES YES

Republic of Croatia blister , supplied in a box

INDAP capsules Pro. Med.CS Praha a.s., Prag, 30 (3x10) capsules in a blister Czech Republic (PVC/Al), supplied in a box YES YES

Indap capsules Pro. Med.CS Praha a.s., Prag, 30 (3x10) capsules in a blister, Czech Republic supplied in a box YES YES

Pliva Croatia Ltd., Ulica grada

Indapamid SR Pliva tablets prolonged-release tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in a white PVC/Al YES

Croatia blister, supplied in a box

YES

Indometacin 100 mg Belupo, lijekovi i kozmetika d.d., 10 (2x5) suppositories in a strip,

suppositories suppositories Ulica Danica 5, Koprivnica, YES YES Republic of Croatia supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Indometacin 25 mg capsules capsules Ulica Danica 5, Koprivnica, 30 (2x15) capsules in a blister, YES YES

Republic of Croatia supplied in a box

Indometacin 75 mg retard Belupo, lijekovi i kozmetika d.d., capsules prolonged-release capsules Ulica Danica 5, Koprivnica,

30 (2x15) capsules in a PVC/Al blister,

Republic of Croatia supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 291

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Merck Sharp & Dohme B.V.,

Inegy 10 mg/10 mg tablets Waarderweg 39, Postbus 581, 28 (2x14) tablets in a blister (Al/Al), YES

Haarlem, the Netherlands supplied in a box

YES YES

Merck Sharp & Dohme B.V.,

Inegy 10 mg/20 mg tablets Waarderweg 39, Postbus 581, 28 (2x14) tablets in a blister

Haarlem, the Netherlands (PVC/Aclar/Al), supplied in a box

YES YES YES

Merck Sharp & Dohme B.V.,

Inegy 10 mg/40 mg tablets Waarderweg 39, Postbus 581, 28 (4x7) tablets in a blister YES YES

Haarlem, the Netherlands (PVC/Aclar/Al), supplied in a box

YES

Merck Sharp & Dohme B.V.,

Inegy 10 mg/80 mg tablets Waarderweg 39, Postbus 581, 28 (4x7) tablets in a blister YES YES YES

Haarlem, the Netherlands (PVC/Aclar/Al), supplied in a box

Infanrix diphtheria, tetanus and GlaxoSmithKline Biologicals s.a., Box with one glass syringe containing

pertussis (acellular) vaccine, intramuscular suspension Rue de lInstitut 89, Rixensart, 1 dose of vaccine (0.5 mL), needle YES YES

absorbed Belgium and needle protection

One glass syringe with 0.5 mL of liquid

Infanrix Hexa lyophilisate and suspension

GlaxoSmithKline Biologicals s.a., vaccine component (DTP-HBV-IPV),

for parenteral use Rue de lInstitut 89, Rixensart, one glass bottle with Hib lyophilisate YES YES Belgium and two needles with protective caps,

supplied in a box

INFANRIX-IPV+Hib, Combined Box with 1 glass syringe containing 0.5

Diphtheria, Tetanus, acellular powder and suspension for GlaxoSmithKline Biologicals s.a., mL of suspension (component Infanrix

Pertussis,inactivated Polio and preparation of suspension Rue de lInstitut 89, Rixensart, IPV), 1 glass bottle with powder YES YES

Haemophilus influenzae type B for injection Belgium (component Hib) and 2 needles with

conjugate Vaccine protection

Influvac (inactivated influenza Solvay Pharmaceuticals B.V., Box with 1 pre-filled syringe (glass,

vaccine, surface antigen) suspension for injection Veerweg 12, 8121 AA Olst, the type I) with 1 dose of vaccine (0.5 mL YES YES Netherlands of suspension)

Pliva Croatia Ltd., Ulica grada

Infusol (solution for infusion) solution for intravenous infusion Vukovara 49, Zagreb, Republic of 10 glass vials with 500 mL of solution, YES

Croatia supplied in a box

YES

Pharmacia Limited, Whalton 30 (3x10) film coated tablets in a

Inspra 25 mg tablets film coated tablets Road, Morpeth, Northumberland nontransparent PVC/Al blister, YES YES YES YES

NE613YA, Great Britain supplied in a carton box

Pharmacia Limited, Whalton 30 (3x10) film coated tablets in a

Inspra 50 mg tablets film coated tablets Road, Morpeth, Northumberland nontransparent PVC/Al blister, YES YES YES YES

NE613YA, Great Britain supplied in a carton box

Instillagel 11 mL gel Almed GmbH, Motzener Str. 41, 10 syringes each containing 11 mL of Berlin, Germany gel in a blister, supplied in a box YES YES

Instillagel 6 mL gel Almed GmbH, Motzener Str. 41, 10 syringes each containing 6 mL of Berlin, Germany gel in a blister, supplied in a box YES YES

Insulatard HM 100 solution for injection (for s.c. Novo Nordisk A/S, Novo Allé, 10 mL of suspension in a glass bottle, use) DK-2880 Bagsvaerd, Denmark supplied in a box YES YES

Novo Nordisk A/S, Novo Alle,

Bagsvaerd, Denmark Novo 5 glass cartridges with 3 mL of

Insulatard Penfill suspension for subcutaneous injection Nordisk Production SAS, 45, suspension in a blister, supplied in a YES YES

Avenue d' Orleans, Chartres, box

France

Schering-Plough Labo N.V.,

Integrilin solution for infusion Heist-op-den-Berg, Belgium and One glass vial with 10 mL of solution,

0.75 mg/mL solution for infusion Glaxo Operations UK Ltd., Great supplied in a box YES YES YES YES

Britain

Schering-Plough Labo N.V.,

Integrilin solution for injection 2 Heist-op-den-Berg, Belgium and One glass vial with 10 mL of solution,

mg/mL solution for injection Glaxo Operations UK Ltd., Great supplied in a box YES YES YES YES

Britain

14509/1/11 REV 1 WS/jj 292

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Fresenius Kabi Austria GmbH, Glass infusion bottle containing 500

Intralipid 10% emulsion for infusion Graz, Austria and Fresenius Kabi mL of emulsion, 10 bottles in a carton YES YES

AB, Uppsala, Sweden box

Plastic bag ("Excel") containing 500

mL of emulsion for infusion with two

attachments for drug administration

Intralipid 10% emulsion for infusion Fresenius Kabi AB, Uppsala, Sweden and for infusion, one small bag YES YES

containing oxygen absorber, and one

bag with solution for packaging

airtightness control

Fresenius Kabi Austria GmbH, Glass infusion bottle containing 100

Intralipid 10% emulsion for infusion Graz, Austria and Fresenius Kabi mL of emulsion, 10 bottles in a carton YES YES

AB, Uppsala, Sweden box

Plastic bag ("Excel") containing 100

mL of emulsion for infusion with two

attachments for drug administration

Intralipid 10% emulsion for infusion Fresenius Kabi AB, Uppsala, Sweden and for infusion, one small bag YES YES

containing oxygen absorber, and one

bag with solution for packaging

airtightness control

Plastic bag ("Excel") containing 100

mL of emulsion for infusion with two

attachments for drug administration

Intralipid 20% emulsion for infusion Fresenius Kabi AB, Uppsala, Sweden and for infusion, one small bag YES YES

containing oxygen absorber, and one

bag with solution for packaging

airtightness control

Fresenius Kabi Austria GmbH, Glass infusion bottle containing 500

Intralipid 20% emulsion for infusion Graz, Austria and Fresenius Kabi mL of emulsion, 10 bottles in a carton YES YES

AB, Uppsala, Sweden box

Fresenius Kabi Austria GmbH, Glass infusion bottle containing 100

Intralipid 20% emulsion for infusion Graz, Austria and Fresenius Kabi mL of emulsion, 10 bottles in a carton YES YES

AB, Uppsala, Sweden box

Plastic bag ("Excel") containing 500

mL of emulsion for infusion with two

attachments for drug administration

Intralipid 20% emulsion for infusion Fresenius Kabi AB, Uppsala, Sweden and for infusion, one small bag YES YES

containing oxygen absorber, and one

bag with solution for packaging

airtightness control

Intron A 18 million IU solution for Schering-Plough (Brinny)

One multi-dose syringe with a

injection, multi-dose syringe solution for injection Company, Innishannon, County

cartridge containing 1.2 mL of solution

Cork, Republic of Ireland otopine, 12 needles and 12 cotton

YES YES YES

wool riolls, supplied in a box

One multi-dose syringe with a

Intron A 30 million IU solution for Schering-Plough (Brinny) cartridge containing 1.2 mL of solution

injection, multi-dose syringe solution for injection Company, Innishannon, County YES YES Cork, Republic of Ireland otopine, 12 needles and 12 cotton YES

wool riolls, supplied in a box

Intron A solution for injection 18 solution for subcutaneous Schering-Plough (Brinny)

Box with 1 pen injection device with a

glass cartridge containing 1.2 mL of

mil.IU, multi-dose injector administration Company, Innishannon, County Cork, Republic of Ireland solution, 6 Novofine needles and 6 YES YES YES

gauze pads

Box with 1 pen injection device with a

Intron A solution for injection 30 solution for subcutaneous Schering-Plough (Brinny) mil.IU, multidozni injektor administration Company, Innishannon, County glass cartridge containing 1.2 mL of YES YES YES

Cork, Republic of Ireland solution, 6 Novofine needles and 6 gauze pads

Invanz 1 g powder for powder for concentrate for Merck Sharp & Dohme B.V., 20-mL glass bottle with powder

concentrate for infusion solution infusion solution Waarderweg 39, Postbus 581, YES YES YES Haarlem, the Netherlands supplied in a box

14509/1/11 REV 1 WS/jj 293

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Iopamiro 300 solution for Bracco s.p.a., Via Egidio Folli 50, injection solution for injection Milano, Italy Patheon Italia SpA, 30 mL of solution in a glass bottle, YES YES Via Morolense 87, Ferentino, Italy supplied in a box

Iopamiro 300 solution for Bracco s.p.a., Via Egidio Folli 50, injection solution for injection Milano, Italy Patheon Italia SpA,

100 mL of solution in a glass bottle ,

Via Morolense 87, Ferentino, Italy supplied in a box

YES YES

Iopamiro 300 solution for Bracco s.p.a., Via Egidio Folli 50, 50 mL of solution in a glass bottle,

injection solution for injection Milano, Italy Patheon Italia SpA, Via Morolense 87, Ferentino, Italy supplied in a box YES YES

Iopamiro 370 solution for Bracco s.p.a., Via Egidio Folli 50, injection solution for injection Milano, Italy Patheon Italia SpA, 100 mL of solution in a glass bottle, YES YES Via Morolense 87, Ferentino, Italy supplied in a box

Iopamiro 370 solution for Bracco s.p.a., Via Egidio Folli 50, injection solution for injection Milano, Italy Patheon Italia SpA, 30 mL of solution in a glass bottle, YES Via Morolense 87, Ferentino, Italy supplied in a box

YES

Iopamiro 370 solution for Bracco s.p.a., Via Egidio Folli 50, 50 mL of solution in a glass bottle,

injection solution for injection Milano, Italy Patheon Italia SpA, YES YES Via Morolense 87, Ferentino, Italy supplied in a box

Iopamiro 370 solution for Bracco s.p.a., Via Egidio Folli 50, injection solution for injection Milano, Italy Patheon Italia SpA,

200 mL of solution in a glass bottle,

Via Morolense 87, Ferentino, Italy supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

IRUMED 10 mg tablets tablets Ulica Danica 5, Koprivnica, 60 (2x30) tablets in a blister

Republic of Croatia (PVC/PVDC-Al foil), supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Irumed 2.5 mg tablets tablets Ulica Danica 5, Koprivnica, 30 (1x30) tablets in a blister

Republic of Croatia (PVC/PVDC-Al folil), supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Irumed 20 mg tablets tablets Ulica Danica 5, Koprivnica, 30 (1x30) tablets in a blister YES

Republic of Croatia (PVC/PVDC-Al folil), supplied in a box

YES

Belupo, lijekovi i kozmetika d.d.,

Irumed 5 mg tablets tablets Ulica Danica 5, Koprivnica, 30 (1x30) tablets in a blister

Republic of Croatia (PVC/PVDC-Al folil), supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d., 30 (1x30) tablets in a transparent

Iruzid 10/12.5 mg tablets tablets Ulica Danica 5, Koprivnica, blister (PVC/PVDC-Al foil), supplied in YES YES

Republic of Croatia a box

Belupo, lijekovi i kozmetika d.d., 31 (1x30) tablets in a transparent

Iruzid 20/12.5 mg tablets tablets Ulica Danica 5, Koprivnica, blister (PVC/PVDC-Al foil), supplied in YES YES

Republic of Croatia a box

Belupo, lijekovi i kozmetika d.d., 32 (1x30) tablets in a transparent

Iruzid 20/25 mg tablets tablets Ulica Danica 5, Koprivnica, blister (PVC/PVDC-Al foil), supplied in YES YES

Republic of Croatia a box

ISMN Genericon 20 mg tablets tablets Genericon Pharma Ges.m.b.H, 20 (2x10) tablets in PVC/Al blister, Lannach, Austria supplied in a box YES YES

ISMN Genericon 40 mg tablets tablets Genericon Pharma Ges.m.b.H, 20 (2x10) tablets in PVC/Al blister, Lannach, Austria supplied in a box YES YES

Jadran - Galenski laboratorij d.d.,

ISMN Jadran 20 tablets Pulac bb, Rijeka, Republic of 60 (6x10) tablets in a blister, supplied

Croatia in a box

YES YES

Jadran - Galenski laboratorij d.d.,

ISMN Jadran 40 tablets Pulac bb, Rijeka, Republic of 60 (6x10) tablets in a blister, supplied

Croatia in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Isoptin 120 tablets film coated tablets Vukovara 49, Zagreb, Republic of 20 (2x10) film coated tablets in PVC/Al

Croatia blister, supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 294

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pliva Croatia Ltd., Ulica grada

Isoptin 40 tablets film coated tablets Vukovara 49, Zagreb, Republic of 30 (3x10) film coated tablets in a YES YES

Croatia PVC/Al blister, supplied in a box

Pliva Croatia Ltd., Ulica grada

Isoptin 80 tablets film coated tablets Vukovara 49, Zagreb, Republic of 50 (5x10) film coated tablets in a

Croatia blister (PVC/Al), supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada 2 mL of solution in a glass ampoule,

Isoptin injection solution for injection Vukovara 49, Zagreb, Republic of 50 (5x10) ampoules in a plastic holder, YES YES

Croatia supplied in a box

Pliva Croatia Ltd., Zagreb, 20 (2x10) prolonged-release tablets in

ISOPTIN RR tablets prolonged-release tablets Republic of Croatia and Abbott GmbH and Co. KG, PVC/PVDC//Al blister, supplied in a YES YES

Ludwigshafen, Germany box

ISOPTO TEARS eyel drops eye drops Alcon-Couvreur s.a., Rijksweg 15 mL of solution in a platic bottle with 14, Puurs, Belgium dropper attachment, supplied in a box YES YES YES

Belupo, lijekovi i kozmetika, d.d.,

ITRAC 3 capsules capsules, hard Koprivnica, Republic of Croatia in 4 capsules in a blister cooperation with Janssen (PVC/PE/PVDC/Al), supplied in a box YES YES

Pharmaceutica, Beerse, Belgium

Izosorbid MN retard 40 mg prolonged release tablets Farmal d.d., Branitelja tablets (film coated) domovinskog rata 8, Ludbreg, Box with 50 tablets (blister, 5x10 YES Republic of Croatia tablets)

YES

Izosorbid MN retard 60 mg prolonged release tablets Farmal d.d., Branitelja tablets (film coated) domovinskog rata 8, Ludbreg,

Box with 50 tablets (blister, 5x10

Republic of Croatia tablets)

YES YES

Isotonic solution of sodium B. Braun Melsungen AG, Carl 500 mL of solution for infusion in a

chloride 0.9% Braun solution for infusion Braun-Straße 1, Melsungen, YES YES Germany plastic bottle (10 bottles in a box)

Sodium chloride isotonic solution B. Braun Melsungen AG, Carl 1000 mL of infusion solution in a

0.9% Braun solution for infusion Braun-Straße 1, Melsungen, Germany plastic bottle (10 bottles in a box) YES YES

Sodium chloride isotonic solution B. Braun Melsungen AG, Carl 0.9% Braun solution for infusion Braun-Straße 1, Melsungen,

250-mL of solution for infusion in a

Germany plastic bottle (10 bottles in a box)

YES YES

Sodium chloride isotinic solution B. Braun Melsungen AG, Carl 0.9% Braun solution for infusion Braun-Straße 1, Melsungen, 100 mL of infusion solution in a YES Germany plastic bottle (20 bottles in a box)

YES

Jeanine film tablets film coated tablets Jenapharm GmbH & Co KG, 3x21 tablets in a blister, supplied in a Jena, Germany box YES YES

Jeanine film tablets film coated tablets Jenapharm GmbH & Co KG, 1x21 tablets in a blister, supplied in a Jena, Germany box YES YES

CHINOIN Pharmaceutical and

Chemical Works Co. Ltd.,

Jumex 5 mg tablets Budimpešta, Madarska i 50 (5x10) tablets in an Al/OPA/PVC/Al CHINOIN Pharmaceutical and blister, supplied in a box YES YES

Chemical Works Co.

Ltd.,Veresegyhaz, Madarska

Plastic bag for 1540 mL of blend (in

Kabiven emulsion for infusion Fresenius Kabi AB, Uppsala, three separate compartments) in a Sweden plastic protective casing, 4 bags in a YES YES YES

box

Plastic bag for 1026 mL of blend (in

Kabiven emulsion for infusion Fresenius Kabi AB, Uppsala, three separate compartments) in a Sweden plastic protective casing, 4 bags in a YES YES YES

box

14509/1/11 REV 1 WS/jj 295

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Plastic bag for 2053 mL of blend (in

Kabiven emulsion for infusion Fresenius Kabi AB, Uppsala, three separate compartments) in a Sweden plastic protective casing, 2 bags in a YES YES YES

box

Plastic bag for 2566 mL of blend (in

Kabiven emulsion for infusion Fresenius Kabi AB, Uppsala, three separate compartments) in a Sweden plastic protective casing, 2 bags in a YES YES YES

box

Plastic bag for 1440 mL of blend (in

Kabiven Peripheral emulsion for infusion Fresenius Kabi AB, Uppsala, three separate compartments) in a Sweden plastic protective casing, 4 bags in a YES YES YES

box

Plastic bag for 1920 mL of blend (in

Kabiven Peripheral emulsion for infusion Fresenius Kabi AB, Uppsala, three separate compartments) in a Sweden plastic protective casing, 2 bags in a YES YES YES

box

Calsium folinate Pliva injection 20-mL bottle containing solution, with 200 mg/20 mL solution for injection

Pliva Lachema, Karasek 1, 62133

Brno, Czech Republic bromobutyl stopper and aluminum cap, YES YES supplied in a box

Calcium folinate Pliva injection 50-mL bottle with solution, closed 500 mg/50 mL solution for injection

Pliva Lachema, Karasek 1, 62133

Brno, Czech Republic bromobutyl stopper and aluminum cap, YES YES supplied in a box

Calcium Folinate Pliva 10-mL bottle containing solution, with injection100 mg/10 mL solution for injection

Pliva Lachema, Karasek 1, 62133

Brno, Czech Republic bromobutyl stopper and aluminum cap, YES YES supplied in a box

Calcium carbonate Krka 1 g Krka d.d., Šmarješka cesta 6,

tablets tablets Novo mesto, Republic of 50 tablets in a bottle, supplied in a box YES YES Slovenia

KALETRA 133.3 mg/33.3 mg Abbott Laboratories Ltd., Kent, 2 plastic (HDPE) bottles each

soft capsules capsules, soft Great Britain, Abbott S.p.A., containing 90 capsules, supplied in a YES YES YES YES Campoverde di Aprilia, Italy box

KALETRA 200 mg/50 mg film Abbott Laboratories Ltd, Kent, 120 tablets in a plastic (HDPE) bottle,

tablets film coated tablets Great Britain, Abbott GmbH&Co. KG, Ludwigshafen, Germany supplied in a box YES YES YES YES

Kaletra 80 mg + 20 mg/mL oral Abbott Laboratories Ltd., Kent, 5 plastic (PET) brown bottles for

solution oral solution Great Britain, Abbott S.p.A., multiple use with 60 mL of solution, YES YES YES YES Campoverde di Aprilia, Italy supplied in a box

Kaletra capsules capsules Abbott Laboratories Ltd, Box with 2 plastic bottles each Queenborough, Great Britain containing 90 capsules YES YES YES YES

Box with 5 plastic bottles each with 60

Kaletra oral solution oral solution Abbott Laboratories Ltd, Queenborough, Great Britain mL of solution and 5 filling syringes of YES YES YES YES

5 mL

POTASSIUM CHLORIDE Jadran - Galenski laboratorij d.d.,

JADRAN 500 mg tablets for oral tablets for oral solution Pulac bb, Rijeka, Republic of 20 (2x10) tablets for oral solution in a YES YES solution Croatia blister (PVC/Al), supplied in a box

Nordmark Arzneimittel GmbH &

Kalinor effervescent tablets effervescent tablets Co. KG, Pinnauallee 4, Uetersen, Plastic tube with 15 effervescent YES YES

Germany tablets, supplied in a box

Krka d.d., Šmarješka cesta 6,

KAMIREN tablets 1 mg tablets Novo mesto, Republic of 21 (2x10 tablets in PVC/PVDC/Al YES

Slovenia blister, supplied in a box

YES

Krka d.d., Šmarješka cesta 6,

KAMIREN tablets 2 mg tablets Novo mesto, Republic of 22 (2x10 tablets in PVC/PVDC/Al

Slovenia blister, supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6,

KAMIREN tablets 4 mg tablets Novo mesto, Republic of 23 (2x10 tablets in PVC/PVDC/Al

Slovenia blister, supplied in a box

YES YES

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ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Krka d.d., Šmarješka cesta 6,

Kamiren XL modified release tablets Novo mesto, Republic of 60 (6x10) tablets in an OPA/Al/PVC//Al

Slovenia blister, supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6,

Kamiren XL modified release tablets Novo mesto, Republic of 30 (3x10) tablets in a OPA/Al/PVC//Al

Slovenia blister, supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Katena 100 mg capsules capsules Ulica Danica 5, Koprivnica, 20 (2x10) capsules in a blister,

Republic of Croatia supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Katena 300 mg capsules capsules Ulica Danica 5, Koprivnica, 50 (5x10) capsules in a blister,

Republic of Croatia supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Katena 400 mg tablets capsules Ulica Danica 5, Koprivnica, 50 (5x10) capsules in a blister,

Republic of Croatia supplied in a box

YES YES

Kenalog 40 mg/1 mL suspension Krka d.d., Šmarješka cesta 6, 5 ampoules (each with 1 mL of

for injection suspension for injection Novo mesto, Republic of suspension) in a blister, supplied in a YES YES Slovenia box

300 mL of solution in an amber glass

Keppra 100 mg/mL oral solution oral solution NextPharma SAS, Limay, France bottle with a plastic temper-evident YES YES YES YES

stopper, supplied in a box

Keppra 1000 mg film coated UCB S.A., Braine l'Alleud, 60 (6x10) tablets in a blister (PVC/Al),

tablets film coated tablets Belgium supplied in a box YES YES YES YES

Keppra 250 mg film coated 60 (6x10) tablets in a blister (PVC/Al),

tablets film coated tablets

UCB S.A., Braine l'Alleud,

Belgium supplied in a box YES YES YES YES

Keppra 500 mg film coated UCB S.A., Braine l'Alleud, 60 (6x10) tablets in a blister (PVC/Al),

tablets film coated tablets Belgium supplied in a box YES YES YES YES

50 g of ointment in an aluminium tube

KERASAL ointment ointment Spirig Pharma AG, Egerkingen, Switzerland with a plastic stopper, supplied in a YES YES YES

box

Ketek 400 mg film coated tablets Aventis Pharma S.p.A., S.S. 17 10 (1x10) tablets in a blister, supplied KM 22, Scoppito, Italy in a box YES YES

Ketocef injection 1.5 g powder for solution for

Pliva Croatia Ltd., Ulica grada

injection Vukovara 49, Zagreb, Republic of

5 glass bottles with powder, supplied

Croatia in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Ketocef injection 250 mg powder for solution for injection Vukovara 49, Zagreb, Republic of 5 glass bottles with powder, supplied

Croatia in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Ketocef injection 750 mg powder for solution for 5 glass bottles with powder, supplied injection Vukovara 49, Zagreb, Republic of

Croatia in a box

YES YES

Lek farmacevtska družba d.d.,

KetoGel 2.5% gel gel Verovškova 57, Ljubljana, 50 g of gel in an aluminium tube, YES YES

Republic of Slovenia supplied in a box

YES

Lek farmacevtska družba d.d.,

Ketonal 100 mg suppositories suppositories Verovškova 57, Ljubljana, 12 suppositories in a strip (Al/PE), YES YES

Republic of Slovenia supplied in a box

Lek farmacevtska družba d.d.,

Ketonal 100 mg/2 mL injection solution for injection Verovškova 57, Ljubljana, 2 mL of solution for injection in a glass YES YES

Republic of Slovenia ampoule, 10 ampoules in a box

Ketonal 150 mg prolonged Lek farmacevtska družba d.d., 20 prolonged-release tablets in an

release tablets prolonged-release tablets Verovškova 57, Ljubljana, amber glass bottle with plastic cap, YES YES Republic of Slovenia supplied in a box

14509/1/11 REV 1 WS/jj 297

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Lek farmacevtska družba d.d.,

Ketonal 5% cream cream Verovškova 57, Ljubljana, 30 g of cream in an aluminium tube,

Republic of Slovenia supplied in a box

YES YES YES

Lek farmacevtska družba d.d.,

Ketonal 50 mg capsules capsules, hard Verovškova 57, Ljubljana, 25 capsules in an amber glass bottle YES YES

Republic of Slovenia with plastic cap , supplied in a box

Lek farmacevtska družba d.d., 20 (2x10) capsules in a blister

Ketonal DUO 150 mg capsules modified release capsules, hard Verovškova 57, Ljubljana, (PVC/TE/PVDC//PVC/Al), supplied in a YES YES

Republic of Slovenia box

Lek farmacevtska družba d.d., 20 film coated tablets in an amber

Ketonal forte 100 mg tablets film coated tablets Verovškova 57, Ljubljana, glass bottle with plastic cap, supplied YES YES

Republic of Slovenia in a box

Farmal d.d., Ludbreg, Republic of

KLAVAX BID 1000 mg tablets film coated tablets Croatia in cooperation with Bilim 14 tablets in a A/Al blister, supplied in YES

Pharmaceuticals Inc., Turkey a box

YES

Farmal d.d., Ludbreg, Republic of

KLAVAX BID syrup 400/57 mg powder for preparation of Glass bottle of 100 mL with a oral suspension Croatia in cooperation with Bilim

Pharmaceuticals Inc., Turkey polyethylene cap, supplied in a box

YES YES

Powder for preparation of 70 mL of

suspension (by the addition of 59 mL

Pliva Croatia Ltd., Ulica grada of water) in an amber glass bottle with

Klavocin bid syrup powder for preparation of oral suspension Vukovara 49, Zagreb, Republic of a plastic stopper (high density YES YES

Croatia polyethylene) and a 5 mL measuring

syringe (polystyrene/polyethylene low

density), supplied in a box

Powder for preparation of 140 mL of

suspension (by the addition of 118 mL

Klavocin bid syrup powder for preparation of

Pliva Croatia Ltd., Ulica grada of water) in an amber glass bottle with

oral suspension Vukovara 49, Zagreb, Republic of a plastic stopper (high density YES YES Croatia polyethylene) and a 5 mL measuring

syringe (polystyrene), supplied in a

box

Powder for preparation of 35 mL of

suspension (by the addition of 29.5 mL

of water) in an amber glass bottle with

Klavocin bid syrup powder for preparation of

Pliva Croatia Ltd., Ulica grada

oral suspension Vukovara 49, Zagreb, Republic of a plastic stopper (high density YES YES Croatia polyethylene) and a 5 mL measuring

syringe (polystyrene/polyethylene low

density), supplied in a box

Pliva Croatia Ltd., Ulica grada

Klavocin bid tablets 1 g film coated tablets Vukovara 49, Zagreb, Republic of 10 (2x5) film coated tablets in a Al/Al YES YES

Croatia blister, supplied in a box

Pliva Croatia Ltd., Ulica grada 5 bottles (glass of hydrolytic group I)

Klavocin 1.2 g injection powder for injection solution Vukovara 49, Zagreb, Republic of with a rubber stopper and a protective YES YES

Croatia flip-off Al cap, supplied in a box

5 bottles (glass of hydrolytic group I)

Klavocin injection 600 mg powder for solution for

Pliva Croatia Ltd., Ulica grada

injection Vukovara 49, Zagreb, Republic of with a rubber stopper and a protective YES YES Croatia flip-off Al cap, supplied in a box

Klimicin 150 mg capsules capsules Lek farmacevtska družba d.d., 16 capsules in an amber glass bottle, Ljubljana, Republic of Slovenia supplied in a box YES YES

Klimicin 300 mg capsules capsules Lek farmacevtska družba d.d., 16 capsules in an amber glass bottle, Ljubljana, Republic of Slovenia supplied in a box YES YES

Klimicin 300 mg/2 mL injection solution for intramuscular Lek farmacevtska družba d.d., 10 glass ampoules each containing 2 and intravenous injection Ljubljana, Republic of Slovenia mL of solution, supplied in a box YES YES

14509/1/11 REV 1 WS/jj 298

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Klimicin 600 mg/4 mL injection solution for intramuscular Lek farmacevtska družba d.d., 10 glass bottles with à 4 mL of and intravenous injection Ljubljana, Republic of Slovenia solution, supplied in a box YES YES

Lek farmacevtska družba d.d.,

Klimicin T 1% gel gel Verovškova 57, Ljubljana, 30 g of gel in a tube, supplied in a box YES YES

Republic of Slovenia

Lek farmacevtska družba d.d.,

Klimicin T 1% dermal solution dermal solution Verovškova 57, Ljubljana, 30 mL of solution in a plastic bottle, YES YES

Republic of Slovenia supplied in a box

Lek farmacevtska družba d.d.,

Klimicin V 2% vaginal cream vaginal cream Verovškova 57, Ljubljana, 40 g of cream in a tube with 7 plastic YES YES

Republic of Slovenia applicators, supplied in a box

28 film-coated tablets in a plastic

Kliogest film coated tablets Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark container (dispenser with marked days YES YES

of the week), supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Klomifen 50 mg tablets tablets Ulica Danica 5, Koprivnica, 10 (1x10) tablets in a PVC/AI blister, YES

Republic of Croatia supplied in a box

YES

Klosterfrau Sedinal sugar-coated 60 (2x30) sugar coated tablets in a

tablets sugar-coated tablets

M.C.M. Klosterfrau Vertriebs

GmbH, Germany blister, supplied in a box YES YES YES

Belupo, lijekovi i kozmetika d.d.,

Knavon 100 mg suppositories suppositories Ulica Danica 5, Koprivnica, 12 (2x6) suppositories in a strip,

Republic of Croatia supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d., 10 glass ampoules with á 2 mL of

Knavon 100 mg/2 mg injection intramuscular injection Ulica Danica 5, Koprivnica, solution in a plastic container, supplied YES YES

Republic of Croatia in a box

Belupo, lijekovi i kozmetika d.d.,

Knavon 50 mg capsules capsules Ulica Danica 5, Koprivnica, 25 (1x25) capsules in a blister, YES YES

Republic of Croatia supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Knavon forte 100 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 20 tablets in an amber glass bottle with

Republic of Croatia Al cap, supplied in a carton box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Knavon retard 150 mg tablets prolonged-release tablets Ulica Danica 5, Koprivnica, 20 tablets in an amber glass bottle, YES

Republic of Croatia supplied in a carton box

YES

Bosnalijek d.d., Jukićeva 53,

Kofan tablets tablets Sarajevo, Bosnia and 20 (2x10) tablets in PVC/Al blister,

Herzegovina supplied in a box

YES YES YES

Vial with Bio-set device containing

powder, pre-filled syringe with diluent,

Kogenate Bayer 1000 IU powder powder and diluent for Bayer Biologicals S.r.l., Torriseparate plunger, venipuncture set,

and diluent for injection solution solution for injection Sovicille, Italy two disposable sterile cotton pads YES YES YES YES YES drenched in a Acohol, two dry cotton

pads and two plasters, supplied in a

box

Vial with Bio-set device containing

powder, pre-filled syringe with diluent,

Kogenate Bayer 250 IU powder powder and diluent for Bayer Biologicals S.r.l., Torriseparate plunger, venipuncture set,

and diluent for injection solution solution for injection Sovicille, Italy two disposable sterile cotton pads YES YES YES YES YES drenched in a Acohol, two dry cotton

pads and two plasters, supplied in a

box

Vial with Bio-set device containing

powder, pre-filled syringe with diluent,

Kogenate Bayer 500 IU powder powder and diluent for Bayer Biologicals S.r.l., Torriseparate plunger, venipuncture set,

and diluent for injection solution solution for injection Sovicille, Italy two disposable sterile cotton pads YES YES YES YES YES

drenched in a Acohol, two dry cotton

pads and two plasters, supplied in a

14509/1/11 REV 1 WS/jj 299

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

box

Alkaloid AD - Skopje, Bulevar

Kompensan tablets Aleksandar Makedonski 12, 20 (2x10) tablets in PVC/Al blister, YES YES YES

Skopje, FYROM supplied in a box

Konakion MM injection solution for intravenous F. Hoffmann-La Roche Ltd., 10mg/1mL injection Grenzacherstrasse 124, Basel,

5 ampoules (amber glass) with 1 mL of

Switzerland solution, supplied in a box

YES YES

Konakion MM 2 mg/0.2 mL, solution for peroral, F. Hoffmann-La Roche Ltd., 5 ampoules (amber glass) with 0.2 mL

paediatric intramuscular and Grenzacherstrasse 124, Basel, of solution and 5 plastic measuring YES YES intravenous injection Switzerland devices, supplied in a box

Kreon 10 000 capsules filled with gastric Solvay Pharmaceuticals GmbH, resistant granules Hannover, Germany 20 tablets in a plastic bottle YES YES

Kreon 10 000 capsules filled with gastric Solvay Pharmaceuticals GmbH, resistant granules Hannover, Germany 100 capsules in a plastic bottle YES YES

Kreon 25 000 capsules filled with gastric Solvay Pharmaceuticals GmbH, resistant granules Hannover, Germany 100 capsules in a plastic bottle YES YES

KREON 40 000 hard capsules with gastric Solvay Pharmaceuticals GmbH, 50 capsules in a plastic (HDPE) resistant granules Neustadt, Germany container, supplied in a box YES YES

STADA Arzneimittel AG, 10 mL of solution in a polyethylene

Kromoglicin STADA eye drops eye drops, solution Stadtstraße 2-18, Bad Vilbel, bottle with dropper attachment and YES YES YES

Germany cap, supplied in a box

STADA Arzneimittel AG,

Kromoglicin STADA nasal spray nasal spray, solution Stadtstraße 2-18, Bad Vilbel, 15 mL of solution in a polyethylene YES

Germany bottle with nebulizer, supplied in a box

YES YES

Lek farmacevtska družba d.d.,

Kuterid 0.05 % cream cream Verovškova 57, Ljubljana, 20 grams of cream in an aluminum

Republic of Slovenia tube, supplied in a box

YES YES

Lek farmacevtska družba d.d.,

Kuterid 0.05% ointment ointment Verovškova 57, Ljubljana, 20 grams of ointment in an aluminum YES

Republic of Slovenia tube, supplied in a box

YES

One glass vial with powder, one glass

Kybernin P 500 powder for solution for CSL Behring GmbH, Marburg, injection or infusion Germany vial with 10 mL of diluent and one YES YES

transfer spike, supplied in a box

Kytril 1mg/1 mL concentrate for concentrate for infusion F. Hoffmann-La Roche Ltd., solution for infusion solution (for intravenous Grenzacherstrasse 124, Basel,

5 ampoules with 1 mL of solution,

use) Switzerland supplied in a box

YES YES

Kytril 3 mg/3 mL concentrate for concentrate for solution for F. Hoffmann-La Roche Ltd., solution for infusion intravenous infusion Grenzacherstrasse 124, Basel,

5 ampoules with 3 mL of solution,

Switzerland supplied in a box

YES YES

F. Hoffmann-La Roche Ltd.,

Kytril film coated tablets film coated tablets Grenzacherstrasse 124, Basel, 10 tablets in a PVC/Al blister, supplied

Switzerland in a box

YES YES

KRKA FARMA d.o.o., DPC

Laaven HD tablets tablets Jastrebarsko, Cvetkovići bb, 60 (6x10) tablets in a PVC/PVDC//Al

Jastrebarsko, Republic of Croatia blister, supplied in a box

YES YES

KRKA FARMA d.o.o., DPC

Laaven HD tablets tablets Jastrebarsko, Cvetkovići bb, 33 (3x10) tablets in a PVC/PVDC//Al

Jastrebarsko, Republic of Croatia blister, supplied in a box

YES YES

KRKA FARMA d.o.o., DPC

Laaven HL 20 tablets tablets Jastrebarsko, Cvetkovići bb, 34 (3x10) tablets in a PVC/PVDC//Al

Jastrebarsko, Republic of Croatia blister, supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 300

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

KRKA FARMA d.o.o., DPC

Laaven HL tablets tablets Jastrebarsko, Cvetkovići bb, 30 (3x10) in a blister (PVC/PVDC/Al), YES YES

Jastrebarsko, Republic of Croatia supplied in a box

KRKA FARMA d.o.o., DPC

Laaven tablets 10 mg tablets Jastrebarsko, Cvetkovići bb, 31 (3x10) tablets in a PVC/Al blister,

Jastrebarsko, Republic of Croatia supplied in a box

YES YES

KRKA FARMA d.o.o., DPC

Laaven tablets 10 mg tablets Jastrebarsko, Cvetkovići bb, 90 (9x10) tablets in a PVC/Al blister,

Jastrebarsko, Republic of Croatia supplied in a box

YES YES

KRKA FARMA d.o.o., DPC

Laaven tablets 2.5 mg tablets Jastrebarsko, Cvetkovići bb, 90 (9x10) tablets in a PVC/Al blister,

Jastrebarsko, Republic of Croatia supplied in a box

YES YES

KRKA FARMA d.o.o., DPC

Laaven tablets 20 mg tablets Jastrebarsko, Cvetkovići bb, 32 (3x10) tablets in a PVC/Al blister,

Jastrebarsko, Republic of Croatia supplied in a box

YES YES

KRKA FARMA d.o.o., DPC

Laaven tablets 5 mg tablets Jastrebarsko, Cvetkovići bb, 33 (3x10) tablets in a PVC/Al blister, YES

Jastrebarsko, Republic of Croatia supplied in a box

YES

Pliva Croatia Ltd., Ulica grada

LACIDIPIN PLIVA tablets 4 mg film coated tablets Vukovara 49, Zagreb, Republic of 28 (4x7) film coated tablets in a blister

Croatia (PA/Al/PVC//PE/Al), supplied in a box

YES YES

Glaxo Wellcome S.A., Burgos,

Aranda de Duero, Spain and

Lacipil tablets 4 mg film coated tablets GlaxoSmithKline 28 (4x7) tablets in a blister, supplied in

Pharmaceuticals S.A., Poznan, a box

YES YES

Poland

Lacipil tablets 6 mg film coated tablets Glaxo Wellcome S.A., Aranda de 28 (4x7) tablets in a blister Duero, Burgos, Spain (OPA/AL/PVC//Al) , supplied in a box YES YES

Lakea 50 mg film coated tablets film coated tablets Lek farmacevtska družba d.d., 30 (3x10) tablets in a OPA/Al/PVC//Al Ljubljana, Republic of Slovenia blister, supplied in a box YES YES

Alkaloid AD - Skopje, Bulevar

Lamal 100 mg tablets tablets Aleksandar Makedonski 12, 33 (2x15) capsules in a PVC/Al blister,

Skopje, FYROM supplied in a box

YES YES

Alkaloid AD - Skopje, Bulevar

Lamal 200 mg tablets tablets Aleksandar Makedonski 12, 34 (2x15) capsules in a PVC/Al blister,

Skopje, FYROM supplied in a box

YES YES

Alkaloid AD - Skopje, Bulevar

Lamal 25 mg tablets tablets Aleksandar Makedonski 12, 30 (3x10) tablets in a blister (PVC/Al) , YES

Skopje, FYROM supplied in a box

YES

Alkaloid AD - Skopje, Bulevar

Lamal 50 mg tablets tablets Aleksandar Makedonski 12, 30 (3x10) tablets in a blister (PVC/Al) ,

Skopje, FYROM supplied in a box

YES YES

Lameptil 100 mg dispersible Lek farmacevtska družba d.d., 30 (3x10) dispersible tablets in a

tablets dispersible tablets Verovškova 57, Ljubljana, blister (PVC/PE/PVDC//Al), supplied in YES YES YES Republic of Slovenia a box

Lameptil 200 mg dispersible Lek farmacevtska družba d.d., 31 (3x10) dispersible tablets in a

tablets dispersible tablets Verovškova 57, Ljubljana, blister (PVC/PE/PVDC//Al), supplied in YES YES YES Republic of Slovenia a box

Lameptil 25 mg dispersible Lek farmacevtska družba d.d., 32 (3x10) dispersible tablets in a

tablets dispersible tablets Verovškova 57, Ljubljana, blister (PVC/PE/PVDC//Al), supplied in YES YES YES Republic of Slovenia a box

Lameptil 50 mg dispersible Lek farmacevtska družba d.d., 33 (3x10) dispersible tablets in a

tablets dispersible tablets Verovškova 57, Ljubljana, blister (PVC/PE/PVDC//Al), supplied in YES YES YES Republic of Slovenia a box

14509/1/11 REV 1 WS/jj 301

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Lamictal 100 mg tablets tablets Glaxo Wellcome Operations, 30 (3x10) tablets in a blister, supplied Greenford, Great Britain in a box YES YES

Lamictal 25 mg tablets tablets Glaxo Wellcome Operations, 30 (3x10) tablets in a blister, supplied Greenford, Great Britain in a box YES YES

Lamictal 50 mg tablets tablets Glaxo Wellcome Operations, 30 (3x10) tablets in a blister, supplied Greenford, Great Britain in a box YES YES

Glaxo Operations UK Limited,

Ware, Hertfordshire, Great Britain

Lamictal 5 mg chewing tablets / chewing tablets/ tablets for (Glaxo Wellcome Operations, 30 (3x10) tablets in a blister

tablets for oral suspension 5 mg oral suspension Greenford, Great Britain), (PVC/PVDC//Al), inserted in a carton YES YES GlaxoSmithKline box

Pharmaceuticals, Poznan,

Poland

LAMISIL 1 % aerosol for external aerosol for external use, Novartis Pharma S.A.S., 30 mL of solution in a plastic bottle

use solution Huningue Cedex, France with a spray attachment, supplied in a YES YES box

Novartis Pharma Produktions

LAMISIL 1% cream cream GmbH, Wehr, Germany and 15 g of cream in an aluminum tube, Novartis Consumer Health SA, supplied in a box YES YES

Nyon, Switzerland

Novartis Pharmaceuticals UK

Lamisil 250 mg tablets tablets Limited, Horsham, West Sussex, 14 (1x14) tablets in a blister (PVC/Al),

Great Britain supplied in a box

YES YES

Novartis Pharma Produktions

Lamisil DermGel 1% gel gel GmbH, Wehr, Germany and 5 g of gel in an aluminium tube with a Novartis Consumer Health SA, propylene stopper, supplied in a box YES YES

Nyon, Switzerland

Novartis Consumer Health S.A., 4 g of solution in an aluminium

Lamisil once 1% dermal solution dermal solution Route de l' Etraz, Nyon, (PE/Al/PE) tube with a plastic stopper, YES YES YES

Switzerland supplied in a protective plastic box

Pliva Croatia Ltd., Ulica grada

Lanicor tablets tablets Vukovara 49, Zagreb, Republic of 22 (2x10) tablets in a blister (PVC/Al) , YES YES

Croatia supplied in a box

Pliva Croatia Ltd., Ulica grada

Lanitop injection solution for injection Vukovara 49, Zagreb, Republic of 10 2-mL ampoules supplied in a box YES YES

Croatia

Pliva Croatia Ltd., Ulica grada

Lanitop tablets tablets Vukovara 49, Zagreb, Republic of 50 (5x10) tablets in a blister, supplied YES YES

Croatia in a box

Lantus 100 IU/mL ( 3-mL solution for subcutaneous Sanofi - Aventis Deutschland 5 glass cartridges with 3 mL of solution

cartridge for OptiClik) injection GmbH, Frankfurt am Main, (with an integrated plastic injector YES YES YES Germany holder), supplied in a box

Lantus 100 IU/mL (3 mL glass solution for subcutaneous Aventis Pharma Deutschland cartridge) injection GmbH, Brunningstrasse 50,

Box with 5 glass cartridges each with 3

Frankfurt am Main, Germany mL of solution (in a blister)

YES YES

Lantus 100 IU/mL OptiSet

(injector with glass cartridge of 3 solution for injection in a

Aventis Pharma Deutschland

mL) cartridge

GmbH, Brunningstrasse 50, 5 injectors with cartridges each with 3

Frankfurt am Main, Germany mL of solution, supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6,

Lanzul capsules 30 mg capsules Novo mesto, Republic of 14 (2X7) capsules in a PVC/PE/PVDC YES

Slovenia – Al blister, supplied in a box

YES

Jadran - Galenski laboratorij d.d., 28 capsules in a plastic (HDPE) bottle

LARONA 15 mg gastric-resistant capsules, hard Pulac bb, Rijeka, Republic of with PP closure (with desiccant ), YES YES

Croatia supplied in a box

14509/1/11 REV 1 WS/jj 302

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Jadran - Galenski laboratorij d.d., 29 capsules in a plastic (HDPE) bottle

LARONA 30 mg gastric-resistant capsules, hard Pulac bb, Rijeka, Republic of with PP closure (with desiccant ), YES YES

Croatia supplied in a box

Lazid tablets 80 mg tablets CP Pharmaceuticals Ltd, 60 (3x20) tablets in a blister (PVC/Al), Wrexham, Great Britain supplied in a box YES YES

LAZOL 15 mg capsules gastric-resistant capsules,

Farmal d.d., Branitelja

hard domovinskog rata 8, Ludbreg,

28 (4x7) capsules in a blister

Republic of Croatia (OPA/Al/PVC//Al), supplied in a box

YES YES

Farmal d.d., Branitelja

LAZOL 30 mg capsules gastric-resistant capsules, hard domovinskog rata 8, Ludbreg, 14 (2x7) capsules in a blister YES

Republic of Croatia (OPA/Al/PVC//Al), supplied in a box

YES

Alkaloid AD, Skopje, Bulevar A.

Makedonski 12, FYROM in 150 mL of solution in an amber glass

Legofer oral solution cooperation-under the licence bottle with plastic cap and measuring YES YES

(concession) Italfarmaco vessel , supplied in a box

S.p.a.A., Milano, Italy

Lekadol 500 mg film coated Lek farmacevtska družba d.d., tablets film coated tablets Verovškova 57, Ljubljana, 18 (3x6) tablets in a blister, supplied in YES Republic of Slovenia a box

YES YES

Lek farmacevtska družba d.d.,

Lekadol direkt 500 mg tablets orodispersible tablets Verovškova 57, Ljubljana, 12 (2x6) dispersible tablets in

Republic of Slovenia PA/Al/PVC-Al blister, supplied in a box

YES YES YES

Lekadol plus C granules granules for preparation of

Lek farmacevtska družba d.d.,

suspension Verovškova 57, Ljubljana,

10 bags each containing 5 g of

Republic of Slovenia granules, supplied in a box

YES YES YES

Lek farmacevtska družba d.d.,

Lekadol tablets tablets Verovškova 57, Ljubljana, 20 (2x10) tablets in a blister, supplied YES YES

Republic of Slovenia in a box

Lek farmacevtska družba d.d.,

Lekoklar 250 mg tablets tablets Verovškova 57, Ljubljana, 14 (2x7) tablets in a A/PVC blister, YES YES

Republic of Slovenia supplied in a box

Lek farmacevtska družba d.d.,

Lekoklar 500 mg tablets tablets Verovškova 57, Ljubljana, 14 (2x7) tablets in a A/PVC blister, YES YES

Republic of Slovenia supplied in a box

Lekoklar XL 500 mg film-coated modified-release film coated Lek farmacevtska družba d.d., tablets with modified release tablets Verovškova 57, Ljubljana, 5 (1x5) tablets in an Al/Al blister, YES Republic of Slovenia supplied in a box

YES

Lek farmacevtska družba d.d.,

Lekotam 1.5 mg tablets tablets Verovškova 57, Ljubljana, 45 (3x10) tablets in a PVC/Al blister,

Republic of Slovenia supplied in a box

YES YES

Lek farmacevtska družba d.d.,

Lekotam 3 mg tablets tablets Verovškova 57, Ljubljana, 46 (3x10) tablets in a PVC/Al blister, YES

Republic of Slovenia supplied in a box

YES

Lek farmacevtska družba d.d.,

Lekotam 6 mg tablets tablets Verovškova 57, Ljubljana, 20 (2x10) tablets in PVC/Al blister,

Republic of Slovenia supplied in a box

YES YES

Lendacin 1g power for injection powder for preparation of Lek farmacevtska družba d.d., 10 glass bottles with powder, supplied

solution injection for i.v. and i.m. Verovškova 57, Ljubljana, solution Republic of Slovenia in a box YES YES

Lendacin 2 g powder for solution powder for solution for Lek farmacevtska družba d.d., for infusion infusion Verovškova 57, Ljubljana,

5 glass bottles with powder for solution

Republic of Slovenia for infusion, supplied in a box

YES YES

Novartis Pharmaceuticals UK

Leponex 100 mg tablets tablets Limited, Horsham, West Sussex, 50 (5x10) tablets in a blister, supplied

Great Britain in a box

YES YES

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ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Novartis Pharmaceuticals UK

Leponex 25 mg tablets tablets Limited, Horsham, West Sussex, 50 (5x10) tablets in a blister, supplied YES YES

Great Britain in a box

Berlin-Chemie AG (Menarini

Lercanil film coated tablets Group), Berlin, Germany; 7 (1x7) tablets in a blister (non Recordati Industria Chimica e transparent PVC/Al), supplied in a box YES YES

Farmaceutica S.p.A., Milano, Italy

Novartis Farmacéutica S.A.,

Lescol 40 mg capsules capsules Ronda Santa María 158, 28 (4x7) capsules in a blister, supplied

Barcelona, Spain in a box

YES YES

Lescol XL 80 mg prolonged Novartis Farmacéutica S.A., release tablets prolonged-release tablets Ronda Santa María 158, 28 (2x14) tablets in a blister, supplied YES YES Barcelona, Spain in a box

Krka d.d., Šmarješka cesta 6,

Letizen film coated tablets 10 mg film coated tablets Novo mesto, Republic of 20 (2x10) film coated tablets in a

Slovenia (PVC/Al) blister, supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6, 120 mL of solution in an amber glass

Letizen oral solution 1 mg/1 mL oral solution Novo mesto, Republic of botlle with plastic cap, supplied in a YES YES

Slovenia box

Letizen S 10 mg film coated Krka d.d., Šmarješka cesta 6, 10 (1x10) film coted tablets in a

tablets film coated tablets Novo mesto, Republic of Slovenia PVC/Al) blister, supplied in a box YES YES YES

Berlin-Chemie AG (Menarini 50 (2x25) tablets in a white non

Letrox 100 tablets Group), Glienicker Weg 125, transparent (PVDC/PVC//Al) blister, YES YES

Berlin, Germany supplied in a box

Berlin-Chemie AG (Menarini 50 (2x25) tablets in a white non

Letrox 150 tablets Group), Glienicker Weg 125, transparent (PVDC/PVC//Al) blister, YES YES

Berlin, Germany supplied in a box

Berlin-Chemie AG (Menarini 50 (2x25) tablets in a white non

Letrox 50 tablets Group), Glienicker Weg 125, transparent (PVDC/PVC//Al) blister, YES YES

Berlin, Germany supplied in a box

solution for injection in 5 pens with a FlexPen glass cartridge

Levemir FlexPen cartridge for subcutaneous Novo Nordisk A/S, Novo Allé,

use DK-2880 Bagsvaerd, Denmark

containing 3 mL of solution, supplied in YES YES YES

a carton box

solution for injection in

Levemir Penfill cartridge for subcutaneous Novo Nordisk A/S, Novo Allé, 5 Penfill glass cartridges with 3 mL of

use DK-2880 Bagsvaerd, Denmark solution, supplied in a carton box

YES YES YES

Levitra 10 mg film coated tablets film coated tablets Bayer HealthCare AG, 51368 2 tablets in a PP/Al blister, supplied in Leverkusen, Germany a box YES YES

Levitra 20 mg film coated tablets film coated tablets Bayer HealthCare AG, 51368 2 tablets in a PP/Al blister, supplied in Leverkusen, Germany a box YES YES

Levitra 5 mg film coated tablets film coated tablets Bayer HealthCare AG, 51368 2 tablets in a PP/Al blister, supplied in Leverkusen, Germany a box YES YES

Krka d.d., Šmarješka cesta 6,

Lexaurin tablets 1.5 mg tablets Novo mesto, Republic of 30 (2x15) tablets in a blister, supplied

Slovenia in a box

YES YES

Krka d.d., Šmarješka cesta 6,

Lexaurin tablets 3 mg tablets Novo mesto, Republic of 31 (2x15) tablets in a blister, supplied

Slovenia in a box

YES YES

Krka d.d., Šmarješka cesta 6,

Lexaurin tablets 6 mg tablets Novo mesto, Republic of 32 (2x15) tablets in a blister, supplied

Slovenia in a box

YES YES

14509/1/11 REV 1 WS/jj 304

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Alkaloid AD, Skopje, FYROM in

Lexilium 1.5 mg tablets tablets cooperation with F. Hoffmann-La 30 (3x10) tablets in a blister, supplied YES YES

Roche Ltd, Basel, Switzerland in a box

Alkaloid AD, Skopje, FYORM in

Lexilium 3 mg tablets tablets cooperation with F. Hoffmann-La 30 (3x10) tablets in a blister, supplied

Roche Ltd, Basel, Switzerland in a box

YES YES

Alkaloid AD, Skopje, FYROM in

Lexilium 6 mg tablets tablets cooperation with F. Hoffmann-La 30 (3x10) tablets in a blister, supplied

Roche Ltd, Basel, Switzerland in a box

YES YES

powder for preparation of

Lidacef injection 1g solution for i.v. and i.m. Pliva Krakow, Krakow, Poland Glass bottle (10 mL) with powder,

injection supplied in a box

YES YES

Lidacef injection 2 g powder for preparation of solution for i.v. infusion Pliva Krakow, Krakow, Poland Glass bottle (20 mL) with powder, supplied in a box YES YES

200 mL of solution, dropper, cap, and

LINOLA FETT ÖLBAD bath additive, solution Dr. August Wolff GmbH & Co. Arzneimittel, Bielefeld, Germany measuring 20 mL cup, supplied in a YES YES YES

box

LINOLA UREA cream Dr. August Wolff GmbH & Co. 75 g of cream in an aluminium tube, Arzneimittel, Bielefeld, Germany supplied in a box YES YES YES

100 grams of cream in an aluminum

Linoladiol vaginal cream Dr. August Wolff GmbH & Co. Arzneimittel, Bielefeld, Germany tube and a plastic vaginal applicator in YES YES

a protective bag, supplied in a box

50 g of cream in an aluminium tube

Linoladiol vaginal cream Dr. August Wolff GmbH & Co. Arzneimittel, Bielefeld, Germany and a plastic vaginal applicator in a YES YES

protective bag, supplied in a box

Linola-fett oily cream (water/oil Dr. August Wolff GmbH & Co. emulsion) Arzneimittel, Bielefeld, Germany Box with 75 g of cream in an Al tube YES YES YES

Lioresal 10 mg tablets tablets Novartis Farma S.p.A., Torre 50 (5x10) tablets in a blister (PVC/Al), Annunziata (Napoli), Italy supplied in a box YES YES

Novartis Farmacéutica S.A.,

Lioresal 25 mg tablets tablets Ronda Santa María 158, 50 (5x10) tablets in a blister YES YES

Barcelona, Spain (PVC/PE/PVDC//Al), supplied in a box

Merck Sharp & Dohme B.V.,

Lipex 10 mg film coated tablets film coated tablets Waarderweg 39, Postbus 581, 20 (2x10) tablets in a blister, supplied

Haarlem, the Netherlands in a box

YES YES

Merck Sharp & Dohme B.V.,

Lipex 20 mg film coated tablets film coated tablets Waarderweg 39, Postbus 581, 20 (2x10) tablets in a blister, supplied

Haarlem, the Netherlands in a box

YES YES

Merck Sharp & Dohme B.V.,

Lipex 40 mg film coated tablets film coated tablets Waarderweg 39, Postbus 581, 28 (2x14) tablets in a blister, supplied YES

Haarlem, the Netherlands in a box

YES

Merck Sharp & Dohme B.V.,

Lipex 80 mg film coated tablets film coated tablets Waarderweg 39, Postbus 581, 30 (2x14) film coated tablets in a

Haarlem, the Netherlands blister, supplied in a box

YES YES

Lipidil 145 mg film coated tablets Laboratoires Fournier S.A.,

31 (3x10) film coated tablets in a

Fontaine Les Dijon, France blister (PVC/PE/PVDC/Al), supplied in YES YES YES YES a box

Lipidil 160 mg film coated tablets Laboratoires Fournier S.A.,

32 (3x10) film coated tablets in a

Fontaine Les Dijon, France blister (PVC/PE/PVDC/Al), supplied in YES YES YES YES a box

LIPIDIL 200 M capsules, hard Laboratories Fournier S.A., 30 (3x10) capsules in a blister Fontaine Les Dijon, France (PVC/Al), supplied in a box YES YES YES

14509/1/11 REV 1 WS/jj 305

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

B. Braun Melsungen AG, Carl

Lipofundin MCT/LCT 10% emulsion for infusion Braun-Straße 1, Melsungen, 500 mL of emulsion for infusion in a

Germany glass bottle, 10 bottles per box

YES YES

B. Braun Melsungen AG, Carl

Lipofundin MCT/LCT 10% emulsion for infusion Braun-Straße 1, Melsungen, 100 mL of emulsion in a glass bottle, YES

Germany 10 bottles in a box

YES

B. Braun Melsungen AG, Carl

Lipofundin MCT/LCT 20% emulsion for infusion Braun-Straße 1, Melsungen, 500 mL of emulsion for infusion in a

Germany glass bottle, 10 bottles per box

YES YES

B. Braun Melsungen AG, Carl

Lipofundin MCT/LCT 20% emulsion for infusion Braun-Straße 1, Melsungen, 100 mL of emulsion for infusion in a YES YES

Germany glass bottle, 10 bottles in a box

LISINOLEX 10 mg tablets Galex d.d., Murska Sobota, 36 (3x10) tablets in a PVC/PVdC/Al Republic of Slovenia blister, supplied in a box YES YES

LISINOLEX 20 mg tablets Galex d.d., Murska Sobota, 37 (3x10) tablets in a PVC/PVdC/Al Republic of Slovenia blister, supplied in a box YES YES

LISINOLEX 5 mg tablets Galex d.d., Murska Sobota, 38 (3x10) tablets in a PVC/PVdC/Al Republic of Slovenia blister, supplied in a box YES YES

Clear type I glass vial, containing 5 mL

Litak 2 mg/mL solution for of solution, with a rubber bromobutyl

injection solution for injection

Lipomed AG, Arlesheim,

Switzerland stopper and protective aluminum ring, YES YES YES YES

supplied in a box

5 colourless glass bottles (glass type I)

Litak 2 mg/mL solution for with a rubber bromobutyl stopper and

injection solution for injection

Lipomed AG, Arlesheim,

Switzerland a protective aluminium ring containing YES YES YES YES

5 mL of solution, supplied in a box

Litalir capsules capsules Bristol Myers-Squibb S.r.I., 100 capsules in a brown plastic bottle, Sermoneta, Latina, Italy supplied in a box YES YES

LITIJ KARBONAT JADRAN 300 Jadran - Galenski laboratorij d.d., 100 tablets in an amber glass bottle,

mg tablets tablets Pulac bb, Rijeka, Republic of Croatia supplied in a box YES YES

N.V. Organon, Oss, the

Livial 2.5 mg tablets tablets Netherlands; Organon Republic of Ireland Ltd., Co. Dublin, 28 tablets in a blister, supplied in a box YES YES

Republic of Ireland

Farmal d.d., Branitelja

Lizinopril 10 mg tablets tablets domovinskog rata 8, Ludbreg, 30 tablets in a blister, supplied in a box YES YES

Republic of Croatia

Farmal d.d., Branitelja

Lizinopril 20 mg tablets tablets domovinskog rata 8, Ludbreg, 30 tablets in a blister, supplied in a box YES YES

Republic of Croatia

Farmal d.d., Branitelja

Lizinopril 5 mg tablets tablets domovinskog rata 8, Ludbreg, 30 tablets in a blister, supplied in a box YES YES

Republic of Croatia

LIZINOPRIL H 10 mg/12.5 mg Farmal d.d., Ludbreg, Republic of

tablets tablets Croatia in cooperation with 30 (3x10) tablets, supplied in a box YES YES Actavis hf., Hafnarfjordur, Island

LIZINOPRIL H 20 mg/12.5 mg Farmal d.d., Branitelja

tablets tablets domovinskog rata 8, Ludbreg, 30 (3x10) tablets, supplied in a box YES YES Republic of Croatia

Salutas Pharma GmbH,

Lizinopril Lek 10 mg tablets tablets Dieselstrasse 5, Gerlingen, 30 (3x10) tablets in a blister (PVC/Al), YES YES YES

Germany supplied in a box

14509/1/11 REV 1 WS/jj 306

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Salutas Pharma GmbH,

Lizinopril Lek 2.5 mg tablets tablets Dieselstrasse 5, Gerlingen, 30 (3x10) tablets in a blister (PVC/Al), YES YES YES

Germany supplied in a box

Salutas Pharma GmbH,

Lizinopril Lek 20 mg tablets tablets Dieselstrasse 5, Gerlingen, 30 (3x10) tablets in a blister (PVC/Al), YES YES

Germany supplied in a box

YES

Salutas Pharma GmbH,

Lizinopril Lek 5 mg tablets tablets Dieselstrasse 5, Gerlingen, 30 (3x10) tablets in a blister (PVC/Al), YES

Germany supplied in a box

YES YES

Merck KGaA, Frankfurter Straße

Lodoz 10 mg/6.25 mg film 30 (3x10) tablets in a blister, supplied

coated tablets film coated tablets

250, Darmstadt, Germany; Merck

SANTE s.a.s., 2, Rue du Pressoir in a box YES YES

Vert, Semoy, France

Merck KGaA, Frankfurter Straße

Lodoz 2.5 mg/6.25 mg film 30 (3x10) tablets in a blister, supplied

coated tablets film coated tablets

250, Darmstadt, Germany; Merck

SANTE s.a.s., 2, Rue du Pressoir in a box YES YES

Vert, Semoy, France

Merck KGaA, Frankfurter Straße

Lodoz 5 mg/6.25 mg film coated 30 (3x10) tablets in a blister, supplied

tablets film coated tablets

250, Darmstadt, Germany; Merck

SANTE s.a.s., 2, Rue du Pressoir in a box YES YES

Vert, Semoy, France

Logest coated tablets coated tablets Schering S.A., Lys Lez Lannoy, France Box with 21 coated tablets in a blister YES YES

Farmal d.d., Branitelja

Lopin tablets 10 mg tablets domovinskog rata 8, Ludbreg, 30 (3x10) tablets in a PVC/PVDC//Al YES YES

Republic of Croatia blister, supplied in a box

Farmal d.d., Branitelja

Lopin tablets 5 mg tablets domovinskog rata 8, Ludbreg, 31 (3x10) tablets in a PVC/PVDC//Al

Republic of Croatia blister, supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6,

Lorista 50 mg film coated tablets film coated tablets Novo mesto, Republic of 28 (4x7) tablets in a PVC/PVDC/Alu

Slovenia blister, supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6, 28 (4x7) film coated tablets in a

Lorista H film coated tablets Novo mesto, Republic of PVC/PVDC//Al blister, supplied in a YES YES YES YES

Slovenia box

Belupo, lijekovi i kozmetika d.d.,

Lorsilan 1 mg tablets tablets Ulica Danica 5, Koprivnica, 30 (1x30) tablets in a blister (PVC/Al),

Republic of Croatia supplied in a carton box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Lorsilan 2.5 mg tablets tablets Ulica Danica 5, Koprivnica, 20 (1x20) tablets in a blister (PVC/Al) , YES YES

Republic of Croatia supplied in a carton box

Pliva Croatia Ltd., Ulica grada

Losartic Plus tablets film coated tablets Vukovara 49, Zagreb, Republic of 28 (2x14) tablets in a blister, supplied

Croatia in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Losartic tablets 25 mg film coated tablets Vukovara 49, Zagreb, Republic of 28 (2x14) tablets in a blister, supplied

Croatia in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Losartic tablets 50 mg film coated tablets Vukovara 49, Zagreb, Republic of 28 (2x14) tablets in a blister, supplied YES YES

Croatia in a box

Loseprazol 20 mg capsules Pro. Med.CS Praha a.s., Prag, 14 (2x7) capsules in a OPA/Al/PVC//Al Czech Republic blister, supplied in a box YES YES

Loseprazol 20 mg capsules Pro. Med.CS Praha a.s., Prag, 14 (2x7) capsules in a blister, supplied Czech Republic in a box YES YES

14509/1/11 REV 1 WS/jj 307

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Schering-Plough Labo N.V.

Lotriderm cream cream Industrepark 30, Heist-op-den 15 g of cream in an aluminum tube,

Berg, Belgium supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Lubor 10 mg capsules capsules Ulica Danica 5, Koprivnica, 20 (1x20) tablets in a blister (PVC/Al) ,

Republic of Croatia supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Lubor 20 mg suppositories suppositories Ulica Danica 5, Koprivnica, 10 (2x5) suppositories in a Al/PE strip,

Republic of Croatia supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Lubor 20 mg capsules capsules Ulica Danica 5, Koprivnica, 20 (1x20) tablets in a blister (PVC/Al) ,

Republic of Croatia supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d., 50 g of cream in an aluminium tube

Luboreta cream cream Ulica Danica 5, Koprivnica, with a polyethylene stopper, supplied YES YES YES

Republic of Croatia in a box

Lucentis 10 mg/mL solution for Novartis Pharma Stein AG, injection solution for injection Schaffhauserstrasse, Stein, One glass bottle with 0.3 mL of YES YES Switzerland solution, supplied in a box

YES YES

Lumidol 100 mg/2 mL injections solution for injection ( i.v.,

Belupo, lijekovi i kozmetika d.d.,

i.m. and s.c.) Ulica Danica 5, Koprivnica,

5 glass ampoules with 2 mL of

Republic of Croatia solution, supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d., 10 mL of solution in an amber glass

LUMIDOL 100 mg/mL oral drops oral drops, solution Ulica Danica 5, Koprivnica, bottle with fitted plastic dropper and YES YES

Republic of Croatia plastic cap, supplied in a box

Belupo, lijekovi i kozmetika d.d., 20 capsules in a 50 mL plastic brown

LUMIDOL 50 mg capsules capsules, hard Ulica Danica 5, Koprivnica, bottle with temper-proof closure, YES YES

Republic of Croatia supplied in a box

Lumidol 50 mg/mL injection solution for injection ( i.v.,

Belupo, lijekovi i kozmetika d.d.,

i.m. and s.c.) Ulica Danica 5, Koprivnica,

5 glass ampoules with 1 mL of

Republic of Croatia solution, supplied in a box

YES YES

Allergan Pharmaceuticals

Lumigan 0.3 mg/mL eyel drops eye drops, solution Republic of Ireland, Castlebar 3 mL solution in a plastic bottle, Road, Westport, Co Mayo, supplied in a box YES YES YES

Republic of Ireland

Belupo, lijekovi i kozmetika d.d.,

LUPOCET 250 mg suppositories suppositories Ulica Danica 5, Koprivnica, 10 (2x5) suppositories in a Al/PE strip YES YES YES

Republic of Croatia foil, supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Lupocet 500 mg tablets tablets Ulica Danica 5, Koprivnica, 10 (1x10) tablets in a PVC/Al blister, YES

Republic of Croatia supplied in a box

YES YES

Lupocet BABY 120 mg Belupo, lijekovi i kozmetika d.d., 10 (2x5) suppositories in a PE/Al strip,

suppositories suppositories Ulica Danica 5, Koprivnica, YES YES YES Republic of Croatia supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Lupocet flu effervescent tablets Ulica Danica 5, Koprivnica, 10 effervescent tablets in a plastic

Republic of Croatia tube, supplied in a box

YES YES YES

Belupo, lijekovi i kozmetika d.d.,

Lupocet JUNIOR syrup syrup Ulica Danica 5, Koprivnica, 100 mL of syrup in an amber glass YES YES

Republic of Croatia bottle, supplied in a box

YES

Belupo, lijekovi i kozmetika d.d.,

Lupocet TEEN 300 mg capsules capsules Ulica Danica 5, Koprivnica, 20 (2x10) capsules in a (PVC/Al) YES YES YES

Republic of Croatia blister, supplied in a box

powder and diluent for Vial with powder and vial with diluent,

Luveris 75 IU preparation of solution for Industria Farmaceutica Serono injection (for subcutaneous S.p.A., Bari, Italy in a protective container, supplied in a YES YES YES

use) box

14509/1/11 REV 1 WS/jj 308

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pliva Croatia Ltd., Ulica grada

Luxeta tablets 100 mg film tablets Vukovara 49, Zagreb, Republic of 28 tablets in a blister, supplied in a box YES YES

Croatia

Pliva Croatia Ltd., Ulica grada

Luxeta tablets 50 mg film tablets Vukovara 49, Zagreb, Republic of 28 tablets in a blister, supplied in a box YES YES

Croatia

Pfizer GmbH Arzneimittelwerk

Lyrica 100 mg capsules capsules, hard Gödecke, Mooswaldallee 1, 84 (4x21) capsules in a blister

Freiburg, Germany (PVC/Al), supplied in a box

YES YES YES

Pfizer GmbH Arzneimittelwerk

Lyrica 150 mg capsules capsules, hard Gödecke, Mooswaldallee 1, 56 (4x14) capsules in a blister YES YES

Freiburg, Germany (PVC/Al), supplied in a box

YES

Pfizer GmbH Arzneimittelwerk

Lyrica 200 mg capsules capsules, hard Gödecke, Mooswaldallee 1, 84 (4x21) capsules in a blister

Freiburg, Germany (PVC/Al), supplied in a box

YES YES YES

Pfizer GmbH Arzneimittelwerk

Lyrica 25 mg capsules capsules, hard Gödecke, Mooswaldallee 1, 56 (4x14) capsules in a blister YES YES YES

Freiburg, Germany (PVC/Al), supplied in a box

Pfizer GmbH Arzneimittelwerk

Lyrica 300 mg capsules capsules, hard Gödecke, Mooswaldallee 1, 56 (4x14) capsules in a blister

Freiburg, Germany (PVC/Al), supplied in a box

YES YES YES

Pfizer GmbH Arzneimittelwerk

Lyrica 50 mg capsules capsules, hard Gödecke, Mooswaldallee 1, 56 (4x14) capsules in a blister

Freiburg, Germany (PVC/Al), supplied in a box

YES YES YES

Pfizer GmbH Arzneimittelwerk

Lyrica 75 mg capsules capsules, hard Gödecke, Mooswaldallee 1, 56 (4x14) capsules in a blister YES YES

Freiburg, Germany (PVC/Al), supplied in a box

YES

LYSOBACT oriblets tablets for oral cavity oral

Bosnalijek d.d., Jukićeva 53, 30 (3x10) tablets in a blister, supplied

(orbilettes) Sarajevo, Bosnia and YES YES YES Herzegovina in a box

MabCampath 30 mg/mL concentrate for infusion Schering AG, Muellerstrasse 3x1 glass bottles with 1 mL of

concentrate for infusion solution solution 170-178, Berlin, Germany concentrate for solution for infusion, YES YES YES supplied in a box

MabThera 100 mg solution solution concentrate for F. Hoffmann-La Roche Ltd., 10 mL of infusion solution concentrate

concentrate for infusion infusion Grenzacherstrasse 124, Basel, Switzerland in a glass bottle, 2 bottles in a box YES YES YES YES

MabThera 500 mg concentrate concentrate of solution for F. Hoffmann-La Roche Ltd., 50 mL of solution for infusion

of solution for infusion infusion Grenzacherstrasse 124, Basel, concentrate in a glass bottle, supplied YES YES YES YES Switzerland in a box

One glass pre-filled syringe with

Macugen 0.3 mg solution for injection Pfizer Health AB, Stockholm, Sweden needle, in a protective bag, supplied in YES YES YES YES

a box

F. Hoffmann-La Roche Ltd.,

Madopar 125 tablets tablets Grenzacherstrasse 124, Basel, 100 tablets in an amber glass bottle

Switzerland (with desiccant), supplied in a box

YES YES

F. Hoffmann-La Roche Ltd.,

Madopar HBS 125 capsules capsules Grenzacherstrasse 124, Basel, 30 capsules in an amber glass bottle

Switzerland (with a desiccant), supplied in a box

YES YES

Madopar LIQ 125 tablets for oral F. Hoffmann-La Roche Ltd., suspension tablets for oral suspension Grenzacherstrasse 124, Basel,

100 tablets in an amber glass bottle

Switzerland (with dessicant), supplied in a box

YES YES

Magnevist solution for injection solution for injection Schering AG, Muellerstrasse 20 mL of solution in a glass bottle with 170-178, Berlin, Germany rubber stopper, supplied in a box YES YES

Magnevist solution for injection solution for injection Schering AG, Muellerstrasse 10 mL of solution in a glass bottle with 170-178, Berlin, Germany rubber stopper, supplied in a box YES YES

14509/1/11 REV 1 WS/jj 309

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Belupo, lijekovi i kozmetika d.d.,

Makcin 500 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 14 (1x14) tablets in a blister, supplied YES

Republic of Croatia in a box

YES

Pliva Croatia Ltd., Ulica grada 500 mL of solution in a glass infusion

MANIT 10% solution for infusion Vukovara 49, Zagreb, Republic of bottle with a rubber stopper and a YES YES

Croatia protective cap, 10 bottles in a box

Pliva Croatia Ltd., Ulica grada 250-mL of solution in a glass bottle for

MANIT 20% solution for infusion Vukovara 49, Zagreb, Republic of infusion with rubber stopper and YES YES

Croatia protective cap, 10 bottles in a box

Krka d.d., Novo mesto, Republic

Marivarin 3 mg tablets tablets of Slovenia in cooperation with 50 tablets in an amber glass bottle with Orion Corporation, Espoo, an aluminium stopper YES YES

Finland

Materna with selenium film coated tablets Wyeth Lederle S.p.A., Catania, 30 tablets in a HDPE bottle, supplied Italy in a box YES YES YES

2 (2x1) oral lyophilisate in a blister

MAXALT RPD 10 mg oral Merck Sharp & Dohme B.V., (PVC/PVDC//Al) and protective bag

lyophilisates oral lyophilisate Waarderweg 39, Postbus 581, YES Haarlem, The Nederlands (paper/PE/Al), in a plastic box, YES YES

supplied in a carton box

2 (2x1) oral lyophilisate in a blister

MAXALT RPD 5 mg oral Merck Sharp & Dohme B.V., (PVC/PVDC//Al) and protective bag

lyophilisates oral lyophilisate Waarderweg 39, Postbus 581, YES YES Haarlem, the Netherlands (paper/PE/Al), in a plastic box, YES

supplied in a carton box

Pliva Croatia Ltd., Ulica grada 10 effervescent tablets with or without

MAXFLU lemon flavour effervescent tablets Vukovara 49, Zagreb, Republic of an Al foil, in a polypropylene tube with YES YES

Croatia a cap (PE) with silicagel and tamper

YES

proof ring, supplied in a box

Maxidex 1 mg/g eye ointment eye ointment Alcon-Couvreur s.a., Rijksweg 3.5 g of ointment in an aluminum tube, 14, Puurs, Belgium supplied in a box YES YES

Maxidex 1 mg/mL eye drops, 5 mL of suspension in a polyethylene

suspension eye drops, suspension

Alcon-Couvreur s.a., Rijksweg

14, Puurs, Belgium bottle with a dropper, supplied in a box YES YES

Maxipime 1 g powder for preparation of

Jadran - Galenski laboratorij d.d.,

i.m. and i.v. injections Pulac bb, Rijeka, Republic of

Glass bottle with powder, supplied in a YES

Croatia box

YES

Jadran - Galenski laboratorij d.d.,

Maxipime 2 g powder for preparation of Glass bottle with powder, supplied in a i.m. and i.v. injections Pulac bb, Rijeka, Republic of YES YES

Croatia box

Maxipime 500 mg powder for preparation of

Jadran - Galenski laboratorij d.d.,

i.m. and i.v. injections Pulac bb, Rijeka, Republic of

Glass bottle with powder, supplied in a

Croatia box

YES YES

Maxitrol eye drops, suspension eye drops, suspension Alcon-Couvreur s.a., Rijksweg Polyethylene bottle with 5 mL of drops, 14, Puurs, Belgium supplied in a box YES YES

Maxitrol eye ointment eye ointment Alcon-Couvreur s.a., Rijksweg 3.5 g of ointment in an aluminum tube, 14, Puurs, Belgium supplied in a box YES YES

Medazol 0.5 % solution for Belupo, lijekovi i kozmetika d.d., infusion solution for infusion Ulica Danica 5, Koprivnica,

100 mL of solution in a glass bottle for

Republic of Croatia infusion, supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Medazol 250 mg tablets tablets Ulica Danica 5, Koprivnica, 20 tablets in a plastic (polypropylene)

Republic of Croatia bottles, supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Medazol 400 mg tablets tablets Ulica Danica 5, Koprivnica, 10 (1x10) tablets in a PVC/Al blister,

Republic of Croatia supplied in a box

YES YES

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Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Belupo, lijekovi i kozmetika d.d.,

Medazol 500 mg vaginal tablets vaginal tablets Ulica Danica 5, Koprivnica, 10 (1x10) vaginal tablets in a PVC/Al

Republic of Croatia blister, supplied in a box

YES YES

Messer Croatia Plin d.o.o., Pressurized steel bottles (150 or 200

Medical gas, O2 medical medical gas Zaprešić, Industrijska 1, Republic bar) with 2, 3, 5, 10, 20, 27, 30, 40 or YES YES

of Croatia 50 liters of gaseous medical oxygen

MEDROL tablets 16 mg tablets Pfizer Italia S.r.l., Marina De 50 (5x10) tablets in a blister (PVC/Al), Tronto, Ascoli Piceno, Italy supplied in a box YES YES

MEDROL tablets 32 mg tablets Pfizer Italia S.r.l., Marina De 20 (2x10) tablets in a blister (PVC/Al), Tronto, Ascoli Piceno, Italy supplied in a box YES YES

MEDROL 4 mg tablets tablets Pfizer Italia S.r.l., Marina De 30 tablets in an amber glass bottle with Tronto, Ascoli Piceno, Italy a plastic stopper, supplied in a box YES YES

Haupt Pharma Regensburg

Megace tablets 160 mg tablets GmbH, Regensburg, Germany 100 tablets in a plastic (HDPE) bottle, YES

for Bristol-Myers Squibb supplied in a box

YES

Krka d.d., Šmarješka cesta 6,

Meglimid 1 mg tablets tablets Novo mesto, Republic of 30 (3x10) tablets in transparent

Slovenia PVC//Al blister, supplied in a box

YES YES YES YES

Krka d.d., Šmarješka cesta 6,

Meglimid 2 mg tablets tablets Novo mesto, Republic of 31 (3x10) tablets in transparent

Slovenia PVC//Al blister, supplied in a box

YES YES YES YES

Krka d.d., Šmarješka cesta 6,

Meglimid 3 mg tablets tablets Novo mesto, Republic of 32 (3x10) tablets in transparent YES YES YES YES

Slovenia PVC//Al blister, supplied in a box

240 mL suspension in a plastic

MEGOSTAT oral suspension oral suspension Bristol-Myers Squibb, Epernon, (HDPE) bottle with child resistant France closure, 20 mL plastic measuring YES YES

glass, supplied in a box

Alkaloid AD - Skopje, Bulevar

Mendilex tablets Aleksandar Makedonski 12, 50 (5x10) tablets in a blister (PVC/Al),

Skopje, FYROM supplied in a box

YES YES

lyophilisate and diluent for 10 bottles with lyophilisate and 10

Menopur preparation of solution for Ferring GmbH, Wittland 1, Kiel, YES YES YES

injection Germany

ampoules with diluent, supplied in a

carton box

lyophilisate and diluent for 5 bottles with lyophilisate and 5

Menopur preparation of solution for Ferring GmbH, Wittland 1, Kiel, YES YES YES

injection Germany

ampoules with solvent, supplied in a

box

Box with 1 bottle with 1 dose of

MERIEUX INACTIVATED lyophilisate for preparation Sanofi Pasteur S.A., 2 avenue lyophilised vaccine, 1 pre-filled syringe

RABIES VACCINE of intramuscular injection Pont Pasteur, Lyon, France containing 1 mL of water for injection YES YES

and a needle

AstraZeneca UK Limited, Silk

Meronem i.v. 1 g powder for preparation of Road Business Park, 10 bottles with powder, supplied in a i.v. injection Macclesfield, Cheshire, Great box YES YES

Britain

AstraZeneca UK Limited, Silk

Meronem i.v. 500 mg powder for preparation of Road Business Park, 10 bottles with powder, supplied in a i.v. injection Macclesfield, Cheshire, Great box YES YES

Britain

10 glass bottles with à 20 mL of

METHOTREXATE PLIVA Pliva Croatia Ltd., Ulica grada injection 1000 solution for infusion Vukovara 49, Zagreb, Republic of solution for injection (with rubber YES YES

Croatia stopper, aluminum cap and plastic cover), supplied in a box

METHOTREXATE PLIVA Pliva Croatia Ltd., Ulica grada 10 glass bottles with à 2 mL of solution

injection 20 solution for injection Vukovara 49, Zagreb, Republic of for injection (with rubber stopper, YES YES Croatia aluminum cap and plastic cover),

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Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

supplied in a box

METHOTREXATE PLIVA Pliva Croatia Ltd., Ulica grada

10 glass bottles with à 2 mL of solution

for injection (with rubber stopper,

injection 5 solution for injection Vukovara 49, Zagreb, Republic of Croatia aluminum cap and plastic cover), YES YES

supplied in a box

10 glass bottles with à 5 mL of solution

METHOTREXATE PLIVA Pliva Croatia Ltd., Ulica grada for injection (with rubber stopper,

injection 50 solution for injection Vukovara 49, Zagreb, Republic of YES Croatia aluminum cap and plastic cover), YES

supplied in a box

Jadran - Galenski laboratorij d.d.,

Metopran tablets Pulac bb, Rijeka, Republic of 40 (4x10) tablets in a blister (PVC/Al), YES YES

Croatia supplied in a box

Metronidazol Genericon 0.5 % Genericon Pharma Ges.m.b.H., 10 (10x1) glass bottles with 100 mL of

solution for infusion solution for infusion Hafnerstrasse 211, Graz, Austria infusion solution, supplied in a box YES YES

Boehringer Ingelheim Pharma

Mexitil 200 mg capsules capsules GmbH & Co. KG, Birkendorfer 50 (5x10) capsules in a blister, Strasse 65, Biberach an der Riss, supplied in a box YES YES

Germany

Novartis Pharma Stein AG,

Miacalcic 100 IU injection solution for injection Schaffhauserstrasse, Stein, 5 ampoules with 1 mL of solution,

Switzerland supplied in a box

YES YES

Miacalcic 200 IU aerosol nasal spray, solution Novartis Pharma S.A.S., Solution in a glass bottle with spray Huningue Cedex, France (for nasal use), supplied in a box YES YES

Boehringer Ingelheim Pharma

Micardis 40 mg tablets tablets GmbH & Co. KG, Binger Strasse 28 (4x7) tablets in a blister 173, Ingelheim am Rhein, (PA/Al/PVC/Al), supplied in a box YES YES YES

Germany

Boehringer Ingelheim Pharma

Micardis 80 mg tablets tablets GmbH & Co. KG, Binger Strasse 28 (4x7) tablets in a blister 173, Ingelheim am Rhein, (PA/Al/PVC/Al), supplied in a box YES YES YES

Germany

Boehringer Ingelheim Pharma

MicardisPlus 40/12.5 mg tablets tablets GmbH & Co. KG, Binger Strasse 28 (4x7) tablets in a blister 173, Ingelheim am Rhein, (PA/Al/PVC/Al), supplied in a box YES YES YES

Germany

Boehringer Ingelheim Pharma

MicardisPlus 80/12.5 mg tablets tablets GmbH & Co. KG, Binger Strasse 28 (4x7) tablets in a blister 173, Ingelheim am Rhein, (PA/Al/PVC/Al), supplied in a box YES YES YES

Germany

MIDAZOLAM TORREX 15 mg/3 Torrex Chiesi Pharma GmbH, 10 (2x5) ampoules with 3 mL of

mL solution for injection Gonzagagasse 16/16, Vienna, solution, on a plastic tray, supplied in a YES YES Austria box

MIDAZOLAM TORREX 2 mg/2 Torrex Chiesi Pharma GmbH, 10 (2x5) ampoules with 2 mL of

mL solution for injection Gonzagagasse 16/16, Vienna, solution, on a plastic tray, supplied in a YES YES Austria box

MIDAZOLAM TORREX 5 mg/5 Torrex Chiesi Pharma GmbH, 10 (2x5) ampoules with 5 mL of

mL solution for injection Gonzagagasse 16/16, Vienna, solution, on a plastic tray, supplied in a YES YES Austria box

Torrex Chiesi Pharma GmbH, 10 (2x5) ampoules with 1 mL of

MIDAZOLAM TORREX 5 mg/mL solution for injection Gonzagagasse 16/16, Vienna, solution, on a plastic tray, supplied in a YES YES

Austria box

MIDAZOLAM TORREX 50 Torrex Chiesi Pharma GmbH, 10 (2x5) ampoules with 10 mL of

mg/10 mL solution for injection Gonzagagasse 16/16, Vienna, solution, on a plastic tray, supplied in a YES YES Austria box

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Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Minerva sugar-coated tablets sugar-coated tablets Schering AG, Muellerstrasse 63 (3x21) tablets in a PVC/Al blister, 170-178, Berlin, Germany supplied in a box YES YES

Minirin Melt 120 µg oral lyophilisate Ferring AB, Limhamn, Sweden 30 (3x10) oral lyophilisate in a blister (Al/Al), supplied in a box YES YES

Minirin Melt 60 µg oral lyophilisate Ferring AB, Limhamn, Sweden 31 (3x10) oral lyophilisate in a blister (Al/Al), supplied in a box YES YES

Ferring AB, Limhamn, Sweden; 5 mL of solution (50 doses à 10 µg) in

Minirin nasal spray nasal spray (solution) Ferring International Center SA, an amber glass bottle with a spray Chemin de la Vergognausaz, attachment and a plastic attachment YES YES

Switzerland for nasal use, supplied in a box

Ferring AB, Limhamn, Sweden;

Minirin 0.2 mg tablets tablets Ferring International Center SA, 30 tablets in a plastic bottle, supplied Chemin de la Vergognausaz, in a box YES YES

Switzerland

Boehringer Ingelheim Pharma

Mirapexin tablets 0.25 mg tablets GmbH & Co. KG, Binger Strasse 30 (3x10) tablets in a PA/Al/PVC-Al 173, Ingelheim am Rhein, blister, supplied in a box YES YES YES

Germany

Boehringer Ingelheim Pharma

Mirapexin tablets 1 mg tablets GmbH & Co. KG, Binger Strasse 31 (3x10) tablets in a PA/Al/PVC-Al 173, Ingelheim am Rhein, blister, supplied in a box YES YES YES

Germany

intrauterine system (20 Intrauterine system with integrated

Mirena intrauterine system mcg/24 h release of active substance) with integrated Schering OY, Turku, Finland applicator in a blister (APET/Tyvek), YES YES

applicator supplied in a box

Pliva Croatia Ltd., Ulica grada

Mirocef injection 1 g powder for solution for 5 glass bottles with powder, supplied injection Vukovara 49, Zagreb, Republic of

Croatia in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Mirocef injection 500 mg powder for solution for 5 glass bottles with powder, supplied injection Vukovara 49, Zagreb, Republic of

Croatia in a box

YES YES

Mirzaten 30 mg film coated Krka d.d., Šmarješka cesta 6, tablets film coated tablets Novo mesto, Republic of

30 tablets (3x10) in a PVC//PVDC/Al

Slovenia blister, supplied in a box

YES YES

Mirzaten 45 mg film coated Krka d.d., Šmarješka cesta 6, tablets film coated tablets Novo mesto, Republic of 30 tablets (3x10) in a PVC/PVDC/Al YES YES Slovenia blister, supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Misar 0.25 mg tablets tablets Ulica Danica 5, Koprivnica, 30 (1x30) tablets in a blister, supplied YES YES

Republic of Croatia in a box

Belupo, lijekovi i kozmetika d.d.,

Misar 0.5 mg tablets tablets Ulica Danica 5, Koprivnica, 30 (1x30) tablets in a blister, supplied

Republic of Croatia in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Misar 1 mg tablets tablets Ulica Danica 5, Koprivnica, 30 (1x30) tablets in a blister, supplied

Republic of Croatia in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Misar SR 0.5 mg tablets prolonged-release tablets Ulica Danica 5, Koprivnica, 30 (2x15) tablets in a blister, supplied

Republic of Croatia in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Misar SR 1 mg tablets prolonged-release tablets Ulica Danica 5, Koprivnica, 30 (2x15) tablets in a blister, supplied YES

Republic of Croatia in a box

YES

Pliva Croatia Ltd., Ulica grada Colourless glass bottle with 15 mL of

Mitoxantrone Pliva concentrate of solution for infusion solutio Vukovara 49, Zagreb, Republic of concentrate of solution for infusion, YES YES

Croatia closed with a rubber stopper and an

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Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

aluminium cap with a plastic lid,

supplied in a box

Novo Nordisk A/S, Novo Alle,

Bagsvaerd, Denmark Novo 5 glass cartridges with 3 mL of

Mixtard 30 Penfill 3 mL suspension for isubcutaneous injection Nordisk Production SAS, 45, suspension in a blister, supplied in a YES YES

Avenue d' Orleans, Chartres, box

France

Mixtard 40 Penfill 3 mL suspension for Novo Nordisk A/S, Novo Allé,

5 glass cartridges with 3 mL of

isubcutaneous injection DK-2880 Bagsvaerd, Denmark suspension in a blister, supplied in a YES YES box

Mixtard 50 Penfill 3 mL suspension for Novo Nordisk A/S, Novo Allé,

5 glass cartridges with 3 mL of

isubcutaneous injection DK-2880 Bagsvaerd, Denmark suspension in a blister, supplied in a YES YES box

Krka d.d., Novo mesto, R.

Moditen depo injections 25 mg/1 oily solution for Republic of Slovenia in 5 amber glass ampoules each with 1 mL intramuscular injection cooperation with Bristol-Myers mL of solution, supplied in a carton YES YES Squibb, New York, USA box

KRKA d.d., Novo Mesto,

Moditen coated tablets 1 mg coated tablets Republic of Slovenia in 25 tablets in an amber glass bottle, cooperation with Bristol-Myers supplied in a box YES YES

Squibb, NY, USA

KRKA d.d., Novo Mesto,

Moditen coated tablets 2.5 mg coated tablets Republic of Slovenia in 100 tablets in an amber glass bottle, cooperation with Bristol-Myers supplied in a carton box YES YES

Squibb, NY, USA

KRKA d.d., Novo Mesto,

Moditen coated tablets 5 mg coated tablets Republic of Slovenia in 100 tablets in an amber glass bottle, cooperation with Bristol-Myers supplied in a carton box YES YES

Squibb, NY, USA

Lek farmacevtska družba d.d.,

Moduretic tablets tablets Verovškova 57, Ljubljana, 40 tablets in an amber glass bottle, YES

Republic of Slovenia supplied in a box

YES

Jadran -Galenski laboratorij d.d.,

Rijeka, Republic of Croatia, in

Monopril 10 mg tablets cooperation with Bristol-Myers 28 (2x14) tablets in a blister (white YES

Squibb S.p.A., Contrada Fontana PVC/PVDC//Al), supplied in a box

YES

del Cerasp. Anagni, Italy

Jadran -Galenski laboratorij d.d.,

Rijeka, Republic of Croatia, in

Monopril 20 mg tablets cooperation with Bristol-Myers 28 (2x14) tablets in a blister (white YES

Squibb S.p.A., Contrada Fontana PVC/PVDC//Al), supplied in a box

YES

del Cerasp. Anagni, Italy

Jadran - Galenski laboratorij d.d., 28 (2x14) tablets in a nontransparent

Monopril plus 20/12.5 tablets Pulac bb, Rijeka, Republic of PVC/PVDC/Alu blister, supplied in a YES YES

Croatia box

Schering-Plough Farma, Lda, 25 grams of ointment in a white

Monsalic ointment ointment Casal do Colaride, Agualva enamel tube with white polypropylene YES YES YES YES

Cacem, Portugal screw cap, supplied in a carton box

ALKALOID Morphine Alkaloid AD - Skopje, Bulevar 10 amber glass ampoules each

hydrochloride 20 mg/1 mL solution for injection Aleksandar Makedonski 12, containing 1 mL of solution, supplied in YES YES Skopje, FYROM a box

ALKALOID Morphine Alkaloid AD - Skopje, Bulevar 10 amber glass ampoules each

hydrochloride 4 mg/1 mL solution for injection Aleksandar Makedonski 12, containing 1 mL of solution, supplied in YES YES Skopje, FYROM a box

Pliva Croatia Ltd., Ulica grada

Mostrafin tablets film coated tablets Vukovara 49, Zagreb, Republic of 28 (4x7) tablets in a blister, supplied in

Croatia a box

YES YES

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Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pliva Croatia Ltd., Ulica grada

Mostrafin tablets film coated tablets Vukovara 49, Zagreb, Republic of 28 (2x14) tablets in a blister, supplied

Croatia in a box

YES YES

Boehringer Ingelheim Pharma

Movalis 15 mg tablets tablets GmbH & Co. KG, Binger Strasse 20 (1x20) tablets in a PVC/PVDC/Al 173, Ingelheim am Rhein, blister, supplied in a box YES YES

Germany

Boehringer Ingelheim Espana,

Movalis 15 mg/1.5 mL injection solution for injection S.A., Sant Cugat del Valles 5 ampoules with 1.5 mL of solution, YES YES

(Barcelona), Spain supplied in a box

Boehringer Ingelheim Pharma

Movalis 7.5 mg tablets tablets GmbH & Co. KG, Binger Strasse 20 (1x20) tablets in a PVC/PVDC/Al 173, Ingelheim am Rhein, blister, supplied in a box YES YES

Germany

Bard Pharmaceuticals Ltd.,

Cambridge,Great Britain,

MST CONTINUS 10 mg prolonged-release film coated tablets Mundipharma Gm.b.H., Limburg, 30 (3x10) tablets in a blister

Germany, Mundipharma (PVdC/PVC/Al), supplied in a box

YES YES

Ges.m.b.H, Vienna, Austria

Bard Pharmaceuticals Limited,

MST Continus 10 mg film coated tablets with

Cambridge, Great Britain, 60 (2x30) tablets in a blister

prolonged-release Mundipharma Gm.b.H., Limburg, YES Njemačka, Mundipharma (PVC/PVDC-Al), supplied in a box YES

Ges.m.b.H, Beč, Austria

Bard Pharmaceuticals Limited,

Cambridge, Great Britain,

MST Continus 100 mg film coated tablets with prolonged-release Mundipharma Gm.b.H., Limburg, 60 (2x30) tablets in a blister YES YES

Njemačka, Mundipharma (PVC/PVDC-Al), supplied in a box

Ges.m.b.H, Beč, Austria

Bard Pharmaceuticals Ltd.,

Cambridge,Great Britain,

MST CONTINUS 100 mg prolonged-release film 30 (3x10) tablets in a blister coated tablets Mundipharma Gm.b.H., Limburg,

Germany, Mundipharma (PVdC/PVC/Al), supplied in a box

YES YES

Ges.m.b.H, Vienna, Austria

Bard Pharmaceuticals Limited,

MST Continus 30 mg film coated tablets with

Cambridge, Great Britain, 60 (2x30) tablets in a blister

prolonged-release Mundipharma Gm.b.H., Limburg, YES Njemačka, Mundipharma (PVC/PVDC-Al), supplied in a box YES

Ges.m.b.H, Beč, Austria

Bard Pharmaceuticals Ltd.,

Cambridge,Great Britain,

MST CONTINUS 30 mg prolonged-release film coated tablets Mundipharma Gm.b.H., Limburg, 30 (3x10) tablets in ablister

Germany, Mundipharma (PVdC/PVC/Al), supplied in a box

YES YES

Ges.m.b.H, Vienna, Austria

Bard Pharmaceuticals Ltd.,

Cambridge,Great Britain,

MST CONTINUS 60 mg prolonged-release film coated tablets Mundipharma Gm.b.H., Limburg, 30 (3x10) tablets in a blister

Germany, Mundipharma (PVdC/PVC/Al), supplied in a box

YES YES

Ges.m.b.H, Vienna, Austria

Bard Pharmaceuticals Limited,

MST Continus 60 mg film coated tablets with

Cambridge, Great Britain, 60 (2x30) tablets in a blister

prolonged-release Mundipharma Gm.b.H., Limburg, YES Njemačka, Mundipharma (PVC/PVDC-Al), supplied in a box YES

Ges.m.b.H, Beč, Austria

Krka tovarna zdravil, d.d., Novo

Mukolen coated tablets 50 mg coated tablets mesto,Republic of Slovenia in 20 (2x10) coated tablets in PVC/Al cooperation with E Pharma, blister, supplied in a box YES YES

France

MULTIBIONTA FORTE N 20 (2x10) capsules in PVC/PVDC-Al

capsules capsules, soft

Merck Selbstmedikation GmbH,

Darmstadt, Germany blister, supplied in a box YES YES YES

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Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Novartis Pharma Stein AG,

Myfortic 180 mg tablets gastric-resistant tablets Schaffhauserstrasse, Stein, 120 (12x10) tablets in a PA/Al/PVC- Al YES

Switzerland blister, supplied in a box

YES YES

Novartis Pharma Stein AG,

Myfortic 360 mg tablets gastric-resistant tablets Schaffhauserstrasse, Stein, 120 (12x10) tablets in a PA/Al/PVC- Al

Switzerland blister, supplied in a box

YES YES YES

Pliva Croatia Ltd., Ulica grada

Myoflex tablets Vukovara 49, Zagreb, Republic of 20 (2x10) tablets in a blister (PVC/Al), YES YES

Croatia supplied in a box

5 mL of solution in a white plastic

Naclof eye drops, solution EXCELVISION, Annonay, France (LDPE) bottle with a dropper and a plastic (HDPE) stopper with a safety YES YES

ring, supplied in a box

Cardinal Health,

NAGLAZYME 5 mL concentrate concentrate for solution for Northamptonshire, Great Britain; One glass vial with 5 mL of

for solution for infusion infusion Cardinal Health, Westhoughton, concentrate, supplied in a box YES YES YES YES

Bolton, Great Britain

Krka d.d., Šmarješka cesta 6, 10 (2x5) suppositories in a

Naklofen suppositories 50 mg suppositories Novo mesto, Republic of Al/PE//PE/AL strip, supplied in a carton YES YES

Slovenia box

Krka d.d., Šmarješka cesta 6, 20 (2x10) hard capsules in a blister

Naklofen duo capsules 75 mg hard capsules Novo mesto, Republic of (PVC/PE/PVDC/PE/PVC//Al), supplied YES YES

Slovenia in a box

Krka d.d., Šmarješka cesta 6,

Naklofen gel gel Novo mesto, Republic of 60 g of gel in an aluminium tube, YES

Slovenia supplied in a carton box

YES YES

Naklofen solution for injection 75 Krka d.d., Šmarješka cesta 6, 3 mL solution for injectionin a glass

mg/3mL solution for injection Novo mesto, Republic of YES YES Slovenia ampoule, 5 ampoules in a box

Krka d.d., Šmarješka cesta 6,

Naklofen SR prolonged-release tablets Novo mesto, Republic of 20 (2x10) prolonged-release tablets in YES YES

Slovenia PVC/Al blister, supplied in a box

Naklofen gastric-resistant tablets Krka d.d., Šmarješka cesta 6, 50 mg gastric-resistant tablets Novo mesto, Republic of

20 (2x10) gastric-resistant tablets in

Slovenia PVC/Al blister, supplied in a box

YES YES

Lek farmacevtska družba d.d.,

Nakom 250 mg / 25 mg tablets tablets Verovškova 57, Ljubljana, 100 (10x10) tablets in PVC/Al blister,

Republic of Slovenia supplied in a box

YES YES

Nalgesin forte 550 mg film Krka d.d., Šmarješka cesta 6, coated tablets film coated tablets Novo mesto, Republic of 10 (1x10) film coated tablets in a YES Slovenia PVC/Al blister, supplied in a box

YES

Nalgesin S 275 mg film coated Krka d.d., Šmarješka cesta 6, 10 (1x10) film coated tablets in a

tablets film coated tablets Novo mesto, Republic of YES YES Slovenia PVC/Al blister, supplied in a box

Box with powder and a box with a

Nanotiv 1000 IU powder and diluent for Octapharma AB, Stockholm, bottle containing 10 mL of water for solution for injection Sweden injection, application kit, supplied in a YES YES

box

Box with powder and a box with a

Nanotiv 500 IU powder and diluent for Octapharma AB, Stockholm, bottle containing 5 mL of water for solution for injection Sweden injection, application kit, supplied in a YES YES

box

10 mL of solution in a whilte plastic

Nasivin 0.05% nasal spray nasal spray, solution Merck KGaA, Frankfurter Straße bottle with a plastic attachment (with 250, Darmstadt, Germany internal atomizing tube) and plastic YES YES YES

cap, supplied in a box

Nasivin 0.05% nasal spray 10 mL of solution in a white plastic without preservative nasal spray, solution

Merck KGaA, Frankfurter Straße

250, Darmstadt, Germany bottle with a 3K system and protective YES YES YES cap, supplied in a box

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Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Nasivin D 0.05% nasal spray nasal spray, solution Merck KGaA, Frankfurter Straße

10 mL of solution in an amber glass

250, Darmstadt, Germany bottle with a plastic atomizer pump and YES YES YES protective cap, supplied in a box

5 mL of solution in an amber glass

Nasivin K 0.01% nasal drops nasal drops, solution Merck KGaA, Frankfurter Straße bottle with a plastic stopper and a 250, Darmstadt, Germany glass dropper with a rubber pump, YES YES YES

supplied in a box

10 mL of solution in an amber glass

Nasivin K 0.025% nasal drops nasal drops, solution Merck KGaA, Frankfurter Straße bottle with a yellow plastic cap and 250, Darmstadt, Germany glass dropper with rubber bulb, YES YES YES

supplied in a box

10 mL of solution in an amber glass

Nasivin K 0.05% nasal drops nasal drops, solution Merck KGaA, Frankfurter Straße bottle with while plastic cap and glass 250, Darmstadt, Germany dropper with rubber bulb, supplied in a YES YES YES

box

Schering-Plough Labo N.V. Plastic bottle with an attachment for

Nasonex nasal spray nasal spray, suspension Industrepark 30, Heist-op-dennasal administration containing 120 YES YES

Berg, Belgium doses, supplied in a box

Natrii chloridi infundibile Pliva Croatia Ltd., Ulica grada

500 mL of solution for infusion in a

compositum Pliva solution for infusion Vukovara 49, Zagreb, Republic of

glass bottle with a rubber stopper and YES YES

Croatia an aluminium cap with a plastic lid, 10 bottles in a box

Natrii chloridi infundibile solution solution for intravenous Hrvatski zavod za transfuzijsku 100 mL in a glass infusion bottle, (10

for intravenous infusion, 100 mL infusion medicinu, Petrova 3, Zagreb, YES YES Republic of Croatia bottles with plastic holders in a box)

Natrii chloridi infundibile solution Hrvatski zavod za transfuzijsku

for intravenous infusion, 1000 solution for intravenous 1000 mL in a glass infusion bottle (10 YES YES mL infusion

medicinu, Petrova 3, Zagreb,

Republic of Croatia bottles with plastic holders in a box)

Natrii chloridi infundibile solution solution for intravenous Hrvatski zavod za transfuzijsku 250 mL in a glass infusion bottle, (10

for intravenous infusion, 250 mL infusion medicinu, Petrova 3, Zagreb, bottles with plastic hoders, supplied in YES YES Republic of Croatia a box)

Natrii chloridi infundibile solution solution for intravenous Hrvatski zavod za transfuzijsku 500 mL in a glass infusion bottle (10

for intravenous infusion, 500 mL infusion medicinu, Petrova 3, Zagreb, bottles with plastic holders, supplied in YES YES Republic of Croatia a box)

Pliva Croatia Ltd., Ulica grada

Natrii chloridi infundibile Pliva solution for infusion Vukovara 49, Zagreb, Republic of 6 bags with 2000 mL of solution,

Croatia supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Natrii chloridi infundibile Pliva solution for infusion Vukovara 49, Zagreb, Republic of 12 bags with 1000 mL of solution,

Croatia supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Natrii chloridi infundibile Pliva solution for infusion Vukovara 49, Zagreb, Republic of 12 bags with 500 mL of solution,

Croatia supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Natrii chloridi infundibile Pliva solution for infusion Vukovara 49, Zagreb, Republic of 10 glass vials with 250 mL of solution,

Croatia supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Natrii chloridi infundibile Pliva solution for infusion Vukovara 49, Zagreb, Republic of 10 glass vials with 500 mL of solution,

Croatia supplied in a box

YES YES

SODIUM Pliva Croatia Ltd., Ulica grada 20 mL of infusion solution in a glass

HYDROGENCARBONATE 1- solution for infusion Vukovara 49, Zagreb, Republic of ampoule (clear glass, colourbreak), 10 YES YES

molar solution PLIVA Croatia ampoules in a box

Baxter S.A., Belgium; Baxter

Healthcare Ltd, Great Britain; 10 plastic Viaflo bags with sa 1000 mL

Sodium chloride 0.9% Viaflo solution for infusion Bieffe Medital Sabinanigo, Spain; of infusion solution, in a protective bag, YES YES

Baxter Healthcare S.A., Republic supplied in a box

of Ireland

14509/1/11 REV 1 WS/jj 317

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Baxter S.A., Belgium; Baxter

Healthcare Ltd, Great Britain; 50 plastic Viaflo bags with 100 mL of

Sodium chloride 0.9%, Viaflo solution for infusion Bieffe Medital Sabinanigo, Spain; solution for infusion in a protective YES YES

Baxter Healthcare S.A., Republic bag, supplied in a box

of Ireland

Baxter S.A., Belgium; Baxter

Healthcare Ltd, Great Britain; 20 plastic Viaflo bags with 500 mL of

Sodium chloride 0.9% Viaflo solution for infusion Bieffe Medital Sabinanigo, Spain; infusion solution, in a protective bag, YES YES

Baxter Healthcare S.A., Republic supplied in a box

of Ireland

Baxter S.A., Belgium; Baxter

Healthcare Ltd, Great Britain; 30 plastic Viaflo bags with 250 mL of

Sodium chloride 0.9%, Viaflo solution for infusion Bieffe Medital Sabinanigo, Spain; solution for infusion in a protective YES YES

Baxter Healthcare S.A., Republic bag, supplied in a box

of Ireland

Baxter S.A., Belgium; Baxter

Healthcare Ltd, Great Britain; 50 plastic Viaflo bags with 50 mL of

Sodium chloride 0.9%, Viaflo solution for infusion Bieffe Medital Sabinanigo, Spain; solution for infusion in a protective YES YES

Baxter Healthcare S.A., Republic bag, supplied in a box

of Ireland

Sodium chloride 10% concentrate for intravenous Hrvatski zavod za transfuzijsku electrolytes concentrate , 50 mL use after reconstitution medicinu, Petrova 3, Zagreb,

50 mL in a glass injection bottle (40

Republic of Croatia bottles per bag)

YES YES

Natural Wealth Ginkgo Forte film coated tablets NBTY Inc., New York, USA 48 (2x24) film coated tablets in a blister (PVC/Al), supplied in a box YES YES YES

Natural Wealth Vitamin E-200 100 capsules in a brown plastic bottle,

IU, capsules capsules NBTY Inc. New York, USA supplied in a box YES YES

Novartis Pharma Stein AG,

Navoban injection 5 mg/5 mL solution for injection and 5 mL of solution in a glass ampoule, infusion, oral solution Schaffhauserstrasse, Stein, YES YES

Switzerland 10 ampoules in a box

Novartis Farmacéutica S.A.,

Navoban capsules 5 mg capsules, hard Ronda Santa María 158, 5 (1x5) capsules in a blister YES YES

Barcelona, Spain (PVC/PVDC//Al), supplied in a box

Nazol 0.05% nasal drops, Jadran - Galenski laboratorij d.d., 10 mL of nasal drops in a clear plastic

solution nasal drops, solution Pulac bb, Rijeka, Republic of (PE) bottle with a dropper attachment, YES YES YES Croatia supplied in a box

Jadran - Galenski laboratorij d.d., 10 mL of nasal drops in a clear plastic

Nazol 0.1% nasal drops, solution nasal drops, solution Pulac bb, Rijeka, Republic of (PE) bottle with a dropper attachment, YES YES YES

Croatia supplied in a box

Nebido 1000 mg/4 mL solution 4 mL of solution in an amber glass

for injection solution for injection

Schering AG, Muellerstrasse

170-178, Berlin, Germany ampoule, 1 ampoule in a box YES YES YES YES

Berlin-Chemie AG (Menarini

Nebilet tablets Group), Glienicker Weg 125, 14 (2x7) tablets in a PVC/Al blister,

Berlin, Germany supplied in a carton box

YES YES YES YES

Berlin-Chemie AG (Menarini

Nebilet tablets Group), Glienicker Weg 125, 14 (1x14) tablets in a PVC/Al blister, YES YES YES YES

Berlin, Germany supplied in a carton box

solution for injection for Lek farmacevtska družba d.d.,

Neloren 300 mg/mL injection intramuscular use and Verovškova 57, Ljubljana, 10 ampoules each containing 1 mL of

intravenus infusion Republic of Slovenia solution, supplied in a box

YES YES

solution for injection for Lek farmacevtska družba d.d.,

Neloren 600 mg/2 mL injection intramuscular use and Verovškova 57, Ljubljana, 10 ampoules each containing 2 mL of YES YES

intravenus infusion Republic of Slovenia solution, supplied in a box

24 (2x12) lozenges in a

Neo-angin sugar-free lozenges lozenges DIVAPHARMA GmbH, Motzener Straße 41, Berlin, Germany PVC/PE/PVDC-Al blister, supplied in a YES YES YES

box

14509/1/11 REV 1 WS/jj 318

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Neo-angin lozenges lozenges DIVAPHARMA GmbH, Motzener 24 (2x12) lozenges in a PVC/PVDC-Al Straße 41, Berlin, Germany blister, supplied in a box YES YES YES

Neodolpasse solution for infusion Fresenius Kabi Austria GmbH, Box with 10 glass bottles with 250 mL Graz, Austria of solution YES YES

Belupo, lijekovi i kozmetika d.d.,

Neofen 200 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 20 (2x10) tablets in a blister (PVC/Al) ,

Republic of Croatia supplied in a box

YES YES YES

Belupo, lijekovi i kozmetika d.d.,

Neofen forte film coated tablets Ulica Danica 5, Koprivnica, 10 (1x10) tablets in a PVC/Al blister,

Republic of Croatia supplied in a carton box

YES YES YES

NeoRecormon 10.000 IU Roche Diagnostics GmbH, 6 (2x3) glass syringes (with a needle) solution for in ajection in a presolution for injection Sandhofeer Strasse 116, D- each with 0.6 mL of solution, in filled syringe 68305 Mannheim, Germany protective packaging, supplied in a

YES YES YES

carton box

6 (2x3) glass syringes (with a needle)

NeoRecormon 1000 IU solution Roche Diagnostics GmbH, each with 0.3 mL of solution in

for injection in a pre-filled syringe solution for in injection Sandhofeer Strasse 116, D- 68305 Mannheim, Germany protective packaging, supplied in a YES YES YES

carton box

NeoRecormon 2000 IU solution Roche Diagnostics GmbH, 6 (2x3) glass syringes (with a needle) for in ajection in a pre-filled solution for injection Sandhofeer Strasse 116, D- each with 0.3 mL of solution in YES YES syringe 68305 Mannheim, Germany protective packaging, supplied in a

YES

carton box

NeoRecormon 30.000 IU Roche Diagnostics GmbH, One glass syringe (with needle) solution for injection in a presolution for injection Sandhofeer Strasse 116, D- containing 0.6 mL of solution, in a YES YES filled syringe 68305 Mannheim, Germany protective container, supplied in a

YES

carton box

NeoRecormon 3000 IU solution Roche Diagnostics GmbH, 6 (2x3) glass syringes (with a needle) for in ajection in a pre-filled solution for injection Sandhofeer Strasse 116, D- each with 0.3 mL of solution in YES YES YES

syringe 68305 Mannheim, Germany protective packaging, supplied in a carton box

NeoRecormon 4000 IU solution Roche Diagnostics GmbH, 6 (2x3) glass syringes (with a needle) for in ajection in a pre-filled solution for injection Sandhofeer Strasse 116, D- each with 0.3 mL of solution in YES YES YES

syringe 68305 Mannheim, Germany protective packaging, supplied in a carton box

NeoRecormon 500 IU solution Roche Diagnostics GmbH, 6 (2x3) glass syringes (with a needle) for in ajection in a pre-filled solution for injection Sandhofeer Strasse 116, D- each with 0.3 mL of solution, in syringe 68305 Mannheim, Germany protective packaging, supplied in a

YES YES YES

carton box

NeoRecormon 6000 IU solution Roche Diagnostics GmbH, 6 (2x3) glass syringes (with a needle) for in ajection in a pre-filled solution for injection Sandhofeer Strasse 116, D- each with 0.3 mL of solution in syringe 68305 Mannheim, Germany protective packaging, supplied in a

YES YES YES

carton box

NeoRecormon Multidose 100

000 IU powder and diluent for powder and diluent for

Roche Diagnostics GmbH, Vial with powder for solution for

Sandhofeer Strasse 116, D- injection and ampoule with diluent, YES YES YES

solution for injection solution for injection 68305 Mannheim, Germany supplied in a box

NeoRecormon Multidose 50 000 Roche Diagnostics GmbH, Vial with powder for solution for

IU powder and diluent for powder and diluent for injection and ampoule with diluent, YES YES YES solution for injection solution for injection

Sandhofeer Strasse 116, D-

68305 Mannheim, Germany supplied in a carton box

Neostigmin injection solution for injection (for Rotexmedica GmbH, Trittau, 1-mL of solution in an amber glass i.m., i.v. and s.c.use) Germany ampoule, 10 ampoules in a box YES YES

F. Hoffmann-La Roche Ltd.,

Neotigason capsules 10 mg capsules, hard Grenzacherstrasse 124, Basel, 30 (3x10) capsules in a blister YES YES

Switzerland (PVC/PE/PVDC//Al) , supplied in a box

F. Hoffmann-La Roche Ltd.,

Neotigason capsules 25 mg capsules, hard Grenzacherstrasse 124, Basel, 30 (3x10) capsules in a blister

Switzerland (PVC/PE/PVDC//Al) , supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 319

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Nephrotect solution for infusion Fresenius Kabi Austria GmbH,

10 glass infusion bottles with 250 mL

Graz, Austria (10x250mL) of solution, supplied in a YES YES carton box

Nephrotect solution for infusion Fresenius Kabi Austria GmbH,

10 glass infusion bottles with 500 mL

Graz, Austria (10x500mL) of solution, supplied in a YES YES carton box

Netromycine injection 150 solution for injection for Schering-Plough Labo N.V. 1.5-mL of solution in a glass vial,

mg/1.5 mL intramuscular and Industrepark 30, Heist-op-den YES YES intravenous use Berg, Belgium supplied in a box

Neupogen 30 solution for injection (for s.c.

F. Hoffmann-La Roche Ltd., One glass syringe with needle

and i.v. use) Grenzacherstrasse 124, Basel, containing 0.5 mL of solution, in a YES YES Switzerland plastic container, supplied in a box

Nexavar 200 mg film coated 112 (4x28) tablets in transparent

tablets film coated tablets

Bayer HealthCare AG, 51368

Leverkusen, Germany (PP/Al) blister, supplied in a box YES YES YES YES

Nexium 20 mg gastric-resistant tablets AstraZeneca AB, Södertälje, 14 (2x7) tablets in a A/Al blister, Sweden supplied in a box YES YES

Nexium 40 mg gastric-resistant tablets AstraZeneca AB, Södertälje, 14 (2x7) tablets in a A/Al blister, Sweden supplied in a box YES YES

Nexium i.v. 40 mg powder for preparation of AstraZeneca AB, Södertälje, injection/infusion solution Sweden 10 bottles, supplied in a box YES YES

Merck KGaA, Darmstadt,

Niaspan 1000 mg tablets prolonged-release tablets Germany, Merck Santé s.a.s., 14 (1x14) tablets in a blister YES YES

Semoy, France (PVC/PE/Aclar-Al), supplied in a box

Merck KGaA, Darmstadt,

Niaspan 1000 mg tablets prolonged-release tablets Germany Merck SANTE s.a.s., 14 (1x14) tablets in a blister

Semoy, France (PVC/PE/Aclar-Al), supplied in a box

YES YES

Merck KGaA, Darmstadt,

Niaspan 375 mg tablets prolonged-release tablets Germany, Merck Santé s.a.s., 14 (1x14) tablets in a blister

Semoy, France (PVC/PE/Aclar-Al), supplied in a box

YES YES

Merck KGaA, Darmstadt,

Niaspan 375 mg tablets prolonged-release tablets Germany Merck SANTE s.a.s., 14 (1x14) tablets in a blister YES

Semoy, France (PVC/PE/Aclar-Al), supplied in a box

YES

Merck KGaA, Darmstadt,

Niaspan 500 mg tablets prolonged-release tablets Germany, Merck Santé s.a.s., 14 (1x14) tablets in a blister

Semoy, France (PVC/PE/Aclar-Al), supplied in a box

YES YES

Merck KGaA, Darmstadt,

Niaspan 500 mg tablets prolonged-release tablets Germany Merck SANTE s.a.s., 14 (1x14) tablets in a blister YES

Semoy, France (PVC/PE/Aclar-Al), supplied in a box

YES

Merck KGaA, Darmstadt,

Niaspan 750 mg tablets prolonged-release tablets Germany Merck SANTE s.a.s., 14 (1x14) tablets in a blister YES YES

Semoy, France (PVC/PE/Aclar-Al), supplied in a box

Merck KGaA, Darmstadt,

Niaspan 750 mg tablets prolonged-release tablets Germany, Merck Santé s.a.s., 14 (1x14) tablets in a blister YES YES

Semoy, France (PVC/PE/Aclar-Al), supplied in a box

Belupo, lijekovi i kozmetika d.d.,

NIBEL 5 mg tablets tablets Ulica Danica 5, Koprivnica, 14 (1x14) tablets in a blister

Republic of Croatia (PVC/PE/PVDC/Al), supplied in a box

YES YES

Nicorette Freshmint Gum 2 mg chewing gum Pfizer Health AB, Norrbroplatsen 15 (1x15) chewing gums in a blister 2, Helsingborg, Sweden (PVC/PVDC//Al), supplied in a box YES YES YES

Nicorette Freshmint Gum 4 mg chewing gum Pfizer Health AB, Norrbroplatsen 15 (1x15) chewing gums in a blister 2, Helsingborg, Sweden (PVC/PVDC//Al), supplied in a box YES YES YES

14509/1/11 REV 1 WS/jj 320

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Nicorette patch 10 mg/16 h transdermal patch Pfizer Health AB, Norrbroplasten

7 (7x1) transdermal patches in a

2, Helsingborg, Sweden protective (PE/A1/Barex) bag, supplied YES YES YES in a box

7 (7x1) transdermal patches in a

Nicorette patch 15 mg/16 h transdermal patch Pfizer Health AB, Norrbroplasten 2, Helsingborg, Sweden protective (PE/A1/Barex) bag, supplied YES YES YES

in a box

Nicorette patch 5 mg/16 h transdermal patch Pfizer Health AB, Norrbroplasten

7 (7x1) transdermal patches in a

2, Helsingborg, Sweden protective (PE/A1/Barex) bag, supplied YES YES YES in a box

Farmal d.d., Ludbreg, Republic of

Nifedipin retard 20 mg tablets prolonged release tablets Croatia, in cooperation with Box with 30 tablets (blister, 3x10 tbl.) YES YES

Valpharma Int. s.a., San Marino

Nimotop S film coated tablets film coated tablets Bayer HealthCare AG, 51368 100 (10x10) film coated tablets in Leverkusen, Germany PP/Al blisters, supplied in a box YES YES

Nimotop S solution for infusion solution for infusion Bayer HealthCare AG, 51368

50 mL of solution for infusion in an

Leverkusen, Germany amber glass bottle and a plastic (PE) YES YES infusion pipe, supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Ninur 50 mg capsules capsules Ulica Danica 5, Koprivnica, Box with 30 capsules (blister, 3x10

Republic of Croatia capsules)

YES YES

Belupo, lijekovi i kozmetika d.d.,

NINUR 50 mg capsules capsules Ulica Danica 5, Koprivnica, 30 (2x15) capsules in a PVC/Al blister, YES YES

Republic of Croatia supplied in a box

Cardinal Health, 7 (7x1) transdermal patches in a

Niquitin CQ 14 mg transdermal patch Northamptonshire, Great Britain; Cardinal Health, Westhoughton, protective (PET/LDPE/Al/acrylonitrile) YES YES YES YES

Bolton, Great Britain bag, supplied in a box

Cardinal Health,

Niquitin CQ 21 mg transdermal patch Northamptonshire, Great Britain;

7 (7x1) transdermal patches in a

Cardinal Health, Westhoughton, protective (PET/LDPE/Al/acrylonitrile) YES YES YES YES Bolton, Great Britain bag, supplied in a box

Cardinal Health, 7 (7x1) transdermal patches in a

Niquitin CQ 7 mg transdermal patch Northamptonshire, Great Britain; Cardinal Health, Westhoughton, protective (PET/LDPE/Al/acrylonitrile) YES YES YES YES

Bolton, Great Britain bag, supplied in a box

Pliva Croatia Ltd., Ulica grada

Nistatin Pliva drops powder for preparation of Amber glass bottle with a dropper oral suspension Vukovara 49, Zagreb, Republic of YES YES

Croatia containing powder, supplied in a box

Pliva Croatia Ltd., Ulica grada

Nistatin Pliva ointment ointment Vukovara 49, Zagreb, Republic of Aluminum tube containing 20 g of YES YES

Croatia ointment, supplied in a box

12.2 mL of solution in a clear glass

bottle (coated with red plastic layer on

Nitrolingual aerosol sublingual spray G.Pohl- Boskamp GmbH&Co., Germany the outside) with metering pump and YES YES

plastic spray activator with plastic

protective cap, supplied in a box

Nolicin film coated tablets 400 Krka d.d., Šmarješka cesta 6, mg film coated tablets Novo mesto, Republic of

20 (2x10) tablets in a blister, supplied

Slovenia in a box

YES YES

Les Laboratoires Servier

Industrie, Gidy, France; Servier 30 (1x30) tablets in a blister (PVC/Al)

Noliprel 2 mg/0.625 mg tablets Republic of Ireland Industries inserted into a protective bag YES YES

Ltd., Arcklow, Co. Wicklow, (PE/Al/PE) with desiccant, supplied in

Republic of Ireland a box

Nolpaza 20 mg gastric-resistant film-coated

Krka Farma d.o.o., Radnička

tablets cesta 48, Zagreb, Republic of

28 (2x14) tablets in a blister

Croatia (OPA/Al/PVC//Al), supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 321

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Nolpaza 40 mg gastric-resistant film-coated

Krka Farma d.o.o., Radnička 14 (1x14) tablets in a blister

tablets cesta 48, Zagreb, Republic of Croatia (OPA/Al/PVC//Al), supplied in a box YES YES

AstraZeneca UK Limited, Silk

Nolvadex tablets film tablets Road Business Park, 30 (3x10) tablets in an aluminium Macclesfield, Cheshire, Great blister, supplied in a box YES YES

Britain

N.V. Organon, Oss, the 50 ampoules with powder and 50

Norcuron 4 mg powder for solution for i.v. Injection Netherlands; Organon S.A., ampoules with 1 mL of water for YES YES

Eragny Sur Epte, France injection, supplied in a box

One glass cartridge with 1.5 mL of

Norditropin SimpleXx 10 mg/1.5 Novo Nordisk A/S, Novo Allé, solution (with a rubber plunger and

mL solution for injection DK-2880 Bagsvaerd, Denmark rubber stopper with aluminium ring and YES YES YES plastic closure) in a plastic container,

supplied in a box

One glass cartridge with 1.5 mL of

Norditropin SimpleXx 15 mg/ 1.5 Novo Nordisk A/S, Novo Allé, solution (with a rubber plunger and

mL solution for injection DK-2880 Bagsvaerd, Denmark rubber stopper with aluminium ring and YES YES YES plastic closure) in a plastic container,

supplied in a box

One glass cartridge with 1.5 mL of

Norditropin SimpleXx 5 mg/1.5 solution (with a rubber plunger and mL solution for injection

Novo Nordisk A/S, Novo Allé,

DK-2880 Bagsvaerd, Denmark rubber stopper with aluminium ring and YES YES YES plastic closure) in a plastic container,

supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Normabel 10 mg tablets tablets Ulica Danica 5, Koprivnica, 30 tablets in a blister, supplied in a box YES YES

Republic of Croatia

Belupo, lijekovi i kozmetika d.d., 10 amber glass ampoules each

Normabel 10 mg/2 mL injection solution for injection Ulica Danica 5, Koprivnica, containing 2 mL of solution, supplied YES YES

Republic of Croatia in a box

Belupo, lijekovi i kozmetika d.d.,

Normabel 2 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 30 (1x30) film coated tablets in a

Republic of Croatia PVC/Al blister, supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Normabel 5 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 31 (1x30) film coated tablets in a YES

Republic of Croatia PVC/Al blister, supplied in a box

YES

Norprolac tablets 150 µg tablets Ferring GmbH, Wittland 1, Kiel, 30 (3x10) tablets in a blister (A1/A1), Germany supplied in a box YES YES YES

3 tablets of 25 µg + 3 tablets of 50 µg

Norprolac tablets 25 µg/ 50 µg tablets Ferring GmbH, Wittland 1, Kiel, in a blister(PVC/PVDC//A1), inserted a Germany protective aluminium sachet, supplied YES YES YES

in a box

Norprolac tablets 75 µg tablets Ferring GmbH, Wittland 1, Kiel, 31 (3x10) tablets in a blister (A1/A1), Germany supplied in a box YES YES YES

Wyeth Medica Republic of

Novantrone 20 concentrate for concentrated solution for Ireland, Co. Kildare, Republic of Vial with 10 mL of concentrated preparation of infusion solution infusion Ireland and Wyeth Lederle solution and stopper with aluminium YES YES S.p.A., Catania, Italy cap, supplied in a box

Pliva Croatia Ltd., Ulica grada

Novocef tablets 125 mg film tablets Vukovara 49, Zagreb, Republic of 10 (1x10) film tablets in a blister, YES YES

Croatia supplied in a box

Pliva Croatia Ltd., Ulica grada

Novocef tablets 250 mg film tablets Vukovara 49, Zagreb, Republic of 10 (1x10) film tablets in a blister,

Croatia supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 322

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pliva Croatia Ltd., Ulica grada

Novocef tablets 500 mg film tablets Vukovara 49, Zagreb, Republic of 10 (1x10) film tablets in a blister,

Croatia supplied in a box

YES YES

28 tablets (16 red and 12 white tablets)

Novofem film coated tablets Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark in a plastic, circular calendar pack, YES YES

supplied in a box

Novo Nordisk A/S, Novo Alle,

Bagsvaerd, Denmark Novo Box with 5 injection devices each with

NovoMix 30 FlexPen suspension for subcutaneous injection Nordisk Production SAS, 45, 3 mL of suspension in a glass YES YES YES YES

Avenue d' Orleans, Chartres, cartridge

France

Novo Nordisk A/S, Novo Alle,

Bagsvaerd, Denmark Novo 5 glass cartridges with 3 mL of

NovoMix 30 Penfill suspension for subcutaneous injection Nordisk Production SAS, 45, suspension in a blister, supplied in a YES YES YES YES

Avenue d' Orleans, Chartres, box

France

NovoMix 50 FlexPen suspension for injections, Novo Nordisk A/S, Novo Allé,

5 pens (injectors) with a glass

cartridge in a pre-filled pen DK-2880 Bagsvaerd, Denmark cartridge containing 3 mL of YES YES YES suspension, supplied in a box

NovoMix 50 Penfill suspension for injection in a Novo Nordisk A/S, Novo Allé,

5 glass cartridges each with 3 mL of

cartridge DK-2880 Bagsvaerd, Denmark suspension in protective packaging, YES YES YES supplied in a box

NovoMix 70 FlexPen suspension for injection, Novo Nordisk A/S, Novo Allé,

5 pens (injectors) with a glass

cartridge in a pre-filled pen DK-2880 Bagsvaerd, Denmark cartridge containing 3 mL of YES YES YES suspension, supplied in a box

5 glass cartridges each with 3 mL of

NovoMix 70 Penfill suspension for injection in a Novo Nordisk A/S, Novo Allé, cartridge DK-2880 Bagsvaerd, Denmark suspension in protective packaging, YES YES YES

supplied in a box

NovoNorm 0.5 mg tablets Novo Nordisk A/S, Novo Allé, 30 (2x15) tablets in a blister, supplied DK-2880 Bagsvaerd, Denmark in a box YES YES

NovoNorm 1 mg tablets Novo Nordisk A/S, Novo Allé, 30 (2x15) tablets in a blister, supplied DK-2880 Bagsvaerd, Denmark in a box YES YES

NovoNorm 2 mg tablets Novo Nordisk A/S, Novo Allé, 30 (2x15) tablets in a blister, supplied DK-2880 Bagsvaerd, Denmark in a box YES YES

NovoRapid solution for injection Novo Nordisk A/S, Novo Allé, One glass vial with 10 mL of solution, DK-2880 Bagsvaerd, Denmark supplied in a box YES YES

NovoRapid FlexPen solution for injection Novo Nordisk A/S, Novo Allé, 5 injectors, with 3 mL of solution per DK-2880 Bagsvaerd, Denmark glass cartridge, supplied in a box YES YES

Novo Nordisk A/S, Bagsvaerd,

NovoRapid Penfill solution for injection Denmark i Novo Nordisk

5 glass cartridges each with 3 mL of

Productions SAS, Chartes, solution in protective packaging, YES YES YES YES France supplied in a box

One glass vial with powder and one

glass vial with 2.2 mL of Water for

Injection in a box, one sterile

NovoSeven 1.2 mg powder and diluent for Novo Nordisk A/S, Novo Allé, attachment for reconstitution vial, one solution for injection DK-2880 Bagsvaerd, Denmark disposable sterile syringe for YES YES YES YES

reconstitution and administration of

medicinal product, one sterile infusion

set

14509/1/11 REV 1 WS/jj 323

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

One glass vial with powder and one

glass vial with 4.3 mL of Water for

Injection in a box, one sterile

NovoSeven 2.4 mg powder and diluent for Novo Nordisk A/S, Novo Allé, attachment for reconstitution vial, one solution for injection DK-2880 Bagsvaerd, Denmark disposable sterile syringe for YES YES YES YES

reconstitution and administration of

medicinal product, one sterile infusion

set

One glass vial with powder and one

glass vial with 8.5 mL of Water for

Injection in a box, one sterile

NovoSeven 4.8 mg powder and diluent for Novo Nordisk A/S, Novo Allé, attachment for reconstitution vial, one solution for injection DK-2880 Bagsvaerd, Denmark disposable sterile syringe for YES YES YES YES

reconstitution and administration of

medicinal product, one sterile infusion

set

Novuroxim injection 1500 mg powder for preparation of 5 (20 mL) glass bottles with powder, solution for i.v. injection Pliva Krakow, Krakow, Poland supplied in a box YES YES

powder for preparation of

Novuroxim injection 250 mg solution/suspension for i.m. Pliva Krakow, Krakow, Poland 5 (7.5 mL) glass bottles with powder, YES YES

and i.v. injection supplied in a box

powder for preparation of

Novuroxim 750 mg injection solution/suspension for i.m. Pliva Krakow, Krakow, Poland 5 (10 mL) glass bottles with powder, YES YES

and i.v. injection supplied in a box

Novuroxim tablets 125 mg film tablets Pliva Krakow, Krakow, Poland 10 (1x10) tablets in a blister, supplied in a box YES YES

Novuroxim tablets 250 mg film tablets Pliva Krakow, Krakow, Poland 10 (1x10) tablets in a blister, supplied in a box YES YES

Novuroxim tablets 500 mg film tablets Pliva Krakow, Krakow, Poland 10 (1x10) tablets in a blister, supplied in a box YES YES

Belupo, lijekovi i kozmetika d.d.,

Nozid 5 mg tablets tablets Ulica Danica 5, Koprivnica, 50 tablets in an amber glass bottle,

Republic of Croatia supplied in a box

YES YES

Famar Lyon, 29 Avenue du

Nozinan 100 mg tablets film coated tablets General de Gualle 69230 Saint 20 (2x10) tablets in a blister, supplied

Genis Laval, France in a box

YES YES

Famar Lyon, 29 Avenue du

Nozinan 100 mg tablets film coated tablets General de Gaulle 69230 Saint 20 (2x10) tablets in a blister (PVC/Al),

Genis Laval, France supplied in a box

YES YES

Famar Lyon, 29 Avenue du

Nozinan 25 mg tablets film coated tablets General de Gaulle 69230 Saint 20 (2x10) tablets in a blister, supplied

Genis Laval, France in a box

YES YES

Famar Lyon, 29 Avenue du

Nozinan 25 mg tablets film coated tablets General de Gaulle 69230 Saint 20 (2x10) tablets in a blister (PVC/Al),

Genis Laval, France supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 324

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

NUROFEN Cold and Flu film Reckitt Benckiser Healthcare coated tablets film coated tablets International Ltd., Thane Road,

12 (1x12) film coated tablets in

Nottingham, Great Britain PVC/PVdC/Al blister, supplied in a box

YES YES YES

NUROFEN Cold and Flu film Reckitt Benckiser Healthcare coated tablets film coated tablets International Ltd., Thane Road,

12 (1x12) film coated tablets in

Nottingham, Great Britain PVC/PVdC/Al blister, supplied in a box

YES YES YES

Reckitt Benckiser Healthcare

International Ltd., Nottingham,

Nurofen Liquid capsules capsules, soft Great Britain, in cooperation with 10 (1x10) capsules in a PVC/PVdC/Al

Banner Pharmacaps Europe blister, supplied in a box

YES YES YES

B.V., Tilburg, the Netherlands

Reckitt Benckiser Healthcare

International Ltd., Nottingham,

Nurofen Liquid capsules capsules, soft Great Britain in cooperation with 10 (1x10) capsules in a PVC/PVdC/Al

Banner Pharmacaps Europe blister, supplied in a box

YES YES YES

B.V., Tilburg, the Netherlands

Reckitt Benckiser Healthcare 12 (1x12) coated tablets in a

NUROFEN coated tablets coated tablets International Ltd., Thane Road, PVC/PVdC/Al blister, supplied in a YES YES YES

Nottingham, Great Britain carton box

Reckitt Benckiser Healthcare 12 (1x12) coated tablets in a

NUROFEN coated tablets coated tablets International Ltd., Thane Road, PVC/PVdC/Al blister, supplied in a YES YES YES

Nottingham, Great Britain plastic box

Reckitt Benckiser Healthcare 12 (1x12) coated tablets in a

NUROFEN coated tablets coated tablets International Ltd., Thane Road, PVC/PVdC/Al blister, supplied in a YES YES YES

Nottingham, Great Britain plastic box

Reckitt Benckiser Healthcare 12 (1x12) coated tablets in a

NUROFEN coated tablets coated tablets International Ltd., Thane Road, PVC/PVdC/Al blister, supplied in a YES YES YES

Nottingham, Great Britain carton box

101 mL of suspension in a brown

NUROFEN oral suspension for Reckitt Benckiser Healthcare plastic (PET) bottle with temper-proof

children oral suspension International Ltd., Thane Road, closure with protective plastic ring, and YES YES Nottingham, Great Britain 5-mL graduated plastic syringe,

supplied in a box

Boots Contract Manufacture Ltd., 100 mL of suspension in a brown

NUROFEN oral suspension for Nottingham, Great Britain or plastic (PET) bottle with temper-proof

children oral suspension Hermal Kurt Herrmann closure with protective plastic ring, and YES YES

GmbH&Co., Reinbeck, Germany 5-mL graduated plastic syringe, supplied in a box

Plastic (PVC) Viaflex bag containing

2000 mL of solution for peritoneal

Nutrineal PD4 with 1.1% amino solution for peritoneal BAXTER Healthcare S.A., dialysis, feeding tube (PVC),

acids dialysis Monreen Road, Castlebar, connector with protective cap, drain YES YES County Mayo, Republic of Ireland tube, drug administration attachment

and a Vialex plastic collection bag

(individual packages)

N.V. Organon, Oss, The

NuvaRing intravaginal ring Nederlands; Organon Republic of Intravaginal ring in protective Al Ireland Ltd., Co. Dublin, Republic sachet, supplied in a box YES YES YES

of Ireland

Octapharma Pharmazeutika

Produktionsges.m.b.H., Vienna,

OCTAGAM 1 g solution for infusion Austria, Octapharma S.A.S., One glass vial with 20 mL of solution Lingolsheim, France and for infusion, supplied in a box YES YES

Octapharma AB, Stockholm,

Sweden

Octapharma Pharmazeutika

Produktionsges.m.b.H., Vienna,

OCTAGAM 10 g solution for infusion Austria, Octapharma S.A.S., One glass vial with 200 mL of solution Lingolsheim, France and for infusion, supplied in a box YES YES

Octapharma AB, Stockholm,

Sweden

14509/1/11 REV 1 WS/jj 325

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Octapharma Pharmazeutika

Produktionsges.m.b.H., Vienna,

OCTAGAM 2.5 g solution for infusion Austria, Octapharma S.A.S., One glass vial containing 50 mL of Lingolsheim, France and solution for infusion, supplied in a box YES YES

Octapharma AB, Stockholm,

Sweden

Octapharma Pharmazeutika

Produktionsges.m.b.H., Vienna,

OCTAGAM 5 g solution for infusion Austria, Octapharma S.A.S., One glass vial with 100 mL of solution Lingolsheim, France and for infusion, supplied in a box YES YES

Octapharma AB, Stockholm,

Sweden

Octapharma Pharmazeutika 200 mL of solution in sterile PVC

Octaplas SD blood type 0 solution for infusion Produktionsges.m.b.H., Vienna, transfusion bags coated with YES YES

Austria polyamide/polyethylene film

Octapharma Pharmazeutika 200 mL of solution in sterile PVC

Octaplas SD blood type A solution for infusion Produktionsges.m.b.H., Vienna, transfusion bags coated with YES YES

Austria polyamide/polyethylene film

Octapharma Pharmazeutika 200 mL of solution in sterile PVC

Octaplas SD blood type AB solution for infusion Produktionsges.m.b.H., Vienna, transfusion bags coated with YES YES

Austria polyamide/polyethylene film

Octapharma Pharmazeutika 200 mL of solution in sterile PVC

Octaplas SD blood type B solution for infusion Produktionsges.m.b.H., Vienna, transfusion bags coated with YES YES

Austria polyamide/polyethylene film

Octenisept solution Schulke & Mayr GmbH, 50 mL of solution in a plastic bottle Norderstedt, Germany with a spray pump YES YES YES

Pliva Croatia Ltd., Ulica grada

Oikamid capsules Vukovara 49, Zagreb, Republic of Box with 60 capsules in a blister

Croatia (5x12)

YES YES

Pliva Croatia Ltd., Ulica grada

Oikamid injection solution for injection Vukovara 49, Zagreb, Republic of 10 ampoules each containing 5 mL of

Croatia solution, supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Oikamid injection solution for injection Vukovara 49, Zagreb, Republic of 10 ampoules each containing 5 mL of YES YES

Croatia solution, supplied in a box

Pliva Croatia Ltd., Ulica grada

Oikamid capsules capsules Vukovara 49, Zagreb, Republic of Box with 60 capsules in a blister

Croatia (5x12)

YES YES

Belupo, lijekovi i kozmetika d.d.,

Oksazepam 10 mg tablets tablets Ulica Danica 5, Koprivnica, 30 (3X10) tablets in a PVC/Al foil

Republic of Croatia blister, supplied in a carton box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Oksazepam 30 mg tablets tablets Ulica Danica 5, Koprivnica, 20 (1x20) tablets in a PVC/Al blister, YES YES

Republic of Croatia supplied in a box

30 (3x10) film coated tablets in a

Olanzapin CIPLA 10 mg film coated tablets Cipla Ltd., Kurkumbh Industrial Area, Maharashtra State, India blister (OPA/Al/PVC//Al), supplied in a YES YES

box

Olanzapin CIPLA 2.5 mg film coated tablets Cipla Ltd., Kurkumbh Industrial

31 (3x10) film coated tablets in a

Area, Maharashtra State, India blister (OPA/Al/PVC//Al), supplied in a YES YES box

32 (3x10) film coated tablets in a

Olanzapin CIPLA 5 mg film coated tablets Cipla Ltd., Kurkumbh Industrial Area, Maharashtra State, India blister (OPA/Al/PVC//Al), supplied in a YES YES

box

Belupo, lijekovi i kozmetika d.d.,

Olicard 40 mg retard prolonged release capsules Ulica Danica 5, Koprivnica, 50 (5x10) capsules in a blister

Republic of Croatia (PVC/Al), supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 326

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Belupo, lijekovi i kozmetika d.d.,

Olicard 60 mg retard prolonged release capsules Ulica Danica 5, Koprivnica, 50 (5x10) capsules in a blister YES YES

Republic of Croatia (PVC/Al), supplied in a box

Plastic bag for 2000 mL of blend (in

OliClinomel N4 - 550E emulsion for infusion Clintec Parenteral S.A., France; three separate compartments) in a Baxter S.A., Lessines, Belgium plastic protective casing, 4 bags in a YES YES

box

Plastic bag with 1000 mL of blend (in

OliClinomel N4 - 550E emulsion for infusion Clintec Parenteral S.A., France; three separate compartments) in a Baxter S.A., Lessines, Belgium plastic protective casing, 6 bags in a YES YES

carton box

Plastic bag for 2000 mL of blend (in

OliClinomel N6 - 900 E emulsion for infusion Clintec Parenteral S.A., France; three separate compartments) in a Baxter S.A., Lessines, Belgium plastic protective casing, 4 bags in a YES YES

box

Plastic bag for 2000 mL of blend (in

OliClinomel N7 - 1000 E emulsion for infusion Clintec Parenteral S.A., France; three separate compartments) in a Baxter S.A., Lessines, Belgium plastic protective casing, 4 bags in a YES YES

box

Plastic bag with 1000 mL of blend (in

OliClinomel N7 - 1000 E emulsion for infusion Clintec Parenteral S.A., France; three separate compartments) in a Baxter S.A., Lessines, Belgium plastic protective casing, 6 bags in a YES YES

carton box

Lek farmacevtska družba d.d.,

Olivin 10 mg tablets tablets Verovškova 57, Ljubljana, 20 (2x10) tablets in a blister, supplied

Republic of Slovenia in a box

YES YES

Lek farmacevtska družba d.d.,

Olivin 20 mg tablets tablets Verovškova 57, Ljubljana, 20 (2x10) tablets in a blister, supplied YES

Republic of Slovenia in a box

YES

Lek farmacevtska družba d.d.,

Olivin 5 mg tablets tablets Verovškova 57, Ljubljana, 20 (2x10) tablets in a blister, supplied

Republic of Slovenia in a box

YES YES

10 mL of solution in an amber glass

Olynth 0.05% nasal spray nasal spray, solution Pfizer PGM, Orleans Cedex, France bottle with a plastic atomizer extension YES YES YES

and protective cap, supplied in a box

Olynth 0.1% nasal drops nasal drops, solution Pfizer PGM, Orleans Cedex, 10 mL of solution in an amber glass France bottle with dropper, supplied in a box YES YES YES

10 mL of solution in an amber glass

Olynth 0.1% nasal spray nasal spray, solution Pfizer PGM, Orleans Cedex, France bottle with a plastic atomizer extension YES YES YES

and protective cap, supplied in a box

Olynth 0.5% nasal drops nasal drops, solution Pfizer PGM, Orleans Cedex, 10 mL of solution in an amber glass France bottle with dropper, supplied in a box YES YES YES

URSAPHARM Arzneimittel 10 mL of solution in a white plastic

Olynth HA 0.05% nasal spray nasal spray, solution GmbH&Co., Saarbrucken, bottle with a 3K system and protective YES YES YES

Germany cap, supplied in a box

URSAPHARM Arzneimittel 10 mL of solution in a white plastic

Olynth HA 0.1% nasal spray nasal spray, solution GmbH&Co., Saarbrucken, bottle with a 3K system and protective YES YES YES

Germany cap, supplied in a box

Omacor capsules (soft, transparent, Solvay Pharmaceuticals GmbH, gelatinous) Neustadt, Germany 28 capsules in a plastic bottle YES YES YES

10 glass bottles with 100 mL of

Omegaven emulsion for infusion Fresenius Kabi Austria GmbH, Graz, Austria emulsion (10x100 mL), supplied in a YES YES

box

10 glass bottles with 50 mL of

Omegaven emulsion for infusion Fresenius Kabi Austria GmbH, Graz, Austria emulsion (10x50 mL), supplied in a YES YES

box

14509/1/11 REV 1 WS/jj 327

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Farmal d.d., Branitelja

Omezol capsules 20 mg gastric-resistant capsules, hard domovinskog rata 8, Ludbreg, 14 (2x7) capsules in a OPA/Al/PVC//Al

Republic of Croatia blister, supplied in a box

YES YES

Astellas Pharma Europe B.V.,

Omnic 0.4 mg prolonged-release capsules Elisabethhof 19, Leiderdorp, the Box with 3x10 prolonged release YES

Netherlands capsules in an Al/polypropylene blister

YES

Amersham Health IDA Business

Omnipaque 240 solution solution for injection Park, Carrigtwohill, Co. Cork, 10 bottles containing 10 mL of

Republic of Ireland solution, supplied in a box

YES YES

Amersham Health IDA Business

Omnipaque 300 solution solution for injection/infusion Park, Carrigtwohill, Co. Cork, 10 bottles containing 100 mL of YES YES

Republic of Ireland solution, supplied in a box

Amersham Health IDA Business

Omnipaque 300 solution solution for injection/infusion Park, Carrigtwohill, Co. Cork, 10 bottles containing 50 mL of

Republic of Ireland solution, supplied in a box

YES YES

Amersham Health IDA Business

Omnipaque 300 solution solution for injection Park, Carrigtwohill, Co. Cork, 10 bottles containing 10 mL of

Republic of Ireland solution, supplied in a box

YES YES

Amersham Health IDA Business

Omnipaque 350 solution solution for injection Park, Carrigtwohill, Co. Cork, 6 bottles with 200 mL of solution, YES YES

Republic of Ireland supplied in a box

Amersham Health IDA Business

Omnipaque 350 solution solution for injection Park, Carrigtwohill, Co. Cork, 25 bottles each with 20 mL of solution,

Republic of Ireland supplied in a box

YES YES

Amersham Health IDA Business

Omnipaque 350 solution solution for injection Park, Carrigtwohill, Co. Cork, 10 bottles containing 50 mL of

Republic of Ireland solution, supplied in a box

YES YES

Amersham Health IDA Business

Omnipaque 350 solution solution for injection/infusion Park, Carrigtwohill, Co. Cork, 10 bottles containing 100 mL of YES

Republic of Ireland solution, supplied in a box

YES

GE Healthcare Republic of

Omniscan 0.5 mmol/mL solution Ireland, Carrigtwohill, Co. Cork, for injection solution for injection Republic of Ireland; GE 10 glass bottles with 20 mL of solution, YES YES Healthcare AS, Nydalen, Oslo, supplied in a box

Norway

GE Healthcare Republic of

Omniscan 0.5 mmol/mL solution Ireland, Carrigtwohill, Co. Cork, for injection solution for injection Republic of Ireland; GE

10 glass bottles with 10 mL of solution,

Healthcare AS, Nydalen, Oslo, supplied in a box

YES YES

Norway

Omniscan 0.5 mmol/mL solution

for injection (pre-filled syringe) solution for injection

GE Healthcare AS, Nydalen, 10 plastic syringes with 20 mL of

Oslo, Norway solution, supplied in a box YES YES

Omniscan 0.5 mmol/mL solution 10 plastic syringes with 10 mL of

for injection (pre-filled syringe) solution for injection

GE Healthcare AS, Nydalen,

Oslo, Norway solution, supplied in a box YES YES

GE Healthcare Republic of

Omniscan 0.5 mmol/mL solution Ireland, Carrigtwohill, Co. Cork, 10 plastic syringes with 5 mL of

for injection (pre-filled syringe) solution for injection Republic of Ireland; GE Healthcare AS, Nydalen, Oslo, solution, supplied in a box YES YES

Norway

Alcon Couvreur N.V., Rijksweg Plastic bottle (low density

Opatanol 1 mg/mL eye drops eye drops 14, Puurs, Belgium; Alcon Cusi polyethylene) with a dropper and a S.A., Camil Fabra 58, El Masnou, stopper (polypropylene) containing 5 YES YES

Barcelona, Spain mL of solution, supplied in a box

Lek farmacevtska družba d.d.,

Operil 0.05% nasal drops nasal drops Verovškova 57, Ljubljana, 10 mL of solution in a plastic bottle YES YES YES

Republic of Slovenia with a dropper, supplied in a box

14509/1/11 REV 1 WS/jj 328

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Lek farmacevtska družba d.d.,

Operil 0.05% nasal spray nasal spray (solution) Verovškova 57, Ljubljana, 10 mL of solution in a plastic box with YES YES YES

Republic of Slovenia atomizer extension, supplied in a box

Lek farmacevtska družba d.d.,

Operil P 0.025% nasal drops nasal drops Verovškova 57, Ljubljana, 10 mL of solution in a plastic bottle YES YES

Republic of Slovenia with a dropper, supplied in a box

YES

Lek farmacevtska družba d.d.,

Operil P 0.025% nasal spray nasal spray (solution) Verovškova 57, Ljubljana, 10 mL of solution in a plastic box with YES

Republic of Slovenia atomizer extension, supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Optimon 10 mg tablets tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in a blister (PVC/Al),

Croatia supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Optimon 20 mg tablets tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in ablister (PVC/Al), YES YES

Croatia supplied in a box

Pliva Croatia Ltd., Ulica grada

Optimon 5 mg tablets tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in a blister (PVC/Al),

Croatia supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Optimon Plus 10/12.5 mg tablets tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in a blister

Croatia (PVC/PVDC/Al), supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Optimon Plus 20/12.5 mg tablets tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in a blister YES YES

Croatia (PVC/PVDC/Al), supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Ormidol 100 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 14 (1x14) tablets in a blister, supplied

Republic of Croatia in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Ormidol 25 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 30 tablets (3x10) in a PVC/Al blister,

Republic of Croatia supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Ormidol 50 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 30 tablets (3x10) in a PVC/Al blister, YES

Republic of Croatia supplied in a box

YES

Krka d.d., Novo Mesto, Republic

Oronazol cream cream of Slovenia in cooperation with 30 g of cream in a tube, supplied in a Janssen Pharmaceutica, Beerse, box YES YES

Belgium

Janssen Pharmaceutica NV,

Oronazol shampoo shampoo Turnhouseweg 30, Beerse, 100 mL of shampoo in a plastic bottle,

Belgium supplied in a box

YES YES YES

Krka d.d., Novo Mesto, Republic

Oronazol tablets tablets of Slovenia in cooperation with 20 tablets in an amber glass bottle, Janssen Pharmaceutica, Beerse, supplied in a carton box YES YES

Belgium

Jadran - Galenski laboratorij d.d.,

Ortalox 10 mg capsules Pulac bb, Rijeka, Republic of 14 capsules in a plastic bottle (HDPE), YES YES

Croatia supplied in a box

Jadran - Galenski laboratorij d.d.,

Ortalox 20 mg capsules Pulac bb, Rijeka, Republic of 14 capsules in a plastic bottle (HDPE),

Croatia supplied in a box

YES YES

Lek farmacevtska družba d.d.,

Ortanol 20 mg capsules capsules Verovškova 57, Ljubljana, 7 capsules in an amber glass bottle,

Republic of Slovenia supplied in a box

YES YES

Lek farmacevtska družba d.d.,

Ortanol 40 mg capsules capsules Verovškova 57, Ljubljana, 7 (1x7) capsules in a blister, supplied

Republic of Slovenia in a box

YES YES

14509/1/11 REV 1 WS/jj 329

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Lek farmacevtska družba d.d.,

Ortanol S 10 mg capsules capsules Verovškova 57, Ljubljana, 7 (1x7) capsules in a blister, supplied YES YES

Republic of Slovenia in a box

Lek farmacevtska družba d.d.,

Ortanol S 10 mg capsules capsules Verovškova 57, Ljubljana, 28 (4x7) capsules in a blister, supplied

Republic of Slovenia in a box

YES YES

Les Laboratories Servier

Osseor 2 g granules for oral suspension Industrie, 905 route de Saran, 7 bags (paper/PE/Al/PE) with

45520 Gidy, France granules, supplied in a box

YES YES YES

powder and diluent for Vial with powder and vial with diluent

OVITRELLE 250 mg preparation of solution for Industria Farmaceutica Serono YES YES YES

injection S.p.A., Bari, Italy

with 1 mL of Water for Injection,

supplied in a box

OVITRELLE 250 micrograms/0.5 solution for injection in a Industria Farmaceutica Serono One glass syringe with needle in a

mL syringe S.p.A., Bari, Italy plastic container, supplied in a box YES YES YES

Pliva Croatia Ltd., Ulica grada Powder for solution for infusion in a

Oxaliplatin Pliva 100 mg powder for solution for glass bottle (50 mL) with a rubber infusion Vukovara 49, Zagreb, Republic of

Croatia stopper, aluminium ring and plastic

YES YES

cap, supplied in a box

Powder for solution for infusion in a

Oxaliplatin Pliva 50 mg powder for solution for

Pliva Croatia Ltd., Ulica grada glass bottle (26 mL) with a rubber

infusion Vukovara 49, Zagreb, Republic of Croatia stopper, aluminium ring and plastic YES YES

cap, supplied in a box

Bosnalijek d.d., Jukićeva 53,

Oxetin film coated tablets 20 mg film coated tablets Sarajevo, Bosnia and 20 (2x10) tablets in PVC/Al blister, Herzegovina in cooperation with supplied in a box YES YES

JMP, Jordan

Mundipharma Gm.b.H., Limburg,

OxyContin 10 mg prolonged-release tablets Germany and Mundipharma 30 tablets (3x10) in a PVC/Al blister, YES

GES.m.b.H., Vienna, Austria supplied in a box

YES

Mundipharma Gm.b.H., Limburg,

OxyContin 20 mg prolonged-release tablets Germany and Mundipharma 30 tablets (3x10) in a PVC/Al blister, YES YES

GES.m.b.H., Vienna, Austria supplied in a box

Mundipharma Gm.b.H., Limburg,

OxyContin 40 mg prolonged-release tablets Germany and Mundipharma 30 tablets (3x10) in a PVC/Al blister,

GES.m.b.H., Vienna, Austria supplied in a box

YES YES

Mundipharma Gm.b.H., Limburg,

OxyContin 80 mg prolonged-release tablets Germany and Mundipharma 30 tablets (3x10) in a PVC/Al blister,

GES.m.b.H., Vienna, Austria supplied in a box

YES YES

OxyContin tablets 10 mg prolonged release tablets Bard Pharmaceuticals Ltd., 56 (4x14) tablets in a PVC/Al blister, Cambridge, Great Britain supplied in a box YES YES

OxyContin tablets 20 mg prolonged release tablets Bard Pharmaceuticals Ltd., 56 (4x14) tablets in a PVC/Al blister, Cambridge, Great Britain supplied in a box YES YES

OxyContin tablets 40 mg prolonged release tablets Bard Pharmaceuticals Ltd., 56 (4x14) tablets in a PVC/Al blister, Cambridge, Great Britain supplied in a box YES YES

OxyContin tablets 80 mg prolonged release tablets Bard Pharmaceuticals Ltd., 56 (4x14) tablets in a PVC/Al blister, Cambridge, Great Britain supplied in a box YES YES

Ebewe Pharma Ges. m.b.H. Nfg.

Paclitaxel Ebewe 150 mg/25 mL concentrate of solution for 25 mL of solution in a glass bottle, infusion KG, Mondseestrasse 11, YES YES

Unterach, Austria supplied in a box

Paclitaxel Ebewe 30 mg/5 mL concentrate of solution for

Ebewe Pharma Ges. m.b.H. Nfg.

infusion KG, Mondseestrasse 11,

5 mL of solution in a glass bottle,

Unterach, Austria supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 330

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pliva Croatia Ltd., Ulica grada

Paclitaxel Pliva 100 mg/16.7 mL concentrate for solution for infusion Vukovara 49, Zagreb, Republic of One glass vial in a box YES YES

Croatia

Paclitaxel Pliva 30 mg/5 mL concentrate for solution for

Pliva Croatia Ltd., Ulica grada

infusion Vukovara 49, Zagreb, Republic of One glass vial in a box YES YES Croatia

50 mL of solution concentrate in a

PACLITAXEL PLIVA 300 mg/50 concentrate of solution for Pliva Croatia Ltd., Ulica grada glass bottle (multy dose vial) with a

mL infusion Vukovara 49, Zagreb, Republic of YES Croatia rubber stopper, an aluminium cap and YES

a protective lid, supplied in a box

16.7 mL of concentrate for infusion

solution in a clear glass bottle with

Paclitaxin 6 mg/mL concentrate of solution for Pharmachemie B.V., Haarlem, infusion the Netherlands teflon-coated rubber (bromobutyl) YES YES YES YES

stopper and aluminium ring with plastic

(PP) lid, supplied in a box

5 mL of solution for infusion

Paclitaxin 6 mg/mL concentrate of solution for Pharmachemie B.V., Haarlem,

concentrate in a colourless glass bottle

infusion the Netherlands with a rubber (bromobutyl) stopper YES YES YES YES coated with Teflon and an Al ring with

a plastic (PP) lid, supplied in a box

25 mL of concentrate for infusion

solution in a clear glass bottle with

Paclitaxin 6 mg/mL concentrate of solution for Pharmachemie B.V., Haarlem, infusion the Netherlands rubber (bromobutyl) stopper coated YES YES YES YES

with teflon and Al ring with plastic (PP)

lid, supplied in a box

50 mL of solution for infusion

concentrate in a colourless glass bottle

Paclitaxin 6 mg/mL concentrate of solution for Pharmachemie B.V., Haarlem, with a rubber (bromobutyl) stopper infusion the Netherlands coated with Teflon and an aluminium YES YES YES YES

ring with a plastic (PP) lid, supplied in

a box

Palladone SR capsules 16 mg prolonged-release capsules Mundipharma Ges.m.b.H., 56 (4x14) capsules in a blister Vienna, Austria (PVDC/PVC//Al), supplied in a box YES YES

Palladone SR capsules 4 mg prolonged-release capsules Mundipharma Ges.m.b.H., 56 (4x14) capsules in a blister Vienna, Austria (PVDC/PVC//Al), supplied in a box YES YES

Palladone SR capsules 8 mg prolonged-release capsules Mundipharma Ges.m.b.H., 56 (4x14) capsules in a blister Vienna, Austria (PVDC/PVC//Al), supplied in a box YES YES

Pamitor 15 mg/mL concentrate concentrate for infusion Torrex-Pharma GmbH, Vienna, One clear glass ampoule containing 4

for infusion solution solution Austria mL of solution, supplied in a box YES YES

Pamitor 15 mg/mL concentrate concentrate of solution for Torrex-Pharma GmbH, Vienna, Polyethylene ampoule containing 2 mL

of solution for infusion infusion Austria of solution, supplied in a box YES YES

Pamitor 15 mg/mL concentrate concentrate for infusion Torrex-Pharma GmbH, Vienna, A clear glass ampoule containing 6 mL

for infusion solution solution Austria of solution, supplied in a box YES YES

Pamitor 15 mg/mL concentrate concentrate of solution for Torrex-Pharma GmbH, Vienna, Polyethylene ampoule containing 4 mL

of solution for infusion infusion Austria of solution, supplied in a box YES YES

Pamitor15 mg/mL concentrate of concentrate of solution for Torrex-Pharma GmbH, Vienna, Polyethylene ampoule containing 6 mL

solution for infusion infusion Austria of solution, supplied in a box YES YES

Pamitor15 mg/mL concentrate concentrate for infusion Torrex-Pharma GmbH, Vienna, One clear glass ampoule containing 2

for infusion solution solution Austria mL of solution, supplied in a box YES YES

14509/1/11 REV 1 WS/jj 331

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

GlaxoSmithKline Dungarvan Ltd.,

Panadol film coated tablets Knockbrack, Dungarvan, Co. 12 (1x12) tablets in a PVC/Al blister, YES YES

Waterford, Republic of Ireland supplied in a box

YES

300 mL of suspension in an amber

Glaxo Wellcome Production, glass bottle with a plastic temper

Panadol Baby oral suspension Avenue du General de Gaulle, evident stopper and a plastic YES YES YES

Herouville Saint Clair, France measuring device (0.5 mL to 8 mL),

supplied in a box

Glaxo Wellcome Production, 100 mL of suspension in an amber

Panadol Baby oral suspension Avenue du General de Gaulle, glass bottle with plastic temper-proof YES YES YES

Herouville Saint Clair, France closure and plastic dispenser (0.5 mL to 8 mL), supplied in a box

GlaxoSmithKline Dungarvan Ltd.,

Panadol Extra film coated tablets Knockbrack, Dungarvan, Co. 12 (1x12) tablets in PVC/Al blister, YES YES

Waterford, Republic of Ireland supplied in a carton box

YES

Panadol Rapid film coated tablets GlaxoSmith Kline Dungarvan 10 (1x10) tablets in a PVC/AI blister, Limited, Republic of Ireland supplied in a box YES YES YES

Panaze 10000 capsules capsules (with gastric

Krka d.d., Šmarješka cesta 6,

resistant microfilm tablets) Novo mesto, Republic of

20 capsules in an amber glass bottle,

Slovenia supplied in a box

YES YES

Pancuronium injection BP 4 mg solution for intravenous Rotexmedica GmbH, Trittau, 2 mL of solution in a glass ampoule, injection Germany 10 ampoules in a box YES YES

Pankreoflat coated tablets Solvay Pharmaceuticals GmbH, 50 (2x25) tablets in a blister, supplied Hannover, Germany in a box YES YES YES

Jadran - Galenski laboratorij d.d.,

Pantexol cream cream Pulac bb, Rijeka, Republic of 25 grams of cream in an aluminium YES YES

Croatia tube with plastic cap, supplied in a box

YES

Jadran - Galenski laboratorij d.d.,

Pantexol ointment ointment Pulac bb, Rijeka, Republic of 25 grams of ointment in an aluminium YES YES YES

Croatia tube with plastic cap, supplied in a box

Paracetamol JADRAN syrup 150 Jadran - Galenski laboratorij d.d., 150 mL of syrup in an amber glass

mL syrup Pulac bb, Rijeka, Republic of bottle and a plastic measuring glass, YES YES YES Croatia supplied in a box

Paraplatin 150 mg/15 mL 15 mL of concentrate for infusion

concentrate for solution for concentrate of solution for Bristol-Myers Squibb S.r.l., infusion infusion Sermoneta, Latina, Italy

solution in a glass bottle, supplied in a YES YES

box

Paraplatin 50 mg/5 mL 5 mL of solution for infusion

concentrate for solution for concentrate of solution for Bristol-Myers Squibb S.r.l., infusion infusion Sermoneta, Latina, Italy

concentrate in a glass bottle, supplied YES YES

in a box

Box with one pre-filled syringe and a

Partobulin SDF 1250 IU solution for injection Baxter AG, Industriestrasse 67, A-1220 Vienna, Austria needle with one dose of 250 ug (1250 YES YES

IU) of preparation

Patentex Oval N pessary Merz Pharma GmbH & Co KGaA, 6 (1x6) pessaries in a PVC/PVDC/PE Frankfurt am Main, Germany strip, supplied in a box YES YES YES

N.V. Organon, Oss, the

Pavulon 4 mg=2 mL solution for injection Netherlands; Organon S.A., 50 ampoules with 2 mL of solution,

Eragny Sur Epte, France supplied in a box

YES YES

PEDIACEL vaccine against

diphtheria, tetanus, pertussis 0.5-mL of suspension in a glass bottle

(acellular, five component), (glass type I, Ph.Eur), with a

poliomyelitis (inactivated) and suspension for injection

Sanofi Pasteur Limited, Toronto,

Canada bromobutyl stopper that does not YES YES

Haemofilus influenzae type B contain latex, supplied in a box

(conjugated), absorbed

14509/1/11 REV 1 WS/jj 332

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

PEGASYS 135 micrograms of F. Hoffmann-La Roche Ltd.,

solution for injection in pre-filled solution for injection Grenzacherstrasse 124, Basel, Box with 1 syringe containing 0.5 mL YES YES YES YES syringe Switzerland of solution and a needle

PEGASYS 180 micrograms of F. Hoffmann-La Roche Ltd.,

solution for injection in pre-filled solution for injection Grenzacherstrasse 124, Basel, Box with 1 syringe containing 0.5 mL YES YES YES YES syringe Switzerland of solution and a needle

Vial containing powder and ampoule

PegIntron 100 ug powder and powder and diluent for Schering-Plough (Brinny)

with diluent for solution for injection

diluent for injection solution preparation of solution for Company, Innishannon, County

(Water for Injection), one syringe for YES

injection Cork, Republic of Ireland injection, two needles for injection and

YES YES

one absorbent cotton-wool roll,

supplied in a box

Syringe with cartridge containing

PegIntron 100 ug powder and powder and diluent for Schering-Plough (Brinny) powder and diluent for solution for

diluent for solution for injection in solution for injection in a Company, Innishannon, County injection (Water for injection), one YES YES YES

syringe with cartridge cartridge Cork, Republic of Ireland injection needle and two absorbent

cotton wool rolls, supplied in a box

Vial containing powder and ampoule

with diluent for solution for injection

PegIntron 120 ug powder and powder and diluent for Schering-Plough (Brinny) (Water for Injection), one syringe for

diluent for injection solution preparation of solution for Company, Innishannon, County YES YES YES injection Cork, Republic of Ireland injection, two needles for injection and

one absorbent cotton-wool roll,

supplied in a box

Syringe with cartridge containing

PegIntron 120 ug powder and powder and diluent for Schering-Plough (Brinny) powder and diluent for solution for

diluent for solution for injection in solution for injection in a Company, Innishannon, County injection (Water for injection), one YES YES YES

syringe with cartridge cartridge Cork, Republic of Ireland injection needle and two absorbent

cotton wool rolls, supplied in a box

Vial containing powder and ampoule

PegIntron 150 ug powder and powder and diluent for Schering-Plough (Brinny)

with diluent for solution for injection

diluent for injection solution preparation of solution for Company, Innishannon, County

(Water for Injection), one syringe for

injection Cork, Republic of Ireland injection, two needles for injection and

YES YES YES

one absorbent cotton-wool roll,

supplied in a box

Syringe with cartridge containing

PegIntron 150 ug powder and powder and diluent for Schering-Plough (Brinny) powder and diluent for solution for

diluent for solution for injection in solution for injection in a Company, Innishannon, County injection (Water for injection), one YES YES YES

syringe with cartridge cartridge Cork, Republic of Ireland injection needle and two absorbent

cotton wool rolls, supplied in a box

Vial containing powder and ampoule

PegIntron 50 ug powder and powder and diluent for Schering-Plough (Brinny)

with diluent for solution for injection

diluent for injection solution preparation of solution for Company, Innishannon, County

(Water for Injection), one syringe for YES

injection Cork, Republic of Ireland injection, two needles for injection and

YES YES

one absorbent cotton-wool roll,

supplied in a box

Syringe with cartridge containing

PegIntron 50 ug powder and powder and diluent for Schering-Plough (Brinny) powder and diluent for solution for

diluent for solution for injection in solution for injection in a Company, Innishannon, County injection (Water for injection), one YES YES YES

syringe with cartridge cartridge Cork, Republic of Ireland injection needle and two absorbent

cotton wool rolls, supplied in a box

Vial containing powder and ampoule

with diluent for solution for injection

PegIntron 80 ug powder and powder and diluent for Schering-Plough (Brinny) (Water for Injection), one syringe for

diluent for injection solution preparation of solution for Company, Innishannon, County injection Cork, Republic of Ireland injection, two needles for injection and YES YES YES

one absorbent cotton-wool roll,

supplied in a box

Syringe with cartridge containing

PegIntron 80 ug powder and powder and diluent for Schering-Plough (Brinny) powder and diluent for solution for

diluent for solution for injection in solution for injection in a Company, Innishannon, County injection (Water for injection), one YES YES YES

syringe with cartridge cartridge Cork, Republic of Ireland injection needle and two absorbent

cotton wool rolls, supplied in a box

14509/1/11 REV 1 WS/jj 333

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pliva Croatia Ltd., Ulica grada

Penbritin injection 1 g powder for solution for 50 colourless glass bottles with injection Vukovara 49, Zagreb, Republic of YES YES

Croatia powder, supplied in a box

Penbritin injection 500 mg powder for solution for

Pliva Croatia Ltd., Ulica grada

injection Vukovara 49, Zagreb, Republic of

50 colourless glass bottles with

Croatia powder, supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Pentamon film coated tablets with 20 (2x10) film coated tablets in a prolonged-release Vukovara 49, Zagreb, Republic of

Croatia (PVC/Al) blister, supplied in a box

YES YES

Pentasa 1 g suppositories suppositories Ferring A/S, Vanlose, Denmark 28 (4x7) suppositories in an aluminium blister, supplied in a box YES YES

7 individually packed containers (in

Pentasa 1 g suspension for suspension for rectal Ferring-Lečiva a.s., Jesenice u bags) with 100 mL of suspension and

rectal administration administration Prahy, Czech Republic an application attachment, in a YES YES protective bag and 7 plastic hygiene

bags, supplied in a box

Ferring A/S, Vanlose, Denmark;

Pentasa 500 mg tablets prolonged release tablets Ferring Intercontinental Center 100 (10x10) tablets in auminum

SA, St-Prex, Switzerland blisters, supplied in a box

YES YES

PENTAXIM, diphtheria, tetanus,

pertussis (acellular), poliomyelitis Box with a glass bottle with powder (inactivated), and Haemophilus powder and suspension for Sanofi Pasteur S.A., 2 avenue and a glass syringe with 0.5 mL of YES influenzae type B conjugated suspension for injection Pont Pasteur, Lyon, France suspension with a needle and a needle

YES

vaccine protection

PENTILIN solution for injection Krka d.d., Šmarješka cesta 6, 5 mL of solution for injection in a glass

100 mg/5 mL solution for injection Novo mesto, Republic of YES YES Slovenia ampoule, 5 ampoules in a box

Krka d.d., Šmarješka cesta 6,

PENTILIN tablets 400 mg prolonged-release tablets Novo mesto, Republic of 20 (2x10) prolonged-release tablets in

Slovenia PVC/Al blister, supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada 10 (1x10) film coated tablets in a

Peptoran 75 tablets film coated tablets Vukovara 49, Zagreb, Republic of OPA/Al/PVC//Al blister, supplied in a YES YES YES

Croatia box

Bristol-Myers Squibb, 304, One glass vial with 100 mL of solution

Perfalgan 10 mg/mL solution for infusion avenue du Dr Jean Bru, Agen, for infusion, 12 vials in a transparent YES YES YES

France protective container (polyethylene with

YES

thermo film)

Bristol-Myers Squibb, 304, One glass vial with 50 mL of solution

Perfalgan 10 mg/mL solution for infusion avenue du Dr Jean Bru, Agen, for infusion, 12 vials in a transparent YES YES YES YES

France protective container (polyethylene with thermo film)

Boehringer Ingelheim France, 12, 50 coated tablets in a white plastic

Persantin 75 mg coated tablets coated tablets Rue Andre Huet, Reims, Cedex, container (PP) with a white stopper YES YES

France (PE), supplied in a box

Lek farmacevtska družba d.d.,

Persen sugar-coated tablets sugar-coated tablets Verovškova 57, Ljubljana, Box with 40 sugar coated tablets YES

Republic of Slovenia (blister, 4x10 sugar coated tablets)

YES YES

Persen forte capsules capsules, hard Lek farmacevtska družba d.d.,

20 (2x10) capsules in a

Ljubljana, Republic of Slovenia (PVC/PCTFE//Al) blister, supplied in a YES YES YES box

Lek farmacevtska družba d.d.,

Persen forte capsules capsules Verovškova 57, Ljubljana, Box with 20 capsules (blister, 2x10 YES YES YES

Republic of Slovenia capsules)

Persen tablets coated tablets Lek farmacevtska družba d.d., 40 (4x10) coated tablets in a blister Ljubljana, Republic of Slovenia (PVC/TE/PVDC//Al), supplied in a box YES YES YES

14509/1/11 REV 1 WS/jj 334

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

powder (lyophilisate) and Pliva Croatia Ltd., Ulica grada 5 ampoules with powder and 5

Phenobarbiton sodium injection diluent for preparation of Vukovara 49, Zagreb, Republic of ampoules each with 2 mL of solvent YES YES

injections Croatia (water for injection), supplied in a box

PHENOBARBITON PLIVA 100 Pliva Croatia Ltd., Ulica grada mg tablets tablets Vukovara 49, Zagreb, Republic of

10 (1x10) tablets in an orange blister

Croatia (PVC/Al), supplied in a box

YES YES

PHENOBARBITON PLIVA15 mg Pliva Croatia Ltd., Ulica grada tablets tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in an orange blister YES Croatia (PVC/Al), supplied in a box

YES

Alkaloid AD - Skopje, Bulevar

PHOLCODIN 10 mg capsules capsules Aleksandar Makedonski 12, 20 capsules in an amber glass bottle,

Skopje, FYROM supplied in a box

YES YES

PHOLCODIN 15 mg/15 mL oral Alkaloid AD - Skopje, Bulevar 150 mL of solution in an amber glass

solution oral solution Aleksandar Makedonski 12, bottle with plastic closure and 15-mL YES YES Skopje, FYROM plastic dispenser, supplied in a box

PHOLCODIN 4 mg/5 mL oral Alkaloid AD - Skopje, Bulevar

60 mL of solution in an amber glass

solution for children oral solution Aleksandar Makedonski 12,

bottle with a plastic stopper and a

Skopje, FYROM plastic measuring unit of 2.5 mL,

YES YES

supplied in a box

Physiotens 0.2 film coated tablets Solvay Pharmaceuticals S.A.S., 28 (1x28) film coated tablets in a Châtillon sur Chalaronne, France PVC/PVDC/Al blister, supplied in a box YES YES

Physiotens 0.4 film coated tablets Solvay Pharmaceuticals S.A.S., 28 (1x28) film coated tablets in a Châtillon sur Chalaronne, France PVC/PVDC/Al blister, supplied in a box YES YES

Jadran -Galenski laboratorij d.d.,

Pigrel film coated tablets Rijeka in cooperation with Krka 28 (4x7) tablets in a blister, supplied in YES

Farma d.o.o., Zagreb a box

YES

Bosnalijek d.d., Jukićeva 53,

Pilfud 2% lotion lotion Sarajevo, Bosnia and 60 mL of lotion in an amber glass

Herzegovina bottle, supplied in a box

YES YES YES

Bosnalijek d.d., Jukićeva 53, 60 mL of solution in a plastic bag with

Pilfud 5% lotion skin spray, solution Sarajevo, Bosnia and a spray pump and a temper-evident YES YES YES

Herzegovina stopper, supplied in a box

Piramil 1.25 mg tablets tablets LEK S.A., Stryków, Poland; LEK 28 (7x4) tablets in a strip , supplied in S.A., Warszawa, Poland a box YES YES

Piramil 10 mg tablets tablets LEK S.A., Stryków, Poland; LEK 28 (7x4) tablets in a blister, supplied in S.A., Warszawa, Poland a box YES YES

Piramil 2.5 mg tablets tablets LEK S.A., Stryków, Poland; LEK 28 (7x4) tablets in a blister, supplied in S.A., Warszawa, Poland a box YES YES

Piramil 5 mg tablets tablets LEK S.A., Stryków, Poland; LEK 28 (7x4) tablets in a blister, supplied in S.A., Warszawa, Poland a box YES YES

"Planinski čaj" - herbal laxative Trešnjevka laboratorij d.o.o., tea herbal laxative tea Jukićeva 32, Zagreb, Republic of 75 g of tea in a plastic (PP) bag, YES Croatia supplied in a box

YES YES

Platinex 10 mg/20 mL concentrate for infusion Bristol-Myers Squibb S.r.l., 20 mL of infusion solution concentrate

concentrate for infusion solution solution Sermoneta, Latina, Italy in an amber glass bottle, supplied in a YES YES box

Platinex 50 mg/100 mL concentrate for infusion Bristol-Myers Squibb S.r.l., 100 mL of concentrate for infusion

concentrate for infusion solution solution Sermoneta, Latina, Italy solution in an amber glass bottle, YES YES supplied in a box

14509/1/11 REV 1 WS/jj 335

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Sanofi Winthrop Industrie,

Plavix film coated tablets Ambares et Lagrave, Carbon 28 (2x14) film coated tablets in a YES

Blanc Cedex, France blister (Al/Al), supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada 10 (1x10) film coated tablets in an

PLICET EFFECT tablets film coated tablets Vukovara 49, Zagreb, Republic of orange PVC/PVDC//Al blister, supplied YES YES YES

Croatia in a box

Pliva Croatia Ltd., Ulica grada 100 mL of syrup in an amber glass

Plicet syrup syrup Vukovara 49, Zagreb, Republic of bottle and a 5-mL spoon, supplied in a YES YES YES

Croatia box

Pliva Croatia Ltd., Ulica grada

Plicet tablets tablets Vukovara 49, Zagreb, Republic of 20 (2x10) tablets in PVC/Al blister, YES YES

Croatia supplied in a box

YES

Pliva Croatia Ltd., Ulica grada

Plicet tablets tablets Vukovara 49, Zagreb, Republic of 10 (1x10) tablets in a PVC/Al blister, YES YES YES

Croatia supplied in a box

Pliva Croatia Ltd., Ulica grada

Plimycol cream cream Vukovara 49, Zagreb, Republic of 20 grams of cream in an aluminium

Croatia tube, supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

PLIVADON tablets Vukovara 49, Zagreb, Republic of 10 (1x10) tablets in an orange blister YES YES YES

Croatia (PVC/PVDC//Al), supplied in a box

Pliva Croatia Ltd., Ulica grada

PLIVIT B1 injection 100 mg solution for injection Vukovara 49, Zagreb, Republic of 1-mL of solution for injection in a glass

Croatia ampoule, 50 ampoules in a box

YES YES

Pliva Croatia Ltd., Ulica grada

PLIVIT B1 injection 250 mg solution for injection Vukovara 49, Zagreb, Republic of 2 mL of solution for injection in a glass

Croatia ampoule , 50 ampoules in a box

YES YES

Pliva Croatia Ltd., Ulica grada

PLIVIT B1 tablets tablets Vukovara 49, Zagreb, Republic of 20 (2x10) tablets in a blister YES YES YES

Croatia (PVC/PVDC//Al), supplied in a box

Pliva Croatia Ltd., Ulica grada 5 mL of solution for injection in an

PLIVIT B6 injection 250 mg solution for injection Vukovara 49, Zagreb, Republic of amber glass ampoule, 50 ampoules in YES YES

Croatia a box

Pliva Croatia Ltd., Ulica grada 2 mL of solution for injection in an

PLIVIT B6 injection 50 mg solution for injection Vukovara 49, Zagreb, Republic of amber glass ampoule , 50 ampoules in YES YES

Croatia a box

Pliva Croatia Ltd., Ulica grada

PLIVIT B6 tablets tablets Vukovara 49, Zagreb, Republic of 20 (2x10) tablets in a blister YES YES

Croatia (PVC/PVDC//Al), supplied in a box

YES

PLIVIT C 1000 mg sugar-free Pliva Croatia Ltd., Ulica grada 10 effervescent tablets in a effervescent tablets, lemon effervescent tablets Vukovara 49, Zagreb, Republic of polypropylene tube (cap with silicagel YES YES YES

flavoured Croatia and tamper-proof ring), supplied in a box

YES YES YES

box

Pliva Croatia Ltd., Ulica grada

PLIVIT C tablets 50 mg tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in a PVC/PVDC//Al YES YES

Croatia blister, supplied in a box

YES

Pliva Croatia Ltd., Ulica grada

PLIVIT C tablets 500 mg tablets Vukovara 49, Zagreb, Republic of 20 (2x10) tablets in a blister YES YES YES

Croatia (PVC/PVDC//Al), supplied in a box

PLIVIT C 500 mg prolongedfilm coated prolonged Pliva Croatia Ltd., Ulica grada 10 (1x10) prolonged-release film

release tablets release tablets Vukovara 49, Zagreb, Republic of coated tablets in a PVC/PVDC//Al YES YES YES Croatia blister, supplied in a box

14509/1/11 REV 1 WS/jj 336

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pliva Croatia Ltd., Ulica grada 10 mL of solution in an amber glass

Plivit D3 oral drops, solution Vukovara 49, Zagreb, Republic of bottle with plastic dropper attachment, YES YES

Croatia supplied in a box

Pliva Croatia Ltd., Ulica grada

Plymicol vaginal tablets vaginal tablets Vukovara 49, Zagreb, Republic of 3 vaginal tablets in a blister, supplied YES YES

Croatia in a box

PNEUMO 23 Pneumococcal Box with 1 glass syringe containing 0.5 polysaccharide vaccine solution for injection

Sanofi Pasteur S.A., 2 avenue

Pont Pasteur, Lyon, France mL of vaccine and a needle with YES YES protection

Poliosabin (Oral) trovalent live,

attenuated vaccine against GlaxoSmithKline Biologicals s.a., Box with 25 plastic tubes with one poliomyelitis, Sabin strain, oral suspension Rue de lInstitut 89, Rixensart, YES YES stabilized in MgCl Belgium

vaccine dose

Pollinex tree, extract of birch, Pliva Croatia Ltd., Zagreb, hazel and alder tree pollen for suspension for Republic of Croatia and Allergy

One 1.5 mL of suspension in a glass

vial, 3 glass syringes and 4 needles for YES YES

specific immunotherapy subcutaneous injection Therapeutics Ltd., Worthing, Great Britain injection, supplied in a box

Pollinex tree, extract of birch, Pliva Croatia Ltd., Zagreb, 3 red glass syringes each containing hazel and alder tree pollen for suspension for Republic of Croatia and Allergy specific immunotherapy subcutaneous injection Therapeutics Ltd., Worthing,

0.5 mL of suspension and 4 needles YES YES

Great Britain for injection, supplied in a box

Pollinex tree, extract of birch, Pliva Croatia Ltd., Zagreb, hazel and alder tree pollen for suspension for Republic of Croatia and Allergy

3 glass syringes each containing 0.5

YES

specific immunotherapy subcutaneous injection Therapeutics Ltd., Worthing,

mL of suspension and 4 needles for YES

Great Britain injection, supplied in a box

Pollinex tree, extract of birch, Pliva Croatia Ltd., Zagreb, hazel and alder tree pollen for suspension for Republic of Croatia and Allergy

3 glass bottles each containing 1 mL of

YES

specific immunotherapy subcutaneous injection Therapeutics Ltd., Worthing,

suspension, 5 syringes and 6 needles YES

Great Britain for injection, supplied in a box

Pollinex tree, extract of birch, Pliva Croatia Ltd., Zagreb, hazel and alder tree pollen for suspension for Republic of Croatia and Allergy

One 1.5 mL of suspension in a glass

YES YES

specific immunotherapy subcutaneous injection Therapeutics Ltd., Worthing,

vial, 3 glass syringes and 4 needles for

Great Britain injection, supplied in a box

Pollinex grass and rye, extract of Pliva Croatia Ltd., Zagreb, grass and rye for specific suspension for Republic of Croatia and Allergy

4 glass syringes each containing 0.5

YES YES

immunotherapy subcutaneous injection Therapeutics Ltd., Worthing,

mL of suspension and 4 needles for

Great Britain injection, supplied in a box

Pollinex grass and rye, extract of Pliva Croatia Ltd., Zagreb, grass and rye for specific suspension for Republic of Croatia and Allergy

4 glass bottles each containing 1 mL of

suspension, 5 syringes and 6 needles YES YES

immunotherapy subcutaneous injection Therapeutics Ltd., Worthing, Great Britain for injection, supplied in a box

Pollinex grass and rye, extract of Pliva Croatia Ltd., Zagreb, 5 glass syringes each containing 0.5 grass and rye for specific suspension for Republic of Croatia and Allergy mL of suspension and 4 needles for YES YES

immunotherapy subcutaneous injection Therapeutics Ltd., Worthing, Great Britain injection, supplied in a box

Lek farmacevtska družba d.d.,

Portal 20 mg capsules capsules Verovškova 57, Ljubljana, 28 (4x7) capsules in a blister, supplied YES

Republic of Slovenia in a box

YES

Lek farmacevtska družba d.d.,

Portal 20 mg capsules capsules Verovškova 57, Ljubljana, 14 (2x7) capsules in a blister, supplied

Republic of Slovenia in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Portalak syrup syrup Ulica Danica 5, Koprivnica, 20 bags (PET/Al/PE) with à 15 mL of YES

Republic of Croatia syrup, supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Portalak syrup syrup Ulica Danica 5, Koprivnica, 5 (PET/Al/PE) bags each with 15 mL

Republic of Croatia of syrup, supplied in a box

YES YES YES

Belupo, lijekovi i kozmetika d.d.,

Portalak syrup syrup Ulica Danica 5, Koprivnica, 250-mL of syrup in a plastic bottle with

Republic of Croatia screw cap, supplied in a box

YES YES YES

14509/1/11 REV 1 WS/jj 337

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Prazine sugar-coated tablets 100 Pliva Croatia Ltd., Ulica grada mg sugar-coated tablets Vukovara 49, Zagreb, Republic of

50 sugar coated tablets (5x10) in a

Croatia blister, supplied in a box

YES YES

Prazine sugar-coated tablets 25 Pliva Croatia Ltd., Ulica grada mg sugar-coated tablets Vukovara 49, Zagreb, Republic of 50 sugar coated tablets (5x10) in a YES YES Croatia blister, supplied in a box

Pliva Croatia Ltd., Ulica grada

Prazine injection 100 mg solution for injection Vukovara 49, Zagreb, Republic of Box with 10 ampoules with 2 mL of YES YES

Croatia solution

Pliva Croatia Ltd., Ulica grada

Prazine injection 50 mg solution for injection Vukovara 49, Zagreb, Republic of Box with 10 ampoules with 1 mL of YES YES

Croatia solution

Les Laboratories Servier

Preductal film coated tablets Industrie, 905 route de Saran, 60 (2x30) tablets in a PVX/Al blister,

45520 Gidy, France supplied in a box

YES YES

Krka d.d., Novo mesto, Republic

PRENESSA tablets 4 mg tablets of Slovenia; KRKA Polska 30 (3x10) tablets in PVC/PE/PVDC//Al

Sp.z.o.o., Warszawa, Poland blister, supplied in a box

YES YES YES YES

Prevenar S. Pneumoniae One glass vial with 0.5 mL of vaccine

saccharide conjugated vaccine, suspension for injection John Wyeth & Brother Ltd., absorbed Hants, Great Britain

suspension, one syringe and two YES YES

needles, supplied in a box

Prevenar, saccharide,

conjugated and absorbed suspension for injection John Wyeth & Brother Ltd., 10 syringes with 0.5 mL of vaccine vaccine against S. pneumoniae Hants, Great Britain suspension, supplied in a box

YES YES

Prevenar S. Pneumoniae

saccharide conjugated vaccine, suspension for injections John Wyeth & Brother Ltd., One syringe with 0.5 mL of vaccine absorbed Hants, Great Britain suspension, supplied in a box

YES YES

Prevenar S. Pneumoniae One syringe with 0.5 mL of vaccine

saccharide conjugated vaccine, suspension for injections John Wyeth & Brother Ltd., absorbed Hants, Great Britain

suspension, with separate needle, YES YES

supplied in a box

Prevenar S. Pneumoniae

saccharide conjugated vaccine, suspension for injection John Wyeth & Brother Ltd., One glass vial with 0.5 mL of vaccine absorbed Hants, Great Britain suspension, supplied in a box

YES YES

Les Laboratoires Servier

Industrie, Gidy, France; Servier

Prexanil 4 mg tablets Republic of Ireland Industries 30 (1x30) tablets in a blister (PVC/Al), YES

Ltd., Arcklow, Co. Wicklow, supplied in a box

YES

Republic of Ireland

Les Laboratoires Servier

Industrie, Gidy, France; Servier

PREXANIL 8 mg tablets tablets Republic of Ireland Industries 30 (1x30) tablets in a blister (PVC/Al), YES

Ltd., Arcklow, Co. Wicklow, supplied in a box

YES

Republic of Ireland

Les Laboratoires Servier

Industrie, Gidy, France; Servier

Prexanil Combi tablets Republic of Ireland Industries 30 (1x30) tablets in a blister (PVC/Al), YES

Ltd., Arcklow, Co. Wicklow, supplied in a box

YES

Republic of Ireland

Schering GmbH und Co.

Primolut-Nor tablets tablets Produktions KG, 20 tablets in an amber glass bottle, Doebereinerstrasse 20, Weimar, supplied in a carton box YES YES

Germany

Primus tea tea Fitofarmacija d.o.o., Zagreb, 14 bags each containing 5 g of tea, Republic of Croatia supplied in a box YES YES YES

Merck Sharp & Dohme B.V.,

Prinivil 10 mg tablets tablets Waarderweg 39, Postbus 581, 28 (2x14) tablets in a blister, supplied

Haarlem, the Netherlands in a box

YES YES

14509/1/11 REV 1 WS/jj 338

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Merck Sharp & Dohme B.V.,

Prinivil 20 mg tablets tablets Waarderweg 39, Postbus 581, 28 (2x14) tablets in a blister, supplied

Haarlem, the Netherlands in a box

YES YES

Merck Sharp & Dohme B.V.,

Prinivil 5 mg tablets tablets Waarderweg 39, Postbus 581, 28 (2x14) tablets in a blister, supplied YES

Haarlem, the Netherlands in a box

YES

Merck Sharp & Dohme B.V.,

Prinzide 20/12.5 mg tablets tablets Waarderweg 39, Postbus 581, 28 (2x14) tablets in a PVC/Al blister,

Haarlem, the Netherlands supplied in a box

YES YES

Vial containing single dose of

PRIORIX, combined, live GlaxoSmithKline Biologicals s.a., lyophilised vaccine (powder), syringe

lyophilized vaccine against powder and diluent for with pre-filled 0.5 mL of diluent, YES YES YES YES YES morbilli, parotitis and rubella solution for injection

Rue de lInstitut 89, Rixensart,

Belgium Water for injection, and two needles

with protective caps, supplied in a box

SmithKline Beecham

PRITOR 40 mg tablets tablets Pharmaceuticals, Crawley, West 28 (4x7) tablets in a blister

Sussex, Great Britain (PA/Al/PVC//Al), supplied in a box

YES YES YES YES

SmithKline Beecham

PRITOR 80 mg tablets tablets Pharmaceuticals, Crawley, West 28 (4x7) tablets in a blister

Sussex, Great Britain (PA/Al/PVC//Al), supplied in a box

YES YES YES YES

SmithKline Beecham 28 (4x7) tablets in a blister

PritorPlus 40/12.5 mg tablets tablets Pharmaceuticals, Crawley, West (OPA/Al/PVC/Al blister), supplied in a YES YES YES

Sussex, Great Britain box

SmithKline Beecham 28 (4x7) tablets in a blister

PritorPlus 80/12.5 mg tablets tablets Pharmaceuticals, Crawley, West (OPA/Al/PVC/Al blister), supplied in a YES YES YES

Sussex, Great Britain box

Les Laboratoires Servier

Industrie, 905 route de Saran,

45520 Gidy, France; Servier

(Republic of Ireland) Industries

Procoralan 5 mg film coated Ltd., Gorey Road, Arklow, Co. 29 (2x14) film coated tablets in a

tablets film coated tablets Wicklow, Republic of Ireland; PVC/Al blister, supplied in a carton box YES YES YES YES

Przedsiebiorstwo

Farmaceutyczne Anpharm S.A.,

Ul. Annopol 603-236, Warszava,

Poland

Les Laboratoires Servier

Industrie, 905 route de Saran,

45520 Gidy, France; Servier

(Republic of Ireland) Industries

Procoralan 7.5 mg film coated Ltd., Gorey Road, Arklow, Co. 30 (2x14) film coated tablets in a

tablets film coated tablets Wicklow, Republic of Ireland; PVC/Al blister, supplied in a carton box YES YES YES YES

Przedsiebiorstwo

Farmaceutyczne Anpharm S.A.,

Ul. Annopol 603-236, Warszava,

Poland

STADA Arzneimittel AG, 20 grams of ointment in an aluminum

Proctosan ointment Stadtstraße 2-18, Bad Vilbel, tube with a plastic cap, supplied in a YES YES YES

Germany box

STADA Arzneimittel AG,

Proctosan forte suppositories Stadtstraße 2-18, Bad Vilbel, 10 (2x5) suppositories in a strip

Germany (PVC/LDPE foil), supplied in a box

YES YES YES

Alkaloid AD - Skopje, Bulevar 10 mL of solution in an amber glass

Proculin eye drops, solution Aleksandar Makedonski 12, bottle and plastic sterile dropper

Skopje, FYROM attachment in a protective plastic bag,

YES YES

supplied in a box

Pro-famosal 20 mg coated tablets Pro. Med.CS Praha a.s., Prag, Czech Republic Box with 20 tablets (blister) YES YES

14509/1/11 REV 1 WS/jj 339

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pro-famosal 20 mg coated tablets Pro. Med.CS Praha a.s., Prag, Czech Republic Box with 20 tablets (blister) YES YES

Pro-famosal 40 mg coated tablets Pro. Med.CS Praha a.s., Prag, Czech Republic Box with 10 tablets (blister) YES YES

Pro-famosalL 40 mg coated tablets Pro. Med.CS Praha a.s., Prag, Czech Republic Box with 10 tablets (blister) YES YES

30 (3x10) capsules in a blister

Prograf capsules 0.5 mg capsules, hard Astellas Republic of Ireland Co. (PVC/PVDC//Al), in protective Ltd., Killorglin, Republic of Ireland aluminum envelope with desiccant, YES YES YES

supplied in a box

60 (6x10) capsules in a blister, in

Prograf capsules 1 mg capsules Astellas Republic of Ireland Co. Ltd., Killorglin, Republic of Ireland protective aluminium foil, supplied in a YES YES YES

box

30 (3x10) capsules in a blister, in

Prograf capsules 5 mg capsules Astellas Republic of Ireland Co. Ltd., Killorglin, Republic of Ireland protective aluminum envelope, YES YES YES

supplied in a box

Jadran - Galenski laboratorij d.d.,

Prolax suppositories for children suppositories Pulac bb, Rijeka, Republic of 10 (2x5) suppositories in a Al/PE strip,

Croatia supplied in a box

YES YES YES

Jadran - Galenski laboratorij d.d.,

Prolax suppositories for children suppositories Pulac bb, Rijeka, Republic of 10 (2x5) suppositories in a Al/PE strip,

Croatia supplied in a box

YES YES YES

Propafenon Alkaloid 150 mg film Alkaloid AD - Skopje, Bulevar 50 tablets in an amber glass bottle with

coated tablets film coated tablets Aleksandar Makedonski 12, an aluminium stopper, supplied in a YES YES Skopje, FYROM box

Propafenon Alkaloid 35 mg/10 Alkaloid AD - Skopje, Bulevar mL solution for injection solution for injection Aleksandar Makedonski 12, 10 (2x5) ampoules each containing 10 YES YES Skopje, FYROM mL of solution, supplied in a box

Propafenon Genericon 150 mg Genericon Pharma Ges.m.b.H., 50 (5x10) film coated tablets in a

film coated tablets film coated tablets Hafnerstrasse 211, Graz, Austria blister (PVC/Al), supplied in a box YES YES

Propafenon Genericon 300 mg 50 (5x10) film coated tablets in a

film coated tablets film coated tablets

Genericon Pharma Ges.m.b.H.,

Hafnerstrasse 211, Graz, Austria blister (PVC/Al), supplied in a box YES YES

Merck Sharp & Dohme B.V.,

Propecia 1 mg film coated tablets Waarderweg 39, Postbus 581, 28 (4x7) tablets in a Alu/Alu blister, YES YES

Haarlem, the Netherlands supplied in a box

Alkaloid AD - Skopje, Bulevar

Propiltiouracil Alkaloid 50 mg tablets Aleksandar Makedonski 12, 20 tablets in an amber glass bottle,

Skopje, FYROM supplied in a carton box

YES YES

Lek farmacevtska družba d.d.,

Propranolol Lek 40 mg tablets tablets Verovškova 57, Ljubljana, 50 tablets in a glass bottle, supplied in

Republic of Slovenia a box

YES YES

Merck Sharp & Dohme B.V.,

Proscar 5 mg film coated tablets Waarderweg 39, Postbus 581, 28 (2x14) tablets in a blister, supplied YES

Haarlem, the Netherlands in a box

YES

Prospan acute effervescent Engelhard Arzneimittel GmbH & 10 effervescent tablets in a plastic tube

tablets effervescent tablets Co.KG, Niederdorfelden, (desiccant in polyethylene cap), YES YES YES Germany supplied in a box

Engelhard Arzneimittel GmbH &

Prospan Liquid oral solution Co.KG, Niederdorfelden, 30 bags each with 5 mL of solution, YES YES YES

Germany supplied in a box

14509/1/11 REV 1 WS/jj 340

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

100 mL of solution in an amber glass

Engelhard Arzneimittel GmbH & bottle with plastic

Prospan oral solution oral solution Co.KG, Niederdorfelden, extensionattachment, screw cap and YES YES YES

Germany 10 mL measuring glass, supplied in a

box

Belupo, lijekovi i kozmetika d.d., 20 (1x20) tablets in a

Prospera 1 mg tablets tablets Ulica Danica 5, Koprivnica, PVC/PE/PVDC/Al blister, supplied in a YES YES

Republic of Croatia box

Belupo, lijekovi i kozmetika d.d., 20 (1x20) tablets in a

Prospera 2 mg tablets tablets Ulica Danica 5, Koprivnica, PVC/PE/PVDC/Al blister, supplied in a YES YES

Republic of Croatia box

Belupo, lijekovi i kozmetika d.d., 20 (1x20) tablets in a

Prospera 3 mg tablets tablets Ulica Danica 5, Koprivnica, PVC/PE/PVDC/Al blister, supplied in a YES YES

Republic of Croatia box

Belupo, lijekovi i kozmetika d.d., 20 (1x20) tablets in a

Prospera 4 mg tablets tablets Ulica Danica 5, Koprivnica, PVC/PE/PVDC/Al blister, supplied in a YES YES

Republic of Croatia box

Belupo, lijekovi i kozmetika d.d., 28 (1x28) tablets in a transparent

Protecta 10 mg tablets film coated tablets Ulica Danica 5, Koprivnica, blister (PVC/PE/PVDC//Al), supplied in YES YES

Republic of Croatia a box

Belupo, lijekovi i kozmetika d.d., 28 (2x14) tablets in a transparent

Protecta 20 mg tablets film coated tablets Ulica Danica 5, Koprivnica, blister (PVC/PE/PVDC//Al), supplied in YES YES

Republic of Croatia a box

Belupo, lijekovi i kozmetika d.d., 29 (2x14) tablets in a transparent

Protecta 40 mg tablets film coated tablets Ulica Danica 5, Koprivnica, blister (PVC/PE/PVDC//Al), supplied in YES YES

Republic of Croatia a box

PROVERA tablets 10 mg tablets Pfizer Italia S.r.l., Marina De 30 (3x10) tablets in a blister (PVC/Al), Tronto, Ascoli Piceno, Italy supplied in a box YES YES

PROVERA tablets 5 mg tablets Pfizer Italia S.r.l., Marina De 24 tablets in an amber glass bottle with Tronto, Ascoli Piceno, Italy plastic cap, supplied in a box YES YES

Eli Lilly and Company Limited,

Prozac 20 mg capsules capsules Basingstoke, Hampshire, Great 14 (1x14) capsules in a blister YES YES

Britain (PVC/Al), supplied in a box

Prozac dispersible tablets 20 mg freely dispersible tablets Lilly, S.A., Avendia de la Industria 14 (1x14) tablets in a blister 30, Alcobendas, Madrid, Spain (PVC/PE/Aclar//Al), supplied in a box YES YES

Lilly, S.A., Avendia de la Industria

Prozac Liquid 20 mg/5 mL oral 30, Alcobendas, Madrid, Spain;

70 mL of oral solution in an amber

glass bottle and a plastic measuring

solution oral solution Patheon France, 40, boulevard YES de Champaret, Bourgoin-Jallieu, cup (with a 5 mL graduate line), YES

France supplied in a box

100 grams of solution in a plastic

Psorimed dermal solution Dr. August Wolff GmbH & Co. Arzneimittel, Bielefeld, Germany (HDPE) bottle with applicator-shaped YES YES

PP cap, supplied in a box

F. Hoffmann-La Roche Ltd., 2.5 mL of solution in a plastic

Pulmozyme solution for inhalation Grenzacherstrasse 124, Basel, (polyethylene) ampoule, 6 ampoules in YES YES

Switzerland a protective foil, supplied in a box

Purisan granules granules Cedevita d.o.o., Zagreb, Republic of Croatia 14 bags in a box YES YES YES

PYRAZINAMID Krka tablets 500 Krka d.d., Šmarješka cesta 6, mg tablets Novo mesto, Republic of

100 tablets in an amber glass bottle

Slovenia with aluminum cap, supplied in a box

YES YES

Farmal d.d., Branitelja

Ramipril 10 mg tablets tablets domovinskog rata 8, Ludbreg, 28 (4x7) tablets in a Al/OPA/PVC/Al

Republic of Croatia blister, supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 341

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Farmal d.d., Branitelja

Ramipril 2.5 mg tablets tablets domovinskog rata 8, Ludbreg, 28 (4x7) tablets in a Al/OPA/PVC/Al

Republic of Croatia blister, supplied in a box

YES YES

Farmal d.d., Branitelja

Ramipril 5 mg tablets tablets domovinskog rata 8, Ludbreg, 28 (4x7) tablets in a Al/OPA/PVC/Al YES

Republic of Croatia blister, supplied in a box

YES

Ramipril H 2.5mg/12.5 mg Farmal d.d., Branitelja 28 (4x7) tablets in a Al/OPA/PVC/Al

tablets tablets domovinskog rata 8, Ludbreg, Republic of Croatia blister, supplied in a box YES YES

Farmal d.d., Branitelja

Ramipril H 5 mg/25 mg tablets tablets domovinskog rata 8, Ludbreg, 28 (4x7) tablets in a Al/OPA/PVC/Al

Republic of Croatia blister, supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

RAMIPRIL PLIVA 10 mg tablets tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in a blister YES YES

Croatia (Al/OPA//PVC/Al), supplied in a box

Pliva Croatia Ltd., Ulica grada

RAMIPRIL PLIVA 2.5 mg tablets tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in a blister YES YES

Croatia (Al/OPA//PVC/Al), supplied in a box

Pliva Croatia Ltd., Ulica grada

RAMIPRIL PLIVA 5 mg tablets tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in a blister

Croatia (Al/OPA//PVC/Al), supplied in a box

YES YES

RAMIPRIL PLUS PLIVA 2.5/12.5 Pliva Croatia Ltd., Ulica grada mg tablets tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in a blister YES YES Croatia (Al/OPA//PVC/Al), supplied in a box

RAMIPRIL PLUS PLIVA 5/25 mg Pliva Croatia Ltd., Ulica grada tablets tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in a blister YES Croatia (Al/OPA//PVC/Al), supplied in a box

YES

Ranisan 150 mg film coated tablets Pro. Med.CS Praha a.s., Prague, 20 (2x10) tablets in a blister, supplied Czech Republic in a box YES YES

Ranisan 150 mg film coated tablets Pro. Med.CS Praha a.s., Prague, 60 (6x10) tablets in a blister (Al/Al), Czech Republic supplied in a box YES YES

Ranisan 150 mg film coated tablets Pro. Med.CS Praha a.s., Prague, 20 (2x10) tablets in a blister (Al/Al), Czech Republic supplied in a box YES YES

Ranisan 150 mg film coated tablets Pro. Med.CS Praha a.s., Prague, 30 (3x10) tablets in a blister (Al/Al), Czech Republic supplied in a box YES YES

Ranisan 75 mg film coated tablets Pro. Med.CS Praha a.s., Prague, 10 (1x10) tablets in a blister, supplied Czech Republic in a box YES YES YES

Ranisan 75 mg film coated tablets Pro. Med.CS Praha a.s., Prague, 10 (1x10) tablets in a Al/Al blister, Czech Republic supplied in a box YES YES YES

Farmal d.d., Ludbreg, Republic of

Ranital injection 50 mg/2 mL solution for injection Croatia in cooperation with Lek

5 ampoules each with 2 mL of water

d.d., Ljubljana, Republic of for injection in a blister, supplied in a YES YES Slovenia box

Farmal d.d., Ludbreg, Republic of

Ranital tablets 150 mg film coated tablets Croatia in cooperation with Lek 20 (2x10 tablets in Al/Al blister, d.d., Ljubljana, Republic of supplied in a box YES YES

Slovenia

Farmal d.d., Ludbreg, Republic of

Ranital tablets 300 mg film coated tablets Croatia in cooperation with Lek 30 (3x10) tablets in a Al/Al blister, d.d., Ljubljana, Republic of supplied in a box YES YES

Slovenia

14509/1/11 REV 1 WS/jj 342

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Ranitidin Europharma injection Pliva Croatia Ltd., Ulica grada 50 mg/2 mL solution for injection Vukovara 49, Zagreb, Republic of

5 ampoules each with 2 mL of solution,

Croatia supplied in a box

YES YES

Ranitidin Europharma tablets Pliva Croatia Ltd., Ulica grada 150 mg film coated tablets Vukovara 49, Zagreb, Republic of

20 (2x10) tablets in a blister, supplied

Croatia in a box

YES YES

Ranitidin Europharma tablets Pliva Croatia Ltd., Ulica grada 300 mg film coated tablets Vukovara 49, Zagreb, Republic of

10 (1x10) tablets in a blister, supplied

Croatia in a box

YES YES

Jadran - Galenski laboratorij d.d.,

Ranix 150 film tablets Pulac bb, Rijeka, Republic of 20 (2x10) tablets in a blister, supplied

Croatia in a box

YES YES

Jadran - Galenski laboratorij d.d.,

Ranix 300 film tablets Pulac bb, Rijeka, Republic of 10 (1x10) tablets in a blister, supplied YES YES

Croatia in a box

Ranix injection solution forintramuscular

Jadran - Galenski laboratorij d.d.,

and intravenous injection Pulac bb, Rijeka, Republic of

5 amber glass ampoules with 2 mL of YES YES

Croatia solution, supplied in a box

Wyeth Pharmaceuticals, New

Rapamune 1 mg coated tablets coated tablets Lane, Havant, Hampshire P09 30 (3x10) tablets in a PVC/PE/Aclar/Al YES YES YES

2NG, Great Britain blister, supplied in a box

2 glass bottles with 10 units of powder,

Rapilysin 10 U powder and powder and diluent for Roche Diagnostics GmbH, 2 pre-filled syringes with 10 mL of

diluent for injection solution solution for injection Sandhofeer Strasse 116, D- YES 68305 Mannheim, Germany diluent, 2 reconstitution kits and 2 YES YES YES

injection needles

Laboratories Serono S.A., One glass vial with powder, a syringe

Raptiva 100 mg/mL powder and diluent for Aubonne, Switzerland i Industria with 1.3 mL of diluent, a reconstitution solution for injection Farmaceutica Serono S.p.A., needle and an injection needle, YES YES YES

Rome, Italy supplied in a box

RAWEL SR prolonged-release film

Krka d.d., Šmarješka cesta 6,

coated tablets Novo mesto, Republic of

32 (3x10) tablets in a PVC/PVDC//Al YES

Slovenia blister, supplied in a box

YES YES YES

Krka d.d., Šmarješka cesta 6,

RAWEL SR film coated tablets with 60 (6x10) tablets in a PVC/PVDC//Al prolonged-release Novo mesto, Republic of YES YES YES YES

Slovenia blister, supplied in a box

REBETOL 200 mg hard Schering-Plough Labo N.V. 84 (7x12) capsules in a blister

capsules hard capsules Industrepark 30, Heist-op-den Berg, Belgium (PVC/PE/PVDC//Al), supplied in a box YES YES YES YES

REBETOL 40 mg/mL oral Schering-Plough Labo N.V. 100 mL of oral solution in an amber

solution oral solution Industrepark 30, Heist-op-denglass bottle with temper-proof plastic YES YES YES YES Berg, Belgium closure, 1 glass bottle in a box

Industria Farmaceutica Serono Pre-filled 1-mL glass syringe with fixed

Rebif 22 micrograms -solution S.p.A., Bari, Italy i Laboratories stainless steel needle containing a

for injection solution for injection Serono S.A., Aubonne, single 0.5 mL dose of solution for YES YES

Switzerland injection, supplied in a box

Industria Farmaceutica Serono Pre-filled 1-mL glass syringe with fixed

Rebif 44 micrograms -solution S.p.A., Bari, Italy; Laboratories stainless steel needle containing a

for injection solution for injection Serono S.A., Aubonne, single 0.5 mL dose of solution for YES YES

Switzerland injection, supplied in a box

30 mL bottle with lyophilized drug,

lyophilisate and solvent for bottle with 10 mL of solvent (water for

Recombinate 1000 IU preparation of intravenous Baxter S.A, Hyland Immuno, injection), sterile double needle for

solution (injections/infusion) Lessines, Belgium dissolution, sterile filter needle, sterile

YES YES

mini infusion kit, disposable sterile

syringe, supplied in a box

30 mL bottle with lyophilized drug,

lyophilisate and solvent for bottle with 10 mL of solvent (water for

Recombinate 250 IU intravenous solution Baxter S.A, Hyland Immuno, injection), sterile double needle for YES YES

(injections/infusion) Lessines, Belgium dissolution, sterile filter needle, sterile

mini infusion kit, disposable sterile

14509/1/11 REV 1 WS/jj 343

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

syringe, supplied in a box

30 mL bottle with lyophilized drug,

lyophilisate and solvent for bottle with 10 mL of solvent (water for

Recombinate 500 IU preparation of i.v. solution Baxter S.A, Hyland Immuno, injection), sterile double needle for YES

(injections/infusion) Lessines, Belgium dissolution, sterile filter needle, sterile

YES

mini infusion kit, disposable sterile

syringe, supplied in a box

4 suppositories in a white non

Rectodelt 100 mg suppositories suppositories Trommsdorff GmbH & Co.KG Arzneimittel, Alsdorf, Germany transparent strip (PVC/PE), supplied in YES YES

a box

Reductil 10 mg capsules capsules Abbott GmbH & Co. KG, 28 (2x14) capsules in a blister, Ludwigshafen, Germany supplied in a box YES YES

Reductil 15 mg capsules capsules Abbott GmbH & Co. KG, 28 (2x14) capsules in a blister, Ludwigshafen, Germany supplied in a box YES YES

solution for intramuscular Alkaloid AD, Skopje, FYROM in

Reglan injection injection and intravenous cooperation with Sanofi 30 ampoules (6 x 5 on a plastic pad)

infusion Synthelabo, France with 2 mL of solution, supplied in a box

YES YES

Alkaloid AD - Skopje, Bulevar

REGLAN solution oral solution Aleksandar Makedonski 12, 120 mL of solution in an amber glass

Skopje, FYROM bottle with dispenser, supplied in a box

YES YES

Alkaloid AD, Skopje, FYROM in

Reglan tablets tablets cooperation with Sanofi 40 tablets in an amber glass bottle,

Synthelabo, France supplied in a box

YES YES

GlaxoWellcome Production, 5 rotadisk blisters (PVC/Al) each with 4

Relenza inhalation powder, dosed Evreux, France and doses of powder, in a plastic box with GlaxoSmithKline Australia Pty 1 diskhaler (applicator), supplied in a YES YES YES

Ltd., Australia box

Remicade powder for powder for preparation of One glass vial with powder supplied in concentrate of infusion solution concentrate for infusion

Centocor B.V., Einsteinweg 101,

solution 2333 CB Leiden, the Netherlands a box

YES YES

Renagel 800 mg film coated Genzyme Limited Great Britain;

tablets film coated tablets Genzyme Republic of Ireland 180 tablets in a plastic bottle YES YES YES YES Limited, Republic of Ireland

Bayer Sante Familiale, 33 rue de

Rennie chewing tablets L'industrie, 74240 Gaillard, 24 (4x6) tablets in a blister, supplied in YES YES YES

France a box

Replagal 1 mg/1 mL concentrate concentrate for infusion TKT Europe AB, Danderyd, 5-mL glass bottle with 3.5-mL of

for infusion solution solution Sweden concentrate supplied in a box YES YES YES YES YES

Replagal 1 mg/1 mL concentrate concentrate for infusion TKT Europe AB, Danderyd, 3-mL glass bottle with 1-mL of

for solution for infusion solution Sweden concentrate supplied in a box YES YES YES YES YES

SmithKline Beecham

Requip 0.25 mg tablets film coated tablets Pharmaceuticals, Crawley, West 210 tablets in a PVC/PVDC blister,

Sussex, Great Britain supplied in a box

YES YES

SmithKline Beecham

Requip 1 mg tablets film coated tablets Pharmaceuticals, Crawley, West 21 tablets in a PVC/PVDC blister,

Sussex, Great Britain supplied in a box

YES YES

SmithKline Beecham

Requip 2 mg tablets film coated tablets Pharmaceuticals, Crawley, West 21 tablets in a PVC/PVDC blister,

Sussex, Great Britain supplied in a box

YES YES

SmithKline Beecham

Requip 5 mg tablets film coated tablets Pharmaceuticals, Crawley, West 21 tablets in a PVC/PVDC blister,

Sussex, Great Britain supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 344

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Retafer 100 mg film coated Krka d.d., Šmarješka cesta 6, 30 tablets in an amber glass bottle with

tablets film coated tablets Novo mesto, Republic of an aluminium stopper, supplied in a YES YES Slovenia box

Revatio 20 mg tablets film coated tablets Pfizer PGM, Poce sur Cisse, 90 (6x15) tablets in a blister (PVC/Al), France supplied in a box YES YES YES YES

28 (4x7) tablets in a white

Revia film coated tablets Bristol-Myers Squibb, Epernon, France nontransparent PVC/PE/Aclar/Al YES YES

blister, supplied in a box

Aventis Boehring GmbH, Emil Box with 1 ampoule with 1.5 mL of

Rhesogamma P solution for intramuscular injection von-Behring Strasse 76, solution (not less than 300 µg = 1500 YES YES

Marburg, Germany IU)

lyophilisate and diluent for Lyophilisate in a glass bottle (8 mL)

Rhesonativ 1250 IU preparation of solution for Octapharma AB, Stockholm, and 2 mL of solvent (water for YES

i.m. injection Sweden injection) in an ampoule, supplied in a

YES

box

Bosnalijek d.d., Jukićeva 53, 100 mL of syrup in an amber glass

RHINOSTOP syrup syrup Sarajevo, Bosnia and bottle with plastic cap and a 5-mL YES

Herzegovina plastic measuring spoon, supplied in a

YES YES

box

Bosnalijek d.d., Jukićeva 53,

RHINOSTOP tablets tablets Sarajevo, Bosnia and 10 (1x10) tablets in a Al/PVC blister,

Herzegovina supplied in a box

YES YES YES

500 mL in a glass infusion bottle with a

Ringer's solution for intravenous solution for intravenous Hrvatski zavod za transfuzijsku chlorobutyl stopper protected with an

infusion, 500 mL infusion medicinu, Petrova 3, Zagreb, aluminium cap with a plastic lid (10 YES YES Republic of Croatia bottles with plastic holders, supplied in

a box)

B. Braun Melsungen AG, Carl

Ringer’s solution solution for infusion Braun-Straße 1, Melsungen, 10 polyethylene bottles with 1000 mL

Germany of solution, supplied in a box

YES YES

B. Braun Melsungen AG, Carl

Ringer’s solution solution for infusion Braun-Straße 1, Melsungen, 10 polyethylene bottles with 500 mL of

Germany solution, supplied in a box

YES YES

Baxter S.A., Belgium; Baxter 10 plastic Viaflo bags with 1000 mL of

Ringer’s solution Viaflo solution for infusion Healthcare Ltd, Great Britain; infusion solution, in a protective bag, YES YES

Bieffe Medital Sabinanigo, Spain supplied in a box

Baxter S.A., Belgium; Baxter 20 plastic Viaflo bags with 500 mL of

Ringer’s solution Viaflo solution for infusion Healthcare Ltd, Great Britain; infusion solution, in a protective bag, YES YES

Bieffe Medital Sabinanigo, Spain supplied in a box

Pliva Croatia Ltd., Ulica grada 100 mL of syrup in a 125 mL amber

Rinolan syrup syrup Vukovara 49, Zagreb, Republic of glass bottle with aluminum cap and a

Croatia 5-mL plastic (poylethyrene) spoon,

YES YES

supplied in a box

Pliva Croatia Ltd., Ulica grada

Rinolan tablets tablets Vukovara 49, Zagreb, Republic of 10 (1x10) tablets in a PVC/Al blister,

Croatia supplied in a box

YES YES

Rispolept 1 mg/mL solution for Janssen Pharmaceutica NV, 100 mL of oral solution in an amber

oral use oral solution Turnhouseweg 30, Beerse, glass bottle with temper-prooft plastic YES YES Belgium closure and pipette, supplied in a box

65.6 mg of powder (microspheres) in

prolonged-release Cilag AG, Schaffhausen, a glass bottle, 2 mL of solvent in a

Rispolept Consta 25 mg suspension for i.m. Switzerland for Janssen syringe, 2 needles for preparation of

injections Pharmaceutica N.V., Beerse, suspension and 1 needle for i.v.

YES YES

Belgium administration, in a plastic container,

supplied in a box

prolonged-release Cilag AG, Schaffhausen, 98.4 mg of powder (microspheres) in a

Rispolept Consta 37.5 mg suspension for i.m. Switzerland for Janssen glass bottle, 2 mL of solvent in a

injections Pharmaceutica N.V., Beerse, syringe, 2 needles for preparation of

YES YES

Belgium suspension and a needle for i.v.

14509/1/11 REV 1 WS/jj 345

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

administration, inserted into a plastic

container, supplied in a box

131.2 mg powder (microsphere) in a

Cilag AG, Schaffhausen, glass bottle, 2 mL of diluent in a

Rispolept Consta 50 mg prolonged-release Switzerland for Janssen syringe, 2 needles for suspension suspension for i.m. injection Pharmaceutica N.V., Beerse, preparation and one needle for YES YES

Belgium intramuscular administration, inserted

in a plastic container, supplied in a box

Rispolept tablets 1 mg film coated tablets Janssen-Cilag S.p.A., Borgo San 20 (2x10) tablets in a blister Michele, Latina, Italy (PVC/PE/PVDC//Al) , supplied in a box YES YES

Rispolept tablets 2 mg film coated tablets Janssen-Cilag S.p.A., Borgo San 60 (6x10) tablets in a blister Michele, Latina, Italy (PVC/PE/PVDC//Al), supplied in a box YES YES

Rispolept tablets 3 mg film coated tablets Janssen-Cilag S.p.A., Borgo San 60 (6x10) tablets in a blister Michele, Latina, Italy (PVC/PE/PVDC//Al), supplied in a box YES YES

Rispolept tablets 4 mg film coated tablets Janssen-Cilag S.p.A., Borgo San 60 (6x10) tablets in a blister Michele, Latina, Italy (PVC/PE/PVDC//Al), supplied in a box YES YES

Lek farmacevtska družba d.d.,

Rispolux 1 mg film coated tablets Verovškova 57, Ljubljana, 20 (2x10) tablets in PVC/PE/PVDC/Al YES YES

Republic of Slovenia blister, supplied in a box

YES

Lek farmacevtska družba d.d.,

Rispolux 2 mg film coated tablets Verovškova 57, Ljubljana, 20 (2x10) tablets in PVC/PE/PVDC/Al YES

Republic of Slovenia blister, supplied in a box

YES YES

Lek farmacevtska družba d.d.,

Rispolux 3 mg film coated tablets Verovškova 57, Ljubljana, 20 (2x10) tablets in PVC/PE/PVDC/Al YES YES YES

Republic of Slovenia blister, supplied in a box

Lek farmacevtska družba d.d.,

Rispolux 4 mg film coated tablets Verovškova 57, Ljubljana, 20 (2x10) tablets in PVC/PE/PVDC/Al

Republic of Slovenia blister, supplied in a box

YES YES YES

Pliva Croatia Ltd., Ulica grada 20 (2x10) film coated tablets in an

Risset tablets 1 mg film coated tablets Vukovara 49, Zagreb, Republic of orange PVC/PVDC/A1 blister, supplied YES YES

Croatia in a box

Pliva Croatia Ltd., Ulica grada 20 (2x10) film coated tablets in an

Risset tablets 2 mg film coated tablets Vukovara 49, Zagreb, Republic of orange PVC/PVDC/A1 blister, supplied YES YES

Croatia in a box

Pliva Croatia Ltd., Ulica grada 20 (2x10) film coated tablets in an

Risset tablets 3 mg film coated tablets Vukovara 49, Zagreb, Republic of orange PVC/PVDC/A1 blister, supplied YES YES

Croatia in a box

Pliva Croatia Ltd., Ulica grada 20 (2x10) film coated tablets in an

Risset tablets 4 mg film coated tablets Vukovara 49, Zagreb, Republic of orange PVC/PVDC/A1 blister, supplied YES YES

Croatia in a box

F. Hoffmann-La Roche Ltd., 50 tablets in an amber glass bottle with

Rivotril 0.5 mg tablets tablets Grenzacherstrasse 124, Basel, a plastic (PE) stopper, supplied in a YES YES

Switzerland box

F. Hoffmann-La Roche Ltd., 30 tablets in an amber glass bottle with

Rivotril 2 mg tablets tablets Grenzacherstrasse 124, Basel, a plastic (PE) stopper, supplied in a YES YES

Switzerland box

F. Hoffmann-La Roche Ltd.,

Roaccutane soft capsules 10 mg soft capsules Grenzacherstrasse 124, Basel, 30 (3x10) soft capsules in a blister YES YES

Switzerland (PVC/PE/PVDC//Al), supplied in a box

F. Hoffmann-La Roche Ltd.,

Rocaltrol 0.25 µg capsules soft capsules Grenzacherstrasse 124, Basel, 100 (5x20) capsules in PVC/Al blister,

Switzerland supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 346

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

F. Hoffmann-La Roche Ltd.,

Rocaltrol 0.5 µg capsules soft capsules Grenzacherstrasse 124, Basel, 100 (5x20) capsules in a PVC/Al YES

Switzerland blister, supplied in a box

YES

powder for preparation of F. Hoffmann-La Roche Ltd., 2 g of powder in a vial and 3.5 mL of

Rocephin 1 g i.m. solution for intramuscular Grenzacherstrasse 124, Basel, diluent (Water for Injection) in an YES YES

injection Switzerland ampoule, supplied in a box

powder for preparation of F. Hoffmann-La Roche Ltd., 1 g of powder in a vial and 10mL of

Rocephin 1 g i.v. solution for intravenous Grenzacherstrasse 124, Basel, diluent (Water for Injection) in an YES YES

injection Switzerland ampoule, supplied in a box

Rocephin 2g powder for infusion powder for solution for F. Hoffmann-La Roche Ltd., One 50 mL glass vial for infusion

solution infusion (for i.v. use) Grenzacherstrasse 124, Basel, containing powder,with rubber cap, YES YES Switzerland supplied in a vial

F. Hoffmann-La Roche Ltd., One glass syringe containing 0.5 mL of

Roferon-A 3 MIU/0.5 mL solution for injection (for solution, closed with protective cap single s.c. administration) Grenzacherstrasse 124, Basel, YES

Switzerland and a needle (in a plastic container),

YES

supplied in a box

F. Hoffmann-La Roche Ltd., One glass syringe with 0.5 mL of

Roferon-A 4.5 MIU/0.5 mL solution for injection (for solution closed with a protective cap single s.c. administration) Grenzacherstrasse 124, Basel, YES

Switzerland and one needle (in a plastic container),

YES

supplied in a box

F. Hoffmann-La Roche Ltd., One glass syringe with 0.5 mL of

Roferon-A 6 MIU/0.5 mL solution for injection (for solution closed with a protective cap single s.c. administration) Grenzacherstrasse 124, Basel, YES

Switzerland and one needle (in a plastic container),

YES

supplied in a box

F. Hoffmann-La Roche Ltd., One glass syringe with 0.5 mL of

Roferon-A 9 MIU/0.5 mL solution for injection (for solution closed with a protective cap single s.c. administration) Grenzacherstrasse 124, Basel, YES YES

Switzerland and one needle (in a plastic container), supplied in a box

Belupo, lijekovi i kozmetika d.d.,

ROJAZOL 200 mg pessary pessary Ulica Danica 5, Koprivnica, 7 (1 x7) pessaries in an Al/PE strip, YES YES

Republic of Croatia supplied in a box

Belupo, lijekovi i kozmetika d.d., 30 g of cream in an aluminium tube

ROJAZOL cream cream Ulica Danica 5, Koprivnica, with a plastic stopper, supplied in a YES YES

Republic of Croatia box

Belupo, lijekovi i kozmetika d.d., 40 g of oral gel in an aluminium tube

ROJAZOL oral gel oral gel Ulica Danica 5, Koprivnica, with a 5 mL plastic measuring spoon, YES YES

Republic of Croatia supplied in a box

A.C.R.A.F. S.p.A., Via Vecchia

Rosalgin granules granules for vaginal solution del Pinocchio, 22, 60131 Ancona, 4 bags (2x2), each with 9.44 g of

Italy granulate, supplied in a box

YES YES

A.C.R.A.F. S.p.A., Via Vecchia 140 mL of solution in a plastic bottle

Rosalgin solution vaginal solution del Pinocchio, 22, 60131 Ancona, with plastic applicator attachment, 5 YES YES

Italy bottles in a carton box

ROWA PHARMACEUTICALS

ROWAchol capsules capsules LTD., Newtown, Bantry, Co. 30 (3x10) capsules in a blister, YES YES YES

Cork, Republic of Ireland supplied in a box

ROWA PHARMACEUTICALS

ROWAtinex capsules capsules LTD., Newtown, Bantry, Co. 30 (3x10) capsules in a blister,

Cork, Republic of Ireland supplied in a box

YES YES YES

Jadran - Galenski laboratorij d.d.,

Rozamet 1% cream cream Pulac bb, Rijeka, Republic of 25 grams of cream in an Al tube, YES

Croatia supplied in a carton box

YES

RUDAKOL 135 mg coated Belupo, lijekovi i kozmetika d.d., 50 coated tablets in an amber glass

tablets coated tablets Ulica Danica 5, Koprivnica, bottle with an aluminium stopper, YES YES Republic of Croatia supplied in a box

14509/1/11 REV 1 WS/jj 347

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Rupurut chewing tablets chewing tablets Bayer HealthCare AG, 51368 20 (2x10) chewing tablets in a blister, Leverkusen, Germany supplied in a box YES YES YES

Krka d.d., Šmarješka cesta 6,

Rutacid chewing tablets 500 mg chewing tablets Novo mesto, Republic of 20 (2x10) tablets in a blister YES

Slovenia (PVC/PVDC-Al), supplied in a box

YES YES

Rytmonorm 150 mg film tablets film coated tablets Abbott GmbH & Co. KG,

50 (5x10) film coated tablets in a

Ludwigshafen, Germany blister (PVC/Al or PP/Al) , supplied in a YES YES box

Rytmonorm 300 mg film tablets film coated tablets Abbott GmbH & Co. KG,

50 (5x10) film coated tablets in a

Ludwigshafen, Germany blister (PVC/Al or PP/Al), supplied in a YES YES box

Ebewe Pharma Ges. m.b.H. Nfg. 20 mL of injection solution in a glass

Rytmonorm solution for injection solution for injection KG, Mondseestrasse 11, ampoule, 5 ampoules supplied in a YES YES

Unterach, Austria box

Salazopyrin EN tablets 500 mg gastric-resistant tablets Pfizer Health AB, Uppsala, 100 tablets in a polyethylene bottle, Sweden supplied in a box YES YES

Salofalk suppositories 250 mg suppositories dr. Falk Pharma GmbH, Freiburg, 30 (6x5) suppositories in a strip Germany (PVC/LDPE), supplied in a box YES YES

Salofalk suppositories 500 mg suppositories dr. Falk Pharma GmbH, Freiburg, 30 (6x5) suppositories in a strip Germany (PVC/LDPE), supplied in a box YES YES

7 plastic containers each with 60 mL of

Salofalk suspension for rectal suspension for rectal dr. Falk Pharma GmbH, Freiburg, suspension (with attachment for rectal

administration 4 g/60 mL administration Germany administration) in a protective blister, YES YES

supplied in a box

100 (10x10) tablets in a

Salofalk 250 mg tablets gastric-resistant tablets dr. Falk Pharma GmbH, Freiburg, Germany PVC/PVDC//Al blister, supplied in a YES YES

box

100 (10x10) tablets in a

Salofalk 500 mg tablets gastric-resistant tablets dr. Falk Pharma GmbH, Freiburg, Germany PVC/PVDC//Al blister, supplied in a YES YES

box

Pliva Croatia Ltd., Ulica grada 250-mL of solution for infusion in a

Salviamin L8b.UH solution for infusion Vukovara 49, Zagreb, Republic of plastic bottle for infusion, 10 bottles YES YES

Croatia and plastic bottle holders in a box

Pliva Croatia Ltd., Ulica grada 500 mL of solution for infusion in a

Salviamin L8b.UH solution for infusion Vukovara 49, Zagreb, Republic of glass infusion bottle, 10 bottles and YES YES

Croatia plastic bottle holders in a box

Pliva Croatia Ltd., Ulica grada 500 mL of solution for infusion in a

Salviamin LX6 solution for infusion Vukovara 49, Zagreb, Republic of glass infusion bottle, 10 bottles in a YES YES

Croatia box

Sandimmun 50 mg/mL concentrate for intravenous Novartis Pharma Stein AG, 10 ampoules containing 5 mL of

concentrate for infusion infusion Schaffhauserstrasse, Stein, concentrate for infusion, supplied in a YES YES Switzerland box

Sandimmun Neoral 100 mg Novartis Pharma Stein AG, capsules soft gelatinous capsules Schaffhauserstrasse, Stein,

50 (10x5) capsules in an Al blister,

Switzerland supplied in a box

YES YES

Sandimmun Neoral capsules 25 Novartis Pharma Stein AG, mg soft gelatinous capsules Schaffhauserstrasse, Stein, 50 (10x5) capsules in an Al blister, YES YES Switzerland supplied in a box

Sandimmun Neoral capsules 50 Novartis Pharma Stein AG, mg soft gelatinous capsules Schaffhauserstrasse, Stein,

50 (10x5) capsules in an Al blister,

Switzerland supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 348

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Sandimmun Neoral 100 mg/mL Novartis Pharma S.A.S., 50 mL of solution in an amber glass

oral solution oral solution Huningue Cedex, France bottle with a measuring kit (in a YES YES protective container), supplied in a box

Novartis Pharma Stein AG,

Sandostatin 0.05 mg injection solution for injection Schaffhauserstrasse, Stein, 5 ampoules each with 1 mL of solution YES YES

Switzerland for injection, supplied in a box

Novartis Pharma Stein AG,

Sandostatin 0.1 mg injection solution for injection Schaffhauserstrasse, Stein, 5 ampoules each with 1 mL of solution

Switzerland for injection, supplied in a box

YES YES

Novartis Pharma Stein AG,

Sandostatin 0.5 mg injection solution for injection Schaffhauserstrasse, Stein, 5 ampoules each with 1 mL of solution

Switzerland for injection, supplied in a box

YES YES

Vial with powder, pre-filled syringe with

Novartis Pharma Stein AG, 2.5 mL of diluent for suspension, and

Sandostatin LAR 10 mg powder and diluent for two needles (1.1x40 mm, 19 G x 1 suspension for injection Schaffhauserstrasse, Stein,

Switzerland 1/2'') in individual packages, inserted

YES YES

into protective plastic container,

supplied in a carton box

Vial with powder, pre-filled syringe with

Novartis Pharma Stein AG, 2.5 mL of diluent for suspension, two

Sandostatin LAR 20 mg powder and diluent for needles (1.1x40 mm, 19 G x 1 1/2'') in suspension for injection Schaffhauserstrasse, Stein, YES YES

Switzerland individual packages, inserted into a protective plastic container, supplied in

a carton box

Vial with powder, pre-filled syringe with

Novartis Pharma Stein AG, 2.5 mL of diluent for suspension, two

Sandostatin LAR 30 mg powder and diluent for needles (1.1x40 mm, 19 G x 1 1/2'') in suspension for injection Schaffhauserstrasse, Stein, YES

Switzerland individual packages, inserted into a

YES

protective plastic container, supplied in

a carton box

Lek farmacevtska družba d.d.,

Sanval 10 mg tablets film coated tablets Verovškova 57, Ljubljana, 20 (2x10) tablets in PVC/Al blister,

Republic of Slovenia supplied in a box

YES YES

Lek farmacevtska družba d.d.,

Sanval 10 mg tablets film coated tablets Verovškova 57, Ljubljana, 20 (2x10) tablets in PVC/Al blister,

Republic of Slovenia supplied in a box

YES YES

Lek farmacevtska družba d.d.,

Sanval 5 mg tablets film coated tablets Verovškova 57, Ljubljana, 20 (2x10) tablets in PVC/Al blister, YES YES

Republic of Slovenia supplied in a box

Bayer Sante Familiale, 33 rue de

Saridon tablets L'industrie, 74240 Gaillard, 10 (1x10) tablets in a PVC/Al blister, YES

France supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6,

Seldiar capsules capsules Novo mesto, Republic of 20 capsules in an amber glass bottle,

Slovenia supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6,

Septolete lozenges Novo mesto, Republic of 31 (3x10) lozenges in a blister, YES YES YES

Slovenia supplied in a box

Krka d.d., Šmarješka cesta 6,

Septolete D lozenges Novo mesto, Republic of 32 (3x10) lozenges in a blister, YES YES

Slovenia supplied in a box

YES

Krka d.d., Šmarješka cesta 6,

Septolete wild cherry lozenges Novo mesto, Republic of 18 (2x9) lozenges in a blister YES

Slovenia (PVC/PVDC-Al), supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6,

Septolete lemon lozenges Novo mesto, Republic of 18 (2x9) lozenges in a blister YES YES YES

Slovenia (PVC/PVDC-Al), supplied in a box

14509/1/11 REV 1 WS/jj 349

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Krka d.d., Šmarješka cesta 6,

Septolete Plus lozenges lozenges Novo mesto, Republic of 30 (3x10) lozenges in a blister YES YES

Slovenia (PVC/PVDC-Al), supplied in a box

YES

Krka d.d., Šmarješka cesta 6,

Septolete green apple lozenges Novo mesto, Republic of 18 (2x9) lozenges in a blister YES

Slovenia (PVC/PVDC-Al), supplied in a box

YES YES

Serdolect 12 mg film coated 28 (4x7) tablets in a blister

tablets film coated tablets

H. Lundbeck A/S, Ottilavej 9,

Copenhagen-Valby, Denmark (PVC/PVdC/Al), supplied in a box YES YES YES

Serdolect 16 mg film coated 28 (4x7) tablets in a blister

tablets film coated tablets

H. Lundbeck A/S, Ottilavej 9,

Copenhagen-Valby, Denmark (PVC/PVdC/Al), supplied in a box YES YES YES

Serdolect 20 mg film coated

tablets film coated tablets

H. Lundbeck A/S, Ottilavej 9, 28 (4x7) tablets in a blister

Copenhagen-Valby, Denmark (PVC/PVdC/Al), supplied in a box YES YES YES

Serdolect 4 mg film coated 31 (3x10) tablets in a PVC/PVdC/Al

tablets film coated tablets

H. Lundbeck A/S, Ottilavej 9,

Copenhagen-Valby, Denmark blister, supplied in a box YES YES YES

Seretide 100 discus inhalation powder Glaxo Wellcome Operations,

60 doses of powder in an aluminium

Greenford, Great Britain blister (with protective foil) in a plastic YES YES YES housing, supplied in a box

One metal container (120 doses) with

Seretide 125 Inhaler inhalation aerosol Glaxo Wellcome Production, Evreux, France metering valve in plastic atomizer for YES YES YES

oral administration, supplied in a box

60 doses of powder in an aluminium

Seretide 250 diskus inhalation powder Glaxo Wellcome Operations, Greenford, Great Britain blister (with protective foil) in a plastic YES YES YES

housing, supplied in a box

One metal container (120 doses) with

Seretide 250 Inhaler inhalation aerosol Glaxo Wellcome Production, Evreux, France metering valve in plastic atomizer for YES YES YES

oral administration, supplied in a box

One metal container (120 doses) with

Seretide 50 Inhaler inhalation aerosol Glaxo Wellcome Production, Evreux, France metering valve in plastic atomizer for YES YES YES

oral administration, supplied in a box

60 doses of powder in an aluminium

Seretide 500 diskus inhalation powder Glaxo Wellcome Operations, Greenford, Great Britain blister (with protective foil) in a plastic YES YES YES

housing, supplied in a box

60 doses of powder in an aluminium

Serevent Discus inhalation powder Glaxo Wellcome Production, Evreux, France blister, in a plastic housing, supplied in YES YES

a box

GlaxoSmithKline

Pharmaceuticals S.A., Ul.

Serevent Inhaler inhalation aerosol Grunwaldzka 189, Poznan,

120 doses in a metal (aluminum) bottle

(suspension) Polish Glaxo Wellcome with metering valve in plastic YES YES

Production, 23 Rue Lavoisier, nebulizer, supplied in a box

Evreux, France

AstraZeneca UK Limited, Silk

SEROQUEL tablets 100 mg film coated tablets Road Business Park, 60 tablets (6x10) in a blister, supplied Macclesfield, Cheshire, Great in a box YES YES YES

Britain

AstraZeneca UK Limited, Silk

SEROQUEL tablets 200 mg film coated tablets Road Business Park, 60 tablets (6x10) in a blister, supplied Macclesfield, Cheshire, Great in a box YES YES YES

Britain

AstraZeneca UK Limited, Silk

SEROQUEL tablets 25 mg film coated tablets Road Business Park, 60 tablets (6x10) in a blister, supplied Macclesfield, Cheshire, Great in a box YES YES YES

Britain

14509/1/11 REV 1 WS/jj 350

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

AstraZeneca UK Limited, Silk

Seroquel tablets 300 mg film coated tablets Road Business Park, 60 (6x10) tablets in a blister (PVC/Al), Macclesfield, Cheshire, Great supplied in a box YES YES YES

Britain

Belupo lijekovi i kozmetika d.d.,

Seroxat 20 mg tablets film coated tablets Koprivnica, Republic of Croatia in 30 (3x10) tablets in a blister, supplied cooperation with in a box YES YES

GlaxoSmithKline, Great Britain

Belupo lijekovi i kozmetika d.d.,

Seroxat 30 mg tablets film coated tablets Koprivnica, Republic of Croatia in 30 (3x10) tablets in a blister, supplied cooperation with in a box YES YES

GlaxoSmithKline, Great Britain

Belupo lijekovi i kozmetika d.d.,

Seroxat oral suspension oral suspension Koprivnica, Republic of Croatia in 150 mL of suspension in an amber cooperation with glass bottle, supplied in a box YES YES

GlaxoSmithKline, Great Britain

Pliva Croatia Ltd., Ulica grada

Setronon injection 4 mg/2 mL solution for injection Vukovara 49, Zagreb, Republic of Box with 5 ampoules containing 2 mL

Croatia of solution

YES YES

Pliva Croatia Ltd., Ulica grada

Setronon injection 8 mg/4 mL solution for injection Vukovara 49, Zagreb, Republic of Box with 5 ampoules containing 4 mL YES YES

Croatia of solution

Pliva Croatia Ltd., Ulica grada

Setronon tablets 4 mg film tablets Vukovara 49, Zagreb, Republic of Box with 10 tablets (blister) YES YES

Croatia

Pliva Croatia Ltd., Ulica grada

Setronon tablets 8 mg film tablets Vukovara 49, Zagreb, Republic of Box with 10 tablets (blister) YES YES

Croatia

Brown polyethylene bottle with 250 mL

Sevorane inhalate, solution Abbott Laboratories Ltd., Queenborough, Great Britain of solution and a temper-evident YES YES

stopper, supplied in a box

Sevredol 10 mg film coated Bard Pharmaceuticals Ltd., Milton 56 (4x14) tablets in a PVC/PVDC/Al

tablets film coated tablets Road, Cambridge, Great Britain blister, supplied in a box YES YES

Sevredol 10 mg film coated Mundipharma Gm.b.H., Limburg, tablets film coated tablets Germany and Mundipharma 30 (3x10) tablets in a PVC/PVdC/Al YES YES GES.m.b.H., Vienna, Austria blister, supplied in a box

Sevredol 20 mg film coated Bard Pharmaceuticals Ltd., Milton 56 (4x14) tablets in a PVC/PVDC/Al

tablets film coated tablets Road, Cambridge, Great Britain blister, supplied in a box YES YES

Sevredol 20 mg film coated Mundipharma Gm.b.H., Limburg, 31 (3x10) tablets in a PVC/PVdC/Al

tablets film coated tablets Germany and Mundipharma YES YES GES.m.b.H., Vienna, Austria blister, supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Silapen 1000 oral suspension oral suspension Ulica Danica 5, Koprivnica, 150 mL of suspension in an amber

Republic of Croatia glass bottle, supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Silapen 1000 tablets tablets Ulica Danica 5, Koprivnica, 15 tablets in a plastic bottle, supplied YES

Republic of Croatia in a box

YES

Belupo, lijekovi i kozmetika d.d.,

Silapen 1500 tablets tablets Ulica Danica 5, Koprivnica, 30 tablets in a blister, supplied in a box YES YES

Republic of Croatia

Belupo, lijekovi i kozmetika d.d.,

Silymarin capsules capsules Ulica Danica 5, Koprivnica, 30 (3x10) capsules in a PVC/Al blister, YES YES

Republic of Croatia supplied in a box

YES

Cipla Ltd., MIDC Industrial Area,

Simcard 10 film coated tablets Kurkumbh, Pune, Maharashtra 20 (2x10) tablets in a blister (white

State, India PVC/PVDC/Al), supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 351

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Cipla Ltd., MIDC Industrial Area,

Simcard 20 film coated tablets Kurkumbh, Pune, Maharashtra 20 (2x10) tablets in a blister (white YES

State, India PVC/PVDC/Al), supplied in a box

YES

Cipla Ltd., MIDC Industrial Area,

Simcard 40 film coated tablets Kurkumbh, Pune, Maharashtra 28 (2x14) tablets in a blister (white

State, India PVC/PVDC/Al), supplied in a box

YES YES

Simdax 2.5 mg/mL concentrate concentrate for solution for Orion Corporation ORION One glass vial with 5 mL of solution

for solution for infusion infusion PHARMA, Espoo, Finland concentrate, supplied in a box YES YES YES

powder and solvent for Novartis Pharma Stein AG, Vial containing medicinal product

Simulect 10 mg preparation of solution for Schaffhauserstrasse, Stein, (powder) and ampoule with 5mL of

injection or infusion Switzerland diluent (Water for Injection), supplied

YES YES

in a box

powder and solvent for Novartis Pharma Stein AG, Vial containing medicinal product

Simulect 20 mg preparation of solution for Schaffhauserstrasse, Stein, (powder) and ampoule with 5mL of YES

injection or infusion Switzerland diluent (Water for Injection), supplied

YES

in a box

Lek farmacevtska družba d.d.,

Simvastatin Lek 10 mg film Ljubljana, Republic of Slovenia, coated tablets film coated tablets LEK S.A., Warszawa, Poland and 28 (2x14) tablets in a PVC/Al blister, YES YES YES Salutas Pharma GmbH, supplied in a box

Barleben, Germany

Lek farmacevtska družba d.d.,

Simvastatin Lek 20 mg film Ljubljana, Republic of Slovenia, coated tablets film coated tablets LEK S.A., Warszawa, Poland and

28 (2x14) tablets in a PVC/Al blister,

Salutas Pharma GmbH, supplied in a box

YES YES YES

Barleben, Germany

Lek farmacevtska družba d.d.,

Simvastatin Lek 40 mg film Ljubljana, Republic of Slovenia, coated tablets film coated tablets LEK S.A., Warszawa, Poland and

28 (2x14) tablets in a PVC/Al blister,

Salutas Pharma GmbH, supplied in a box

YES YES YES

Barleben, Germany

Jadran - Galenski laboratorij d.d., 20 (2x10) film coated tablets in a

Simvax 10 mg film coated tablets film coated tablets Pulac bb, Rijeka, Republic of (PVC/PVDC/Al) blister, supplied in a YES YES

Croatia box

Jadran - Galenski laboratorij d.d.,

Simvax 10 mg film coated tablets film coated tablets Pulac bb, Rijeka, Republic of 28 (1x28) film coated tablets in a

Croatia PVC/PVDC/Al blister, supplied in a box

YES YES

Jadran - Galenski laboratorij d.d., 20 (2x10) film coated tablets in a

Simvax 20 mg film coated tablets film coated tablets Pulac bb, Rijeka, Republic of (PVC/PVDC/Al) blister, supplied in a YES YES

Croatia box

Jadran - Galenski laboratorij d.d., 20 (2x10) film coated tablets in a

Simvax 40 mg film coated tablets film coated tablets Pulac bb, Rijeka, Republic of (PVC/PVDC/Al) blister, supplied in a YES YES

Croatia box

Novartis Saglik, Turkey za

Sinecod 50 film coated tablets film coated tablets Novartis Consumer Health S.A., 10 (1x10) tablets in a blister, supplied

Switzerland in a box

YES YES

Novartis Consumer Health S.A., 20 mL of solution in a plastic bottle

Sinecod oral drops oral drops, solution Route de l' Etraz, Nyon, with dropper attachment, supplied in a YES YES

Switzerland box

Novartis Consumer Health S.A., 200 mL of syrup in an amber glass

Sinecod syrup syrup Route de l' Etraz, Nyon, bottle and a plastic measuring vessel, YES YES

Switzerland supplied in a box

Merck Sharp & Dohme B.V.,

Sinemet CR tablets controlled-release tablets Waarderweg 39, Postbus 581, 100 tablets in an amber glass bottle,

Haarlem, the Netherlands supplied in a box

YES YES

Merck Sharp & Dohme B.V.,

Sinemet tablets tablets Waarderweg 39, Postbus 581, 100 (10x10) tablets in a blister,

Haarlem, the Netherlands supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 352

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pliva Croatia Ltd., Ulica grada

SINERSUL forte tablets tablets Vukovara 49, Zagreb, Republic of 10 (1x10) tablets in a PVC/AI blister, YES

Croatia supplied in a box

YES

Pliva Croatia Ltd., Ulica grada 100 mL of syrup in an amber glass

SINERSUL syrup syrup Vukovara 49, Zagreb, Republic of bottle with aluminum cap and a 5-mL YES YES

Croatia plastic spoon, supplied in a box

Pliva Croatia Ltd., Ulica grada

SINERSUL tablets tablets Vukovara 49, Zagreb, Republic of 20 (2x10) tablets in a blister (PVC/Al), YES YES

Croatia supplied in a box

Singulair 10 mg film coated Merck Sharp & Dohme B.V., tablets film coated tablets Waarderweg 39, Postbus 581,

28 (2x14) tablets in a PA/PVC/Al

Haarlem, the Netherlands blister, supplied in a box

YES YES

Singulair junior 5 mg chewing Merck Sharp & Dohme B.V., 28 (2x14) tablets in a PA/PVC/Al

tablets chewing tablets Waarderweg 39, Postbus 581, Haarlem, the Netherlands blister, supplied in a box YES YES

Merck Sharp & Dohme B.V.,

Singulair mini 4 mg oral granules granules for oral solution Waarderweg 39, Postbus 581, 28 aluminum bags each containing YES

Haarlem, the Netherlands 500 mg of granules, supplied in a box

YES

Singulair mini 4 mg chewing Merck Sharp & Dohme B.V., 28 (2x14) tablets in a PA/PVC/Al

tablets chewing tablets Waarderweg 39, Postbus 581, YES YES Haarlem, the Netherlands blister, supplied in a box

Berlin-Chemie AG (Menarini

Siofor 500 film coated tablets Group), Glienicker Weg 125, 39 (3x10) tablets in a PVC/Al blister, YES YES

Berlin, Germany supplied in a box

Berlin-Chemie AG (Menarini

Siofor 850 film coated tablets Group), Glienicker Weg 125, 30 (2x15) tablets in a PVC/Al blister, YES YES

Berlin, Germany supplied in a box

Trešnjevka laboratorij d.o.o., 220 mL of syrup in an amber glass

Iceland lichen syrup syrup Jukićeva 32, Zagreb, Republic of bottle with aluminum cap, supplied in a YES YES YES

Croatia box

Skinoren cream cream Intendis Manufacturing S.p.A., 30 g of cream in an aluminium tube, Segrate, Milano, Italy supplied in a box YES YES

Alkaloid AD - Skopje, Bulevar

Skopryl 10 mg tablets Aleksandar Makedonski 12, 36 (3x10) tablets in a PVC/Al blister, YES YES

Skopje, FYROM supplied in a box

Alkaloid AD - Skopje, Bulevar

Skopryl 20 mg tablets Aleksandar Makedonski 12, 37 (3x10) tablets in a PVC/Al blister, YES YES

Skopje, FYROM supplied in a box

Compound sodium lactate B. Braun Melsungen AG, Carlsolution (Hartmann's solution) solution for infusion Braun-Straße 1, Melsungen,

1000 mL of infusion solution in a

Germany plastic bottle (10 bottles in a box)

YES YES

Compound sodium lactate B. Braun Melsungen AG, Carl 500 mL of solution for infusion in a

solution (Hartmann's solution) solution for infusion Braun-Straße 1, Melsungen, Germany plastic bottle (10 bottles in a box) YES YES

Smecta powder for preparation of Beaufor Ipsen Industrie, Dreux,

30 bags (LDPE/Al/paper) each with

oral suspension France 3.76 g of powder for oral suspension, YES YES YES supplied in a box

10 bags (LDPE/Al/paper) each

Smecta powder for oral suspension Beaufor Ipsen Industrie, Dreux, France containing 3.76 g of powder for oral YES YES YES

suspension, supplied in a box

SMOFlipid 20% emulsion for Plastic bag ("Excel") containing 100 infusion emulsion for infusion

Fresenius Kabi AB, Uppsala,

Sweden mL of emulsion for infusion with two YES YES YES attachments for drug administration

14509/1/11 REV 1 WS/jj 353

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

and for infusion, one small bag

containing oxygen absorber, and one

bag with solution for packaging

airtightness control

Plastic bag ("Excel") containing 500

mL of emulsion for infusion with two

SMOFlipid 20% emulsion for Fresenius Kabi AB, Uppsala, attachments for drug administration

infusion emulsion for infusion Sweden and for infusion, one small bag YES YES YES containing oxygen absorber, and one

bag with solution for packaging

airtightness control

Plastic bag ("Excel") containing 250

mL of emulsion for infusion with two

SMOFlipid 20% emulsion for attachments for drug administration infusion emulsion for infusion

Fresenius Kabi AB, Uppsala,

Sweden and for infusion, one small bag YES YES YES containing oxygen absorber, and one

bag with solution for packaging

airtightness control

Glass infusion bottle with 500 mL of

SMOFlipid 20% emulsion for Fresenius Kabi Austria GmbH, emulsion (with rubber stopper,

infusion emulsion for infusion Graz, Austria aluminum ring and plastic protective YES YES YES

cap), 10 bottles in a carton box

Glass infusion bottle with 250 mL

SMOFlipid 20% emulsion for emulsion (with rubber stopper,

infusion emulsion for infusion

Fresenius Kabi Austria GmbH,

Graz, Austria aluminum ring and plastic protective YES YES YES

cap), 10 bottles in a carton box

Glass infusion bottle with 100 mL of

SMOFlipid 20% emulsion for emulsion (with rubber stopper,

infusion emulsion for infusion

Fresenius Kabi Austria GmbH,

Graz, Austria aluminum ring and plastic protective YES YES YES

cap), 10 bottles in a carton box

SOLPADEINE capsules capsules Glaxo Wellcome Production, 12 (1x12) capsules in a PVC/Al blister, Mayenne, France supplied in a box YES YES YES

SOLPADEINE effervescent GlaxoSmithKline Dungarvan Ltd., 12 (3x4) effervescent tablets in

tablets effervescent tablets Knockbrack, Dungarvan, Co. multilayer strip packing YES YES YES Waterford, Republic of Ireland (paper/PE/Al/PE), supplied in a box

GlaxoSmithKline Dungarvan Ltd.,

SOLPADEINE tablets tablets Knockbrack, Dungarvan, Co. 12 (1x12) tablets in PVC/Al blister, YES YES YES

Waterford, Republic of Ireland supplied in a box

Glass bottle with lyophilisate in a lower

Solu-Cortef injection 100 mg lyophilisate and diluent for Pfizer Manufacturing Belgium solution for injection NV, Rijksweg 12, Puurs, Belgium part and solvent (2 mL) in the upper YES YES

part, supplied in a box

Pliva Croatia Ltd., Ulica grada 10 glass bottles with à 20 mL of

Soludeks 1 solution for injection Vukovara 49, Zagreb, Republic of solution for injection (with rubber

Croatia stopper and aluminum cap), supplied

YES YES

in a box

Pliva Croatia Ltd., Ulica grada 10 glass nfusion bottles each

Soludeks 40 solution for infusion Vukovara 49, Zagreb, Republic of contiaining 500 mL of infusion solution

Croatia and plastic holders for infusion bottles,

YES YES

supplied in a box

Pliva Croatia Ltd., Ulica grada 11 glass nfusion bottles each

Soludeks 70 solution for infusion Vukovara 49, Zagreb, Republic of contiaining 500 mL of infusion solution

Croatia and plastic holders for infusion bottles,

YES YES

supplied in a box

Glass bottle with lyophilisate in a lower

SOLU-MEDROL injection 1000 lyophilisate and diluent for Pfizer Manufacturing Belgium part and solvent (15.60 mL for

mg solution for injection NV, Rijksweg 12, Puurs, Belgium reconstitution of lyophilisate), supplied YES YES

in a box

SOLU-MEDROL injection 125 lyophilisate and diluent for Pfizer Manufacturing Belgium Glass bottle with lyophilisate in a lower

mg solution for injection NV, Rijksweg 12, Puurs, Belgium part and solvent (2 mL) in the upper YES YES part, supplied in a box

14509/1/11 REV 1 WS/jj 354

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

SOLU-MEDROL injection 250 lyophilisate and diluent for Pfizer Manufacturing Belgium Glass bottle with lyophilisate in a lower

mg solution for injection NV, Rijksweg 12, Puurs, Belgium part and solvent (4 mL) in the upper YES YES part, supplied in a box

Glass bottle with lyophilisate in a lower

SOLU-MEDROL injection 40 mg lyophilisate and diluent for Pfizer Manufacturing Belgium solution for injection NV, Rijksweg 12, Puurs, Belgium part and solvent (1mL) in the upper YES YES

part, supplied in a box

Glass bottle with lyophilisate in a lower

SOLU-MEDROL injection 500 lyophilisate and diluent for Pfizer Manufacturing Belgium part and solvent (7.8 mL for

mg solution for injection NV, Rijksweg 12, Puurs, Belgium reconstitution of lyophilisate), supplied YES YES

in a box

Glass bottle of 6 mL with powder and a

SOMAVERT injection 10 mg powder and diluent for Pfizer Manufacturing Belgium glass bottle with 8 mL of water for solution for injection NV, Rijksweg 12, Puurs, Belgium injection 30 bottles with powder and 30 YES YES YES YES

bottles with solvent, supplied in a box

Glass bottle of 6 mL with powder and a

SOMAVERT injection 15 mg powder and diluent for Pfizer Manufacturing Belgium glass bottle with 8 mL of water for solution for injection NV, Rijksweg 12, Puurs, Belgium injection 30 bottles with powder and 30 YES YES YES YES

bottles with solvent, supplied in a box

Glass bottle of 6 mL with powder and a

SOMAVERT injection 20 mg powder and diluent for Pfizer Manufacturing Belgium glass bottle with 8 mL of water for solution for injection NV, Rijksweg 12, Puurs, Belgium injection 30 bottles with powder and 30 YES YES YES YES

bottles with solvent, supplied in a box

Glass bottle of 6 mL with powder and a

bottle with solvent, supplied in a box

Jadran - Galenski laboratorij d.d.,

Sonalia 50 mg film coated tablets Pulac bb, Rijeka, Republic of 28 (2x14) tablets in a PVC/Al blister, YES

Croatia supplied in a box

YES

Gödecke GmbH, Mooswaldalle 1,

Freiburg, Germany; Heinrich

Mack Nacf. GmbH&Co.KG,

Sortis 10 mg tablets film coated tablets Heinrich Mack Strasse 35, 14 (2x7) tablets in a (PA/Al/PVC//Al)

Illertisen, Germany; Pfizer Italia blister, supplied in a box

YES YES

S.r.l., Strada statale 156, km 50,

Borgo san Michele, Latina, Italy

Gödecke GmbH, Mooswaldalle 1,

Freiburg, Germany; Heinrich

Mack Nacf. GmbH&Co.KG,

Sortis 20 mg tablets film coated tablets Heinrich Mack Strasse 35, 15 (2x7) tablets in a (PA/Al/PVC//Al)

Illertisen, Germany; Pfizer Italia blister, supplied in a box

YES YES

S.r.l., Strada statale 156, km 50,

Borgo san Michele, Latina, Italy

Gödecke GmbH, Mooswaldalle 1,

Freiburg, Germany; Heinrich

Mack Nacf. GmbH&Co.KG,

Sortis 40 mg tablets film coated tablets Heinrich Mack Strasse 35, 16 (2x7) tablets in a (PA/Al/PVC//Al)

Illertisen, Germany; Pfizer Italia blister, supplied in a box

YES YES

S.r.l., Strada statale 156, km 50,

Borgo san Michele, Latina, Italy

Gödecke GmbH, Mooswaldalle 1,

Freiburg, Germany; Heinrich

Mack Nacf. GmbH&Co.KG,

Sortis 80 mg tablets film coated tablets Heinrich Mack Strasse 35, 17 (2x7) tablets in a (PA/Al/PVC//Al) YES

Illertisen, Germany; Pfizer Italia blister, supplied in a box

YES

S.r.l., Strada statale 156, km 50,

Borgo san Michele, Latina, Italy

Lek farmacevtska družba d.d., 50 (5x10) amber glass ampoules with

Spasmex 0.2 mg/5 mL injection solution for injection Verovškova 57, Ljubljana, 5 mL of solution for injection in a YES YES

Republic of Slovenia plastic container, supplied in a box

14509/1/11 REV 1 WS/jj 355

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Lek farmacevtska družba d.d.,

Spasmex forte 5 mg tablets tablets Verovškova 57, Ljubljana, 20 (2x10) tablets in a blister

Republic of Slovenia (PVC/PVDC//Al), supplied in a box

YES YES

Boehringer Ingelheim Pharma 30 capsules (3 blisters with 10 (2x5)

Spiriva 18 micrograms, inhalation powder, hard GmbH & Co. KG, Binger Strasse capsules) in a blister (Al/PVC/Al) and

inhalation powder, hard capsule capsules 173, Ingelheim am Rhein, an inhaler (HandiHaler), supplied in a YES YES YES

Germany box

Stalevo 100 mg/25 mg/200 mg film coated tablets Orion Corporation ORION 100 tablets in a plastic (HDPE) bottle, PHARMA, Espoo, Finland supplied in a box YES YES YES

Stalevo 150 mg/37.5 mg/200 mg film coated tablets Orion Corporation ORION 100 tablets in a plastic (HDPE) bottle, PHARMA, Espoo, Finland supplied in a box YES YES YES

Stalevo 50 mg/12.5 mg/200 mg film coated tablets Orion Corporation ORION 100 tablets in a plastic (HDPE) bottle, PHARMA, Espoo, Finland supplied in a box YES YES YES

One glass vial with a single dose of

STAMARIL, attenuated vaccine powder and diluent for Sanofi Pasteur S.A., 2 avenue lyophilized vaccine and a pre-filled

against yellow fever , 1 dose suspension for injection Pont Pasteur, Lyon, France glass syringe with fixed needle YES YES containing 0.5mL of diluent, supplied in

a box

Pliva Croatia Ltd., Ulica grada

Starcitin tablets 10 mg film tablets Vukovara 49, Zagreb, Republic of 28 (2x14) tablets in a blister, supplied

Croatia in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Starcitin tablets 20 mg film tablets Vukovara 49, Zagreb, Republic of 28 (2x14) tablets in a blister, supplied

Croatia in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Starcitin tablets 40 mg film tablets Vukovara 49, Zagreb, Republic of 28 (4x7) tablets in a blister, supplied in YES YES

Croatia a box

Pliva Croatia Ltd., Ulica grada

Statex 20 film tablets Vukovara 49, Zagreb, Republic of Box with 20 tablets (blister, 2x10 tbl.) YES YES

Croatia

Wyeth Medica Republic of

Stediril-d sugar coated tablets sugar coated tablets Ireland, Newbridge, Republic of 21 (1x21) tablets in PVC/Al blister, YES

Ireland supplied in a carton box

YES

Wyeth Medica Republic of

Stediril-m sugar coated tablets sugar coated tablets Ireland, Newbridge, Republic of 21 (1x21) tablets in PVC/Al blister, Ireland or Haupt Pharma Munster supplied in a carton box YES YES

GmbH, Munster, SR Germany

Wyeth Medica Republic of

Stediril-m sugar coated tablets sugar coated tablets Ireland, Newbridge, Republic of 21 (1x21) tablets in PVC/Al blister, Ireland or Haupt Pharma Munster supplied in a carton box YES YES

GmbH, Munster, SR Germany

Merck Sharp & Dohme B.V.,

Stocrin 100 mg capsules capsules Waarderweg 39, Postbus 581, 30 capsules in a HDPE bottle with a YES

Haarlem, the Netherlands PP stopper, supplied in a box

YES YES YES

STOCRIN 200 mg film coated Merck Sharp & Dohme B.V., 90 tablets in a plastic (HDPE) bottle

tablets film coated tablets Waarderweg 39, Postbus 581, with a temper-evident stopper, YES YES YES YES Haarlem, the Netherlands supplied in a box

Merck Sharp & Dohme B.V.,

Stocrin 200 mg capsules capsules Waarderweg 39, Postbus 581, 90 capsules in a HDPE bottle with a YES YES YES YES

Haarlem, the Netherlands PP stopper, supplied in a box

STOCRIN 50 mg film coated Merck Sharp & Dohme B.V., 30 tablets in a plastic (HDPE) bottle

tablets film coated tablets Waarderweg 39, Postbus 581, with a temper-evident stopper and YES YES YES YES Haarlem, the Netherlands desiccant, supplied in a box

Merck Sharp & Dohme B.V.,

Stocrin 50 mg capsules capsules Waarderweg 39, Postbus 581, 30 capsules in a HDPE bottle with a YES YES YES YES

Haarlem, the Netherlands PP stopper, supplied in a box

14509/1/11 REV 1 WS/jj 356

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

STOCRIN 600 mg film coated Merck Sharp & Dohme B.V., 30 tablets in a plastic (HDPE) bottle

tablets film coated tablets Waarderweg 39, Postbus 581, with a temper-evident stopper and YES YES YES YES Haarlem, the Netherlands desiccant, supplied in a box

Bosnalijek d.d., Jukićeva 53, 200 mL of solution in an amber glass

STOMATIDIN solution solution Sarajevo, Bosnia and bottle with aluminum cap, supplied in a YES YES YES

Herzegovina carton box

STRATTERA 10 mg hard Eli Lilly and Company Limited, 7 (1x7) capsules in a

capsules capsules, hard Basingstoke, Hampshire, Great PVC/PE/PCTFE/Al blister, supplied in YES YES YES YES Britain a box

STRATTERA 18 mg hard Eli Lilly and Company Limited, 7 (1x7) capsules in a

capsules capsules, hard Basingstoke, Hampshire, Great PVC/PE/PCTFE/Al blister, supplied in YES YES YES YES Britain a box

STRATTERA 25 mg hard Eli Lilly and Company Limited, 28 (2x14) capsules in a

capsules capsules, hard Basingstoke, Hampshire, Great PVC/PE/PCTFE/Al blister, supplied in YES YES YES YES Britain a box

STRATTERA 40 mg hard Eli Lilly and Company Limited, 28 (2x14) capsules in a

capsules capsules, hard Basingstoke, Hampshire, Great PVC/PE/PCTFE/Al blister, supplied in YES YES YES YES Britain a box

STRATTERA 60 mg hard Eli Lilly and Company Limited, 28 (2x14) capsules in a

capsules capsules, hard Basingstoke, Hampshire, Great PVC/PE/PCTFE/Al blister, supplied in YES YES YES YES Britain a box

STREPSILS sugar-free Reckitt Benckiser Healthcare lozenges, lemon flavour lozenges International Ltd., Thane Road,

16 lozenges (2x8) in a blister, supplied

Nottingham, Great Britain in a box

YES YES YES

Strepsils sugar-free lozenges, Reckitt Benckiser Healthcare lemon flavour lozenges International Ltd., Thane Road,

16 (2x8) lozenges in a blister, supplied

Nottingham, Great Britain in a box

YES YES YES

Strepsils lozenges - honey and Reckitt Benckiser Healthcare lemon lozenges International Ltd., Thane Road,

24 (2X12) lozenges in a blister

Nottingham, Great Britain (PVC/PVDC-Al), supplied in a box

YES YES YES

Strepsils honey and lemon Reckitt Benckiser Healthcare lozenges lozenges International Ltd., Thane Road, 12 (1x12) lozenges in PVC/PVDC-Al YES Nottingham, Great Britain blister, supplied in a tin box

YES YES

Strepsils honey and lemon Reckitt Benckiser Healthcare 12 (1x12) lozenges in a blister,

lozenges lozenges International Ltd., Thane Road, Nottingham, Great Britain supplied in a tin box YES YES YES

Strepsils lozenges - menthol and Reckitt Benckiser Healthcare eucalyptus lozenges International Ltd., Thane Road, 24 (2X12) lozenges in a blister, YES YES Nottingham, Great Britain supplied in a box

YES

Strepsils lozenges - menthol and Reckitt Benckiser Healthcare 24 (2X12) lozenges in a blister

eucalyptus lozenges International Ltd., Thane Road, Nottingham, Great Britain (PVC/PVDC-Al), supplied in a box YES YES YES

Strepsils lozenges - orange with Reckitt Benckiser Healthcare vitamin C lozenges International Ltd., Thane Road, 24 (2X12) lozenges in a blister YES YES Nottingham, Great Britain (PVC/PVDC-Al), supplied in a box

YES

Strepsils lozenges - orange with Reckitt Benckiser Healthcare 24 (2X12) lozenges in a blister,

vitamin C lozenges International Ltd., Thane Road, YES YES YES Nottingham, Great Britain supplied in a box

Reckitt Benckiser Healthcare

Strepsils original lozenges lozenges International Ltd., Thane Road, 24 (2X12) lozenges in a blister, YES YES

Nottingham, Great Britain supplied in a box

YES

Reckitt Benckiser Healthcare

Strepsils original lozenges lozenges International Ltd., Thane Road, 24 (2X12) lozenges in a blister,

Nottingham, Great Britain supplied in a box

YES YES YES

Reckitt Benckiser Healthcare

Strepsils Plus lozenges lozenges International Ltd., Thane Road, 24 (2X12) lozenges in a blister,

Nottingham, Great Britain supplied in a box

YES YES YES

14509/1/11 REV 1 WS/jj 357

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Reckitt Benckiser Healthcare

Strepsils Plus lozenges lozenges International Ltd., Thane Road, 24 (2X12) lozenges in a blister YES YES YES

Nottingham, Great Britain (PVC/PVDC-Al), supplied in a box

Plastic bag ("Excel") containing 500

mL of emulsion for infusion with two

attachments for drug administration

Structolipid 20% emulsion for infusion Fresenius Kabi AB, Uppsala, Sweden and for infusion, one small bag YES YES YES

containing oxygen absorber, and one

bag with solution for packaging

airtightness control

Plastic bag ("Excel") containing 250

mL of emulsion for infusion with two

attachments for drug administration

Structolipid 20% emulsion for infusion Fresenius Kabi AB, Uppsala, Sweden and for infusion, one small bag YES YES YES

containing oxygen absorber, and one

bag with solution for packaging

airtightness control

Krka d.d., Novo mesto, Republic

Stugeron forte tablets tablets of Slovenia in cooperation with 50 (5x10) tablets in a PVC/Al blister, Janssen Pharmaceutica, Beerse, supplied in a box YES YES

Belgium

Reckitt Benckiser Healthcare

Subutex 0.4 mg sublingual (UK) Limited, East Yorkshire, 7 (1x7) tablets in a PVC/PVDC-Al

tablets sublingual tablets Great Britain for Schering-Plough blister, supplied in a box YES YES YES

Corporation, USA

Reckitt Benckiser Healthcare

Subutex sublingvalne tablets 2

mg sublingual tablets

(UK) Limited, East Yorkshire, 7 (1x7) tablets in a PVC/PVDC-Al

Great Britain for Schering-Plough blister, supplied in a box YES YES YES

Corporation, USA

Subutex sublingvalne tablets 8 Reckitt Benckiser Healthcare

mg sublingual tablets International Ltd., Thane Road, 7 tablets, supplied in a box YES YES YES Nottingham, Great Britain

Reckitt Benckiser Healthcare

Subutex sublingvalne tablets 8 (UK) Limited, East Yorkshire, 7 (1x7) tablets in a PVC/PVDC-Al

mg sublingual tablets Great Britain for Schering-Plough blister, supplied in a box YES YES YES

Corporation, USA

Pliva Croatia Ltd., Ulica grada 10 mL of solution in a PE bottle with

Sulfasol 4% eye drops, solution Vukovara 49, Zagreb, Republic of dropper attachment and PP cap, YES YES

Croatia supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Sulotrim 100/20 mg tablets tablets Ulica Danica 5, Koprivnica, 20 (1x20) tablets in a PVC/Al blister,

Republic of Croatia supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Sulotrim 400/80 mg tablets tablets Ulica Danica 5, Koprivnica, 20 tablets in an amber glass bottle,

Republic of Croatia supplied in a carton box

YES YES

Sulotrim Forte 800/160 mg Belupo, lijekovi i kozmetika d.d., tablets tablets Ulica Danica 5, Koprivnica,

20 tablets in an amber glass bottle,

Republic of Croatia supplied in a carton box

YES YES

Belupo, lijekovi i kozmetika d.d., 100 mL of suspension in an amber

Sulotrim oral suspension oral suspension Ulica Danica 5, Koprivnica, glass bottle and a plastic measuring YES YES

Republic of Croatia spoon, supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Sulpirid 100 mg/2 mL injection solution for injection Ulica Danica 5, Koprivnica, 2 mL of solution for injection in a glass

Republic of Croatia ampoule, 6 ampoules in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Sulpirid 200 mg capsules capsules Ulica Danica 5, Koprivnica, 12 capsules in a plastic bottle with

Republic of Croatia closure, supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

Sulpirid 50 mg capsules capsules Ulica Danica 5, Koprivnica, 30 (2x15) capsules in a PVC/Al blister,

Republic of Croatia supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 358

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pliva Croatia Ltd., Ulica grada One HDPE bottle with powder, one

Sumamed forte syrup powder for preparation of oral suspension Vukovara 49, Zagreb, Republic of plastic spoon and one plastic syringe YES YES

Croatia for dose delivery, supplied in a box

Pliva Croatia Ltd., Ulica grada

Sumamed injection powder for solution for infusion Vukovara 49, Zagreb, Republic of 5 glass bottles with powder, supplied YES

Croatia in a box

YES

Pliva Croatia Ltd., Ulica grada

Sumamed capsules capsules Vukovara 49, Zagreb, Republic of 6 (1x6) capsules in a PVC/PVDC//Al

Croatia blister, supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Sumamed S capsules 250 mg capsules Vukovara 49, Zagreb, Republic of Box with 4 capsules (blister) YES YES

Croatia

Pliva Croatia Ltd., Ulica grada

Sumamed S tablets 500 mg film tablets Vukovara 49, Zagreb, Republic of Box with 2 film tablets (blister) YES YES

Croatia

Pliva Croatia Ltd., Ulica grada One HDPE bottle with powder, one

Sumamed syrup powder for preparation of oral suspension Vukovara 49, Zagreb, Republic of plastic spoon and one plastic syringe YES YES

Croatia for dose delivery, supplied in a box

One HDPE bottle with powder, one

Sumamed syrup 1200 powder for preparation of

Pliva Croatia Ltd., Ulica grada

oral suspension Vukovara 49, Zagreb, Republic of plastic spoon and one plastic syringe YES YES Croatia for dose delivery, supplied in a box

Pliva Croatia Ltd., Ulica grada One HDPE bottle with powder, one

Sumamed syrup 1200 XL powder for preparation of oral suspension Vukovara 49, Zagreb, Republic of plastic spoon and one plastic syringe YES YES

Croatia for dose delivery, supplied in a box

Pliva Croatia Ltd., Ulica grada

Sumamed tablets 125 mg film coated tablets Vukovara 49, Zagreb, Republic of 6 (1x6) tablets in a PVC/Al blister,

Croatia supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Sumamed tablets 500 mg film coated tablets Vukovara 49, Zagreb, Republic of 4 (1x3) tablets in a PVC/Al blister, YES

Croatia supplied in a box

YES

Pliva Croatia Ltd., Ulica grada 200 mL of syrup in an amber glass

Supremin syrup Vukovara 49, Zagreb, Republic of bottle with aluminum cap and a 5-mL YES YES

Croatia polystyrene spoon, supplied in a box

30 capsules in a plastic (HDPE) bottle

Sutent 12.5 mg capsules capsules, hard Pfizer Italia S.r.l., Marina del Tronto, Ascoli Piceno, Italy with a plastic stopper, supplied in a YES YES YES YES

box

Sutent 25 mg capsules capsules, hard Pfizer Italia S.r.l., Marina del

30 capsules in a plastic (HDPE) bottle

Tronto, Ascoli Piceno, Italy with a plastic stopper, supplied in a YES YES YES YES box

30 capsules in a plastic (HDPE) bottle

Sutent 50 mg capsules capsules, hard Pfizer Italia S.r.l., Marina del Tronto, Ascoli Piceno, Italy with a plastic stopper, supplied in a YES YES YES YES

box

AstraZeneca Södertälje, Sweden

Symbicort Turbuhaler 160/4.5 µg inhalation powder or AstraZeneca GmbH, 120 doses in a plastic inhaler with

Plankstadt, Germany mouthpiece, supplied in a box

YES YES

AstraZeneca AB, S-151-85

Symbicort Turbuhaler 160/4.5 µg inhalation powder Södertälje, Sweden; AstraZeneca 60 doses in a plastic inhaler with a GmbH, D-68721 Plankstadt, mouthpiece, supplied in a box YES YES

Germany

AstraZeneca AB, S-151-85

Symbicort Turbuhaler 320/9 µg inhalation powder Södertälje, Sweden; AstraZeneca 60 doses in a plastic inhaler with a GmbH, D-68721 Plankstadt, mouthpiece, supplied in a box YES YES

Germany

AstraZeneca AB, S-151-85

Symbicort Turbuhaler 80/4.5 µg inhalation powder Södertälje, Sweden; AstraZeneca 60 doses in a plastic inhaler with a GmbH, D-68721 Plankstadt, mouthpiece, supplied in a box YES YES

Germany

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Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

AstraZeneca Södertälje, Sweden

Symbicort Turbuhaler 80/4.5 µg inhalation powder or AstraZeneca GmbH, 120 doses in a plastic inhaler with YES YES

Plankstadt, Germany mouthpiece, supplied in a box

Synagis 100 mg powder and lyophilisate and diluent for Abbott S.p.A., Via Pontina 52, I- Box with one bottle with 100 mg of

diluent for injections preparation of solution 04010 Campoverde di Aprilia preparation, 1 mL of solvent in an YES YES YES (Latina), Italy ampoule and a leaflet

Synagis 50 mg powder and lyophilisate and diluent for Abbott S.p.A., Via Pontina 52, I- Box with one bottle with 50 mg of

diluent for injections preparation of solution 04010 Campoverde di Aprilia preparation and 1 mL of solvent in an YES YES YES (Latina), Italy ampoule

Pliva Croatia Ltd., Zagreb,

Synopen injection solution for injection Republic of Croatia in 2 mL of solution for injecion in an cooperation with Novartis, Basel, ampoule, 10 ampoules in a box YES YES

Switzerland

Pliva Croatia Ltd., Zagreb,

Synopen ointment ointment Republic of Croatia in 20 grams of ointment in an Al tube, cooperation with Novartis, Basel, supplied in a box YES YES

Switzerland

solution for Novartis Pharma Stein AG,

Syntocinon 5 IU injection intramuscular/intravenous Schaffhauserstrasse, Stein, Box with 10 ampoules with 1 mL of YES YES

injection Switzerland solution

Novartis Pharma S.A.S.,

Syntocinon aerosol nasal aerosol Huningue Cedex, France for Bottle with 5 mL of solution with a Novartis Pharma AG, Basel, spray attachment, supplied in a box YES YES

Switzerland

Belupo, lijekovi i kozmetika d.d., 100 mL of syrup in an amber glass

Tabex forte syrup syrup Ulica Danica 5, Koprivnica, bottle and a 5-mL plastic measuring YES YES YES

Republic of Croatia spoon, supplied in a box

Belupo, lijekovi i kozmetika d.d., 100 mL of syrup in an amber glass

Tabex syrup syrup Ulica Danica 5, Koprivnica, bottle and a 5-mL plastic measuring YES YES YES

Republic of Croatia spoon, supplied in a box

One collagen sponge for wound

TachoComb 2.5x3.0x0.5 cm spongy absorbent wound Nycomed Austria GmbH, St. dressing (2.5x3.0x0.5 cm) in a double dressing Peter-Strasse 25, Linz, Austria package (plastic foil/alufoil) and a YES YES

silicagel bag, supplied in a box

One collagen sponge for wound

TachoComb 9.5x4.8x0.5 cm spongy absorbent wound Nycomed Austria GmbH, St. dressing (9.5x4.8x0.5 cm) in a double dressing Peter-Strasse 25, Linz, Austria package (plastic foil/alufoil) and a YES YES

silicagel bag, supplied in a box

One collagen sponge for wound

TachoSil 2.5x3.0x0.5 cm spongy absorbent wound Nycomed Austria GmbH, St. dressing (2.5x3.0x0.5 cm) in a double dressing Peter Strasse 25, Linz, Austria package (blister) and a silicagel bag, YES YES

supplied in a box

One collagen sponge for wound

TachoSil 9.5x4.8x0.5 cm spongy absorbent wound Nycomed Austria GmbH, St. dressing (9.5x4.8x0.5 cm) in a double dressing Peter Strasse 25, Linz, Austria package (blister) and a silicagel bag, YES YES

supplied in a box

Tadenan capsules, soft Laboratoires Fournier S.A., 60 (6x10) soft capsules in a blister Fontaine Les Dijon, France (PVC/Al), supplied in a box YES YES YES

Lek farmacevtska družba d.d., 10 mL of suspension (200 inhalation

Tafen 50 µg nasal spray nasal spray, suspension Verovškova 57, Ljubljana, doses) in a brown glass bottle with a

Republic of Slovenia plastic atomizer pump and plastic

YES YES

protective cap, supplied in a box

Lek d.d., Ljubljana, Republic of

Tafen Novolizer 200 µg Slovenia in cooperation with One cartridge with 2.18 g of powder on inhalation powder inhalation powder Sofotec GmbH & Co.KG, average (teh cartridge contains 200 YES YES Germany doses of powder), supplied in a box

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Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Lek d.d., Ljubljana, Republic of One inhaler and one cartridge with

Tafen Novolizer 200 µg powder Slovenia in cooperation with approx. 2.18 g of powder (the

for inhalation inhalation powder Sofotec GmbH & Co.KG, cartridge contains 200 doses of YES YES

Germany powder), supplied in a box

Tagren 250 mg film coated Krka d.d., Šmarješka cesta 6, tablets film coated tablets Novo mesto, Republic of 40 (3x10) tablets in a PVC/Al blister, YES YES Slovenia supplied in a box

30 g of powder for oral suspension in a

glass bottle with a plastic temper

Tamiflu 12 mg/mL powder for powder for preparation of F. Hoffmann-La Roche Ltd., evident stopper, a plastic measuring

oral suspension oral suspension Grenzacherstrasse 124, Basel, cup for solvent, a plastic attachment YES YES YES YES Switzerland affixed to the bottle and a plastic

syringe for application of oral

suspension, supplied in a box

F. Hoffmann-La Roche Ltd.,

Tamiflu 75 mg hard capsules hard capsules Grenzacherstrasse 124, Basel, 10 (1x10) capsules in a blister,

Switzerland supplied in a box

YES YES YES YES

Tamosin 0.4 mg extendedprolonged-release capsules, Belupo, lijekovi i kozmetika d.d., 30 (2x15) capsules in a PVC/PVDC//Al

release capsules hard Ulica Danica 5, Koprivnica, YES YES Republic of Croatia blister, supplied in a box

30 mL of solution in an amber glass

Tanakan 40 mg/mL oral solution oral solution Beaufor Ipsen Industrie, Dreux, bottle with a plastic stopper and 1 mL France measuring plastic syringe with a YES YES YES

protective casing, supplied in a box

Tanakan film coated tablets film coated tablets Beaufor Ipsen Industrie, Dreux, 90 (6x15) film coated tablets in a France PVC/Al blister, supplied in a box YES YES YES

A.C.R.A.F. S.p.A., Via Vecchia 10 individually paper-wrapped

Tantum Lemon lozenges lozenges del Pinocchio, 22, 60131 Ancona, lozenges in a protective PE/paper/Al YES YES YES

Italy wrapping, 20 (2x10) lozenges in a box

Tantum Verde gargling solution oromucosal solution Sanochemia Pharmazeutika AG,

1000 mL of solution in a plastic bottle

Neufeld/Leitha, Austria with temper-proof closure and YES YES YES metering pump, supplied in a box

1000 mL of solution in a plastic bottle

Tantum Verde gargling solution oromucosal solution Sanochemia Pharmazeutika AG, Neufeld/Leitha, Austria with temper-proof closure, supplied in YES YES YES

a box

150 mL of solution in a plastic bottle

Tantum Verde gargling solution oromucosal solution Sanochemia Pharmazeutika AG, Neufeld/Leitha, Austria with temper-proof closure and YES YES YES

atomizer pump, supplied in a box

Tantum Verde gargling solution oromucosal solution Sanochemia Pharmazeutika AG,

150 mL of solution in a plastic bottle

Neufeld/Leitha, Austria with temper-proof closure cap, YES YES YES supplied in a box

60 mL of solution in a glass bottle with

Tantum Verde gargling solution oromucosal solution Sanochemia Pharmazeutika AG, Neufeld/Leitha, Austria a temper--evident stopper, supplied in YES YES YES

a box

A.C.R.A.F. S.p.A., Via Vecchia 11 individually paper-wrapped

Tantum Verde lozenges lozenges del Pinocchio, 22, 60131 Ancona, lozenges in a protective PE/paper/Al YES YES YES

Italy wrapping, 20 (2x10) lozenges in a box

A.C.R.A.F. S.p.A., Via Vecchia 30 mL of solution in a plastic bottle

Tantum Verde spray 0.15% oromucosal spray del Pinocchio, 22, 60131 Ancona, with a spray attachment, supplied in a YES YES YES

Italy box

A.C.R.A.F. S.p.A., Via Vecchia 15 mL of solution in a plastic bottle

Tantum Verde spray 0.30% oromucosal spray del Pinocchio, 22, 60131 Ancona, with nebullizer attachment, supplied in YES YES YES

Italy a box

Krka d.d., Šmarješka cesta 6, 60 (6x10) capsules in a

TANYZ 0.4 mg prolonged release capsules Novo mesto, Republic of PVC/PE/PVDC/Al blister, supplied in a YES YES YES YES

Slovenia box

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ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Krka d.d., Šmarješka cesta 6, 30 (3x10) capsules in a

TANYZ 0.4 mg prolonged-release capsules Novo mesto, Republic of PVC/PE/PVDC/Al blister, supplied in a YES YES YES YES

Slovenia box

Tarceva 100 mg film coated F. Hoffmann-La Roche Ltd., tablets film coated tablets Grenzacherstrasse 124, Basel, 30 (3x10) film coated tablets in a YES YES Switzerland blister (PVC/Al) , supplied in a box

YES

Tarceva 150 mg film coated F. Hoffmann-La Roche Ltd., tablets film coated tablets Grenzacherstrasse 124, Basel, 30 (3x10) film coated tablets in a YES Switzerland blister (PVC/Al), supplied in a box

YES YES

Tarceva 25 mg film coated F. Hoffmann-La Roche Ltd., 30 (3x10) film coated tablets in a

tablets film coated tablets Grenzacherstrasse 124, Basel, YES YES YES Switzerland blister (PVC/Al) , supplied in a box

Belupo, lijekovi i kozmetika d.d.,

Target 10 capsules Ulica Danica 5, Koprivnica, 7 capsules in an amber glass bottle,

Republic of Croatia supplied in a box

YES YES YES

Belupo, lijekovi i kozmetika d.d.,

Target Plus capsules capsules Ulica Danica 5, Koprivnica, 14 capsules in an amber glass bottle, YES

Republic of Croatia supplied in a box

YES

Targocid 200 mg powder for preparation of Gruppo Lepetit S.p.A, Anagni, Vial with powder and ampoule with solution for injection Italy diluent supplied in a box YES YES

Targocid 400 mg powder for preparation of Gruppo Lepetit S.p.A, Anagni, Vial with powder and ampoule with solution for injection Italy diluent supplied in a box YES YES

Tarka capsules Abbott GmbH & Co. KG, 28 capsules (2x14) in a PVC/Al blister Ludwigshafen, Germany , supplied in a box YES YES

28 (2x14) modified-release tablets in a

Tarka 180 mg/2 mg tablets modified-release tablets Abbott GmbH & Co. KG, Ludwigshafen, Germany blister (PVC/PVDC//Al) , supplied in a YES YES

box

28 (2x14) modified-release tablets in a

TARKA 240 mg/2 mg tablets modified-release tablets Abbott GmbH & Co.KG., Ludwigshafen, Germany blister (PVC/PVDC//Al) , supplied in a YES YES

box

28 (2x14) modified-release tablets in a

TARKA 240 mg/4 mg tablets modified-release tablets Abbott GmbH & Co.KG., Ludwigshafen, Germany blister (PVC/PVDC//Al) , supplied in a YES YES

box

Aventis Pharma Deutschland

Tavanic 250 mg tablets film tablets GmbH, Brunningstrasse 50, 10 tablets in a blister, supplied in a box YES YES YES

Frankfurt am Main, Germany

Aventis Pharma Deutschland

Tavanic 500 mg tablets film tablets GmbH, Brunningstrasse 50, 10 tablets in a blister, supplied in a box YES YES YES

Frankfurt am Main, Germany

Aventis Pharma Deutschland

Tavanic i.v. 500 mg solution for intravenous 100 mL of solution in a glass bottle, infusion GmbH, Brunningstrasse 50, YES YES YES

Frankfurt am Main, Germany supplied in a box

Taxol injection 100 mg / 16.7 mL concentrate for solution for Bristol Myers-Squibb S.r.I., One glass vial with 16.7 mL of solution infusion Sermoneta, Latina, Italy concentrate, supplied in a carton box YES YES YES

Taxol injection 30 mg / 5 mL concentrate for solution for Bristol Myers-Squibb S.r.I., One glass vial with 5 mL of solution infusion Sermoneta, Latina, Italy concentrate, supplied in a carton box YES YES YES

Taxol injection 300 mg / 50 mL concentrate for solution for Bristol Myers-Squibb S.r.I., One glass vial with 50 mL of solution infusion Sermoneta, Latina, Italy concentrate, supplied in a carton box YES YES YES

Taxotere 20 mg concentrate for solution for Aventis Pharma Dagenham,

One glass vial with 0.5 mL of

infusion Dagenham, Essex, Great Britain concentrate and one glass vial YES YES containing 1.5 mL of diluent in a

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Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

blister, supplied in a box

One glass vial with 2 mL of

Taxotere 80 mg concentrate for solution for Aventis Pharma Dagenham, concentrate and one glass vial with infusion Dagenham, Essex, Great Britain 6mL of diluent in a blister, supplied in a YES YES

box

Clear glass 72-mL bottle with 4.5 g of

Tazocin 4.5 g injection for powder for preparation of Wyeth Lederle S.p.A., Catania, lyophilisate equipped with a grey

intravenous use solution for injection or Italy; Wyeth Laboratories, New bromobutyl stopper and flip-off cap of YES YES infusion Lane, Havant, Great Britain aluminum and plastic coloured pink,

supplied in a box

Telebrix 35 solution for injection Guerbet, Cedex, France Vial with 50 mL of solution, supplied in a box YES YES

Aventis Pharma Deutschland

Telfast 120 mg film coated tablets GmbH, Brunningstrasse 50, 10 tablets in a blister, supplied in a box YES YES

Frankfurt am Main, Germany

Aventis Pharma Deutschland

Telfast 180 mg film coated tablets GmbH, Brunningstrasse 50, 10 tablets in a blister, supplied in a box YES YES

Frankfurt am Main, Germany

Telfast 30 mg film coated tablets Aventis Pharma S.p.A., S.S. 17 60 (4x15) tablets in a blister, supplied KM 22, Scoppito, Italy in a box YES YES

Schering-Plough Labo N.V.

Temodal capsules 100 mg capsules, hard Industrepark 30, Heist-op-den 5 capsules in a glass bottle with a YES

Berg, Belgium plastic stopper, supplied in a box

YES

Schering-Plough Labo N.V.

Temodal capsules 20 mg capsules, hard Industrepark 30, Heist-op-den 5 capsules in a glass bottle with a

Berg, Belgium plastic stopper, supplied in a box

YES YES

Schering-Plough Labo N.V.

Temodal capsules 250 mg capsules, hard Industrepark 30, Heist-op-den 5 capsules in a glass bottle with a

Berg, Belgium plastic stopper, supplied in a box

YES YES

Schering-Plough Labo N.V.

Temodal capsules 5 mg capsules, hard Industrepark 30, Heist-op-den 5 capsules in a glass bottle with a YES YES

Berg, Belgium plastic stopper, supplied in a box

powder for preparation of

Tenicef 0.5 g injection solution for i.v. and i.m. Pliva Krakow, Krakow, Poland 5 (10 mL) glass bottles with powder, YES

injection supplied in a box

YES

powder for preparation of

Tenicef 1g injection solution for i.v. and i.m. Pliva Krakow, Krakow, Poland 5 (15 mL) glass bottles with powder,

injection supplied in a box

YES YES

powder for preparation of

Tenicef 2g injection injection/infusion solution Pliva Krakow, Krakow, Poland 5 (15 mL) glass bottles with powder,

for i.v. use supplied in a box

YES YES

AstraZeneca UK Limited, Silk 28 (2x14) film coated tablets in a

Tenormin 100 mg tablets film coated tablets Road Business Park, Macclesfield, Cheshire, Great blister (PVC/PVDC//Al), supplied in a YES YES

Britain box

AstraZeneca UK Limited, Silk 29 (2x14) film coated tablets in a

Tenormin 50 mg tablets film coated tablets Road Business Park, Macclesfield, Cheshire, Great blister (PVC/PVDC//Al), supplied in a YES YES

Britain box

Krka d.d., Novo Mesto, Republic

Tenox 10 mg tablets tablets of Slovenia; Krka Farma d.o.o., 30 (3x10) tablets in a blister, supplied DPC Jastrebarsko, Republic of in a box YES YES

Croatia

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Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Krka d.d., Novo Mesto, Republic

Tenox 5 mg tablets tablets of Slovenia; Krka Farma d.o.o., 30 (3x10) tablets in a blister, supplied DPC Jastrebarsko, Republic of in a box YES YES

Croatia

Teolin retard 125 mg tablets prolonged-release tablets Lek farmacevtska družba d.d., 40 tablets in a glass bottle, supplied in Ljubljana, Republic of Slovenia a carton box YES YES

Teolin retard 300 mg tablets prolonged-release tablets Lek farmacevtska družba d.d., 40 (4x10) tablets in a PVC/Al blister, Ljubljana, Republic of Slovenia supplied in a carton box YES YES

Krka d.d., Novo mesto,

Teotard 200 mg prolongedprolonged-release capsules, Šmarješka cesta 6, Republic of 40 (4x10) capsules in a blister

release capsules hard Slovenia in cooperation with Astellas Pharma GmbH, (PVC/Al), supplied in a box YES YES

Germany

Krka d.d., Novo mesto,

Teotard capsules prolongedprolonged-release capsules, Šmarješka cesta 6, Republic of 40 (4x10) capsules in a blister

release 350 mg hard Slovenia in cooperation with YES Astellas Pharma GmbH, (PVC/Al), supplied in a box YES

Germany

Les Laboratories Servier

Tertensif film coated tablets Industrie, 905 route de Saran, 30 (1x30) tablets in a PVC/Alu blister ,

45520 Gidy, France supplied in a box

YES YES

Tertensif SR sustained-release film

Les Laboratories Servier

tablets Industrie, 905 route de Saran, Box with 30 tablets (2x15) in a blister YES YES 45520 Gidy, France

Tetanus antitoxin (equine) 1500 Imunološki zavod d.d., IU solution for parenteral use Rockefellerova 2, Zagreb, Box with 1 ampoule with 1500 IU of YES Republic of Croatia preparation

YES

Tetanus antitoxin (equine) 1500 Imunološki zavod d.d., IU solution for parenteral use Rockefellerova 2, Zagreb,

Box with 50 ampoules each with 1500

Republic of Croatia IU of preparation

YES YES

Tetanus antitoxin (equine) 3000 Imunološki zavod d.d., Box with 50 ampoules each with 3000

IU solution for parenteral use Rockefellerova 2, Zagreb, YES YES Republic of Croatia IU of preparation

Tetanus antitoxin (equine) 3000 Imunološki zavod d.d., Box with 1 ampoule with 3000 IU of

IU solution for parenteral use Rockefellerova 2, Zagreb, Republic of Croatia preparation YES YES

TETRAct - HIB, combined lyophilisate and suspension

diphtheria, tetanus, pertussis for preparation of Sanofi Pasteur S.A., 2 avenue Box with 1 bottle containing and Haemophilus influenzae suspension for i.m. and Pont Pasteur, Lyon, France lyophilisate and 1 glass syringe with YES YES type B vaccine deep subcutaneoud use 0.5 mL of suspension

TETRAXIM diphtheria, tetanusa,

pertussis (acellular) and

poliomyelitis (inactivated) suspension for injections

Sanofi Pasteur S.A., 2 avenue Glass syringe with a needle containing

Pont Pasteur, Lyon, France 0.5 mL of suspension for injections YES YES

vaccine , absorbed

30 (2x14) film coated tablets in a

TEVETEN 600 mg film coated tablets Solvay Pharmaceuticals B.V., Weesp, the Netherlands blister (PVC/Aclar//Al), supplied in a YES YES

box

Solvay Pharmaceuticals B.V.,

TEVETEN 600 mg film coated tablets C.J. van Houtenlaan 36, 1381 CP 28 (2x14) tablets in a blister

Weesp, the Netherlands (PVC/Aclar/Al), supplied in a box

YES YES YES

Solvay Pharmaceuticals GmbH, 28 (2x14) tablets in a nontransparent

Teveten plus film coated tablets Hannover, Germany Solvay Pharmaceuticals B.V., Weesp, PVC/Aclar/Alu blister, supplied in a YES YES YES

the Netherlands box

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Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Thyrogen 0.9 mg powder for powder for solution for Genzyme Ltd., 37 Hollands Clear type I glass 5-mL vials with

solution for injection injection Road, Haverhill, Suffolk CB9 siliconized butyl stopper with tamper YES YES YES YES YES 8PU, Great Britain proof flip-off cap, supplied in a box

Pliva Croatia Ltd., Ulica grada

TIAREN capsules Vukovara 49, Zagreb, Republic of 40 (4x10) capsules in blister (PVC/Al),

Croatia supplied in a box

YES YES

Merck Sharp & Dohme B.V., 5 (115 mL) glass bottles with powder

Tienam i.v. Infusion powder for preparation of solution for infusion Waarderweg 39, Postbus 581, for solution for infusion, supplied in a YES YES

Haarlem, The Nederlands box

Jadran - Galenski laboratorij d.d.,

Timalen 0.25% eyel drops eye drops Pulac bb, Rijeka, Republic of Box with 5 mL of solution in a plastic

Croatia bottle with a dropper

YES YES

Jadran - Galenski laboratorij d.d.,

Timalen 0.5% eyel drops eye drops Pulac bb, Rijeka, Republic of Box with 5 mL of solution in a plastic YES

Croatia bottle with a dropper

YES

Pliva Croatia Ltd., Ulica grada

TINIDIL sublingual tablets Vukovara 49, Zagreb, Republic of 40 (4x10) lozenges in an orange blister

Croatia (PVC/PVDC//Al), supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

TIRAMAT 100 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 60 (3x20) tablets in a blister YES YES

Republic of Croatia (PVC/PE/PVDC//AI), supplied in a box

Belupo, lijekovi i kozmetika d.d.,

TIRAMAT 200 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 60 (5x12) tablets in a blister YES YES

Republic of Croatia (PVC/PE/PVDC//AI), supplied in a box

Belupo, lijekovi i kozmetika d.d.,

TIRAMAT 25 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 60 (2x30) tablets in a blister

Republic of Croatia (PVC/PE/PVDC-Al), supplied in a box

YES YES

Belupo, lijekovi i kozmetika d.d.,

TIRAMAT 50 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 60 (2x30) tablets in a blister YES

Republic of Croatia (PVC/PE/PVDC-Al), supplied in a box

YES

5 glass bottles: Tissucol lyophilisate, 1

lyophilisates for preparation mL of aprotinin solution, Trombin 4

Tissucol kit 1.0 mL of two-component fibrin Baxter AG, Industriestrasse 67,

adhesives A-1220 Vienna, Austria

lyophilisate, trombin 500 lyophilisate, 1 YES YES

mL of calcium chloride solution;

application kit (Duploject)

5 glass bottles: Tissucol lyophilisate, 2

lyophilisates for preparation

Tissucol kit 2.0 mL of two-component fibrin Baxter AG, Industriestrasse 67,

mL of aprotinin solution, Trombin 4

lyophilisate, trombin 500 lyophilisate, 2 YES YES

adhesive A-1220 Vienna, Austria mL of calcium chloride solution;

application kit (Duploject)

5 glass bottles: Tissucol lyophilisate, 5

lyophilisates for preparation mL of aprotinin solution, Trombin 4

Tissucol kit 5.0 mL of two-component fibrin Baxter AG, Industriestrasse 67, lyophilisate, trombin 500 lyophilisate, 5 YES YES

adhesive A-1220 Vienna, Austria mL of calcium chloride solution;

application kit (Duploject)

5 mL of suspension in a polyethylene

TOBRADEX eye drops, Alcon-Couvreur s.a., Rijksweg bottle with a drop tainer and an LDPE

suspension eye drops, suspension 14, Puurs, Belgium dropper with a PP temper-evident YES YES

screw cap, supplied in a box

TOBRADEX eye ointment eye ointment Alcon-Couvreur s.a., Rijksweg 3.5 g of ointment in an aluminum tube, 14, Puurs, Belgium supplied in a box YES YES

Tobrex eye drops eye drops, solution Alcon-Couvreur s.a., Rijksweg 5 mL of solution in a plastic bottle with 14, Puurs, Belgium a dropper, supplied in a box YES YES

Tobrex eye ointment eye ointment Alcon-Couvreur s.a., Rijksweg 3.5 g of ointment in an aluminum tube, 14, Puurs, Belgium supplied in a box YES YES

14509/1/11 REV 1 WS/jj 365

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pliva Croatia Ltd., Ulica grada

TONOCARDIN 2 mg tablets Vukovara 49, Zagreb, Republic of 20 (2x10) tablets in a blister YES YES

Croatia (PVC/PVDC//Al), supplied in a box

Pliva Croatia Ltd., Ulica grada

TONOCARDIN 4 mg tablets Vukovara 49, Zagreb, Republic of 23 (2x10 tablets in PVC/PVDC/Al

Croatia blister, supplied in a box

YES YES

Topamax 100 mg tablets film coated tablets Cilag AG, Schaffhausen, 60 (6x10) tablets in a blister, supplied Switzerland in a box YES YES

Topamax 200 mg tablets film coated tablets Cilag AG, Schaffhausen, 60 (6x10) tablets in a blister, supplied Switzerland in a box YES YES

Topamax 25 mg tablets film coated tablets Cilag AG, Schaffhausen, 60 (6x10) tablets in a blister, supplied Switzerland in a box YES YES

Topamax 50 mg tablets film coated tablets Cilag AG, Schaffhausen, 60 (6x10) tablets in a blister, supplied Switzerland in a box YES YES

Krka d.d., Novo mesto, Republic

Torecan suppositories 6.5 mg suppositories of Slovenia in cooperation with 6 (1x6) suppositories in a strip Novartis Pharma Ltd., (Al/LDPE), supplied in a box YES YES

Switzerland

Krka d.d., Novo mesto, Republic

Torecan solution for injection 6.5 solution for injection (for of Slovenia in cooperation with 1-mL of solution for injection in a glas mg/1 mL i.m., i.v. and s.c.use) Novartis Pharma Ltd., ampoule ; 50 (5x10) ampoules in a YES YES Switzerland blister, supplied in a box

Krka, d.d., Novo mesto, Republic

Torendo 1-mg film coated tablets film coated tablets of Slovenia or Krka-Farma d.o.o., 20 (2x10) tablets in a blister YES

Zagreb, Republic of Croatia (PVC/PE/PVDC//Al), supplied in a box

YES

Krka Farma d.o.o., Radnička

Torendo 2-mg film coated tablets film coated tablets cesta 48, Zagreb, Republic of 20 (2x10) tablets in a blister

Croatia (PVC/PE/PVDC//Al), supplied in a box

YES YES

Krka Farma d.o.o., Radnička

Torendo 3-mg film coated tablets film coated tablets cesta 48, Zagreb, Republic of 20 (2x10) tablets in a blister YES

Croatia (PVC/PE/PVDC//Al), supplied in a box

YES

Krka Farma d.o.o., Radnička

Torendo 4-mg film coated tablets film coated tablets cesta 48, Zagreb, Republic of 20 (2x10) tablets in a blister

Croatia (PVC/PE/PVDC//Al), supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6, 100 mL of solution in an amber glass

Torendo oral solution 1 mg/1 mL oral solution Novo mesto, Republic of bottle with plastic (PP) cap and 3 mL YES YES

Slovenia metered-dose syringe, supplied in a box

Torendo Q-Tab 0.5-mg Krka Farma d.o.o., Radnička orodispersible tablets orodispersible tablets cesta 48, Zagreb, Republic of 28 (4x7) tablets in a blister YES Croatia (OPA/Al/PVC//Al), supplied in a box

YES

Torendo Q-Tab 1-mg Krka Farma d.o.o., Radnička orodispersible tablets orodispersible tablets cesta 48, Zagreb, Republic of

28 (4x7) tablets in a blister

Croatia (OPA/Al/PVC//Al), supplied in a box

YES YES

Torendo Q-Tab 2-mg Krka Farma d.o.o., Radnička 28 (4x7) tablets in a blister

orodispersible tablets 2 mg orodispersible tablets cesta 48, Zagreb, Republic of YES YES Croatia (OPA/Al/PVC//Al), supplied in a box

Tractocile 7.5 mg/mL Ferring GmbH, Wittland 1, Kiel, concentrate of solution for concentrate of solution for Germany; Ferring International 5 mL of concentrate in a glass bottle, YES infusion infusion Center SA, Chemin de la supplied in a box

YES

Vergognausaz, Switzerland

Ferring GmbH, Wittland 1, Kiel,

Tractocile 7.5 mg/mL, solution 0.9-mL of solution in a glass bottle,

for injection solution for injection

Germany; Ferring International

Center SA, Chemin de la supplied in a box YES YES

Vergognausaz, Switzerland

14509/1/11 REV 1 WS/jj 366

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Farmal d.d., Branitelja

TRALIN tablets 100 mg film coated tablets domovinskog rata 8, Ludbreg, 28 (2x14) tablets in a PVC/PVDC/Al YES YES

Republic of Croatia blister, supplied in a box

Farmal d.d., Branitelja

TRALIN tablets 50 mg film coated tablets domovinskog rata 8, Ludbreg, 28 (2x14) tablets in a PVC/PVDC/Al

Republic of Croatia blister, supplied in a box

YES YES

Farmal d.d., Branitelja

Tramadol injection 100 mg/2 mL solution for injection domovinskog rata 8, Ludbreg, 5 ampoules each with 2 mL of solution,

Republic of Croatia supplied in a box

YES YES

Farmal d.d., Branitelja

Tramadol injection 50 mg/mL solution for injection domovinskog rata 8, Ludbreg, 5 ampoules each with 1 mL of solution, YES

Republic of Croatia supplied in a box

YES

Farmal d.d., Branitelja 10 mL of solution in an amber glass

Tramadol kapi 100 mg/mL oral drops, solution domovinskog rata 8, Ludbreg, bottle with dropper attachment and YES YES

Republic of Croatia plastic cap, suplied in a box

Farmal d.d., Branitelja

Tramadol capsules 50 mg capsules domovinskog rata 8, Ludbreg, 20 (2x10) capsules in a blister

Republic of Croatia (PVC/Al), supplied in a box

YES YES

Farmal d.d., Branitelja

Tramadol suppositories 100 mg suppositories domovinskog rata 8, Ludbreg, 5 suppositories in an Al/PE pack, YES YES

Republic of Croatia supplied in a box

Tramal 100 mg solution for 5 ampoules with 2 mL of solution,

injection solution for injection

Grünenthal GmbH, Stolberg,

Germany supplied in a box YES YES

Tramal 50 mg solution for 5 ampoules with 1 mL of solution,

injection solution for injection

Grünenthal GmbH, Stolberg,

Germany supplied in a box YES YES

Tramal suppositories suppositories Grünenthal GmbH, Stolberg, 5 suppositories in a strip, supplied in a Germany box YES YES

96 mL of solution in an amber glass

Tramal drops 96 mL solution, oral drops Grünenthal GmbH, Stolberg, Germany bottle with a metering pump, supplied YES YES

in a box

Tramal kapi, solution for oral Grünenthal GmbH, Stolberg, 10 mL of solution in an amber glass

drops solution, oral drops Germany bottle, supplied in a box YES YES

Tramal capsules capsules Grünenthal GmbH, Stolberg, 20 (2x10) capsules in a blister, Germany supplied in a box YES YES

Tramal retard tablets 100 mg film coated tablets with Grünenthal GmbH, Stolberg, prolonged-release Germany Box with 30 tablets in a blister YES YES

Tramal retard tablets 150 mg film coated tablets with Grünenthal GmbH, Stolberg, prolonged-release Germany Box with 30 tablets in a blister YES YES

Tramal 200 mg retard tablets prolonged-release film Grünenthal GmbH, Stolberg, coated tablets Germany 30 tablets in a blister, supplied in a box YES YES

Mundipharma Gm.b.H., Limburg,

Tramundin retard prolonged release tablets Germany and Mundipharma 50 (5x10) tablets in a blister (PVC/Al) ,

GES.m.b.H., Vienna, Austria supplied in a box

YES YES

Transtec 35 µg/h transdermal patch Grünenthal GmbH, Zieglerstrasse

One transdermal patch in a multilayer

6, D-52078 Aachen, Germany bag (paper/PE/Al/surlin), 4 patches in YES YES YES a carton box

One transdermal patch in a multilayer

Transtec 35 µg/h transdermal patch Grünenthal GmbH, Zieglerstrasse 6, D-52078 Aachen, Germany bag (paper/PE/Al/surlin), 16 patches in YES YES YES

a carton box

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ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Transtec 52.5 µg/h transdermal patch Grünenthal GmbH, Zieglerstrasse

One transdermal patch in a multilayer

6, D-52078 Aachen, Germany bag (paper/PE/Al/surlin), 4 patches in YES YES YES a carton box

One transdermal patch in a multilayer

Transtec 70 µg/h transdermal patch Grünenthal GmbH, Zieglerstrasse 6, D-52078 Aachen, Germany bag (paper/PE/Al/surlin), 4 patches in YES YES YES

a carton box

Alcon Couvreur N.V., Rijksweg

Travatan 40 µg/mL eyel drops, 14, Puurs, Belgium; Alcon Cusi 2.5 mL of solution in a polypropylene solution eye drops S.A., Camil Fabra 58, El Masnou, bottle with dropper attachment, in foil, YES YES Barcelona, Spain supplied in a box

Travocort cream cream Intendis Manufacturing S.p.A., Segrate, Milano, Italy 15 g of cream in an Al tube YES YES

Trental 400 mg tablets modified-release film-coated Aventis Pharma S.p.A., S.S. 17 20 (2x10) tablets in a blister, supplied tablets KM 22, Scoppito, Italy in a box YES YES

33 (3x10) film coated tablets in a

Tricor 145 mg film coated tablets Laboratoires Fournier S.A., Fontaine Les Dijon, France blister (PVC/PE/PVDC/Al), supplied in YES YES YES YES

a box

34 (3x10) film coated tablets in a

Tricor 160 mg film coated tablets Laboratoires Fournier S.A., Fontaine Les Dijon, France blister (PVC/PE/PVDC/Al), supplied in YES YES YES YES

a box

Schering-Plough Labo N.V.

Triderm cream cream Industrepark 30, Heist-op-den 15 g of cream in an aluminum tube, YES YES

Berg, Belgium supplied in a box

Schering-Plough Farma, Lda,

Triderm ointment ointment Casal do Colaride, Agualva 15 g of cream in an aluminum tube,

Cacem, Portugal supplied in a box

YES YES

Trileptal 150 mg film coated Novartis Farma S.p.A., Torre 50 (5x10) tablets in a blister

tablets film coated tablets Annunziata (Napoli), Italy (PVC/PE/PVDC/Al), supplied in a box YES YES YES

Trileptal 300 mg film coated 50 (5x10) tablets in a blister

tablets film coated tablets

Novartis Farma S.p.A., Torre

Annunziata (Napoli), Italy (PVC/PE/PVDC/Al), supplied in a box YES YES YES

250-mL of oral suspension in an

amber glass bottle with plastic temper

Trileptal 60 mg/mL oral proof closure, 10-mL plastic syringe for

suspension oral suspension

Novartis Pharma S.A.S.,

Huningue Cedex, France administration of oral suspension and YES YES YES

a plastic bottle attachment, supplied in

a box

Trileptal 600 mg film coated Novartis Farma S.p.A., Torre 50 (5x10) tablets in a blister

tablets film coated tablets Annunziata (Napoli), Italy (PVC/PE/PVDC/Al), supplied in a box YES YES YES

1-mL of concentrate for the solution for

Trinitrosan 5 mg concentrate for solution for Merck KGaA, Frankfurter Straße infusion 250, Darmstadt, Germany infusion in a glass ampoule, 5 YES YES

ampoules in a box

Trinovum tablets tablets Cilag AG, Schaffhausen,

21 (1x21) tablets (7 white, 7 pink and 7

Switzerland orange) in a blister (PVC/Al), supplied YES YES in a box

21 coated tablets (6 red-brown, 5 white

Triquilar coated tablets Schering AG, Muellerstrasse 170-178, Berlin, Germany and 10 dar yellow) in blister (PVC/Al), YES YES

supplied in a box

28 (12 blue, 10 white, 6 red) tablets in

Trisequens film coated tablets Novo Nordisk A/S, Novo Allé, a plastic calendar dial pack (dispenser DK-2880 Bagsvaerd, Denmark with marked days of the week), YES YES

supplied in a box

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ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Tritace 1.25 tablets Aventis Pharma S.p.A., S.S. 17 28 (2x14) tablets in a blister, supplied KM 22, Scoppito, Italy in a box YES YES

Tritace 2.5 tablets Aventis Pharma S.p.A., S.S. 17 28 (2x14) tablets in a blister, supplied KM 22, Scoppito, Italy in a box YES YES

Tritace 5 tablets Aventis Pharma S.p.A., S.S. 17 28 (2x14) tablets in a blister, supplied KM 22, Scoppito, Italy in a box YES YES

Tritazide 2.5 mg/12.5 mg tablets Aventis Pharma S.p.A., S.S. 17 28 (2x14) tablets in a green blister KM 22, Scoppito, Italy (PVC/Al), supplied in a box YES YES

Tritazide 5 mg/25 mg tablets Aventis Pharma S.p.A., S.S. 17 28 (2x14) tablets in a green blister KM 22, Scoppito, Italy (PVC/Al), supplied in a box YES YES

Merck Sharp & Dohme B.V.,

Trusopt eye drops eye drops Waarderweg 39, Postbus 581, 5 mL of solution in a plastic container

Haarlem, the Netherlands OCUMETER PLUS, supplied in a box

YES YES

Tuberkulin PPD RT 23 SSI 10 Statens Serum Institut, Box with 1 glass bottle containing 1.5

T.U./0.1 mL solution for intradermal use Copenhagen, Denmark mL of tuberculin of 10 T.U./0.1 mL YES YES

Tuberkulin PPD RT 23 SSI 2

T.U./0.1 mL solution for intradermal use

Statens Serum Institut, Box with 1 glass bottle containing 1.5

Copenhagen, Denmark mL of tuberculin of 2 T.U./0.1 mL YES YES

Tuberkulin PPD RT 23 SSI 2 Box with 1 glass bottle containing 5 mL

T.U./0.1 mL solution for intradermal use

Statens Serum Institut,

Copenhagen, Denmark of tuberculin of 2 T.U../0.1 mL YES YES

Tulip 10 mg film coated tablets film coated tablets Lek farmacevtska družba d.d., 30 (3x10) tablets in a blister, supplied Ljubljana, Republic of Slovenia in a box YES YES

Lek farmacevtska družba d.d.,

Tulip 10 mg film coated tablets film-tablets Verovškova 57, Ljubljana, 60 tablets (6x10) in a blister, supplied YES

Republic of Slovenia in a box

YES

Tulip 20 mg film coated tablets film coated tablets Lek farmacevtska družba d.d., 30 (3x10) tablets in a blister, supplied Ljubljana, Republic of Slovenia in a box YES YES

Lek farmacevtska družba d.d.,

Tulip 20 mg film coated tablets film-tablets Verovškova 57, Ljubljana, 60 tablets (6x10) in a blister, supplied YES

Republic of Slovenia in a box

YES

Tulip 40 mg film coated tablets film coated tablets Lek farmacevtska družba d.d., 30 (3x10) tablets in a blister Ljubljana, Republic of Slovenia (Al/PVC//PVC//Al), supplied in a box YES YES

Tusidil sugar coated tablets sugar coated tablets AD JAKA 80 Radoviš, Radoviš, 20 (1x20) sugar-coated tablets in a A- FYROM PVC blister, supplied in a box YES YES

Tusidil syrup for children syrup AD JAKA 80 Radoviš, Radoviš, 60 mL of syrup in an amber glass FYROM bottle, supplied in a box YES YES

Jadran - Galenski laboratorij d.d.,

Tusifan syrup 1 mg/mL syrup Pulac bb, Rijeka, Republic of 150 mL of syrup in a dark brown YES YES

Croatia plastic bottle, supplied in a box

YES

Jadran - Galenski laboratorij d.d.,

Tusifan syrup 3 mg/mL syrup Pulac bb, Rijeka, Republic of 150 mL of syrup in a dark brown YES

Croatia plastic bottle, supplied in a box

YES YES

GlaxoSmithKline Biologicals s.a., Pre-filled glass syringe containing a

TWINRIX Adult suspension for injection Rue de lInstitut 89, Rixensart, single dose of the vaccine (1 mL of YES YES

Belgium suspension) with plunge stopper and

14509/1/11 REV 1 WS/jj 369

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

needle, supplied in a carton box

GlaxoSmithKline Biologicals s.a., Pre-filled glass syringe containing a

TWINRIX Paediatric suspension for injection Rue de lInstitut 89, Rixensart, single dose of the vaccine (0.5 mL of YES

Belgium suspension) with plunge stopper and

YES

needle, supplied in a carton box

TYPHIM Vi, thyphoid solution for intramuscular Sanofi Pasteur S.A., 2 avenue Box with 1 glass syringe containing 1

polysaccharide vaccine, purified and subcutaneous use Pont Pasteur, Lyon, France dose of vaccine (0.5 mL) and a needle YES YES with a needle protection

Krka d.d., Šmarješka cesta 6,

Ulfamid tablets 20 mg film coated tablets Novo mesto, Republic of 20 (2x10) tablets in a blister, supplied YES

Slovenia in a box

YES

Krka d.d., Šmarješka cesta 6,

Ulfamid tablets 40 mg film coated tablets Novo mesto, Republic of 10 (1x10) tablets in a blister, supplied

Slovenia in a box

YES YES

Krka d.d., Šmarješka cesta 6, 14 capsules in a plastic (HDPE) bottle

Ultop capsules 20 mg gastric-resistant capsules, hard Novo mesto, Republic of with plastic PP cap and desiccant, YES YES

Slovenia supplied in a box

28 capsules in a plastic (HDPE) bottle

Ultop capsules 20 mg gastric-resistant capsules,

Krka d.d., Šmarješka cesta 6,

hard Novo mesto, Republic of with plastic (PP) closure and YES YES Slovenia desiccant, supplied in a box

Krka d.d., Šmarješka cesta 6,

Ultop capsules 40 mg capsules Novo mesto, Republic of 14 capsules in a plastic bottle (with YES

Slovenia desiccant), supplied in a box

YES

Ultop powder for solution for powder for solution for Krka d.d., Šmarješka cesta 6, Colourless glass bottle with

infusion 40 mg infusion Novo mesto, Republic of lyophilisate (closed with a rubber YES YES Slovenia stopper and Al ring), supplied in a box

Krka d.d., Šmarješka cesta 6,

Ultop S capsules 10 mg capsules Novo mesto, Republic of 28 capsules in a plastic bottle (with YES YES

Slovenia desiccant), supplied in a box

Ultraproct suppositories suppositories Intendis Manufacturing SpA, 10 suppositories in a strip (Al/LDPE Segrate, Milano, Italy foil), supplied in a box YES YES

Ultraproct oitment rectal ointment Intendis Manufacturing SpA,

30 g of ointment in an aluminium tube

Segrate, Milano, Italy with a plastic applicator, supplied in a YES YES box

Ultravist 240 solution for infusion solution for infusion Schering AG, Muellerstrasse 10 infusion bottles each with 50 mL of 170-178, Berlin, Germany solution, supplied in a box YES YES

Ultravist 300 solution for infusion solution for infusion Schering AG, Muellerstrasse 10 infusion bottles each with 100 mL of 170-178, Berlin, Germany solution, supplied in a box YES YES

Ultravist 300 solution for infusion solution for infusion Schering AG, Muellerstrasse 10 infusion bottles each with 50 mL of 170-178, Berlin, Germany solution, supplied in a box YES YES

Ultravist 300 solution for injection solution for injection Schering AG, Muellerstrasse 10 ampoules each containing 20 mL of 170-178, Berlin, Germany solution, supplied in a box YES YES

Ultravist 370 solution for infusion solution for infusion Schering AG, Muellerstrasse 10 infusion bottles each with 100 mL of 170-178, Berlin, Germany solution, supplied in a box YES YES

Schering AG, Muellerstrasse 200 mL in a glass bottle for infusion,

14509/1/11 REV 1 WS/jj 370

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Ultravist 370 solution for infusion solution for infusion Schering AG, Muellerstrasse 500 mL of solution in a glass infusion 170-178, Berlin, Germany bottle, 8 bottles in a box YES YES

Ultravist 370 solution for infusion solution for infusion Schering AG, Muellerstrasse 10 infusion bottles each with 50 mL of 170-178, Berlin, Germany solution, supplied in a box YES YES

Ultravist 370 solution for injection solution for injection Schering AG, Muellerstrasse 10 ampoules each containing 30 mL of 170-178, Berlin, Germany solution, supplied in a box YES YES

Pliva Croatia Ltd., Ulica grada

Ulzol capsules Vukovara 49, Zagreb, Republic of 14 (2x7) capsules in a blister, supplied YES YES

Croatia in a box

UPFEN 200 mg film coated Bristol-Myers Squibb, 304, 20 (2x10) film coated tablets in a

tablets film coated tablets avenue du Dr Jean Bru, Agen, France PVC-Al blister, supplied in a box YES YES YES

Bristol-Myers Squibb, 304,

UPFEN 200 mg effervescent avenue du Dr. Jean Bru, Agen, 2 plastic tubes each with 10

tablets effervescent tablets France; Bristol-Myers Squibb, effervescent tablets, supplied in a box YES YES YES 979 Avenue des Pyrenees, Le (desiccant in the plastic cap)

Passage, France

Bristol-Myers Squibb, 304,

avenue du Dr. Jean Bru, Agen, 10 effervescent tablets in a

UPSARIN plus vitamin C effervescent tablets France; Bristol-Myers Squibb, polypropylene tube (desiccant in YES YES YES

979 Avenue des Pyrenees, Le polyethylene cap), supplied in a box

Passage, France

Bristol-Myers Squibb, 304,

avenue du Dr. Jean Bru, Agen, 10 effervescent tablets in a

Upsavit vitamin C 1000 mg effervescent tablets France; Bristol-Myers Squibb, polypropylene tube (desiccant in YES YES YES

979 Avenue des Pyrenees, Le polyethylene cap), supplied in a box

Passage, France

Uromitexan injection solution for intravenous Baxter Oncology GmbH, 15 (3x5) ampoules with 4 mL of injection Kantstrasse 2, Halle, Germany solution, supplied in a box YES YES

Belupo, lijekovi i kozmetika d.d.,

Urosal M plus capsules capsules, soft Ulica Danica 5, Koprivnica, 30 (3x10) capsules in a PVC/Al blister,

Republic of Croatia supplied in a box

YES YES YES

Ursofalk capsules capsules dr. Falk Pharma GmbH, Freiburg, 100 (4 x 25) tablets in PVC//Al blister, Germany supplied in a box YES YES

Belupo, lijekovi i kozmetika d.d.,

Urutal 8 mg tablets tablets Ulica Danica 5, Koprivnica, Bottle with 100 tablets, supplied in a YES

Republic of Croatia box

YES

Belupo, lijekovi i kozmetika d.d.,

Urutal forte 16 mg tablets tablets Ulica Danica 5, Koprivnica, 60 (3x20) tablets in a PVC/PVDC/Al

Republic of Croatia blister, supplied in a box

YES YES

Laboratoires Besins International,

UTROGESTAN 100 mg 30 (2x15) capsules in a PVC/Al blister,

capsules capsules, soft

Montrouge, France; Besins

International Belgique S.A., supplied in a box YES YES

Drogenbos, Belgium

Uvin H Forte tea blend tea blend Cedevita d.o.o., Zagreb, Republic Polypropylene bag with 50 g, supplied of Croatia in a carton box YES YES YES

Uvin H Forte tea blend in filter 25 filter bags (microcrystal cellulose) bags tea blend in filter bags

Cedevita d.o.o., Zagreb, Republic

of Croatia each with 1.5 g of tea blend, supplied YES YES YES in a box

Cedevita d.o.o., Zagreb, Republic 14 bags (paper/Al/PE) each containing

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ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Vagifem vaginal tablets Novo Nordisk A/S, Novo Allé,

15 (3x5) applicators each with one

DK-2880 Bagsvaerd, Denmark vaginal tablet, in blister packs, YES YES supplied in a box

Vagisan vaginal tablets Dr. August Wolff GmbH & Co. 7 vaginal tablets in a strip, supplied in Arzneimittel, Bielefeld, Germany a box YES YES

Belupo, lijekovi i kozmetika d.d.,

Vaira 10 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 28 (1x28) tablets in a blister, supplied YES YES

Republic of Croatia in a box

Belupo, lijekovi i kozmetika d.d.,

Vaira 5 mg tablets film coated tablets Ulica Danica 5, Koprivnica, 28 (1x28) tablets in a blister, supplied

Republic of Croatia in a box

YES YES

Valcyte 450 mg film coated F. Hoffmann-La Roche Ltd., 60 tablets in a plastic (HDPE) bottle,

tablets film coated tablets Grenzacherstrasse 124, Basel, YES YES YES Switzerland supplied in a carton box

Vaqta 25 IU/0.5 mL (purified, Merck Sharp & Dohme B.V., Box with 1 glass bottle containing 0.5

inactivated hepatitis A vaccine) suspension for injections Waarderweg 39, Postbus 581, YES YES Haarlem, the Netherlands mL of suspension

Vaqta 50 IU/1 mL (purified, Merck Sharp & Dohme B.V., Box with 1 glass bottle containing 0.5

inactivated hepatitis A vaccine) suspension for injections Waarderweg 39, Postbus 581, Haarlem, the Netherlands mL of suspension YES YES

Krka d.d., Šmarješka cesta 6, 30 (3x10) tablets in a

Vasilip film coated tablets 10 mg film coated tablets Novo mesto, Republic of PVC/PE/PVDC//Al blister, supplied in a YES YES

Slovenia box

Krka d.d., Šmarješka cesta 6, 20 (2x10) tablets in a blister

Vasilip 10 mg film-coated tablets film coated tablets Novo mesto, Republic of PVC/PE/PVDC/PE/PVC//Al), supplied YES YES

Slovenia in a box

Krka d.d., Šmarješka cesta 6, 31 (3x10) tablets in a

Vasilip film coated tablets 20 mg film coated tablets Novo mesto, Republic of PVC/PE/PVDC//Al blister, supplied in a YES YES

Slovenia box

Krka d.d., Šmarješka cesta 6, 20 (2x10) tablets in a blister

Vasilip 20 mg film-coated tablets film coated tablets Novo mesto, Republic of PVC/PE/PVDC/PE/PVC//Al), supplied YES YES

Slovenia in a box

Krka d.d., Šmarješka cesta 6, 32 (3x10) tablets in a

Vasilip film coated tablets 40 mg film coated tablets Novo mesto, Republic of PVC/PE/PVDC//Al blister, supplied in a YES YES

Slovenia box

Krka d.d., Šmarješka cesta 6, 28 (4x7) tablets in a blister

Vasilip film coated tablets 40 mg film coated tablets Novo mesto, Republic of PVC/PE/PVDC/PE/PVC//Al), supplied YES YES

Slovenia in a box

Alkaloid AD - Skopje, Bulevar

Vasoflex 1 mg tablets Aleksandar Makedonski 12, 30 tablets in an amber glass bottle,

Skopje, FYROM supplied in a box

YES YES

Pre-filled glass syringe (glass type I)

VAXIGRIP - inactivated vaccine with a needle and a chlorobromobutyl against influenza (fragmented) suspension for injection

Sanofi Pasteur S.A., Lyon,

France or chlorobutyl stopper, containing YES YES single dose (0.5 mL) of suspension for

injection, supplied in a box

Pre-filled glass syringe with a needle

VAXIGRIP inactivated vaccine Sanofi Pasteur S.A., 2 avenue containing a single dose (0.5 mL) of

against influenza (fragmented) suspension for injection Pont Pasteur, Lyon, France the suspension for injection, supplied YES YES

in a box

VAXIGRIP Pediatric use - Pre-filled glass syringe with needle

inactivated vaccine against containing a single dose (0.25 mL) of

influenza (fragmented) for suspension for injection

Sanofi Pasteur S.A., 2 avenue

Pont Pasteur, Lyon, France suspension for injection, supplied in a YES YES

children box

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ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pliva Croatia Ltd., Ulica grada

Velafax tablets 37.5 mg tablets Vukovara 49, Zagreb, Republic of 28 (2x14) tablets in a blister, supplied YES

Croatia in a box

YES

Pliva Croatia Ltd., Ulica grada

Velafax tablets 75 mg tablets Vukovara 49, Zagreb, Republic of 28 (2x14) tablets in a blister, supplied

Croatia in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Velafax XL capsules 150 mg prolonged-release capsules, 28 (2x14) capsules in a transparent hard Vukovara 49, Zagreb, Republic of YES YES

Croatia blister (PVC/Al) , supplied in a box

Velafax XL capsules 75 mg prolonged-release capsules,

Pliva Croatia Ltd., Ulica grada

hard Vukovara 49, Zagreb, Republic of

28 (2x14) capsules in a transparent

Croatia blister (PVC/Al) , supplied in a box

YES YES

Velcade powder for solution for powder for solution for Janssen Pharmaceutica NV, 10-mL glass vial containing 38.5 mg

injection injection Turnhouseweg 30, Beerse, of powder for solution for injection, YES YES YES Belgium supplied in a box

Vifor International Inc., St. Gallen,

Venofer 100 mg/5 mL solution Switzerland for Lek farmacevtska 5 ampoules each with 5 mL of solution,

for intravenous injection solution for injection družba d.d. Ljubljana, Republic of supplied in a box YES YES

Slovenia

VENTAVIS 10 µg/mL solution for Schering AG, Berlin, Germany 3-mL glass ampoule containing 2 mL

atomizer solution for atomizer and BERLIMED S.A., Alcala de of solution for nebulizer, 100 ampoules YES YES YES Henares, Madrid, Spain in a box

Pliva Croatia Ltd., Ulica grada 10 mL of solution in an amber glass

Ventolin inhalation solution nebulisation solution Vukovara 49, Zagreb, Republic of bottle with plastic cap, supplied in a YES YES

Croatia box

Pliva Croatia Ltd., Ulica grada 200 mL of syrup in an amber glass

Ventolin syrup syrup Vukovara 49, Zagreb, Republic of bottle with aluminum cap and plastic YES YES

Croatia measuring spoon, supplied in a box

Pliva Croatia Ltd., Ulica grada

Ventolin tablets tablets Vukovara 49, Zagreb, Republic of 60 (2x30) tablets in a blister (PVC/Al), YES

Croatia supplied in a box

YES

5 mL of solution in a glass bottle,

Vepesid injection 100 mg/5 mL solution for injection (for Bristol-Myers Squibb S.r.l., preparation of i.v. infusion) Sermoneta, Latina, Italy supplied in a box (10 boxes in a YES YES

collective carton packaging)

Vepesid capsules 100 mg capsules Bristol-Myers Squibb S.r.l., 10 capsules in an amber glass bottle, Sermoneta, Latina, Italy supplied in a box YES YES

Vepesid capsules 50 mg capsules Bristol-Myers Squibb S.r.l., 20 capsules in an amber glass bottle, Sermoneta, Latina, Italy supplied in a box YES YES

Pliva Croatia Ltd., Ulica grada

Verbinaf 125 mg tablets tablets Vukovara 49, Zagreb, Republic of 14 (1x14) tablets in a blister, supplied YES

Croatia in a box

YES

Pliva Croatia Ltd., Ulica grada

Verbinaf 250 mg ablets tablets Vukovara 49, Zagreb, Republic of 14 (1x14) tablets in a blister, supplied

Croatia in a box

YES YES

Krka d.d., Novo mesto, Republic

Vermox 100 mg/5 mL oral 30 mL of suspension in an amber suspension oral suspension

of Slovenia in cooperation with

Janssen Pharmaceutica, Beerse, glass bottle with a 5 mL plastic YES YES Belgium measuring spoon, supplied in a box

Krka d.d., Novo mesto, Republic

Vermox tablets 100 mg tablets of Slovenia in cooperation with 6 (1x6) tablets in a strip (Al/PE), Janssen Pharmaceutica, Beerse, supplied in a box YES YES

Belgium

Krka d.d., Šmarješka cesta 6,

Verolax Senna film coated tablets Novo mesto, Republic of 23 (2x10) tablets in a PVC/PVD//Al) YES YES YES

Slovenia blister, supplied in a box

14509/1/11 REV 1 WS/jj 373

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

F. Hoffmann-La Roche Ltd.,

Vesanoid soft capsules 10 mg soft capsules Grenzacherstrasse 124, Basel, 100 soft capsules in a brown plastic YES

Switzerland bottle, supplied in a box

YES

VFEND 200 mg powder for powder for solution for Pfizer PGM, Pocé-sur-Cisse, One glass vial with rubber cap and

solution for infusion infusion France aluminum ring, containing powder, YES YES YES supplied in a box

45 g of powder for oral suspension in a

plastic bottle with a temper-evident

VFEND 40 mg/mL powder for stopper, a plastic measuring cup for oral suspension powder for oral suspension

Pfizer PGM, Pocé-sur-Cisse,

France solvent (23 mL), a plastic attachment YES YES YES for bottle neck and a plastic syringe for

administration of oral suspension,

supplied in a box

VFEND tablets 200 mg film coated tablets Heinrich Mack Nachf. GmbH & 28 (2x14) tablets in a blister (PVC/Al), Co., Illertissen, Germany supplied in a box YES YES YES

VFEND tablets 50 mg film coated tablets Heinrich Mack Nachf. GmbH & 28 (2x14) tablets in a blister (PVC/Al), Co., Illertissen, Germany supplied in a box YES YES YES

Viagra tablets 100 mg film coated tablets Pfizer PGM, Poce-sur-Cisse, One (1x1) film coated tablet in a blister France (PVC/Al), supplied in a box YES YES YES

Viagra tablets 25 mg film coated tablets Pfizer PGM, Poce-sur-Cisse, One (1x1) film coated tablet in a blister France (PVC/Al) supplied in a box YES YES YES

Viagra tablets 50 mg film coated tablets Pfizer PGM, Poce-sur-Cisse, One (1x1) film coated tablet in a blister France (PVC/Al) supplied in a box YES YES YES

Videx capsules 125 mg gastric-resistant capsules, Bristol-Myers Squibb, Meymac,

30 (3x10) capsules in a

hard France PVC/PE/ACLAR/Al blister, supplied in YES YES YES YES a carton box

Videx capsules 250 mg gastric-resistant capsules, Bristol-Myers Squibb, Meymac,

30 (3x10) capsules in a

hard France PVC/PE/ACLAR/Al blister, supplied in YES YES YES YES a carton box

Videx capsules 400 mg gastric-resistant capsules, Bristol-Myers Squibb, Meymac,

30 (3x10) capsules in a

hard France PVC/PE/ACLAR/Al blister, supplied in YES YES YES YES a carton box

Pliva Croatia Ltd., Ulica grada

Vilpin 10 mg tablets tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in an orange YES YES

Croatia PVC/PVDC//Al, supplied in a box

Pliva Croatia Ltd., Ulica grada

Vilpin 5 mg tablets tablets Vukovara 49, Zagreb, Republic of 30 (3x10) tablets in a blister (orange

Croatia PVC/PVDC//Al) , supplied in a box

YES YES

Vincristine injection 1 mg solution for injection (for Pfizer (Perth) Pty Limited, 1-mL of solution for injection in a intravenous use) Bentley WA, Australija plastic bottle, 5 bottles in a box YES YES

VIRACEPT 250 mg film coated F. Hoffmann-La Roche Ltd., 270 film-coated tablets in a plastic

tablets film coated tablets Grenzacherstrasse 124, Basel, (HDPE) bottle with child resistant YES YES YES Switzerland closure, supplied in a box

Boehringer Ingelheim Pharma

GmbH & Co. KG, Ingelheim am

Viramune tablets 200 mg tablets Rhein, Germany and Boehringer 60 (6x10) tablets in a blister (PVC/Al), YES YES YES

Ingelheim Ellas A.E., Atika, supplied in a box

Greece

Krka d.d., Šmarješka cesta 6,

Virolex cream cream Novo mesto, Republic of 5 g of cream in a tube, supplied in a

Slovenia box

YES YES

14509/1/11 REV 1 WS/jj 374

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Virolex lyophilisate for lyophilisate for preparation Krka d.d., Novo Mesto, Republic 5 glass bottles each with 250 mg of

preparation of infusion solution of solution for infusion of Slovenia in cooperation with YES YES Glaxo SmithKline lyophilisate, supplied in a box

Krka d.d., Šmarješka cesta 6,

Virolex eye ointment eye ointment Novo mesto, Republic of 4.5 g of ointment in a tube, supplied in

Slovenia a box

YES YES

Krka d.d., Šmarješka cesta 6,

Virolex tablets tablets Novo mesto, Republic of 20 (2x10) tablets in a blister, supplied YES

Slovenia in a box

YES

GE Healthcare Republic of

Ireland, Carrigtwohill, Co. Cork, Gass bottle (with rubber stopper,

Visipaque 270 mgI/mL solution for injection Republic of Ireland; GE aluminum ring and plastic protective YES YES

Healthcare AS, Nydalen, Oslo, cap) containing 50 mL of solution, 10

Norway ampoules in a box

GE Healthcare Republic of

Ireland, Carrigtwohill, Co. Cork, Gass bottle (with rubber stopper,

Visipaque 270 mgI/mL solution for injection Republic of Ireland; GE aluminum ring and plastic protective

Healthcare AS, Nydalen, Oslo, cap) containing 100 mL of solution, 10

YES YES

Norway ampoules in a box

GE Healthcare Republic of Plastic (polypropylene) bottle

Ireland, Carrigtwohill, Co. Cork, containing 50 mL of solution with a

Visipaque 270 mgI/mL solution for injection Republic of Ireland; GE rubber stopper and plastic YES YES

Healthcare AS, Nydalen, Oslo, (polypropylene) closure with protective

Norway ring and cap, 10 bottles in a box

GE Healthcare Republic of Plastic (polypropylene) bottle

Ireland, Carrigtwohill, Co. Cork, containing 100 mL of solution with a

Visipaque 270 mgI/mL solution for injection Republic of Ireland; GE rubber stopper and plastic YES YES

Healthcare AS, Nydalen, Oslo, (polypropylene) closure with protective

Norway ring and cap, 10 bottles in a box

GE Healthcare Republic of Plastic (polypropylene) bottle

Ireland, Carrigtwohill, Co. Cork, containing 100 mL of solution with a

Visipaque 320 mgI/mL solution for injection Republic of Ireland; GE rubber stopper and plastic YES YES

Healthcare AS, Nydalen, Oslo, (polypropylene) closure with protective

Norway ring and cap, 10 bottles in a box

GE Healthcare Republic of

Ireland, Carrigtwohill, Co. Cork, Glass bottle (with rubber stopper,

Visipaque 320 mgI/mL solution for injection Republic of Ireland; GE aluminum ring and plastic cap) YES

Healthcare AS, Nydalen, Oslo, containing 200 mL of solution, 6

YES

Norway bottles in a box

GE Healthcare Republic of

Ireland, Carrigtwohill, Co. Cork, Glass bottle (with rubber stopper,

Visipaque 320 mgI/mL solution for injection Republic of Ireland; GE aluminum ring and plastic protective YES YES

Healthcare AS, Nydalen, Oslo, cap) containing 100 mL of solution, 10

Norway ampoules in a box

GE Healthcare Republic of

Ireland, Carrigtwohill, Co. Cork, Glass bottle (with rubber stopper,

Visipaque 320 mgI/mL solution for injection Republic of Ireland; GE aluminum ring and plastic protective

Healthcare AS, Nydalen, Oslo, cap) containing 50 mL of solution, 10

YES YES

Norway ampoules in a box

GE Healthcare Republic of Plastic (polypropylene) bottle

Ireland, Carrigtwohill, Co. Cork, containing 500 mL of solution with a

Visipaque 320 mgI/mL solution for injection Republic of Ireland; GE rubber stopper and plastic YES YES

Healthcare AS, Nydalen, Oslo, (polypropylene) closure with protective

Norway ring and cap, 6 bottles in a box

GE Healthcare Republic of Plastic (polypropylene) bottle

Ireland, Carrigtwohill, Co. Cork, containing 200 mL of solution with a

Visipaque 320 mgI/mL solution for injection Republic of Ireland; GE rubber stopper and plastic YES YES

Healthcare AS, Nydalen, Oslo, (polypropylene) closure with protective

Norway ring and cap, 10 bottles in a box

14509/1/11 REV 1 WS/jj 375

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

GE Healthcare Republic of Plastic (polypropylene) bottle

Ireland, Carrigtwohill, Co. Cork, containing 50 mL of solution with a

Visipaque 320 mgI/mL solution for injection Republic of Ireland; GE rubber stopper and plastic YES YES

Healthcare AS, Nydalen, Oslo, (polypropylene) closure with protective

Norway ring and cap, 10 bottles in a box

GE Healthcare Republic of

Ireland, Carrigtwohill, Co. Cork, Plastic (polypropylene) bottle

Visipaque 320 mgI/mL solution for injection Republic of Ireland; GE containing 20 mL of solution, with a YES YES

Healthcare AS, Nydalen, Oslo, plastic twist-off cap, 10 bottles in a box

Norway

Allergan Pharmaceuticals

Vistagan Liquifilm 0.5 % eye Republic of Ireland, Castlebar 5 mL of solution in a plastic bottle with

drops eye drops, solution Road, Westport, Co Mayo, a dropper, supplied in a box YES YES

Republic of Ireland

Visudyne powder for solution for Novartis Pharma S.A.S.,

One glass vial containing powder with

infusion Huningue Cedex, France rubber stopper and aluminum ring, YES YES YES supplied in a box

Vitamin B12 Krka solution for Krka d.d., Šmarješka cesta 6, injection 100 µg/1 mL solution for injection Novo mesto, Republic of 100 ampoules with 1 mL of solution, YES Slovenia supplied in a box

YES

Vitamin B12 Krka solution for Krka d.d., Šmarješka cesta 6, injection 500 µg/1 mL solution for injection Novo mesto, Republic of

100 ampoules with 1 mL of solution,

Slovenia supplied in a box

YES YES

STADA Arzneimittel AG,

Vitopril 10 mg tablets Stadtstraße 2-18, Bad Vilbel, 30 (3x10) tablets in a PVC/PVdC/Alu

Germany blister, supplied in a box

YES YES

STADA Arzneimittel AG,

Vitopril 20 mg tablets Stadtstraße 2-18, Bad Vilbel, 31 (3x10) tablets in a PVC/PVdC/Alu YES

Germany blister, supplied in a box

YES

STADA Arzneimittel AG,

Vitopril 5 mg tablets Stadtstraße 2-18, Bad Vilbel, 32 (3x10) tablets in a PVC/PVdC/Alu

Germany blister, supplied in a box

YES YES

Jadran - Galenski laboratorij d.d., 10 mL of nasal drops in a clear plastic

Vizol eyel drops solution eye drops, solution Pulac bb, Rijeka, Republic of (PE) bottle with a dropper attachment, YES YES YES

Croatia supplied in a box

Alkaloid AD - Skopje, Bulevar 50 colourless glass ampoules with 5

Water for Injection, Alkaloid diluent for parenteral use Aleksandar Makedonski 12, mL of water for injection, supplied in a YES YES

Skopje, FYROM box

Baxter S.A., Belgium; Baxter

Healthcare Ltd, Great Britain; 20 plastic Viaflo bags with 500 mL of

Water for Injections Viaflo diluent for parenteral use Bieffe Medital Sabinanigo, Spain; infusion solution, in a protective bag, YES YES

Baxter Healthcare S.A., Republic supplied in a box

of Ireland

Baxter S.A., Belgium; Baxter

Healthcare Ltd, Great Britain; 30 plastic Viaflo bags with 250 mL of

Water for Injection, Viaflo diluent for parenteral use Bieffe Medital Sabinanigo, Spain; water for injection in a protective bag, YES YES

Baxter Healthcare S.A., Republic supplied in a box

of Ireland

Novartis Consumer Health S.A.,

Route de l' Etraz, Nyon,

Voltaren Emulgel 1 % gel Switzerland Novartis Pharma 50 g of gel in an aluminium tube,

Produktions GmbH, Oflinger supplied in a box

YES YES YES

Strasse 44, Wehr, Germany

Pliva Croatia Ltd., Ulica grada

Voltaren forte film coated tablets Vukovara 49, Zagreb, Republic of Box with 20 tablets (blister, 2x10 tbl.) YES YES

Croatia

Pliva Croatia Ltd., Ulica grada

Voltaren injection solution for injection Vukovara 49, Zagreb, Republic of 5 ampoules each with 3 mL of solution

Croatia for injection, supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 376

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pliva Croatia Ltd., Zagreb,

Voltaren rapid coated tablets Republic of Croatia in

10 (1x10) film coted tablets in a

cooperation with Novartis PVC//Al ili PVC/PE/PVDC//Al blister, YES YES Pharma AG, Basel, Switzerland supplied in a box

Voluven 6% solution for infusion solution for infusion Fresenius Kabi Deutschland 500 mL of solution in a transparent GmbH, Germany plastic bag (Freeflex), 15 bags in a box YES YES YES

Voluven 6% solution for infusion solution for infusion Fresenius Kabi Deutschland 500 mL of solution in a glass bottle, 10 GmbH, Germany bottles in a box YES YES YES

2.5 mL of solution in a 5 mL plastic

Xalacom eye drops, solution Pfizer Manufacturing Belgium (LDPE) bottle with dropper attachment NV, Rijksweg 12, Puurs, Belgium and plastic (HDPE) temper-proof YES YES YES

closure, supplied in a box

Xalatan eye drops, solution Pfizer Manufacturing Belgium

2.5 mL eye drops, solution in a 5 mL

NV, Rijksweg 12, Puurs, Belgium plastic bottle with dropper attachment, YES YES supplied in a box

Pfizer Manufacturing Belgium

Xanax SR 0.5 mg tablets modified release tablets NV, Rijksweg 12, Puurs, Belgium; 30 (3x10) tablets in a PA/Al//Al blister, Pfizer Italia; s.r.l. Localita Marino supplied in a box YES YES

del Tronto, Ascoli Piceno, Italy

Pfizer Manufacturing Belgium

Xanax SR 1 mg tablets modified release tablets NV, Rijksweg 12, Puurs, Belgium; 31 (3x10) tablets in a PA/Al//Al blister, Pfizer Italia; s.r.l. Localita Marino supplied in a box YES YES

del Tronto, Ascoli Piceno, Italy

Pfizer Manufacturing Belgium

Xanax SR tablets 2 mg modified release tablets NV, Rijksweg 12, Puurs, Belgium; 33 (3x10) tablets in a PVC/Al blister , Pfizer Italia s.r.l. Localita Marino supplied in a box YES YES

del Tronto, Ascoli Piceno, Italy

Pfizer Manufacturing Belgium

Xanax tablets 0.25 mg tablets NV, Rijksweg 12, Puurs, Belgium; 31 (3x10) tablets in a PVC/Al blister , Pfizer Italia s.r.l. Localita Marino supplied in a box YES YES

del Tronto, Ascoli Piceno, Italy

Pfizer Manufacturing Belgium

Xanax tablets 0.5 mg tablets NV, Rijksweg 12, Puurs, Belgium; 32 (3x10) tablets in a PVC/Al blister , Pfizer Italia s.r.l. Localita Marino supplied in a box YES YES

del Tronto, Ascoli Piceno, Italy

XELODA 150 mg film coated F. Hoffmann-La Roche Ltd., tablets film coated tablets Grenzacherstrasse 124, Basel, 60 (6x10) tablets in a blister YES YES YES YES Switzerland (PVC/PE/PVDC//Al), supplied in a box

XELODA 500 mg film coated F. Hoffmann-La Roche Ltd., tablets film coated tablets Grenzacherstrasse 124, Basel, 120 (12x10) tablets in a blister YES YES YES YES Switzerland (PVC/PE/PVDC//Al), supplied in a box

F. Hoffmann-La Roche Ltd.,

Xenical capsules Grenzacherstrasse 124, Basel, 42 (2x21) capsules in a blister, YES

Switzerland supplied in a box

YES

Xigris 20 mg powder for solution powder for solution for Lilly Pharma Fertigung und for infusion infusion Distribution GmBH & Co. KG, One glass vial with 20 mg of medicinal YES Giessen, Germany product, supplied in a box

YES

Xigris 5 mg powder for solution powder for solution for Lilly Pharma Fertigung und for infusion infusion Distribution GmBH & Co. KG,

One glass vial with 5 mg of medicinal

Giessen, Germany product, supplied in a box

YES YES

Novartis Pharma Stein AG, One glass vial with powder and one

Xolair 150 mg powder and diluent for solution for injection Schaffhauserstrasse, Stein, glass ampoule with 2 mL of Water for YES YES YES

Switzerland Injection, supplied in a box

Novartis Pharma Stein AG, One glass vial with powder and a glass

Xolair 75 mg powder and diluent for solution for injection Schaffhauserstrasse, Stein, ampoule with 2 mL of Water for YES YES YES

Switzerland Injection, supplied in a box

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ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Xorimax 125 mg film coated 10 (1x10) film coted tablets in a

tablets film coated tablets Sandoz GmbH, Kundl, Austria PA/Al/PE//Al blister or an Al/PE strip, YES YES YES supplied in a box

Xorimax 250 mg film coated 10 (1x10) film coted tablets in a

tablets film coated tablets Sandoz GmbH, Kundl, Austria PA/Al/PE//Al) blister or an Al/PE strip , YES YES YES supplied in a box

Xorimax 500 mg film coated 10 (1x10) film coted tablets in a

tablets film coated tablets Sandoz GmbH, Kundl, Austria PA/Al/PE//Al) blister or an Al/PE strip , YES YES YES supplied in a box

200 mL of oral solution in a glass

XYZAL 0.5 mg/mL oral solution oral solution UCB Pharma S.p.A., Pianezza, bottle with temper-proof closure and a Italy 10-mL plastic nebulizer, supplied in a YES YES YES

box

Xyzal 5 mg film coated tablets film coated tablets UCB Pharma S.p.A., Via Praglia 10 (1x10) tablets in a Al/Al blister, 15, I-10044 Pianezza (TO), Italy supplied in a box YES YES YES

Yasmin film tablets film coated tablets Schering AG, Muellerstrasse 21 (1x21) film-coated tablets in a 170-178, Berlin, Germany blister, supplied in a box YES YES YES

Krka d.d., Šmarješka cesta 6,

Yasnal film coated tablets 10 mg film coated tablets Novo mesto, Republic of 28 (4x7) tablets in a blister

Slovenia (OPA/Al/PVC//Al), supplied in a box

YES YES

Krka d.d., Šmarješka cesta 6,

Yasnal film coated tablets 5 mg film coated tablets Novo mesto, Republic of 28 (4x7) tablets in a blister

Slovenia (PVC/Al/OPA//Al), supplied in a box

YES YES

5 mL of solution in a white plastic

Zaditen eye drops, solution EXCELVISION, Annonay, France (LDPE) bottle with a dropper and a plastic (HDPE) stopper with a safety YES YES YES

ring, supplied in a box

20 (5x4) single-dose plastic (LDPE)

Zaditen SDU eye drops, solution EXCELVISION, Annonay, France containers with 0.4 mL of solution in a protective package (PVC/Al/PA- YES YES YES

Al/papir), supplied in a box

Jadran-Galenski laboratorij d.d.,

Zalasta 10 mg tablets tablets Rijeka, Hrvatska in cooperation 28 (4x7) tablets in a OPA/Al/PVC-Al with Krka d.d., Novo mesto, blister , supplied in a box YES YES

Republic of Slovenia

Jadran-Galenski laboratorij d.d.,

Zalasta 5 mg tablets tablets Rijeka, Hrvatska in cooperation 28 (4x7) tablets in a OPA/Al/PVC-Al with Krka d.d., Novo mesto, blister , supplied in a box YES YES

Republic of Slovenia

Krka Farma d.o.o., Radnička

Zalasta Q-Tab 10 mg orodispersible tablets cesta 48, Zagreb, Republic of 28 (4x7) tablets in a OPA/Al/PVC//Al YES YES

Croatia blister, supplied in a box

Krka Farma d.o.o., Radnička

Zalasta Q-Tab 15 mg orodispersible tablets cesta 48, Zagreb, Republic of 28 (4x7) tablets in a OPA/Al/PVC//Al

Croatia blister, supplied in a box

YES YES

Krka Farma d.o.o., Radnička

Zalasta Q-Tab 20 mg orodispersible tablets cesta 48, Zagreb, Republic of 28 (4x7) tablets in a OPA/Al/PVC//Al

Croatia blister, supplied in a box

YES YES

Krka Farma d.o.o., Radnička

Zalasta Q-Tab 5 mg orodispersible tablets cesta 48, Zagreb, Republic of 28 (4x7) tablets in a OPA/Al/PVC//Al YES YES

Croatia blister, supplied in a box

Zaldiar 37.5 mg/325 mg film coated tablets Grünenthal GmbH, Zieglerstrasse 6, D-52078 Aachen, Germany 10 tablets in a blister, supplied in a box YES YES

Belupo, lijekovi i kozmetika d.d.,

Zan 10 mg capsules capsules Ulica Danica 5, Koprivnica, 7 capsules in a PVC/PVDC/Al blister,

Republic of Croatia supplied in a box

YES YES

14509/1/11 REV 1 WS/jj 378

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Belupo, lijekovi i kozmetika d.d.,

Zan 5 mg capsules capsules Ulica Danica 5, Koprivnica, 7 capsules in a PVC/PVDC/Al blister,

Republic of Croatia supplied in a box

YES YES

Glaxo Operations UK Ltd.

(trading as Glaxo Wellcome

Zeffix tablets film coated tablets Operations), Hertfordshire, Great 28 (2x14) tablets in a blister Britain, GlaxoSmithKline (PVC/PA/Al), supplied in a box YES YES YES YES

Pharmaceuticals S.A., Poznan,

Poland

Heinrich Mack Nachf. GmbH &

ZELDOX 20 mg capsules capsules Co. (Pfizer grupa), Illertissen, Box with 30 capsules (blister, 3x10

Germany capsules)

YES YES

Heinrich Mack Nachf. GmbH &

ZELDOX 40 mg capsules capsules Co. (Pfizer grupa), Illertissen, Box with 30 capsules (blister, 3x10

Germany capsules)

YES YES

Heinrich Mack Nachf. GmbH &

ZELDOX 60 mg capsules capsules Co. (Pfizer grupa), Illertissen, Box with 30 capsules (blister, 3x10

Germany capsules)

YES YES

Heinrich Mack Nachf. GmbH &

ZELDOX 80 mg capsules capsules Co. (Pfizer grupa), Illertissen, Box with 30 capsules (blister, 3x10 YES

Germany capsules)

YES

Zemplar 5 µg/mL solution for Abbott S.p.A., Via Pontina 52, I- injection solution for injection 04010 Campoverde di Aprilia 5 glass ampoules each with 1 mL of YES YES (Latina), Italy solution, supplied in a carton box

YES

Pliva Croatia Ltd., Ulica grada

Zenafluk capsules 100 mg capsules Vukovara 49, Zagreb, Republic of 7 capsules in a PVC/Al blister,

Croatia supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Zenafluk capsules 150 mg capsules Vukovara 49, Zagreb, Republic of One capsule in a PVC/Al blister,

Croatia supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Zenafluk capsules 200 mg capsules Vukovara 49, Zagreb, Republic of 7 capsules in a PVC/Al blister,

Croatia supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Zenafluk capsules 50 mg capsules Vukovara 49, Zagreb, Republic of 7 capsules in a PVC/Al blister, YES YES

Croatia supplied in a box

F. Hoffmann-La Roche Ltd.,

Zenapax concentrate for infusion solution Grenzacherstrasse 124, Basel, Bottle with 5 mL of concentrate, YES YES

Switzerland supplied in a box

YES

Zerit capsules 30 mg capsules Bristol-Myers Squibb, Meymac, 56 (4x14) capsules in a blister, France supplied in a box YES YES

Zerit capsules 40 mg capsules Bristol-Myers Squibb, Meymac, 56 (4x14) capsules in a blister, France supplied in a box YES YES

Ziagen tablets film coated tablets Glaxo Wellcome Operations, 60 (6x10) tablets in a blister, supplied Greenford, Great Britain in a box YES YES

Zinnat suspension 125 mg/5mL granules for oral suspension Glaxo Wellcome Operations,

Granules for 100 mL of suspension in

Greenford, Great Britain a glass bottle, with a plastic spoon and YES YES a measuring device, supplied in a box

Zinnat 125 mg tablets film coated tablets Glaxo Wellcome Operations, Greenford, Great Britain 10 tablets in a blister, supplied in a box YES YES

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ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Zinnat 500 mg tablets film coated tablets Glaxo Wellcome Operations, Greenford, Great Britain 10 tablets in a blister, supplied in a box YES YES

Pliva Croatia Ltd., Ulica grada

Zipantola tablets 20 mg gastric-resistant tablets Vukovara 49, Zagreb, Republic of 28 (2x14) tablets in a OPA/Al/PVC//Al

Croatia blister, supplied in a box

YES YES

Pliva Croatia Ltd., Ulica grada

Zipantola 40 mg tablets gastric-resistant tablets Vukovara 49, Zagreb, Republic of 14 (1x14) tablets in a blister, supplied

Croatia in a box

YES YES

Zofran injection 4 mg solution for intravenous GlaxoSmithKline S.p.A., Parma, 5 ampoules with 2 mL of solution, injection Italy supplied in a box YES YES

Zofran injection 8 mg solution for intravenous GlaxoSmithKline S.p.A., Parma, 5 ampoules with 4 mL of solution, injection Italy supplied in a box YES YES

Glaxo Wellcome S.A., Aranda de

Zofran 4 mg tablets tablets Duero, Spain; GlaxoSmithKline Pharmaceuticals S.A., Poznan, 10 tablets in a blister, supplied in a box YES YES

Poland

Glaxo Wellcome S.A., Aranda de

Zofran 8 mg tablets tablets Duero, Spain; GlaxoSmithKline Pharmaceuticals S.A., Poznan, 10 tablets in a blister, supplied in a box YES YES

Poland

AstraZeneca UK Limited, Silk Implant for s.c. administration in a

Zoladex 3.6 mg subcutaneous implant Road Business Park,

syringe with a safety system

Macclesfield, Cheshire, Great (SafeSystem TM), in a sterile YES YES

Britain protective casing, supplied in a carton box

AstraZeneca UK Limited, Silk Implant for s.c. administration in a syringe with a safety system

Zoladex LA 10.8 mg subcutaneous implant Road Business Park, Macclesfield, Cheshire, Great (SafeSystem TM), in a sterile YES YES

Britain protective casing, supplied in a carton box

Zoloft tablets 100 mg film coated tablets Pfizer Italia S.r.l., Borgo San 28 (2x14) tablets in a blister (PVC/Al), Michele, Latina, Italy supplied in a box YES YES

Zoloft tablets 50 mg film coated tablets Pfizer Italia S.r.l., Borgo San 28 (2x14) tablets in a blister (PVC/Al), Michele, Latina, Italy supplied in a box YES YES

Belupo, lijekovi i kozmetika d.d.,

Zoltex 20 mg tablets gastric-resistant tablets Ulica Danica 5, Koprivnica, 28 (2x14) tablets in a blister YES

Republic of Croatia (PA/Al/PVC//Al), supplied in a box

YES

Belupo, lijekovi i kozmetika d.d.,

Zoltex 40 mg tablets gastric-resistant tablets Ulica Danica 5, Koprivnica, 14 (2x7) tablets in a PA/Al/PVC//Al

Republic of Croatia blister, supplied in a box

YES YES

Zometa 4 mg/5 mL concentrate concentrate of solution for Novartis Pharma Stein AG, 5 mL of solution concentrate in a

for solution for infusion infusion Schaffhauserstrasse, Stein, Switzerland plastic bottle, supplied in a box YES YES

AstraZeneca UK Limited, Silk

Zomig Rapimelt orodispersible tablets Road Business Park, 6 (1x6) tablets in a blister (PVC/Al Macclesfield, Cheshire, Great Al/paper), supplied in a box YES YES

Britain

Zomig tablets 2.5 mg film coated tablets Astra Zeneca UK Limited, Great 3 (1x3) tablete in a blister (Alu/PA- Britain Alu/PVC), supplied in a box YES YES

Pliva Croatia Ltd., Ulica grada

Zonadin 10 mg tablets film tablets Vukovara 49, Zagreb, Republic of 20 (2x10) tablets in a blister, supplied

Croatia in a box

YES YES

14509/1/11 REV 1 WS/jj 380

ANNEX II DG F 2A / DG K 2 EN

Appendix to Annex V

Mention on this list does not prejudge whether or not the medicinal product in question has a marketing authorization in compliance with the acquis.

Pliva Croatia Ltd., Ulica grada

Zonadin 5 mg tablets film tablets Vukovara 49, Zagreb, Republic of 20 (2x10) tablets in a blister, supplied

Croatia in a box

YES YES

Zorac 0.05% gel gel Pierre Fabre Medicament 15 g of gel in an aluminum tube, Production, France supplied in a box YES YES

Zorac 0.1 % gel gel Pierre Fabre Medicament 15 g of gel in an aluminum tube, Production, France supplied in a box YES YES

Zovirax cream Glaxo Operations UK Ltd, 2 grams of cream in an aluminum tube Durham, Great Britain with plastic cap, supplied in a box YES YES YES

GlaxoSmithKline

Zyban prolonged release tablets Pharmaceuticals S.A., Ul. 60 (6x10) tablets in an Al/Al blister, Grunwaldzka 189, Poznan, supplied in a box YES YES

Poland

KRKA FARMA d.o.o., DPC

Zyllt film coated tablets 75 mg film coated tablets Jastrebarsko, Cvetkovići bb, 14 (2x7) tablets in a blister, supplied in

Jastrebarsko, Republic of Croatia a box

YES YES

Lilly Pharma Fertigung und

Zyprexa 10 mg injection powder for solution for injection Distribution GmbH & Co. KG, 5-mL glass vial with powder for YES YES

Giessen, Germany solution for injection, supplied in a box

Eli Lilly and Company Limited,

Zyprexa 10 mg coated tablets film coated tablets Basingstoke, Hampshire, Great 28 (4x7) tablets in a Alu/Alu blister,

Britain supplied in a box

YES YES

Eli Lilly and Company Limited,

Zyprexa 15 mg coated tablets film coated tablets Basingstoke, Hampshire, Great 28 (4x7) tablets in a Alu/Alu blister,

Britain supplied in a box

YES YES

Eli Lilly and Company Limited,

Zyprexa 2.5 mg coated tablets film coated tablets Basingstoke, Hampshire, Great 28 (4x7) tablets in a Alu/Alu blister, YES

Britain supplied in a box

YES

Eli Lilly and Company Limited,

Zyprexa 5 mg coated tablets film coated tablets Basingstoke, Hampshire, Great 28 (4x7) tablets in a Alu/Alu blister, YES YES

Britain supplied in a box

Eli Lilly and Company Limited,

Zyprexa 7.5 mg coated tablets film coated tablets Basingstoke, Hampshire, Great 56 (8x7) tablets in an Al/Al blister,

Britain supplied in a box

YES YES

Zyprexa Velotab 10 mg Eli Lilly and Company Limited, orodispersible tablets orodispersible tablets Basingstoke, Hampshire, Great 28 (4x7) tablets in a blister, supplied in YES YES Britain a box

Zyprexa Velotab 5 mg Eli Lilly and Company Limited, orodispersible tablets orodispersible tablets Basingstoke, Hampshire, Great 28 (4x7) tablets in a blister, supplied in YES Britain a box

YES

Pharmacia & Upjohn Company, 66 g granules in an amber glass bottle

Zyvoxid granules for oral of 240 mL with a plastic tempersuspension

20 mg/mL granules for oral suspension

Michigan, USA and Pfizer

Manufacturing Belgium NV, evident stopper and a plastic YES YES YES

Puurs, Belgium measuring spoon (2.5 mL/5 mL), supplied in a box

Zyvoxid 2 mg/mL solution for Fresenius Kabi Norge, Halden, 300 mL of solution in a plastic infusion

infusion solution for infusion Norway bag, in a protective aluminium casing. YES YES YES 10 bags per box.

Pharmacia & Upjohn Company,

Zyvoxid tablets 600 mg film coated tablets Michigan, USA and Pfizer 10 (1x10) tablets in a PVC/Al blister, Manufacturing Belgium NV, supplied in a box YES YES YES

Puurs, Belgium

_____________________

14509/1/11 REV 1 WS/jj 381

ANNEX II DG F 2A / DG K 2 EN

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Contents

1.

Kerngegevens

2.

Text

THE EUROPEAN UNION

14509/1/11

REV 1

INF 162

ELARG 95

NOTE

ANNEX I

THE EUROPEAN UNION

GENERAL SECRETARIAT

AC 31/11

LIMITE

FINAL EUROPEAN UNION AND CANDIDATE COUNTRY AGREED TEXT ON THE

ACCESSION TREATY

TREATY

BETWEEN

THE KINGDOM OF BELGIUM, THE REPUBLIC OF BULGARIA, THE CZECH

REPUBLIC, THE KINGDOM OF DENMARK, THE FEDERAL REPUBLIC OF

GERMANY, THE REPUBLIC OF ESTONIA, IRELAND, THE HELLENIC REPUBLIC,

THE KINGDOM OF SPAIN, THE FRENCH REPUBLIC, THE ITALIAN REPUBLIC, THE

REPUBLIC OF CYPRUS, THE REPUBLIC OF LATVIA, THE REPUBLIC OF

LITHUANIA, THE GRAND DUCHY OF LUXEMBOURG, THE REPUBLIC OF

HUNGARY, THE REPUBLIC OF MALTA, THE KINGDOM OF THE NETHERLANDS,

THE REPUBLIC OF AUSTRIA, THE REPUBLIC OF POLAND, THE PORTUGUESE

REPUBLIC, ROMANIA, THE REPUBLIC OF SLOVENIA, THE SLOVAK REPUBLIC,

THE REPUBLIC OF FINLAND, THE KINGDOM OF SWEDEN, THE UNITED

KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND

(MEMBER STATES OF THE EUROPEAN UNION)

AND

THE REPUBLIC OF CROATIA,

CONCERNING THE ACCESSION OF THE REPUBLIC OF CROATIA TO THE

EUROPEAN UNION

_________________

ACT

concerning the conditions of accession of the Republic of Croatia and the

adjustments to the Treaty on European Union, the Treaty on the Functioning of the European

Union and the Treaty establishing the European Atomic Energy Community

PRINCIPLES

ADJUSTMENTS TO THE TREATIES

INSTITUTIONAL PROVISIONS

OTHER ADJUSTMENTS

PERMANENT PROVISIONS

TEMPORARY PROVISIONS

TRANSITIONAL MEASURES

INSTITUTIONAL PROVISIONS

FINANCIAL PROVISIONS

OTHER PROVISIONS

PROVISIONS RELATING TO THE IMPLEMENTATION OF THIS ACT

ADAPTATIONS TO THE RULES OF THE INSTITUTIONS AND COMMITTEES

APPLICABILITY OF THE ACTS OF THE INSTITUTIONS

FINAL PROVISIONS

__________________

List of conventions and protocols to which the Republic of Croatia accedes

upon accession (referred to in Article 3(4) of the Act of Accession)

Union and the acts building upon it or otherwise related to it, to be binding on and applicable

in the Republic of Croatia as from accession (referred to in Article 4(1) of the Act of

Accession)

List referred to in Article 15 of the Act of Accession: adaptations to acts adopted by the

institutions

NATIONAL AND REGIONAL QUOTAS

from the 2010/2011 marketing year onwards

Special national de-mining reserve in Croatia

Introduction of direct payments

12. COASTAL WATERS OF SLOVENIA*

Resources for the Convergence objective

Resources for the performance reserve

Specific provisions following the accession of Croatia

Annual breakdown of commitment appropriations for 2007 to 2013

(referred to in Article 18)

Specific provisions following the accession of Croatia

List referred to in Article 16 of the Act of Accession: other permanent provisions

Treaty on the Functioning of the European Union, Part Three, Title II, Free Movement of

Goods

Treaty on the Functioning of European Union, Part Three, Title VII, Chapter 1, Rules on

Competition

Fisheries