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

Kerngegevens
Text
EU Monitor

1. Kerngegevens

Document date	21-09-2011
Publication date	24-09-2011
Reference	14509/11
From	General Secretariat
To	Delegations
External link	original PDF
Original document in PDF

2. Text

COUNCIL OF Brussels, 21 September 2011

THE EUROPEAN UNION

14509/11

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, have been released to the public today pursuant to Regulation (EC)

No 1049/2001 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

14509/11 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'

14509/11 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'

14509/11 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 i 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.

14509/11 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 i (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 i/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 i (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

14509/11 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 i 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 i 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 i 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 i 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 i 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 i 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 i/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 i 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 i 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 i/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 i 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 i 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 i 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 i 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 i 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)

14509/11 WS/jj 77

Council Decision 2010/252 i/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 i/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 i 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

14509/11 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:

14509/11 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:

14509/11 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

14509/11 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 i 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

14509/11 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 i 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 i 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.

14509/11 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.

14509/11 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 i 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 i 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 ;

14509/11 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 i

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 i 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 i 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 i 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 i

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 i and repealing

Directives 64/221/EEC i, 68/360/EEC, 72/194/EEC i, 73/148/EEC, 75/34/EEC i, 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 i 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 i 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 i 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 i 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 i:
  
  -
  
  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 i 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

14509/11 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 i

as well as Council Directive 76/769/EEC i and Commission Directives 91/155/EEC i, 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.

14509/11 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 i 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 i 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 i 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 i 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 i 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 i/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.

_____________________

NAME OF THE NATURE AND CONTENTS Generic

PHARMACEUTICAL FORM MANUFACTURER Domestic Imported Proprietary nCADREAC CP MRP OTC Herbal MEDICINAL PRODUCT OF CONTAINER UDMP

1M potassium-chloride concentrate for Hrvatski zavod za 50 mL of solution in a glass

(7.45%) concentrate 50 intravenous after transfuzijsku medicinu, injection bottle with a YES YES

mL reconstitution Petrova 3, Zagreb, chlorobutyl stopper protected

1M sodium Hrvatski zavod za 100 mL of solution in a glass

hydrogencarbonate (8.4%) solution for intravenous transfuzijsku medicinu, infusion bottle with rubber YES YES

solution for intravenous infusion Petrova 3, Zagreb, stopper protected by Al cap,

infusion, 100 mL Republic of Croatia 20 bottles with plastic holders

Merck KGaA, 15 mL of solution in an A.T. 10 solution oral solution YES YES

Frankfurter Straße 250, amber glass bottle with

Abaktal 400 mg film Darmstadt, Germany Lek farmacevtska plastic dropper attachment, 10 (1x10) tablets in a blister,

film coated tablets YES YES coated tablets družba d.d., supplied in a box

Abaktal 400 mg/5 mL Verovškova 57, Lek farmacevtska 10 ampoules each containing

solution for injection YES YES solution for injection družba d.d., 5 mL of solution, supplied in

Verovškova 57,

Gödecke GmbH, dio a box 30 (3x10) tablets in a blister,

Accupro 10 mg tablets film coated tablets YES YES

Pfizer grupe, supplied in a box

Karlsruhe, Germany Gödecke GmbH, dio 31 (3x10) tablets in a blister,

Accupro 20 mg tablets film coated tablets YES YES

Pfizer grupe, supplied in a box

Karlsruhe, Germany Gödecke GmbH, dio 32 (3x10) tablets in a blister,

Accupro 5 mg tablets film coated tablets YES YES

Pfizer grupe, supplied in a box

Aclasta 5 mg solution for Karlsruhe, Germany Novartis Pharma Stein 100 mL solution in a plastic

solution for infusion YES YES YES infusion AG, bottle with rubber stopper,

Act HIB, vaccine against lyophilisate and diluent Schaffhauserstrasse, Sanofi Pasteur S.A., 2 aluminum ring and plastic Bottle with 1 dose of

Haemophilus influenzae for preparation of avenue Pont Pasteur, lyophilised vaccine and 1 YES

type B injection solution Lyon, France glass syringe with solvent for

Boehringer Ingelheim 50 mg of lyophilisate in a

lyophilisate and diluent Pharma GmbH & Co. bottle, 50 mL of solvent Actilyse lyophilisate for

for preparation of solution KG, Birkendorfer (water for injection) in a YES YES injection 50 mg

for injection Strasse 65, Biberach bottle and a transfer needle,

an der Riss, Germany supplied in a box

28 tablets in a plastic Novo Nordisk A/S,

calendar dial pack (dispenser Activelle film coated tablets Novo Allé, DK-2880 YES YES

with marked days of the Bagsvaerd, Denmark

week), supplied in a box

Procter & Gamble

Pharmaceuticals 28 (2x14) tablets in a blister, Actonel 30 mg tablets film coated tablets YES YES

Germany GmbH, supplied in a box

Weiterstadt, Germany

Procter & Gamble

Pharmaceuticals 4 (1x4) tablets in a blister, Actonel 35 mg tablets film coated tablets YES YES

Germany GmbH, supplied in a box

Weiterstadt, Germany

Procter & Gamble

Pharmaceuticals 28 (2x14) tablets in a blister, Actonel 5 mg tablets film coated tablets YES YES

Germany GmbH, supplied in a box

Weiterstadt, Germany

Novo Nordisk A/S, solution for injection (for 10 mL of solution in a glass Actrapid HM 100 Novo Allé, DK-2880 YES YES

s.c., i.m. and i.v. use) bottle, supplied in a box Bagsvaerd, Denmark

Novo Nordisk A/S,

Novo Alle, Bagsvaerd, 5 glass cartridges with 3 mL

solution for subcutaneous Denmark Novo Nordisk Actrapid Penfill of solution in a blister, YES YES

injection Production SAS, 45, supplied in a box

Avenue d' Orleans,

Chartres, France SmithKline Beecham 12 (1x12) tablets in Pharmaceuticals,

Adartrel 0.25 mg tablets film coated tablets PVC/PCTFE/Al blister, YES YES YES YES Crawley, West Sussex,

supplied in a box Great Britain

SmithKline Beecham

28 (2x14) tablets in a

Pharmaceuticals,

Adartrel 0.5 mg tablets film coated tablets PVC/PCTFE/Al blister, YES YES YES YES

Crawley, West Sussex,

supplied in a box

Great Britain

SmithKline Beecham

28 (2x14) tablets in a

Pharmaceuticals,

Adartrel 2 mg tablets film coated tablets PVC/PCTFE/Al blister, YES YES YES YES

Crawley, West Sussex,

supplied in a box

Great Britain

5 mL of solution for injection Adriblastina PFS 10 mg Pfizer Italia S.r.I.,

solution for injection in a glass bottle, supplied in YES YES

injection (2 mg/mL) Milano, Italy a box

25 mL of solution for injection Adriblastina PFS 50 mg Pfizer Italia S.r.I.,

solution for injection in a glass bottle, supplied in YES YES

injection (2 mg/mL) Milano, Italy a box

Intendis Manufacturing 15 g of cream in an

Advantan cream cream S.p.A., Segrate, aluminum tube, supplied in a YES YES

Milano, Italy box

Intendis Manufacturing 15 g of cream in an

Advantan ointment ointment S.p.A., Segrate, aluminum tube, supplied in a YES YES

Milano, Italy box

Schering-Plough Labo

60 mL of syrup in an amber

N.V. Industrepark 30,

Aerius syrup of 0.5 mg/mL syrup glass bottle and a measuring YES YES

Heist-op-den-Berg,

spoon, supplied in a box

Belgium

Schering-Plough Labo

Aerius 5 mg film coated N.V. Industrepark 30, 10 (1x10) tablets in a blister, film coated tablets YES YES

tablets Heist-op-den-Berg, supplied in a box

Belgium

Belupo, lijekovi i

20 grams of cream in an

kozmetika d.d., Ulica

Afloderm cream cream aluminum tube with a plastic YES YES

Danica 5, Koprivnica,

cap, supplied in a box

Republic of Croatia

Belupo, lijekovi i

40 g of cream in an

kozmetika d.d., Ulica

Afloderm cream cream aluminium tube with a plastic YES YES

Danica 5, Koprivnica,

stopper, supplied in a box

Republic of Croatia

Belupo, lijekovi i

20 grams of ointment in an

kozmetika d.d., Ulica

Afloderm ointment ointment aluminum tube with a plastic YES YES

Danica 5, Koprivnica,

cap, supplied in a box

Republic of Croatia

Afluria suspension for CSL Limited, 45 Poplar Box with 1 pre-filled syringe

injection in pre-filled Road, Parkville, (glass, type I) with a needle, suspension for injections YES

syringe, influenza vaccine Melbourne, Victoria with 1 dose of vaccine (0.5

(fragmented inactivated) 3052, Australija mL of suspension)

Merck Sharp & Dohme 50 mL of solution

Aggrastat concentrate of concentrate of solution B.V., Waarderweg 39, concentrate in a glass bottle, YES YES YES

solution for infusion for infusion Postbus 581, Haarlem, supplied in a box

The Nederlands

Boehringer Ingelheim 60 capsules in a white plastic

Pharma (PP) container with a plastic Aggrenox 200/25 mg modified release

GmbH&Co.KG, (PE) temper-evident stopper YES YES modified release capsules capsules, hard

Biberach an der Riss, with a desiccant, supplied in

Germany a box

60 tablets in a plastic (HDPE)

bottle with a plastic stopper

Weifa AS, Oslo, (there is a bag in a bottle or a Aglurab 1000 film coated tablets YES YES

Norway capsule in a stopper

containing silicagel to

attenuate the tablet odor)

Weifa AS, Oslo, 36 tablets in a plastic (HDPE) Aglurab 850 film coated tablets YES YES

Norway bottle with a desiccant suspension for Pre-filled syringe with a Agrippal vaccine against

intramuscular or Chiron S.r.l, Siena, needle (containing a single influenza (surface antigen, YES

subcutaneous Italy 0.5-mL vaccine dose in the inactivated)

administration form of suspension)

A pre-filled syringe (glass

Agrippal suspension for type I) containing 0.5 mL of

injections in pre-filled Novartis Vaccines & suspension, equipped with a suspension for injections

syringe, influenza vaccine Diagnostics S.r.l., needle (23G, 1"; or 25G, 1"; YES in a pre-filled syringe

(surface antigens), Siena, Italy or 25G, 5/8";) and a rubber

inactivated plunger stopper, supplied in

a box

Ebewe Pharma Ges. 5 ampoules with 1 mL of

m.b.H. Nfg. KG, Akineton injection solution for injection solution for injection, YES YES

Mondseestrasse 11, supplied in a carton box

Unterach, Austria

Laboratorio

Farmaceutico S.I.T. 50 tablets (5x10) in a PVC/Al Akineton tablets tablets YES YES

Srl, Via Cavour 70, blister, supplied in a box

Mede (PV), Italy

Jadran - Galenski 30 mL of solution in an

laboratorij d.d., Pulac amber glass bottle with a Aknet dermal solution YES YES

bb, Rijeka, Republic of dropper and a plastic

Croatia stopper, supplied in a box

Belupo, lijekovi i 30 (2x15) capsules in a

kozmetika d.d., Ulica Aktivin H capsule capsules PVC/PVDC/Al blister, YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i 60 capsules in a

kozmetika d.d., Ulica Aktivin H capsules capsules polypropylene bag, supplied YES YES

Danica 5, Koprivnica, in a box

Republic of Croatia

Alkaloid AD - Skopje, Amber glass bottle with

Skopje, FYROM in powder for preparation of

Alamcin 250 mg/5 mL powder for preparation of cooperation with BILIM 100 mL of suspension with a

YES YES powder for oral suspension oral suspension PHARMACEUTICALS polyethylene stopper and a

A.S., Maslak Istanbul, plastic spoon, supplied in a

Turkey box

Altana Pharma AG, 25 mL of solution in an

Albothyl solution solution Byk-Gulden Strasse 2, amber glass bottle with black YES YES

Konstanz, Germany plastic cap, supplied in a box

Altana Pharma AG, 6 pessaries in a white non

Albothyl pessaries pessaries Byk-Gulden Strasse 2, transparent plastic foil YES YES

Konstanz, Germany (PVC/PE), supplied in a box

Imunološki zavod d.d., Human albumin 20%

solution for intravenous Rockefellerova 2, Glass bottle with 50 mL of solution for intravenous YES

use Zagreb, Republic of solution, supplied in a box use

Croatia

Imunološki zavod d.d.,

Human albumin 20% solution for intravenous Rockefellerova 2, Glass bottle with 100 mL of

YES solution for i.v. use use Zagreb, Republic of solution, supplied in a box

Croatia

Human albumin 20% Imunološki zavod d.d.,

solution for intravenous Rockefellerova 2, Glass bottle with 50 mL of solution for infusion YES

use (Albumini humani Zagreb, Republic of solution, supplied in a box

solutio), 200g/l Croatia

Human albumin 20% Imunološki zavod d.d.,

solution for intravenous Rockefellerova 2, Glass bottle with 100 mL of solution for infusion YES

use (Albumini humani Zagreb, Republic of solution, supplied in a box

solutio), 200g/l blood Croatia

Imunološki zavod d.d., Albumin (human) 5%

solution for intravenous Rockefellerova 2, One glass vial with 250 mL of solution for intravenous YES

use Zagreb, Republic of solution, supplied in a box use

Croatia

Aldactone 100 mg Roche Farma S.A., 20 (2x10) capsules in PVC/Al capsules YES YES

capsules Madrid, Spain blister, supplied in a box

50 (5x10) coated tablets in a

Aldactone 25 mg coated Roche Farma S.A., coated tablets PVC/Al blister, supplied in a YES YES

tablets Madrid, Spain box

20 (2x10) coated tablets in

Aldactone 50 mg coated Roche Farma S.A., coated tablets PVC/Al blister, supplied in a YES YES

tablets Madrid, Spain box

Alkaloid AD - Skopje,

Bulevar Aleksandar 34 (3x10) tablets in a PVC/Al Aldizem 60 mg tablets YES YES

Makedonski 12, blister, supplied in a box

Skopje, FYROM

Alkaloid AD - Skopje,

Bulevar Aleksandar 35 (3x10) tablets in a PVC/Al Aldizem 90 mg tablets YES YES

Makedonski 12, blister, supplied in a box

Skopje, FYROM

Genzyme Ltd., 37 Aldurazyme 100 U/mL One glass vial with 5 mL of

concentrate for solution Hollands Road, concentrate for solution for solution concentrate, YES YES YES YES

for infusion Haverhill, Suffolk CB9 infusion supplied in a box

8PU, Great Britain

Belupo, lijekovi i 4 (1x4) tablets in a

kozmetika d.d., Ulica Aledox 70 mg tablets tablets PA/Al/PVC//Al blister, YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Pliva Croatia Ltd., Ulica

4 (1x4) tablets in a blister

grada Vukovara 49,

Alendor 70 tablets (PVC/PE/PVDC//AI), YES YES

Zagreb, Republic of

supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 28 (4x7) tablets in a blister, Alendor tablets 5 mg tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 28 (4x7) tablets in a blister, Alendor tablets10 mg tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

Alfuzosin Pliva tablets 10 film coated tablets with grada Vukovara 49, 33 (3x10) tablets in a PVC/Al

YES YES mg prolonged-release Zagreb, Republic of blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

Alfuzosin Pliva tablets 5 prolonged-release filmgrada Vukovara 49, 23 (2x10) tablets in a blister

YES YES mg coated tablets Zagreb, Republic of (PVC/Al) , supplied in a box

Croatia

Alimta 500 mg powder for Lilly France S.A.S., powder for concentrate Glass bottle, supplied in a

infusion solution Rue du Colonel Lilly, YES YES YES for infusion solution box

concentrate Fegersheim, France

Alkaloid AD - Skopje, 50 (5x10) ampoules each

Alkagin 2.5 g/5 mL solution Bulevar Aleksandar with 5 mL of solution in a solution for injection YES YES

for injection Makedonski 12, protective container, supplied

Skopje, FYROM in a box

Alkaloid AD - Skopje,

Bulevar Aleksandar 10 (1x10) tablets in a PVC/Al Alkagin 500 mg tablets tablets YES YES

Makedonski 12, blister, supplied in a box

Skopje, FYROM

Alkaloid AD - Skopje,

Skopje, FYROM in

cooperation with BILIM 16 capsules in a A/PVC Almacin 500 mg capsules capsules YES YES

PHARMACEUTICALS blister, supplied in a box

A.S., Maslak Istanbul,

Turkey

60 mL of solution in a white

Belupo, lijekovi i plastic bottle with a plastic

Alomax 2% dermal kozmetika d.d., Ulica stopper, a metering plastic dermal solution YES YES YES

solution Danica 5, Koprivnica, pump and a spray

Republic of Croatia attachment, in a protective

bag, supplied in a box 60 mL of solution in a white

Belupo, lijekovi i plastic bottle with a plastic

Alomax 5% dermal kozmetika d.d., Ulica stopper, a metering plastic dermal solution YES YES YES

solution Danica 5, Koprivnica, pump and a spray

Republic of Croatia attachment, in a protective

bag, supplied in a box

Alcon-Couvreur s.a., 5 mL of solution in a plastic Alomide 1 mg/mL eye

eye drops Rijksweg 14, Puurs, bottle with a dropper, YES YES drops

Belgium supplied in a carton box

Belupo, lijekovi i

kozmetika d.d., Ulica 100 tablets in a plastic Alopurinol 100 mg tablets tablets YES YES

Danica 5, Koprivnica, bottle, supplied in a box

Republic of Croatia

Helsinn Birex

Pharmaceuticals Ltd.,

One glass vial with 5 mL of

Aloxi, solution for injection solution for injection Damastown, YES YES YES

solution, supplied in a box

Mulhuddart, Dublin 15,

Republic of Ireland

Allergan

Pharmaceuticals

5 mL of solution in a plastic

Republic of Ireland,

Alphagan eye drops eye drops bottle with a dropper, YES YES

Castlebar Road,

supplied in a box

Westport, Co Mayo,

Republic of Ireland

Altana Pharma AG, Al container with a metering pressurized inhalant,

Alvesco 160 Inhaler Byk-Gulden Strasse 2, valve, mouthpiece and YES YES YES solution

Konstanz, Germany stopper, 60 inhalations

Altana Pharma AG, Al container with a metering pressurized inhalant,

Alvesco 40 Inhaler Byk-Gulden Strasse 2, valve, mouthpiece and YES YES YES solution

Konstanz, Germany stopper, 60 inhalations

Altana Pharma AG, Al container with a metering pressurized inhalant,

Alvesco 80 Inhaler Byk-Gulden Strasse 2, valve, mouthpiece and YES YES YES solution

Konstanz, Germany stopper, 60 inhalations

Aventis Pharma S.p.A.,

30 (2x15) tablets in a blister,

Amaryl 1.0 tablets S.S. 17 KM 22, YES YES

supplied in a box

Scoppito, Italy

Aventis Pharma S.p.A.,

30 (2x15) tablets in a blister,

Amaryl 2.0 tablets S.S. 17 KM 22, YES YES

supplied in a box

Scoppito, Italy

Aventis Pharma S.p.A.,

30 (2x15) tablets in a blister,

Amaryl 3.0 tablets S.S. 17 KM 22, YES YES

supplied in a box

Scoppito, Italy

Jadran - Galenski

laboratorij d.d., Pulac 41 (3x10) tablets in a PVC/Al Amicor 10 tablets YES YES

bb, Rijeka, Republic of blister, supplied in a box

Croatia

Jadran - Galenski

laboratorij d.d., Pulac 42 (3x10) tablets in a PVC/Al Amicor 20 tablets YES YES

bb, Rijeka, Republic of blister, supplied in a box

Croatia

Jadran - Galenski

laboratorij d.d., Pulac 20 (1x20) tablets in a PVC/Al Amicor 5 tablets YES YES

bb, Rijeka, Republic of blister, supplied in a box

Croatia

Jadran - Galenski

laboratorij d.d., Pulac 20 (1x20) tablets in a PVC/Al Amicor H 10 tablets YES YES

bb, Rijeka, Republic of blister, supplied in a box

Croatia

Jadran - Galenski

laboratorij d.d., Pulac 43 (3x10) tablets in a PVC/Al Amicor H 10 tablets YES YES

bb, Rijeka, Republic of blister, supplied in a box

Croatia

Jadran - Galenski

laboratorij d.d., Pulac 44 (3x10) tablets in a PVC/Al Amicor H 20 tablets YES YES

bb, Rijeka, Republic of blister, supplied in a box

Croatia Belupo, lijekovi i

kozmetika d.d., Ulica Tube with 25 g of gel, Aminfluorid dental gel dental gel YES YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i 50 mL of solution in a

kozmetika d.d., Ulica polyethylene bag with a Aminfluorid dental solution dental solution YES YES YES

Danica 5, Koprivnica, dropper and a screw cap,

Republic of Croatia supplied in a box

One plastic bag with two

compartments (for solutions

A and B), peel seam and two Fresenius Kabi

attachments connected to solution for infusion (for Deutschland GmbH,

Aminomix 2 Novum the compartments (with YES YES parenteral nutrition) Bad Homburg,

solutions for drug delivery Germany

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 Fresenius Kabi

attachments connected to solution for infusion (for Deutschland GmbH,

Aminomix 2 Novum the compartments (with YES YES parenteral nutrition) Bad Homburg,

solutions for drug delivery Germany

and infusion) in an external

protective bag inserted with

bag with agent

Lek farmacevtska

družba d.d., 50 (5x10) tablets in a blister Aminophyllinum Lek 100

tablets Verovškova 57, (PVC/Al), supplied in a YES YES mg tablets

Ljubljana, Republic of carton box

Slovenia

Lek farmacevtska

Aminophyllinum Lek 250 družba d.d., 50 (5x10) ampoules with 10

mg/10 mL solution for solution for injection Verovškova 57, mL of solution for injection, YES YES

injection Ljubljana, Republic of supplied in a box

Slovenia

Lek farmacevtska

Aminophyllinum Lek 350 družba d.d., 20 (2x10) tablets in a blister

mg prolonged-release prolonged-release tablets Verovškova 57, (PVC/Al) , supplied in a YES YES

tablets Ljubljana, Republic of carton box

Slovenia

B. Braun Melsungen 500 mL of solution for

AG, Carl-Braun-Straße Aminoplasmal - 10% E solution for infusion infusion in a glass bottle, 10 YES YES

1, Melsungen, bottles in a box

Germany

B. Braun Melsungen 500 mL of solution for

AG, Carl-Braun-Straße Aminoplasmal - 5% E solution for infusion infusion in a glass bottle, 10 YES YES

1, Melsungen, bottles in a box

Germany

B. Braun Melsungen 500 mL of solution for

AG, Carl-Braun-Straße Aminoplasmal Hepa - 10% solution for infusion infusion in a glass bottle, 10 YES YES

1, Melsungen, bottles in a box

Germany

Fresenius Kabi Austria One glass bottle for infusion Aminoven 10% solution for infusion YES YES YES

GmbH, Graz, Austria with 500 mL of solution

Fresenius Kabi Austria One glass bottle for infusion Aminoven 5% solution for infusion YES YES YES

GmbH, Graz, Austria with 500 mL of solution

10 glass infusion bottles with Fresenius Kabi Austria

Aminoven Infant 10% solution for infusion 100 mL of solution, supplied YES YES

GmbH, Graz, Austria in a carton box

10 glass infusion bottles with Fresenius Kabi Austria

Aminoven Infant 10% solution for infusion 250 mL of solution, supplied YES YES

GmbH, Graz, Austria in a carton box

Belupo, lijekovi i

Box with 30 (2x15) tablets in

Amiodaron 200 mg tablets tablets kozmetika d.d., Ulica YES YES

a blister

Danica 5, Koprivnica,

Republic of Croatia

Cipla Ltd., Verna 30 (3x10) tablets in a brown

AmLodipin Cipla 10 mg tablets Industrial Estate, Verna PVC/Al blister, supplied in a YES YES

Goa, India box

Cipla Ltd., Verna 30 (3x10) tablets in a brown

AmLodipin Cipla 5 mg tablets Industrial Estate, Verna PVC/Al blister, supplied in a YES YES

Goa, India box

Lek farmacevtska

družba d.d., 20 (2x10) tablets in a blister,

AmLopin 10 mg tablets tablets Verovškova 57, YES YES supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d., 30 (3x10) tablets in a blister,

AmLopin 5 mg tablets tablets Verovškova 57, YES YES supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d., 20 (2x10) tablets in a blister,

AmLopin 5 mg tablets tablets Verovškova 57, YES YES supplied in a box

Ljubljana, Republic of

Slovenia

Belupo, lijekovi i

Amoksicilin 375 mg kozmetika d.d., Ulica 12 capsules in a bottle, capsules YES YES capsules Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

Amoksicilin 500 mg kozmetika d.d., Ulica 16 capsules in a blister, capsules YES YES capsules Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i Bottle with powder for

Amoksicilin powder for oral powder for oral kozmetika d.d., Ulica preparation of 100 mL of

YES YES suspension 250 mg/5 mL suspension Danica 5, Koprivnica, suspension, supplied in a

Republic of Croatia box

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (1x30) tablets in a blister, Amonex 10 mg tablets tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (1x30) tablets in a blister, Amonex 5 mg tablets tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 16 (2x8) tablets in a blister, Amoxil capsules 500 mg capsules YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

powder for preparation of grada Vukovara 49, Amber glass bottle with Amoxil syrup YES YES

oral suspension Zagreb, Republic of powder, supplied in a box

Croatia

Torrex Chiesi Pharma Turbid glass bottle (with 100 powder for preparation of

Amphocil 100 mg GmbH, Gonzagagasse mg of dry matter) with a cap YES YES solution for infusion

16/16, Vienna, Austria and Al ring, supplied in a box

Torrex Chiesi Pharma Turbid glass bottle (with 50 powder for preparation of

Amphocil 50 mg GmbH, Gonzagagasse mg of dry matter) with a cap YES YES solution for infusion

16/16, Vienna, Austria and Al ring, supplied in a box

Jadran - Galenski Amphotericin B, powder One glass vial with powder

powder for preparation of laboratorij d.d., Pulac for preparation of for injection preparation, YES YES

injections bb, Rijeka, Republic of injections supplied in a box

Croatia

Krka d.d., Šmarješka 31 (3x10) tablets in a Ampril HD tablets 5 mg/25

tablets cesta 6, Novo mesto, OPA/Al/PVC//Al blister, YES YES YES YES mg

Republic of Slovenia supplied in a box

Ampril HL tablets 2.5 Krka d.d., Šmarješka 32 (3x10) tablets in a tablets YES YES YES YES

mg/12.5 mg cesta 6, Novo mesto, OPA/Al/PVC//Al blister,

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 33 (3x10) tablets in a

Ampril 1.25 mg tablets tablets cesta 6, Novo mesto, OPA/Al/PVC//Al blister, YES YES YES YES

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 34 (3x10) tablets in a

Ampril 10 mg tablets tablets cesta 6, Novo mesto, OPA/Al/PVC//Al blister, YES YES YES YES

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 35 (3x10) tablets in a

Ampril 2.5 mg tablets tablets cesta 6, Novo mesto, OPA/Al/PVC//Al blister, YES YES YES YES

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 36 (3x10) tablets in a

Ampril 5 mg tablets tablets cesta 6, Novo mesto, OPA/Al/PVC//Al blister, YES YES YES YES

Republic of Slovenia supplied in a box

Lek farmacevtska

družba d.d., Amyzol 10 mg film coated 100 (4X25) tablets in a

film coated tablets Verovškova 57, YES YES tablets blister, supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d., Amyzol 25 mg film coated 30 (3X10) tablets in a blister,

film coated tablets Verovškova 57, YES YES tablets supplied in a box

Ljubljana, Republic of

Slovenia

Pliva Croatia Ltd.,

Zagreb, Republic of 31 (3x10) coated tablets in a ANAFRANIL coated

coated tablets Croatia and Novartis PVC/Al blister, supplied in a YES YES tablets

Pharma Services Inc., box

Basel, Switzerland

Pliva Croatia Ltd., Ulica

5 mL of solution for injection

grada Vukovara 49,

Analgin injections solution for injection in an amber glass ampoule, YES YES

Zagreb, Republic of

50 ampoules in a box

Croatia

Pliva Croatia Ltd., Ulica 10 (1x10) tablets in an

grada Vukovara 49, Analgin tablets tablets orange blister (PVC/Al), YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 23 (2x10 tablets in

grada Vukovara 49, Andol tablets Al/PVC/PVDC blister, YES YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 24 (2x10 tablets in

grada Vukovara 49, Andol 100 tablets Al/PVC/PVDC blister, YES YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 10 tablets in a vial (cap with Andol C effervescent tablets YES YES

Zagreb, Republic of silicagel and protective ring)

Croatia

Schering GmbH und

Co. Produktions KG, 45 (3x15) tablets in a blister, Androcur-10 tablets tablets YES YES

Doebereinerstrasse 20, supplied in a box

Weimar, Germany

Delpharm Lille S.A.S.,

Z.I. De Roubaix Est, 50 (5x10) tablets in a blister Androcur-50 tablets tablets YES YES

Rue de Toufflers, Lys (PVC/Al), supplied in a box

Lez Lannoy, France

Besins International 5 g of gel in a bag Androgel 50 mg, gel in

gel Belgique, Drogenbos, (PET/Al/PE), 30 bags in a YES YES YES bags

Belgium carton box

F. Hoffmann-La Roche

Ltd., 5 mL of solution in a glass solution for injection or

Anexate Grenzacherstrasse ampoule, 10 ampoules in a YES YES infusion

124, Basel, box

Switzerland Lek farmacevtska

družba d.d.,

20 (2x10) lozenges in PVC/Al

Angal lozenges lozenges Verovškova 57, YES YES YES

blister, supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska 30 mL of solution in an

družba d.d., amber glass bottle with a

Angal S oral spray oromucosal spray Verovškova 57, screw cap and automatic YES YES YES

Ljubljana, Republic of sprayer/spraying attachment,

Slovenia supplied in a box

Schering AG,

Angeliq film tablets film coated tablets Muellerstrasse 170- aluminum YES YES YES

178, Berlin, Germany

Lek farmacevtska

družba d.d.,

25 capsules in a glass bottle,

Ansilan 10 mg capsules capsules Verovškova 57, YES YES

supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d., 30 (3x10) capsules in a Ansilan mite 5 mg

capsules Verovškova 57, PVC/Al blister, supplied in a YES YES capsules

Ljubljana, Republic of box

Slovenia

Vial with 1000 IU

antithrombin III, vial with lyophilized powder and

Baxter AG, diluent, portable needle, Antithrombin III Immuno diluent for preparation of

Industriestrasse 67, A- filter needle, vent needle, YES 1000 IU solution for injection or

1220 Vienna, Austria disposable needle, infusion infusion

kit , disposable syringe,

supplied in a box

Vial with 500 IU antithrombin

lyophilized powder or III, vial with diluent, portable Baxter AG,

Antithrombin III Immuno diluent for preparation of needle, filter needle, vent

Industriestrasse 67, A- YES 500 IU solution for injection or needle, disposable needle,

1220 Vienna, Austria infusion infusion kit , disposable

syringe, supplied in a box

Imunološki zavod d.d., Box with 1 bottle containing

Antitoxin (equine) against solution for parenteral Rockefellerova 2, 10 mL of preparation (1

YES European viper venom use Zagreb, Republic of dose), with a sterile needle

Croatia and a disposable syringe

Aventis Pharma

Deutschland GmbH, Apidra 100 IU/mL (10 mL solution for injection (for One glass vial with 10 mL of

Brunningstrasse 50, YES YES YES glass vial) s.c. use) solution, supplied in a box

Frankfurt am Main,

Germany

Sanofi - Aventis Apidra 100 IU/mL (3mL 5 glass cartridges (for

solution for subcutaneous Deutschland GmbH, glass cartridge for use with OptiClik) with 3 mL of YES YES YES

injection Frankfurt am Main, OptiClik injector) solution, supplied in a box

Germany

Aventis Pharma

Deutschland GmbH, Apidra 100 IU/mL (3.0 mL solution for subcutaneous 5 glass cartridges with 3 mL

Brunningstrasse 50, YES YES YES glass cartridge) injection of solution, supplied in a box

Frankfurt am Main,

Germany

Aventis Pharma 5 pens (injectors) with a

Apidra 100 IU/mL OptiSet Deutschland GmbH, solution for subcutaneous glass cartridge containing 3

(injector with glass Brunningstrasse 50, YES YES YES injection mL of solution, supplied in a

cartridge of 3 mL) Frankfurt am Main, box

Germany

Sanofi Winthrop

28 (2x14) tablets in a blister

Industrie, 1 rue de la

Aprovel 150 mg film coated tablets (PC/PVDC/Al), supplied in a YES YES YES

Vierge, 33440

box

Ambares, France

Sanofi Winthrop

28 (2x14) tablets in a blister

Industrie, 1 rue de la

Aprovel 300 mg film coated tablets (PC/PVDC/Al), supplied in a YES YES YES

Vierge, 33440

box

Ambares, France

Sanofi Winthrop

28 (2x14) tablets in a blister

Industrie, 1 rue de la

Aprovel 75 mg film coated tablets (PC/PVDC/Al), supplied in a YES YES YES

Vierge, 33440

box

Ambares, France

Hrvatski zavod za

diluent for preparation of transfuzijsku medicinu, 500 mL of water for injection Aqua pro injectione YES YES

parenteral solutions Petrova 3, Zagreb, in a glass infusion bottle

Republic of Croatia

Hrvatski zavod za 1000 mL of Water for

solvent for preparation of transfuzijsku medicinu, Aqua pro injectione Injection in a glass infusion YES YES

parenteral solutions Petrova 3, Zagreb, bottle

Republic of Croatia

Hrvatski zavod za 100 mL of Water for

solvent for preparation of transfuzijsku medicinu, Aqua pro injectione Injection in a glass infusion YES YES

parenteral solutions Petrova 3, Zagreb, bottle

Republic of Croatia

One disposable glass syringe Aranesp 10 micrograms of Amgen Europe B.V.,

with needle containing 0.4 solution for injection in a solution for injection Minervum 7061, Breda, YES YES YES YES

mL of solution, in a protective pre-filled syringe the Netherlands

container, supplied in a box

A plastic syringe with fitted Aranesp 100 micrograms Amgen Europe B.V.,

glass syringe containing 0.5 of solution for injection in solution for injection Minervum 7061, Breda, YES YES YES YES

mL of solution in a protective a pre-filled syringe the Netherlands

container, supplied in a box

One disposable glass syringe Aranesp 100 micrograms Amgen Europe B.V.,

with needle containing 0.5 of solution for injection in solution for injection Minervum 7061, Breda, YES YES YES YES

mL of solution, in a protective a pre-filled syringe the Netherlands

container, supplied in a box

One disposable glass syringe

Aranesp 15 micrograms of Amgen Europe B.V., with needle containing

solution for injection in a solution for injection Minervum 7061, Breda, 0.375 mL of solution, in a YES YES YES YES

pre-filled syringe the Netherlands protective container, supplied

in a box

A plastic syringe with fitted Aranesp 150 mcg solution Amgen Europe B.V.,

glass syringe containing 0.3 for injection in a pre-filled solution for injection Minervum 7061, Breda, YES YES YES YES

mL of solution in a protective syringe the Netherlands

container, supplied in a box

One disposable glass syringe Aranesp 150 micrograms Amgen Europe B.V.,

with needle containing 0.3 of solution for injection in solution for injection Minervum 7061, Breda, YES YES YES YES

mL of solution, in a protective a pre-filled syringe the Netherlands

container, supplied in a box

A plastic syringe with fitted Aranesp 20 micrograms of Amgen Europe B.V.,

glass syringe containing 0.5 solution for injection in a solution for injection Minervum 7061, Breda, YES YES YES YES

mL of solution in a protective pre-filled syringe the Netherlands

container, supplied in a box

One disposable glass syringe Aranesp 20 micrograms of Amgen Europe B.V.,

with needle containing 0.5 solution for injection in a solution for injection Minervum 7061, Breda, YES YES YES YES

mL of solution, in a protective pre-filled syringe the Netherlands

container, supplied in a box

One disposable glass syringe Aranesp 30 micrograms of Amgen Europe B.V.,

with needle containing 0.3 solution for injection in a solution for injection Minervum 7061, Breda, YES YES YES YES

mL of solution, in a protective pre-filled syringe the Netherlands

container, supplied in a box

A plastic syringe with fitted Aranesp 300 micrograms Amgen Europe B.V.,

glass syringe containing 0.6 of solution for injection in solution for injection Minervum 7061, Breda, YES YES YES YES

mL of solution in a protective a pre-filled syringe the Netherlands

container, supplied in a box

One disposable glass syringe Aranesp 300 micrograms Amgen Europe B.V.,

with needle containing 0.6 of solution for injection in solution for injection Minervum 7061, Breda, YES YES YES YES

mL of solution, in a protective a pre-filled syringe the Netherlands

container, supplied in a box

A plastic syringe with fitted Aranesp 40 micrograms of Amgen Europe B.V.,

glass syringe containing 0.4 solution for injection in a solution for injection Minervum 7061, Breda, YES YES YES YES

mL of solution in a protective pre-filled syringe the Netherlands

container, supplied in a box One disposable glass syringe

Aranesp 40 micrograms of Amgen Europe B.V., with needle containing 0.4 solution for injection in a solution for injection Minervum 7061, Breda, YES YES YES YES

mL of solution, in a protective pre-filled syringe the Netherlands

container, supplied in a box

One disposable glass syringe Aranesp 50 micrograms of Amgen Europe B.V.,

with needle containing 0.5

solution for injection in a solution for injection Minervum 7061, Breda, YES YES YES YES mL of solution, in a protective

pre-filled syringe the Netherlands container, supplied in a box

A plastic syringe with fitted

Aranesp 500 micrograms Amgen Europe B.V., glass syringe containing 1.0

of solution for injection in solution for injection Minervum 7061, Breda, YES YES YES YES mL of solution in a protective

a pre-filled syringe the Netherlands container, supplied in a box

One disposable glass syringe Aranesp 500 micrograms Amgen Europe B.V.,

with needle containing 1.0

of solution for injection in solution for injection Minervum 7061, Breda, YES YES YES YES mL of solution, in a protective

a pre-filled syringe the Netherlands container, supplied in a box

A plastic syringe with fitted

Aranesp 60 micrograms of Amgen Europe B.V., glass syringe containing 0.3

solution for injection in a solution for injection Minervum 7061, Breda, YES YES YES YES mL of solution in a protective

pre-filled syringe the Netherlands container, supplied in a box

One disposable glass syringe Aranesp 60 micrograms of Amgen Europe B.V.,

with needle containing 0.3

solution for injection in a solution for injection Minervum 7061, Breda, YES YES YES YES mL of solution, in a protective

pre-filled syringe the Netherlands container, supplied in a box

A plastic syringe with fitted

Aranesp 80 micrograms of Amgen Europe B.V., glass syringe containing 0.4

solution for injection in a solution for injection Minervum 7061, Breda, YES YES YES YES mL of solution in a protective

pre-filled syringe the Netherlands container, supplied in a box

One disposable glass syringe Aranesp 80 micrograms of Amgen Europe B.V.,

with needle containing 0.4

solution for injection in a solution for injection Minervum 7061, Breda, YES YES YES YES mL of solution, in a protective

pre-filled syringe the Netherlands container, supplied in a box

Aventis

Intercontinental, Route

Box with 30 tablets in a

Arava 10 mg tablets film coated tablets de Choisy au Bac, YES YES

plastic bottle

Compiegne, Cedex,

France

Aventis

Intercontinental, Route

3 tablets in an aluminum

Arava 100 mg tablets film coated tablets de Choisy au Bac, YES YES

blister, supplied in a box

Compiegne, Cedex,

France

Aventis

Intercontinental, Route

Box with 30 tablets in a

Arava 20 mg tablets film coated tablets de Choisy au Bac, YES YES

plastic bottle

Compiegne, Cedex,

France

Merck Sharp & Dohme 7 (1x7) film coated tablets in

Arcoxia 120 mg film B.V., Waarderweg 39, film coated tablets an Al/Al blister, supplied in a YES YES YES YES

coated tablets Postbus 581, Haarlem, box

the Netherlands

Merck Sharp & Dohme 14 (2x7) film coated tablets in

Arcoxia 60 mg film coated B.V., Waarderweg 39, film coated tablets a A/Al blister, supplied in a YES YES YES YES

tablets Postbus 581, Haarlem, box

the Netherlands

Merck Sharp & Dohme 14 (2x7) film coated tablets in

Arcoxia 90 mg film coated B.V., Waarderweg 39, film coated tablets a A/Al blister, supplied in a YES YES YES YES

tablets Postbus 581, Haarlem, box

the Netherlands

4 colourless glass bottles Novartis Pharma Stein

with powder and 4 ampoules powder and diluent for AG,

Aredia 15 mg with 5 mL of solvent (water YES YES solution for infusion Schaffhauserstrasse,

for injection), supplied in a Stein, Switzerland

box

Novartis Pharma Stein 2 clear glass bottles powder and diluent for

Aredia 30 mg AG, containing powder and 2 YES YES solution for infusion

Schaffhauserstrasse, ampoules with 10 mL of Stein, Switzerland diluent (Water for Injection),

supplied in a box

Belupo, lijekovi i 100 capsules in a brown

kozmetika d.d., Ulica Arficin 150 mg capsules capsules plastic bottle, supplied in a YES YES

Danica 5, Koprivnica, box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica Plastic bottle with 100 Arficin 150 mg capsules capsules YES YES

Danica 5, Koprivnica, capsules, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 16 capsules in a white plastic Arficin 300 mg capsules capsules YES YES

Danica 5, Koprivnica, bottle, supplied in a box

Republic of Croatia

Dr. August Wolff

GmbH & Co. 2 pessaries in an Al/Al strip, Arilin rapid pessaries YES YES

Arzneimittel, Bielefeld, supplied in a box

Germany

AstraZeneca UK

Limited, Silk Road 28 (2x14) tablets in a blister

Arimidex film coated tablets Business Park, YES YES

(PVC/al), supplied in a box Macclesfield, Cheshire,

Great Britain

Glaxo Wellcome Arixtra 2.5 mg/0.5 mL 10 glass syringes with 0.5

solution for s.c. and i.v. Production, Notre solution for injection (premL of solution, supplied in a YES YES YES YES

Injection Dame de Bondeville, filled syringe) box

France

Glaxo Wellcome Arixtra 7.5 mg/0.6 mL 10 pre-filled glass syringes

solution for s.c. and i.v. Production, Notre solution for injection (prewith 0.6 mL of solution, YES YES YES YES

Injection Dame de Bondeville, filled syringe) supplied in a box

France

Lek farmacevtska

družba d.d., 21 (2x10) tablets in a blister

Artein 20 mg tablets tablets Verovškova 57, YES YES

(PVC/Al), supplied in a box Ljubljana, Republic of

Slovenia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (1x10) tablets in a blister, Arvind 100 mg tablets tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (1x10) tablets in a blister, Arvind 200 mg tablets tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (1x10) tablets in a blister, Arvind 25 mg tablets tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (1x10) tablets in a blister, Arvind 50 mg tablets tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Lek farmacevtska

družba d.d., Ljubljana, 100 (10x10) gastro-resistant

Asacol 400 mg gastric Republic of Slovenia in gastric-resistant tablets tablets PVC/Al blisters, YES YES

resistant tablets cooperation with supplied in a box

Tillotts Pharma AG,

Ziefen, Switzerland

Lek farmacevtska

družba d.d., Ljubljana, 50 (5x10) gastro-resistant

Asacol 800 mg gastric Republic of Slovenia in gastric-resistant tablets tablets in a PVC/Al blister, YES YES

resistant tablets cooperation with supplied in a box

Tillotts Pharma AG,

Ziefen, Switzerland

Asentra 100 mg film Krka d.d., Šmarješka 28 (4x7) tablets in a blister, film coated tablets YES YES

coated tablets cesta 6, Novo mesto, supplied in a box

Republic of Slovenia

Krka d.d., Šmarješka Asentra 50 mg film coated 28 (4x7) tablets in a blister,

film coated tablets cesta 6, Novo mesto, YES YES tablets supplied in a box

Republic of Slovenia

Bayer HealthCare AG,

20 (2x10) tablets in a blister,

Aspirin 100 mg tablets tablets 51368 Leverkusen, YES YES YES

supplied in a box

Germany

Bayer HealthCare AG,

20 (2x10) tablets in a blister,

Aspirin 500 mg tablets tablets 51368 Leverkusen, YES YES YES

supplied in a box

Germany

Bayer HealthCare AG,

10 (5x2) tablets in a strip,

Aspirin direct chewing tablets 51368 Leverkusen, YES YES YES

supplied in a box

Germany

Bayer HealthCare AG,

10 (5x2) effervescent tablets

Aspirin plus C effervescent tablets 51368 Leverkusen, YES YES YES

in a strip, supplied in a box

Germany

Bayer HealthCare AG, Aspirin protect 100 mg 30 (3x10) tablets in a blister,

gastric-resistant tablets 51368 Leverkusen, YES YES gastric-resistant tablets supplied in a box

Germany

Bayer HealthCare AG, Aspirin protect 300 mg 30 (3x10) tablets in a blister,

gastric-resistant tablets 51368 Leverkusen, YES YES gastric-resistant tablets supplied in a box

Germany

Farmal d.d., Branitelja

20 (2x10) film coated tablets

domovinskog rata 8,

Astax tablets 10 mg film coated tablets in a (PVC/TE/PVDC/Al) YES YES

Ludbreg, Republic of

blister, supplied in a box

Croatia

Farmal d.d., Branitelja

20 (2x10) film coated tablets

domovinskog rata 8,

Astax tablets 20 mg film coated tablets in a (PVC/TE/PVDC/Al) YES YES

Ludbreg, Republic of

blister, supplied in a box

Croatia

Farmal d.d., Branitelja

20 (2x10) film coated tablets

domovinskog rata 8,

Astax tablets 40 mg film coated tablets in a (PVC/TE/PVDC/Al) YES YES

Ludbreg, Republic of

blister, supplied in a box

Croatia

AstraZeneca AB,

Södertälje, Sweden,

28 (2x14) tablets in a blister

AstraZeneca AB,

Atacand 16 mg tablets tablets (PVC/PVDC//Al), supplied in YES YES YES

Umea, Sweden and

a box

AstraZeneca GmbH,

Plankstadt, Germany

AstraZeneca AB,

Södertälje, Sweden,

28 (2x14) tablets in a blister

AstraZeneca AB,

Atacand 32 mg tablets tablets (PVC/PVDC//Al), supplied in YES YES YES

Umea, Sweden and

a box

AstraZeneca GmbH,

Plankstadt, Germany

AstraZeneca AB,

Södertälje, Sweden,

28 (2x14) tablets in a blister

AstraZeneca AB,

Atacand 4 mg tablets tablets (PVC/PVDC//Al), supplied in YES YES YES

Umea, Sweden and

a box

AstraZeneca GmbH,

Plankstadt, Germany

AstraZeneca AB,

Södertälje, Sweden,

28 (2x14) tablets in a blister

AstraZeneca AB,

Atacand 8 mg tablets tablets (PVC/PVDC//Al), supplied in YES YES YES

Umea, Sweden and

a box

AstraZeneca GmbH,

Plankstadt, Germany

AstraZeneca AB,

Södertälje, Sweden,

28 (2x14) tablets in a blister

AstraZeneca AB,

Atacand Plus tablets (PVC/PVDC//Al), supplied in YES YES YES

Umea, Sweden and

a box

AstraZeneca GmbH,

Plankstadt, Germany Glass bottle with 50 mL of

lyophilisate and diluent Octapharma AB, ATenativ 1000 IU lyophilisate and a bottle with YES

for intravenous solution Stockholm, Sweden 20 mL of solvent

Glass bottle with 100 mL of lyophilisate and diluent Octapharma AB,

ATenativ 1500 IU lyophilisate and a bottle with YES for intravenous solution Stockholm, Sweden

30 mL of solvent

Glass bottle with 50 mL of lyophilisate and diluent Octapharma AB,

ATenativ 500 IU lyophilisate and a bottle with YES for intravenous solution Stockholm, Sweden

10 mL of solvent

Pliva Croatia Ltd., Ulica 14 (1x14) tablets in a blister

grada Vukovara 49, Atenolol Pliva 100 mg tablets (PVC/PVDC/Al), supplied in YES YES

Zagreb, Republic of a box

Croatia

Pliva Croatia Ltd., Ulica 30 (3x10) tablets in a

grada Vukovara 49, Atenolol Pliva 50 mg tablets PVC/PVdC/A1 blister, YES YES

Zagreb, Republic of supplied in a box

Croatia

Fresenius Biotech One glass bottle with 5 mL of concentrate for infusion

ATG-Fresenius GmbH, Am Haag 6-7, concentrate, supplied in a YES solution

Gräfelfing, Germany box

Jadran - Galenski

laboratorij d.d., Pulac 34 (3x10) tablets in a PVC/Al Athyrazol tablets YES YES

bb, Rijeka, Republic of blister, supplied in a box

Croatia

Krka, d.d., Novo

mesto, Republic of 60 (6x10) tablets in an

Atoris tablets 10 mg film coated tablets Slovenia ili Krka-Farma OPA/Al/PVC//Al blister, YES YES

d.o.o., Zagreb, supplied in a box

Republic of Croatia

Krka d.d., Novo Mesto,

Republic of Slovenia; 30 (3x10) tablets in a blister,

Atoris 10 mg tablets film coated tablets Krka Farma d.o.o., YES YES supplied in a box

DPC Jastrebarsko,

Republic of Croatia

Krka d.d., Novo Mesto,

Republic of Slovenia; 30 (3x10) tablets in a blister,

Atoris 20 mg tablets film coated tablets Krka Farma d.o.o., YES YES supplied in a box

DPC Jastrebarsko,

Republic of Croatia

Krka, d.d., Novo

mesto, Republic of 60 (6x10) tablets in an

Atoris tablets 20 mg film coated tablets Slovenia ili Krka-Farma OPA/Al/PVC//Al blister, YES YES

d.o.o., Zagreb, supplied in a box

Republic of Croatia

Krka d.d., Novo mesto,

Republic of Slovenia or 30 (3x10) tablets in a blister

KRKA - FARMA d.o.o., Atoris tablets 40 mg film coated tablets (OPA/Al/PVC-Al), supplied in YES YES

DPC Jastrebarsko, a box

Jastrebarsko, Republic

of Croatia

Pliva Croatia Ltd., Ulica 30 (3x10) film coated tablets

grada Vukovara 49, Atorvox tablets 10 mg film coated tablets in a OPA/Al/PVC//Al blister, YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 30 (3x10) film coated tablets

grada Vukovara 49, Atorvox tablets 20 mg film coated tablets in a OPA/Al/PVC//Al blister, YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 31 (3x10) film coated tablets

grada Vukovara 49, Atorvox tablets 40 mg film coated tablets in a OPA/Al/PVC//Al blister, YES YES

Zagreb, Republic of supplied in a box

Croatia

Belupo, lijekovi i 50 colourless glass

Atropini sulfas 0.5 mg/mL solution for s.c., i.m. and kozmetika d.d., Ulica ampoules each with 1 mL of YES YES

injection i.v. Injection Danica 5, Koprivnica, solution, supplied in a box

Republic of Croatia Belupo, lijekovi i 50 colourless glass

Atropini sulfas 1 mg/mL solution for s.c., i.m. and kozmetika d.d., Ulica ampoules each with 1 mL of YES YES

injection i.v. Injection Danica 5, Koprivnica, solution, supplied in a box

Republic of Croatia

20 mL of solution in an

Instituto de Angeli amber glass bottle with a Atrovent 0.025%

inhalation solution S.r.l., Regello plastic (PE) dropper and a YES YES inhalation solution

(Firenca), Italy plastic (PP) cap, supplied in

a box

Boehringer Ingelheim 200 inhalation doses in a

Pharma GmbH & Co. metal container with metering Atrovent N inhalation

aerosol KG, Binger Strasse valve and plastic YES YES aerosol

173, Ingelheim am mouthpiece, supplied in a

Rhein, Germany box

SmithKline Beecham 5 glass bottles each with a

powder for solution for Pharmaceuticals, Augmentin injection 1.2 g dose of drug, supplied in a YES YES

injection or infusion Crawley, West Sussex, box

Great Britain

SmithKline Beecham One glass vial containing one powder for solution for

Augmentin injection 2.2 g S.A., Heppignies, dose of medicinal product, YES YES injection or infusion

Belgium supplied in a box

Powder for preparation of 70

SmithKline Beecham mL of suspension (by the

Augmentin syrup 457mg/5 powder for preparation of Pharmaceuticals, addition of 64 mL of water) in

YES YES mL oral suspension Crawley, West Sussex, a glass bottle (with

Great Britain aluminium stopper), supplied

in a box

14 (2x7) film coated tablets in SmithKline Beecham

a PVC/PVDC//Al blister Pharmaceuticals,

Augmentin tablets 1 g film coated tablets inserted in a protective YES YES

Crawley, West Sussex, aluminum bags (with

Great Britain desiccant), supplied in a box

Helsinn Birex 6 bags each with 2 g of

Pharmaceuticals Ltd., granules for preparation of

Aulin 100 mg granules granules Damastown, YES YES oral suspension, supplied in

Mulhuddart, Dublin 15, a box

Republic of Ireland

Helsinn Birex

Pharmaceuticals Ltd., 6 (1x6) tablets in a blister

Aulin 100 mg tablets tablets Damastown, (white non-transparent YES YES

Mulhuddart, Dublin 15, PVC/Al), supplied in a box

Republic of Ireland

Krka d.d., Šmarješka 30 film coated tablets in an Auropan film coated

film coated tablets cesta 6, Novo mesto, amber glass bottle, supplied YES YES tablets 3 mg

Republic of Slovenia in a box

F. Hoffmann-La Roche

Ltd., 38 (3x10) tablets in a PVC/Al

Aurorix film coated tablets Grenzacherstrasse YES YES blister, supplied in a box

124, Basel,

Switzerland

GlaxoWellcome S.A.,

Avenida de 56 (4x14) film coated tablets Avandamet 2 mg/1000 mg

film coated tablets Extremadura 3, 9400 in a PVC/PVDC//Al blister, YES YES YES YES tablets

Aranda de Duero, supplied in a carton box

Burgos, Spain

GlaxoWellcome S.A.,

Avenida de 56 (4x14) film coated tablets Avandamet 4 mg/1000 mg

film coated tablets Extremadura 3, 9400 in a PVC/PVDC//Al blister, YES YES YES YES tablets

Aranda de Duero, supplied in a carton box

Burgos, Spain

Glaxo Wellcome 56 (4x14) tablets in a blister,

Avandia 2 mg film-tablets film coated tablets Production, Mayenne, YES YES YES YES supplied in a box

France

Glaxo Wellcome 28 (2x14) tablets in a blister,

Avandia 4 mg film-tablets film coated tablets Production, Mayenne, YES YES YES YES supplied in a box

France Glaxo Wellcome 28 (2x14) tablets in a blister,

Avandia 8 mg film-tablets film coated tablets Production, Mayenne, YES YES YES YES supplied in a box

France

F. Hoffmann-La Roche

Avastin 25 mg/mL Ltd., 16 mL of infusion solution concentrate of solution

concentrate for infusion Grenzacherstrasse concentrate in a glass bottle, YES YES YES YES for infusion

solution 124, Basel, supplied in a box

Switzerland

F. Hoffmann-La Roche

4 mL of concentrate for

Avastin 25 mg/mL Ltd.,

concentrate for infusion solution for infusion in a

concentrate for infusion Grenzacherstrasse YES YES YES YES

solution glass bottle, supplied in a

solution 124, Basel,

box

Switzerland

Bayer HealthCare AG, 5 (1x5) film coated tablets in Avelox 400 mg film coated

film coated tablets 51368 Leverkusen, a blister (PP/Al), supplied in YES YES YES tablets

Germany a box

Bayer HealthCare AG, One glass bottle with 250 mL Avelox 400 mg/250 mL

solution for infusion 51368 Leverkusen, of infusion solution, supplied YES YES solution for infusion

Germany in a box

RP Scherer S.A., 30 (3x10) capsules in a AVODART 0.5 mg soft

soft capsules Beinheim, France (for blister (PVC/PVdC/Al), YES YES YES capsules

GlaxoSmithKline) supplied in a box

Box with 4 bottles with BIO BIOGEN Idec BV,

AVONEX 30 µg powder powder and diluent for SET reconstitution kit, 4

2132 WX Hoofddorp, YES YES YES and diluent for injection solution for injection syringes with solvent and 4

the Netherlands

needles (BIO SET kit)

Teva Pharmaceuticals

7 (1x7) tablets in a blister

Azilect 1 mg tablets tablets Europe B.V., the YES YES YES YES

(Al/Al), supplied in a box

Netherlands

30 tablets in a plastic (HDPE) Teva Pharmaceuticals

bottle (desiccant in a plastic

Azilect 1 mg tablets tablets Europe B.V., the YES YES YES YES

PP stopper), supplied in a Netherlands

box

Pliva Croatia Ltd., Ulica

6 (1x6) capsules in a

grada Vukovara 49,

AZIMED capsules 250 mg capsules PVC/PVDC//Al blister, YES YES

Zagreb, Republic of

supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 3 (1x3) tablets in a PVC/Al AZIMED tablets 500 mg film coated tablets YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Sandoz S.R.L., TG. 6 (1x6) film coated tablets in Azitromicin Lek 250 mg

film coated tablets Mures, Mures District, a blister (PVC/PVDC//Al), YES YES

film coated tablets

Rumunjska supplied in a box

Sandoz S.R.L., TG. 3 (1x3) film-coated tablets in Azitromicin Lek 500 mg

film coated tablets Mures, Mures District, a blister (PVC/PVDC//Al), YES YES

film coated tablets

Rumunjska supplied in a box

Alcon-Couvreur s.a., Box with 5 mL of suspension

Azopt eye drops eye drops Rijksweg 14, Puurs, in a plastic bottle with a YES YES

Belgium dropper

Polpharma S.A., 50 tablets in a polypropylene Baclofen 10 mg tablets YES YES

Poland bottle, supplied in a box

Polpharma S.A., 50 tablets in a polypropylene Baclofen 25 mg tablets YES YES

Poland bottle, supplied in a box

4 unit packs (“Stay Safe

Fresenius Medical Balance system”) each with

Balance 1.5 % glucose, solution for peritoneal Care Deutschland 2000 mL of solution for

YES YES YES 1.25 mmol/l calcium dialysis GmbH, St. Wendel, peritoneal dialysis in a

Germany protective plastic bag,

supplied in a carton box

4 unit packs (“Stay Safe

Fresenius Medical Balance system”) each with

Balance 1.5 % glucose, solution for peritoneal Care Deutschland 2500 mL of solution for

YES YES YES 1.25 mmol/l calcium dialysis GmbH, St. Wendel, peritoneal dialysis in a

Germany protective plastic bag,

supplied in a carton box

4 unit packs (“Stay Safe

Fresenius Medical Balance system”) each with

Balance 1.5% glucose, solution for peritoneal Care Deutschland 2500 mL of solution for

YES YES YES 1.75 mmol/l calcium dialysis GmbH, St. Wendel, peritoneal dialysis in a

Germany protective plastic bag,

supplied in a carton box

4 unit packs (“Stay Safe

Fresenius Medical Balance system”) each with

Balance 1.5% glucose, solution for peritoneal Care Deutschland 2000 mL of solution for

YES YES YES 1.75 mmol/l calcium dialysis GmbH, St. Wendel, peritoneal dialysis in a

Germany protective plastic bag,

supplied in a carton box

4 unit packs (“Stay Safe

Fresenius Medical Balance system”) each with

Balance 2.3 % glucose, solution for peritoneal Care Deutschland 2500 mL of solution for

YES YES YES 1.25 mmol/l calcium dialysis GmbH, St. Wendel, peritoneal dialysis in a

Germany protective plastic bag,

supplied in a carton box

4 unit packs (“Stay Safe

Fresenius Medical Balance system”) each with

Balance 2.3 % glucose, solution for peritoneal Care Deutschland 2000 mL of solution for

YES YES YES 1.25 mmol/l calcium dialysis GmbH, St. Wendel, peritoneal dialysis in a

Germany protective plastic bag,

supplied in a carton box

4 unit packs (“Stay Safe

Fresenius Medical Balance system”) each with

Balance 2.3% glucose, solution for peritoneal Care Deutschland 2500 mL of solution for

YES YES YES 1.75 mmol/l calcium dialysis GmbH, St. Wendel, peritoneal dialysis in a

Germany protective plastic bag,

supplied in a carton box

4 unit packs (“Stay Safe

Fresenius Medical Balance system”) each with

Balance 2.3% glucose, solution for peritoneal Care Deutschland 2000 mL of solution for

YES YES YES 1.75 mmol/l calcium dialysis GmbH, St. Wendel, peritoneal dialysis in a

Germany protective plastic bag,

supplied in a carton box

4 unit packs (“Stay Safe

Fresenius Medical Balance system”) each with

Balance 4.25 % glucose, solution for peritoneal Care Deutschland 2500 mL of solution for

YES YES YES 1.25 mmol/l calcium dialysis GmbH, St. Wendel, peritoneal dialysis in a

Germany protective plastic bag,

supplied in a carton box

4 unit packs (“Stay Safe

Fresenius Medical Balance system”) each with

Balance 4.25 % glucose, solution for peritoneal Care Deutschland 2000 mL of solution for

YES YES YES 1.25 mmol/l calcium dialysis GmbH, St. Wendel, peritoneal dialysis in a

Germany protective plastic bag,

supplied in a carton box

4 unit packs (“Stay Safe

Fresenius Medical Balance system”) each with

Balance 4.25% glucose, solution for peritoneal Care Deutschland 2500 mL of solution for

YES YES YES 1.75 mmol/l calcium dialysis GmbH, St. Wendel, peritoneal dialysis in a

Germany protective plastic bag,

supplied in a carton box

4 unit packs (“Stay Safe

Fresenius Medical Balance system”) each with

Balance 4.25% glucose, solution for peritoneal Care Deutschland 2000 mL of solution for

YES YES YES 1.75 mmol/l calcium dialysis GmbH, St. Wendel, peritoneal dialysis in a

Germany protective plastic bag,

supplied in a carton box

Aventis Pharma

Deutschland GmbH, 20 (2x10) tablets in a blister,

Baralgin M film tablets Brunningstrasse 50, YES YES supplied in a box

Frankfurt am Main,

Germany

Bazetham capsules 0.4 modified release Pliva Croatia Ltd., Ulica 30 (3x10) capsules in an

YES YES mg capsules, hard grada Vukovara 49, orange blister

Zagreb, Republic of (PVC/PE/PVDC/Al), supplied

Croatia in a box

Box with 10 glass bottles

BCG VACCINE SSI, Statens Serum Institut, each with 10 doses of lyophilisate and solvent

vaccine against Artillerivej, lyophilised vaccine (0.75 mg) for preparation of YES

tuberculosis - BCG SSI, Copenhagen S, and a box with 10 glass suspension for injection

0.75 mg Denmark bottles each with 1 mL of

solvent Sauton SSI

Box with 10 glass bottles

Statens Serum Institut, each containing 20 doses of BCG VACCINE SSI, lyophilisate and solvent

Artillerivej, lyophilised vaccine (1.5 mg) tuberculosis vaccine - for preparation of YES

Copenhagen S, and a box with 10 glass BCG SSI, 1.5 mg suspension for injection

Denmark bottles each containing 2 mL

of solvent Sauton SSI

Krka d.d., Šmarješka 70 g of granules in a

B-COMPLEX granules granules cesta 6, Novo mesto, YES YES YES (PEPT/Al/PE) bag

Republic of Slovenia

Krka d.d., Šmarješka B-COMPLEX coated 31 (2x15) capsules in a PVC-

coated tablets cesta 6, Novo mesto, YES YES YES tablets Al blister, supplied in a box

Republic of Slovenia

Roha Arzneimittel 80 g of tea in a round carton

Bekunis herbal tea herbal tea GmbH, Bremen, box closed with aluminium YES YES

Germany foil and a plastic lid

Roha Arzneimittel 45 coated tablets in a plastic

Bekunis coated tablets coated tablets GmbH, Bremen, tube with a plastic stopper, YES YES

Germany supplied in a box

21 (1x21) tablets in a blister Grünenthal GmbH,

Belara film coated tablets (PVC/PVDC//Al), supplied in YES YES YES

Stolberg, Germany a box

Pliva Croatia Ltd., Ulica 63 (3x21) tablets in a

grada Vukovara 49, transparent blister (PVC/Al) Bellune 35 coated tablets YES YES

Zagreb, Republic of calendar dial pack, supplied

Croatia in a box

Belupo, lijekovi i

kozmetika d.d., Ulica 15 g of cream in a tube, Beloderm cream cream YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 15 g of cream in a tube, Beloderm ointment ointment YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica Belodin tablets Box with 7 tablets (blister) YES YES

Danica 5, Koprivnica,

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica Belodin 10mg tablets tablets Box with 10 tablets (blister) YES YES

Danica 5, Koprivnica,

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 15 g of cream in a tube, Belogent cream cream YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 15 g of cream in a tube, Belogent ointment ointment YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 10 (1x10) tablets in a blister, Belomet 200 mg tablets film coated tablets YES YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i 10 (2x5) ampoules each solution for injection for

Belomet 200 mg/2 mL kozmetika d.d., Ulica containing 2 mL of solution intramuscular and YES YES

injection Danica 5, Koprivnica, for injection, supplied in a intravenous use

Republic of Croatia box Belupo, lijekovi i

kozmetika d.d., Ulica 50 mL of lotion in a plastic Belosalic lotion lotion YES YES

Danica 5, Koprivnica, bottle, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 g of ointment in a tube, Belosalic ointment ointment YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

200 mL of solution in an Belupo, lijekovi i

amber glass bottle with kozmetika d.d., Ulica

Belosept solution oromucosal solution aluminum cap and a 10 mL YES YES YES Danica 5, Koprivnica,

graduated plastic cup, Republic of Croatia

supplied in a box

Krka d.d., Šmarješka 10-mL of solution in a glass

Benil 0.5 ‰ nasal drops nasal drops cesta 6, Novo mesto, bottle with plastic dropper YES YES YES

Republic of Slovenia attachment, supplied in a box

Krka d.d., Šmarješka 10-mL of solution in a glass

Benil nasal drops 1.0 ‰ nasal drops cesta 6, Novo mesto, bottle with plastic dropper YES YES YES

Republic of Slovenia attachment, supplied in a box

Jadran - Galenski

150 mL of emulsion in an

laboratorij d.d., Pulac

Benzyl benzoate, Jadran skin emulsion amber glass bottle with a YES YES

bb, Rijeka, Republic of

plastic cap, supplied in a box

Croatia

Bottle with a lyophilized drug

Aventis Boehring and a bottle with water for

lyophilized preparation GmbH, Emil-voninjection in a carton box also Beriate P 500 YES

and diluent Behring Strasse 76, containing a leaflet,

Marburg, Germany dissolution kit, and a filter

needle

Alkaloid AD-Skopje,

Skopje, FYROM in 100 mL of solution in a

Betadine 1 % solution gargling solution cooperation with brown plastic bottle, supplied YES YES YES

Mundipharma AG, in a box

Basel, Switzerland

Alkaloid AD-Skopje,

Skopje, FYROM in 20 grams of cream in an

Betadine 10 % ointment ointment cooperation with aluminum tube, supplied in a YES YES

Mundipharma AG, box

Basel, Switzerland

Alkaloid AD-Skopje,

Skopje, FYROM in 100 mL of solution in a

Betadine 10 % solution solution cooperation with brown plastic bottle, supplied YES YES YES

Mundipharma AG, in a box

Basel, Switzerland

Alkaloid AD-Skopje,

Skopje, FYROM in 14 (2x7) pessaries in a Betadine 200 mg

pessaries cooperation with PVC/PE foil, supplied in a YES YES pessaries

Mundipharma AG, box

Basel, Switzerland

Alkaloid AD-Skopje,

Skopje, FYROM in solution for cleansing and 1000 mL of solution in a Betadine 7.5 % solution cooperation with YES YES YES

disinfection of skin white polyethylene bottle Mundipharma AG,

Basel, Switzerland

Boehringer Ingelheim

Pharma KG, Biberach

an der Riss, Germany lyophilisate and diluent 15 3-mL bottles with

and Chiron Betaferon for prepartion of solution lyophilisate and 15 3-mL YES YES YES

Corporation, for injection bottles with 2 mL of diluent

Emeryville, US for

Schering AG, Berlin,

Germany

Boehringer Ingelheim

15 lyophilisate bottles and 15

lyophilisate and diluent Pharma KG, Biberach,

syringes with 1.2 mL of

Betaferon injection for preparation of solution Germany and Chiron YES YES YES

diluent (0.54% sodium

for injection Corporation,

chloride solution)

Emeryville, US for

Schering AG, Berlin,

Germany

Pliva Croatia Ltd., Ulica 32 (3x10) tablets in a

grada Vukovara 49, Betaglid 1 mg tablets tablets PVC/PVdC/Al blister, YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 33 (3x10) tablets in a

grada Vukovara 49, Betaglid 2 mg tablets tablets PVC/PVdC/Al blister, YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 34 (3x10) tablets in a

grada Vukovara 49, Betaglid 3 mg tablets tablets PVC/PVdC/Al blister, YES YES

Zagreb, Republic of supplied in a box

Croatia

Krka d.d., Šmarješka 10 (5x2) tablets in a

Betaklav duo tablets tablets cesta 6, Novo mesto, AL/PE//AL strip, supplied in a YES YES

Republic of Slovenia box

100-mL glass bottle Krka d.d., Šmarješka

Betaklav powder for powder for solution for containing 2.2 g of powder cesta 6, Novo mesto, YES YES

solution for infusion 2.2 infusion for solution for infusion,

Republic of Slovenia supplied in a box

20-mL glass bottle containing Krka d.d., Šmarješka

Betaklav powder for powder for solution for 1.2 g of powder for solution cesta 6, Novo mesto, YES YES

solution for injection 1.2 injection for injection, supplied in a

Republic of Slovenia box

Solvay

Pharmaceuticals B.V.,

Weesp, the 60 (3x20) tablets in a

Netherlands i Solvay Betaserc 16 mg tablets PVC/PVDC/Al blister, YES YES

Pharmaceuticals, Lieu supplied in a box

dit Maillard, Chatillon

sur Chalaronne,

France

Solvay

Pharmaceuticals B.V.,

Weesp, the 20 (1x20) tablets in a

Netherlands i Solvay Betaserc 24 mg tablets PVC/PVDC blister, supplied YES YES

Pharmaceuticals, Lieu in a box

dit Maillard, Chatillon

sur Chalaronne,

France

Solvay

Pharmaceuticals B.V.,

Weesp, the 100 (4x25) tablets in a

Netherlands i Solvay Betaserc 8 mg tablets PVC/PVDC/Al blister, YES YES

Pharmaceuticals, Lieu supplied in a box

dit Maillard, Chatillon

sur Chalaronne,

France

Jadran - Galenski 25 grams of cream in an

laboratorij d.d., Pulac Betazon cream cream aluminium tube, supplied in a YES YES

bb, Rijeka, Republic of box

Croatia

Jadran - Galenski 25 grams of cream in an

laboratorij d.d., Pulac Betazon ointment ointment aluminium tube, supplied in a YES YES

bb, Rijeka, Republic of box

Croatia

Alcon-Couvreur s.a., 5 mL of solution in a plastic

Betoptic 0.5 % eye drops eye drops Rijksweg 14, Puurs, YES YES bottle, supplied in a box

Belgium

Pliva Croatia Ltd., Ulica

grada Vukovara 49, Betrion ointment Aluminium tube YES YES

Zagreb, Republic of

Croatia

powder and diluent for Bristol Myers-Squibb Vial with powder and vial with

BiCNU injection 100 mg preparation of solution for S.r.I., Sermoneta, 3 mL of diluent, supplied in a YES YES

infusion Latina, Italy box Krka d.d., Šmarješka 20 (2x10) capsules in a

Bilobil forte capsules 80 capsules cesta 6, Novo mesto, blister (PVC-Al), supplied in a YES YES

Republic of Slovenia box

Krka d.d., Šmarješka 20 (2x10) capsules in a

Bilobil capsules capsules cesta 6, Novo mesto, YES YES blister, supplied in a box

Republic of Slovenia

Belupo, lijekovi i

30 (1x30) tablets in a blister

kozmetika d.d., Ulica

Bisobel 10 mg tablets tablets (PVC/PVDC-Al), supplied in YES YES

Danica 5, Koprivnica,

a box

Republic of Croatia

Belupo, lijekovi i

30 (1x30) tablets in a blister

kozmetika d.d., Ulica

Bisobel 5 mg tablets tablets (PVC/PVDC-Al), supplied in YES YES

Danica 5, Koprivnica,

a box

Republic of Croatia

Pliva Croatia Ltd., Ulica 20 (2x10) tablets in an

grada Vukovara 49, Bisolex F tablets tablets orange blister (PVC/Al), YES YES YES

Zagreb, Republic of supplied in a box

Croatia

30 mL of solution in an Pliva Croatia Ltd., Ulica

amber glass bottle with a grada Vukovara 49,

Bisolex solution oral drops, solution dropper and a plastic 6 mL YES YES YES Zagreb, Republic of

measuring cup, supplied in a Croatia

box

200 mL of solution in an Pliva Croatia Ltd., Ulica

amber glass bottle with an grada Vukovara 49,

Bisolex syrup syrup aluminum cap and a 5 mL YES YES YES Zagreb, Republic of

plastic measuring spoon, Croatia

supplied in a box

Pliva Croatia Ltd., Ulica 20 (2x10) tablets in an

grada Vukovara 49, Bisolex tablets tablets orange blister (PVC/Al), YES YES YES

Zagreb, Republic of supplied in a box

Croatia

40 mL of solution in an

amber glass bottle with a oral and inhalation Instituto de Angeli,

Bisolvon 2 mg/mL solution plastic dropper and a YES YES YES solution Regello (FI), Italy

measuring graduated (1-6

mL) cup, supplied in a box

250-mL of syrup in an amber

glass bottle, a plastic Boehringer Ingelheim

dispenser glass with 2.5 and France, 12, Rue Andre

Bisolvon syrup 4 mg/5 mL syrup 5 mL printed graduation lines YES YES YES Huet, Reims, Cedex,

or plastic dispenser spoon France

with 2.5 an 5 mL graduation

marks, supplied in a box

Boehringer Ingelheim

20 (2x10) tablets in a white

France, 12, Rue Andre

Bisolvon 8 mg tablets tablets blister (PVC/PVDC//Al), YES YES YES

Huet, Reims, Cedex,

supplied in a box

France

Merck KGaA,

30 (3x10) tablets in a PVC/Al

Bisopromerck 10 film coated tablets Frankfurter Straße 250, YES YES

blister, supplied in a box

Darmstadt, Germany

Merck KGaA,

30 (3x10) tablets in a PVC/Al

Bisopromerck 5 film coated tablets Frankfurter Straße 250, YES YES

blister, supplied in a box

Darmstadt, Germany

One amber glass bottle with Lek farmacevtska

powder, one glass bottle with družba d.d.,

Bivacyn eye and nasal 10 mL of diluent, and a eye and nasal drops Verovškova 57, YES YES

drops plastic dropper attachment

Ljubljana, Republic of

(in a protective package),

Slovenia

supplied in a box

Lek farmacevtska

družba d.d., 30 g of ointment in an

Bivacyn ointment ointment Verovškova 57, aluminium tube, supplied in a YES YES

Ljubljana, Republic of box

Slovenia Lek farmacevtska

družba d.d., 3.5 g of ointment in an

Bivacyn eye ointment eye ointment Verovškova 57, aluminum tube, supplied in a YES YES

Ljubljana, Republic of box

Slovenia

Lek farmacevtska

družba d.d., 5 g of powder in a plastic

Bivacyn dermal powder dermal powder Verovškova 57, YES YES bottle, supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska 150 mL of spray (in a

družba d.d., Bivacyn dermatological dermatological spray, Powder form) in an aluminum

Verovškova 57, YES YES spray, powder powder container with nebulizer,

Ljubljana, Republic of

supplied in a box

Slovenia

Euro Nippon Kayaku 10-mL clear glass bottle powder for solution for

BLEOCIN - S GmbH, Frankfurt am containing powder, supplied YES YES injection

Main, Germany in a box

Krka d.d., Šmarješka 30 (3x10) tablets in a blister,

Bloxan 100 mg tablets tablets cesta 6, Novo mesto, YES YES supplied in a box

Republic of Slovenia

Roche Diagnostics Bondronat 2 mg One glass vial with 2-mL of

concentrate for infusion GmbH, Sandhofeer concentrate for solution for concentrate, supplied in a YES YES YES YES

solution Strasse 116, D-68305 infusion box

Mannheim, Germany

F. Hoffmann-La Roche

Ltd., Bondronat 50 mg film 28 (4x7) tablets in a blister

film coated tablets Grenzacherstrasse YES YES YES YES coated tablets (A1/Al), supplied in a box

124, Basel,

Switzerland

Roche Diagnostics Bondronat 6 mg One glass vial with 6 mL of

concentrate for solution GmbH, Sandhofeer concentrate for solution for concentrate, supplied in a YES YES YES YES

for infusion Strasse 116, D-68305 infusion box

Mannheim, Germany

100 capsules in a plastic Schering Oy, Turku,

Bonefos 400 mg capsules capsules (HDPE) bottle, supplied in a YES YES

Finland box

Bonefos 60 mg/mL 5 glass ampoules with 5 mL concentrate of solution Schering Oy, Turku,

concentrate of solution for of solution concentrate, YES YES for infusion Finland

infusion supplied in a box

Bonefos 60 mg/mL 5 glass ampoules with 5 mL concentrate of solution Schering Oy, Turku,

concentrate of solution for of solution concentrate, YES YES for infusion Finland

infusion supplied in a box

Schering Oy, Turku, 60 tablets in a PVC/Al blister, Bonefos 800 mg tablets film coated tablets YES YES

Finland supplied in a box

Belupo, lijekovi i 4 (1x4) tablets in a blister

kozmetika d.d., Ulica Bonna 35 mg tablets film coated tablets (PVC/PE/PVDC//AI), YES YES

Danica 5, Koprivnica,

supplied in a box

Republic of Croatia

Belupo, lijekovi i 28 (1x28) tablets in a

kozmetika d.d., Ulica Bonna 5 mg tablets film coated tablets PVC/PE/PVDC//AI blister, YES YES

Danica 5, Koprivnica,

supplied in a box

Republic of Croatia

F. Hoffmann-La Roche

Ltd., One film coated tablet in a Bonviva 150 mg film

film coated tablets Grenzacherstrasse blister (Al/Al), supplied in a YES YES YES YES coated tablets

124, Basel, box

Switzerland

Roche Diagnostics Bonviva 3 mg solution for Pre-filled syringe containing

solution for injection (in GmbH, Sandhofeer injection in a pre-filled 3 mL of solution, supplied in YES YES YES YES

pre-filled syringe) Strasse 116, D-68305 syringe a box

Mannheim, Germany

Allergan lyophilisate for Glass bottle of 10 mL

Pharmaceuticals Botox preparation of injection containing 1.4 mg of YES YES

Republic of Ireland, for intramuscular use lyophilisate, supplied in a box

Castlebar Road, Westport, Co Mayo,

Republic of Ireland

Krka d.d., Novo Mesto,

Republic of Slovenia in

50 (5x10) tablets in a blister,

Brinerdin coated tablets coated tablets cooperation with YES YES

supplied in a box

Novartis Pharma Ltd.,

Switzerland

Berlin-Chemie AG 7 tablets in a blister

(Menarini Group), Brivuzost tablets (PVC/Al), supplied in a YES YES YES

Glienicker Weg 125, carton box

Berlin, Germany

Lek farmacevtska

družba d.d.,

30 tablets in an amber glass

Bromergon 2.5 mg tablets tablets Verovškova 57, YES YES

bottle, supplied in a box

Ljubljana, Republic of

Slovenia

Abbott GmbH & Co. 30 (3x10) tablets in a PVC/Al Brufen 400 film coated

film coated tablets KG, Ludwigshafen, or PVC/PVDC/Al blister, YES YES tablets

Germany supplied in a box

Abbott GmbH & Co. 30 (3x10) tablets in a PVC/Al Brufen 600 film coated

film coated tablets KG, Ludwigshafen, or PVC/PVDC/Al blister, YES YES tablets

Germany supplied in a box

60 mL of shampoo in an

AD JAKA 80 Radoviš, amber glass bottle with an Bubil shampoo shampoo YES YES

Radoviš, FYROM aluminium stopper, supplied

in a box

Pliva Croatia Ltd., Ulica

grada Vukovara 49, Box with 20 (2x10) sugar Buscol dragee sugar-coated tablets YES YES

Zagreb, Republic of coated tablets in a blister

Croatia

Boehringer Ingelheim

Buscopan 10 mg coated France, 12, Rue Andre 20 (1x20) tablets in PVC/Al coated tablets YES YES YES

tablets Huet, Reims, Cedex, blister, supplied in a box

France

Lek farmacevtska

50 (5x10) tablets in a blister

družba d.d.,

Byol 10 mg film coated (PVC/PE/PVDC/Al), in an

film coated tablets Verovškova 57, YES YES

tablets aluminium bag, supplied in a

Ljubljana, Republic of

carton box

Slovenia

Lek farmacevtska

družba d.d., 30 (3X10) tablets in a blister, Byol 10 mg film coated

film coated tablets Verovškova 57, in an aluminium bag, YES YES tablets

Ljubljana, Republic of supplied in a box

Slovenia

Lek farmacevtska

50 (5x10) tablets in a blister

družba d.d.,

Byol 5 mg film coated (PVC/PE/PVDC/Al), in an

film coated tablets Verovškova 57, YES YES

tablets aluminium bag, supplied in a

Ljubljana, Republic of

carton box

Slovenia

Lek farmacevtska

družba d.d., 30 (3X10) tablets in a blister, Byol 5 mg film coated

film coated tablets Verovškova 57, in an aluminium bag, YES YES tablets

Ljubljana, Republic of supplied in a box

Slovenia

Krka d.d., Novo Mesto,

Republic of Slovenia 10 effervescent tablets in an

Ca-C 500 Sandoz effervescent tablets for Novartis Consumer Al-foil in a vial, supplied in a YES YES YES

Health S.A., Nyon, box

Switzerland

Pfizer GmbH

30 (3x10) film coated tablets

Arzneimittelwerk

Caduet 10 mg/10 mg in a blister

film coated tablets Gödecke, YES YES YES YES

tablets (polyamide/aluminum/PVC),

Mooswaldalle 1,

supplied in a carton box

Freiburg, Germany

Pfizer GmbH 31 (3x10) film coated tablets Caduet 5 mg/10 mg tablets film coated tablets YES YES YES YES

Arzneimittelwerk in a blister Gödecke, (polyamide/aluminum/PVC),

Mooswaldalle 1, supplied in a carton box

Freiburg, Germany

Alkaloid AD - Skopje, 10 (1x10) tablets in a

Bulevar Aleksandar Caffetin Cold film coated tablets PVC/TE/PVdc-Al blister, YES YES YES

Makedonski 12, supplied in a box

Skopje, FYROM

Alkaloid AD - Skopje,

Bulevar Aleksandar 12 (2x6) tablets in Al/PE Caffetin tablets tablets YES YES YES

Makedonski 12, strip, supplied in a box

Skopje, FYROM

1.8 g of herbal tea in a filter Droga Kolinska d.d.,

bag wrapped in paper "Droga" herbal laxative herbal laxative tea Ljubljana, Republic of YES YES

envelope, 20 filter bags in a Slovenia

box

Novartis Pharma Stein solution for injection for 10 mL of solution in a glass Calcium Sandoz 10 % AG,

intramuscular and ampoule, 5 ampoules in a YES YES injection Schaffhauserstrasse,

intravenous use carton box Stein, Switzerland

Krka d.d., Šmarješka 10 effervescent tablets Calciumvita C effervescent

effervescent tablets cesta 6, Novo mesto, wrapped in an Al-foil in a vial, YES YES YES tablets

Republic of Slovenia supplied in a box

GlaxoSmithKline

Pharmaceuticals S.A., 10 g of gel in aluminum tube, Calgel gum gel gum gel YES YES YES

Ul. Grunwaldzka 189, supplied in a box

Poznan, Poland

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (3x10) tablets in a blister, Calixta 15 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (3x10) tablets in a blister, Calixta 30 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (3x10) tablets in a blister, Calixta 45 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Aventis Pharma concentrate for Amber glass bottle

Dagenham, CAMPTO 100 mg/5 mL preparation of solution for containing 5 mL of solution, YES YES

Dagenham, Essex, infusion supplied in a box

Great Britain

Aventis Pharma concentrate for Amber glass bottle

Dagenham, CAMPTO 40 mg/2 mL preparation of solution for containing 2 mL of solution, YES YES

Dagenham, Essex, infusion supplied in a box

Great Britain

Merck Sharp & Dohme CANCIDAS 50 mg powder

powder for concentrate B.V., Waarderweg 39, 10-mL glass bottle with for concentrate for infusion YES YES YES

for infusion solution Postbus 581, Haarlem, powder, supplied in a box solution

The Nederlands

Merck Sharp & Dohme CANCIDAS 70 mg powder

powder for concentrate B.V., Waarderweg 39, 10-mL glass bottle with for concentrate for infusion YES YES YES

for infusion solution Postbus 581, Haarlem, powder supplied ina box solution

the Netherlands

One vaginal tablet in a Bayer HealthCare AG,

Canesten 1 vaginal tablet PA/Al/PVC/Al blister pack vaginal tablets 51368 Leverkusen, YES YES

0.5 g and one applicator, supplied

Germany in a box

One vaginal tablet in a

Bayer HealthCare AG, PA/Al/PVC/Al blister pack, 20 Canesten 1 vaginal tablet

vaginal tablets and cream 51368 Leverkusen, g of cream in an aluminum YES YES 0.5 g/Canesten cream

Germany tube and applicator, supplied

in a box

Bayer HealthCare AG,

20 grams of cream and 3

Canesten 3 vaginal cream vaginal cream 51368 Leverkusen, YES YES

applicators, supplied in a box

Germany

3 (1x3) vaginal tablets in a

Bayer HealthCare AG,

Canesten 3 vaginal tablets blister (PA/Al/PVC/Al) and

vaginal tablets 51368 Leverkusen, YES YES

0.2 g one applicator, supplied in a

Germany

box

3 vaginal tablets in a blister Bayer HealthCare AG,

Canesten 3 vaginal tablets (PA/Al/PVC/Al), 20 g cream vaginal tablet and cream 51368 Leverkusen, YES YES

0.2 g / Canesten cream in aluminum tube and an

Germany applicator, supplied in a box

Bayer HealthCare AG, 20 grams of cream in an

Canesten cream cream 51368 Leverkusen, aluminum tube, supplied in a YES YES

Germany box

Bayer HealthCare AG, 20 mL of solution in a plastic

Canesten solution solution (for external use) 51368 Leverkusen, bottle with dropper YES YES

Germany attachment, supplied in a box

Bayer HealthCare AG,

30 g of powder in a plastic

Canesten dermal powder dermal powder 51368 Leverkusen, YES YES

bottle, supplied in a box

Germany

Bayer HealthCare AG, 30 mL of solution in a plastic Canesten dermatological dermatological spray,

51368 Leverkusen, bottle with a spray YES YES spray, solution solution

Germany attachment, supplied in a box

Dr. August Wolff 30 mL of solution in an

GmbH & Co. amber glass bottle with a Canifug 1% solution dermal solution YES YES

Arzneimittel, Bielefeld, spray applicator supplied in a

Germany box

One plastic bag with 5000

mL of solution, a feeding

tube, a connector (with

Fresenius Medical protective cap) to the dialysis

CAPD/DPCA 17 sleep solution for peritoneal Care Deutschland machine ("sleep safe

YES YES safe dialysis GmbH, St. Wendel, cycler") and drug

Germany 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 connector with Fresenius Medical

housing and solution drain solution for peritoneal Care Deutschland

CAPD/DPCA 17 stay safe regulator, a catheter YES YES dialysis GmbH, St. Wendel,

connector (with protective Germany

cap), a collecting bag with

drain tube and attachments

("Injection Unit")

4 plastic bags with 2000 mL Fresenius Medical

of solution and an empty solution for peritoneal Care Deutschland

CAPD/DPCA 17 stay safe collection bag, inserted in a YES YES YES dialysis GmbH, St. Wendel,

protective plastic bag, Germany

supplied in a box

One plastic bag with 2000

mL of solution, an feeding

tube, a disc connector with Fresenius Medical

housing and solution drain solution for peritoneal Care Deutschland

CAPD/DPCA 17 stay safe regulator, a catheter YES YES dialysis GmbH, St. Wendel,

connector (with protective Germany

cap), a collecting bag with

drain tube and attachments

("Injection Unit")

4 plastic bags with 2500 mL Fresenius Medical

of solution and an empty solution for peritoneal Care Deutschland

CAPD/DPCA 17 stay safe collection bag, inserted in a YES YES YES dialysis GmbH, St. Wendel,

protective plastic bag, Germany

supplied in a box

One plastic bag with 5000 Fresenius Medical

mL of solution, a feeding

CAPD/DPCA 18 sleep solution for peritoneal Care Deutschland tube, a connector (with YES YES

safe dialysis GmbH, St. Wendel, protective cap) to the dialysis

Germany

machine ("sleep safe

cycler") and 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 connector with Fresenius Medical

housing and solution drain solution for peritoneal Care Deutschland

CAPD/DPCA 18 stay safe regulator, a catheter YES YES dialysis GmbH, St. Wendel,

connector (with protective Germany

cap), a collecting bag with

drain tube and attachments

("Injection Unit")

One plastic bag with 2000

mL of solution, an feeding

tube, a disc connector with Fresenius Medical

housing and solution drain solution for peritoneal Care Deutschland

CAPD/DPCA 18 stay safe regulator, a catheter YES YES dialysis GmbH, St. Wendel,

connector (with protective Germany

cap), a collecting bag with

drain tube and attachments

("Injection Unit")

4 plastic bags with 2500 mL Fresenius Medical

of solution and an empty solution for peritoneal Care Deutschland

CAPD/DPCA 18 stay safe collection bag, inserted in a YES YES YES dialysis GmbH, St. Wendel,

protective plastic bag, Germany

supplied in a box

4 plastic bags with 2000 mL Fresenius Medical

of solution and an empty solution for peritoneal Care Deutschland

CAPD/DPCA 18 stay safe collection bag, inserted in a YES YES YES dialysis GmbH, St. Wendel,

protective plastic bag, Germany

supplied in a box

One plastic bag with 5000

mL of solution, a feeding

tube, a connector (with

Fresenius Medical protective cap) to the dialysis

CAPD/DPCA 19 sleep solution for peritoneal Care Deutschland machine ("sleep safe

YES YES safe dialysis GmbH, St. Wendel, cycler") and drug

Germany administration attachment,

two plastic bags with 5000

mL of solution, supplied in a

box

4 plastic bags with 2000 mL Fresenius Medical

of solution and an empty solution for peritoneal Care Deutschland

CAPD/DPCA 19 stay safe collection bag, inserted in a YES YES YES dialysis GmbH, St. Wendel,

protective plastic bag, Germany

supplied in a box

4 plastic bags with 2500 mL Fresenius Medical

of solution and an empty solution for peritoneal Care Deutschland

CAPD/DPCA 19 stay safe collection bag, inserted in a YES YES YES dialysis GmbH, St. Wendel,

protective plastic bag, Germany

supplied in a box

One plastic bag with 2000

mL of solution, an feeding

tube, a disc connector with Fresenius Medical

casing and solution drain solution for peritoneal Care Deutschland

CAPD/DPCA 19 stay safe regulator, a catheter YES YES dialysis GmbH, St. Wendel,

connector (with protective Germany

cap), a collecting bag with

drain tube and attachments

("Injection Unit")

One plastic bag with 2500 Fresenius Medical

mL of solution, an feeding solution for peritoneal Care Deutschland

CAPD/DPCA 19 stay safe tube, a disc connector with YES YES dialysis GmbH, St. Wendel,

housing and solution drain Germany

regulator, a catheter connector (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 (with

Fresenius Medical protective cap) to the dialysis

solution for peritoneal Care Deutschland machine ("sleep safe CAPD/DPCA 2 sleep safe YES YES

dialysis GmbH, St. Wendel, cycler") and drug

Germany administration attachment,

two plastic bags with 5000

mL of solution, supplied in a

box

Fresenius Medical 4 plastic bags with 2000 mL

solution for peritoneal Care Deutschland of solution, inserted in a CAPD/DPCA 2 stay safe YES YES

dialysis GmbH, St. Wendel, protective plastic bag,

Germany supplied in a box

One plastic bag with 2000

mL of solution, an feeding

tube, a disc connector with Fresenius Medical

housing and solution drain solution for peritoneal Care Deutschland

CAPD/DPCA 2 stay safe regulator, a catheter YES YES dialysis GmbH, St. Wendel,

connector (with protective Germany

cap), a collecting bag with

drain tube and attachments

("Injection Unit")

One plastic bag with 5000

mL of solution, a feeding

tube, a connector (with

Fresenius Medical protective cap) to the dialysis

solution for peritoneal Care Deutschland machine ("sleep safe CAPD/DPCA 3 sleep safe YES YES

dialysis GmbH, St. Wendel, cycler") and drug

Germany 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 connector with Fresenius Medical

housing and solution drain solution for peritoneal Care Deutschland

CAPD/DPCA 3 stay safe regulator, a catheter YES YES dialysis GmbH, St. Wendel,

connector (with protective Germany

cap), a collecting bag with

drain tube and attachments

("Injection Unit")

Fresenius Medical 4 plastic bags with 2000 mL

solution for peritoneal Care Deutschland of solution, inserted in a CAPD/DPCA 3 stay safe YES YES

dialysis GmbH, St. Wendel, protective plastic bag,

Germany supplied in a box

One plastic bag with 5000

mL of solution, a feeding

tube, a connector (with

Fresenius Medical protective cap) to the dialysis

solution for peritoneal Care Deutschland machine ("sleep safe CAPD/DPCA 4 sleep safe YES YES

dialysis GmbH, St. Wendel, cycler") and drug

Germany administration attachment,

two plastic bags with 5000

mL of solution, supplied in a

box"

Fresenius Medical 4 plastic bags with 2000 mL

solution for peritoneal Care Deutschland CAPD/DPCA 4 stay safe of solution, inserted in a YES YES

dialysis GmbH, St. Wendel, protective plastic bag

Germany

Fresenius Medical One plastic bag with 2000 solution for peritoneal

CAPD/DPCA 4 stay safe Care Deutschland mL of solution, an feeding YES YES dialysis

GmbH, St. Wendel, tube, a disc connector with Germany housing and solution drain

regulator, a catheter

connector (with protective

cap), a collecting bag with

drain tube and attachments

("Injection Unit")

Jadran - Galenski

50 g of granules in an amber

laboratorij d.d., Pulac

Carbomed granules granules glass bottle, supplied in a YES YES YES

bb, Rijeka, Republic of

box

Croatia

Jadran - Galenski

laboratorij d.d., Pulac 30 (3x10) tablets in a PVC/Al Carbomed tablets tablets YES YES YES

bb, Rijeka, Republic of blister, supplied in a box

Croatia

Ebewe Pharma Ges. 15 mL of solution

CARBOPLATIN EBEWE concentrate of solution m.b.H. Nfg. KG, concentrate in an amber

YES YES 150 mg/15 mL for infusion Mondseestrasse 11, glass bottle (with rubber

Unterach, Austria stopper), supplied in a box

Ebewe Pharma Ges. 5 mL of solution concentrate

CARBOPLATIN EBEWE concentrate of solution m.b.H. Nfg. KG, in an amber glass bottle (with

YES YES 50 mg/5 mL for infusion Mondseestrasse 11, a rubber stopper), supplied in

Unterach, Austria a box

15 mL of concentrate in a Pliva Croatia Ltd., Ulica

glass bottle (amber orclear, concentrate of solution grada Vukovara 49,

Carboplatin Pliva 150 with rubber stopper and YES YES for infusion Zagreb, Republic of

aluminum cap with plastic Croatia

lid), supplied in a box

5 mL of concentrate in a Pliva Croatia Ltd., Ulica

glass bottle (amber or concentrate of solution grada Vukovara 49,

Carboplatin Pliva 50 colourless, with a rubber YES YES for infusion Zagreb, Republic of

stopper and an Al cap with a Croatia

plastic lid), supplied in a box

Lannacher Heilmittel Cardiopirin 100 mg gastric 30 (3x10) tablets in a blister,

gastric-resistant tablets GmbH, Lannach, YES YES resistant tablets supplied in a box

Austria

Lannacher Heilmittel Cardiopirin 50 mg gastric 30 (3x10) tablets in a blister,

gastric-resistant tablets GmbH, Lannach, YES YES resistant tablets supplied in a box

Austria

40 mL of solution in a glass

Dr. A.&L. Schmidgall, bottle with a plastic dropper CARMOL drops drops, solutiojn YES YES YES

Vienna, Austria and a plastic stopper,

supplied in a box

Belupo, lijekovi i

kozmetika, d.d.,

Koprivnica in 28 tablets in a blister, Carvelol 12.5 mg tablets tablets YES YES

cooperation with F. supplied in a box

Hoffmann-La Roche

Ltd, Basel, Switzerland

Belupo, lijekovi i

kozmetika, d.d.,

Koprivnica in 28 tablets in a blister, Carvelol 25 mg tablets tablets YES YES

cooperation with F. supplied in a box

Hoffmann-La Roche

Ltd, Basel, Switzerland

Belupo, lijekovi i 30 (3x10) tablets in

kozmetika d.d., Ulica Carvelol 3.125 mg tablets tablets transparent PVC/PVDC/Al YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika, d.d.,

Koprivnica in 28 tablets in a blister, Carvelol 6.25 mg tablets tablets YES YES

cooperation with F. supplied in a box

Hoffmann-La Roche

Ltd, Basel, Switzerland

Pliva Croatia Ltd., Ulica 28 (2x14) tablets in a CARVETREND tablets each tablet contains 12.5

grada Vukovara 49, PVC/PVDC//Al blister, YES YES 12.5 mg mg of carvedilolum

Zagreb, Republic of supplied in a box Croatia

Pliva Croatia Ltd., Ulica 28 (1x28) tablets in a

CARVETREND tablets 25 each tablet contains 25 grada Vukovara 49,

PVC/PVDC//Al blister, YES YES mg mg of carvedilolum Zagreb, Republic of

supplied in a box Croatia

Pliva Croatia Ltd., Ulica 28 (2x14) tablets in a

CARVETREND tablets each tablet contains grada Vukovara 49,

PVC/PVDC//Al blister, YES YES 3.125 mg 3.125 mg of carvedilolum Zagreb, Republic of

supplied in a box Croatia

Pliva Croatia Ltd., Ulica 28 (2x14) tablets in a

CARVETREND tablets each tablet contains 6.25 grada Vukovara 49,

PVC/PVDC//Al blister, YES YES 6.25 mg mg of carvedilolum Zagreb, Republic of

supplied in a box Croatia

AstraZeneca GmbH,

Plankstadt, Germany 28 (2x14) tablets in a blister

Casodex tablets 150 mg film coated tablets and AstraZeneca UK YES YES

(PVC/Al), supplied in a box Limited, Macclesfield,

Cheshire, Great Britain

AstraZeneca GmbH,

Plankstadt, Germany; 28 (2x14) tablets in a blister

Casodex tablets 50 mg film coated tablets AstraZeneca UK (PVC/Alu foil), supplied in a YES YES

Limited, Cheshire, carton box

Great Britain

SIFI S.p.A., Aci S. 5 capsules in a strip,

Cedax capsules 400 mg capsules YES YES

Antonio, Catania, Italy supplied in a box

Cedax powder for 15 grams of powder for powder for preparation of SIFI S.p.A., Aci S.

preparation of oral preparation of 60 mL oral YES YES oral suspension Antonio, Catania, Italy

suspension 180 mg/5 mL suspension

Belupo, lijekovi i 16 (1x16) capsules in a

Cefaleksin 500 mg kozmetika d.d., Ulica capsules PVC/Al blister, supplied in a YES YES

capsules Danica 5, Koprivnica, box

Republic of Croatia

Belupo, lijekovi i

Cefaleksin 250 mg/5 mL powder for preparation of kozmetika d.d., Ulica Amber glass bottle with an

YES YES powder for oral suspension oral suspension Danica 5, Koprivnica, aluminium screw cap

Republic of Croatia

Amber glass bottle with

Alkaloid AD - Skopje, powder for preparation of Cefalexin Alkaloid 250 mg

powder for preparation of Bulevar Aleksandar 100 mL of suspension with /5 mL powder for oral YES YES

oral suspension Makedonski 12, an aluminium stopper and a suspension

Skopje, FYROM plastic measuring soon,

supplied in a box

Alkaloid AD - Skopje, 16 (2x8) capsules in a

Cefalexin Alkaloid 500 mg Bulevar Aleksandar capsules PVC/Al blister, supplied in a YES YES

capsules Makedonski 12, carton box

Skopje, FYROM

16 capsules (2x8) in a Pliva Krakow, Krakow,

Cefalin capsules 500 mg capsules PVC/Al blister, supplied in a YES YES Poland

box

Amber glass bottle of 100 mL powder for preparation of Pliva Krakow, Krakow,

Cefalin syrup 250 mg/5 mL with a plastic stopper and YES YES oral suspension Poland

ROPP cap

Pliva Krakow, Krakow, 16 tablets (2x8) in a PVC/Al Cefalin tablets 1 g film coated tablets YES YES

Poland blister, supplied in a box

53 g of powder for Alkaloid AD - Skopje,

preparation of 100 mL of powder for preparation of Bulevar Aleksandar

Cefixim suspension suspension in an amber YES YES oral suspension Makedonski 12,

glass bottle, supplied in a Skopje, FYROM

box

Alkaloid AD - Skopje,

Bulevar Aleksandar 10 tablets in an amber glass Cefixim tablets film coated tablets YES YES

Makedonski 12, bottle, supplied in a box

Skopje, FYROM

powder for preparation of Farmal d.d., Ludbreg, One glass vial with 1.0 g of Cefotaksim injection 1 g YES YES

injection solution Branitelja domovinskog powder, supplied in a box rata 8, Republic of

Croatia in cooperation

with Lek d.d.,

Ljubljana, Verovškova

57, Republic of

Slovenia

Farmal d.d., Ludbreg,

Branitelja domovinskog

rata 8, Republic of

powder for preparation of Croatia in cooperation One glass vial with 2.0 g of Cefotaksim injection 2 g YES YES

solution for injection with Lek d.d., powder, supplied in a box

Ljubljana, Verovškova

57, Republic of

Slovenia

Jadran -Galenski

laboratorij d.d., Rijeka,

30 g of powder for oral

Republic of Croatia, in

suspension in a 60 mL

Cefzil 250 mg/5 mL powder for preparation of cooperation with

plastic (HDPE) bottle with a YES YES

powder for oral suspension oral suspension Bristol-Myers Squibb

plastic measuring spoon,

S.p.A., Contrada

supplied in a box

Fontana del Cerasp.

Anagni, Italy

Jadran -Galenski

laboratorij d.d., Rijeka,

Republic of Croatia, in 10 (2x5) film coated tablets in

cooperation with Cefzil 500 mg film-tablets film coated tablets a PVC/PVDC//Al blister, YES YES

Bristol-Myers Squibb supplied in a box

S.p.A., Contrada

Fontana del Cerasp.

Anagni, Italy

Pharmacia Limited,

Whalton Road,

Morpeth, 10 capsules in a blister, Celebrex capsules 200 mg capsules YES YES

Northumberland supplied in a box

NE613YA, Great

Britain

F. Hoffmann-La Roche

Ltd., 100 (10x10) capsules in a

CellCept 250 mg capsules capsules Grenzacherstrasse PVC/Al blister, supplied in a YES YES YES YES

124, Basel, box

Switzerland

F. Hoffmann-La Roche

Ltd.,

50 (5x10) tablets in a blister

CellCept 500 mg tablets film coated tablets Grenzacherstrasse YES YES YES YES

(PVC/Al), supplied in a box

124, Basel,

Switzerland

Genzyme Ltd., 37 One glass vial with powder Cerezyme 200 U powder

powder for concentrate Hollands Road, for infusion solution for concentrate for solution YES YES YES

for solution for infusion Haverhill, Suffolk CB9 concentrate supplied, in a for infusion

8PU, Great Britain carton box

Genzyme Ltd., 37 One glass vial with powder Cerezyme 400 U powder

powder for concentrate Hollands Road, for infusion solution for concentrate for solution YES YES YES

for solution for infusion Haverhill, Suffolk CB9 concentrate supplied, in a for infusion

8PU, Great Britain carton box

Belupo, lijekovi i

kozmetika d.d., Ulica 10 (1x10) tablets in a PVC/Al Cerson 5 mg tablets tablets YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Novartis Pharma Stein

60 (6x10) tablets in a blister

Certican 0.1 mg tablets for tablets for oral AG,

(PA/Al/PVC//Al), supplied in YES YES YES

oral suspension susupension Schaffhauserstrasse,

a box

Stein, Switzerland

Novartis Pharma Stein

60 (6x10) tablets in a blister

AG,

Certican 0.25 mg tablets tablets (PA/Al/PVC//Al), supplied in YES YES YES

Schaffhauserstrasse,

a box

Stein, Switzerland

Novartis Pharma Stein

60 (6x10) tablets in a blister

Certican 0.25 mg tablets tablets for oral AG,

(PA/Al/PVC//Al), supplied in YES YES YES

for oral suspension susupension Schaffhauserstrasse,

a box

Stein, Switzerland

Novartis Pharma Stein

60 (6x10) tablets in a blister

AG,

Certican 0.5 mg tablets tablets (PA/Al/PVC//Al), supplied in YES YES YES

Schaffhauserstrasse,

a box

Stein, Switzerland

Novartis Pharma Stein

60 (6x10) tablets in a blister

AG,

Certican 0.75 mg tablets tablets (PA/Al/PVC//Al), supplied in YES YES YES

Schaffhauserstrasse,

a box

Stein, Switzerland

Novartis Pharma Stein

60 (6x10) tablets in a blister

AG,

Certican 1.0 mg tablets tablets (PA/Al/PVC//Al), supplied in YES YES YES

Schaffhauserstrasse,

a box

Stein, Switzerland

Baxter Oncology powder and diluent for Vial with powder and syringe CETROTIDE 0.25 mg GmbH, Kantstrasse 2, YES YES

solution for injection with diluent, supplied in a box Halle, Germany

Baxter Oncology powder and diluent for Vial with powder and syringe CETROTIDE 3 mg GmbH, Kantstrasse 2, YES YES

solution for injection with diluent, supplied in a box Halle, Germany

Eleven 0.5 mL tablets in a

Heinrich Mack Nachf. blister (Aclar/PVC//Al) + Champix tablets 0.5 mg/1

film coated tablets GmbH & Co., fourteen1-mg tablets in a YES YES YES YES mg

Illertissen, Germany blister (Aclar/PVC//Al),

supplied in a carton box

Heinrich Mack Nachf. 28 (2x14) tablets in a blister

Champix tablets 1 mg film coated tablets GmbH & Co., (Aclar/PVC//Al) in a carton YES YES YES YES

Illertissen, Germany wrapping

solution for Abbott S.p.A., Via 10 polypropylene ampoules

Chirocaine 2.5 mg/mL injection/concentrate for Pontina 52, I-04010 each containing 10 mL of

YES YES solution for injection preparation of infusion Campoverde di Aprilia solution for injection,

solution (Latina), Italy supplied in a box

solution for Abbott S.p.A., Via 10 polypropylene ampoules

Chirocaine 5 mg/mL injection/concentrate for Pontina 52, I-04010 each containing 10 mL of

YES YES solution for injection preparation of infusion Campoverde di Aprilia solution for injection,

solution (Latina), Italy supplied in a box

solution for Abbott S.p.A., Via 10 polypropylene ampoules

Chirocaine 7.5 mg/mL injection/concentrate for Pontina 52, I-04010 Each containing 10 mL of

YES YES solution for injection preparation of infusion Campoverde di Aprilia solution for injection,

solution (Latina), Italy supplied in a box

Krka d.d., Šmarješka Chloramphenicol Krka eye 5 g of ointment in a tube,

eye ointment cesta 6, Novo mesto, YES YES

ointment supplied in a box

Republic of Slovenia

Eli Lilly and Company

4 tablets in a blister

Limited, Basingstoke,

Cialis 10 mg tablets film coated tablets (PVC/PE/Aclar/Al), supplied YES YES YES

Hampshire, Great

in a carton box

Britain

Eli Lilly and Company

2 tablets in a blister

Limited, Basingstoke,

Cialis 20 mg tablets film coated tablets (PVC/PE/Aclar/Al), supplied YES YES YES

Hampshire, Great

in a carton box

Britain

Eli Lilly and Company

4 tablets in a blister

Limited, Basingstoke,

Cialis 20 mg tablets film coated tablets (PVC/PE/Aclar/Al), supplied YES YES YES

Hampshire, Great

in a carton box

Britain

Belupo, lijekovi i

kozmetika d.d., Ulica 10 (1x10) tablets in a PVC/AI Ciflox 250 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 10 (1x10) tablets in a PVC/AI Ciflox 500 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia Belupo, lijekovi i

kozmetika d.d., Ulica 10 (1x10) tablets in a PVC/AI Ciflox 750 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 30 (3x10) film tablets in a Cilazil 2.5mg film tablets YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 30 (3x10) film tablets in a Cilazil 5mg film tablets YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

30 (3x10) film coated tablets

grada Vukovara 49,

Cilazil plus film coated tablets in a blister (OPA/Al/PVC//Al), YES YES

Zagreb, Republic of

supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 30 (3x10) film tablets in a Cilazil tablets 1 mg film tablets YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Cilag AG,

21 (1x21) tablets in a blister

Cilest tablets tablets Schaffhausen, YES YES

(PVC/A1), supplied in a box

Switzerland

Pliva Croatia Ltd., Ulica 30 (3x10) capsules in a

grada Vukovara 49, CIMOLAN capsules capsules blister (PVC/AI), supplied in a YES YES YES

Zagreb, Republic of box

Croatia

200 mL of syrup in an amber Pliva Croatia Ltd., Ulica

glass bottle with aluminum grada Vukovara 49,

CIMOLAN P syrup syrup cap and a 5-mL plastic YES YES YES Zagreb, Republic of

measuring spoon, supplied in Croatia

a box

200 mL of syrup in an amber Pliva Croatia Ltd., Ulica

glass bottle with aluminum grada Vukovara 49,

CIMOLAN syrup syrup cap and a 5-mL plastic YES YES YES Zagreb, Republic of

measuring spoon, supplied in Croatia

a box

Lek farmacevtska

družba d.d., Cinarizin forte 75mg Box with 50 tablets (blister,

tablets Verovškova 57, YES YES tablets 5x10 tablets)

Ljubljana, Republic of

Slovenia

Deutsche

Homöopathie - Union,

100 (5x20) tablets in PVC/Al

CINNABSIN tablets DHU - Arzneimittel YES YES

blister, supplied in a box

GmbH & Co.KG,

Karlsruhe, Germany

H. Lundbeck A/S,

Ottilavej 9, 28 (2x14) tablets in a blister, Cipralex 10 mg film-tablets film coated tablets YES YES

Copenhagen-Valby, supplied in a box

Denmark

H. Lundbeck A/S,

Ottilavej 9, 28 (2x14) tablets in a blister, Cipralex 5 mg film-tablets film coated tablets YES YES

Copenhagen-Valby, supplied in a box

Denmark

H. Lundbeck A/S,

Ottilavej 9, Box with 28 tablets (blister, Cipralex, 10mg film-tablets film tablets YES YES

Copenhagen-Valby, 2x14 tbl.)

Denmark

H. Lundbeck A/S,

Ottilavej 9, Box with 28 tablets (blister, Cipralex, 5mg film-tablets film tablets YES YES

Copenhagen-Valby, 2x14 tbl.)

Denmark

Krka d.d., Šmarješka 10 (1x10) tablets in a Ciprinol film coated tablets

film coated tablets cesta 6, Novo mesto, PVC/PVDC//Al blister, YES YES 250 mg

Republic of Slovenia supplied in a box Krka d.d., Šmarješka 10 (1x10) tablets in a

Ciprinol film coated tablets film coated tablets cesta 6, Novo mesto, PVC/PVDC//Al blister, YES YES 500 mg

Republic of Slovenia supplied in a box

10 mL of infusion solution

Ciprinol 100 mg/10 mL Krka d.d., Šmarješka solution concentrate for concentrate in a glass

solution concentrate for cesta 6, Novo mesto, YES YES infusion ampoule, 5 ampoules on a

infusion Republic of Slovenia plastic tray, supplied in a box

50 mL of solution for infusion

in a glass bottle (with a Krka d.d., Šmarješka

Ciprinol solution for rubber stopper, aluminium solution for infusion cesta 6, Novo mesto, YES YES infusion 100 mg/50 mL ring and a plastic flip off

Republic of Slovenia stopper), supplied in a carton

box

100 mL of infusion solution Krka d.d., Šmarješka

Ciprinol 200 mg/100 mL in a glass bottle (with rubber solution for infusion cesta 6, Novo mesto, YES YES solution for infusion stopper and aluminum ring),

Republic of Slovenia

supplied in a carton box

200 mL of solution for

Krka d.d., Šmarješka infusion in a glass bottle (with Ciprinol solution for

solution for infusion cesta 6, Novo mesto, rubber stopper, aluminum YES YES

infusion 400 mg/200 mL

Republic of Slovenia ring and plastic cap/flip off),

supplied in a carton box

Bayer HealthCare AG, 100 mL of infusion solution Ciprobay 200 mg/100 mL

solution for infusion 51368 Leverkusen, in a plastic bottle, supplied in YES YES solution for infusion

Germany a box

Bayer HealthCare AG, 10 (1x10) film coted tablets in Ciprobay 250 mg film

film coated tablets 51368 Leverkusen, a PP/Al blister, supplied in a YES YES coated tablets

Germany box

Bayer HealthCare AG, 200 mL of solution for Ciprobay 400 mg/200 mL

solution for infusion 51368 Leverkusen, infusion in a glass bottle, YES YES solution for infusion

Germany supplied in a box

Bayer HealthCare AG, 10 (1x10) film coted tablets in Ciprobay 500 mg film

film coated tablets 51368 Leverkusen, a PP/Al) blister, supplied in a YES YES coated tablets

Germany box

Pliva Croatia Ltd., Ulica

grada Vukovara 49, Cipromed tablets 250mg film tablets Box with 10 tablets (blister) YES YES

Zagreb, Republic of

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, Cipromed tablets 500 mg film tablets Box with 10 tablets (blister) YES YES

Zagreb, Republic of

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, Cipromed tablets 750mg film tablets Box with 10 tablets (blister) YES YES

Zagreb, Republic of

Croatia

Amber glass bottle with 20 Pliva Croatia Ltd., Ulica

mL of concentrate (with a concentrate of solution grada Vukovara 49,

Cisplatin Pliva 10 rubber stopper, and an YES YES for infusion Zagreb, Republic of

aluminium cap with a plastic Croatia

lid), 10 bottles in a box

Pliva Croatia Ltd., Ulica

10 amber glass vials each

solution concentrate for grada Vukovara 49,

Cisplatin Pliva 10 containing 20 mL of solution, YES YES

infusion Zagreb, Republic of

u supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

100 mL of solution in an

concentrate of solution grada Vukovara 49,

Cisplatin Pliva 50 amber glass bottle, supplied YES YES

for infusion Zagreb, Republic of

in a box

Croatia

Amber glass bottle with 100 Pliva Croatia Ltd., Ulica

mL of concentrate (with a concentrate of solution grada Vukovara 49,

Cisplatin Pliva 50 rubber stopper, and YES YES for infusion Zagreb, Republic of

aluminium cap with a plastic Croatia

lid), supplied in a box

Sandoz 28 (2x14) tablets in a Citalon 10 mg film coated

film coated tablets Pharmaceuticals PVC/PVDC/Alu blister, YES YES YES tablets

GmbH, Carl-Zeiss-Ring supplied in a carton box 3, Ismaning, Germany

Sandoz

28 (2x14) tablets in a

Citalon 20 mg film coated Pharmaceuticals

film coated tablets PVC/PVDC/Alu blister, YES YES YES

tablets GmbH, Carl-Zeiss-Ring

supplied in a carton box

3, Ismaning, Germany

Sandoz

28 (2x14) tablets in a

Citalon 40 mg film coated Pharmaceuticals

film coated tablets PVC/PVDC/Alu blister, YES YES YES

tablets GmbH, Carl-Zeiss-Ring

supplied in a carton box

3, Ismaning, Germany

Alkaloid AD - Skopje, Citeral 100 mg/10 mL 5 ampoules with 10 mL of

concentrate for infusion Bulevar Aleksandar concentrate for solution for solution, supplied in a carton YES YES

solution Makedonski 12, infusion box

Skopje, FYROM

Alkaloid AD - Skopje, 10 tablets in an amber glass

Citeral 250 mg film coated Bulevar Aleksandar film coated tablets bottle, supplied in a carton YES YES tablets Makedonski 12,

box Skopje, FYROM

Alkaloid AD - Skopje, 10 tablets in an amber glass

Citeral 500 mg film coated Bulevar Aleksandar film coated tablets bottle, supplied in a carton YES YES tablets Makedonski 12,

box Skopje, FYROM

Absorbed diphtheria and Imunološki zavod d.d.,

Box with 1 glass ampoule

tetanus vaccine for Rockefellerova 2, suspension for injection containing 1 dose of vaccine YES

children (above the age of Zagreb, Republic of

(0.5 mL of suspension)

7)

and adults, 1 dose Croatia

Absorbed diphtheria and Imunološki zavod d.d.,

Box with 1 glass bottle

tetanus vaccine for Rockefellerova 2, suspension for injection containing 10 doses of YES

children (above the age of Zagreb, Republic of vaccine (5 mL of suspension)

7)

and adults, 10 doses Croatia

Absorbed diphtheria and Imunološki zavod d.d., Box with 1 glass bottle

tetanus vaccine for Rockefellerova 2, containing 20 doses of suspension for injection YES

children (above the age of Zagreb, Republic of vaccine (10 mL of

7)

and adults, 20 doses Croatia suspension)

Imunološki zavod d.d.,

Box with 1 glass ampoule

Absorbed diphtheria and Rockefellerova 2,

suspension for injection containing 1 dose of vaccine YES

tetanus vaccine, 1 dose Zagreb, Republic of

(0.5 mL of suspension)

Croatia

Imunološki zavod d.d.,

Box with 1 glass bottle

Absorbed diphtheria and Rockefellerova 2,

suspension for injection containing 10 doses of YES

tetanus vaccine 10 doses Zagreb, Republic of

vaccine (5 mL of suspension)

Croatia

Imunološki zavod d.d., Absorbed diphtheria, Box with 50 glass bottles with

Rockefellerova 2, tetanus and pertussis suspension for injection 10 doses of vaccine (5 mL of YES

Zagreb, Republic of vaccine, 10 doses suspension)

Croatia

Imunološki zavod d.d., Absorbed diphtheria, Box with 1 glass ampoule

Rockefellerova 2, tetanus and pertussis suspension for injection containing 1 dose of vaccine YES

Zagreb, Republic of vaccine, 1 dose (0.5 mL of suspension)

Croatia

Imunološki zavod d.d., Box with 1 glass bottle Absorbed diphtheria,

Rockefellerova 2, containing 20 doses of tetanus and pertussis suspension for injection YES

Zagreb, Republic of vaccine (10 mL of vaccine, 20 doses

Croatia suspension)

Amber glass lyophilisation

bottle, volume of 3.5 mL with Meningococcal group A Imunološki zavod d.d.,

lyophilisate and diluent 0.5 mL of lyophilisate for one and group C Rockefellerova 2,

for suspension for dose of vaccine + ampoule YES polysaccharide vaccine, Zagreb, Republic of

injection with the volume of 2 mL with lyophilized, 1 dose Croatia

0.5 mL of solvent for one

dose of vaccine

Amber glass lyophilisation Imunološki zavod d.d.,

Meningococcal A and C lyophilisate and diluent bottle, volume of 5.5 mL with

Rockefellerova 2, polysaccharide vaccine, for suspension for 0.5 mL of lyophilisate for ten YES

Zagreb, Republic of lyophilized, 10 doses injection doses of vaccine + ampoule

Croatia

with 5 mL of solvent for ten

doses of vaccine

Box with 1 glass bottle with 1

dose of lyophilised vaccine Live, lyophilized morbilli Imunološki zavod d.d.,

lyophilisate and diluent (for 0.5 mL of reconstituted and rubella vaccine, Rockefellerova 2,

for suspension for vaccine) + 1 ampoule with YES Edmonston-Zagreb, HDS; Zagreb, Republic of

injection 0.5 mL of solvent for vaccine RA 27/3, HDS, 1 dose Croatia

against measles and rubella,

sterile water for injection

Box with 50 glass bottles with

10 doses of lyophilised

Live, lyophilzed morbilli Imunološki zavod d.d., vaccine (for 5 mL of lyophilisate and diluent

and rubella vaccine, Rockefellerova 2, reconstituted vaccine) + 50 for suspension for YES

Edmonston-Zagreb, HDS; Zagreb, Republic of ampoules with 5 mL of injection

RA 27/3, HDS, 10 doses Croatia solvent for vaccine against

measles and rubella, sterile

water for injection

Box with 50 glass bottles with

10 doses of lyophilised

Live, lyophilzed morbilli Imunološki zavod d.d., vaccine (for 2.5 mL of lyophilisate and diluent

and rubella vaccine, Rockefellerova 2, reconstituted vaccine) + 50 for suspension for YES

Edmonston-Zagreb, HDS; Zagreb, Republic of ampoules with 2.5 mL of injection

RA 27/3, HDS, 5 doza Croatia solvent for vaccine against

measles and rubella, sterile

water for injection

Box with 1 glass bottle

containing 1 dose of Live, lyophilized vaccine

lyophilised vaccine (for 0.5 against morbilli, rubella, Imunološki zavod d.d.,

lyophilisate and diluent mL of reconstituted vaccine) parotitis, Edmonston Rockefellerova 2,

for suspension for and 1 ampoule with 0.5 mL YES Zagreb, HDS, RA 27/3, Zagreb, Republic of

injection of solvent for vaccine against HDS i L-Zagreb, PF, 1 Croatia

measles, rubella and doza

parotitis, sterile water for

injection

Box with 50 glass bottles with

10 doses of lyophilised Live, lyophilzed morbilli,

vaccine (for 5 mL of rubella and parotitis Imunološki zavod d.d.,

lyophilisate and diluent reconstituted vaccine) + 50 vaccine, Edmonston Rockefellerova 2,

for suspension for ampoules with 5 mL of YES Zagreb, HDS; RA 27/3, Zagreb, Republic of

injection solvent for vaccine against HDS; L-Zagreb, PF, 10 Croatia

measles, rubella and doses

parotitis, sterile water for

injection

Box with 50 glass bottles with

5 doses of lyophilised Live, lyophilzed morbilli,

vaccine (for 2.5 mL of rubella and parotitis Imunološki zavod d.d.,

lyophilisate and diluent reconstituted vaccine) + 50 vaccine, Edmonston Rockefellerova 2,

for suspension for ampoules with 2.5 mL of YES Zagreb, HDS; RA 27/3, Zagreb, Republic of

injection solvent for vaccine against HDS; L-Zagreb, PF, 5 Croatia

measles, rubella and doses

parotitis, sterile water for

injection

One glass vial with singe

dose of lyophilized vaccine Imunološki zavod d.d.,

Live, lyophilized morbilli lyophilisate and diluent (for 0.5 mL of reconstituted

Rockefellerova 2, vaccine, Edmonstonfor suspension for vaccine) and one ampoule YES

Zagreb, Republic of Zagreb, HDS 1 dose injection with 0.5 mL of diluent, sterile

Croatia

Water for Injection, supplied

in a carton box

50 glass bottles with 5 doses

of lyophilised vaccine (for 2.5

Imunološki zavod d.d., mL of reconstituted vaccine), Live, lyophilized morbilli lyophilisate and diluent

Rockefellerova 2, supplied in a carton box, and vaccine, Edmonstonfor suspension for YES

Zagreb, Republic of 50 ampoules with 2.5 mL of Zagreb, HDS, 5 doses injection

Croatia solvent, sterile water for

injection, supplied in a carton

box 50 glass bottles with 10

doses of lyophilised vaccine

Imunološki zavod d.d., (for 5 mL of reconstituted Live, lyophilized morbilli lyophilisate and diluent

Rockefellerova 2, solvent), supplied in a carton vaccine, Edmonstonfor suspension for YES

Zagreb, Republic of box, and 50 ampoules with 5 Zagreb, HDS, 10 doses injection

Croatia mL of solvent, sterile water

for injection, supplied in a

carton box

Box with a glass bottle with 1

dose of lyophilised vaccine

Imunološki zavod d.d., against parotitis (for 0.5 mL Live, lyophilized parotitis lyophilisate and diluent

Rockefellerova 2, of reconstituted vaccine) + 1 vaccine, L-Zagreb, PF, 1 for suspension for YES

Zagreb, Republic of ampoule with 0.5 mL of doza injection

Croatia solvent for vaccine against

parotitis, sterile water for

injection

Box with 50 glass bottles with

10 doses of lyophilised

Imunološki zavod d.d., vaccine against parotitis (for Live, lyophilized parotitis lyophilisate and diluent

Rockefellerova 2, 5 mL of reconstituted vaccine, L-Zagreb, PF, 10 for suspension for YES

Zagreb, Republic of vaccine) + 50 ampoules with doza injection

Croatia 5 mL of solvent for vaccine

against parotitis, sterile water

for injection

Box with 1 glass bottle

containing 1 dose of

lyophilised vaccine against Imunološki zavod d.d.,

Live, lyophilized rubella lyophilisate and diluent rubella (for 0.5 mL of Rockefellerova 2,

vaccine RA 27/3, HDS, 1 for suspension for reconstituted vaccine) + 1 YES Zagreb, Republic of

dose injection ampoule with 0.5 mL of Croatia

solvent for vaccine against

rubella, sterile water for

injection

Box with 50 glass bottles with

10 doses of lyophilised

Imunološki zavod d.d., vaccine against rubella (for 5 Live, lyophilized rubella lyophilisate and diluent

Rockefellerova 2, mL of reconstituted vaccine) vaccine, RA 27/3, HDS, 10 for suspension for YES

Zagreb, Republic of + 50 ampoules with 5 mL of doses injection

Croatia solvent for vaccine against

rubella, sterile water for

injection

Box with 50 glass bottles with

5 doses of lyophilised

Imunološki zavod d.d., vaccine against rubella (for Live, lyophilized rubella lyophilisate and diluent

Rockefellerova 2, 2.5 mL of reconstituted vaccine, RA 27/3, HDS, 5 for suspension for YES

Zagreb, Republic of vaccine) + 50 ampoules with doses injection

Croatia 2.5 mL of solvent for vaccine

against rubella, sterile water

for injection

Imunološki zavod d.d., Box with 1 glass ampoule

Anti-tetanus vaccine, Rockefellerova 2, containing 1 dose of tetanus suspension for injections YES

absorbed, 1 dose Zagreb, Republic of vaccine (0.5 mL of

Croatia suspension)

Imunološki zavod d.d., Box with 1 glass bottle

Anti-tetanus vaccine, Rockefellerova 2, containing 10 doses of suspension for injections YES

absorbed, 1 dose Zagreb, Republic of tetanus vaccine (5 mL of

Croatia suspension)

Imunološki zavod d.d., Box with 1 glass bottle with

Absorbed tetanus vaccine, Rockefellerova 2, suspension for injection 20 doses of tetanus vaccine YES

20 doses Zagreb, Republic of (5 mL of suspension)

Croatia

Ebewe Pharma Ges. 5 amber glass ampoules with

Claccium Folinat Ebewe m.b.H. Nfg. KG, solution for injection 10 mL of solution, supplied in YES YES

100 mg/10 mL Mondseestrasse 11, a box

Unterach, Austria

Claccium Folinat Ebewe Ebewe Pharma Ges. 5 amber glass ampoules with solution for injection YES YES

14509/11 WS/jj 256

Mondseestrasse 11, a box

Unterach, Austria

Ebewe Pharma Ges.

5 amber glass ampoules with

Claccium Folinat Ebewe m.b.H. Nfg. KG,

solution for injection 5 mL of solution, supplied in YES YES

50 mg/5 mL Mondseestrasse 11,

a box

Unterach, Austria

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 14 tablets in PVC/Al blister, Clarexid tablets 250 mg film coated tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 14 tablets in PVC/Al blister, Clarexid tablets 500 mg film coated tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Schering-Plough Labo 10 tablets in a

Clarinase 5 mg/120 mg N.V. Industrepark 30, PVC/PE/PCTFE//Al or prolonged release tablets YES YES YES

prolonged-release tablets Heist-op-den-Berg, PVC/PCTFE//Al blister,

Belgium supplied in a box

Schering-Plough Labo 120 mL of solution in an

N.V. Industrepark 30, Claritine syrup 1mg/mL syrup amber glass botlle, supplied YES YES

Heist-op-den-Berg, in a box

Belgium

Schering-Plough Labo 10 (1x10) tablets in a

N.V. Industrepark 30, PVC/PVDC//AI OR Claritine tablets 10 mg tablets YES YES YES

Heist-op-den-Berg, PVC/PCTFE//AL blister,

Belgium supplied in a box

White polypropylene tube

with granules for oral

Grünenthal GmbH, suspension, closed with

granules for oral Zieglerstrasse 6, D- propylene cap on the top and Clarosip 125 mg YES YES YES

suspension 52078 Aachen, regulator (porous structure)

Germany for the control of suspension

flow at the bottom, in

protective aluminum bag

White polypropylene tube

with granules for oral

Grünenthal GmbH, suspension, closed with

granules for oral Zieglerstrasse 6, D- propylene cap on the top and Clarosip 187.5 mg YES YES YES

suspension 52078 Aachen, regulator (porous structure)

Germany for the control of suspension

flow at the bottom, in

protective aluminum bag

White polypropylene tube

with granules for oral

Grünenthal GmbH, suspension, closed with

granules for oral Zieglerstrasse 6, D- propylene cap on the top and Clarosip 250 mg YES YES YES

suspension 52078 Aachen, regulator (porous structure)

Germany for the control of suspension

flow at the bottom, in

protective aluminum bag

Aventis

2 glass syringes with needles

solution for injection (for Intercontinental,

Clexane 10.000 IU anti(each containing 1.0 mL of

s.c. and i.v. use in France i Aventis YES YES

Xa/1.0 mL injections solution) in a blister, supplied

haemodyalisis) Pharma Le Trait,

in a box

France

Aventis

2 glass syringes with needles

solution for injection (for Intercontinental,

Clexane 2000 IU anti(each containing 0.2 mL of

s.c. and i.v. use in Maisons Alfort, France; YES YES

xa/0.2 mL injection solution) in a blister, supplied

haemodyalisis) Aventis Pharma Le

in a box

Trait, Le Trait, France

Aventis

2 glass syringes with needles

solution for injection (for Intercontinental,

Clexane 4000 IU anti(each containing 0.4 mL of

s.c. and i.v. use in Maisons Alfort, France; YES YES

xa/0.4 mL injection solution) in a blister, supplied

haemodyalisis) Aventis Pharma Le

in a box

Trait, Le Trait, France

Aventis

2 glass syringes with needles

solution for injection (for Intercontinental,

Clexane 6000 IU anti(each containing 0.6 mL of

s.c. and i.v. use in France i Aventis YES YES

Xa/0.6 mL injection solution) in a blister, supplied

haemodyalisis) Pharma Le Trait,

in a box

France

Aventis 2 glass syringes with needles

solution for injection (for Intercontinental, Clexane 8000 IU anti(each containing 0.8 mL of

s.c. and i.v. use in France i Aventis YES YES Xa/0.8 mL injection solution) in a blister, supplied

haemodyalisis) Pharma Le Trait, in a box

France

Schering AG,

Climen coated tablets Muellerstrasse 170- Coated tablets YES YES

178, Berlin, Germany

10 (2x5) glass syringes (with

Abbott GmbH & Co. needle) each containing 0.25 solution for subcutaneous

Clivarin 1432 KG, Ludwigshafen, mLL of solution, in a YES YES injection

Germany protective container, supplied

in a carton box

10 (5x2) syringes with Abbott GmbH & Co. solution for subcutaneous needles each containing Clivarin 1750 KG, Ludwigshafen, YES YES

injection 0.25 mL of solution in a Germany

blister, supplied in a box

10 (2x5) glass syringes (with

Abbott GmbH & Co. needle) each containing 0.6 solution for subcutaneous

Clivarin 3436 KG, Ludwigshafen, mLL of solution, in a YES YES injection

Germany protective container, supplied

in a carton box

10 (2x5) glass syringes (with

Abbott GmbH & Co. needle) each containing 0.9 solution for injection (for

Clivarin 5153 KG, Ludwigshafen, mLL of solution, in a YES YES s.c. use)

Germany protective container, supplied

in a box

H. Lundbeck A/S, Clopixol acuphase 50

solution for intramuscular Ottilavej 9, 5 ampoules each with 1 mL mg/mL solution for YES YES

injection Copenhagen-Valby, of solution, supplied in a box injection

Denmark

H. Lundbeck A/S, 10 ampoules each containing

Clopixol depot 200 mg/mL solution for injection for Ottilavej 9,

1 mL of solution, supplied in YES YES solution for injection intramuscular use Copenhagen-Valby,

a box Denmark

H. Lundbeck A/S, 50 tablets in a polypropylene

Ottilavej 9, container with a specially Clopixol 10 mg tablets film coated tablets YES YES

Copenhagen-Valby, designed stopper with a

Denmark leaflet

H. Lundbeck A/S, 50 tablets in a polypropylene

Ottilavej 9, container with a specially Clopixol 25 mg tablets film coated tablets YES YES

Copenhagen-Valby, designed stopper with a

Denmark leaflet

Sanofi Winthrop 28 (2x14) tablets in a blister

Coaprovel 150 mg/12.5 Industrie, 1 rue de la film coated tablets (PVC/PVDC/Al), supplied in YES YES YES

mg Vierge, 33440 a box

Ambares, France

Sanofi Winthrop 28 (2x14) tablets in a blister

Coaprovel 300 mg/12.5 Industrie, 1 rue de la film coated tablets (PVC/PVDC/Al), supplied in YES YES YES

mg Vierge, 33440 a box

Ambares, France

Les Laboratories 30 (1x30) tablets in a

Servier Industrie, 905 Coaxil coated tablets PVC/Alu blister , supplied in YES YES

route de Saran, 45520

a carton box

Gidy, France

Les Laboratories

Servier Industrie, 905 60 (2x30) tablets in a blister Coaxil coated tablets YES YES

route de Saran, 45520 (PVC/Al), supplied in a box

Gidy, France

Alkaloid AD - Skopje, 10 (1x10) tablets in a Codeini phosphatis

tablets Bulevar Aleksandar Al/PE//PE/Al strip, supplied in YES YES Alkaloid

Makedonski 12, a box Skopje, FYROM

Novartis Pharma Stein

CO-Diovan film-tablets AG, 28 (2x14) tablets in a blister, film coated tablets YES YES YES YES

160/12.5 mg Schaffhauserstrasse, supplied in a box

Stein, Switzerland

Novartis Pharma Stein

CO-Diovan film-tablets AG, 28 (2x14) tablets in a blister, film coated tablets YES YES YES YES

160/25 mg Schaffhauserstrasse, supplied in a box

Stein, Switzerland

Novartis Pharma

CO-Diovan film-tablets Produktions GmbH, 28 (2x14) tablets in a blister, film coated tablets YES YES YES YES

80/12.5 mg Öflinger Strasse 44, supplied in a box

Wehr, Germany

Coldrex HotRem powder for preparation of SmithKline Beecham 5 bags with 5 g of powder,

YES YES YES Blackcurrant oral solution S.A., Madrid, Spain supplied in a box

Famar S.A., Atena, 16 (2x8) tablets in a blister, Coldrex Junior film coated tablets YES YES YES

Greece supplied in a box

160 mL of oral solution in an Wrafton Laboratories

amber glass bottle with a Ltd., Wrafton,

COLDREX JUNIOR syrup oral solution platic (PP) temper-proof YES YES YES Braunton, North

closure and 20-ml measuring Devon, Great Britain

glass, supplied in a box

powder for preparation of SmithKline Beecham 5 bags with 6.4 g of powder, Coldrex MaxGrip Lemon YES YES YES

oral solution S.A., Madrid, Spain supplied in a box

GlaxoSmithKline

Dungarvan Ltd.,

Knockbrack, 12 tablets in a blister, Coldrex tablets tablets YES YES YES

Dungarvan, Co. supplied in a box

Waterford, Republic of

Ireland

Glaxo Wellcome

Operations, Greenford,

60 (6x10) film coated tablets

Great Britain i

Combivir tablets film coated tablets in a blister (PVC/Al), supplied YES YES

GlxoSmithKline

in a box

Pharmaceuticals S.A.,

Poznan, Poland

Novartis

30 film coated tablets in an

Pharmaceuticals UK

COMTAN 200 mg filmamber glass bottle with a

film coated tablets Limited, Horsham, YES YES

tablets plastic (HDPP) stopper,

West Sussex, Great

supplied in a box

Britain

Janssen 30 tablets in a plastic (HDPE)

Pharmaceutica NV, bottle with a temper-evident Concerta 18 mg prolonged-release tablets YES YES YES YES

Turnhouseweg 30, stopper and desiccant,

Beerse, Belgium supplied in a box

Janssen 30 tablets in a plastic (HDPE)

Pharmaceutica NV, bottle with a temper-evident Concerta 36 mg prolonged-release tablets YES YES YES YES

Turnhouseweg 30, stopper and desiccant,

Beerse, Belgium supplied in a box

Janssen 30 tablets in a plastic (HDPE)

Pharmaceutica NV, bottle with a temper-evident Concerta 54 mg prolonged-release tablets YES YES YES YES

Turnhouseweg 30, stopper and desiccant,

Beerse, Belgium supplied in a box

Merck KGaA,

30 (3x10) tablets in a blister,

Concor 10 film coated tablets Frankfurter Straße 250, YES YES

supplied in a box

Darmstadt, Germany

Merck KGaA,

30 (3x10) tablets in a blister,

Concor 5 film coated tablets Frankfurter Straße 250, YES YES

supplied in a box

Darmstadt, Germany

Merck KGaA,

Box with 20 tablets (blister,

Concor Cor 1.25 mg film tablets Frankfurter Straße 250, YES YES

2x10 tbl.)

Darmstadt, Germany

Merck KGaA,

Box with 30 tablets (blister,

Concor Cor 2.5 mg film tablets Frankfurter Straße 250, YES YES

3x10 tbl.)

Darmstadt, Germany

Merz Pharma GmbH &

10 g of gel in aluminum tube,

Contractubex gel gel Co KGaA, Frankfurt YES YES YES

supplied in a box

am Main, Germany

Jadran - Galenski

laboratorij d.d., Pulac Contral tablets Box with 10 tablets (blister) YES YES

bb, Rijeka, Republic of

Croatia

28 (2X14) gastric-resistant Altana Pharma

tablets in a blister Controloc 20 mg tablets gastric-resistant tablets Oranienburg GmBH, YES YES

(OPA/Al/PE//Al), supplied in Oranienburg, Germany

a box

14 (1x14) gastric-resistant Altana Pharma

tablets in a blister Controloc 40 mg tablets gastric-resistant tablets Oranienburg GmbH, YES YES

(OPA/Al/PE//Al), supplied in Oranienburg, Germany

a box

Altana Pharma AG, powder for solution for One glasss vial with Controloc intravenous Byk-Gulden Strasse 2, YES YES

injection lyophilisate, supplied in a box Konstanz, Germany

28 (4x7) amber glass bottles

Copaxone 20 mg, powder Teva Pharmaceutical with powder and 28 (4x7) powder and diluent for

and diluent for solution for Industries Ltd., Kfar ampoules with diluent for YES YES YES YES solution for injection

injection Saba, Izrael solution for injection,

supplied in a box

Pre-filled syringe with 1 mL Teva Pharmaceuticals

of solution for injection with a

Copaxone 20 mg/mL solution for injection, Europe B.V., needle, in a blister, 28 (4x7) YES YES

solution for injection pre-filled syringe Mijadrecht, The pre-filled syringes supplied in Nederlands

a box

F. Hoffmann-La Roche

Ltd., 42 film coated tablets in a

Copegus 200 mg film coated tablets Grenzacherstrasse polyethylene bag, supplied in YES YES YES YES

124, Basel, a box

Switzerland

Sanofi Winthrop

6 ampoules each with 3 mL

Cordarone 150 mg/3 mL Industrie, 1 rue de la

solution for injection of solution for injection, YES YES

injection Vierge, 33440

supplied in a box

Ambares, France

Sanofi Winthrop

30 (3x10) tablets in a blister

Industrie, 1 rue de la

Cordarone 200 mg tablets film coated tablets (PVC/Alu-foil) supplied in a YES YES

Vierge, 33440

box

Ambares, France

Krka d.d., Šmarješka 20 (2x10 tablets in

Cordipin XL tablets 40 mg modified release tablets cesta 6, Novo mesto, PVC/PVD/Al blister, supplied YES YES

Republic of Slovenia in a box

Krka d.d., Šmarješka 30 (3x10) tablets in a

Cordipin XL tablets 40 mg modified release tablets cesta 6, Novo mesto, PVC/PVD/Al blister , supplied YES YES

Republic of Slovenia in a box

Les Laboratoires

Servier Industrie, 905

route de Saran, 45520

Gidy, France; Servier

(Republic of Ireland)

Industries Ltd., Gorey

28 (2x14) film coated tablets

Corlentor 5 mg film coated Road, Arklow, Co.

film coated tablets in a PVC/Al blister, supplied YES YES YES YES

tablets Wicklow, Republic of

in a carton box

Ireland;

Przedsiebiorstwo

Farmaceutyczne

Anpharm S.A., Ul.

Annopol 603-236,

Warszava, Poland

Les Laboratoires

Servier Industrie, 905

28 (2x14) film coated tablets

Corlentor 7.5 mg film route de Saran, 45520

film coated tablets in a PVC/Al blister, supplied YES YES YES YES

coated tablets Gidy, France; Servier

in a carton box

(Republic of Ireland)

Industries Ltd., Gorey Road, Arklow, Co.

Wicklow, Republic of

Ireland;

Przedsiebiorstwo

Farmaceutyczne

Anpharm S.A., Ul.

Annopol 603-236,

Warszava, Poland

Pantheon YM Inc.,

Toronto, Canada i 100 tablets in an amber

CORTEF tablets 10 mg tablets Pfizer Manufacturing glass bottle, supplied in a YES YES

Belgium, Puurs, box

Belgium

Krka d.d., Šmarješka 28 (4x7) tablets in a

Coryol tablets 12.5 mg tablets cesta 6, Novo mesto, OPA/Al/PVC//Al blister, YES YES

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 28 (4x7) tablets in a

Coryol tablets 25 mg tablets cesta 6, Novo mesto, OPA/Al/PVC//Al blister, YES YES

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 28 (4x7) tablets in a

Coryol tablets 3.125 mg tablets cesta 6, Novo mesto, OPA/Al/PVC//Al blister, YES YES

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 28 (4x7) tablets in a

Coryol tablets 6.25 mg tablets cesta 6, Novo mesto, OPA/Al/PVC//Al blister, YES YES

Republic of Slovenia supplied in a box

Merck Sharp & Dohme

5 mL of solution in a plastic

B.V., Waarderweg 39,

Cosopt eye drops eye drops, solution container OCUMETER YES YES

Postbus 581, Haarlem,

PLUS, supplied in a box

The Nederlands

Merck Sharp & Dohme

Cozaar 100 mg filmom B.V., Waarderweg 39, 28 (2x14) tablets in a blister, film coated tablets YES YES

obložete tablets Postbus 581, Haarlem, supplied in a box

the Netherlands

Merck Sharp & Dohme

Cozaar 50 mg film coated B.V., Waarderweg 39, 28 (2x14) tablets in a blister, film coated tablets YES YES

tablets Postbus 581, Haarlem, supplied in a box

the Netherlands

AstraZeneca GmbH,

Plankstadt, Germany; 28 (2x14) film coated tablets

AstraZeneca UK

in a blister of aluminum

Crestor 10 mg film coated tablets Limited, Silk Road YES YES YES YES

laminate and aluminum foil,

Business Park,

supplied in a carton box

Macclesfield, Cheshire,

Great Britain

AstraZeneca GmbH,

Plankstadt, Germany; 29 (2x14) film coated tablets

AstraZeneca UK

in a blister of aluminum

Crestor 20 mg film coated tablets Limited, Silk Road YES YES YES YES

laminate and aluminum foil,

Business Park,

supplied in a carton box

Macclesfield, Cheshire,

Great Britain

AstraZeneca GmbH,

Plankstadt, Germany;

28 (4x7) film coated tablets

AstraZeneca UK

of aluminum laminate and

Crestor 40 mg film coated tablets Limited, Silk Road YES YES YES YES

aluminum foil, supplied in a

Business Park,

carton box

Macclesfield, Cheshire,

Great Britain

AstraZeneca GmbH,

Plankstadt, Germany; 30 (2x14) film coated tablets

AstraZeneca UK

in a blister of aluminum

Crestor 5 mg film coated tablets Limited, Silk Road YES YES YES YES

laminate and aluminum foil,

Business Park,

supplied in a carton box

Macclesfield, Cheshire,

Great Britain

M.Y. Healthcare 1.45 g of gel in an applicator CRINONE 8% vaginal gel vaginal gel YES YES

Packaging Limited, for single use, inserted in a Bedfordshire, Great protective bag

Britain (paper/Al/PE), 15 bags in a

box

Merck Sharp & Dohme 180 capsules in a

CRIXIVAN 100 mg B.V., Waarderweg 39, capsules polyethylene (HDPE) YES YES YES

capsules Postbus 581, Haarlem, container

the Netherlands

Merck Sharp & Dohme 360 capsules in a

B.V., Waarderweg 39, Crixivan 200 mg capsules capsules polyethylene (HDPE) YES YES YES

Postbus 581, Haarlem, container

the Netherlands

Merck Sharp & Dohme 135 capsules in a

CRIXIVAN 333 mg B.V., Waarderweg 39, capsules polyethylene (HDPE) YES YES YES

capsules Postbus 581, Haarlem, container

the Netherlands

Merck Sharp & Dohme 180 capsules in a

B.V., Waarderweg 39, Crixivan 400 mg capsules capsules polyethylene (HDPE) YES YES YES

Postbus 581, Haarlem, container

the Netherlands

Pliva Croatia Ltd., Ulica

powder for solution for grada Vukovara 49, 50 bottles with powder, Crystacillin YES YES

injection Zagreb, Republic of supplied in a box

Croatia

Lilly, S.A., Avendia de 28 (2x14) capsules in a

Cymbalta 30 mg hard gastric-resistant la Industria 30, blister (PVC/PE/PCTFE//Al), YES YES YES

gastric-resistant capsules capsules, hard Alcobendas, Madrid, supplied in a box

Spain

Lilly, S.A., Avendia de 28 (2x14) capsules in a

Cymbalta 60 mg hard gastric-resistant la Industria 30, blister (PVC/PE/PCTFE//Al), YES YES YES

gastric-resistant capsules capsules, hard Alcobendas, Madrid, supplied in a box

Spain

F. Hoffmann-La Roche

Ltd., 10-mL glass vial with powder Cymevene powder for powder for solution for

Grenzacherstrasse (for multiple use) supplied in YES YES solution for infusion infusion

124, Basel, a box

Switzerland

Belupo, lijekovi i

kozmetika d.d., Ulica 30 tablets in a blister, Dabroston 10 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Lyophilisate in an amber Pliva Croatia Ltd., Ulica lyophilisate for glass bottle (with a rubber DACARBAZINE PLIVA grada Vukovara 49,

preparation of solution for stopper and an aluminium YES YES 100 Zagreb, Republic of

injection or infusion cap with a plastic lid), 10 Croatia

bottles in a box

Lyophilisate in an amber Pliva Croatia Ltd., Ulica lyophilisate for glass bottle (with a rubber DACARBAZINE PLIVA grada Vukovara 49,

preparation of solution for stopper and an aluminium YES YES 200 Zagreb, Republic of

injection or infusion cap with a plastic lid), 10 Croatia

bottles in a box

Krka d.d., Novo Mesto,

R. Republic of Slovenia

in cooperation with 30 g of cream in a tube, Daktarin cream cream YES YES

Janssen supplied in a box

Pharmaceutica,

Beerse, Belgium

Krka d.d., Novo Mesto,

R. Republic of Slovenia

40 g of gel in a tube with a

in cooperation with

Daktarin oral gel oral gel measuring spoon, supplied in YES YES

Janssen

a box

Pharmaceutica,

Beerse, Belgium

Krka d.d., Šmarješka DALERON C granules for 10 bags each containing 5 g

granules for oral solution cesta 6, Novo mesto, YES YES YES oral solution of granules, supplied in a box

Republic of Slovenia Krka d.d., Šmarješka

DALERON C JUNIOR 10 bags each containing 5 g granules for oral solution cesta 6, Novo mesto, YES YES YES

granules for oral solution of granules, supplied in a box

Republic of Slovenia

Abbott S.p.A., Via

Brown polyethylene bottle

Pontina 52, I-04010

Dalsy syrup syrup with 100 mL of syrup, YES YES

Campoverde di Aprilia

supplied in a box

(Latina), Italy

Abbott S.p.A., Via

Brown polyethylene bottle

Pontina 52, I-04010

Dalsy syrup syrup with 200 mL of syrup, YES YES

Campoverde di Aprilia

supplied in a box

(Latina), Italy

Pliva Croatia Ltd., Ulica 30 (3x10) tablets in a

grada Vukovara 49, Danoptin 100 mg tablets tablets PVC/Aclar/Al blister, supplied YES YES

Zagreb, Republic of in a box

Croatia

Pliva Croatia Ltd., Ulica 30 (3x10) tablets in a

grada Vukovara 49, Danoptin 25 mg tablets tablets PVC/Aclar/Al blister, supplied YES YES

Zagreb, Republic of in a box

Croatia

Pliva Croatia Ltd., Ulica 31 (3x10) tablets in a

grada Vukovara 49, Danoptin tablets 50 mg tablets PVC/Aclar/Al blister, supplied YES YES

Zagreb, Republic of in a box

Croatia

Pliva Croatia Ltd., Ulica 32 (3x10) tablets in a

Danoptin tablets for oral grada Vukovara 49, tablets for oral solution PVC/Aclar/Al blister, supplied YES YES

suspension 5 mg Zagreb, Republic of in a box

Croatia

Krka d.d., Šmarješka 100 capsules in a brown

Danoval capsules 100 mg capsules cesta 6, Novo mesto, plastic bottle with aluminum YES YES

Republic of Slovenia cap, supplied in a carton box

Abbott GmbH & Co.

50 (5x10) tablets in a blister,

Darob tablets KG, Ludwigshafen, YES YES

supplied in a box

Germany

Abbott GmbH & Co.

50 (5x10) tablets in a blister,

Darob mite tablets KG, Ludwigshafen, YES YES

supplied in a box

Germany

Lek farmacevtska

družba d.d.,

20 (2x10) tablets in a blister,

Dartelin 400 mg tablets film coated tablets Verovškova 57, YES YES

supplied in a box

Ljubljana, Republic of

Slovenia

Amersham Health BV,

DaTscan 74 MBq/mL Den Dolech 2, 10-mL glass vial with 5.0 mL solution for injection YES YES YES

solution for injection Eindhoven, NL 5612 of solution, supplied in a box

AZ, the Netherlands

Amersham Health BV,

DaTscan 74 MBq/mL Den Dolech 2, 10-mL glass vial with 2.5 mL solution for injection YES YES YES

solution for injection Eindhoven, NL 5612 of solution, supplied in a box

AZ, the Netherlands

Ferring GmbH,

Wittland 1, Kiel,

Germany; Ferring 7 syringes each with 1 mL of solution for subcutaneous

Decapeptyl 0.1 mg International Center solution for injection in a YES YES injection

SA, Chemin de la blister, supplied in a box

Vergognausaz,

Switzerland

Ferring GmbH,

micro-capsules for Wittland 1, Kiel, One syringe with 172 mg

preparation of Germany; Ferring microcapsules, one syringe

Decapeptyl CR suspension for International Center with 1 mL of suspending YES YES

subcutaneous or SA, Chemin de la agent, one adapter and one

intramuscular injection Vergognausaz, needle, supplied in a box

Switzerland

Merck KGaA,

10 (1x10) tablets in a PVC/Al

Decortin 20 tablets Frankfurter Straße 250, YES YES

blister, supplied in a box

Darmstadt, Germany

Merck KGaA,

24 (2x10) tablets in a blister

Decortin 5 tablets Frankfurter Straße 250, YES YES

(PVC/Al), supplied in a box

Darmstadt, Germany

The Mentholatum

Company Ltd, 1

35 g of gel in an alumininum

Redwood Avenue,

Deep Freeze Cold gel gel tube with a plastic (HDPE) YES YES YES

Peel Park Campus,

stopper, supplied in a box

East Kilbride, Great

Britain

The Mentholatum

Company Ltd, 1 200 mL (135 g) of spray

Redwood Avenue, solution in a metal container Deep Freeze spray spray, solution YES YES YES

Peel Park Campus, (with PE tube and PP

East Kilbride, Great atmizer) with plastic (PP) cap

Britain

The Mentholatum

Company Ltd, 1 15 g of cream in an

Redwood Avenue, aluminum tube with plastic Deep heat rub cream cream YES YES YES

Peel Park Campus, (HDPE) cap, supplied in a

East Kilbride, Great box

Britain

The Mentholatum

Company Ltd, 1 150 mL of sprey solution in a

Redwood Avenue, metal container (with PE tube Deep Heat spray spray, solution YES YES YES

Peel Park Campus, and PP nebulizer) with

East Kilbride, Great plastic (HDPE) cap

Britain

The Mentholatum

Company Ltd, 1 100 grams of gel in an

Redwood Avenue, Deep relief gel gel aluminum tube, supplied in a YES YES YES

Peel Park Campus, box

East Kilbride, Great

Britain

Dentinox Gesellschaft

10 g of solution in an amber

für pharmazeutische

drops, oromucosal glass bottle with plastic

Dentinox N Präparate Lenk & YES YES

solution dropper and cap, supplied in

Schuppan, Berlin,

a box

Germany

Sanofi Winthrop 100 tablets (two plastic

film coated modified Industrie, 1 rue de la Depakine Chrono 300 mg containers with 50 tablets YES YES

release tablets Vierge, 33440 each) supplied in a box

Ambares, France

Sanofi Winthrop

modified release film Industrie, 1 rue de la 30 tablets in a plastic Depakine Chrono 500 mg YES YES

coated tablets Vierge, 33440 container, supplied in a box

Ambares, France

DEPAKINE Sanofi Winthrop prolonged-release 30 bags with granules,

CHRONOSPHERE 100 Industrie, AMILLY, YES YES granules supplied in a box

mg France

DEPAKINE Sanofi Winthrop prolonged-release 30 bags with granules,

CHRONOSPHERE 1000 Industrie, AMILLY, YES YES granules supplied in a box

mg France

DEPAKINE Sanofi Winthrop prolonged-release 30 bags with granules,

CHRONOSPHERE 250 Industrie, AMILLY, YES YES granules supplied in a box

mg France

DEPAKINE Sanofi Winthrop prolonged-release 30 bags with granules,

CHRONOSPHERE 500 Industrie, AMILLY, YES YES granules supplied in a box

mg France

DEPAKINE Sanofi Winthrop prolonged-release 30 bags with granules,

CHRONOSPHERE 750 Industrie, AMILLY, YES YES granules supplied in a box

mg France

Pliva Croatia Ltd., Ulica

grada Vukovara 49, Box with 30 tablets (blister, Deprozel tablets 20 mg film coated tablets YES YES

Zagreb, Republic of 3x10 tbl.)

Croatia Pliva Croatia Ltd., Ulica

grada Vukovara 49, Box with 30 tablets (blister, Deprozel tablets 30 mg film coated tablets YES YES

Zagreb, Republic of 3x10 tbl.)

Croatia

Dr. August Wolff 100 grams of suspension in

suspension for topical GmbH & Co. Dercome Clear a plastic tube, supplied in a YES YES

application to the skin Arzneimittel, Bielefeld, box

Germany

Les Laboratories 30 (2x15) film coated tablets

Servier Industrie, 905 Detralex film coated tablets in a PVC/Al blister, supplied YES YES

route de Saran, 45520 in a box

Gidy, France

30 (3x10) coated tablets in a Detrunorm coated tablets Apogepha Arzneimittel

coated tablets PVC/A1 blister, supplied in a YES YES 15 mg GmbH, Germany

box

Krka d.d., Šmarješka 25 ampoules (5x5) each Dexamethason Krka

solution for injection cesta 6, Novo mesto, containing 1 mL of solution in YES YES solution for injection

Republic of Slovenia a blister, supplied in a box

Krka d.d., Šmarješka Dexamethason Krka 10 tablets in a blister,

tablets cesta 6, Novo mesto, YES YES tablets supplied in a box

Republic of Slovenia

Schering AG, Diane-35 sugar-coated 63 (3x21) tablets in a PVC/Al

sugar-coated tablets Muellerstrasse 170- YES YES tablets blister, supplied in a box

178, Berlin, Germany

BAXTER Healthcare 5x1 plastic bags with 2000 Dianeal PD1 solution for

S.A., Monreen Road, mL of solution and 5x1 empty peritoneal dialysis with solution for peritoneal

Castlebar, County bags (for draining of liquid), YES YES 1.36% glucose and dialysis

Mayo, Republic of in a protective plastic bag; electrolytes

Ireland supplied in a carton box

BAXTER Healthcare 5x1 plastic bags with 2000 Dianeal PD1 solution for

S.A., Monreen Road, mL of solution and 5x1 empty peritoneal dialysis with solution for peritoneal

Castlebar, County bags (for draining of liquid), YES YES 2.27% glucose and dialysis

Mayo, Republic of in a protective plastic bag; electrolytes

Ireland supplied in a carton box

BAXTER Healthcare 5x1 plastic bags with 2000 Dianeal PD1 solution for

S.A., Monreen Road, mL of solution and 5x1 empty peritoneal dialysis with solution for peritoneal

Castlebar, County bags (for draining of liquid), YES YES 3.86% glucose and dialysis

Mayo, Republic of in a protective plastic bag; electrolytes

Ireland supplied in a carton box

BAXTER Healthcare Dianeal PD4 solution for 2x1 plastic bags containing

S.A., Monreen Road, peritoneal dialysis with solution for peritoneal 5000 mL of solution in a

Castlebar, County YES YES 1.36% glucose and dialysis protective plastic bag,

Mayo, Republic of electrolytes supplied in a box

Ireland

5x1 plastic bags with 2000 BAXTER Healthcare

Dianeal PD4 solution for mL of solution with

S.A., Monreen Road, peritoneal dialysis with solution for peritoneal attachments and one empty

Castlebar, County YES YES 1.36% glucose and dialysis bag (for draining of liquid), in

Mayo, Republic of electrolytes a protective plastic bag;

Ireland supplied in a box

4x1 plastic bags with 2500 BAXTER Healthcare

Dianeal PD4 solution for mL of solution with

S.A., Monreen Road, peritoneal dialysis with solution for peritoneal attachments and one empty

Castlebar, County YES YES 1.36% glucose and dialysis bag (for draining of liquid), in

Mayo, Republic of electrolytes a protective plastic bag,

Ireland supplied in a box

BAXTER Healthcare Dianeal PD4 solution for

S.A., Monreen Road, 5x1 plastic bags with 2000 peritoneal dialysis with solution for peritoneal

Castlebar, County mL of solution in a protective YES YES 1.36% glucose and dialysis

Mayo, Republic of plastic bag, supplied in a box electrolytes

Ireland

5x1 plastic bags with 2000 BAXTER Healthcare

Dianeal PD4 solution for mL of solution with

S.A., Monreen Road, peritoneal dialysis with solution for peritoneal attachments and one empty

Castlebar, County YES YES 2.27% glucose and dialysis bag (for draining of liquid), in

Mayo, Republic of electrolytes a protective plastic bag;

Ireland supplied in a box

BAXTER Healthcare Dianeal PD4 solution for

S.A., Monreen Road, 5x1 plastic bags with 2000 peritoneal dialysis with solution for peritoneal

Castlebar, County mL of solution in a protective YES YES 2.27% glucose and dialysis

Mayo, Republic of plastic bag, supplied in a box electrolytes

Ireland

BAXTER Healthcare Dianeal PD4 solution for 2x1 plastic bags containing

S.A., Monreen Road, peritoneal dialysis with solution for peritoneal 5000 mL of solution in a

Castlebar, County YES YES 2.27% glucose and dialysis protective plastic bag,

Mayo, Republic of electrolytes supplied in a box

Ireland

4x1 plastic bags with 2500 BAXTER Healthcare

Dianeal PD4 solution for mL of solution with

S.A., Monreen Road, peritoneal dialysis with solution for peritoneal attachments and one empty

Castlebar, County YES YES 2.27% glucose and dialysis bag (for draining of liquid), in

Mayo, Republic of electrolytes a protective plastic bag,

Ireland supplied in a box

BAXTER Healthcare Dianeal PD4 solution for

S.A., Monreen Road, 5x1 plastic bags with 2000 peritoneal dialysis with solution for peritoneal

Castlebar, County mL of solution in a protective YES YES 3.86% glucose and dialysis

Mayo, Republic of plastic bag, supplied in a box electrolytes

Ireland

4x1 plastic bags with 2500 BAXTER Healthcare

Dianeal PD4 solution for mL of solution with

S.A., Monreen Road, peritoneal dialysis with solution for peritoneal attachments and one empty

Castlebar, County YES YES 3.86% glucose and dialysis bag (for draining of liquid), in

Mayo, Republic of electrolytes a protective plastic bag,

Ireland supplied in a box

BAXTER Healthcare Dianeal PD4 solution for 2x1 plastic bags containing

S.A., Monreen Road, peritoneal dialysis with solution for peritoneal 5000 mL of solution in a

Castlebar, County YES YES 3.86% glucose and dialysis protective plastic bag,

Mayo, Republic of electrolytes supplied in a box

Ireland

5x1 plastic bags with 2000 BAXTER Healthcare

Dianeal PD4 solution for mL of solution with

S.A., Monreen Road, peritoneal dialysis with solution for peritoneal attachments and one empty

Castlebar, County YES YES 3.86% glucose and dialysis bag (for draining of liquid), in

Mayo, Republic of electrolytes a protective plastic bag;

Ireland supplied in a box

Les Laboratories

Servier Industrie, 905 60 (3x20) tablets in a blister, Diaprel tablets YES YES

route de Saran, 45520 supplied in a box

Gidy, France

Les Laboratoires

Servier Industrie, Gidy,

France; Servier 60 (2x30) tablets in a blister

Diaprel MR modified release tablets Republic of Ireland YES YES

(PVC/Al), supplied in a box Industries Ltd.,

Arcklow, Co. Wicklow,

Republic of Ireland

Alkaloid AD - Skopje, Diazepam Alkaloid 10 10 amber glass ampoules

Bulevar Aleksandar mg/2 mL solution for solution for injection each containing 2 mL of YES YES

Makedonski 12, injection solution, supplied in a box

Skopje, FYROM

Alkaloid AD - Skopje, 30 coated tablets in a 15 mL

Diazepam Alkaloid 2 mg Bulevar Aleksandar coated tablets amber glass bottle, supplied YES YES

coated tablets Makedonski 12, in a box

Skopje, FYROM

Alkaloid AD - Skopje, 30 coated tablets in a 15 mL

Diazepam Alkaloid 5 mg Bulevar Aleksandar coated tablets amber glass bottle, supplied YES YES

coated tablets Makedonski 12, in a box

Skopje, FYROM

5 (5x1) plastic containers

Desitin Arzneimittel each with 2.5 mL of solution Diazepam Desitin 10 mg

rectal solution GmbH, Hamburg, (with applicator for rectal YES YES rectal solution

Germany administration) in a protective

bag, supplied in a box 5 (5x1) plastic containers

Desitin Arzneimittel each with 2.5 mL of solution Diazepam Desitin 5 mg

rectal solution GmbH, Hamburg, (with applicator for rectal YES YES rectal solution

Germany administration) in a protective

bag, supplied in a box

Jadran - Galenski

laboratorij d.d., Pulac 30 (3x10) tablets in a blister, Diazepam Jadran 10 mg tablets YES YES

bb, Rijeka, Republic of supplied in a box

Croatia

Jadran - Galenski

laboratorij d.d., Pulac 30 (3x10) tablets in a blister, Diazepam Jadran 2 mg tablets YES YES

bb, Rijeka, Republic of supplied in a box

Croatia

Jadran - Galenski

laboratorij d.d., Pulac Box with 30 (3x10) tablets in Diazepam Jadran 5 mg tablets YES YES

bb, Rijeka, Republic of a blister

Croatia

TemmLer Werke 20 (2x10) capsules in a modified release

Diclo Duo capsules 75 mg GmbH, München, blister (PVC/PVDC/Al), YES YES capsules, hard

Germany supplied in a box

15-mL amber glass bottle Pharbil Waltrop GmbH,

containing 12.5 g solution, dermatological spray, Im Wirrigen 25, D-

Diclo Duo spray 4% with metering pump/ spraying YES YES YES YES YES solution 45731 Waltrop,

attachment and protective Germany

cap, supplied in a carton box

Astellas Pharma 10 (1x10) capsules in a gastric-resistant

DICLORAPID 75 mg GmbH, München, PVC/PVdC/Al blister, YES YES YES YES capsules, hard

Germany supplied in a box

Astellas Pharma 20 (2x10) capsules in a gastric-resistant

Diclorapid 75 mg GmbH, München, PVC/PVDC/Al blister, YES YES YES YES capsules, hard

Germany supplied in a box

Lek farmacevtska

solution for injection for družba d.d., 10 (2x5) ampoules each Dicynone 250 mg/2 mL

intramuscular use and Verovškova 57, containing 2 mL of solution in YES YES injection

intravenus infusion Ljubljana, Republic of a blister, supplied in a box

Slovenia

Pliva Croatia Ltd., Ulica 100 (10x10) tablets in

grada Vukovara 49, DIFETOIN tablets OPA/Al/PVC//Al blister, YES YES

Zagreb, Republic of supplied in a box

Croatia

DIFLUCAN 100 mg Pfizer PGM, Poce-sur 7 (1x7) capsules in (PVC/Al) capsules YES YES

capsules Cisse, France blister, supplied in a box

DIFLUCAN 150 mg Pfizer PGM, Poce-sur One (1x1) capsule in a blister capsules YES YES

capsules Cisse, France (PVC/Al) supplied in a box

DIFLUCAN 50 mg Pfizer PGM, Poce-sur 7 (1x7) capsules in (PVC/Al) capsules YES YES

capsules Cisse, France blister, supplied in a box

100 mL of solution in a glass

DIFLUCAN solution for Pfizer PGM, Poce-sursolution for infusion bottle for infusion, supplied in YES YES

infusion Cisse, France a box

Plastic (HDPE) bottle of 60

mL (with a plastic, temperevident

stopper) with powder

DIFLUCAN powder for powder for oral Pfizer PGM, Poce-surfor preparation of 35 mL of YES YES

suspension 50 mg/7 mL suspension Cisse, France suspension and a plastic

measuring spoon (of 5 mL),

supplied in a box

Imunološki zavod d.d.,

Diphtheria antitoxin solution for parenteral Rockefellerova 2, Box with 1 bottle containing

YES (equine) 10000 IU use Zagreb, Republic of 10000 IU of preparation

Croatia

Imunološki zavod d.d.,

Diphtheria antitoxin solution for parenteral Rockefellerova 2, Box with 50 bottles with

YES (equine) 10000 IU use Zagreb, Republic of 10000 IU of preparation

Croatia

Pliva Croatia Ltd., Ulica 60 (6x10) tablets in a blister, Diglical tablets 80 mg tablets YES YES

grada Vukovara 49, supplied in a box Zagreb, Republic of

Croatia

Krka d.d., Novo Mesto,

Republic of Slovenia in

30 (2x15) tablets in a blister,

Dihalar tablets tablets cooperation with YES YES

supplied in a box

Novartis Pharma Ltd.,

Switzerland

Farmal d.d., Branitelja

Diklofenak retard 100 mg domovinskog rata 8, 20 (2x10) tablets in a blister, prolonged-release tablets YES YES

tablets Ludbreg, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 60 g of gel in an aluminium Diklonat P gel gel YES YES YES

Zagreb, Republic of tube, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

30 (3x10) tablets in a PVC/Al

grada Vukovara 49,

Diltiazem Pliva 60 mg tablets blister, supplied in a carton YES YES

Zagreb, Republic of

box

Croatia

Pliva Croatia Ltd., Ulica

30 (3x10) tablets in a PVC/Al

grada Vukovara 49,

Diltiazem Pliva 90 mg tablets blister, supplied in a carton YES YES

Zagreb, Republic of

box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 32 (3x10) tablets in a PVC/Al Dimidril tablets tablets YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, One (1x1) tablet in a blister Dinamico tablets 100 mg film tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, One (1x1) tablet in a blister Dinamico tablets 25 mg film tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, One (1x1) tablet in a blister Dinamico tablets 50 mg film tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Novartis Pharma

Produktions GmbH, 28 (2x14) tablets in a blister, Diovan 160 mg film-tablets film coated tablets YES YES YES YES

Öflinger Strasse 44, supplied in a box

Wehr, Germany

Novartis Pharma

28 (2x14) tablets in a blister

Produktions GmbH,

Diovan 320 mg film-tablets film coated tablets (PVC/PVDC//Al), supplied in YES YES YES YES

Öflinger Strasse 44,

a box

Wehr, Germany

Novartis Pharma

Produktions GmbH, 28 (2x14) tablets in a blister, Diovan 40 mg film-tablets film coated tablets YES YES YES YES

Öflinger Strasse 44, supplied in a box

Wehr, Germany

Novartis Pharma

Produktions GmbH, 28 (2x14) tablets in a blister, Diovan 80 mg flim-tablets film coated tablets YES YES YES YES

Öflinger Strasse 44, supplied in a box

Wehr, Germany

Schering-Plough Labo 15 g of cream in an

N.V. Industrepark 30, Diprogenta cream cream aluminum tube, supplied in a YES YES

Heist-op-den-Berg, box

Belgium

Schering-Plough Labo

N.V. Industrepark 30, Aluminium tube with 15 g of Diprogenta ointment ointment YES YES

Heist-op-den-Berg, ointment, supplied in a box

Belgium

Schering-Plough Labo

30 mL of lotion in a plastic

Diprosalic losion lotion N.V., Heist-op-den YES YES

bottle, supplied in a box

Berg, Belgium;

Schering-Plough

France, Herouville

Saint-Clair, France

Schering-Plough Labo 15 g of cream in an

N.V. Industrepark 30, Diprosalic ointment ointment aluminum tube, supplied in a YES YES

Heist-op-den-Berg, box

Belgium

Fresenius Kabi AB,

Stockholm, Sweden

and AstraZeneca SpA, Box with 5 ampoules

Disoprivan 1% propofolum emulsion for infusion Caponago, Italy for YES YES containing 20 mL of emulsion

AstraZeneca UK Ltd.,

Macclesfield, Cheshire,

Great Britain

Jadran - Galenski 50 capsules in an amber

laboratorij d.d., Pulac Disopyramide JADRAN capsules glass bottle, supplied in a YES YES

bb, Rijeka, Republic of box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 20 (2x10) tablets in a blister, Diuver 10 mg tablets tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 20 (2x10) tablets in a blister, Diuver 5 mg tablets tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Wuelfing Pharma 50 mL of solution for infusion

Dobutamin Admeda 250 solution for infusion GmbH, Gronau, in a glass ampoule, 1 YES YES

Germany ampoule in a box

Belupo, lijekovi i 6 capsules in a white plastic

DOKSICIKLIN 100 mg kozmetika d.d., Ulica (PP) bottle of 50 mL bag with capsules, hard YES YES

capsules Danica 5, Koprivnica, a temper-evident (PP/PE)

Republic of Croatia stopper, supplied in a box

Jadran - Galenski 25 grams of gel in an

laboratorij d.d., Pulac aluminum tube with plastic Dolokain gel gel YES YES

bb, Rijeka, Republic of cap (in a protective bag),

Croatia supplied in a carton box

5 glass ampoules each with

concentrate of solution Wuelfing Pharma 10.3 mL of solution for Dopamin Admeda 200 YES YES

for infusion GmbH infusion concentrate,

supplied in a box

5 glass ampoules each with

concentrate of solution Wuelfing Pharma 5.3 mL of solution for infusion Dopamin Admeda 50 YES YES

for infusion GmbH concentrate, supplied in a

box

F. Hoffmann-La Roche

Ltd., 10 (1x10) tablets in a blister,

Dormicum 15 mg tablets film coated tablets Grenzacherstrasse YES YES supplied in a box

124, Basel,

Switzerland

F. Hoffmann-La Roche

Ltd., Dormicum 15 mg/3 mL 5 ampoules with 3 mL of

solution for injection Grenzacherstrasse YES YES injection solution, supplied in a box

124, Basel,

Switzerland

F. Hoffmann-La Roche

Ltd., 10 ampoules each containing Dormicum 5 mg/1 mL

solution for injection Grenzacherstrasse 1 mL of solution, supplied in YES YES injection

124, Basel, a box

Switzerland

F. Hoffmann-La Roche

Ltd., 10 (1x10) tablets in a blister,

Dormicum 7.5 mg tablets film coated tablets Grenzacherstrasse YES YES supplied in a box

124, Basel,

Switzerland

20 mL of solution in a glass

Guerbet, Roissy CdG

Dotarem 0.5 mmol/mL solution for injection bottle with rubber stopper, YES YES YES

Cedex, France

supplied in a box

15 mL of solution in a glass Guerbet, Roissy CdG

Dotarem 0.5 mmol/mL solution for injection bottle with rubber stopper, YES YES YES

Cedex, France supplied in a box

Jadran - Galenski

laboratorij d.d., Pulac 20 (2x10) tablets in a blister, Doxazin 2 mg tablets YES YES

bb, Rijeka, Republic of supplied in a box

Croatia

Jadran - Galenski

laboratorij d.d., Pulac 20 (2x10) tablets in a blister, Doxazin 4 mg tablets YES YES

bb, Rijeka, Republic of supplied in a box

Croatia

Ebewe Pharma Ges. 5 mL of solution concentrate

DOXORUBICIN EBEWE concentrate of solution m.b.H. Nfg. KG, in an amber glass bottle (with

YES YES 10 mg/ 5 mg for infusion Mondseestrasse 11, a rubber stopper), supplied in

Unterach, Austria a box

Ebewe Pharma Ges. 25 mL of solution

DOXORUBICIN EBEWE concentrate of solution m.b.H. Nfg. KG, concentrate in an amber

YES YES 50 mg/ 25 mg for infusion Mondseestrasse 11, glass bottle (with rubber

Unterach, Austria stopper), supplied in a box

5-mL bottle containing 10 mg Pliva Lachema,

Doxorubicin Pliva injection powder for solution for of powder, with bromobutyl

Karasek 1, 62133 YES YES 10 mg injection stopper and aluminum cap

Brno, Czech Republic

and ring, supplied in a box

25-mL bottle containing 50

Pliva Lachema, mg of powder, with Doxorubicin Pliva injection powder for solution for

Karasek 1, 62133 bromobutyl stopper and YES YES 50 mg injection

Brno, Czech Republic aluminum cap and ring,

supplied in a box

Colourless glass bottle (glass

type I) with a rubber stopper

Pharmachemie B.V., (chlorobutyl) coated with

Doxorubicin-Teva 2 mg/mL solution for injection Haarlem, the fluoropolymer film, aluminium YES YES YES YES

Netherlands ring and polypropylene lid

containing 5 mL of solution,

supplied in a box

Colourless glass bottle (glass

type I) with a rubber stopper

Pharmachemie B.V., (chlorobutyl) coated with

Doxorubicin-Teva 2 mg/mL solution for injection Haarlem, the fluoropolymer film, aluminium YES YES YES YES

Netherlands ring and polypropylene lid

containing 25 mL of solution,

supplied in a box

Dr. Theiss Mucoplant Dr. Theiss Naturwaren 50 g of ointment in an amber

eucalyptus balm against ointment GmbH, Homburg, glass bottle with a wide neck, YES YES

cold Germany supplied in a box

Jadran - Galenski

laboratorij d.d., Pulac 10 tablets in a A/PVC blister, Dramina tablets YES YES YES

bb, Rijeka, Republic of supplied in a carton box

Croatia

Laboratories Fournier

60 (2x30) tablets in a blister

Driptane tablets S.A., Fontaine les YES YES

(PVC/Al), supplied in a box

Dijon, France

Boehringer Ingelheim

6 suppositories in aluminium

Dulcolax suppositories suppositories Italia S.p.A., Firenca, YES YES YES

foil, supplied in a box

Italy

Boehringer Ingelheim

30 (3x10) coated tablets in a

France, 12, Rue Andre

Dulcolax coated tablets coated tablets PVC/PVDC-Al blister, YES YES YES

Huet, Reims, Cedex,

supplied in a box

France

Solvay 100 mL of intestinal gel in a

Pharmaceuticals PVC bag with a plastic tube

Duodopa intestinal gel intestinal gel GmbH, Justus-vonand pump attachement, YES YES YES YES

Liebig-Strasse 33, inside a hard plastic

Neustadt, Germany cassette, carton with 7

casettes

Solvay

Pharmaceuticals B.V., 42 (3x14) tablets in a blister Duphaston film coated tablets YES YES

Weesp, the (PVC/Al), supplied in a box

Netherlands

Solvay

Pharmaceuticals B.V., 20 (1x20) tablets in a blister Duphaston film coated tablets YES YES

Weesp, the (PVC/Al), supplied in a box

Netherlands

Jadran -Galenski

laboratorij d.d., Rijeka,

Republic of Croatia, in 12 capsules (2x6) in

DURACEF 250 mg cooperation with capsules PVC/PVDC//Al blister, YES YES

capsules Bristol-Myers Squibb supplied in a box

S.p.A., Contrada

Fontana del Cerasp.

Anagni, Italy

Jadran -Galenski

laboratorij d.d., Rijeka,

Republic of Croatia, in 12 capsules (2x6) in

DURACEF 500 mg cooperation with capsules PVC/PVDC//Al blister, YES YES

capsules Bristol-Myers Squibb supplied in a box

S.p.A., Contrada

Fontana del Cerasp.

Anagni, Italy

Jadran -Galenski

laboratorij d.d., Rijeka, 35 g of powder for oral

Republic of Croatia, in suspension in a 60 mL

Duracef powder for oral powder for preparation of cooperation with plastic (HDPE) bottle with a YES YES

suspension 250 mg/5 mL oral suspension Bristol-Myers Squibb plastic measuring spoon,

S.p.A., Contrada supplied in a box

Fontana del Cerasp.

Anagni, Italy

Jadran -Galenski

laboratorij d.d., Rijeka,

Republic of Croatia, in

Duracef 1 g dispersible cooperation with 10 (2x5) tablets in blisters, dispersible tablets YES YES

tablets Bristol-Myers Squibb supplied in a box

S.p.A., Contrada

Fontana del Cerasp.

Anagni, Italy

Janssen 5 transdermal patches

Durogesic transdermal Pharmaceutica NV, (individually packed in a transdermal patch YES YES

patch 100 ug/h Turnhouseweg 30, protective bag), supplied in a

Beerse, Belgium box

Janssen 5 transdermal patches

Durogesic transdermal Pharmaceutica NV, (individually packed in a transdermal patch YES YES

patch 12 µg/h Turnhouseweg 30, protective bag), supplied in a

Beerse, Belgium box

Janssen 5 transdermal patches

Durogesic transdermal Pharmaceutica NV, (individually packed in a transdermal patch YES YES

patch 12 microg/h Turnhouseweg 30, protective bag), supplied in a

Beerse, Belgium box

Janssen 5 transdermal patches

Durogesic transdermal Pharmaceutica NV, (individually packed in a transdermal patch YES YES

patch 25 ug/h Turnhouseweg 30, protective bag), supplied in a

Beerse, Belgium box

Janssen 5 transdermal patches

Durogesic transdermal Pharmaceutica NV, (individually packed in a transdermal patch YES YES

patch 50 ug/h Turnhouseweg 30, protective bag), supplied in a

Beerse, Belgium box

Janssen 5 transdermal patches

Durogesic transdermal Pharmaceutica NV, (individually packed in a transdermal patch YES YES

patch 75 µg/h Turnhouseweg 30, protective bag), supplied in a

Beerse, Belgium box SOL SpA, Cremona, 10 or 40 l of nitrogen oxidule

Nitric oxidul medical gas Italy i SOL SpA, in stainless steel bottles YES YES

Marcianise, Italy under pressure of 50 bars

Messer Croatia Plin 11 or 40 l of nitrogen oxidule

d.o.o., Zaprešić, Nitric oxidul medical gas in stainless steel bottles YES YES

Industrijska 1, Republic under pressure of 50 bars

of Croatia

IPSEN BIOPHARM 2 glass bottles of lyophilisate lyophilisate for solution

Dysport LIMITED, Wrexham, for preparation of injection, YES for injection

Great Britain supplied in a box

lyophilisate for IPSEN BIOPHARM Glass vial with lyophilisate for

Dysport preparation of solution for LIMITED, Wrexham, preparation of injection, YES

injections Great Britain supplied in a box

H. Lundbeck A/S,

Ottilavej 9, 28 (2x14) tablets in a blister, Ebixa 10 mg tablets film coated tablets YES YES

Copenhagen-Valby, supplied in a box

Denmark

H. Lundbeck A/S, 50 g of solution in an amber

Ottilavej 9, glass bottle with a dropper Ebixa 10 mg/g oral drops solution for oral drops YES YES

Copenhagen-Valby, and a plastic stopper,

Denmark supplied in a box

Altana Pharma AG, 5 ampoules each with 5 mL

Ebrantil 25 iv. solution for injection Byk-Gulden Strasse 2, YES YES of solution, supplied in a box

Konstanz, Germany

50 prolonged release Altana Pharma prolonged release capsules in a plastic bottle Ebrantil 30 capsules Oranienburg GmbH, YES YES

capsules with a desiccant, supplied in Oranienburg, Germany

a box

Altana Pharma AG, 5 ampoules each with 10 mL

Ebrantil 50 iv. solution for injection Byk-Gulden Strasse 2, YES YES of solution, supplied in a box

Konstanz, Germany

50 prolonged release Altana Pharma prolonged release capsules in a plastic bottle Ebrantil 60 capsules Oranienburg GmbH, YES YES

capsules with a desiccant, supplied in Oranienburg, Germany

a box

50 prolonged release Altana Pharma prolonged release capsules in a plastic bottle Ebrantil 90 capsules Oranienburg GmbH, YES YES

capsules with a desiccant, supplied in Oranienburg, Germany

a box

Lek farmacevtska

družba d.d., 20 tablets in an amber glass Edemid forte 500 mg

tablets Verovškova 57, bottle, supplied in a carton YES YES tablets

Ljubljana, Republic of box

Slovenia

Lek farmacevtska

družba d.d., 5 ampoules with 10 mL of Edemid forte 250mg/10mL solution for infusion

Verovškova 57, solution in a plastic YES YES injection (concentrate)

Ljubljana, Republic of container, supplied in a box

Slovenia

Lek farmacevtska

družba d.d., One glass vial with powder Edicin 0.5 g injection for

powder for injection Verovškova 57, for injection, supplied in a YES YES intravenous infusion

Ljubljana, Republic of box

Slovenia

Lek farmacevtska

družba d.d., One glass vial with powder Edicin 1.0 g injection for

powder for injection Verovškova 57, for injection, supplied in a YES YES intravenous infusion

Ljubljana, Republic of box

Slovenia

Pfizer Italia S.r.l., 60 (3x20) tablets in a blister,

EDRONAX tablets 4 mg tablets Marina De Tronto, YES YES supplied in a box

Ascoli Piceno, Italy

Wyeth Medica

Efectin ER capsules 150 prolonged release Republic of Ireland, Box with 28 capsules (blister,

YES YES mg capsules Newbridge, Republic of 2x14 capsules)

Ireland Wyeth Medica

Efectin ER capsules 37.5 prolonged-release Republic of Ireland, Box with 30 capsules (blister,

YES YES mg capsules Newbridge, Republic of 3x10 capsules)

Ireland

Wyeth Medica

prolonged release Republic of Ireland, Box with 28 capsules (blister, Efectin ER capsules 75 mg YES YES

capsules Newbridge, Republic of 2x14 capsules)

Ireland

Bristol-Myers Squibb,

304, avenue du Dr.

Jean Bru, Agen, 8 effervescent tablets in a Efferalgan 1 g effervescent

effervescent tablets France; Bristol-Myers plastic tube, supplied in a YES YES YES tablets

Squibb, 979 Avenue box

des Pyrenees, Le

Passage, France

Bristol-Myers Squibb,

10 (2x5) suppositories in a

Efferalgan 150 mg 304, avenue du Dr

suppositories PVC/PE strip, supplied in a YES YES YES

suppositories Jean Bru, Agen,

box

France

Bristol-Myers Squibb,

10 (2x5) suppositories in a

Efferalgan 300 mg 304, avenue du Dr

suppositories PVC/PE strip, supplied in a YES YES YES

suppositories Jean Bru, Agen,

box

France

Bristol-Myers Squibb,

304, avenue du Dr

Jean Bru, Agen, 16 (4x4) effervescent tablets EFFERALGAN 500 mg,

effervescent tablets France i Bristol-Myers in a strip (Al/PE), supplied in YES YES YES effervescent tablets

Squibb, 979 Avenue a box

des Pyrénés, Le

Passage, France

Bristol-Myers Squibb,

10 (2x5) suppositories in a

Efferalgan 80 mg 304, avenue du Dr

suppositories PVC/PE strip, supplied in a YES YES YES

suppositories Jean Bru, Agen,

box

France

Bristol-Myers Squibb, 90 mL of solution in a brown

Efferalgan solution for 304, avenue du Dr plastic bottle with a tempersolution for oral use YES YES YES

children Jean Bru, Agen, evident stopper, supplied in a

France box

Bristol-Myers Squibb,

304, avenue du Dr.

EFFERALGAN plus Jean Bru, Agen, 10 effervescent tablets in a

vitamin C, effervescent effervescent tablets France; Bristol-Myers polypropylene tube, supplied YES YES YES

tablets Squibb, 979 Avenue in a box

des Pyrenees, Le

Passage, France

Allergan

Pharmaceuticals 5 mL of suspension in a

Efflumidex Liquifilm eye Republic of Ireland, eye drops, suspension plastic bottle with a dropper, YES YES

drops Castlebar Road, supplied in a box

Westport, Co Mayo,

Republic of Ireland

Farmal d.d., Branitelja

domovinskog rata 8, 10 (1x10) tablets in a Al/Al EFOX tablets 250 mg film coated tablets YES YES

Ludbreg, Republic of blister, supplied in a box

Croatia

Farmal d.d., Branitelja

domovinskog rata 8, 10 (1x10) tablets in a Al/Al Efox tablets 500 mg film coated tablets YES YES

Ludbreg, Republic of blister, supplied in a box

Croatia

Alkaloid AD-Skopje, 30 colourless glass

Eglonyl 100 mg/2 mL Skopje, FYROM in ampoules each containing 2 solution for injection YES YES

solution for injection cooperation with mL of solution, supplied in a

Sanofi-Aventis, France box

Alkaloid AD-Skopje, 120 mL of solution in an

Eglonyl 25 mg/5 mL oral Skopje, FYROM in oral solution amber glass botlle with YES YES

solution cooperation with dispenser, supplied in a box Sanofi-Aventis, France

Alkaloid AD - Skopje, 30 capsules in an amber

Bulevar Aleksandar Eglonyl 50 mg capsules capsules glass bottle, supplied in a YES YES

Makedonski 12, box

Skopje, FYROM

Alkaloid AD-Skopje,

Skopje, FYROM in 12 tablets in an amber glass Eglonyl forte tablets tablets YES YES

cooperation with bottle, supplied in a box

Sanofi-Aventis, France

Elaprase 2 mg/mL Shire Human Genetic 5-mL glass bottle with 3-mL concentrate for infusion

concentrate for infusion Therapies AB, of concentrate supplied in a YES YES YES YES solution

solution Danderyd, Sweden box

Elaprase 2 mg/mL Shire Human Genetic 10 5-mL glass bottles with 3 concentrate for solution

concentrate for infusion Therapies AB, mL of concentrate, supplied YES YES YES YES for infusion

solution Danderyd, Sweden in a box

Elaprase 2 mg/mL Shire Human Genetic 4 glass bottles (à 5 mL) with concentrate for solution

concentrate for solution for Therapies AB, 3 mL of concentrate, YES YES YES YES for infusion

infusion Danderyd, Sweden supplied in a box

30 (3x10) film coated tablets Rottendorf Pharma

ELEVIT PRONATAL film in a blister film coated tablets GmbH, Enningerloh, YES YES YES

coated tablets (PVC/PE/PVDC//Al),

Germany supplied in a box

Novartis Pharma 15 g of cream in an

Produktions GmbH, Elidel 1 % cream 15 g cream aluminum tube, supplied in a YES YES

Öflinger Strasse 44, box

Wehr, Germany

Schering-Plough Labo 15 g of cream in an

N.V. Industrepark 30, Elocom cream cream aluminum tube, supplied in a YES YES

Heist-op-den-Berg, box

Belgium

Schering-Plough Labo

20 mL of lotion in a plastic

N.V. Industrepark 30,

Elocom lotion lotion bottle with dropper YES YES

Heist-op-den-Berg,

attachment, supplied in a box

Belgium

Schering-Plough Labo 15 g of cream in an

N.V. Industrepark 30, Elocom ointment ointment aluminum tube, supplied in a YES YES

Heist-op-den-Berg, box

Belgium

Alcon-Couvreur s.a., Bottle-dropper with 5 mL of

Emadine eye drops eye drops Rijksweg 14, Puurs, sterile solution, supplied in a YES YES

Belgium box

Merck Sharp & Dohme

One (1x1) capsule in a blister

Emend 125 mg hard B.V., Waarderweg 39,

capsules, hard back (Al/Al) supplied in a YES YES YES YES

capsules Postbus 581, Haarlem,

carton box

The Nederlands

Merck Sharp & Dohme One 125-mg capsule in a Emend 125 mg hard

B.V., Waarderweg 39, blister (Al/Al) and two 80-mg capsules / Emend 80 mg hard capsules YES YES YES YES

Postbus 581, Haarlem, capsules in a blister (A/Al), hard capsules

the Netherlands supplied in a box

Merck Sharp & Dohme

Emend 40 mg hard B.V., Waarderweg 39, One capsule in a blister capsules, hard YES YES YES YES

capsules Postbus 581, Haarlem, (Al/Al), supplied in a box

the Netherlands

Merck Sharp & Dohme

Emend 80 mg hard B.V., Waarderweg 39, 2 (1x2) capsules in a blister capsules, hard YES YES YES YES

capsules Postbus 581, Haarlem, (Al/Al), supplied in a box

the Netherlands

Belupo, lijekovi i 210 tablets in a white plastic

kozmetika d.d., Ulica (HDPE) bottle with temper Eminens 0.25 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, proof closure and desiccant,

Republic of Croatia supplied in a box

Belupo, lijekovi i 21 tablets in a white (HDPE)

kozmetika d.d., Ulica plastic bottle with temper Eminens 0.5 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, proof closure and desiccant,

Republic of Croatia supplied in a box

Belupo, lijekovi i 21 tablets in a white (HDPE) Eminens 1 mg tablets film coated tablets YES YES

kozmetika d.d., Ulica plastic bottle with temper Danica 5, Koprivnica, proof closure and desiccant,

Republic of Croatia supplied in a box

Belupo, lijekovi i 21 tablets in a white (HDPE)

kozmetika d.d., Ulica plastic bottle with temper Eminens 2 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, proof closure and desiccant,

Republic of Croatia supplied in a box

Belupo, lijekovi i 21 tablets in a white (HDPE)

kozmetika d.d., Ulica plastic bottle with temper Eminens 5 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, proof closure and desiccant,

Republic of Croatia supplied in a box

Novartis Pharma Stein 28 (4x7) tablets in a blister

AG, Emselex 15 mg prolonged-release tablets (PVC/PVDC//Al), supplied in YES YES YES

Schaffhauserstrasse, a box

Stein, Switzerland

Novartis Pharma Stein 28 (4x7) tablets in a blister

AG, Emselex 7.5 mg prolonged-release tablets (PVC/PVDC//Al), supplied in YES YES YES

Schaffhauserstrasse, a box

Stein, Switzerland

Krka d.d., Šmarješka 20 (2x10) tablets in a blister

Enap -H tablets tablets cesta 6, Novo mesto, (OPA/Al/PVC//Al), supplied in YES YES

Republic of Slovenia a box

Krka d.d., Šmarješka 20 (2x10) tablets in a blister,

Enap HL tablets tablets cesta 6, Novo mesto, YES YES supplied in a box Republic of Slovenia

Krka d.d., Šmarješka 20 (2x10) tablets in a blister

Enap tablets 10 mg tablets cesta 6, Novo mesto, (OPA/Al/PVC//Al), supplied in YES YES

Republic of Slovenia a box

Krka d.d., Šmarješka 20 (2x10) tablets in a blister

Enap tablets 20 mg tablets cesta 6, Novo mesto, (OPA/Al/PVC//Al), supplied in YES YES

Republic of Slovenia a box

Krka d.d., Šmarješka 20 (2x10) tablets in a blister

Enap tablets 5 mg tablets cesta 6, Novo mesto, (OPA/Al/PVC//Al), supplied in YES YES

Republic of Slovenia a box

Krka d.d., Šmarješka 60 (6x10) tablets in a blister,

Enap-HL 20 tablets tablets cesta 6, Novo mesto, YES YES supplied in a box Republic of Slovenia

Krka d.d., Šmarješka 20 (2x10) tablets in a blister,

Enap-HL 20 tablets tablets cesta 6, Novo mesto, YES YES supplied in a box Republic of Slovenia

Pliva Croatia Ltd., Ulica 20 (2x10) tablets in a blister

grada Vukovara 49, Enazil 10 tablets (OPA/Al/PVC//Al), supplied in YES YES

Zagreb, Republic of a box

Croatia

Pliva Croatia Ltd., Ulica 20 (2x10) tablets in a blister

grada Vukovara 49, Enazil 20 tablets (OPA/Al/PVC//Al), supplied in YES YES

Zagreb, Republic of a box

Croatia

Pliva Croatia Ltd., Ulica 20 (2x10) tablets in a blister

grada Vukovara 49, ENAZIL 5 tablets (OPA/Al/PVC//Al), supplied in YES YES

Zagreb, Republic of a box

Croatia

Box with 4 glass bottles

containing 25 mg of

Wyeth lyophilised powder, 4

Enbrel 25 mg powder and Pharmaceuticals, New syringes with needle filled powder and diluent for

diluent for solution for Lane, Havant, with solvent (water for YES YES solution for injection

injection Hampshire P092NG, injection), 4 needles with

Great Britain protection, 3 bottle adapters

and 8 alcohol impregnated

pads

Box with 4 glass bottles Wyeth

containing 25 mg of

Enbrel 25 mg powder and Pharmaceuticals, New powder and diluent for lyophilised powder, 4

diluent for solution for Lane, Havant, YES YES solution for injection syringes with needle filled

injection Hampshire P092NG, with solvent (water for

Great Britain injection) and 8 alcohol impregnated pads

Wyeth Box with 4 glass bottles

Pharmaceuticals, New Enbrel 25 mg powder for powder for solution for containing 25 mg of

Lane, Havant, YES YES solution for injection injection lyophilised powder and 8

Hampshire P092NG, alcohol impregnated pads

Great Britain

ENCEPUR for for children,

Box with 1 pre-filled syringe vaccine against viral Chiron Behring GmbH

with a needle with 1 dose of Middle-European tickintramuscular suspension & Co, Marburg, YES

vaccine (0.25 mL of borne meningoencephalitis Germany

suspension) (inactivated, absorbed)

ENCEPUR Adult,

Box with 1 pre-filled syringe inactivated absorbed Chiron Behring GmbH

with a needle with 1 dose of vaccine against viral intramuscular suspension & Co, Marburg, YES

vaccine (0.5 mL of Central European tick-born Germany

suspension) meningoencephalitis

Baxter Oncology 50 (5x10) coated tablets in a Endoxan coated tablets 50

coated tablets GmbH, Kantstrasse 2, blister (PVC/PVDC/Al), YES YES mg

Halle, Germany supplied in a box

powder for injection Baxter Oncology Powder for solution for Endoxan 1 g powder for

solution (for intravenous GmbH, Kantstrasse 2, injection in a glass bottle, YES YES solution for injection

use) Halle, Germany supplied in a box

Baxter Oncology Powder for solution for

Endoxan 200 mg powder powder for solution for

GmbH, Kantstrasse 2, injection in a glass bottle, YES YES for solution for injection intravenous injection

Halle, Germany supplied in a box

Baxter Oncology Powder for solution for

Endoxan powder for powder for solution for

GmbH, Kantstrasse 2, injection in a glass bottle, YES YES injection solution 500 mg intravenous injection

Halle, Germany supplied in a box

GlaxoSmithKline Engerix-B Dosis Adulta; Box with one pre-filled

Biologicals s.a., Rue recombinant hepatitis B intramuscular suspension syringe with 1 mL of vaccine, YES

de lInstitut 89, vaccine for adults needle and needle protection

Rixensart, Belgium

GlaxoSmithKline Engerix-B Dosis Adulta;

Biologicals s.a., Rue Box with 25 glass bottles with recombinant hepatitis B intramuscular suspension YES

de lInstitut 89, 1 mL of vaccine

vaccine for adults

Rixensart, Belgium

Engerix-B Dosis GlaxoSmithKline

Paediatrica; recombinant Biologicals s.a., Rue Box with 25 glass bottles with intramuscular suspension YES hepatitis B vaccine for de lInstitut 89, 0.5 mL of vaccine

children Rixensart, Belgium

Engerix-B Dosis GlaxoSmithKline Box with one pre-filled

Paediatrica; recombinant Biologicals s.a., Rue syringe with 0.5 mL of intramuscular suspension YES hepatitis B vaccine for de lInstitut 89, vaccine, needle and needle

children Rixensart, Belgium protection

Pliva Croatia Ltd., Ulica 60 (6x10) tablets in an

grada Vukovara 49, Epiramat tablets 100 mg film coated tablets OPA/Al/PVC//Al blister, YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 60 (6x10) tablets in an

grada Vukovara 49, Epiramat tablets 200 mg film coated tablets OPA/Al/PVC//Al blister, YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 60 (6x10) tablets in an

grada Vukovara 49, Epiramat tablets 25 mg film coated tablets OPA/Al/PVC//Al blister, YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 60 (6x10) tablets in an

grada Vukovara 49, Epiramat tablets 50 mg film coated tablets OPA/Al/PVC//Al blister, YES YES

Zagreb, Republic of supplied in a box

Croatia

Ebewe Pharma Ges. 5 mL of solution for infusion

Epirubicin Ebewe 10 mg/5 concentrate of solution m.b.H. Nfg. KG, concentrate in a glass bottle

YES YES mL for infusion Mondseestrasse 11, (with a rubber stopper),

Unterach, Austria supplied in a box

Ebewe Pharma Ges. 50 mL of solution for infusion

Epirubicin Ebewe 100 concentrate of solution m.b.H. Nfg. KG, concentrate in a glass bottle

YES YES mg/50 mL for infusion Mondseestrasse 11, (with a rubber stopper),

Unterach, Austria supplied in a box

Ebewe Pharma Ges. 25 mL of infusion solution

Epirubicin Ebewe 50 mg/ concentrate of solution m.b.H. Nfg. KG, concentrate in a glass bottle

YES YES 25 mL for infusion Mondseestrasse 11, (with rubber stopper),

Unterach, Austria supplied in a box

Glaxo Wellcome

60 tablets in a polyethylene

Epivir tablets 150 mg film coated tablets Operations, Greenford, YES YES

bottle, supplied in a box

Great Britain

Pliva Croatia Ltd., Ulica

Epoetal injection 2000 grada Vukovara 49, solution for injection One ampoule in a box YES YES

IU/mL Zagreb, Republic of

Croatia

Pliva Croatia Ltd., Ulica

Epoetal injection 4000 grada Vukovara 49, solution for injection One ampoule in a box YES YES

IU/mL Zagreb, Republic of

Croatia

6 bottles with rubber

Cilag AG, stoppers containing 1.0 mL

Eprex 10 000 injection solution for injection Schaffhausen, of solution for injection, in YES YES YES YES

Switzerland protective packaging,

supplied in a box

6 syringes with a needle Cilag AG,

(disposable) with 1.0 mL of

Eprex 10 000 injection solution for injection Schaffhausen, YES YES YES YES solution, in protective

Switzerland packaging, supplied in a box

6 syringes with a needle Cilag AG,

(disposable) with 0.5 mL of

Eprex 2 000 injection solution for injection Schaffhausen, YES YES YES YES solution, in protective

Switzerland packaging, supplied in a box

Pre-filled disposable syringe Cilag AG,

containing 0.5 mL of solution Eprex 20 000 injection solution for injection Schaffhausen, YES YES YES YES

for injection in a protective Switzerland

container, supplied in a box

6 syringes with a needle Cilag AG,

(disposable) with 0.3 mL of

Eprex 3 000 injection solution for injection Schaffhausen, YES YES YES YES solution, in protective

Switzerland packaging, supplied in a box

6 syringes with a needle Cilag AG,

(disposable) with 0.4 mL of

Eprex 4 000 injection solution for injection Schaffhausen, YES YES YES YES solution, in protective

Switzerland packaging, supplied in a box

Vial containing 1 mL of

Cilag AG, solution for injection, with

Eprex 40 000 injection solution for injection Schaffhausen, rubber stopper, in a YES YES YES YES

Switzerland protective container, supplied

in a box

Pre-filled disposable syringe Cilag AG,

containing 1.0 mL of solution Eprex 40 000 injection solution for injection Schaffhausen, YES YES YES YES

for injection in a protective Switzerland

container, supplied in a box

IVAX-Pharmaceuticals

50 (5x10) capsules in an

s.r.o., Ostravska 29,

Equoral 100 mg soft capsules Al/Al blister, supplied in a YES YES

Opava - Komarov,

carton box

Czech Republic

IVAX-Pharmaceuticals

50 (5x10) capsules in an

s.r.o., Ostravska 29,

Equoral 25 mg soft capsules Al/Al blister, supplied in a YES YES

Opava - Komarov,

carton box

Czech Republic

IVAX-Pharmaceuticals

50 (5x10) capsules in an

s.r.o., Ostravska 29,

Equoral 50 mg soft capsules Al/Al blister, supplied in a YES YES

Opava - Komarov,

carton box

Czech Republic

50 mL of solution in an

amber glass bottle in a

protective container, 1 plastic IVAX-Pharmaceuticals

syringe of 4 mL, 1 plastic s.r.o., Ostravska 29,

Equoral solution oral solution pipe for extraction of bottle YES YES

Opava - Komarov,

content in a protective plastic

Czech Republic

container and 1 plastic

temper-evident screw cap,

supplied in a carton box

Farmal d.d., Ludbreg,

Republic of Croatia in 20 (2x10) capsules in a

ERAZON capsules 10 mg capsules, hard cooperation with Krka blister (PVC -Al), supplied in YES YES

d.d., Novo mesto, a box

Republic of Slovenia

Farmal d.d., Ludbreg,

Republic of Croatia in 20 (2x10) capsules in a

ERAZON capsules 20 mg capsules, hard cooperation with Krka blister (PVC -Al), supplied in YES YES

d.d., Novo mesto, a box

Republic of Slovenia

Farmal d.d., Ludbreg,

Republic of Croatia in

10 (2x5) suppositories in a

ERAZON suppositories suppositories cooperation with Krka YES YES

strip, supplied in a box

d.d., Novo mesto,

Republic of Slovenia

Merck KGaA, Erbitux 2 mg/mL solution 50 mL of solution in a glass

solution for infusion Frankfurter Straße 250, YES YES YES for infusion bottle, supplied in a box

Darmstadt, Germany

Lek farmacevtska

družba d.d., 20 film coated tablets in an Ergometrin Lek 0.2 mg film

film coated tablets Verovškova 57, amber glass bottle, supplied YES YES coated tablets

Ljubljana, Republic of in a box

Slovenia

Lek farmacevtska

družba d.d., 50 ampoules with 1 mL of Ergometrin Lek 0.2 mg/mL

solution for injection Verovškova 57, solution, supplied in a carton YES YES solution for injection

Ljubljana, Republic of box

Slovenia

Belupo, lijekovi i

Eritromicin 250 mg kozmetika d.d., Ulica 16 (1x16) capsules in a capsules YES YES

capsules Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Schaper & Brümmer 50 (5x10) tablets in a blister

Esberitox N tablets tablets GmbH & Co. KG, (PVC/PVDC/Al), supplied in YES YES

Salzgitter, Germany a box

10 mL of solution for injection

solution for injection (for N.V. Organon, Oss, in a glass bottle with rubber Esmeron YES YES

intravenous use) The Nederlands stopper, 10 glass bottles in a

box

N.V. Organon, Oss, the

5 mL of solution for injection

Netherlands;

solution for injection (for in a glass bottle with a rubber

Esmeron ORGANON S.A., YES YES

intravenous use) stopper, 12 glass bottles in a

Usine Saint Charles,

box

France

Berlin-Chemie AG 25 (1x25) capsules in a

(Menarini Group), Espumisan capsules, soft PVC/Al blister, supplied in a YES YES YES

Glienicker Weg 125, box

Berlin, Germany

4 transdermal patches

Estraderm TTS 50 and 4 Novartis Pharma Stein

transdermal patches AG,

Estracomb TTS transdermal patch Estragest TTS 250/50 YES YES

Schaffhauserstrasse, (individually packed in a

Stein, Switzerland

protective Surlyn/Al bag),

supplied in a box

Pliva Croatia Ltd., 40 capsules in an amber

Estracyt capsules Zagreb, Republic of glass bottle, supplied in a YES YES

Croatia in cooperation box with Pharmacia &

Upjohn S.p.A., Milano,

Italy

Novartis Pharma Stein 6 (3x2) transdermal patches

AG, (individually packed in a Estraderm TTS 100 transdermal patch YES YES

Schaffhauserstrasse, protective Surlyn/Al bag),

Stein, Switzerland supplied in a box

Novartis Pharma Stein 6 (3x2) transdermal patches

AG, (individually packed in a Estraderm TTS 25 patch YES YES

Schaffhauserstrasse, protective Surlyn/Al bag),

Stein, Switzerland supplied in a box

Novartis Pharma Stein 6 (3x2) transdermal patches

AG, (individually packed in a Estraderm TTS 50 transdermal patch YES YES

Schaffhauserstrasse, protective Surlyn/Al bag),

Stein, Switzerland supplied in a box

28 tablets in a plastic Novo Nordisk A/S,

calendar pack (dispenser

Estrofem 1 mg film coated tablets Novo Allé, DK-2880 YES YES YES with marked days of the

Bagsvaerd, Denmark week), supplied in a box

28 tablets in a plastic Novo Nordisk A/S,

calendar dial pack (dispenser

Estrofem 2 mg film coated tablets Novo Allé, DK-2880 YES YES YES with marked days of the

Bagsvaerd, Denmark week), supplied in a box

Belupo, lijekovi i 100 tablets in an amber

kozmetika d.d., Ulica Etambutol 400 mg tablets tablets glass bottle, supplied in a YES YES

Danica 5, Koprivnica, box

Republic of Croatia

Alkaloid AD - Skopje, 100 tablets in an amber

Bulevar Aleksandar Etambutol Alkaloid tablets glass bottle, supplied in a YES YES

Makedonski 12, box

Skopje, FYROM

Ebewe Pharma Ges. 5 mL of solution concentrate

ETOPOSIDE EBEWE 100 concentrate of solution m.b.H. Nfg. KG, in an amber glass bottle (with

YES YES mg/5 mL for infusion Mondseestrasse 11, a rubber stopper), supplied in

Unterach, Austria a carton box

50 mL of solution Ebewe Pharma Ges.

concentrate in an amber ETOPOSIDE EBEWE concentrate of solution m.b.H. Nfg. KG,

glass bottle (with a rubber YES YES 1000 mg/50 mL for infusion Mondseestrasse 11,

stopper), supplied in a carton Unterach, Austria

box

Ebewe Pharma Ges. 10 mL of concentrate in an

ETOPOSIDE EBEWE 200 solution concentrate for m.b.H. Nfg. KG, amber glass bottle (with

YES YES mg/10 mL infusion Mondseestrasse 11, rubber stopper), supplied in a

Unterach, Austria carton box

2.5 mL of solution Ebewe Pharma Ges.

concentrate in an amber ETOPOSIDE EBEWE 50 concentrate of solution m.b.H. Nfg. KG,

glass bottle (with rubber YES YES mg/2.5 mL for infusion Mondseestrasse 11,

stopper), supplied in a carton Unterach, Austria

box

50 mL of emulsion in an Novartis Consumer

amber glass bottle with a emulsion for application Health S.A., Route de l'

EURAX emulsion plastic measuring insert and YES YES YES on skin Etraz, Nyon,

a plastic stopper, supplied in Switzerland

a box

Novartis Consumer 20 grams of cream in an

Health S.A., Route de l' EURAX cream cream aluminum tube with plastic YES YES YES

Etraz, Nyon, cap, supplied in a box

Switzerland

Merck KGaA, 100 (4X25) tablets in a

Euthyrox 100 tablets tablets Frankfurter Straße 250, YES YES blister, supplied in a box

Darmstadt, Germany

Merck KGaA, 100 (4X25) tablets in a

Euthyrox 150 tablets tablets Frankfurter Straße 250, YES YES blister, supplied in a box

Darmstadt, Germany

Merck KGaA, 100 (4X25) tablets in a

Euthyrox 25 tablets tablets Frankfurter Straße 250, YES YES blister, supplied in a box

Darmstadt, Germany Merck KGaA, 100 (4X25) tablets in a

Euthyrox 50 tablets tablets Frankfurter Straße 250, YES YES blister, supplied in a box Darmstadt, Germany

Lilly, S.A., Avendia de 28 (2x14) film coated tablets

Evista 60 mg film coated la Industria 30, in a blister film coated tablets YES YES YES

tablets Alcobendas, Madrid, (PVC/PE/Aclar//Al), supplied

Spain in a box

9 patches individually

Janssen packaged in protective

Pharmaceutica NV, sachets (paper/LDPE/Al Evra transdermal patch transdermal patch YES YES

Turnhouseweg 30, foil/LDPE), wrapped à 3 in a

Beerse, Belgium transparent plastic bag,

supplied in a box

3 patches individually

Janssen packaged in protective bags

Pharmaceutica NV, (paper/LDPE/Al-foil/LDPE) Evra transdermal patch transdermal patch YES YES

Turnhouseweg 30, inserted in a common

Beerse, Belgium transparent plastic bag,

supplied in a box

Novartis Pharma Stein

28 (2x14) tablets in a blister

Exforge 5 mg/160 mg film AG,

film coated tablets (PVC/PVDC//Al), supplied in YES YES YES YES

coated tablets Schaffhauserstrasse,

a box

Stein, Switzerland

Novartis Pharma Stein

28 (2x14) tablets in a blister

Exforge 5 mg/80 mg film AG,

film coated tablets (PVC/PVDC//Al), supplied in YES YES YES YES

coated tablets Schaffhauserstrasse,

a box

Stein, Switzerland

Novartis Pharma Stein

28 (4x7) tablets in a blister

EXJADE 125 mg tablets tablets for oral AG,

(PVC/PE/PVDC//Al), YES YES YES YES

for oral suspension suspension Schaffhauserstrasse,

supplied in a box

Stein, Switzerland

Novartis Pharma Stein

28 (4x7) tablets in a blister

EXJADE 250 mg tablets tablets for oral AG,

(PVC/PE/PVDC//Al), YES YES YES YES

for oral suspension suspension Schaffhauserstrasse,

supplied in a box

Stein, Switzerland

Novartis Pharma Stein

28 (4x7) tablets in a blister

EXJADE 500 mg tablets tablets for oral AG,

(PVC/PE/PVDC//Al), YES YES YES YES

for oral suspension suspension Schaffhauserstrasse,

supplied in a box

Stein, Switzerland

4 plastic (PVC) Viaflex bags

with 2500 mL of solution, a

supply/drain pipe (PVC), a BAXTER Healthcare

connector with a protective S.A., Monreen Road, solution for peritoneal cap, an attachment for drug Extraneal Castlebar, County YES YES YES

dialysis administration, and a Mayo, Republic of

collective plastic Viaflex bag Ireland

(individual packaging in a

protective plastic bag),

supplied in a box

5 plastic (PVC) Viaflex bags

with 2000 mL of solution, a

BAXTER Healthcare supply/drain pipe (PVC), a

S.A., Monreen Road, connector with a safety cap, solution for peritoneal

Extraneal Castlebar, County a dispensing unit and a YES YES YES dialysis

Mayo, Republic of collective plastic Viaflex bag

Ireland (individual packaging in a

protective plastic bag),

supplied in a box

5 plastic (PVC) Viaflex bags

BAXTER Healthcare with 2000 mL of solution,

S.A., Monreen Road, with a connector with a solution for peritoneal

Extraneal Castlebar, County safety cap and a dispensing YES YES YES dialysis

Mayo, Republic of unit (individual packaging in

Ireland a protective plastic bag),

supplied in a box

Merck Sharp & Dohme 28 (2x14) tablets in an Ezetrol 10 mg tablets YES YES YES

B.V., Waarderweg 39, Aclar/PVC/Al blister, supplied Postbus 581, Haarlem, in a box

the Netherlands

Genzyme Ltd., 37

One glass vial containing

powder for concentrate Hollands Road,

Fabrazyme 35 mg powder for concentrate, YES YES YES

for solution for infusion Haverhill, Suffolk CB9

supplied in a box

8PU, Great Britain

Genzyme Ltd., 37

One glass vial containing

powder for concentrate Hollands Road,

Fabrazyme 5 mg powder for concentrate, YES YES YES

for solution for infusion Haverhill, Suffolk CB9

supplied in a box

8PU, Great Britain

Altana Pharma AG, 10 (2x5) suppositories in a

Faktu suppositories suppositories Byk-Gulden Strasse 2, PVC/PE strip, supplied in a YES YES

Konstanz, Germany box

20 grams of ointment in an Altana Pharma AG,

aluminum tube and an Faktu ointment ointment Byk-Gulden Strasse 2, YES YES

applicator for rectal use, Konstanz, Germany

supplied in a box

Alkaloid AD - Skopje,

Bulevar Aleksandar 20 (1x20) tablets in a blister, Famosan 20 mg film coated tablets YES YES

Makedonski 12, supplied in a box

Skopje, FYROM

Alkaloid AD - Skopje,

Bulevar Aleksandar 10 (1x10) tablets in a blister, Famosan 40 mg film coated tablets YES YES

Makedonski 12, supplied in a box

Skopje, FYROM

Pfizer Italia s.r.l., Viale Farmorubicin PFS 10 mg solution for intravenus Box with a bottle with 5 mL of

Pasteur 10, Nerviano YES YES injection (2 mg/mL) and intravesical use solution

Plant, Milano, Italy

Pfizer Italia s.r.l., Viale Farmorubicin PFS 50 mg solution for intravenus Box with a bottle with 25 mL

Pasteur 10, Nerviano YES YES injection (2 mg/mL) and intravesical use of solution

Plant, Milano, Italy

AstraZeneca UK

One glass syringe with 5 mL

Limited, Silk Road

Faslodex 250 mg/5 mL solution for injection (in a of solution, with child

Business Park, YES YES YES YES

solution for injection pre-filled syringe) resistant closure, in a plastic

Macclesfield, Cheshire,

container, supplied in a box

Great Britain

A. Menarini 20 grams of gel in an

Manufacturing Logistic Fastum Gel gel aluminum tube with plastic YES YES YES

and Services S.r.l., cap, supplied in a box

Firenca, Italy

Belupo, lijekovi i

Amber glass bottle (10 mL)

kozmetika d.d., Ulica

Favora Eusin drops drops, solution with a plastic screw cap and YES YES

Danica 5, Koprivnica,

a dropper, supplied in a box

Republic of Croatia

Belupo, lijekovi i 200 grams of powder in a PP

kozmetika d.d., Ulica vessel with PE cap and Favora Fitolax powder powder YES YES

Danica 5, Koprivnica, measuring spoon, supplied in

Republic of Croatia a box

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (3x10) lozenges in a Favora Orasept lozenges lozenges YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 50 (2x25) capsules in a Favora Urosal capsules capsules YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Box with a bottle with lyophilisate for Baxter AG,

Feiba TIM 4 immuno 1000 lyophilisate, bottle with 20 mL preparation of Industriestrasse 67, A- YES

FJ of water for injection and intravenous solutions 1220 Vienna, Austria

dissolution and injection kit

Box with a bottle with lyophilisate for Baxter AG,

Feiba TIM 4 immuno 500 lyophilisate, bottle with 20 mL preparation of Industriestrasse 67, A- YES

FJ of water for injection and intravenous solutions 1220 Vienna, Austria

dissolution and injection kit

Novartis Pharma Stein 30 (3x10) tablets in a Femara 2.5 mg film-tablets film coated tablets YES YES YES

AG, PVC/PE/PVDC/Al blister, Schaffhauserstrasse, supplied in a box

Stein, Switzerland

Solvay 28 (1x28) tablets (14 white

Pharmaceuticals B.V., Femoston 1/10 film coated tablets and 14 grey) in a blister, YES YES

Veerweg 12, 8121 AA supplied in a box

Olst, the Netherlands

Solvay 28 (1x28) tablets (14 pink

Pharmaceuticals B.V., Femoston 2/10 film coated tablets and 14 yellow) in a blister, YES YES

Veerweg 12, 8121 AA supplied in a box

Olst, the Netherlands

Solvay

Pharmaceuticals B.V., 28 (1x28) tablets in a blister, Femoston Conti 1/5 film coated tablets YES YES

Veerweg 12, 8121 AA supplied in a box

Olst, the Netherlands

20 mL of solution in an Novartis Consumer

amber glass bottle with a Health S.A., Route de l'

Fenistil 0.1% oral drops oral drops (solution) polyethylene dropper and a YES YES

Etraz, Nyon, polypropylene cap, supplied

Switzerland in a box

Novartis Consumer Al tube with 30 g of gel with a

Health S.A., Route de l' Fenistil gel gel polyethylene cap, supplied in YES YES

Etraz, Nyon, a box

Switzerland

One transdermal patch in a

Fentanil M Lek 100 Hexal AG, Holzkirchen, protective bag transdermal patch YES YES

transdermal patch Germany (PE/Al/PE/paper foil), 5

patches in a box

One transdermal patch in a

Fentanil M Lek 25 Hexal AG, Holzkirchen, protective bag transdermal patch YES YES

transdermal patch Germany (PE/Al/PE/paper foil), 5

patches in a box

One transdermal patch in a

Fentanil M Lek 50 Hexal AG, Holzkirchen, protective bag transdermal patch YES YES

transdermal patch Germany (PE/Al/PE/paper foil), 5

patches in a box

One transdermal patch in a

Fentanil R Lek 100 Hexal AG, Holzkirchen, protective bag transdermal patch YES YES

transdermal patch Germany (PE/Al/PE/paper foil), 5

patches in a box

One transdermal patch in a

Fentanil R Lek 25 Hexal AG, Holzkirchen, protective bag transdermal patch YES YES

transdermal patch Germany (PE/Al/PE/paper foil), 5

patches in a box

One transdermal patch in a

Fentanil R Lek 50 Hexal AG, Holzkirchen, protective bag transdermal patch YES YES

transdermal patch Germany (PE/Al/PE/paper foil), 5

patches in a box

Janssen 50 ampoules with 10 mL of

solution for intravenous Pharmaceutica NV, FENTANYL injection solution for injection, YES YES

injection Turnhouseweg 30, supplied in a box

Beerse, Belgium

Janssen 50 ampoules with 2 mL of

solution for intravenous Pharmaceutica NV, FENTANYL injection solution for injection, YES YES

injection Turnhouseweg 30, supplied in a box

Beerse, Belgium

Lek farmacevtska

družba d.d., Ferrum Lek 100 mg 30 (3x10) chewable tablets in

chewing tablets Verovškova 57, YES YES chewing tablets a strip, supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d., 100 mL of syrup in an amber Ferrum Lek 50 mg/5 mL

syrup Verovškova 57, glass bottle and a measuring YES YES syrup

Ljubljana, Republic of spoon, supplied in a box

Slovenia Bristol-Myers Squibb,

304, avenue du Dr

Jean Bru, Agen,

8 bags each with 13.100 g of

FERVEX granules for oral solution France; Bristol-Myers YES YES YES

granules, supplied in a box

Squibb, 979 Avenue

des Pyrénées, Le

Passage, France

Bristol-Myers Squibb,

304, avenue du Dr

Jean Bru, Agen,

8 bags each with 4.950 g of

FERVEX sugar-free granules for oral solution France; Bristol-Myers YES YES YES

granules, supplied in a box

Squibb, 979 Avenue

des Pyrénées, Le

Passage, France

Bristol-Myers Squibb,

304, avenue du Dr

Jean Bru, Agen,

8 bags each with 3.0 g of

FERVEX for children granules for oral solution France; Bristol-Myers YES YES YES

granules, supplied in a box

Squibb, 979 Avenue

des Pyrénées, Le

Passage, France

Solvay

Pharmaceuticals B.V.,

Weesp, the 15 (1x15) film coated tablets

Fevarin film coated tablets Netherlands Solvay in PVC/PVDC/Al blister, YES YES

Pharmaceuticals supplied in a box

S.A.S., Châtillon sur

Chalaronne, France

28 (2x14) tablets in a blister Cipla Ltd, Bangalore,

FINCAR 5 mg film coated tablets (PVC/PVDC/Al), supplied in YES YES

India a box

Glaxo Wellcome S.A., 120 doses of suspension in a

Flixonase nasal spray water suspension Aranda de Duero, glass bottle with plastic YES YES

Burgos, Spain dispenser, supplied in a box

Glaxo Wellcome

Operations, Greenford, 60 doses of powder in an

Flixotide 100 Diskus inhalation powder Vel. Britanija; Glaxo aluminium blister, in a plastic YES YES

Wellcome Production, housing, supplied in a box

Evreux, France

GlaxoSmithKline

Pharmaceuticals SA, Aluminium container with a

Flixotide 125 Inhaler inhalation aerosol poznan, Poland; Glaxo plastic mouthpiece YES YES

Wellcome Production, containing 60 doses

Evreux, France

Glaxo Wellcome

Operations, Greenford, 60 doses of powder in an

Flixotide 250 Diskus inhalation powder Vel. Britanija; Glaxo aluminium blister, in a plastic YES YES

Wellcome Production, housing, supplied in a box

Evreux, France

GlaxoSmithKline

Pharmaceuticals SA, Aluminium container with a

Flixotide 250 Inhaler inhalation aerosol Poznan, Poland; Glaxo plastic mouthpiece YES YES

Wellcome Production, containing 60 doses

Evreux, France

120 doses (not less than GlaxoSmithKline

10.0 g of suspension) in an Pharmaceuticals S.A.,

Flixotide 50 Inhaler inhalation aerosol aluminum container with YES YES

Ul. Grunwaldzka 189,

metering valve in a plastic

Poznan, Poland

nebulizer, supplied in a box

Glaxo Wellcome

Operations, Greenford, 60 doses of powder in an

Flixotide 500 Diskus inhalation powder Vel. Britanija; Glaxo aluminium blister, in a plastic YES YES

Wellcome Production, housing, supplied in a box

Evreux, France

Lek farmacevtska

10 (1x10 ) tablets in a blister,

Flonidan 10 mg tablets tablets družba d.d., YES YES

suplied in a box

Verovškova 57,

Ljubljana, Republic of

Slovenia

Lek farmacevtska 120 mL of solution in an

družba d.d., Flonidan 5mg/5mL amber glass botlle and

oral suspension Verovškova 57, YES YES suspension plastic spoon, supplied in a

Ljubljana, Republic of box

Slovenia

Krka d.d., Šmarješka 5 ampoules each with 1 mL Flosteron suspension for

suspension for injection cesta 6, Novo mesto, of suspension, supplied in a YES YES injections

Republic of Slovenia box

Jadran - Galenski

laboratorij d.d., Pulac 30 g of gel in an aluminium Fluacet gel gel YES YES

bb, Rijeka, Republic of tube, supplied in a box

Croatia

Novartis Vaccines & Fluad MF59C.1

Diagnostics S.r.l., Pre-filled syringe with a adjuvanted vaccine

suspension for injection Siena, Italy and needle containing 0.5 mL of against influenza in ready YES

in pre-filled syringe Imunološki zavod d.d., suspension, supplied in a to-use syringe, inactivated

Zagreb, Republic of box (surface antigens)

Croatia

Sächsisches

Fluarix vaccine against Serumwerk Dresden

Box with 1 glass syringe with

influenza, inactivated, NL der SmithKline suspension for injections a needle containing 1 dose of YES

fragmented (without Beecham Pharma vaccine of 0.5 mL

preservative) GmbH & Co. KG,

Germany

Schering-Plough Labo

100 (10x10) tablets in an

N.V. Industrepark 30,

Flucinom tablets 250 mg tablets orange (PVC/Al) blister, YES YES

Heist-op-den-Berg,

supplied in a box

Belgium

Jadran - Galenski 7 (1x7) capsules in

laboratorij d.d., Pulac Fluconax 100 mg capsules capsules (PVC/PVDC/Al) blister, YES YES

bb, Rijeka, Republic of supplied in a box

Croatia

Jadran - Galenski One capsule in a

laboratorij d.d., Pulac Fluconax 150 mg capsules capsules PVC/PVDC/Al blister, YES YES

bb, Rijeka, Republic of supplied in a box

Croatia

Jadran - Galenski 7 (1x7) capsules in

laboratorij d.d., Pulac Fluconax 200 mg capsules capsules (PVC/PVDC/Al) blister, YES YES

bb, Rijeka, Republic of supplied in a box

Croatia

Jadran - Galenski 100 mL of solution in a glass Fluconax 2mg/1mL

solution for intravenous laboratorij d.d., Pulac bottle for infusion and a solution for intravenous YES YES

infusion bb, Rijeka, Republic of plastic bottle holder, supplied infusion

Croatia in a box

Jadran - Galenski 7 (1x7) capsules in

laboratorij d.d., Pulac Fluconax 50 mg capsules capsules (PVC/PVDC/Al) blister, YES YES

bb, Rijeka, Republic of supplied in a box

Croatia

Schering AG, powder for solution for 5 glass bottles with powder, Fludara Muellerstrasse 170- YES YES

injection or infusion supplied in a box 178, Berlin, Germany

20 (4x5) tablets in a blister Schering AG,

Fludara oral 10 mg film (PA/Al/PP//Al) in a 150 mL film coated tablets Muellerstrasse 170- YES YES YES

coated tablets plastic (HDPE) bottle with a

178, Berlin, Germany

plastic child resistant closure

Lek farmacevtska

družba d.d., Fluimukan 100 mg 30 bags each containing 5 g

granules for oral solution Verovškova 57, YES YES YES granules for oral solution of granules, supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

Fluimukan 200 mg družba d.d., 20 bags with à 5 grams of granules for oral solution YES YES YES

granules for oral solution Verovškova 57, granules, supplied in a box

Ljubljana, Republic of Slovenia

Glass vial containing 0.5 mL

of suspension for injection,

plastic syringe, needle for Imunološki zavod d.d.,

FLUIMUN, vaccine against drawing suspension from the Rockefellerova 2,

influenza (surface antigen, suspension for injection bottle (21Gx1"; inch) and YES Zagreb, Republic of

inactivated) one needle for drug Croatia

administration (23Gx1 inch or

25Gx1 inch or 25Gx5/8 inch),

supplied in a box

Belupo, lijekovi i 400 tablets in a plastic (PP)

FLUONATRIL 0.25 mg kozmetika d.d., Ulica

tablets bottle with a stopper, YES YES

tablets Danica 5, Koprivnica,

supplied in a box

Republic of Croatia

Belupo, lijekovi i 250 tablets in a plastic (PP)

kozmetika d.d., Ulica FLUONATRIL 1 mg tablets tablets bottle with a cap, supplied in YES YES

Danica 5, Koprivnica, a box

Republic of Croatia

Pliva Croatia Ltd., Ulica

10 glass vials each

Fluorouracil Pliva injection grada Vukovara 49,

solution for injection containing 5 mL of solution, YES YES

250 mg/5 mL Zagreb, Republic of

supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

Fluorouracil Pliva injection grada Vukovara 49, One glass vial with 10 mL of

solution for injection YES YES

500 mg/10 mL Zagreb, Republic of solution, supplied in a box

Croatia

Krka d.d., Šmarješka 14 (2x7) capsules in a blister

Fluval capsules 20 mg capsules cesta 6, Novo mesto, (PVC/PVDC//Al), supplied in YES YES

Republic of Slovenia a box

Krka d.d., Šmarješka

10 (1x10) capsules in a

Fluzepam capsules 15 mg capsules cesta 6, Novo mesto, YES YES

blister, supplied in a box

Republic of Slovenia

Krka d.d., Šmarješka

10 (1x10) capsules in a

Fluzepam capsules 30 mg capsules cesta 6, Novo mesto, YES YES

blister, supplied in a box

Republic of Slovenia

Jadran - Galenski

laboratorij d.d., Pulac 20 tablets in a PE vial, Folacin tablets YES YES

bb, Rijeka, Republic of supplied in a carton box

Croatia

Abbott Laboratories Box with 100 mL of liquid in

Forane inhalation liquid Ltd, Queenborough, YES YES

an amber glass bottle

Great Britain

Forteo 20 micrograms/80 Pen-injector containing 3 mL Lilly France S.A.S.,

microliters, solution for of solution (750 µg solution for injection Rue du Colonel Lilly, YES YES

injection in a pre-filled penteriparatide) in a glass Fegersheim, France

injector cartridge

Krka d.d., Novo mesto, 10 ampoules each containing

Fortral solution for injection Republic of Slovenia in

solution for injection 1 mL of solution, supplied in YES YES

30 mg/1 mL cooperation with

a box

Sanofi, France

Krka d.d., Novo mesto,

100 tablets in an amber

Republic of Slovenia in

Fortral tablets 50 mg tablets glass bottle, supplied in a YES YES

cooperation with

box

Sanofi, France

4 bags (LDPE/Al/paper) each Beaufor Ipsen

Fortrans powder for oral with 73.69 g of powder for

powder for oral solution Industrie, Dreux, YES YES

solution oral solution, supplied in a

France

box

Merck Sharp & Dohme 31 (2x14) film coated tablets

B.V., Waarderweg 39, Fortzaar film coated tablets in a blister, supplied in a YES YES

Postbus 581, Haarlem, carton box

the Netherlands

Merck Sharp & Dohme Box with 4 tablets (blister, 1 x

Fosamax T tablets B.V., Waarderweg 39, YES YES YES

Postbus 581, Haarlem,

14509/11 WS/jj 285

the Netherlands

Merck Sharp & Dohme 4 (1x4) tablets in a blister

B.V., Waarderweg 39, (Al/Al) in a carton casing Fosavance tablets tablets YES YES YES

Postbus 581, Haarlem, (with a leaflet), supplied in a

the Netherlands box

Glaxo Wellcome Box with 10 syringes with a

Fraxiparine 2850 IU Production, Notre subcutaneous injection needle containing 0.3 mL of YES YES

AXa/0.3 mL injection Dame de Bondeville, solution

France

Glaxo Wellcome Box with 10 syringes with a

Fraxiparine 3800 IU Production, Notre subcutaneous injection needle containing 0.4 mL of YES YES

AXa/0.4 mL injection Dame de Bondeville, solution

France

Glaxo Wellcome Box with 10 syringes with a

Fraxiparine 5700 IU Production, Notre subcutaneous injection needle containing 0.6 mL of YES YES

AXa/0.6 mL injection Dame de Bondeville, solution

France

Glaxo Wellcome Box with 10 syringes with a

Fraxiparine 7600 IU Production, Notre subcutaneous injection needle containing 0.8 mL of YES YES

AXa/0.8 mL injection Dame de Bondeville, solution

France

Glaxo Wellcome Box with 10 syringes with a

Fraxiparine 9500 IU AXa/1 Production, Notre subcutaneous injection needle containing 1 mL of YES YES

mL injection Dame de Bondeville, solution

France

Krka d.d., Šmarješka 14 tablets (2x7) in

Fromilid 250 tablets film coated tablets cesta 6, Novo mesto, A/PVC/PVDC blister, YES YES

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 14 tablets (2x7) in

Fromilid 500 tablets film coated tablets cesta 6, Novo mesto, A/PVC/PVDC blister, YES YES

Republic of Slovenia supplied in a box

25 grams of granules for the

preparation of 60 mL of oral Fromilid 125 mg/5 mL Krka d.d., Šmarješka

granules for oral suspension in a glass bottle granules for oral cesta 6, Novo mesto, YES YES

suspension and a 5 mL plastic syringe for suspension Republic of Slovenia

oral dose delivery, supplied

in a box

Krka d.d., Šmarješka 14 (2x7) tablets in a Fromilid uno prolongedprolonged-release

tablets cesta 6, Novo mesto, PVC/PVDC//Al blister, YES YES release tablets 500 mg

Republic of Slovenia supplied in a box

Fromilid uno 500 mg Krka d.d., Šmarješka 5 (1x5) tablets in a

tablets with prolonged prolonged release tablets cesta 6, Novo mesto, PVC/PVDC//Al blister, YES YES

release Republic of Slovenia supplied in a box

FSME Immun inject,

Baxter AG, Box with 1 pre-filled syringe inactivated vaccine against

intramuscular suspension Industriestrasse 67, A- with 1 dose of vaccine (0.5 YES viral tick-borne

1220 Vienna, Austria mL susp), with a needle meningoencephalitis

Pre-filled syringe with needle Baxter AG,

FSME-IMMUN 0.25 mL containing one 0.25 mL of suspension for injection Industriestrasse 67, A- YES

Junior vaccine dose, supplied in a

1220 Vienna, Austria box

Bosnalijek d.d.,

7 (1x7) capsules in

Jukićeva 53, Sarajevo,

Funzol capsules 100 mg capsules (PVC/PVDC/Al) blister, YES YES

Bosnia and

supplied in a box

Herzegovina

Bosnalijek d.d., One (1x1) capsule in a

Jukićeva 53, Sarajevo, Funzol capsules 150 mg capsules PVC/PVDC/Al blister YES YES

Bosnia and

supplied in a box

Herzegovina

Bosnalijek d.d.,

7 (1x7) capsules in

Jukićeva 53, Sarajevo,

Funzol capsules 50 mg capsules (PVC/PVDC/Al) blister, YES YES

Bosnia and

supplied in a box

Herzegovina

Fursemid 20 mg/2 mL Belupo, lijekovi i 5 ampoules each with 2 mL solution for injection YES YES

injection kozmetika d.d., Ulica of solution in a plastic holder,

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 12 (1x12) tablets in a blister, Fursemid 40 mg tablets tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 20 (1x20) tablets in a blister, Fursemid 40 mg tablets tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

Fursemid forte 500 mg kozmetika d.d., Ulica 20 (2x10) tablets in PVC/Al tablets YES YES tablets Danica 5, Koprivnica, blister , supplied in a box

Republic of Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 20 (2x10) capsules in a Gabalept capsules 100 mg capsules YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 50 (5x10) capsules in a Gabalept capsules 300 mg capsules YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 50 (5x10) capsules in a Gabalept capsules 400 mg capsules YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

7.5 mL of solution in a glass Schering AG,

Gadovist 1.0 mmol/mL syringe, 5 syringes solution for injection Muellerstrasse 170- YES YES YES

injection individually packed in a

178, Berlin, Germany

blister, supplied in a box

Schering AG, Gadovist 1.0 mmol/mL 15 mL of solution in a glass

solution for injection Muellerstrasse 170- YES YES YES solution for injection bottle, 10 bottles in a box

178, Berlin, Germany

Bottle with lyophilisate,

bottle with 192 mL of diluent, lyophilisate and solvent Baxter S.A, Hyland

sterile set for lyophilisate

Gammagard S/D 10 g for preparation of solution Immuno, Lessines, YES dissolution, and sterile for intravenous infusion Belgium

application kit used with a

filter, supplied in a box

Bottle with lyophilisate,

bottle with 50 mL of diluent, lyophilisate and diluent Baxter S.A, Hyland

sterile kit for lyophilisate

Gammagard S/D 2.5 g for preparation of solution Immuno, Lessines, YES reconstitution, and one sterile

for intravenous infusion Belgium kit for use with filter, supplied

in a box

Botle with lyophilisate, bottle

with 96 mL of diluent, sterile lyophilisate and diluent Baxter S.A, Hyland

kit for lyophilisate

Gammagard S/D 5 g for preparation of solution Immuno, Lessines, YES reconstitution, and sterile kit

for intravenous infusion Belgium for use with filter, supplied in

a box

Allergan

3 mL of solution in a 5 mL

Pharmaceuticals

plastic (LDPE) bottle with

Republic of Ireland,

GANFORT eye drops eye drops, solution dropper attachment and YES YES YES

Castlebar Road,

plastic (HDPE) temper-proof

Westport, Co Mayo,

closure, 1 bottle in a box

Republic of Ireland

Schering-Plough Labo

N.V. Industrepark 30, 5 mL of solution in a plastic Garasone eye/nasal drops eye/nasal drops YES YES

Heist-op-den-Berg, (10 mL) bottle with a dropper

Belgium

GARDASIL, suspension Pre-filled glass syringe (glass

for injections in a pre-filled Merck Sharp & Dohme type I) with 0.5 mL of

syringe, vaccine against suspension for injections B.V., Waarderweg 39, suspension for injection, a

YES YES YES YES human papillomavirus in a pre-filled syringe Postbus 581, Haarlem, needle with protective

[type 6, 11, 16, 18] the Netherlands mechanism, and two

(recombinant, absorbed) needles, supplied in a box

GARDASIL, suspension

Merck Sharp & Dohme Tyle 1 glass ampoule for injection, human

B.V., Waarderweg 39, containing 0.5 mL of papillomavirus vaccine suspension for injection YES YES YES YES

Postbus 581, Haarlem, suspension, supplied in a [types 6, 11, 16, 18]

the Netherlands box (recombinant, absorbed)

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 24 (4x6) tablets in a blister, Gastal tablets peppermint tablets YES YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 24 (4x6) tablets in a blister, Gastal tablets spearmint tablets YES YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 24 (4x6) tablets in a blister, Gastal tablets, sour cherry tablets YES YES YES

Zagreb, Republic of supplied in a box

Croatia

100 mL of solution in an Berlimed S.A., Madrid,

Gastrografin solution solution amber glass bottle with YES YES

Spain

plastic cap, supplied in a box

Lilly France S.A.S., Gemzar 1 g powder for powder for solution for One glasss vial with

Rue du Colonel Lilly, YES YES solution for infusion infusion lyophilisate, supplied in a box

Fegersheim, France

Lilly France S.A.S., Gemzar 200 mg powder powder for solution for One glasss vial with

Rue du Colonel Lilly, YES YES for solution for infusion infusion lyophilisate, supplied in a box

Fegersheim, France

5 two-part glass cartridges

powder and diluent for with lyophilisate (front part (I) Pfizer Health AB,

Genotropin 5.3 mg solution for subcutaneous and solvent (rear part (II)) in YES YES

Stockholm, Sweden injection a plastic container, supplied

in a box

Belupo, lijekovi i

10 ampoules each containing

Gentamicin 120 mg/2 mL kozmetika d.d., Ulica

solution for injection 2 mL of solution, supplied in YES YES

injection Danica 5, Koprivnica,

a box

Republic of Croatia

Belupo, lijekovi i

10 ampoules each containing

Gentamicin 20 mg/2 mL kozmetika d.d., Ulica

solution for injection 2 mL of solution, supplied in YES YES

injection Danica 5, Koprivnica,

a box

Republic of Croatia

Belupo, lijekovi i

10 ampoules each containing

Gentamicin 40 mg/2 mL kozmetika d.d., Ulica

solution for injection 2 mL of solution, supplied in YES YES

injection Danica 5, Koprivnica,

a box

Republic of Croatia

Belupo, lijekovi i

10 ampoules each containing

Gentamicin 80 mg/2 mL kozmetika d.d., Ulica

solution for injection 2 mL of solution, supplied in YES YES

injection Danica 5, Koprivnica,

a box

Republic of Croatia

Bosnalijek d.d.,

50 amber glass ampoules

Gentamicin injection 120 Jukićeva 53, Sarajevo,

solution for injection each with 2 mL of solution, YES YES

mg Bosnia and

supplied in a box

Herzegovina

Farmal d.d., Ludbreg,

Republic of Croatia in 10 ampoules each containing Gentamicin injection 120

solution for injection cooperation with Lek 2 mL of solution, supplied in YES YES mg/2 mL

d.d., Ljubljana, a box

Republic of Slovenia

Bosnalijek d.d.,

50 amber glass ampoules

Gentamicin injection 40 Jukićeva 53, Sarajevo,

solution for injection each with 2 mL of solution, YES YES

mg Bosnia and

supplied in a box

Herzegovina

Farmal d.d., Ludbreg,

Republic of Croatia in 10 ampoules each containing Gentamicin injection 40

solution for injection cooperation with Lek 2 mL of solution, supplied in YES YES mg/2 mL

d.d., Ljubljana, a box

Republic of Slovenia Bosnalijek d.d., 50 amber glass ampoules

Gentamicin injection 80 Jukićeva 53, Sarajevo, solution for injection each with 2 mL of solution, YES YES

mg Bosnia and supplied in a box

Herzegovina

Farmal d.d., Ludbreg,

Republic of Croatia in 10 ampoules each containing Gentamicin injection 80

solution for injection cooperation with Lek 2 mL of solution, supplied in YES YES mg/2 mL

d.d., Ljubljana, a box

Republic of Slovenia

Jadran - Galenski

10 amber glass ampoules

laboratorij d.d., Pulac

Gentamicin Jadran 120 solution for injection each containing 2 mL of YES YES

bb, Rijeka, Republic of

solution, supplied in a box

Croatia

Jadran - Galenski

10 amber glass ampoules

laboratorij d.d., Pulac

Gentamicin Jadran 40 solution for injection each containing 2 mL of YES YES

bb, Rijeka, Republic of

solution, supplied in a box

Croatia

Jadran - Galenski

10 amber glass ampoules

laboratorij d.d., Pulac

Gentamicin Jadran 80 solution for injection each containing 2 mL of YES YES

bb, Rijeka, Republic of

solution, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, Aluminium tube with 20 g of Geokorton ointment 20 g ointment YES YES

Zagreb, Republic of ointment, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 16 (2x8) capsules in a

grada Vukovara 49, Geomycin capsules PVC/Al blister, supplied in a YES YES

Zagreb, Republic of box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 6 (2x3) tablets in a blister Geonistin vaginal tablets YES YES

Zagreb, Republic of (PVC/Al), supplied in a box

Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (1x30) tablets in a blister, Ginkgo film-tablets film coated tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Genericon Pharma Glibenclamid Genericon 30 (3x10) tablets in a PVC/Al

tablets Ges.m.b.H, Lannach, YES YES 3.5 mg tablets blister , supplied in a box

Austria

Genericon Pharma 120 (12x10) tablets in a Glibenclamid Genericon

tablets Ges.m.b.H, Lannach, blister (PVC/Al), supplied in a YES YES 3.5 mg tablets

Austria box

Novartis Pharma Glivec 100 mg film coated 60 (6x10) tablets in a blister

film coated tablets GmbH, Nurnberg, YES YES YES YES tablets (PVC/Al), supplied in a box

Germany

Novartis Pharma Stein

120 (10x12) capsules in a

AG,

Glivec 100 mg capsules hard capsules blister (PVC/Al), supplied in a YES YES YES YES

Schaffhauserstrasse,

box

Stein, Switzerland

Novartis Pharma A.G., 120 (10x12) capsules in a Glivec 100 mg capsules capsules YES YES YES YES

Basel, Switzerland blister, supplied in a box

Novartis Pharma 30 (3x10) tablets in a Glivec 400 mg film coated

film coated tablets GmbH, Nurnberg, PVC/PE/PVDC/Al blister, YES YES YES YES tablets

Germany supplied in a box

Novartis Pharma A.G., 30 (3x10) capsules in a Glivec 50 mg capsules capsules YES YES YES YES

Basel, Switzerland blister, supplied in a box

Novartis Pharma Stein 30 (3x10) capsules in a

AG, Glivec 50 mg capsules hard capsules blister (PVC/Al), supplied in a YES YES YES YES

Schaffhauserstrasse, box

Stein, Switzerland

One glass vial with Novo Nordisk A/S, powder and diluent for lyophilisate and one glass GlucaGen HypoKit Novo Allé, DK-2880 YES YES

solution for injection syringe with needle (1 mL of Bagsvaerd, Denmark

diluent), in a plastic container

Bayer HealthCare AG, 30 tablets (2x15) in a blister

Glucobay 100 mg tablets tablets 51368 Leverkusen, (polypropylene/Al), supplied YES YES

Germany in a box

Bayer HealthCare AG, 32 (2x15) capsules in a

Glucobay 50 mg tablets tablets 51368 Leverkusen, PVC/Al blister, supplied in a YES YES

Germany box

Merck SANTE s.a.s.,

Centere de Production

de Semoy, 2 Rue du 60 (4x15) film coated tablets

Glucomerck 1000 mg film Pressior Vert - 45400 film coated tablets in a transparent blister YES YES

coated tablets Semoy, France; Merck

(PVC/Al), supplied in a box KGcA, Frankfurt

Strasse 250, 64293

Darmstadt, Germany

Merck SANTE s.a.s.,

Centere de Production

de Semoy, 2 Rue du

100 (5x20) film coated

Glucomerck 500 mg film Pressior Vert - 45400

film coated tablets tablets in transparent blister YES YES

coated tablets Semoy, France; Merck

(PVC/Al), supplied in a box

KGcA, Frankfurt

Strasse 250, 64293

Darmstadt, Germany

Merck SANTE s.a.s.,

Centere de Production

de Semoy, 2 Rue du 30 (2x15) film coated tablets

Glucomerck 850 mg film Pressior Vert - 45400 film coated tablets in a transparent PVC/Al YES YES

coated tablets Semoy, France; Merck blister, supplied in a box

KGcA, Frankfurt

Strasse 250, 64293

Darmstadt, Germany

Merck SANTE

s.a.s./Centre de 30 (3x10) film coated tablets Glucophage 1000 mg film

film coated tablets Production de Semoy, in a transparent blister YES YES YES YES coated tablets

France Merck KGaA, (PVC/A1), supplied in a box

Germany

Merck SANTE

s.a.s./Centre de 50 (5x10) film coated tablets Glucophage 500 mg film

film coated tablets Production de Semoy, in a transparent blister YES YES YES YES coated tablets

France Merck KGaA, (PVC/Al), supplied in a box

Germany

Merck Sante s.a.s., Glucophage 850 mg 30 (2x15) tablets in a blister,

film coated tablets Lyon CEDEX 08, YES YES YES YES tablets supplied in a box

France

Merck SANTE s.a.s., 2 Glucovance 500 mg/ 2.5 30 (2x15) tablets in a blister

film coated tablets Rue du Pressoir Vert - YES YES mg tablets (PVC/Al), supplied in a box

45400 Semoy, France

Merck SANTE s.a.s., 2 Glucovance 500 mg/ 5 mg 30 (2x15) tablets in a PVC/Al

film coated tablets Rue du Pressoir Vert - YES YES tablets blister, supplied in a box

45400 Semoy, France

Pliva Croatia Ltd., Ulica

35 (3x10) tablets in a

grada Vukovara 49,

Gluformin 850 mg tablets film coated tablets PVC/PVdC/Al blister, YES YES

Zagreb, Republic of

supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 30 (2x15) tablets in a PVC/Al Gluformin tablets1g film coated tablets YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

100 mL of solution in an Hrvatski zavod za

infusion bottle with rubber

Glukosalina I solution , solution for intravenous transfuzijsku medicinu, stopper protected by Al cap YES YES

100mL infusion Petrova 3, Zagreb, and plastic lid, 10 bottles with

Republic of Croatia

holders in a carton box

250-mL of solution in an Hrvatski zavod za

Glukosalina I solution for infusion bottle with rubber solution for intravenous transfuzijsku medicinu,

intravenous infusion, stopper and protective Al cap YES YES infusion Petrova 3, Zagreb,

250mL with plastic lid (10 bottles

Republic of Croatia

with holders, supplied in a

carton box)

500 mL of solution in an

Hrvatski zavod za infusion bottle with a rubber Glukosalina I solution for

solution for intravenous transfuzijsku medicinu, stopper and an aluminium intravenous infusion, YES YES

infusion Petrova 3, Zagreb, cap with a plastic lid (10 500mL

Republic of Croatia bottles with holders, supplied

in a carton box)

500 mL of solution in an

Hrvatski zavod za infusion bottle with a rubber

Glukosalina III solution for solution for intravenous transfuzijsku medicinu, stopper and an aluminium

YES YES intravenous infusion infusion Petrova 3, Zagreb, cap with a plastic lid (10

Republic of Croatia bottles with holders, supplied

in a carton box)

B. Braun Melsungen 500 mL of solution for

AG, Carl-Braun-Straße Glucose 10% Braun solution for infusion infusion in a plastic bottle (10 YES YES

1, Melsungen, bottles in a box)

Germany

B. Braun Melsungen 1000 mL of infusion solution

AG, Carl-Braun-Straße Glucose 10% Braun solution for infusion in a plastic bottle (10 bottles YES YES

1, Melsungen, in a box)

Germany

Hrvatski zavod za Glucose 10% solution for

transfuzijsku medicinu, 100 mL of solution in a glass intravenous infusion, 100 solution for infusion YES YES

Petrova 3, Zagreb, bottle mL

Republic of Croatia

Hrvatski zavod za Glucose 10% solution for

transfuzijsku medicinu, 250-mL of solution in a glass intravenous infusion, 250 solution for infusion YES YES

Petrova 3, Zagreb, bottle mL

Republic of Croatia

Hrvatski zavod za Glucose 10% solution for

transfuzijsku medicinu, 500 mL of solution in a glass intravenous infusion, 500 solution for infusion YES YES

Petrova 3, Zagreb, bottle mL

Republic of Croatia

Pliva Croatia Ltd., Ulica

Glucose 10% Pliva solution for intravenous grada Vukovara 49, 12 PVC bags with 500 mL of

YES YES solution for infusion infusion Zagreb, Republic of solution, supplied in a box

Croatia

250-mL of solution in a glass Pliva Croatia Ltd., Ulica

Glucose 10% Pliva infusion bottle with rubber solution for intravenous grada Vukovara 49,

solution for infusion 250 stopper and combi-cap (10 YES YES infusion Zagreb, Republic of

mL bottles with polyethylene

Croatia holder supplied in a box)

Pliva Croatia Ltd., Ulica

Glucose 10% Pliva solution for intravenous grada Vukovara 49, 10 glass vials with 500 mL of

YES YES solution for infusion 500mL infusion Zagreb, Republic of solution, supplied in a box

Croatia

Baxter S.A., Belgium;

Baxter Healthcare Ltd, 30 plastic Viaflo bags with

Great Britain; Bieffe 250 mL of solution for

Glucose 5 %, Viaflo solution for infusion Medital Sabinanigo, YES YES infusion in a protective bag,

Spain; Baxter supplied in a box

Healthcare S.A.,

Republic of Ireland

Baxter S.A., Belgium;

Baxter Healthcare Ltd, 10 plastic Viaflo bags with sa

Great Britain; Bieffe 1000 mL of infusion solution,

Glucose 5 % Viaflo solution for infusion Medital Sabinanigo, YES YES in a protective bag, supplied

Spain; Baxter in a box

Healthcare S.A.,

Republic of Ireland

Baxter S.A., Belgium;

Baxter Healthcare Ltd, 50 plastic Viaflo bags with 50

Great Britain; Bieffe mL of solution for infusion in Glukose 5 %, Viaflo solution for infusion YES YES

Medital Sabinanigo, a protective bag, supplied in

Spain; Baxter a box

Healthcare S.A., Republic of Ireland

Baxter S.A., Belgium;

Baxter Healthcare Ltd, 50 plastic bags Viaflo with

Great Britain; Bieffe 100 mL of solution for

Glucose 5 %, Viaflo solution for infusion Medital Sabinanigo, YES YES infusion, in a protective bag,

Spain; Baxter

supplied in a box

Healthcare S.A.,

Republic of Ireland

Baxter S.A., Belgium;

Baxter Healthcare Ltd, 20 plastic Viaflo bags with

Great Britain; Bieffe 500 mL of infusion solution,

Glucose 5 % Viaflo solution for infusion Medital Sabinanigo, YES YES in a protective bag, supplied

Spain; Baxter in a box

Healthcare S.A.,

Republic of Ireland

Hrvatski zavod za

transfuzijsku medicinu, 500 mL of solution in a glass Glucose 5% solution for infusion YES YES

Petrova 3, Zagreb, bottle

Republic of Croatia

Hrvatski zavod za

transfuzijsku medicinu, 100 mL of solution in a glass Glucose 5% solution for infusion YES YES

Petrova 3, Zagreb, bottle

Republic of Croatia

Hrvatski zavod za

transfuzijsku medicinu, 250-mL of solution in a glass Glucose 5% solution for infusion YES YES

Petrova 3, Zagreb, bottle

Republic of Croatia

B. Braun Melsungen 1000 mL of infusion solution

AG, Carl-Braun-Straße Glucose 5% Braun solution for infusion in a plastic bottle (10 bottles YES YES

1, Melsungen, in a box)

Germany

B. Braun Melsungen 250-mL of solution for

AG, Carl-Braun-Straße Glucose 5% Braun solution for infusion infusion in a plastic bottle (10 YES YES

1, Melsungen,

bottles in a box)

Germany

B. Braun Melsungen 500 mL of solution for

AG, Carl-Braun-Straße Glucose 5% Braun solution for infusion infusion in a plastic bottle (10 YES YES

1, Melsungen,

bottles in a box)

Germany

B. Braun Melsungen 100 mL of infusion solution

AG, Carl-Braun-Straße Glucose 5% Braun solution for infusion in a plastic bottle (20 bottles YES YES

1, Melsungen, in a box)

Germany

500 mL of solution in a PVC

Pliva Croatia Ltd., Ulica bag, with a draining

grada Vukovara 49, attachment (closed with Glucose 5% Pliva solution for infusion YES YES

Zagreb, Republic of combiflack stopper) and an

Croatia application attachment, 12

bags in a box

Pliva Croatia Ltd., Ulica 500 mL of solution in a glass

grada Vukovara 49, infusion bottle with a rubber Glucose 5% Pliva solution for infusion YES YES

Zagreb, Republic of stopper and a protective cap,

Croatia 10 bottles in a box

Boehringer Ingelheim 60 (6x10) tablets in a white

Glurenorm 30 mg tablets tablets Ellas A.E., Atena, blister (PVC/PVDC//Al), YES YES

Greece supplied in a box

powder and diluent (in a Industria Farmaceutica Vial with powder and syringe

GONAL-f 1050 IU/1.75 mL syringe) for solution for Serono S.p.A., Bari, with 2 mL of diluent, supplied YES YES YES

injection Italy in a box

Pen-syringe with 0.5 mL of

Industria Farmaceutica solution (in a 3-mL glass solution for injection in

GONAL-f 300 IU/0.5 mL Serono S.p.A., Bari, cartridge) and 5 needles in a YES YES YES pen syringe

Italy plastic container, supplied in

a box powder and diluent (in a Industria Farmaceutica Vial with powder and syringe

GONAL-f 450 IU/0.75 mL syringe) for solution for Serono S.p.A., Bari, with 1 mL of diluent, supplied YES YES YES

injection Italy in a box

Pen-syringe with 0.75 mL of

Industria Farmaceutica solution (in a 3-mL glass solution for injection in

GONAL-f 450 IU/0.75 mL Serono S.p.A., Bari, cartridge) and 7 needles in a YES YES YES pen syringe

Italy plastic container, supplied in

a box

Vial with powder and syringe powder and diluent (in a Industria Farmaceutica

with 1 mL of diluent in a GONAL-f 75 IU syringe) for solution for Serono S.p.A., Bari, YES YES YES

plastic container, supplied in injection Italy

a box

Pen syringe with 1.5 mL of

Industria Farmaceutica solution (in a 3-mL glass solution for injection in

GONAL-f 900 IU/1.5 mL Serono S.p.A., Bari, cartridge) and 14 needles in YES YES YES pen syringe

Italy a plastic container, supplied

in a box

Abbott GmbH & Co. 50 (5x10) capsules in a

Gopten 0.5 mg capsules capsules KG, Ludwigshafen, YES YES blister, supplied in a box

Germany

Abbott GmbH & Co. 28 (2x14) capsules in a

Gopten 2 mg capsules capsules KG, Ludwigshafen, YES YES blister, supplied in a box

Germany

Abbott GmbH & Co. 28 (2x14) capsules in a

Gopten 4 mg capsules capsules KG, Ludwigshafen, YES YES blister, supplied in a box

Germany

STADA Arzneimittel 20 (2x10) capsules in a

Grippostad C capsules AG, Stadtstraße 2-18, blister (PVC/PVDC-Al), YES YES YES

Bad Vilbel, Germany supplied in a box

90 mL of syrup in a glass STADA Arzneimittel

Grippostad Good Night bottle with a plastic tempersyrup AG, Stadtstraße 2-18, YES YES YES

syrup evident stopper (white

Bad Vilbel, Germany

PP/PE), supplied in a box

STADA Arzneimittel 10 bags (Al/paper/PE) each

Grippostad hot drink effervescent powder AG, Stadtstraße 2-18, containing 5.0 g of powder, YES YES YES

Bad Vilbel, Germany supplied in a box

Glass vial with powder,

powder and diluent for ZLB Behring GmbH, glass vial with 10 mL of

Haemate P 500 solution for Emil-von-Behring Str. Water for Injection, transfer YES

injection/infusion 76, Marburg, Germany kit, and disposable filter,

supplied in a box

Krka d.d., Novo mesto,

R. Republic of Slovenia 5 brown ampoules (in a

Haldol depo solution for oily solution for in cooperation with blister) each with 1 mL of YES YES

injection 50 mg/1 mL intramuscular injection Janssen solution, supplied in a box Pharmaceutica,

Beerse, Belgium

Krka d.d. , Novo

mesto, Republic of 30 mL of solution in an

Haldol 10 mg/1 mL oral Slovenia in cooperation oral drops amber glass bottle, supplied YES YES

drops with Janssen in a box

Pharmaceutica,

Beerse, Belgium

Krka d.d. , Novo

mesto, Republic of 10 mL of solution in an

Haldol oral drops 2 mg/1 Slovenia in cooperation oral drops amber glass bottle, supplied YES YES

mL with Janssen in a box

Pharmaceutica,

Beerse, Belgium

Krka d.d., Novo mesto,

R. Republic of Slovenia solution for injection for 10 (2x5) ampoules each Haldol solution for injection in cooperation with

intramuscular and containing 1 mL solution in a YES YES 5 mg/1 mL Janssen

intravenous use blister, supplied in a box Pharmaceutica,

Beerse, Belgium Krka d.d., Novo mesto,

R. Republic of Slovenia

in cooperation with 30 tablets in an amber glass Haldol 10 mg tablets tablets YES YES

Janssen bottle, supplied in a box

Pharmaceutica,

Beerse, Belgium

Krka d.d. , Novo

Mesto, R. Republic of 25 tablets in an amber glass

Slovenia in cooperation Haldol tablets 2 mg tablets bottle, supplied in a carton YES YES

with Janssen box

Pharmaceutica,

Beerse, Belgium

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (2x15) tablets in a blister, Halea 100 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (2x15) tablets in a blister, Halea 50 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Alkaloid AD - Skopje,

Bulevar Aleksandar 30 capsules in a bottle, Heferol capsules YES YES

Makedonski 12, supplied in a box

Skopje, FYROM

75 mg of 13 C-urea in a

polystyrene container with a

closed polyethylene "snap" INFAI Institut für

stopper; equipment for Biomedizinische

Helicobacter test INFAI for sampling and transfer of oral powder Analytik & NMR YES YES YES

infrared spectroscopy samples of expired air (4

Imaging GmbH, glass "vacutainer" test tubes

Bochum, Germany 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 INFAI Institut für

powder for oral solution, with Biomedizinische

Helicobacter test INFAI for powder for preparation of a kit for sampling and

Analytik & NMR YES YES YES infrared spectroscopy oral solution transporting of breath

Imaging GmbH, samples, 50x2 bags with

Bochum, Germany 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 "snap" INFAI Institut für

stopper; equipment for Biomedizinische

Helicobacter test INFAI for sampling and transfer of powder for oral solution Analytik & NMR YES YES YES

mass spectrometry samples of expired air (4

Imaging GmbH, glass "vacutainer" test tubes

Bochum, Germany or plastic"vacuette" of 10 mL

and 1 flexible straw), inserted

in a box

Glass bottle with lyophilisate

and a glass bottle with 10 m

lyophilisate and solvent of solvent, sterile double Hemofil M 250 IU human Baxter S.A., Hyland

for preparation of dissolution needle, sterile coagulation factor VIII, Immuno, Lessines, YES

intravenous solution filter needle, sterile mini monoclonally purified Belgium

(injection/infusion) infusion kit, sterile disposable

syringe of 10 mL, supplied in

a box

Glass bottle with lyophilisate lyophilisate and solvent

Hemofil M 500 IU human Baxter S.A., Hyland and a glass bottle with 10 m for preparation of

coagulation factor VIII, Immuno, Lessines, of solvent, sterile double YES intravenous solution

monoclonally purified Belgium dissolution needle, sterile

(injection/infusion) filter needle, sterile mini infusion kit, sterile disposable

syringe of 10 mL, supplied in

a box

Glass bottle with lyophilisate

and a glass bottle with 10 m

lyophilisate and solvent of solvent, sterile double Hemofil M 500 IU human Baxter S.A., Hyland

for preparation of dissolution needle, sterile coagulation factor VIII, Immuno, Lessines, YES

intravenous solution filter needle, sterile mini monoclonally purified Belgium

(injection/infusion) infusion kit, sterile disposable

syringe of 10 mL, supplied in

a box

Jadran - Galenski

laboratorij d.d., Pulac Box with 50 g of gel in an Al Hepan gel gel YES YES YES

bb, Rijeka, Republic of tube

Croatia

Jadran - Galenski

laboratorij d.d., Pulac Box with 50 g of cream in an Hepan cream cream YES YES YES

bb, Rijeka, Republic of Al tube

Croatia

Belupo, lijekovi i 5 mL of solution in a glass

solution for injection (for kozmetika d.d., Ulica bottle (with a rubber stopper HEPARIN injection YES YES

s.c. and i.v. use) Danica 5, Koprivnica, and an Al cap), 10 bottles in

Republic of Croatia a box

Pliva Croatia Ltd., Ulica solution for intramuscular

grada Vukovara 49, 50 ampoules with 1 mL of Heptanon injection and subcutaneous YES YES

Zagreb, Republic of solution, supplied in a box injection

Croatia

Pliva Croatia Ltd., Ulica 10 mL of solution in an

grada Vukovara 49, amber glass bottle with Heptanon drops oral drops, solution YES YES

Zagreb, Republic of plastic dropper attachment,

Croatia supplied in a box

Pliva Croatia Ltd., Ulica 100 mL of solution in a 125-

grada Vukovara 49, mL brown plastic bottle with Heptanon solution oral solution YES YES

Zagreb, Republic of aluminum cap, supplied in a

Croatia box

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 20 (2x10) tablets in a blister, Heptanon tablets tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

F. Hoffmann-La Roche

HERCEPTIN 150 mg Ltd., powder for concentrate One glass vial with powder,

powder for concentrate for Grenzacherstrasse YES YES YES YES for solution for infusion supplied in a box

solution for infusion 124, Basel,

Switzerland

Hermes Arzneimittel

20 effervescent tablets in a

Hermes Cevitt lemon effervescent powder GmbH, München, YES YES YES

polypropylene tube

Germany

Hermes Arzneimittel

20 effervescent tablets in a

Hermes Cevitt naranca effervescent powder GmbH, München, YES YES YES

polypropylene tube

Germany

Belupo, lijekovi i

kozmetika d.d., Ulica 35 (7x5) tablets in a PVC/Al Herplex 400 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 35 (7x5) tablets in a PVC/Al Herplex 400 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 2 grams of cream in a tube, Herplex cream cream YES YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

GlaxoSmithKline Box with one bottle wtih 1 Hiberix vaccine against

Biologicals s.a., Rue dose of lyophilised vaccine Haemophilus influenzae lyophilisate YES

de lInstitut 89, and 1 syringe with solvent type B, glycoconjugated

Rixensart, Belgium and 2 needles Pliva Croatia Ltd., Ulica

grada Vukovara 49, 5 (1x5) capsules in a blister, Hiramicin capsules YES YES

Zagreb, Republic of supplied in a box

Croatia

Jadran - Galenski

laboratorij d.d., Pulac 20 (2x10) tablets in a blister, Holyplant Purgal tablets tablets YES YES

bb, Rijeka, Republic of supplied in a box

Croatia

Jadran - Galenski 50 g of tea in a

laboratorij d.d., Pulac Holyplant Sena tea herbal tea polypropylene transparent YES YES

bb, Rijeka, Republic of bag, supplied in a box

Croatia

Jadran - Galenski 30 (3x10) oriblettes in a

Holyplant Septogal laboratorij d.d., Pulac oriblettes PVC/Al blister, supplied in a YES YES YES

oriblettes bb, Rijeka, Republic of box

Croatia

5 disposable injectors with Lilly France S.A.S.,

Humaject M3 (30/70) 100 suspension for glass cartridges each with 3

Rue du Colonel Lilly, YES YES IU/mL (3.0 mL) subcutanous injection mL of solution, supplied in a

Fegersheim, France box

5 disposable injectors with Lilly France S.A.S.,

Humaject N 100 IU/mL suspension for glass cartridges each with 3

Rue du Colonel Lilly, YES YES (3.0 mL) subcutanous injection mL of solution, supplied in a

Fegersheim, France box

5 disposable injectors with Lilly France S.A.S.,

Humaject R 100 IU/mL suspension for glass cartridges each with 3

Rue du Colonel Lilly, YES YES (3.0 mL) subcutaneous injection mL of solution, supplied in a

Fegersheim, France box

Lilly France S.A.S., 5 cartridges with 3 mL of Humalog 100 IU/mL

solution for injection Rue du Colonel Lilly, solution in a blister, supplied YES YES cartridge (3.0 mL)

Fegersheim, France in a box

5 glass cartridges with 3.0 Lilly France S.A.S.,

Humalog Mix25 100 IU/mL mL of suspension to be

Fegersheim, France i (suspension in cartridge suspension for injection administered with a pen YES YES YES

Lilly S.A., Alcobendas 3.0 mL) injector, in protective

Madrid, Spain

packaging, supplied in a box

5 injectors with a glass Lilly France S.A.S.,

Humalog Mix25 Pen 100 cartridge with 3.0 mL of suspension for injection Rue du Colonel Lilly, YES YES YES

IU/mL suspension, supplied in a

Fegersheim, France box

5 glass cartridges with 3.0 Lilly France S.A.S.,

Humalog Mix50 100 IU/mL mL of sspension to be

Fegersheim, France i (suspension in cartridge suspension for injection administered with a pen YES YES YES

Lilly S.A., Alcobendas 3.0 mL) injector, in protective

Madrid, Spain

packaging, supplied in a box

5 injectors with a glass Lilly France S.A.S.,

Humalog Mix50 Pen 100 cartridge each with 3.0 mL of suspension for injections Rue du Colonel Lilly, YES YES YES

IU/mL suspension, supplied in a

Fegersheim, France box

5 injectors with a glass Lilly France S.A.S.,

Humalog Pen 100 IU/mL cartridge with 3 mL of solution for injection Rue du Colonel Lilly, YES YES YES

(3 mL) solution, supplied in a carton

Fegersheim, France box

Baxter AG, Human albumin 20% solution for intravenous Box with 1 bottle containing

Industriestrasse 67, A- YES immuno 50 mL use 50 mL of solution

1220 Vienna, Austria

Octapharma

Pharmazeutika

One glass vial with 100 mL of

HUMAN ALBUMIN 20% Produktionsges.m.b.H.,

solution for infusion solution for infusion, supplied YES

OCTAPHARMA 100 mL Vienna, Austria and

in a box

Octapharma SA,

Lingolsheim, France

Octapharma

Paper box with 1 glass bottle

Human Albumin 20% Pharmazeutika

intravenous solution with human albumin solution YES

Octapharma 100 mL Produktionsges.m.b.H.,

à 100 mL

Vienna, Austria

Octapharma

Pharmazeutika

One glass vial containing 50

HUMAN ALBUMIN 20% Produktionsges.m.b.H.,

solution for infusion mL of solution for infusion, YES

OCTAPHARMA 50 mL Vienna, Austria and

supplied in a box

Octapharma SA,

Lingolsheim, France

Octapharma

Paper box with 1 glass bottle

Human Albumin 20% Pharmazeutika

intravenous solution with human albumin solution YES

Octapharma 50 mL Produktionsges.m.b.H.,

à 50 mL

Vienna, Austria

Baxter AG, Human albumin 5% solution for intravenous Box with 1 bottle containing

Industriestrasse 67, A- YES immuno 250 mL use 250 mL of solution

1220 Vienna, Austria

Octapharma

Paper box with 1 glass bottle

Human Albumin 5% Pharmazeutika

intravenous solution with human albumin solution YES

Octapharma 100 mL Produktionsges.m.b.H.,

à 100 mL

Vienna, Austria

Octapharma

One glass vial with 100 mL of

HUMAN ALBUMIN 5% Pharmazeutika

solution for infusion solution for infusion, supplied YES

OCTAPHARMA 100 mL Produktionsges.m.b.H.,

in a box

Vienna, Austria

Octapharma

Paper box with 1 glass bottle

Human Albumin 5% Pharmazeutika

intravenous solution with human albumin solution YES

Octapharma 250 mL Produktionsges.m.b.H.,

à 250 mL

Vienna, Austria

Octapharma

One glass vial with 250 mL of

HUMAN ALBUMIN 5% Pharmazeutika

solution for infusion solution for infusion, supplied YES

OCTAPHARMA 250 mL Produktionsges.m.b.H.,

in a box

Vienna, Austria

One cartridge with

Lilly France S.A.S., lyophilisate, a syringe with

Humatrope 12 mg lyophilisate for injection Rue du Colonel Lilly, 3.15 mL of diluent and a YES YES

Fegersheim, France diluent feed line, supplied in

a box

One cartridge with

Lilly France S.A.S., lyophilisate, a syringe with lyophilisate and diluent

Humatrope 6 mg Rue du Colonel Lilly, diluent, and a needle with YES YES for solution for injection

Fegersheim, France protective plastic cap,

supplied in a box

Abbott Biotehnology Pre-filled glass syringe

Humira solution for Deutschland GmbH, containing 0.8 mL of solution solution for injection YES YES

injection Max-Planck-Ring 2, and one alcohol drenched

Wiesbaden, Germany cotton wool roll in a blister

Lilly France S.A.S., 5 (1x5) cartridges with 3 mL Humulin M3 (30/70) 100 suspension for

Rue du Colonel Lilly, of suspension per blister, YES YES IU/mL (3.0 mLcartridge) subcutanous injection

Fegersheim, France supplied in a box

5 injectors with a glass Lilly France S.A.S.,

Humulin M3 Pen 100 suspension for cartridge each with 3 mL of

Rue du Colonel Lilly, YES YES YES IU/mL subcutaneous injection suspension, supplied in a

Fegersheim, France carton box

Lilly France S.A.S., 5 (1x5) cartridges with 3 mL Humulin N 100 IU/mL (3.0 suspension for

Rue du Colonel Lilly, of suspension per blister, YES YES mL cartridge) subcutanous injection

Fegersheim, France supplied in a box

5 injectors with a glass Lilly France S.A.S., solution for subcutaneous cartridge each with 3 mL of Humulin N Pen 100 IU/mL Rue du Colonel Lilly, YES YES YES

injection suspension, supplied in a Fegersheim, France

carton box

Lilly France S.A.S., 5 (1x5) cartridges with 3 mL Humulin R 100 IU/mL solution for subcutaneous

Rue du Colonel Lilly, of solution per blister, YES YES (cartridge 3.0 mL) injection

Fegersheim, France supplied in a box

Dentinox Gesellschaft

für pharmazeutische 150 mL of solution an amber

HUSTAGIL oral solution Präparate Lenk & glass bottle with Alu cap, YES YES

Schuppan, Berlin, supplied in a box

Germany SmithKline Beecham

Pharmaceuticals, West

lyophilisate for Sussex, Great Britain i 5 glass bottles of 5 mL with Hycamtin YES YES

preparation of infusion GlaxoSmithKline lyophilisate, supplied in a box

Manufacturing S.p.A.,

Parma, Italy

5 g of ointment in an Galenika a.d., Beograd

Hydrocyclin ointment aluminium tube, supplied in a YES YES

-

Zemun, Srbija box

Cedevita d.o.o., 15 bags (paper/Al/PE)

Hyperici Aktiv granules granules Zagreb, Republic of containing 5 g , supplied in a YES YES

Croatia box

Janssen

Pharmaceutica NV, 5 ampoules with 10 mL of HYPNOMIDATE solution for injection YES YES

Turnhouseweg 30, solution, supplied in a box

Beerse, Belgium

Merck Sharp & Dohme

32 (2x14) film coated tablets

B.V., Waarderweg 39,

Hyzaar film coated tablets in a blister, supplied in a YES YES

Postbus 581, Haarlem,

carton box

the Netherlands

Belupo, lijekovi i

100 mL of suspension in an

Ibuprofen 100 mg/5 mL kozmetika d.d., Ulica

oral suspension amber glass bottle, supplied YES YES

oral suspension Danica 5, Koprivnica,

in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (3x10) tablets in a PVC/Al Ibuprofen 400 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 31 (3x10) tablets in a PVC/Al Ibuprofen 600 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Belupo, lijekovi i 30 tablets in a white

kozmetika d.d., Ulica polyethylene (PE) bottle, with Ibuprofen 800 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, a PE screw cap, supplied in

Republic of Croatia a box

The Mentholatum

Company Ltd, 1

50 g of gel in an aluminium

Redwood Avenue,

Ibuprofen gel gel tube with a plastic stopper, YES YES YES

Peel Park Campus,

supplied in a box

East Kilbride, Great

Britain

Farmal d.d., Ludbreg,

Republic of Croatia in Ibuprofen 200 mg coated 30 (3x10) tablets in a blister,

coated tablets cooperation with Lek YES YES tablets supplied in a box

d.d., Ljubljana,

Republic of Slovenia

Farmal d.d., Ludbreg,

Republic of Croatia in Ibuprofen 400 mg coated 30 (3x10) tablets in a blister,

coated tablets cooperation with Lek YES YES tablets supplied in a box

d.d., Ljubljana,

Republic of Slovenia

Farmal d.d., Ludbreg,

Republic of Croatia, in Ibuprofen retard 800 mg Box with 30 tablets (blister,

prolonged release tablets cooperation with YES YES tablets 3x10 tbl.)

Valpharma Int. s.a.,

San Marino

Spirig Pharma AG, 20 grams of cream in an

Imacort cream cream Egerkingen, aluminum tube, supplied in a YES YES

Switzerland box

Spirig Pharma AG,

30 g of paste in an aluminium

Imazol cream-paste paste Egerkingen, YES YES

tube

Switzerland

Spirig Pharma AG, 30 g of cream in an

Imazol Plus cream Egerkingen, aluminium tube, supplied in a YES YES

Switzerland box

Two plastic measuring

Imigran nasal spray of 20 GlaxoSmithKline

nasal spray devices (for nasal spray) in a YES YES

mg S.p.A., Parma, Italy

blister ,supplied in a box

Glaxo Wellcome

Operations, Greenford,

Middlesex, Great 2 tablets in aluminum blister

Britain i Imigran tablets 50 mg film coated tablets (Al/Al), supplied in a carton YES YES

GlaxoSmithKline box

Pharmaceuticals S.A.,

Ul. Grunwaldzka 189,

Poznan, Poland

One glass vial with BCG 81g Sanofi Pasteur Limited,

ImmuCyst, BCG lyophilisate and diluent (lyophilisate) and one glass

Toronto, Ontario, YES Immunotherapeutic agent for intravesical instillation bottle with 3 mL of diluent,

Canada supplied in a box

Bottle with lyophilisate,

lyophilisate and diluent Baxter AG, bottle with 5 mL of diluent,

Immunate 1000 IU for preparation of solution Industriestrasse 67, A- and set for dissolution and YES

for intravenous use 1220 Vienna, Austria injection of medicinal

product, supplied in a box

Bottle with lyophilisate,

lyophilisate and diluent Baxter AG, bottle with 5 mL of diluent,

Immunate 250 IU for preparation of solution Industriestrasse 67, A- and set for dissolution and YES

for intravenous use 1220 Vienna, Austria injection of medicinal

product, supplied in a box

Bottle with lyophilisate, bottle

lyophilisate and diluent Baxter AG, with 5 mL of diluent, and set

Immunate 500 IU for preparation of solution Industriestrasse 67, A- for dissolution and injection YES

for intravenous use 1220 Vienna, Austria of medicinal product,

supplied in a box

Lyophilisate in a glass bottle, lyophilisate and solvent Baxter AG,

10 mL of solvent in a glass Immunine 1200 IU for preparation of solution Industriestrasse 67, A- YES

bottle and dissolution and for i.v. injection/infusion 1220 Vienna, Austria

injection kit, supplied in a box

Lyophilisate in a glass bottle, lyophilisate and solvent Baxter AG,

5 mL of solvent in a glass Immunine 200 IU for preparation of solution Industriestrasse 67, A- YES

bottle and dissolution and for i.v. injection/infusion 1220 Vienna, Austria

injection kit, supplied in a box

Lyophilisate in a glass bottle, lyophilisate and solvent Baxter AG,

5 mL of solvent in a glass Immunine 600 IU for preparation of solution Industriestrasse 67, A- YES

bottle and dissolution and for i.v. injection/infusion 1220 Vienna, Austria

injection kit, supplied in a box

IMOVAX POLIO suspension for Sanofi Pasteur S.A., 2 0.5-mL of suspension in a

inactivated poliomyelitis intramuscular or avenue Pont Pasteur, glass syring, supplied in a YES

vaccine subcutaneous injection Lyon, France box

Imunološki zavod d.d., Bottle with 5 mL of

Human rabies solution for intramuscular Rockefellerova 2, preparation (not less than YES

immunoglobulin use Zagreb, Republic of

500 IU), supplied in a box Croatia

Imunološki zavod d.d., Bottle with 2 mL of

Human rabies solution for intramuscular Rockefellerova 2, preparation (not less than YES

immunoglobulin use Zagreb, Republic of

200 IU), supplied in a box Croatia

Imunološki zavod d.d., One glass vial with 250 IU of

Human hepatitis B Rockefellerova 2, solution for injection immunoglobulin, supplied in YES

immunoglobulin , 250 IU Zagreb, Republic of a carton box

Croatia

Imunološki zavod d.d., One glass vial with 500 IU of

Human hepatitis B Rockefellerova 2, solution for injection immunoglobulin, supplied in YES

immunoglobulin, 500 IU Zagreb, Republic of a carton box

Croatia

Imunološki zavod d.d.,

Human tetanus solution for intramuscular Rockefellerova 2, Box containing 1 ampoule of

YES immunoglobulin use Zagreb, Republic of preparation - 250 IU/ampoule

Croatia Imunološki zavod d.d., Glass bottle with 50 mL of

Human immunoglobulin for solution for intravenous Rockefellerova 2, solution and an infusion kit, YES

intravenous use use Zagreb, Republic of supplied in a box

Croatia

Imunološki zavod d.d.,

Glass bottle with 100 mL of

Human immunoglobulin for solution for intravenous Rockefellerova 2,

solution and an infusion kit, YES

intravenous use use Zagreb, Republic of

supplied in a box

Croatia

Imunološki zavod d.d.,

Glass bottle with 10 mL of

Human immunoglobulin for solution for intravenous Rockefellerova 2,

solution with a needle and a YES

intravenous use use Zagreb, Republic of

filter, supplied in a box

Croatia

100 (4 x 25) tablets in Heumann PCS GmbH,

Imuran tablets film coated tablets PVC/Al blister, supplied in a YES YES

Feucht, Germany box

Belupo, lijekovi i

30 (1x30) tablets in a white

kozmetika d.d., Ulica

Indamid SR tablets prolonged-release tablets PVC/Al blister , supplied in a YES YES

Danica 5, Koprivnica,

box

Republic of Croatia

Pro. Med.CS Praha 30 (3x10) capsules in a

INDAP capsules a.s., Prag, Czech blister (PVC/Al), supplied in a YES YES

Republic box

Pro. Med.CS Praha

30 (3x10) capsules in a

Indap capsules a.s., Prag, Czech YES YES

blister, supplied in a box

Republic

Pliva Croatia Ltd., Ulica

30 (3x10) tablets in a white

grada Vukovara 49,

Indapamid SR Pliva tablets prolonged-release tablets PVC/Al blister, supplied in a YES YES

Zagreb, Republic of

box

Croatia

Belupo, lijekovi i

Indometacin 100 mg kozmetika d.d., Ulica 10 (2x5) suppositories in a suppositories YES YES suppositories Danica 5, Koprivnica, strip, supplied in a box

Republic of Croatia

Belupo, lijekovi i

Indometacin 25 mg kozmetika d.d., Ulica 30 (2x15) capsules in a capsules YES YES capsules Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Belupo, lijekovi i

30 (2x15) capsules in a

Indometacin 75 mg retard prolonged-release kozmetika d.d., Ulica

PVC/Al blister, supplied in a YES YES

capsules capsules Danica 5, Koprivnica,

box

Republic of Croatia

Merck Sharp & Dohme

B.V., Waarderweg 39, 28 (2x14) tablets in a blister Inegy 10 mg/10 mg tablets YES YES YES

Postbus 581, Haarlem, (Al/Al), supplied in a box

the Netherlands

Merck Sharp & Dohme

28 (2x14) tablets in a blister

B.V., Waarderweg 39,

Inegy 10 mg/20 mg tablets (PVC/Aclar/Al), supplied in a YES YES YES

Postbus 581, Haarlem,

box

the Netherlands

Merck Sharp & Dohme

28 (4x7) tablets in a blister

B.V., Waarderweg 39,

Inegy 10 mg/40 mg tablets (PVC/Aclar/Al), supplied in a YES YES YES

Postbus 581, Haarlem,

box

the Netherlands

Merck Sharp & Dohme

28 (4x7) tablets in a blister

B.V., Waarderweg 39,

Inegy 10 mg/80 mg tablets (PVC/Aclar/Al), supplied in a YES YES YES

Postbus 581, Haarlem,

box

the Netherlands

Infanrix diphtheria, GlaxoSmithKline Box with one glass syringe

tetanus and pertussis Biologicals s.a., Rue containing 1 dose of vaccine intramuscular suspension YES

(acellular) vaccine, de lInstitut 89, (0.5 mL), needle and needle

absorbed Rixensart, Belgium protection

One glass syringe with 0.5

GlaxoSmithKline mL of liquid vaccine lyophilisate and

Biologicals s.a., Rue component (DTP-HBV-IPV), Infanrix Hexa suspension for parenteral YES

de lInstitut 89, one glass bottle with Hib use

Rixensart, Belgium lyophilisate and two needles

with protective caps, supplied in a box

INFANRIX-IPV+Hib,

Box with 1 glass syringe

Combined Diphtheria,

GlaxoSmithKline containing 0.5 mL of Tetanus, acellular powder and suspension

Biologicals s.a., Rue suspension (component Pertussis,inactivated Polio for preparation of YES

de lInstitut 89, Infanrix IPV), 1 glass bottle and Haemophilus suspension for injection

Rixensart, Belgium with powder (component Hib) influenzae type B

and 2 needles with protection conjugate Vaccine

Solvay Box with 1 pre-filled syringe Influvac (inactivated

Pharmaceuticals B.V., (glass, type I) with 1 dose of influenza vaccine, surface suspension for injection YES

Veerweg 12, 8121 AA vaccine (0.5 mL of antigen)

Olst, the Netherlands suspension)

Pliva Croatia Ltd., Ulica

Infusol (solution for solution for intravenous grada Vukovara 49, 10 glass vials with 500 mL of

YES YES infusion) infusion Zagreb, Republic of solution, supplied in a box

Croatia

Pharmacia Limited,

Whalton Road, 30 (3x10) film coated tablets

Morpeth, in a nontransparent PVC/Al Inspra 25 mg tablets film coated tablets YES YES YES YES

Northumberland blister, supplied in a carton

NE613YA, Great box

Britain

Pharmacia Limited,

Whalton Road, 30 (3x10) film coated tablets

Morpeth, in a nontransparent PVC/Al Inspra 50 mg tablets film coated tablets YES YES YES YES

Northumberland blister, supplied in a carton

NE613YA, Great box

Britain

Almed GmbH, 10 syringes each containing

Instillagel 11 mL gel Motzener Str. 41, 11 mL of gel in a blister, YES YES

Berlin, Germany supplied in a box

Almed GmbH, 10 syringes each containing

Instillagel 6 mL gel Motzener Str. 41, 6 mL of gel in a blister, YES YES

Berlin, Germany supplied in a box

Novo Nordisk A/S, 10 mL of suspension in a solution for injection (for

Insulatard HM 100 Novo Allé, DK-2880 glass bottle, supplied in a YES YES s.c. use)

Bagsvaerd, Denmark box

Novo Nordisk A/S,

Novo Alle, Bagsvaerd, 5 glass cartridges with 3 mL

suspension for Denmark Novo Nordisk Insulatard Penfill of suspension in a blister, YES YES

subcutaneous injection Production SAS, 45,

supplied in a box

Avenue d' Orleans,

Chartres, France

Schering-Plough Labo

N.V., Heist-op-den Integrilin solution for One glass vial with 10 mL of

solution for infusion Berg, Belgium and YES YES YES YES infusion 0.75 mg/mL solution, supplied in a box

Glaxo Operations UK

Ltd., Great Britain

Schering-Plough Labo

N.V., Heist-op-den Integrilin solution for One glass vial with 10 mL of

solution for injection Berg, Belgium and YES YES YES YES injection 2 mg/mL solution, supplied in a box

Glaxo Operations UK

Ltd., Great Britain

Fresenius Kabi Austria Glass infusion bottle

GmbH, Graz, Austria containing 500 mL of Intralipid 10% emulsion for infusion YES YES

and Fresenius Kabi emulsion, 10 bottles in a

AB, Uppsala, Sweden carton box

Plastic bag ("Excel")

containing 500 mL of

emulsion for infusion with two

attachments for drug Fresenius Kabi AB,

Intralipid 10% emulsion for infusion administration and for YES YES

Uppsala, Sweden

infusion, one small bag

containing oxygen absorber,

and one bag with solution for

packaging airtightness

control

Fresenius Kabi Austria Glass infusion bottle

GmbH, Graz, Austria containing 100 mL of Intralipid 10% emulsion for infusion YES YES

and Fresenius Kabi emulsion, 10 bottles in a

AB, Uppsala, Sweden carton box

Plastic bag ("Excel")

containing 100 mL of

emulsion for infusion with two

attachments for drug

Fresenius Kabi AB, administration and for Intralipid 10% emulsion for infusion YES YES

Uppsala, Sweden infusion, one small bag

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

Fresenius Kabi AB, administration and for Intralipid 20% emulsion for infusion YES YES

Uppsala, Sweden infusion, one small bag

containing oxygen absorber,

and one bag with solution for

packaging airtightness

control

Fresenius Kabi Austria Glass infusion bottle

GmbH, Graz, Austria containing 500 mL of Intralipid 20% emulsion for infusion YES YES

and Fresenius Kabi emulsion, 10 bottles in a

AB, Uppsala, Sweden carton box

Fresenius Kabi Austria Glass infusion bottle

GmbH, Graz, Austria containing 100 mL of Intralipid 20% emulsion for infusion YES YES

and Fresenius Kabi emulsion, 10 bottles in a

AB, Uppsala, Sweden carton box

Plastic bag ("Excel")

containing 500 mL of

emulsion for infusion with two

attachments for drug

Fresenius Kabi AB, administration and for Intralipid 20% emulsion for infusion YES YES

Uppsala, Sweden infusion, one small bag

containing oxygen absorber,

and one bag with solution for

packaging airtightness

control

Schering-Plough One multi-dose syringe with

Intron A 18 million IU (Brinny) Company, a cartridge containing 1.2

solution for injection, multisolution for injection Innishannon, County mL of solution otopine, 12 YES YES YES

dose syringe Cork, Republic of needles and 12 cotton wool

Ireland riolls, supplied in a box

Schering-Plough One multi-dose syringe with

Intron A 30 million IU (Brinny) Company, a cartridge containing 1.2

solution for injection, multisolution for injection Innishannon, County mL of solution otopine, 12 YES YES YES

dose syringe Cork, Republic of needles and 12 cotton wool

Ireland riolls, supplied in a box

Schering-Plough Box with 1 pen injection

Intron A solution for (Brinny) Company, device with a glass cartridge solution for subcutaneous

injection 18 mil.IU, multi Innishannon, County containing 1.2 mL of solution, YES YES YES administration

dose injector Cork, Republic of 6 Novofine needles and 6

Ireland gauze pads

Schering-Plough Box with 1 pen injection

Intron A solution for (Brinny) Company, device with a glass cartridge solution for subcutaneous

injection 30 mil.IU, Innishannon, County containing 1.2 mL of solution, YES YES YES administration

multidozni injektor Cork, Republic of 6 Novofine needles and 6

Ireland gauze pads

Invanz 1 g powder for Merck Sharp & Dohme powder for concentrate 20-mL glass bottle with

concentrate for infusion B.V., Waarderweg 39, YES YES YES for infusion solution powder supplied in a box

solution Postbus 581, Haarlem, the Netherlands

Bracco s.p.a., Via

Egidio Folli 50, Milano, Iopamiro 300 solution for 30 mL of solution in a glass

solution for injection Italy Patheon Italia YES YES injection bottle, supplied in a box

SpA, Via Morolense

87, Ferentino, Italy

Bracco s.p.a., Via

Egidio Folli 50, Milano, Iopamiro 300 solution for 100 mL of solution in a glass

solution for injection Italy Patheon Italia YES YES injection bottle , supplied in a box

SpA, Via Morolense

87, Ferentino, Italy

Bracco s.p.a., Via

Egidio Folli 50, Milano, Iopamiro 300 solution for 50 mL of solution in a glass

solution for injection Italy Patheon Italia YES YES injection bottle, supplied in a box

SpA, Via Morolense

87, Ferentino, Italy

Bracco s.p.a., Via

Egidio Folli 50, Milano, Iopamiro 370 solution for 100 mL of solution in a glass

solution for injection Italy Patheon Italia YES YES injection bottle, supplied in a box

SpA, Via Morolense

87, Ferentino, Italy

Bracco s.p.a., Via

Egidio Folli 50, Milano, Iopamiro 370 solution for 30 mL of solution in a glass

solution for injection Italy Patheon Italia YES YES injection bottle, supplied in a box

SpA, Via Morolense

87, Ferentino, Italy

Bracco s.p.a., Via

Egidio Folli 50, Milano, Iopamiro 370 solution for 50 mL of solution in a glass

solution for injection Italy Patheon Italia YES YES injection bottle, supplied in a box

SpA, Via Morolense

87, Ferentino, Italy

Bracco s.p.a., Via

Egidio Folli 50, Milano, Iopamiro 370 solution for 200 mL of solution in a glass

solution for injection Italy Patheon Italia YES YES injection bottle, supplied in a box

SpA, Via Morolense

87, Ferentino, Italy

Belupo, lijekovi i 60 (2x30) tablets in a blister

kozmetika d.d., Ulica IRUMED 10 mg tablets tablets (PVC/PVDC-Al foil), supplied YES YES

Danica 5, Koprivnica, in a box

Republic of Croatia

Belupo, lijekovi i 30 (1x30) tablets in a blister

kozmetika d.d., Ulica Irumed 2.5 mg tablets tablets (PVC/PVDC-Al folil), supplied YES YES

Danica 5, Koprivnica, in a box

Republic of Croatia

Belupo, lijekovi i 30 (1x30) tablets in a blister

kozmetika d.d., Ulica Irumed 20 mg tablets tablets (PVC/PVDC-Al folil), supplied YES YES

Danica 5, Koprivnica, in a box

Republic of Croatia

Belupo, lijekovi i 30 (1x30) tablets in a blister

kozmetika d.d., Ulica Irumed 5 mg tablets tablets (PVC/PVDC-Al folil), supplied YES YES

Danica 5, Koprivnica, in a box

Republic of Croatia

Belupo, lijekovi i 30 (1x30) tablets in a

kozmetika d.d., Ulica transparent blister

Iruzid 10/12.5 mg tablets tablets YES YES Danica 5, Koprivnica, (PVC/PVDC-Al foil), supplied

Republic of Croatia in a box

Belupo, lijekovi i 31 (1x30) tablets in a

kozmetika d.d., Ulica transparent blister

Iruzid 20/12.5 mg tablets tablets YES YES Danica 5, Koprivnica, (PVC/PVDC-Al foil), supplied

Republic of Croatia in a box

Belupo, lijekovi i 32 (1x30) tablets in a

kozmetika d.d., Ulica transparent blister

Iruzid 20/25 mg tablets tablets YES YES Danica 5, Koprivnica, (PVC/PVDC-Al foil), supplied

Republic of Croatia in a box Genericon Pharma

ISMN Genericon 20 mg 20 (2x10) tablets in PVC/Al tablets Ges.m.b.H, Lannach, YES YES

tablets blister, supplied in a box

Austria

Genericon Pharma ISMN Genericon 40 mg 20 (2x10) tablets in PVC/Al

tablets Ges.m.b.H, Lannach, YES YES tablets blister, supplied in a box

Austria

Jadran - Galenski

laboratorij d.d., Pulac 60 (6x10) tablets in a blister, ISMN Jadran 20 tablets YES YES

bb, Rijeka, Republic of supplied in a box

Croatia

Jadran - Galenski

laboratorij d.d., Pulac 60 (6x10) tablets in a blister, ISMN Jadran 40 tablets YES YES

bb, Rijeka, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

20 (2x10) film coated tablets

grada Vukovara 49,

Isoptin 120 tablets film coated tablets in PVC/Al blister, supplied in YES YES

Zagreb, Republic of

a box

Croatia

Pliva Croatia Ltd., Ulica

30 (3x10) film coated tablets

grada Vukovara 49,

Isoptin 40 tablets film coated tablets in a PVC/Al blister, supplied YES YES

Zagreb, Republic of

in a box

Croatia

Pliva Croatia Ltd., Ulica

50 (5x10) film coated tablets

grada Vukovara 49,

Isoptin 80 tablets film coated tablets in a blister (PVC/Al), supplied YES YES

Zagreb, Republic of

in a box

Croatia

Pliva Croatia Ltd., Ulica 2 mL of solution in a glass

grada Vukovara 49, ampoule, 50 (5x10) Isoptin injection solution for injection YES YES

Zagreb, Republic of ampoules in a plastic holder,

Croatia supplied in a box

Pliva Croatia Ltd.,

Zagreb, Republic of

20 (2x10) prolonged-release

Croatia and Abbott

ISOPTIN RR tablets prolonged-release tablets tablets in PVC/PVDC//Al YES YES

GmbH and Co. KG,

blister, supplied in a box

Ludwigshafen,

Germany

Alcon-Couvreur s.a., 15 mL of solution in a platic ISOPTO TEARS eyel

eye drops Rijksweg 14, Puurs, bottle with dropper YES YES YES drops

Belgium attachment, supplied in a box

Belupo, lijekovi i

kozmetika, d.d.,

Koprivnica, Republic of 4 capsules in a blister

ITRAC 3 capsules capsules, hard Croatia in cooperation (PVC/PE/PVDC/Al), supplied YES YES

with Janssen in a box

Pharmaceutica,

Beerse, Belgium

Farmal d.d., Branitelja

Izosorbid MN retard 40 mg prolonged release tablets domovinskog rata 8, Box with 50 tablets (blister,

YES YES tablets (film coated) Ludbreg, Republic of 5x10 tablets)

Croatia

Farmal d.d., Branitelja

Izosorbid MN retard 60 mg prolonged release tablets domovinskog rata 8, Box with 50 tablets (blister,

YES YES tablets (film coated) Ludbreg, Republic of 5x10 tablets)

Croatia

B. Braun Melsungen 500 mL of solution for

Isotonic solution of sodium AG, Carl-Braun-Straße solution for infusion infusion in a plastic bottle (10 YES YES

chloride 0.9% Braun 1, Melsungen, bottles in a box)

Germany

B. Braun Melsungen

1000 mL of infusion solution

Sodium chloride isotonic AG, Carl-Braun-Straße

solution for infusion in a plastic bottle (10 bottles YES YES

solution 0.9% Braun 1, Melsungen,

in a box)

Germany

B. Braun Melsungen 250-mL of solution for

Sodium chloride isotonic AG, Carl-Braun-Straße solution for infusion infusion in a plastic bottle (10 YES YES

solution 0.9% Braun 1, Melsungen, bottles in a box)

Germany B. Braun Melsungen 100 mL of infusion solution

Sodium chloride isotinic AG, Carl-Braun-Straße solution for infusion in a plastic bottle (20 bottles YES YES solution 0.9% Braun 1, Melsungen,

in a box) Germany

Jenapharm GmbH & 3x21 tablets in a blister, Jeanine film tablets film coated tablets YES YES

Co KG, Jena, Germany supplied in a box

Jenapharm GmbH & 1x21 tablets in a blister, Jeanine film tablets film coated tablets YES YES

Co KG, Jena, Germany supplied in a box

CHINOIN

Pharmaceutical and

Chemical Works Co.

Ltd., Budimpešta, 50 (5x10) tablets in an

Jumex 5 mg tablets Madarska i CHINOIN Al/OPA/PVC/Al blister, YES YES

Pharmaceutical and supplied in a box

Chemical Works Co.

Ltd.,Veresegyhaz,

Madarska

Plastic bag for 1540 mL of

blend (in three separate Fresenius Kabi AB,

Kabiven emulsion for infusion compartments) in a plastic YES YES YES Uppsala, Sweden

protective casing, 4 bags in a

box

Plastic bag for 1026 mL of

blend (in three separate Fresenius Kabi AB,

Kabiven emulsion for infusion compartments) in a plastic YES YES YES Uppsala, Sweden

protective casing, 4 bags in a

box

Plastic bag for 2053 mL of

blend (in three separate Fresenius Kabi AB,

Kabiven emulsion for infusion compartments) in a plastic YES YES YES Uppsala, Sweden

protective casing, 2 bags in a

box

Plastic bag for 2566 mL of

blend (in three separate Fresenius Kabi AB,

Kabiven emulsion for infusion compartments) in a plastic YES YES YES Uppsala, Sweden

protective casing, 2 bags in a

box

Plastic bag for 1440 mL of

blend (in three separate Fresenius Kabi AB,

Kabiven Peripheral emulsion for infusion compartments) in a plastic YES YES YES Uppsala, Sweden

protective casing, 4 bags in a

box

Plastic bag for 1920 mL of

blend (in three separate Fresenius Kabi AB,

Kabiven Peripheral emulsion for infusion compartments) in a plastic YES YES YES Uppsala, Sweden

protective casing, 2 bags in a

box

20-mL bottle containing Pliva Lachema,

Calsium folinate Pliva solution, with bromobutyl solution for injection Karasek 1, 62133 YES YES injection 200 mg/20 mL stopper and aluminum cap,

Brno, Czech Republic

supplied in a box

50-mL bottle with solution, Pliva Lachema,

Calcium folinate Pliva closed bromobutyl stopper solution for injection Karasek 1, 62133 YES YES injection 500 mg/50 mL and aluminum cap, supplied

Brno, Czech Republic in a box

10-mL bottle containing Pliva Lachema,

Calcium Folinate Pliva solution, with bromobutyl solution for injection Karasek 1, 62133 YES YES injection100 mg/10 mL stopper and aluminum cap,

Brno, Czech Republic

supplied in a box

Krka d.d., Šmarješka Calcium carbonate Krka 1 50 tablets in a bottle,

tablets cesta 6, Novo mesto, YES YES

g tablets supplied in a box

Republic of Slovenia

Abbott Laboratories 2 plastic (HDPE) bottles each

KALETRA 133.3 mg/33.3 Ltd., Kent, Great capsules, soft containing 90 capsules, YES YES YES YES

mg soft capsules Britain, Abbott S.p.A., supplied in a box

Campoverde di Aprilia, Italy

Abbott Laboratories

Ltd, Kent, Great 120 tablets in a plastic

KALETRA 200 mg/50 mg Britain, Abbott film coated tablets (HDPE) bottle, supplied in a YES YES YES YES

film-tablets GmbH&Co. KG, box

Ludwigshafen,

Germany

Abbott Laboratories

Ltd., Kent, Great 5 plastic (PET) brown bottles Kaletra 80 mg + 20 mg/mL

oral solution Britain, Abbott S.p.A., for multiple use with 60 mL of YES YES YES YES oral solution

Campoverde di Aprilia, solution, supplied in a box

Italy

Abbott Laboratories Box with 2 plastic bottles

Kaletra capsules capsules Ltd, Queenborough, YES YES YES YES each containing 90 capsules

Great Britain

Abbott Laboratories Box with 5 plastic bottles

Kaletra oral solution oral solution Ltd, Queenborough, each with 60 mL of solution YES YES YES YES

Great Britain and 5 filling syringes of 5 mL

Jadran - Galenski POTASSIUM CHLORIDE 20 (2x10) tablets for oral

laboratorij d.d., Pulac JADRAN 500 mg tablets tablets for oral solution solution in a blister (PVC/Al), YES YES

bb, Rijeka, Republic of for oral solution supplied in a box

Croatia

Nordmark Arzneimittel

Plastic tube with 15

Kalinor effervescent GmbH & Co. KG,

effervescent tablets effervescent tablets, supplied YES YES

tablets Pinnauallee 4,

in a box

Uetersen, Germany

Krka d.d., Šmarješka 21 (2x10 tablets in

KAMIREN tablets 1 mg tablets cesta 6, Novo mesto, PVC/PVDC/Al blister, YES YES

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 22 (2x10 tablets in

KAMIREN tablets 2 mg tablets cesta 6, Novo mesto, PVC/PVDC/Al blister, YES YES

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 23 (2x10 tablets in

KAMIREN tablets 4 mg tablets cesta 6, Novo mesto, PVC/PVDC/Al blister, YES YES

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 60 (6x10) tablets in an

Kamiren XL modified release tablets cesta 6, Novo mesto, OPA/Al/PVC//Al blister, YES YES

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 30 (3x10) tablets in a

Kamiren XL modified release tablets cesta 6, Novo mesto, OPA/Al/PVC//Al blister, YES YES

Republic of Slovenia supplied in a box

Belupo, lijekovi i

kozmetika d.d., Ulica 20 (2x10) capsules in a Katena 100 mg capsules capsules YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 50 (5x10) capsules in a Katena 300 mg capsules capsules YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 50 (5x10) capsules in a Katena 400 mg tablets capsules YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Krka d.d., Šmarješka 5 ampoules (each with 1 mL Kenalog 40 mg/1 mL

suspension for injection cesta 6, Novo mesto, of suspension) in a blister, YES YES suspension for injection

Republic of Slovenia supplied in a box

300 mL of solution in an

Keppra 100 mg/mL oral NextPharma SAS, amber glass bottle with a oral solution YES YES YES YES

solution Limay, France plastic temper-evident

stopper, supplied in a box

Keppra 1000 mg film UCB S.A., Braine 60 (6x10) tablets in a blister film coated tablets YES YES YES YES

coated tablets l'Alleud, Belgium (PVC/Al), supplied in a box

Keppra 250 mg film coated UCB S.A., Braine 60 (6x10) tablets in a blister film coated tablets YES YES YES YES

tablets l'Alleud, Belgium (PVC/Al), supplied in a box

Keppra 500 mg film coated UCB S.A., Braine 60 (6x10) tablets in a blister film coated tablets YES YES YES YES

tablets l'Alleud, Belgium (PVC/Al), supplied in a box

Spirig Pharma AG, 50 g of ointment in an

KERASAL ointment ointment Egerkingen, aluminium tube with a plastic YES YES YES

Switzerland stopper, supplied in a box

Aventis Pharma S.p.A.,

10 (1x10) tablets in a blister,

Ketek 400 mg film coated tablets S.S. 17 KM 22, YES YES

supplied in a box

Scoppito, Italy

Pliva Croatia Ltd., Ulica

powder for solution for grada Vukovara 49, 5 glass bottles with powder, Ketocef injection 1.5 g YES YES

injection Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

powder for solution for grada Vukovara 49, 5 glass bottles with powder, Ketocef injection 250 mg YES YES

injection Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

powder for solution for grada Vukovara 49, 5 glass bottles with powder, Ketocef injection 750 mg YES YES

injection Zagreb, Republic of supplied in a box

Croatia

Lek farmacevtska

družba d.d.,

50 g of gel in an aluminium

KetoGel 2.5% gel gel Verovškova 57, YES YES YES

tube, supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d., Ketonal 100 mg 12 suppositories in a strip

suppositories Verovškova 57, YES YES suppositories (Al/PE), supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d., 2 mL of solution for injection Ketonal 100 mg/2 mL

solution for injection Verovškova 57, in a glass ampoule, 10 YES YES injection

Ljubljana, Republic of ampoules in a box

Slovenia

Lek farmacevtska

družba d.d., 20 prolonged-release tablets Ketonal 150 mg

prolonged-release tablets Verovškova 57, in an amber glass bottle with YES YES prolonged-release tablets

Ljubljana, Republic of plastic cap, supplied in a box

Slovenia

Lek farmacevtska

družba d.d., 30 g of cream in an

Ketonal 5% cream cream Verovškova 57, aluminium tube, supplied in a YES YES YES

Ljubljana, Republic of box

Slovenia

Lek farmacevtska

družba d.d., 25 capsules in an amber

Ketonal 50 mg capsules capsules, hard Verovškova 57, glass bottle with plastic cap , YES YES

Ljubljana, Republic of supplied in a box

Slovenia

Lek farmacevtska 20 (2x10) capsules in a

družba d.d., Ketonal DUO 150 mg modified release blister

Verovškova 57, YES YES capsules capsules, hard (PVC/TE/PVDC//PVC/Al),

Ljubljana, Republic of supplied in a box

Slovenia

Lek farmacevtska

družba d.d., 20 film coated tablets in an Ketonal forte 100 mg

film coated tablets Verovškova 57, amber glass bottle with YES YES tablets

Ljubljana, Republic of plastic cap, supplied in a box

Slovenia

Farmal d.d., Ludbreg,

Republic of Croatia in KLAVAX BID 1000 mg 14 tablets in a A/Al blister,

film coated tablets cooperation with Bilim YES YES tablets supplied in a box

Pharmaceuticals Inc.,

Turkey Farmal d.d., Ludbreg,

Republic of Croatia in Glass bottle of 100 mL with a KLAVAX BID syrup 400/57 powder for preparation of

cooperation with Bilim polyethylene cap, supplied in YES YES mg oral suspension

Pharmaceuticals Inc., a box

Turkey

Powder for preparation of 70

mL of suspension (by the

addition of 59 mL of water) in

Pliva Croatia Ltd., Ulica an amber glass bottle with a

powder for preparation of grada Vukovara 49, plastic stopper (high density Klavocin bid syrup YES YES

oral suspension Zagreb, Republic of polyethylene) and a 5 mL

Croatia measuring syringe

(polystyrene/polyethylene

low density), supplied in a

box

Powder for preparation of

140 mL of suspension (by

the addition of 118 mL of Pliva Croatia Ltd., Ulica

water) in an amber glass powder for preparation of grada Vukovara 49,

Klavocin bid syrup bottle with a plastic stopper YES YES oral suspension Zagreb, Republic of

(high density polyethylene) Croatia

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)

Pliva Croatia Ltd., Ulica in an amber glass bottle with

powder for preparation of grada Vukovara 49, a plastic stopper (high Klavocin bid syrup YES YES

oral suspension Zagreb, Republic of density polyethylene) and a 5

Croatia mL measuring syringe

(polystyrene/polyethylene

low density), supplied in a

box

Pliva Croatia Ltd., Ulica 10 (2x5) film coated tablets in

grada Vukovara 49, Klavocin bid tablets 1 g film coated tablets a Al/Al blister, supplied in a YES YES

Zagreb, Republic of box

Croatia

Pliva Croatia Ltd., Ulica 5 bottles (glass of hydrolytic

powder for injection grada Vukovara 49, group I) with a rubber Klavocin 1.2 g injection YES YES

solution Zagreb, Republic of stopper and a protective flip

Croatia off Al cap, supplied in a box

Pliva Croatia Ltd., Ulica 5 bottles (glass of hydrolytic

powder for solution for grada Vukovara 49, group I) with a rubber Klavocin injection 600 mg YES YES

injection Zagreb, Republic of stopper and a protective flip

Croatia off Al cap, supplied in a box

Lek farmacevtska 16 capsules in an amber

Klimicin 150 mg capsules capsules družba d.d., Ljubljana, glass bottle, supplied in a YES YES

Republic of Slovenia box

Lek farmacevtska 16 capsules in an amber

Klimicin 300 mg capsules capsules družba d.d., Ljubljana, glass bottle, supplied in a YES YES

Republic of Slovenia box

Lek farmacevtska 10 glass ampoules each Klimicin 300 mg/2 mL solution for intramuscular

družba d.d., Ljubljana, containing 2 mL of solution, YES YES injection and intravenous injection

Republic of Slovenia supplied in a box

Lek farmacevtska Klimicin 600 mg/4 mL solution for intramuscular 10 glass bottles with à 4 mL

družba d.d., Ljubljana, YES YES injection and intravenous injection of solution, supplied in a box

Republic of Slovenia

Lek farmacevtska

družba d.d., 30 g of gel in a tube, supplied

Klimicin T 1% gel gel Verovškova 57, YES YES in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

Klimicin T 1% dermal družba d.d., 30 mL of solution in a plastic dermal solution YES YES

solution Verovškova 57, bottle, supplied in a box

Ljubljana, Republic of Slovenia

Lek farmacevtska

družba d.d., 40 g of cream in a tube with Klimicin V 2% vaginal

vaginal cream Verovškova 57, 7 plastic applicators, supplied YES YES cream

Ljubljana, Republic of in a box

Slovenia

28 film-coated tablets in a Novo Nordisk A/S,

plastic container (dispenser

Kliogest film coated tablets Novo Allé, DK-2880 YES YES with marked days of the

Bagsvaerd, Denmark week), supplied in a box

Belupo, lijekovi i

kozmetika d.d., Ulica 10 (1x10) tablets in a PVC/AI Klomifen 50 mg tablets tablets YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

M.C.M. Klosterfrau 60 (2x30) sugar coated Klosterfrau Sedinal sugarsugar-coated

tablets Vertriebs GmbH, tablets in a blister, supplied YES YES coated tablets

Germany in a box

Belupo, lijekovi i

Knavon 100 mg kozmetika d.d., Ulica 12 (2x6) suppositories in a suppositories YES YES

suppositories Danica 5, Koprivnica, strip, supplied in a box

Republic of Croatia

Belupo, lijekovi i

10 glass ampoules with á 2

Knavon 100 mg/2 mg kozmetika d.d., Ulica

intramuscular injection mL of solution in a plastic YES YES

injection Danica 5, Koprivnica,

container, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 25 (1x25) capsules in a Knavon 50 mg capsules capsules YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Belupo, lijekovi i

20 tablets in an amber glass

Knavon forte 100 mg kozmetika d.d., Ulica

film coated tablets bottle with Al cap, supplied in YES YES

tablets Danica 5, Koprivnica,

a carton box

Republic of Croatia

Belupo, lijekovi i

20 tablets in an amber glass

Knavon retard 150 mg kozmetika d.d., Ulica

prolonged-release tablets bottle, supplied in a carton YES YES

tablets Danica 5, Koprivnica,

box

Republic of Croatia

Bosnalijek d.d.,

Jukićeva 53, Sarajevo, 20 (2x10) tablets in PVC/Al Kofan tablets tablets YES YES YES

Bosnia and blister, supplied in a box

Herzegovina

Vial with Bio-set device

containing powder, pre-filled

syringe with diluent, separate

Kogenate Bayer 1000 IU powder and diluent for Bayer Biologicals S.r.l., plunger, venipuncture set,

powder and diluent for YES YES YES YES solution for injection Torri-Sovicille, Italy two disposable sterile cotton

injection solution pads 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, separate

Kogenate Bayer 250 IU powder and diluent for Bayer Biologicals S.r.l., plunger, venipuncture set,

powder and diluent for YES YES YES YES solution for injection Torri-Sovicille, Italy two disposable sterile cotton

injection solution pads 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, separate

Kogenate Bayer 500 IU powder and diluent for Bayer Biologicals S.r.l., plunger, venipuncture set,

powder and diluent for YES YES YES YES solution for injection Torri-Sovicille, Italy two disposable sterile cotton

injection solution pads drenched in a Acohol,

two dry cotton pads and two

plasters, supplied in a box

Alkaloid AD - Skopje,

Bulevar Aleksandar 20 (2x10) tablets in PVC/Al Kompensan tablets YES YES YES

Makedonski 12, blister, supplied in a box

Skopje, FYROM

F. Hoffmann-La Roche

Ltd., 5 ampoules (amber glass) Konakion MM injection solution for intravenous

Grenzacherstrasse with 1 mL of solution, YES YES 10mg/1mL injection

124, Basel, supplied in a box

Switzerland

F. Hoffmann-La Roche

5 ampoules (amber glass)

solution for peroral, Ltd.,

Konakion MM 2 mg/0.2 with 0.2 mL of solution and 5

intramuscular and Grenzacherstrasse YES YES

mL, paediatric plastic measuring devices,

intravenous injection 124, Basel,

supplied in a box

Switzerland

Solvay

capsules filled with Pharmaceuticals Kreon 10 000 20 tablets in a plastic bottle YES YES

gastric-resistant granules GmbH, Hannover,

Germany

Solvay

capsules filled with Pharmaceuticals 100 capsules in a plastic Kreon 10 000 YES YES

gastric-resistant granules GmbH, Hannover, bottle

Germany

Solvay

capsules filled with Pharmaceuticals 100 capsules in a plastic Kreon 25 000 YES YES

gastric-resistant granules GmbH, Hannover, bottle

Germany

Solvay 50 capsules in a plastic

hard capsules with Pharmaceuticals KREON 40 000 (HDPE) container, supplied YES YES

gastric-resistant granules GmbH, Neustadt, in a box

Germany

10 mL of solution in a STADA Arzneimittel

Kromoglicin STADA eye polyethylene bottle with eye drops, solution AG, Stadtstraße 2-18, YES YES YES

drops dropper attachment and cap,

Bad Vilbel, Germany supplied in a box

STADA Arzneimittel 15 mL of solution in a Kromoglicin STADA nasal

nasal spray, solution AG, Stadtstraße 2-18, polyethylene bottle with YES YES YES spray

Bad Vilbel, Germany nebulizer, supplied in a box

Lek farmacevtska

družba d.d., 20 grams of cream in an

Kuterid 0.05 % cream cream Verovškova 57, aluminum tube, supplied in a YES YES

Ljubljana, Republic of box

Slovenia

Lek farmacevtska

družba d.d., 20 grams of ointment in an

Kuterid 0.05% ointment ointment Verovškova 57, aluminum tube, supplied in a YES YES

Ljubljana, Republic of box

Slovenia

One glass vial with powder,

powder for solution for CSL Behring GmbH, one glass vial with 10 mL of Kybernin P 500 YES

injection or infusion Marburg, Germany diluent and one transfer

spike, supplied in a box

F. Hoffmann-La Roche

Kytril 1mg/1 mL concentrate for infusion Ltd.,

5 ampoules with 1 mL of concentrate for solution for solution (for intravenous Grenzacherstrasse YES YES

solution, supplied in a box

infusion use) 124, Basel,

Switzerland

F. Hoffmann-La Roche

Kytril 3 mg/3 mL Ltd., concentrate for solution 5 ampoules with 3 mL of

concentrate for solution for Grenzacherstrasse YES YES for intravenous infusion solution, supplied in a box

infusion 124, Basel,

Switzerland

F. Hoffmann-La Roche

Ltd.,

10 tablets in a PVC/Al blister,

Kytril film coated tablets film coated tablets Grenzacherstrasse YES YES

supplied in a box

124, Basel,

Switzerland KRKA FARMA d.o.o.,

DPC Jastrebarsko, 60 (6x10) tablets in a

Laaven HD tablets tablets Cvetkovići bb, PVC/PVDC//Al blister, YES YES

Jastrebarsko, Republic supplied in a box

of Croatia

KRKA FARMA d.o.o.,

DPC Jastrebarsko, 33 (3x10) tablets in a

Laaven HD tablets tablets Cvetkovići bb, PVC/PVDC//Al blister, YES YES

Jastrebarsko, Republic supplied in a box

of Croatia

KRKA FARMA d.o.o.,

DPC Jastrebarsko, 34 (3x10) tablets in a

Laaven HL 20 tablets tablets Cvetkovići bb, PVC/PVDC//Al blister, YES YES

Jastrebarsko, Republic supplied in a box

of Croatia

KRKA FARMA d.o.o.,

DPC Jastrebarsko, 30 (3x10) in a blister

Laaven HL tablets tablets Cvetkovići bb, (PVC/PVDC/Al), supplied in YES YES

Jastrebarsko, Republic a box

of Croatia

KRKA FARMA d.o.o.,

DPC Jastrebarsko, 31 (3x10) tablets in a PVC/Al

Laaven tablets 10 mg tablets Cvetkovići bb, YES YES blister, supplied in a box

Jastrebarsko, Republic

of Croatia

KRKA FARMA d.o.o.,

DPC Jastrebarsko, 90 (9x10) tablets in a PVC/Al

Laaven tablets 10 mg tablets Cvetkovići bb, YES YES blister, supplied in a box

Jastrebarsko, Republic

of Croatia

KRKA FARMA d.o.o.,

DPC Jastrebarsko, 90 (9x10) tablets in a PVC/Al

Laaven tablets 2.5 mg tablets Cvetkovići bb, YES YES blister, supplied in a box

Jastrebarsko, Republic

of Croatia

KRKA FARMA d.o.o.,

DPC Jastrebarsko, 32 (3x10) tablets in a PVC/Al

Laaven tablets 20 mg tablets Cvetkovići bb, YES YES blister, supplied in a box

Jastrebarsko, Republic

of Croatia

KRKA FARMA d.o.o.,

DPC Jastrebarsko, 33 (3x10) tablets in a PVC/Al

Laaven tablets 5 mg tablets Cvetkovići bb, YES YES blister, supplied in a box

Jastrebarsko, Republic

of Croatia

Pliva Croatia Ltd., Ulica 28 (4x7) film coated tablets in

LACIDIPIN PLIVA tablets grada Vukovara 49, film coated tablets a blister (PA/Al/PVC//PE/Al), YES YES

4 mg Zagreb, Republic of supplied in a box

Croatia

Glaxo Wellcome S.A.,

Burgos, Aranda de

Duero, Spain and 28 (4x7) tablets in a blister, Lacipil tablets 4 mg film coated tablets YES YES

GlaxoSmithKline supplied in a box

Pharmaceuticals S.A.,

Poznan, Poland

Glaxo Wellcome S.A., 28 (4x7) tablets in a blister

Lacipil tablets 6 mg film coated tablets Aranda de Duero, (OPA/AL/PVC//Al) , supplied YES YES

Burgos, Spain in a box

Lek farmacevtska 30 (3x10) tablets in a

Lakea 50 mg film coated film coated tablets družba d.d., Ljubljana, OPA/Al/PVC//Al blister, YES YES

tablets

Republic of Slovenia supplied in a box

Alkaloid AD - Skopje, 33 (2x15) capsules in a

Bulevar Aleksandar Lamal 100 mg tablets tablets PVC/Al blister, supplied in a YES YES

Makedonski 12, box

Skopje, FYROM

Alkaloid AD - Skopje, 34 (2x15) capsules in a Lamal 200 mg tablets tablets YES YES

Bulevar Aleksandar PVC/Al blister, supplied in a Makedonski 12, box

Skopje, FYROM

Alkaloid AD - Skopje,

Bulevar Aleksandar 30 (3x10) tablets in a blister Lamal 25 mg tablets tablets YES YES

Makedonski 12, (PVC/Al) , supplied in a box

Skopje, FYROM

Alkaloid AD - Skopje,

Bulevar Aleksandar 30 (3x10) tablets in a blister Lamal 50 mg tablets tablets YES YES

Makedonski 12, (PVC/Al) , supplied in a box

Skopje, FYROM

Lek farmacevtska 30 (3x10) dispersible tablets

družba d.d., Lameptil 100 mg in a blister

dispersible tablets Verovškova 57, YES YES YES dispersible tablets (PVC/PE/PVDC//Al),

Ljubljana, Republic of supplied in a box

Slovenia

Lek farmacevtska 31 (3x10) dispersible tablets

družba d.d., Lameptil 200 mg in a blister

dispersible tablets Verovškova 57, YES YES YES dispersible tablets (PVC/PE/PVDC//Al),

Ljubljana, Republic of supplied in a box

Slovenia

Lek farmacevtska 32 (3x10) dispersible tablets

družba d.d., Lameptil 25 mg dispersible in a blister

dispersible tablets Verovškova 57, YES YES YES tablets (PVC/PE/PVDC//Al),

Ljubljana, Republic of supplied in a box

Slovenia

Lek farmacevtska 33 (3x10) dispersible tablets

družba d.d., Lameptil 50 mg dispersible in a blister

dispersible tablets Verovškova 57, YES YES YES tablets (PVC/PE/PVDC//Al),

Ljubljana, Republic of supplied in a box

Slovenia

Glaxo Wellcome 30 (3x10) tablets in a blister,

Lamictal 100 mg tablets tablets Operations, Greenford, YES YES supplied in a box

Great Britain

Glaxo Wellcome 30 (3x10) tablets in a blister,

Lamictal 25 mg tablets tablets Operations, Greenford, YES YES supplied in a box

Great Britain

Glaxo Wellcome 30 (3x10) tablets in a blister,

Lamictal 50 mg tablets tablets Operations, Greenford, YES YES supplied in a box

Great Britain

Glaxo Operations UK

Limited, Ware,

Hertfordshire, Great

Britain (Glaxo Lamictal 5 mg chewing 30 (3x10) tablets in a blister

chewing tablets/ tablets Wellcome Operations, tablets / tablets for oral (PVC/PVDC//Al), inserted in YES YES

for oral suspension Greenford, Great suspension 5 mg a carton box

Britain),

GlaxoSmithKline

Pharmaceuticals,

Poznan, Poland

Novartis Pharma 30 mL of solution in a plastic LAMISIL 1 % aerosol for aerosol for external use,

S.A.S., Huningue bottle with a spray YES YES external use solution

Cedex, France attachment, supplied in a box

Novartis Pharma

Produktions GmbH,

15 g of cream in an

Wehr, Germany and

LAMISIL 1% cream cream aluminum tube, supplied in a YES YES

Novartis Consumer

box

Health SA, Nyon,

Switzerland

Novartis

Pharmaceuticals UK

14 (1x14) tablets in a blister

Lamisil 250 mg tablets tablets Limited, Horsham, YES YES

(PVC/Al), supplied in a box

West Sussex, Great

Britain

Novartis Pharma

5 g of gel in an aluminium

Produktions GmbH,

Lamisil DermGel 1% gel gel tube with a propylene YES YES

Wehr, Germany and

stopper, supplied in a box

Novartis Consumer

Health SA, Nyon,

Switzerland

4 g of solution in an Novartis Consumer

aluminium (PE/Al/PE) tube

Lamisil once 1% dermal Health S.A., Route de l' dermal solution with a plastic stopper, YES YES YES

solution Etraz, Nyon, supplied in a protective

Switzerland plastic box

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 22 (2x10) tablets in a blister Lanicor tablets tablets YES YES

Zagreb, Republic of (PVC/Al) , supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 10 2-mL ampoules supplied Lanitop injection solution for injection YES YES

Zagreb, Republic of in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 50 (5x10) tablets in a blister, Lanitop tablets tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Sanofi - Aventis 5 glass cartridges with 3 mL

Lantus 100 IU/mL ( 3-mL solution for subcutaneous Deutschland GmbH, of solution (with an integrated

YES YES YES cartridge for OptiClik) injection Frankfurt am Main, plastic injector holder),

Germany supplied in a box

Aventis Pharma

Deutschland GmbH, Box with 5 glass cartridges Lantus 100 IU/mL (3 mL solution for subcutaneous

Brunningstrasse 50, each with 3 mL of solution (in YES YES glass cartridge) injection

Frankfurt am Main, a blister)

Germany

Aventis Pharma

Lantus 100 IU/mL OptiSet Deutschland GmbH, 5 injectors with cartridges solution for injection in a

(injector with glass Brunningstrasse 50, each with 3 mL of solution, YES YES cartridge

cartridge of 3 mL) Frankfurt am Main, supplied in a box

Germany

Krka d.d., Šmarješka 14 (2X7) capsules in a

Lanzul capsules 30 mg capsules cesta 6, Novo mesto, PVC/PE/PVDC – Al blister, YES YES

Republic of Slovenia supplied in a box

Jadran - Galenski 28 capsules in a plastic

gastric-resistant laboratorij d.d., Pulac (HDPE) bottle with PP LARONA 15 mg YES YES

capsules, hard bb, Rijeka, Republic of closure (with desiccant ),

Croatia supplied in a box

Jadran - Galenski 29 capsules in a plastic

gastric-resistant laboratorij d.d., Pulac (HDPE) bottle with PP LARONA 30 mg YES YES

capsules, hard bb, Rijeka, Republic of closure (with desiccant ),

Croatia supplied in a box

CP Pharmaceuticals

60 (3x20) tablets in a blister

Lazid tablets 80 mg tablets Ltd, Wrexham, Great YES YES

(PVC/Al), supplied in a box

Britain

Farmal d.d., Branitelja

28 (4x7) capsules in a blister

gastric-resistant domovinskog rata 8,

LAZOL 15 mg capsules (OPA/Al/PVC//Al), supplied in YES YES

capsules, hard Ludbreg, Republic of

a box

Croatia

Farmal d.d., Branitelja

14 (2x7) capsules in a blister

gastric-resistant domovinskog rata 8,

LAZOL 30 mg capsules (OPA/Al/PVC//Al), supplied in YES YES

capsules, hard Ludbreg, Republic of

a box

Croatia

Alkaloid AD, Skopje,

Bulevar A. Makedonski 150 mL of solution in an

12, FYROM in amber glass bottle with

Legofer oral solution cooperation-under the YES YES plastic cap and measuring licence (concession)

vessel , supplied in a box Italfarmaco S.p.a.A.,

Milano, Italy

Lek farmacevtska

Lekadol 500 mg film družba d.d., 18 (3x6) tablets in a blister, film coated tablets YES YES YES

coated tablets Verovškova 57, supplied in a box

Ljubljana, Republic of Slovenia

Lek farmacevtska

družba d.d., 12 (2x6) dispersible tablets in Lekadol direkt 500 mg

orodispersible tablets Verovškova 57, PA/Al/PVC-Al blister, YES YES YES tablets

Ljubljana, Republic of supplied in a box

Slovenia

Lek farmacevtska

družba d.d., granules for preparation 10 bags each containing 5 g Lekadol plus C granules Verovškova 57, YES YES YES

of suspension of granules, supplied in a box Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d.,

20 (2x10) tablets in a blister,

Lekadol tablets tablets Verovškova 57, YES YES

supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d.,

14 (2x7) tablets in a A/PVC

Lekoklar 250 mg tablets tablets Verovškova 57, YES YES

blister, supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d.,

14 (2x7) tablets in a A/PVC

Lekoklar 500 mg tablets tablets Verovškova 57, YES YES

blister, supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

Lekoklar XL 500 mg filmdružba d.d., modified-release film 5 (1x5) tablets in an Al/Al

coated tablets with Verovškova 57, YES YES coated tablets blister, supplied in a box

modified release Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d.,

45 (3x10) tablets in a PVC/Al

Lekotam 1.5 mg tablets tablets Verovškova 57, YES YES

blister, supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d.,

46 (3x10) tablets in a PVC/Al

Lekotam 3 mg tablets tablets Verovškova 57, YES YES

blister, supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d.,

20 (2x10) tablets in PVC/Al

Lekotam 6 mg tablets tablets Verovškova 57, YES YES

blister, supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

powder for preparation of družba d.d., Lendacin 1g power for 10 glass bottles with powder,

injection for i.v. and i.m. Verovškova 57, YES YES injection solution supplied in a box

solution Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d., 5 glass bottles with powder Lendacin 2 g powder for powder for solution for

Verovškova 57, for solution for infusion, YES YES solution for infusion infusion

Ljubljana, Republic of supplied in a box

Slovenia

Novartis

Pharmaceuticals UK

50 (5x10) tablets in a blister,

Leponex 100 mg tablets tablets Limited, Horsham, YES YES

supplied in a box

West Sussex, Great

Britain

Novartis

Pharmaceuticals UK

50 (5x10) tablets in a blister,

Leponex 25 mg tablets tablets Limited, Horsham, YES YES

supplied in a box

West Sussex, Great

Britain Berlin-Chemie AG

(Menarini Group),

Berlin, Germany; 7 (1x7) tablets in a blister

Lercanil film coated tablets Recordati Industria (non-transparent PVC/Al), YES YES

Chimica e supplied in a box

Farmaceutica S.p.A.,

Milano, Italy

Novartis Farmacéutica

S.A., Ronda Santa 28 (4x7) capsules in a blister, Lescol 40 mg capsules capsules YES YES

María 158, Barcelona, supplied in a box

Spain

Novartis Farmacéutica

Lescol XL 80 mg S.A., Ronda Santa 28 (2x14) tablets in a blister, prolonged-release tablets YES YES

prolonged-release tablets María 158, Barcelona, supplied in a box

Spain

Krka d.d., Šmarješka 20 (2x10) film coated tablets Letizen film coated tablets

film coated tablets cesta 6, Novo mesto, in a (PVC/Al) blister, supplied YES YES 10 mg

Republic of Slovenia in a box

Krka d.d., Šmarješka 120 mL of solution in an Letizen oral solution 1

oral solution cesta 6, Novo mesto, amber glass botlle with YES YES mg/1 mL

Republic of Slovenia plastic cap, supplied in a box

Krka d.d., Šmarješka 10 (1x10) film coted tablets in Letizen S 10 mg film

film coated tablets cesta 6, Novo mesto, a PVC/Al) blister, supplied in YES YES YES coated tablets

Republic of Slovenia a box

Berlin-Chemie AG 50 (2x25) tablets in a white

(Menarini Group), non-transparent Letrox 100 tablets YES YES

Glienicker Weg 125, (PVDC/PVC//Al) blister,

Berlin, Germany supplied in a box

Berlin-Chemie AG 50 (2x25) tablets in a white

(Menarini Group), non-transparent Letrox 150 tablets YES YES

Glienicker Weg 125, (PVDC/PVC//Al) blister,

Berlin, Germany supplied in a box

Berlin-Chemie AG 50 (2x25) tablets in a white

(Menarini Group), non-transparent Letrox 50 tablets YES YES

Glienicker Weg 125, (PVDC/PVC//Al) blister,

Berlin, Germany supplied in a box

5 pens with a FlexPen glass solution for injection in Novo Nordisk A/S,

cartridge containing 3 mL of

Levemir FlexPen cartridge for Novo Allé, DK-2880 YES YES YES solution, supplied in a carton subcutaneous use Bagsvaerd, Denmark

box

solution for injection in Novo Nordisk A/S, 5 Penfill glass cartridges with

Levemir Penfill cartridge for Novo Allé, DK-2880 3 mL of solution, supplied in YES YES YES

subcutaneous use Bagsvaerd, Denmark a carton box

Bayer HealthCare AG, Levitra 10 mg film coated 2 tablets in a PP/Al blister,

film coated tablets 51368 Leverkusen, YES YES tablets supplied in a box

Germany

Bayer HealthCare AG, Levitra 20 mg film coated 2 tablets in a PP/Al blister,

film coated tablets 51368 Leverkusen, YES YES tablets supplied in a box

Germany

Bayer HealthCare AG, Levitra 5 mg film coated 2 tablets in a PP/Al blister,

film coated tablets 51368 Leverkusen, YES YES tablets supplied in a box

Germany

Krka d.d., Šmarješka

30 (2x15) tablets in a blister,

Lexaurin tablets 1.5 mg tablets cesta 6, Novo mesto, YES YES

supplied in a box

Republic of Slovenia

Krka d.d., Šmarješka

31 (2x15) tablets in a blister,

Lexaurin tablets 3 mg tablets cesta 6, Novo mesto, YES YES

supplied in a box

Republic of Slovenia

Krka d.d., Šmarješka

32 (2x15) tablets in a blister,

Lexaurin tablets 6 mg tablets cesta 6, Novo mesto, YES YES

supplied in a box

Republic of Slovenia

Alkaloid AD, Skopje,

FYROM in cooperation

30 (3x10) tablets in a blister,

Lexilium 1.5 mg tablets tablets with F. Hoffmann-La YES YES

supplied in a box

Roche Ltd, Basel,

Switzerland Alkaloid AD, Skopje,

FYORM in cooperation

30 (3x10) tablets in a blister,

Lexilium 3 mg tablets tablets with F. Hoffmann-La YES YES

supplied in a box

Roche Ltd, Basel,

Switzerland

Alkaloid AD, Skopje,

FYROM in cooperation

30 (3x10) tablets in a blister,

Lexilium 6 mg tablets tablets with F. Hoffmann-La YES YES

supplied in a box

Roche Ltd, Basel,

Switzerland

powder for preparation of Pliva Krakow, Krakow, Glass bottle (10 mL) with

Lidacef injection 1g solution for i.v. and i.m. YES YES

Poland powder, supplied in a box injection

powder for preparation of Pliva Krakow, Krakow, Glass bottle (20 mL) with Lidacef injection 2 g YES YES

solution for i.v. infusion Poland powder, supplied in a box

Dr. August Wolff

200 mL of solution, dropper,

GmbH & Co.

LINOLA FETT ÖLBAD bath additive, solution cap, and measuring 20 mL YES YES YES

Arzneimittel, Bielefeld,

cup, supplied in a box

Germany

Dr. August Wolff 75 g of cream in an

GmbH & Co. LINOLA UREA cream aluminium tube, supplied in a YES YES YES

Arzneimittel, Bielefeld, box

Germany

100 grams of cream in an Dr. August Wolff

aluminum tube and a plastic GmbH & Co.

Linoladiol vaginal cream vaginal applicator in a YES YES

Arzneimittel, Bielefeld,

protective bag, supplied in a

Germany

box

50 g of cream in an Dr. August Wolff

aluminium tube and a plastic GmbH & Co.

Linoladiol vaginal cream vaginal applicator in a YES YES

Arzneimittel, Bielefeld,

protective bag, supplied in a

Germany

box

Dr. August Wolff

oily cream (water/oil GmbH & Co. Box with 75 g of cream in an Linola-fett YES YES YES

emulsion) Arzneimittel, Bielefeld, Al tube

Germany

Novartis Farma S.p.A.,

50 (5x10) tablets in a blister

Lioresal 10 mg tablets tablets Torre Annunziata YES YES

(PVC/Al), supplied in a box

(Napoli), Italy

Novartis Farmacéutica

50 (5x10) tablets in a blister

S.A., Ronda Santa

Lioresal 25 mg tablets tablets (PVC/PE/PVDC//Al), YES YES

María 158, Barcelona,

supplied in a box

Spain

Merck Sharp & Dohme

Lipex 10 mg film coated B.V., Waarderweg 39, 20 (2x10) tablets in a blister, film coated tablets YES YES

tablets Postbus 581, Haarlem, supplied in a box

the Netherlands

Merck Sharp & Dohme

Lipex 20 mg film coated B.V., Waarderweg 39, 20 (2x10) tablets in a blister, film coated tablets YES YES

tablets Postbus 581, Haarlem, supplied in a box

the Netherlands

Merck Sharp & Dohme

Lipex 40 mg film coated B.V., Waarderweg 39, 28 (2x14) tablets in a blister, film coated tablets YES YES

tablets Postbus 581, Haarlem, supplied in a box

the Netherlands

Merck Sharp & Dohme

Lipex 80 mg film coated B.V., Waarderweg 39, 30 (2x14) film coated tablets film coated tablets YES YES

tablets Postbus 581, Haarlem, in a blister, supplied in a box

the Netherlands

31 (3x10) film coated tablets Laboratoires Fournier

in a blister Lipidil 145 mg film coated tablets S.A., Fontaine Les YES YES YES YES

(PVC/PE/PVDC/Al), supplied Dijon, France

in a box

Laboratoires Fournier 32 (3x10) film coated tablets Lipidil 160 mg film coated tablets YES YES YES YES

S.A., Fontaine Les in a blister Dijon, France (PVC/PE/PVDC/Al), supplied

in a box

Laboratories Fournier 30 (3x10) capsules in a

LIPIDIL 200 M capsules, hard S.A., Fontaine Les blister (PVC/Al), supplied in a YES YES YES

Dijon, France box

B. Braun Melsungen

500 mL of emulsion for

AG, Carl-Braun-Straße

Lipofundin MCT/LCT 10% emulsion for infusion infusion in a glass bottle, 10 YES YES

1, Melsungen,

bottles per box

Germany

B. Braun Melsungen

100 mL of emulsion in a

AG, Carl-Braun-Straße

Lipofundin MCT/LCT 10% emulsion for infusion glass bottle, 10 bottles in a YES YES

1, Melsungen,

box

Germany

B. Braun Melsungen

500 mL of emulsion for

AG, Carl-Braun-Straße

Lipofundin MCT/LCT 20% emulsion for infusion infusion in a glass bottle, 10 YES YES

1, Melsungen,

bottles per box

Germany

B. Braun Melsungen

100 mL of emulsion for

AG, Carl-Braun-Straße

Lipofundin MCT/LCT 20% emulsion for infusion infusion in a glass bottle, 10 YES YES

1, Melsungen,

bottles in a box

Germany

Galex d.d., Murska 36 (3x10) tablets in a

LISINOLEX 10 mg tablets Sobota, Republic of PVC/PVdC/Al blister, YES YES

Slovenia supplied in a box

Galex d.d., Murska 37 (3x10) tablets in a

LISINOLEX 20 mg tablets Sobota, Republic of PVC/PVdC/Al blister, YES YES

Slovenia supplied in a box

Galex d.d., Murska 38 (3x10) tablets in a

LISINOLEX 5 mg tablets Sobota, Republic of PVC/PVdC/Al blister, YES YES

Slovenia supplied in a box

Clear type I glass vial,

containing 5 mL of solution,

Litak 2 mg/mL solution for Lipomed AG, with a rubber bromobutyl solution for injection YES YES YES YES

injection Arlesheim, Switzerland stopper and protective

aluminum ring, supplied in a

box

5 colourless glass bottles

(glass type I) with a rubber

Litak 2 mg/mL solution for Lipomed AG, bromobutyl stopper and a solution for injection YES YES YES YES

injection Arlesheim, Switzerland protective aluminium ring

containing 5 mL of solution,

supplied in a box

Bristol Myers-Squibb 100 capsules in a brown

Litalir capsules capsules S.r.I., Sermoneta, plastic bottle, supplied in a YES YES

Latina, Italy box

Jadran - Galenski

100 tablets in an amber

LITIJ KARBONAT laboratorij d.d., Pulac

tablets glass bottle, supplied in a YES YES

JADRAN 300 mg tablets bb, Rijeka, Republic of

box

Croatia

N.V. Organon, Oss, the

Netherlands; Organon

28 tablets in a blister,

Livial 2.5 mg tablets tablets Republic of Ireland YES YES

supplied in a box

Ltd., Co. Dublin,

Republic of Ireland

Farmal d.d., Branitelja

domovinskog rata 8, 30 tablets in a blister, Lizinopril 10 mg tablets tablets YES YES

Ludbreg, Republic of supplied in a box

Croatia

Farmal d.d., Branitelja

domovinskog rata 8, 30 tablets in a blister, Lizinopril 20 mg tablets tablets YES YES

Ludbreg, Republic of supplied in a box

Croatia

Farmal d.d., Branitelja

domovinskog rata 8, 30 tablets in a blister, Lizinopril 5 mg tablets tablets YES YES

Ludbreg, Republic of supplied in a box

Croatia Farmal d.d., Ludbreg,

Republic of Croatia in LIZINOPRIL H 10 mg/12.5 30 (3x10) tablets, supplied in

tablets cooperation with YES YES

mg tablets a box

Actavis hf.,

Hafnarfjordur, Island

Farmal d.d., Branitelja

LIZINOPRIL H 20 mg/12.5 domovinskog rata 8, 30 (3x10) tablets, supplied in tablets YES YES mg tablets Ludbreg, Republic of a box

Croatia

Salutas Pharma Lizinopril Lek 10 mg 30 (3x10) tablets in a blister

tablets GmbH, Dieselstrasse YES YES YES tablets (PVC/Al), supplied in a box

5, Gerlingen, Germany

Salutas Pharma Lizinopril Lek 2.5 mg 30 (3x10) tablets in a blister

tablets GmbH, Dieselstrasse YES YES YES tablets (PVC/Al), supplied in a box

5, Gerlingen, Germany

Salutas Pharma Lizinopril Lek 20 mg 30 (3x10) tablets in a blister

tablets GmbH, Dieselstrasse YES YES YES tablets (PVC/Al), supplied in a box

5, Gerlingen, Germany

Salutas Pharma 30 (3x10) tablets in a blister

Lizinopril Lek 5 mg tablets tablets GmbH, Dieselstrasse YES YES YES (PVC/Al), supplied in a box

5, Gerlingen, Germany

Merck KGaA,

Frankfurter Straße 250,

Lodoz 10 mg/6.25 mg film Darmstadt, Germany; 30 (3x10) tablets in a blister, film coated tablets YES YES

coated tablets Merck SANTE s.a.s., 2, supplied in a box

Rue du Pressoir Vert,

Semoy, France

Merck KGaA,

Frankfurter Straße 250,

Lodoz 2.5 mg/6.25 mg film Darmstadt, Germany; 30 (3x10) tablets in a blister, film coated tablets YES YES

coated tablets Merck SANTE s.a.s., 2, supplied in a box

Rue du Pressoir Vert,

Semoy, France

Merck KGaA,

Frankfurter Straße 250,

Lodoz 5 mg/6.25 mg film Darmstadt, Germany; 30 (3x10) tablets in a blister, film coated tablets YES YES

coated tablets Merck SANTE s.a.s., 2, supplied in a box

Rue du Pressoir Vert,

Semoy, France

Schering S.A., Lys Lez Box with 21 coated tablets in Logest coated tablets coated tablets YES YES

Lannoy, France a blister

Farmal d.d., Branitelja

30 (3x10) tablets in a

domovinskog rata 8,

Lopin tablets 10 mg tablets PVC/PVDC//Al blister, YES YES

Ludbreg, Republic of

supplied in a box

Croatia

Farmal d.d., Branitelja

31 (3x10) tablets in a

domovinskog rata 8,

Lopin tablets 5 mg tablets PVC/PVDC//Al blister, YES YES

Ludbreg, Republic of

supplied in a box

Croatia

Krka d.d., Šmarješka 28 (4x7) tablets in a Lorista 50 mg film coated

film coated tablets cesta 6, Novo mesto, PVC/PVDC/Alu blister, YES YES

tablets

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 28 (4x7) film coated tablets in

Lorista H film coated tablets cesta 6, Novo mesto, a PVC/PVDC//Al blister, YES YES YES YES

Republic of Slovenia supplied in a box

Belupo, lijekovi i

30 (1x30) tablets in a blister

kozmetika d.d., Ulica

Lorsilan 1 mg tablets tablets (PVC/Al), supplied in a YES YES

Danica 5, Koprivnica,

carton box

Republic of Croatia

Belupo, lijekovi i

20 (1x20) tablets in a blister

kozmetika d.d., Ulica

Lorsilan 2.5 mg tablets tablets (PVC/Al) , supplied in a YES YES

Danica 5, Koprivnica,

carton box

Republic of Croatia

Pliva Croatia Ltd., Ulica 28 (2x14) tablets in a blister,

Losartic Plus tablets film coated tablets grada Vukovara 49, YES YES supplied in a box

Zagreb, Republic of Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 28 (2x14) tablets in a blister, Losartic tablets 25 mg film coated tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 28 (2x14) tablets in a blister, Losartic tablets 50 mg film coated tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pro. Med.CS Praha 14 (2x7) capsules in a

Loseprazol 20 mg capsules a.s., Prag, Czech OPA/Al/PVC//Al blister, YES YES

Republic supplied in a box

Pro. Med.CS Praha

14 (2x7) capsules in a blister,

Loseprazol 20 mg capsules a.s., Prag, Czech YES YES

supplied in a box

Republic

Schering-Plough Labo 15 g of cream in an

N.V. Industrepark 30, Lotriderm cream cream aluminum tube, supplied in a YES YES

Heist-op-den-Berg, box

Belgium

Belupo, lijekovi i

kozmetika d.d., Ulica 20 (1x20) tablets in a blister Lubor 10 mg capsules capsules YES YES

Danica 5, Koprivnica, (PVC/Al) , supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 10 (2x5) suppositories in a Lubor 20 mg suppositories suppositories YES YES

Danica 5, Koprivnica, Al/PE strip, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 20 (1x20) tablets in a blister Lubor 20 mg capsules capsules YES YES

Danica 5, Koprivnica, (PVC/Al) , supplied in a box

Republic of Croatia

Belupo, lijekovi i 50 g of cream in an

kozmetika d.d., Ulica aluminium tube with a Luboreta cream cream YES YES YES

Danica 5, Koprivnica, polyethylene stopper,

Republic of Croatia supplied in a box

Novartis Pharma Stein

Lucentis 10 mg/mL AG, One glass bottle with 0.3 mL solution for injection YES YES YES YES

solution for injection Schaffhauserstrasse, of solution, supplied in a box

Stein, Switzerland

Belupo, lijekovi i

Lumidol 100 mg/2 mL solution for injection ( i.v., kozmetika d.d., Ulica 5 glass ampoules with 2 mL

YES YES injections i.m. and s.c.) Danica 5, Koprivnica, of solution, supplied in a box

Republic of Croatia

Belupo, lijekovi i 10 mL of solution in an

LUMIDOL 100 mg/mL oral kozmetika d.d., Ulica amber glass bottle with fitted oral drops, solution YES YES

drops Danica 5, Koprivnica, plastic dropper and plastic

Republic of Croatia cap, supplied in a box

Belupo, lijekovi i 20 capsules in a 50 mL

kozmetika d.d., Ulica plastic brown bottle with LUMIDOL 50 mg capsules capsules, hard YES YES

Danica 5, Koprivnica, temper-proof closure,

Republic of Croatia supplied in a box

Belupo, lijekovi i

Lumidol 50 mg/mL solution for injection ( i.v., kozmetika d.d., Ulica 5 glass ampoules with 1 mL

YES YES injection i.m. and s.c.) Danica 5, Koprivnica, of solution, supplied in a box

Republic of Croatia

Allergan

Pharmaceuticals

Lumigan 0.3 mg/mL eyel Republic of Ireland, 3 mL solution in a plastic eye drops, solution YES YES YES

drops Castlebar Road, bottle, supplied in a box

Westport, Co Mayo,

Republic of Ireland

Belupo, lijekovi i

10 (2x5) suppositories in a

LUPOCET 250 mg kozmetika d.d., Ulica

suppositories Al/PE strip foil, supplied in a YES YES YES

suppositories Danica 5, Koprivnica,

box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 10 (1x10) tablets in a PVC/Al Lupocet 500 mg tablets tablets YES YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Belupo, lijekovi i

Lupocet BABY 120 mg kozmetika d.d., Ulica 10 (2x5) suppositories in a suppositories YES YES YES

suppositories Danica 5, Koprivnica, PE/Al strip, supplied in a box

Republic of Croatia

Belupo, lijekovi i

10 effervescent tablets in a

kozmetika d.d., Ulica

Lupocet flu effervescent tablets plastic tube, supplied in a YES YES YES

Danica 5, Koprivnica,

box

Republic of Croatia

Belupo, lijekovi i

100 mL of syrup in an amber

kozmetika d.d., Ulica

Lupocet JUNIOR syrup syrup glass bottle, supplied in a YES YES YES

Danica 5, Koprivnica,

box

Republic of Croatia

Belupo, lijekovi i 20 (2x10) capsules in a

Lupocet TEEN 300 mg kozmetika d.d., Ulica capsules (PVC/Al) blister, supplied in a YES YES YES

capsules Danica 5, Koprivnica, box

Republic of Croatia

powder and diluent for Industria Farmaceutica Vial with powder and vial with

preparation of solution for Luveris 75 IU Serono S.p.A., Bari, diluent, in a protective YES YES YES

injection (for Italy container, supplied in a box

subcutaneous use)

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 28 tablets in a blister, Luxeta tablets 100 mg film tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 28 tablets in a blister, Luxeta tablets 50 mg film tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pfizer GmbH

Arzneimittelwerk 84 (4x21) capsules in a

Lyrica 100 mg capsules capsules, hard Gödecke, blister (PVC/Al), supplied in a YES YES YES

Mooswaldallee 1, box

Freiburg, Germany

Pfizer GmbH

Arzneimittelwerk 56 (4x14) capsules in a

Lyrica 150 mg capsules capsules, hard Gödecke, blister (PVC/Al), supplied in a YES YES YES

Mooswaldallee 1, box

Freiburg, Germany

Pfizer GmbH

Arzneimittelwerk 84 (4x21) capsules in a

Lyrica 200 mg capsules capsules, hard Gödecke, blister (PVC/Al), supplied in a YES YES YES

Mooswaldallee 1, box

Freiburg, Germany

Pfizer GmbH

Arzneimittelwerk 56 (4x14) capsules in a

Lyrica 25 mg capsules capsules, hard Gödecke, blister (PVC/Al), supplied in a YES YES YES

Mooswaldallee 1, box

Freiburg, Germany

Pfizer GmbH

Arzneimittelwerk 56 (4x14) capsules in a

Lyrica 300 mg capsules capsules, hard Gödecke, blister (PVC/Al), supplied in a YES YES YES

Mooswaldallee 1, box

Freiburg, Germany

Pfizer GmbH

Arzneimittelwerk 56 (4x14) capsules in a

Lyrica 50 mg capsules capsules, hard Gödecke, blister (PVC/Al), supplied in a YES YES YES

Mooswaldallee 1, box

Freiburg, Germany

Pfizer GmbH

Arzneimittelwerk 56 (4x14) capsules in a

Lyrica 75 mg capsules capsules, hard Gödecke, blister (PVC/Al), supplied in a YES YES YES

Mooswaldallee 1, box

Freiburg, Germany Bosnalijek d.d.,

tablets for oral cavity oral Jukićeva 53, Sarajevo, 30 (3x10) tablets in a blister, LYSOBACT oriblets YES YES YES

(orbilettes) Bosnia and supplied in a box

Herzegovina

MabCampath 30 mg/mL Schering AG, 3x1 glass bottles with 1 mL concentrate for infusion

concentrate for infusion Muellerstrasse 170- of concentrate for solution for YES YES YES solution

solution 178, Berlin, Germany infusion, supplied in a box

F. Hoffmann-La Roche

Ltd., 10 mL of infusion solution MabThera 100 mg solution solution concentrate for

Grenzacherstrasse concentrate in a glass bottle, YES YES YES YES concentrate for infusion infusion

124, Basel, 2 bottles in a box

Switzerland

F. Hoffmann-La Roche

MabThera 500 mg Ltd., 50 mL of solution for infusion concentrate of solution

concentrate of solution for Grenzacherstrasse concentrate in a glass bottle, YES YES YES YES for infusion

infusion 124, Basel, supplied in a box

Switzerland

One glass pre-filled syringe Pfizer Health AB,

Macugen 0.3 mg solution for injection with needle, in a protective YES YES YES YES

Stockholm, Sweden bag, supplied in a box

F. Hoffmann-La Roche

Ltd., 100 tablets in an amber

Madopar 125 tablets tablets Grenzacherstrasse glass bottle (with desiccant), YES YES

124, Basel, supplied in a box

Switzerland

F. Hoffmann-La Roche

Ltd., 30 capsules in an amber Madopar HBS 125

capsules Grenzacherstrasse glass bottle (with a YES YES capsules

124, Basel, desiccant), supplied in a box

Switzerland

F. Hoffmann-La Roche

Ltd., 100 tablets in an amber Madopar LIQ 125 tablets tablets for oral

Grenzacherstrasse glass bottle (with dessicant), YES YES for oral suspension suspension

124, Basel, supplied in a box

Switzerland

Schering AG, 20 mL of solution in a glass Magnevist solution for

solution for injection Muellerstrasse 170- bottle with rubber stopper, YES YES injection

178, Berlin, Germany supplied in a box

Schering AG, 10 mL of solution in a glass Magnevist solution for

solution for injection Muellerstrasse 170- bottle with rubber stopper, YES YES injection

178, Berlin, Germany supplied in a box

Belupo, lijekovi i

kozmetika d.d., Ulica 14 (1x14) tablets in a blister, Makcin 500 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Pliva Croatia Ltd., Ulica 500 mL of solution in a glass

grada Vukovara 49, infusion bottle with a rubber MANIT 10% solution for infusion YES YES

Zagreb, Republic of stopper and a protective cap,

Croatia 10 bottles in a box

Pliva Croatia Ltd., Ulica 250-mL of solution in a glass

grada Vukovara 49, bottle for infusion with rubber MANIT 20% solution for infusion YES YES

Zagreb, Republic of stopper and protective cap,

Croatia 10 bottles in a box

Krka d.d., Novo mesto,

Republic of Slovenia in 50 tablets in an amber glass

Marivarin 3 mg tablets tablets cooperation with Orion bottle with an aluminium YES YES

Corporation, Espoo, stopper

Finland

Wyeth Lederle S.p.A., 30 tablets in a HDPE bottle, Materna with selenium film coated tablets YES YES YES

Catania, Italy supplied in a box

2 (2x1) oral lyophilisate in a Merck Sharp & Dohme

blister (PVC/PVDC//Al) and

MAXALT RPD 10 mg oral B.V., Waarderweg 39, oral lyophilisate protective bag (paper/PE/Al), YES YES YES

lyophilisates Postbus 581, Haarlem, in a plastic box, supplied in a The Nederlands

carton box 2 (2x1) oral lyophilisate in a

Merck Sharp & Dohme

blister (PVC/PVDC//Al) and

MAXALT RPD 5 mg oral B.V., Waarderweg 39,

oral lyophilisate protective bag (paper/PE/Al), YES YES YES

lyophilisates Postbus 581, Haarlem,

in a plastic box, supplied in a

the Netherlands

carton box

10 effervescent tablets with

Pliva Croatia Ltd., Ulica or without an Al foil, in a

grada Vukovara 49, polypropylene tube with a MAXFLU lemon flavour effervescent tablets YES YES YES

Zagreb, Republic of cap (PE) with silicagel and

Croatia tamper-proof ring, supplied in

a box

Alcon-Couvreur s.a., 3.5 g of ointment in an Maxidex 1 mg/g eye

eye ointment Rijksweg 14, Puurs, aluminum tube, supplied in a YES YES ointment

Belgium box

Alcon-Couvreur s.a., 5 mL of suspension in a Maxidex 1 mg/mL eye

eye drops, suspension Rijksweg 14, Puurs, polyethylene bottle with a YES YES drops, suspension

Belgium dropper, supplied in a box

Jadran - Galenski

powder for preparation of laboratorij d.d., Pulac Glass bottle with powder, Maxipime 1 g YES YES

i.m. and i.v. injections bb, Rijeka, Republic of supplied in a box

Croatia

Jadran - Galenski

powder for preparation of laboratorij d.d., Pulac Glass bottle with powder, Maxipime 2 g YES YES

i.m. and i.v. injections bb, Rijeka, Republic of supplied in a box

Croatia

Jadran - Galenski

powder for preparation of laboratorij d.d., Pulac Glass bottle with powder, Maxipime 500 mg YES YES

i.m. and i.v. injections bb, Rijeka, Republic of supplied in a box

Croatia

Alcon-Couvreur s.a., Maxitrol eye drops, Polyethylene bottle with 5 mL

eye drops, suspension Rijksweg 14, Puurs, YES YES suspension of drops, supplied in a box

Belgium

Alcon-Couvreur s.a., 3.5 g of ointment in an

Maxitrol eye ointment eye ointment Rijksweg 14, Puurs, aluminum tube, supplied in a YES YES

Belgium box

Belupo, lijekovi i

100 mL of solution in a glass

Medazol 0.5 % solution for kozmetika d.d., Ulica

solution for infusion bottle for infusion, supplied in YES YES

infusion Danica 5, Koprivnica,

a box

Republic of Croatia

Belupo, lijekovi i 20 tablets in a plastic

kozmetika d.d., Ulica Medazol 250 mg tablets tablets (polypropylene) bottles, YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 10 (1x10) tablets in a PVC/Al Medazol 400 mg tablets tablets YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Belupo, lijekovi i

10 (1x10) vaginal tablets in a

Medazol 500 mg vaginal kozmetika d.d., Ulica

vaginal tablets PVC/Al blister, supplied in a YES YES

tablets Danica 5, Koprivnica,

box

Republic of Croatia

Messer Croatia Plin Pressurized steel bottles

d.o.o., Zaprešić, (150 or 200 bar) with 2, 3, 5, Medical gas, O2 medical medical gas YES YES

Industrijska 1, Republic 10, 20, 27, 30, 40 or 50 liters

of Croatia of gaseous medical oxygen

Pfizer Italia S.r.l.,

50 (5x10) tablets in a blister

MEDROL tablets 16 mg tablets Marina De Tronto, YES YES

(PVC/Al), supplied in a box

Ascoli Piceno, Italy

Pfizer Italia S.r.l.,

20 (2x10) tablets in a blister

MEDROL tablets 32 mg tablets Marina De Tronto, YES YES

(PVC/Al), supplied in a box

Ascoli Piceno, Italy

Pfizer Italia S.r.l., 30 tablets in an amber glass

MEDROL 4 mg tablets tablets Marina De Tronto, bottle with a plastic stopper, YES YES

Ascoli Piceno, Italy supplied in a box

Haupt Pharma 100 tablets in a plastic Megace tablets 160 mg tablets YES YES

Regensburg GmbH, (HDPE) bottle, supplied in a Regensburg, Germany box

for Bristol-Myers

Squibb

Krka d.d., Šmarješka 30 (3x10) tablets in

Meglimid 1 mg tablets tablets cesta 6, Novo mesto, transparent PVC//Al blister, YES YES YES YES

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 31 (3x10) tablets in

Meglimid 2 mg tablets tablets cesta 6, Novo mesto, transparent PVC//Al blister, YES YES YES YES

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 32 (3x10) tablets in

Meglimid 3 mg tablets tablets cesta 6, Novo mesto, transparent PVC//Al blister, YES YES YES YES

Republic of Slovenia supplied in a box

240 mL suspension in a

plastic (HDPE) bottle with

MEGOSTAT oral Bristol-Myers Squibb, oral suspension child resistant closure, 20 mL YES YES

suspension Epernon, France plastic measuring glass,

supplied in a box

Alkaloid AD - Skopje,

Bulevar Aleksandar 50 (5x10) tablets in a blister Mendilex tablets YES YES

Makedonski 12, (PVC/Al), supplied in a box

Skopje, FYROM

10 bottles with lyophilisate lyophilisate and diluent Ferring GmbH,

and 10 ampoules with

Menopur for preparation of solution Wittland 1, Kiel, YES YES YES diluent, supplied in a carton for injection Germany

box

lyophilisate and diluent Ferring GmbH, 5 bottles with lyophilisate and

Menopur for preparation of solution Wittland 1, Kiel, 5 ampoules with solvent, YES YES YES

for injection Germany supplied in a box

Box with 1 bottle with 1 dose

lyophilisate for Sanofi Pasteur S.A., 2 of lyophilised vaccine, 1 pre MERIEUX INACTIVATED

preparation of avenue Pont Pasteur, filled syringe containing 1 mL YES RABIES VACCINE

intramuscular injection Lyon, France of water for injection and a

needle

AstraZeneca UK

Limited, Silk Road powder for preparation of 10 bottles with powder, Meronem i.v. 1 g Business Park, YES YES

i.v. injection supplied in a box Macclesfield, Cheshire,

Great Britain

AstraZeneca UK

Limited, Silk Road powder for preparation of 10 bottles with powder, Meronem i.v. 500 mg Business Park, YES YES

i.v. injection supplied in a box Macclesfield, Cheshire,

Great Britain

10 glass bottles with à 20 mL Pliva Croatia Ltd., Ulica

of solution for injection (with METHOTREXATE PLIVA grada Vukovara 49,

solution for infusion rubber stopper, aluminum YES YES

injection 1000 Zagreb, Republic of cap and plastic cover),

Croatia

supplied in a box

10 glass bottles with à 2 mL Pliva Croatia Ltd., Ulica

of solution for injection (with METHOTREXATE PLIVA grada Vukovara 49,

solution for injection rubber stopper, aluminum YES YES

injection 20 Zagreb, Republic of cap and plastic cover),

Croatia

supplied in a box

10 glass bottles with à 2 mL Pliva Croatia Ltd., Ulica

of solution for injection (with METHOTREXATE PLIVA grada Vukovara 49,

solution for injection rubber stopper, aluminum YES YES

injection 5 Zagreb, Republic of cap and plastic cover),

Croatia

supplied in a box

10 glass bottles with à 5 mL Pliva Croatia Ltd., Ulica

of solution for injection (with METHOTREXATE PLIVA grada Vukovara 49,

solution for injection rubber stopper, aluminum YES YES

injection 50 Zagreb, Republic of cap and plastic cover),

Croatia

supplied in a box

Jadran - Galenski

laboratorij d.d., Pulac 40 (4x10) tablets in a blister Metopran tablets YES YES

bb, Rijeka, Republic of (PVC/Al), supplied in a box

Croatia Genericon Pharma 10 (10x1) glass bottles with

Metronidazol Genericon Ges.m.b.H., solution for infusion 100 mL of infusion solution, YES YES

0.5 % solution for infusion Hafnerstrasse 211, supplied in a box

Graz, Austria

Boehringer Ingelheim

Pharma GmbH & Co. 50 (5x10) capsules in a

Mexitil 200 mg capsules capsules KG, Birkendorfer YES YES blister, supplied in a box

Strasse 65, Biberach

an der Riss, Germany

Novartis Pharma Stein

AG, 5 ampoules with 1 mL of Miacalcic 100 IU injection solution for injection YES YES

Schaffhauserstrasse, solution, supplied in a box

Stein, Switzerland

Novartis Pharma Solution in a glass bottle with

Miacalcic 200 IU aerosol nasal spray, solution S.A.S., Huningue spray (for nasal use), YES YES

Cedex, France supplied in a box

Boehringer Ingelheim

Pharma GmbH & Co. 28 (4x7) tablets in a blister

Micardis 40 mg tablets tablets KG, Binger Strasse (PA/Al/PVC/Al), supplied in a YES YES YES

173, Ingelheim am box

Rhein, Germany

Boehringer Ingelheim

Pharma GmbH & Co. 28 (4x7) tablets in a blister

Micardis 80 mg tablets tablets KG, Binger Strasse (PA/Al/PVC/Al), supplied in a YES YES YES

173, Ingelheim am box

Rhein, Germany

Boehringer Ingelheim

Pharma GmbH & Co. 28 (4x7) tablets in a blister MicardisPlus 40/12.5 mg

tablets KG, Binger Strasse (PA/Al/PVC/Al), supplied in a YES YES YES tablets

173, Ingelheim am box

Rhein, Germany

Boehringer Ingelheim

Pharma GmbH & Co. 28 (4x7) tablets in a blister MicardisPlus 80/12.5 mg

tablets KG, Binger Strasse (PA/Al/PVC/Al), supplied in a YES YES YES tablets

173, Ingelheim am box

Rhein, Germany

Torrex Chiesi Pharma 10 (2x5) ampoules with 3 mL MIDAZOLAM TORREX 15

solution for injection GmbH, Gonzagagasse of solution, on a plastic tray, YES YES mg/3 mL

16/16, Vienna, Austria supplied in a box

Torrex Chiesi Pharma 10 (2x5) ampoules with 2 mL MIDAZOLAM TORREX 2

solution for injection GmbH, Gonzagagasse of solution, on a plastic tray, YES YES mg/2 mL

16/16, Vienna, Austria supplied in a box

Torrex Chiesi Pharma 10 (2x5) ampoules with 5 mL MIDAZOLAM TORREX 5

solution for injection GmbH, Gonzagagasse of solution, on a plastic tray, YES YES mg/5 mL

16/16, Vienna, Austria supplied in a box

Torrex Chiesi Pharma 10 (2x5) ampoules with 1 mL MIDAZOLAM TORREX 5

solution for injection GmbH, Gonzagagasse of solution, on a plastic tray, YES YES mg/mL

16/16, Vienna, Austria supplied in a box

Torrex Chiesi Pharma 10 (2x5) ampoules with 10 MIDAZOLAM TORREX 50

solution for injection GmbH, Gonzagagasse mL of solution, on a plastic YES YES mg/10 mL

16/16, Vienna, Austria tray, supplied in a box

Schering AG, Minerva sugar-coated 63 (3x21) tablets in a PVC/Al

sugar-coated tablets Muellerstrasse 170- YES YES tablets blister, supplied in a box

178, Berlin, Germany

30 (3x10) oral lyophilisate in Ferring AB, Limhamn,

Minirin Melt 120 µg oral lyophilisate a blister (Al/Al), supplied in a YES YES

Sweden box

31 (3x10) oral lyophilisate in Ferring AB, Limhamn,

Minirin Melt 60 µg oral lyophilisate a blister (Al/Al), supplied in a YES YES

Sweden box

Ferring AB, Limhamn, 5 mL of solution (50 doses à

Sweden; Ferring 10 µg) in an amber glass

International Center bottle with a spray Minirin nasal spray nasal spray (solution) YES YES

SA, Chemin de la attachment and a plastic

Vergognausaz, attachment for nasal use,

Switzerland supplied in a box Ferring AB, Limhamn,

Sweden; Ferring

International Center 30 tablets in a plastic bottle, Minirin 0.2 mg tablets tablets YES YES

SA, Chemin de la supplied in a box

Vergognausaz,

Switzerland

Boehringer Ingelheim

Pharma GmbH & Co. 30 (3x10) tablets in a

Mirapexin tablets 0.25 mg tablets KG, Binger Strasse PA/Al/PVC-Al blister, YES YES YES

173, Ingelheim am supplied in a box

Rhein, Germany

Boehringer Ingelheim

Pharma GmbH & Co. 31 (3x10) tablets in a

Mirapexin tablets 1 mg tablets KG, Binger Strasse PA/Al/PVC-Al blister, YES YES YES

173, Ingelheim am supplied in a box

Rhein, Germany

intrauterine system (20 Intrauterine system with

mcg/24 h release of Schering OY, Turku, integrated applicator in a Mirena intrauterine system YES YES

active substance) with Finland blister (APET/Tyvek),

integrated applicator supplied in a box

Pliva Croatia Ltd., Ulica

powder for solution for grada Vukovara 49, 5 glass bottles with powder, Mirocef injection 1 g YES YES

injection Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

powder for solution for grada Vukovara 49, 5 glass bottles with powder, Mirocef injection 500 mg YES YES

injection Zagreb, Republic of supplied in a box

Croatia

Krka d.d., Šmarješka 30 tablets (3x10) in a Mirzaten 30 mg film coated

film coated tablets cesta 6, Novo mesto, PVC//PVDC/Al blister, YES YES tablets

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 30 tablets (3x10) in a Mirzaten 45 mg film coated

film coated tablets cesta 6, Novo mesto, PVC/PVDC/Al blister, YES YES tablets

Republic of Slovenia supplied in a box

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (1x30) tablets in a blister, Misar 0.25 mg tablets tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (1x30) tablets in a blister, Misar 0.5 mg tablets tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (1x30) tablets in a blister, Misar 1 mg tablets tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (2x15) tablets in a blister, Misar SR 0.5 mg tablets prolonged-release tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 (2x15) tablets in a blister, Misar SR 1 mg tablets prolonged-release tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Colourless glass bottle with

Pliva Croatia Ltd., Ulica 15 mL of concentrate of

concentrate of solution grada Vukovara 49, solution for infusion, closed Mitoxantrone Pliva YES YES

for infusion solutio Zagreb, Republic of with a rubber stopper and an

Croatia aluminium cap with a plastic

lid, supplied in a box

Novo Nordisk A/S,

Novo Alle, Bagsvaerd, 5 glass cartridges with 3 mL

suspension for Denmark Novo Nordisk Mixtard 30 Penfill 3 mL of suspension in a blister, YES YES

isubcutaneous injection Production SAS, 45,

supplied in a box

Avenue d' Orleans,

Chartres, France Novo Nordisk A/S, 5 glass cartridges with 3 mL

suspension for Mixtard 40 Penfill 3 mL Novo Allé, DK-2880 of suspension in a blister, YES YES

isubcutaneous injection Bagsvaerd, Denmark supplied in a box

Novo Nordisk A/S, 5 glass cartridges with 3 mL suspension for

Mixtard 50 Penfill 3 mL Novo Allé, DK-2880 of suspension in a blister, YES YES isubcutaneous injection

Bagsvaerd, Denmark supplied in a box

Krka d.d., Novo mesto,

R. Republic of Slovenia 5 amber glass ampoules Moditen depo injections 25 oily solution for

in cooperation with each with 1 mL of solution, YES YES mg/1 mL intramuscular injection

Bristol-Myers Squibb, supplied in a carton box

New York, USA

KRKA d.d., Novo

Mesto, Republic of Moditen coated tablets 1 25 tablets in an amber glass

coated tablets Slovenia in cooperation YES YES

mg bottle, supplied in a box with Bristol-Myers

Squibb, NY, USA

KRKA d.d., Novo

Mesto, Republic of 100 tablets in an amber Moditen coated tablets 2.5

coated tablets Slovenia in cooperation glass bottle, supplied in a YES YES

mg with Bristol-Myers carton box

Squibb, NY, USA

KRKA d.d., Novo

Mesto, Republic of 100 tablets in an amber Moditen coated tablets 5

coated tablets Slovenia in cooperation glass bottle, supplied in a YES YES

mg with Bristol-Myers carton box

Squibb, NY, USA

Lek farmacevtska

družba d.d., 40 tablets in an amber glass

Moduretic tablets tablets Verovškova 57, YES YES bottle, supplied in a box Ljubljana, Republic of

Slovenia

Jadran -Galenski

laboratorij d.d., Rijeka,

Republic of Croatia, in

28 (2x14) tablets in a blister

cooperation with

Monopril 10 mg tablets (white PVC/PVDC//Al), YES YES

Bristol-Myers Squibb

supplied in a box

S.p.A., Contrada

Fontana del Cerasp.

Anagni, Italy

Jadran -Galenski

laboratorij d.d., Rijeka,

Republic of Croatia, in

28 (2x14) tablets in a blister

cooperation with

Monopril 20 mg tablets (white PVC/PVDC//Al), YES YES

Bristol-Myers Squibb

supplied in a box

S.p.A., Contrada

Fontana del Cerasp.

Anagni, Italy

Jadran - Galenski 28 (2x14) tablets in a

laboratorij d.d., Pulac nontransparent Monopril plus 20/12.5 tablets YES YES

bb, Rijeka, Republic of PVC/PVDC/Alu blister,

Croatia supplied in a box

Schering-Plough 25 grams of ointment in a

Farma, Lda, Casal do white enamel tube with white Monsalic ointment ointment YES YES YES YES

Colaride, Agualva polypropylene screw cap,

Cacem, Portugal supplied in a carton box

Alkaloid AD - Skopje,

10 amber glass ampoules

ALKALOID Morphine Bulevar Aleksandar

solution for injection each containing 1 mL of YES YES

hydrochloride 20 mg/1 mL Makedonski 12,

solution, supplied in a box

Skopje, FYROM

Alkaloid AD - Skopje,

10 amber glass ampoules

ALKALOID Morphine Bulevar Aleksandar

solution for injection each containing 1 mL of YES YES

hydrochloride 4 mg/1 mL Makedonski 12,

solution, supplied in a box

Skopje, FYROM

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 28 (4x7) tablets in a blister, Mostrafin tablets film coated tablets YES YES

Zagreb, Republic of supplied in a box

Croatia Pliva Croatia Ltd., Ulica

grada Vukovara 49, 28 (2x14) tablets in a blister, Mostrafin tablets film coated tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Boehringer Ingelheim

Pharma GmbH & Co. 20 (1x20) tablets in a

Movalis 15 mg tablets tablets KG, Binger Strasse PVC/PVDC/Al blister, YES YES

173, Ingelheim am supplied in a box

Rhein, Germany

Boehringer Ingelheim

Movalis 15 mg/1.5 mL Espana, S.A., Sant 5 ampoules with 1.5 mL of solution for injection YES YES

injection Cugat del Valles solution, supplied in a box

(Barcelona), Spain

Boehringer Ingelheim

Pharma GmbH & Co. 20 (1x20) tablets in a

Movalis 7.5 mg tablets tablets KG, Binger Strasse PVC/PVDC/Al blister, YES YES

173, Ingelheim am supplied in a box

Rhein, Germany

Bard Pharmaceuticals

Ltd., Cambridge,Great

Britain, Mundipharma 30 (3x10) tablets in a blister

prolonged-release film Gm.b.H., Limburg, MST CONTINUS 10 mg (PVdC/PVC/Al), supplied in a YES YES

coated tablets Germany, box

Mundipharma

Ges.m.b.H, Vienna,

Austria

Bard Pharmaceuticals

Limited, Cambridge,

Great Britain,

Mundipharma Gm.b.H., 60 (2x30) tablets in a blister film coated tablets with

MST Continus 10 mg Limburg, (PVC/PVDC-Al), supplied in YES YES prolonged-release

Njemačka, a box

Mundipharma

Ges.m.b.H, Beč,

Austria

Bard Pharmaceuticals

Limited, Cambridge,

Great Britain,

Mundipharma Gm.b.H., 60 (2x30) tablets in a blister film coated tablets with

MST Continus 100 mg Limburg, (PVC/PVDC-Al), supplied in YES YES prolonged-release

Njemačka, a box

Mundipharma

Ges.m.b.H, Beč,

Austria

Bard Pharmaceuticals

Ltd., Cambridge,Great

Britain, Mundipharma 30 (3x10) tablets in a blister

prolonged-release film Gm.b.H., Limburg, MST CONTINUS 100 mg (PVdC/PVC/Al), supplied in a YES YES

coated tablets Germany, box

Mundipharma

Ges.m.b.H, Vienna,

Austria

Bard Pharmaceuticals

Limited, Cambridge,

Great Britain,

Mundipharma Gm.b.H., 60 (2x30) tablets in a blister film coated tablets with

MST Continus 30 mg Limburg, (PVC/PVDC-Al), supplied in YES YES prolonged-release

Njemačka, a box

Mundipharma

Ges.m.b.H, Beč,

Austria

Bard Pharmaceuticals

Ltd., Cambridge,Great 30 (3x10) tablets in ablister

prolonged-release film Britain, Mundipharma MST CONTINUS 30 mg (PVdC/PVC/Al), supplied in a YES YES

coated tablets Gm.b.H., Limburg, box

Germany,

Mundipharma Ges.m.b.H, Vienna,

Austria

Bard Pharmaceuticals

Ltd., Cambridge,Great

Britain, Mundipharma

30 (3x10) tablets in a blister

prolonged-release film Gm.b.H., Limburg,

MST CONTINUS 60 mg (PVdC/PVC/Al), supplied in a YES YES

coated tablets Germany,

box

Mundipharma

Ges.m.b.H, Vienna,

Austria

Bard Pharmaceuticals

Limited, Cambridge,

Great Britain,

Mundipharma Gm.b.H., 60 (2x30) tablets in a blister film coated tablets with

MST Continus 60 mg Limburg, (PVC/PVDC-Al), supplied in YES YES prolonged-release

Njemačka, a box

Mundipharma

Ges.m.b.H, Beč,

Austria

Krka tovarna zdravil,

d.d., Novo 20 (2x10) coated tablets in Mukolen coated tablets 50

coated tablets mesto,Republic of PVC/Al blister, supplied in a YES YES mg

Slovenia in cooperation box

with E Pharma, France

Merck 20 (2x10) capsules in

MULTIBIONTA FORTE N Selbstmedikation capsules, soft PVC/PVDC-Al blister, YES YES YES

capsules GmbH, Darmstadt, supplied in a box

Germany

Novartis Pharma Stein 120 (12x10) tablets in a

AG, Myfortic 180 mg tablets gastric-resistant tablets PA/Al/PVC- Al blister, YES YES YES

Schaffhauserstrasse, supplied in a box

Stein, Switzerland

Novartis Pharma Stein 120 (12x10) tablets in a

AG, Myfortic 360 mg tablets gastric-resistant tablets PA/Al/PVC- Al blister, YES YES YES

Schaffhauserstrasse, supplied in a box

Stein, Switzerland

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 20 (2x10) tablets in a blister Myoflex tablets YES YES

Zagreb, Republic of (PVC/Al), supplied in a box

Croatia

5 mL of solution in a white

plastic (LDPE) bottle with a EXCELVISION,

Naclof eye drops, solution dropper and a plastic (HDPE) YES YES

Annonay, France

stopper with a safety ring,

supplied in a box

Cardinal Health,

NAGLAZYME 5 mL Northamptonshire, One glass vial with 5 mL of concentrate for solution

concentrate for solution for Great Britain; Cardinal concentrate, supplied in a YES YES YES YES for infusion

infusion Health, Westhoughton, box

Bolton, Great Britain

Krka d.d., Šmarješka 10 (2x5) suppositories in a Naklofen suppositories 50

suppositories cesta 6, Novo mesto, Al/PE//PE/AL strip, supplied YES YES mg

Republic of Slovenia in a carton box

20 (2x10) hard capsules in a Krka d.d., Šmarješka

Naklofen duo capsules 75 blister hard capsules cesta 6, Novo mesto, YES YES

mg (PVC/PE/PVDC/PE/PVC//Al),

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka

60 g of gel in an aluminium

Naklofen gel gel cesta 6, Novo mesto, YES YES YES

tube, supplied in a carton box

Republic of Slovenia

Krka d.d., Šmarješka 3 mL solution for injectionin a Naklofen solution for

solution for injection cesta 6, Novo mesto, glass ampoule, 5 ampoules YES YES injection 75 mg/3mL

Republic of Slovenia in a box

Krka d.d., Šmarješka 20 (2x10) prolonged-release

Naklofen SR prolonged-release tablets cesta 6, Novo mesto, tablets in PVC/Al blister, YES YES

Republic of Slovenia supplied in a box Krka d.d., Šmarješka 20 (2x10) gastric-resistant

Naklofen gastric-resistant gastric-resistant tablets cesta 6, Novo mesto, tablets in PVC/Al blister, YES YES

tablets 50 mg

Republic of Slovenia supplied in a box

Lek farmacevtska

družba d.d., 100 (10x10) tablets in Nakom 250 mg / 25 mg

tablets Verovškova 57, PVC/Al blister, supplied in a YES YES tablets

Ljubljana, Republic of box

Slovenia

Krka d.d., Šmarješka 10 (1x10) film coated tablets Nalgesin forte 550 mg film

film coated tablets cesta 6, Novo mesto, in a PVC/Al blister, supplied YES YES coated tablets

Republic of Slovenia in a box

Krka d.d., Šmarješka 10 (1x10) film coated tablets Nalgesin S 275 mg film

film coated tablets cesta 6, Novo mesto, in a PVC/Al blister, supplied YES YES coated tablets

Republic of Slovenia in a box

Box with powder and a box

with a bottle containing 10 powder and diluent for Octapharma AB,

Nanotiv 1000 IU mL of water for injection, YES solution for injection Stockholm, Sweden

application kit, supplied in a

box

Box with powder and a box

with a bottle containing 5 mL powder and diluent for Octapharma AB,

Nanotiv 500 IU of water for injection, YES solution for injection Stockholm, Sweden

application kit, supplied in a

box

10 mL of solution in a whilte

Merck KGaA, plastic bottle with a plastic

Nasivin 0.05% nasal spray nasal spray, solution Frankfurter Straße 250, attachment (with internal YES YES YES

Darmstadt, Germany atomizing tube) and plastic

cap, supplied in a box

10 mL of solution in a white Merck KGaA,

Nasivin 0.05% nasal spray plastic bottle with a 3K nasal spray, solution Frankfurter Straße 250, YES YES YES

without preservative system and protective cap,

Darmstadt, Germany supplied in a box

10 mL of solution in an

Merck KGaA, amber glass bottle with a Nasivin D 0.05% nasal

nasal spray, solution Frankfurter Straße 250, plastic atomizer pump and YES YES YES spray

Darmstadt, Germany protective cap, supplied in a

box

5 mL of solution in an amber

Merck KGaA, glass bottle with a plastic Nasivin K 0.01% nasal

nasal drops, solution Frankfurter Straße 250, stopper and a glass dropper YES YES YES drops

Darmstadt, Germany with a rubber pump, supplied

in a box

10 mL of solution in an

Merck KGaA, amber glass bottle with a Nasivin K 0.025% nasal

nasal drops, solution Frankfurter Straße 250, yellow plastic cap and glass YES YES YES drops

Darmstadt, Germany dropper with rubber bulb,

supplied in a box

10 mL of solution in an

Merck KGaA, amber glass bottle with while Nasivin K 0.05% nasal

nasal drops, solution Frankfurter Straße 250, plastic cap and glass dropper YES YES YES drops

Darmstadt, Germany with rubber bulb, supplied in

a box

Schering-Plough Labo Plastic bottle with an

N.V. Industrepark 30, attachment for nasal Nasonex nasal spray nasal spray, suspension YES YES

Heist-op-den-Berg, administration containing 120

Belgium doses, supplied in a box

500 mL of solution for Pliva Croatia Ltd., Ulica

infusion in a glass bottle with

Natrii chloridi infundibile grada Vukovara 49, solution for infusion a rubber stopper and an YES YES

compositum Pliva Zagreb, Republic of aluminium cap with a plastic Croatia

lid, 10 bottles in a box

Hrvatski zavod za Natrii chloridi infundibile 100 mL in a glass infusion

solution for intravenous transfuzijsku medicinu, solution for intravenous bottle, (10 bottles with plastic YES YES

infusion Petrova 3, Zagreb, infusion, 100 mL holders in a box)

Republic of Croatia Hrvatski zavod za

Natrii chloridi infundibile 1000 mL in a glass infusion solution for intravenous transfuzijsku medicinu,

solution for intravenous bottle (10 bottles with plastic YES YES infusion Petrova 3, Zagreb,

infusion, 1000 mL holders in a box)

Republic of Croatia

Hrvatski zavod za Natrii chloridi infundibile 250 mL in a glass infusion

solution for intravenous transfuzijsku medicinu, solution for intravenous bottle, (10 bottles with plastic YES YES

infusion Petrova 3, Zagreb, infusion, 250 mL hoders, supplied in a box)

Republic of Croatia

Hrvatski zavod za Natrii chloridi infundibile 500 mL in a glass infusion

solution for intravenous transfuzijsku medicinu, solution for intravenous bottle (10 bottles with plastic YES YES

infusion Petrova 3, Zagreb, infusion, 500 mL holders, supplied in a box)

Republic of Croatia

Pliva Croatia Ltd., Ulica

Natrii chloridi infundibile grada Vukovara 49, 6 bags with 2000 mL of solution for infusion YES YES

Pliva Zagreb, Republic of solution, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

Natrii chloridi infundibile grada Vukovara 49, 12 bags with 1000 mL of solution for infusion YES YES

Pliva Zagreb, Republic of solution, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

Natrii chloridi infundibile grada Vukovara 49, 12 bags with 500 mL of solution for infusion YES YES

Pliva Zagreb, Republic of solution, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

Natrii chloridi infundibile grada Vukovara 49, 10 glass vials with 250 mL of solution for infusion YES YES

Pliva Zagreb, Republic of solution, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

Natrii chloridi infundibile grada Vukovara 49, 10 glass vials with 500 mL of solution for infusion YES YES

Pliva Zagreb, Republic of solution, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 20 mL of infusion solution in SODIUM

grada Vukovara 49, a glass ampoule (clear glass, HYDROGENCARBONATE solution for infusion YES YES

Zagreb, Republic of colourbreak), 10 ampoules in 1-molar solution PLIVA

Croatia a box

Baxter S.A., Belgium;

Baxter Healthcare Ltd, 10 plastic Viaflo bags with sa

Great Britain; Bieffe Sodium chloride 0.9% 1000 mL of infusion solution,

solution for infusion Medital Sabinanigo, YES YES Viaflo in a protective bag, supplied

Spain; Baxter in a box

Healthcare S.A.,

Republic of Ireland

Baxter S.A., Belgium;

Baxter Healthcare Ltd, 50 plastic Viaflo bags with

Great Britain; Bieffe Sodium chloride 0.9%, 100 mL of solution for

solution for infusion Medital Sabinanigo, YES YES Viaflo infusion in a protective bag,

Spain; Baxter supplied in a box

Healthcare S.A.,

Republic of Ireland

Baxter S.A., Belgium;

Baxter Healthcare Ltd, 20 plastic Viaflo bags with

Great Britain; Bieffe Sodium chloride 0.9% 500 mL of infusion solution,

solution for infusion Medital Sabinanigo, YES YES Viaflo in a protective bag, supplied

Spain; Baxter in a box

Healthcare S.A.,

Republic of Ireland

Baxter S.A., Belgium;

Baxter Healthcare Ltd, 30 plastic Viaflo bags with

Great Britain; Bieffe Sodium chloride 0.9%, 250 mL of solution for

solution for infusion Medital Sabinanigo, YES YES Viaflo infusion in a protective bag,

Spain; Baxter supplied in a box

Healthcare S.A.,

Republic of Ireland

Baxter S.A., Belgium; 50 plastic Viaflo bags with 50 Sodium chloride 0.9%,

solution for infusion Baxter Healthcare Ltd, mL of solution for infusion in YES YES Viaflo

Great Britain; Bieffe a protective bag, supplied in Medital Sabinanigo, a box

Spain; Baxter

Healthcare S.A.,

Republic of Ireland

Hrvatski zavod za Sodium chloride 10% concentrate for

transfuzijsku medicinu, 50 mL in a glass injection electrolytes concentrate , intravenous use after YES YES

Petrova 3, Zagreb, bottle (40 bottles per bag) 50 mL reconstitution

Republic of Croatia

48 (2x24) film coated tablets

Natural Wealth Ginkgo NBTY Inc., New York, film coated tablets in a blister (PVC/Al), supplied YES YES

Forte USA in a box

100 capsules in a brown

Natural Wealth Vitamin E- NBTY Inc. New York, capsules plastic bottle, supplied in a YES YES

200 IU, capsules USA box

Novartis Pharma Stein

5 mL of solution in a glass

Navoban injection 5 mg/5 solution for injection and AG,

ampoule, 10 ampoules in a YES YES

mL infusion, oral solution Schaffhauserstrasse,

box

Stein, Switzerland

Novartis Farmacéutica

5 (1x5) capsules in a blister

S.A., Ronda Santa

Navoban capsules 5 mg capsules, hard (PVC/PVDC//Al), supplied in YES YES

María 158, Barcelona,

a box

Spain

Jadran - Galenski 10 mL of nasal drops in a

Nazol 0.05% nasal drops, laboratorij d.d., Pulac clear plastic (PE) bottle with nasal drops, solution YES YES YES

solution bb, Rijeka, Republic of a dropper attachment,

Croatia supplied in a box

Jadran - Galenski 10 mL of nasal drops in a

Nazol 0.1% nasal drops, laboratorij d.d., Pulac clear plastic (PE) bottle with nasal drops, solution YES YES YES

solution bb, Rijeka, Republic of a dropper attachment,

Croatia supplied in a box

Schering AG, 4 mL of solution in an amber Nebido 1000 mg/4 mL

solution for injection Muellerstrasse 170- glass ampoule, 1 ampoule in YES YES YES YES solution for injection

178, Berlin, Germany a box

Berlin-Chemie AG

14 (2x7) tablets in a PVC/Al

(Menarini Group),

Nebilet tablets blister, supplied in a carton YES YES YES YES

Glienicker Weg 125,

box

Berlin, Germany

Berlin-Chemie AG

14 (1x14) tablets in a PVC/Al

(Menarini Group),

Nebilet tablets blister, supplied in a carton YES YES YES YES

Glienicker Weg 125,

box

Berlin, Germany

Lek farmacevtska

solution for injection for družba d.d., 10 ampoules each containing Neloren 300 mg/mL

intramuscular use and Verovškova 57, 1 mL of solution, supplied in YES YES injection

intravenus infusion Ljubljana, Republic of a box

Slovenia

Lek farmacevtska

solution for injection for družba d.d., 10 ampoules each containing Neloren 600 mg/2 mL

intramuscular use and Verovškova 57, 2 mL of solution, supplied in YES YES injection

intravenus infusion Ljubljana, Republic of a box

Slovenia

DIVAPHARMA GmbH, 24 (2x12) lozenges in a Neo-angin sugar-free

lozenges Motzener Straße 41, PVC/PE/PVDC-Al blister, YES YES YES lozenges

Berlin, Germany supplied in a box

DIVAPHARMA GmbH, 24 (2x12) lozenges in a

Neo-angin lozenges lozenges Motzener Straße 41, PVC/PVDC-Al blister, YES YES YES

Berlin, Germany supplied in a box

Fresenius Kabi Austria Box with 10 glass bottles with Neodolpasse solution for infusion YES YES

GmbH, Graz, Austria 250 mL of solution

Belupo, lijekovi i

kozmetika d.d., Ulica 20 (2x10) tablets in a blister Neofen 200 mg tablets film coated tablets YES YES YES

Danica 5, Koprivnica, (PVC/Al) , supplied in a box

Republic of Croatia

Belupo, lijekovi i 10 (1x10) tablets in a

Neofen forte film coated tablets kozmetika d.d., Ulica PVC/Al blister, supplied in a YES YES YES

Danica 5, Koprivnica, carton box Republic of Croatia

6 (2x3) glass syringes (with a Roche Diagnostics

NeoRecormon 10.000 IU needle) each with 0.6 mL of

GmbH, Sandhofeer solution for in ajection in a solution for injection solution, in protective YES YES YES

Strasse 116, D-68305 pre-filled syringe packaging, supplied in a

Mannheim, Germany

carton box

6 (2x3) glass syringes (with a Roche Diagnostics

NeoRecormon 1000 IU needle) each with 0.3 mL of

GmbH, Sandhofeer solution for injection in a solution for in injection solution in protective YES YES YES

Strasse 116, D-68305 pre-filled syringe packaging, supplied in a

Mannheim, Germany

carton box

6 (2x3) glass syringes (with a Roche Diagnostics

NeoRecormon 2000 IU needle) each with 0.3 mL of

GmbH, Sandhofeer solution for in ajection in a solution for injection solution in protective YES YES YES

Strasse 116, D-68305 pre-filled syringe packaging, supplied in a

Mannheim, Germany

carton box

One glass syringe (with Roche Diagnostics

NeoRecormon 30.000 IU needle) containing 0.6 mL of

GmbH, Sandhofeer solution for injection in a solution for injection solution, in a protective YES YES YES

Strasse 116, D-68305 pre-filled syringe container, supplied in a

Mannheim, Germany

carton box

6 (2x3) glass syringes (with a Roche Diagnostics

NeoRecormon 3000 IU needle) each with 0.3 mL of

GmbH, Sandhofeer solution for in ajection in a solution for injection solution in protective YES YES YES

Strasse 116, D-68305 pre-filled syringe packaging, supplied in a

Mannheim, Germany

carton box

6 (2x3) glass syringes (with a Roche Diagnostics

NeoRecormon 4000 IU needle) each with 0.3 mL of

GmbH, Sandhofeer solution for in ajection in a solution for injection solution in protective YES YES YES

Strasse 116, D-68305 pre-filled syringe packaging, supplied in a

Mannheim, Germany

carton box

6 (2x3) glass syringes (with a Roche Diagnostics

NeoRecormon 500 IU needle) each with 0.3 mL of

GmbH, Sandhofeer solution for in ajection in a solution for injection solution, in protective YES YES YES

Strasse 116, D-68305 pre-filled syringe packaging, supplied in a

Mannheim, Germany

carton box

6 (2x3) glass syringes (with a Roche Diagnostics

NeoRecormon 6000 IU needle) each with 0.3 mL of

GmbH, Sandhofeer solution for in ajection in a solution for injection solution in protective YES YES YES

Strasse 116, D-68305 pre-filled syringe packaging, supplied in a

Mannheim, Germany

carton box

NeoRecormon Multidose Roche Diagnostics

Vial with powder for solution 100 000 IU powder and powder and diluent for GmbH, Sandhofeer

for injection and ampoule YES YES YES diluent for solution for solution for injection Strasse 116, D-68305

with diluent, supplied in a box injection Mannheim, Germany

NeoRecormon Multidose Roche Diagnostics Vial with powder for solution

50 000 IU powder and powder and diluent for GmbH, Sandhofeer for injection and ampoule

YES YES YES diluent for solution for solution for injection Strasse 116, D-68305 with diluent, supplied in a

injection Mannheim, Germany carton box

1-mL of solution in an amber solution for injection (for Rotexmedica GmbH,

Neostigmin injection glass ampoule, 10 ampoules YES YES i.m., i.v. and s.c.use) Trittau, Germany

in a box

F. Hoffmann-La Roche

Ltd., 30 (3x10) capsules in a Neotigason capsules 10

capsules, hard Grenzacherstrasse blister (PVC/PE/PVDC//Al) , YES YES mg

124, Basel, supplied in a box

Switzerland

F. Hoffmann-La Roche

Ltd., 30 (3x10) capsules in a Neotigason capsules 25

capsules, hard Grenzacherstrasse blister (PVC/PE/PVDC//Al) , YES YES mg

124, Basel, supplied in a box

Switzerland

10 glass infusion bottles with

Fresenius Kabi Austria 250 mL (10x250mL) of Nephrotect solution for infusion YES YES

GmbH, Graz, Austria solution, supplied in a carton

box 10 glass infusion bottles with

Fresenius Kabi Austria 500 mL (10x500mL) of Nephrotect solution for infusion YES YES

GmbH, Graz, Austria solution, supplied in a carton

box

Schering-Plough Labo solution for injection for

Netromycine injection 150 N.V. Industrepark 30, 1.5-mL of solution in a glass intramuscular and YES YES

mg/1.5 mL Heist-op-den-Berg, vial, supplied in a box intravenous use

Belgium

F. Hoffmann-La Roche One glass syringe with

Ltd., solution for injection (for needle containing 0.5 mL of Neupogen 30 Grenzacherstrasse YES YES

s.c. and i.v. use) solution, in a plastic 124, Basel,

container, supplied in a box Switzerland

Bayer HealthCare AG, 112 (4x28) tablets in Nexavar 200 mg film

film coated tablets 51368 Leverkusen, transparent (PP/Al) blister, YES YES YES YES coated tablets

Germany supplied in a box

AstraZeneca AB, 14 (2x7) tablets in a A/Al Nexium 20 mg gastric-resistant tablets YES YES

Södertälje, Sweden blister, supplied in a box

AstraZeneca AB, 14 (2x7) tablets in a A/Al Nexium 40 mg gastric-resistant tablets YES YES

Södertälje, Sweden blister, supplied in a box

powder for preparation of AstraZeneca AB, Nexium i.v. 40 mg 10 bottles, supplied in a box YES YES

injection/infusion solution Södertälje, Sweden

Merck KGaA,

14 (1x14) tablets in a blister

Darmstadt, Germany,

Niaspan 1000 mg tablets prolonged-release tablets (PVC/PE/Aclar-Al), supplied YES YES

Merck Santé s.a.s.,

in a box

Semoy, France

Merck KGaA,

14 (1x14) tablets in a blister

Darmstadt, Germany

Niaspan 1000 mg tablets prolonged-release tablets (PVC/PE/Aclar-Al), supplied YES YES

Merck SANTE s.a.s.,

in a box

Semoy, France

Merck KGaA,

14 (1x14) tablets in a blister

Darmstadt, Germany,

Niaspan 375 mg tablets prolonged-release tablets (PVC/PE/Aclar-Al), supplied YES YES

Merck Santé s.a.s.,

in a box

Semoy, France

Merck KGaA,

14 (1x14) tablets in a blister

Darmstadt, Germany

Niaspan 375 mg tablets prolonged-release tablets (PVC/PE/Aclar-Al), supplied YES YES

Merck SANTE s.a.s.,

in a box

Semoy, France

Merck KGaA,

14 (1x14) tablets in a blister

Darmstadt, Germany,

Niaspan 500 mg tablets prolonged-release tablets (PVC/PE/Aclar-Al), supplied YES YES

Merck Santé s.a.s.,

in a box

Semoy, France

Merck KGaA,

14 (1x14) tablets in a blister

Darmstadt, Germany

Niaspan 500 mg tablets prolonged-release tablets (PVC/PE/Aclar-Al), supplied YES YES

Merck SANTE s.a.s.,

in a box

Semoy, France

Merck KGaA,

14 (1x14) tablets in a blister

Darmstadt, Germany

Niaspan 750 mg tablets prolonged-release tablets (PVC/PE/Aclar-Al), supplied YES YES

Merck SANTE s.a.s.,

in a box

Semoy, France

Merck KGaA,

14 (1x14) tablets in a blister

Darmstadt, Germany,

Niaspan 750 mg tablets prolonged-release tablets (PVC/PE/Aclar-Al), supplied YES YES

Merck Santé s.a.s.,

in a box

Semoy, France

Belupo, lijekovi i

14 (1x14) tablets in a blister

kozmetika d.d., Ulica

NIBEL 5 mg tablets tablets (PVC/PE/PVDC/Al), supplied YES YES

Danica 5, Koprivnica,

in a box

Republic of Croatia

Pfizer Health AB, 15 (1x15) chewing gums in a Nicorette Freshmint Gum 2

chewing gum Norrbroplatsen 2, blister (PVC/PVDC//Al), YES YES YES mg

Helsingborg, Sweden supplied in a box

Pfizer Health AB, 15 (1x15) chewing gums in a Nicorette Freshmint Gum 4

chewing gum Norrbroplatsen 2, blister (PVC/PVDC//Al), YES YES YES mg

Helsingborg, Sweden supplied in a box

Pfizer Health AB, 7 (7x1) transdermal patches Nicorette patch 10 mg/16 h transdermal patch YES YES YES

Norrbroplasten 2, in a protective (PE/A1/Barex) Helsingborg, Sweden bag, supplied in a box

Pfizer Health AB, 7 (7x1) transdermal patches

Nicorette patch 15 mg/16 h transdermal patch Norrbroplasten 2, in a protective (PE/A1/Barex) YES YES YES

Helsingborg, Sweden bag, supplied in a box

Pfizer Health AB, 7 (7x1) transdermal patches

Nicorette patch 5 mg/16 h transdermal patch Norrbroplasten 2, in a protective (PE/A1/Barex) YES YES YES

Helsingborg, Sweden bag, supplied in a box

Farmal d.d., Ludbreg,

Republic of Croatia, in Nifedipin retard 20 mg Box with 30 tablets (blister,

prolonged release tablets cooperation with YES YES tablets 3x10 tbl.)

Valpharma Int. s.a.,

San Marino

Bayer HealthCare AG, 100 (10x10) film coated Nimotop S film coated

film coated tablets 51368 Leverkusen, tablets in PP/Al blisters, YES YES tablets

Germany supplied in a box

50 mL of solution for infusion Bayer HealthCare AG,

Nimotop S solution for in an amber glass bottle and solution for infusion 51368 Leverkusen, YES YES

infusion a plastic (PE) infusion pipe,

Germany supplied in a box

Belupo, lijekovi i

kozmetika d.d., Ulica Box with 30 capsules (blister, Ninur 50 mg capsules capsules YES YES

Danica 5, Koprivnica, 3x10 capsules)

Republic of Croatia

Belupo, lijekovi i 30 (2x15) capsules in a

kozmetika d.d., Ulica NINUR 50 mg capsules capsules PVC/Al blister, supplied in a YES YES

Danica 5, Koprivnica, box

Republic of Croatia

Cardinal Health,

7 (7x1) transdermal patches

Northamptonshire,

in a protective

Niquitin CQ 14 mg transdermal patch Great Britain; Cardinal YES YES YES YES

(PET/LDPE/Al/acrylonitrile)

Health, Westhoughton,

bag, supplied in a box

Bolton, Great Britain

Cardinal Health,

7 (7x1) transdermal patches

Northamptonshire,

in a protective

Niquitin CQ 21 mg transdermal patch Great Britain; Cardinal YES YES YES YES

(PET/LDPE/Al/acrylonitrile)

Health, Westhoughton,

bag, supplied in a box

Bolton, Great Britain

Cardinal Health,

7 (7x1) transdermal patches

Northamptonshire,

in a protective

Niquitin CQ 7 mg transdermal patch Great Britain; Cardinal YES YES YES YES

(PET/LDPE/Al/acrylonitrile)

Health, Westhoughton,

bag, supplied in a box

Bolton, Great Britain

Pliva Croatia Ltd., Ulica

Amber glass bottle with a

powder for preparation of grada Vukovara 49,

Nistatin Pliva drops dropper containing powder, YES YES

oral suspension Zagreb, Republic of

supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

Aluminum tube containing 20

grada Vukovara 49,

Nistatin Pliva ointment ointment g of ointment, supplied in a YES YES

Zagreb, Republic of

box

Croatia

12.2 mL of solution in a clear

glass bottle (coated with red

plastic layer on the outside) G.Pohl- Boskamp

Nitrolingual aerosol sublingual spray with metering pump and YES YES

GmbH&Co., Germany

plastic spray activator with

plastic protective cap,

supplied in a box

Krka d.d., Šmarješka Nolicin film coated tablets 20 (2x10) tablets in a blister,

film coated tablets cesta 6, Novo mesto, YES YES 400 mg supplied in a box

Republic of Slovenia

Les Laboratoires 30 (1x30) tablets in a blister

Servier Industrie, Gidy, (PVC/Al) inserted into a

Noliprel 2 mg/0.625 mg tablets France; Servier protective bag (PE/Al/PE) YES YES

Republic of Ireland with desiccant, supplied in a

Industries Ltd., box Arcklow, Co. Wicklow,

Republic of Ireland

Krka Farma d.o.o.,

28 (2x14) tablets in a blister

gastric-resistant film Radnička cesta 48,

Nolpaza 20 mg (OPA/Al/PVC//Al), supplied in YES YES

coated tablets Zagreb, Republic of

a box

Croatia

Krka Farma d.o.o.,

14 (1x14) tablets in a blister

gastric-resistant film Radnička cesta 48,

Nolpaza 40 mg (OPA/Al/PVC//Al), supplied in YES YES

coated tablets Zagreb, Republic of

a box

Croatia

AstraZeneca UK

Limited, Silk Road 30 (3x10) tablets in an

Nolvadex tablets film tablets Business Park, aluminium blister, supplied in YES YES

Macclesfield, Cheshire, a box

Great Britain

N.V. Organon, Oss, the 50 ampoules with powder

powder for solution for Netherlands; Organon and 50 ampoules with 1 mL Norcuron 4 mg YES YES

i.v. Injection S.A., Eragny Sur Epte, of water for injection,

France supplied in a box

One glass cartridge with 1.5

mL of solution (with a rubber Novo Nordisk A/S,

Norditropin SimpleXx 10 plunger and rubber stopper solution for injection Novo Allé, DK-2880 YES YES YES

mg/1.5 mL with aluminium ring and

Bagsvaerd, Denmark

plastic closure) in a plastic

container, supplied in a box

One glass cartridge with 1.5

mL of solution (with a rubber Novo Nordisk A/S,

Norditropin SimpleXx 15 plunger and rubber stopper solution for injection Novo Allé, DK-2880 YES YES YES

mg/ 1.5 mL with aluminium ring and

Bagsvaerd, Denmark

plastic closure) in a plastic

container, supplied in a box

One glass cartridge with 1.5

mL of solution (with a rubber Novo Nordisk A/S,

Norditropin SimpleXx 5 plunger and rubber stopper solution for injection Novo Allé, DK-2880 YES YES YES

mg/1.5 mL with aluminium ring and

Bagsvaerd, Denmark

plastic closure) in a plastic

container, supplied in a box

Belupo, lijekovi i

kozmetika d.d., Ulica 30 tablets in a blister, Normabel 10 mg tablets tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

10 amber glass ampoules

Normabel 10 mg/2 mL kozmetika d.d., Ulica

solution for injection each containing 2 mL of YES YES

injection Danica 5, Koprivnica,

solution, supplied in a box

Republic of Croatia

Belupo, lijekovi i 30 (1x30) film coated tablets

kozmetika d.d., Ulica Normabel 2 mg tablets film coated tablets in a PVC/Al blister, supplied YES YES

Danica 5, Koprivnica, in a box

Republic of Croatia

Belupo, lijekovi i 31 (1x30) film coated tablets

kozmetika d.d., Ulica Normabel 5 mg tablets film coated tablets in a PVC/Al blister, supplied YES YES

Danica 5, Koprivnica, in a box

Republic of Croatia

Ferring GmbH, 30 (3x10) tablets in a blister

Norprolac tablets 150 µg tablets Wittland 1, Kiel, YES YES YES (A1/A1), supplied in a box Germany

3 tablets of 25 µg + 3 tablets

of 50 µg in a Ferring GmbH,

Norprolac tablets 25 µg/ blister(PVC/PVDC//A1), tablets Wittland 1, Kiel, YES YES YES

50 µg inserted a protective

Germany

aluminium sachet, supplied

in a box

Ferring GmbH,

31 (3x10) tablets in a blister

Norprolac tablets 75 µg tablets Wittland 1, Kiel, YES YES YES

(A1/A1), supplied in a box

Germany

Wyeth Medica

Republic of Ireland, Vial with 10 mL of Novantrone 20

concentrated solution for Co. Kildare, Republic concentrated solution and concentrate for preparation YES YES

infusion of Ireland and Wyeth stopper with aluminium cap, of infusion solution

Lederle S.p.A., supplied in a box

Catania, Italy

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 10 (1x10) film tablets in a Novocef tablets 125 mg film tablets YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 10 (1x10) film tablets in a Novocef tablets 250 mg film tablets YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 10 (1x10) film tablets in a Novocef tablets 500 mg film tablets YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

28 tablets (16 red and 12 Novo Nordisk A/S,

white tablets) in a plastic, Novofem film coated tablets Novo Allé, DK-2880 YES YES

circular calendar pack, Bagsvaerd, Denmark

supplied in a box

Novo Nordisk A/S,

Novo Alle, Bagsvaerd, Box with 5 injection devices

suspension for Denmark Novo Nordisk each with 3 mL of NovoMix 30 FlexPen YES YES YES YES

subcutaneous injection Production SAS, 45, suspension in a glass

Avenue d' Orleans, cartridge

Chartres, France

Novo Nordisk A/S,

Novo Alle, Bagsvaerd, 5 glass cartridges with 3 mL

suspension for Denmark Novo Nordisk NovoMix 30 Penfill of suspension in a blister, YES YES YES YES

subcutaneous injection Production SAS, 45,

supplied in a box

Avenue d' Orleans,

Chartres, France

5 pens (injectors) with a suspension for injections, Novo Nordisk A/S,

glass cartridge containing 3 NovoMix 50 FlexPen cartridge in a pre-filled Novo Allé, DK-2880 YES YES YES

mL of suspension, supplied pen Bagsvaerd, Denmark

in a box

5 glass cartridges each with Novo Nordisk A/S, suspension for injection 3 mL of suspension in

NovoMix 50 Penfill Novo Allé, DK-2880 YES YES YES in a cartridge protective packaging,

Bagsvaerd, Denmark

supplied in a box

5 pens (injectors) with a suspension for injection, Novo Nordisk A/S,

glass cartridge containing 3 NovoMix 70 FlexPen cartridge in a pre-filled Novo Allé, DK-2880 YES YES YES

mL of suspension, supplied pen Bagsvaerd, Denmark

in a box

5 glass cartridges each with Novo Nordisk A/S, suspension for injection 3 mL of suspension in

NovoMix 70 Penfill Novo Allé, DK-2880 YES YES YES in a cartridge protective packaging,

Bagsvaerd, Denmark

supplied in a box

Novo Nordisk A/S, 30 (2x15) tablets in a blister,

NovoNorm 0.5 mg tablets Novo Allé, DK-2880 YES YES supplied in a box

Bagsvaerd, Denmark

Novo Nordisk A/S, 30 (2x15) tablets in a blister,

NovoNorm 1 mg tablets Novo Allé, DK-2880 YES YES supplied in a box

Bagsvaerd, Denmark

Novo Nordisk A/S, 30 (2x15) tablets in a blister,

NovoNorm 2 mg tablets Novo Allé, DK-2880 YES YES supplied in a box

Bagsvaerd, Denmark

Novo Nordisk A/S, One glass vial with 10 mL of

NovoRapid solution for injection Novo Allé, DK-2880 YES YES solution, supplied in a box

Bagsvaerd, Denmark

Novo Nordisk A/S, 5 injectors, with 3 mL of

NovoRapid FlexPen solution for injection Novo Allé, DK-2880 solution per glass cartridge, YES YES

Bagsvaerd, Denmark supplied in a box Novo Nordisk A/S,

Bagsvaerd, Denmark i 5 glass cartridges each with

NovoRapid Penfill solution for injection Novo Nordisk 3 mL of solution in protective YES YES YES YES

Productions SAS, packaging, supplied in a box

Chartes, France

One glass vial with powder

and one glass vial with 2.2

mL of Water for Injection in a

box, one sterile attachment Novo Nordisk A/S, powder and diluent for for reconstitution vial, one NovoSeven 1.2 mg Novo Allé, DK-2880 YES YES YES YES

solution for injection disposable sterile syringe for Bagsvaerd, Denmark

reconstitution and

administration of medicinal

product, one sterile infusion

set

One glass vial with powder

and one glass vial with 4.3

mL of Water for Injection in a

box, one sterile attachment Novo Nordisk A/S, powder and diluent for for reconstitution vial, one NovoSeven 2.4 mg Novo Allé, DK-2880 YES YES YES YES

solution for injection disposable sterile syringe for Bagsvaerd, Denmark

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 attachment Novo Nordisk A/S, powder and diluent for for reconstitution vial, one NovoSeven 4.8 mg Novo Allé, DK-2880 YES YES YES YES

solution for injection disposable sterile syringe for Bagsvaerd, Denmark

reconstitution and

administration of medicinal

product, one sterile infusion

set

Novuroxim injection 1500 powder for preparation of Pliva Krakow, Krakow, 5 (20 mL) glass bottles with

YES YES mg solution for i.v. injection Poland powder, supplied in a box

powder for preparation of Novuroxim injection 250 Pliva Krakow, Krakow, 5 (7.5 mL) glass bottles with

solution/suspension for YES YES mg Poland powder, supplied in a box

i.m. and i.v. injection

powder for preparation of Novuroxim 750 mg Pliva Krakow, Krakow, 5 (10 mL) glass bottles with

solution/suspension for YES YES injection Poland powder, supplied in a box

i.m. and i.v. injection

Pliva Krakow, Krakow, 10 (1x10) tablets in a blister, Novuroxim tablets 125 mg film tablets YES YES

Poland supplied in a box

Pliva Krakow, Krakow, 10 (1x10) tablets in a blister, Novuroxim tablets 250 mg film tablets YES YES

Poland supplied in a box

Pliva Krakow, Krakow, 10 (1x10) tablets in a blister, Novuroxim tablets 500 mg film tablets YES YES

Poland supplied in a box

Belupo, lijekovi i

kozmetika d.d., Ulica 50 tablets in an amber glass Nozid 5 mg tablets tablets YES YES

Danica 5, Koprivnica, bottle, supplied in a box

Republic of Croatia

Famar Lyon, 29

Avenue du General de 20 (2x10) tablets in a blister, Nozinan 100 mg tablets film coated tablets YES YES

Gualle 69230 Saint supplied in a box

Genis Laval, France

Famar Lyon, 29

Avenue du General de 20 (2x10) tablets in a blister Nozinan 100 mg tablets film coated tablets YES YES

Gaulle 69230 Saint (PVC/Al), supplied in a box

Genis Laval, France Famar Lyon, 29

Avenue du General de 20 (2x10) tablets in a blister, Nozinan 25 mg tablets film coated tablets YES YES

Gaulle 69230 Saint supplied in a box

Genis Laval, France

Famar Lyon, 29

Avenue du General de 20 (2x10) tablets in a blister Nozinan 25 mg tablets film coated tablets YES YES

Gaulle 69230 Saint (PVC/Al), supplied in a box

Genis Laval, France

Reckitt Benckiser

Healthcare

12 (1x12) film coated tablets

NUROFEN Cold and Flu International Ltd.,

film coated tablets in PVC/PVdC/Al blister, YES YES YES

film coated tablets Thane Road,

supplied in a box

Nottingham, Great

Britain

Reckitt Benckiser

Healthcare

12 (1x12) film coated tablets

NUROFEN Cold and Flu International Ltd.,

film coated tablets in PVC/PVdC/Al blister, YES YES YES

film coated tablets Thane Road,

supplied in a box

Nottingham, Great

Britain

Reckitt Benckiser

Healthcare

International Ltd.,

Nottingham, Great 10 (1x10) capsules in a

Nurofen Liquid capsules capsules, soft Britain, in cooperation PVC/PVdC/Al blister, YES YES YES

with Banner supplied in a box

Pharmacaps Europe

B.V., Tilburg, the

Netherlands

Reckitt Benckiser

Healthcare

International Ltd.,

Nottingham, Great 10 (1x10) capsules in a

Nurofen Liquid capsules capsules, soft Britain in cooperation PVC/PVdC/Al blister, YES YES YES

with Banner supplied in a box

Pharmacaps Europe

B.V., Tilburg, the

Netherlands

Reckitt Benckiser

Healthcare

12 (1x12) coated tablets in a

International Ltd.,

NUROFEN coated tablets coated tablets PVC/PVdC/Al blister, YES YES YES

Thane Road,

supplied in a carton box

Nottingham, Great

Britain

Reckitt Benckiser

Healthcare

12 (1x12) coated tablets in a

International Ltd.,

NUROFEN coated tablets coated tablets PVC/PVdC/Al blister, YES YES YES

Thane Road,

supplied in a plastic box

Nottingham, Great

Britain

Reckitt Benckiser

Healthcare

12 (1x12) coated tablets in a

International Ltd.,

NUROFEN coated tablets coated tablets PVC/PVdC/Al blister, YES YES YES

Thane Road,

supplied in a plastic box

Nottingham, Great

Britain

Reckitt Benckiser

Healthcare

12 (1x12) coated tablets in a

International Ltd.,

NUROFEN coated tablets coated tablets PVC/PVdC/Al blister, YES YES YES

Thane Road,

supplied in a carton box

Nottingham, Great

Britain

Reckitt Benckiser 101 mL of suspension in a

Healthcare brown plastic (PET) bottle NUROFEN oral

oral suspension International Ltd., with temper-proof closure YES YES suspension for children

Thane Road, with protective plastic ring,

Nottingham, Great and 5-mL graduated plastic Britain syringe, supplied in a box

Boots Contract 100 mL of suspension in a

Manufacture Ltd., brown plastic (PET) bottle

NUROFEN oral Nottingham, Great with temper-proof closure oral suspension YES YES suspension for children Britain or Hermal Kurt with protective plastic ring,

Herrmann GmbH&Co., and 5-mL graduated plastic

Reinbeck, Germany syringe, supplied in a box

Plastic (PVC) Viaflex bag

containing 2000 mL of

BAXTER Healthcare solution for peritoneal

S.A., Monreen Road, dialysis, feeding tube (PVC), Nutrineal PD4 with 1.1% solution for peritoneal

Castlebar, County connector with protective YES YES amino acids dialysis

Mayo, Republic of cap, drain tube, drug

Ireland administration attachment

and a Vialex plastic collection

bag (individual packages)

N.V. Organon, Oss,

The Nederlands;

Organon Republic of Intravaginal ring in protective NuvaRing intravaginal ring YES YES YES

Ireland Ltd., Co. Al sachet, supplied in a box

Dublin, Republic of

Ireland

Octapharma

Pharmazeutika

Produktionsges.m.b.H., One glass vial with 20 mL of

Vienna, Austria, OCTAGAM 1 g solution for infusion solution for infusion, supplied YES

Octapharma S.A.S., in a box

Lingolsheim, France

and Octapharma AB,

Stockholm, Sweden

Octapharma

Pharmazeutika

Produktionsges.m.b.H., One glass vial with 200 mL of

Vienna, Austria, OCTAGAM 10 g solution for infusion solution for infusion, supplied YES

Octapharma S.A.S., in a box

Lingolsheim, France

and Octapharma AB,

Stockholm, Sweden

Octapharma

Pharmazeutika

Produktionsges.m.b.H., One glass vial containing 50

Vienna, Austria, OCTAGAM 2.5 g solution for infusion mL of solution for infusion, YES

Octapharma S.A.S.,

supplied in a box

Lingolsheim, France

and Octapharma AB,

Stockholm, Sweden

Octapharma

Pharmazeutika

Produktionsges.m.b.H., One glass vial with 100 mL of

Vienna, Austria, OCTAGAM 5 g solution for infusion solution for infusion, supplied YES

Octapharma S.A.S., in a box

Lingolsheim, France

and Octapharma AB,

Stockholm, Sweden

Octapharma 200 mL of solution in sterile

Pharmazeutika PVC transfusion bags coated Octaplas SD blood type 0 solution for infusion YES

Produktionsges.m.b.H., with polyamide/polyethylene

Vienna, Austria film

Octapharma 200 mL of solution in sterile

Pharmazeutika PVC transfusion bags coated Octaplas SD blood type A solution for infusion YES

Produktionsges.m.b.H., with polyamide/polyethylene

Vienna, Austria film

Octapharma 200 mL of solution in sterile

Octaplas SD blood type Pharmazeutika PVC transfusion bags coated solution for infusion YES

AB Produktionsges.m.b.H., with polyamide/polyethylene

Vienna, Austria film Octapharma 200 mL of solution in sterile

Pharmazeutika PVC transfusion bags coated Octaplas SD blood type B solution for infusion YES

Produktionsges.m.b.H., with polyamide/polyethylene

Vienna, Austria film

Schulke & Mayr

50 mL of solution in a plastic

Octenisept solution GmbH, Norderstedt, YES YES YES

bottle with a spray pump

Germany

Pliva Croatia Ltd., Ulica

grada Vukovara 49, Box with 60 capsules in a Oikamid capsules YES YES

Zagreb, Republic of blister (5x12)

Croatia

Pliva Croatia Ltd., Ulica

10 ampoules each containing

grada Vukovara 49,

Oikamid injection solution for injection 5 mL of solution, supplied in YES YES

Zagreb, Republic of

a box

Croatia

Pliva Croatia Ltd., Ulica

10 ampoules each containing

grada Vukovara 49,

Oikamid injection solution for injection 5 mL of solution, supplied in YES YES

Zagreb, Republic of

a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, Box with 60 capsules in a Oikamid capsules capsules YES YES

Zagreb, Republic of blister (5x12)

Croatia

Belupo, lijekovi i

30 (3X10) tablets in a PVC/Al

kozmetika d.d., Ulica

Oksazepam 10 mg tablets tablets foil blister, supplied in a YES YES

Danica 5, Koprivnica,

carton box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 20 (1x20) tablets in a PVC/Al Oksazepam 30 mg tablets tablets YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Cipla Ltd., Kurkumbh

30 (3x10) film coated tablets

Industrial Area,

Olanzapin CIPLA 10 mg film coated tablets in a blister (OPA/Al/PVC//Al), YES YES

Maharashtra State,

supplied in a box

India

Cipla Ltd., Kurkumbh

31 (3x10) film coated tablets

Industrial Area,

Olanzapin CIPLA 2.5 mg film coated tablets in a blister (OPA/Al/PVC//Al), YES YES

Maharashtra State,

supplied in a box

India

Cipla Ltd., Kurkumbh

32 (3x10) film coated tablets

Industrial Area,

Olanzapin CIPLA 5 mg film coated tablets in a blister (OPA/Al/PVC//Al), YES YES

Maharashtra State,

supplied in a box

India

Belupo, lijekovi i 50 (5x10) capsules in a

prolonged release kozmetika d.d., Ulica Olicard 40 mg retard blister (PVC/Al), supplied in a YES YES

capsules Danica 5, Koprivnica, box

Republic of Croatia

Belupo, lijekovi i 50 (5x10) capsules in a

prolonged release kozmetika d.d., Ulica Olicard 60 mg retard blister (PVC/Al), supplied in a YES YES

capsules Danica 5, Koprivnica, box

Republic of Croatia

Plastic bag for 2000 mL of

Clintec Parenteral S.A., blend (in three separate

OliClinomel N4 - 550E emulsion for infusion France; Baxter S.A., compartments) in a plastic YES YES

Lessines, Belgium protective casing, 4 bags in a

box

Plastic bag with 1000 mL of

Clintec Parenteral S.A., blend (in three separate

OliClinomel N4 - 550E emulsion for infusion France; Baxter S.A., compartments) in a plastic YES YES

Lessines, Belgium protective casing, 6 bags in a

carton box

Plastic bag for 2000 mL of

Clintec Parenteral S.A., blend (in three separate

OliClinomel N6 - 900 E emulsion for infusion France; Baxter S.A., compartments) in a plastic YES YES

Lessines, Belgium protective casing, 4 bags in a

box Plastic bag for 2000 mL of

Clintec Parenteral S.A., blend (in three separate

OliClinomel N7 - 1000 E emulsion for infusion France; Baxter S.A., compartments) in a plastic YES YES

Lessines, Belgium protective casing, 4 bags in a

box

Plastic bag with 1000 mL of

Clintec Parenteral S.A., blend (in three separate

OliClinomel N7 - 1000 E emulsion for infusion France; Baxter S.A., compartments) in a plastic YES YES

Lessines, Belgium protective casing, 6 bags in a

carton box

Lek farmacevtska

družba d.d.,

20 (2x10) tablets in a blister,

Olivin 10 mg tablets tablets Verovškova 57, YES YES

supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d.,

20 (2x10) tablets in a blister,

Olivin 20 mg tablets tablets Verovškova 57, YES YES

supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d.,

20 (2x10) tablets in a blister,

Olivin 5 mg tablets tablets Verovškova 57, YES YES

supplied in a box

Ljubljana, Republic of

Slovenia

10 mL of solution in an

amber glass bottle with a Pfizer PGM, Orleans

Olynth 0.05% nasal spray nasal spray, solution plastic atomizer extension YES YES YES Cedex, France

and protective cap, supplied

in a box

10 mL of solution in an Pfizer PGM, Orleans

Olynth 0.1% nasal drops nasal drops, solution amber glass bottle with YES YES YES Cedex, France

dropper, supplied in a box

10 mL of solution in an

amber glass bottle with a Pfizer PGM, Orleans

Olynth 0.1% nasal spray nasal spray, solution plastic atomizer extension YES YES YES Cedex, France

and protective cap, supplied

in a box

10 mL of solution in an Pfizer PGM, Orleans

Olynth 0.5% nasal drops nasal drops, solution amber glass bottle with YES YES YES Cedex, France

dropper, supplied in a box

URSAPHARM 10 mL of solution in a white

Olynth HA 0.05% nasal Arzneimittel plastic bottle with a 3K nasal spray, solution YES YES YES

spray GmbH&Co., system and protective cap,

Saarbrucken, Germany supplied in a box

URSAPHARM 10 mL of solution in a white

Olynth HA 0.1% nasal Arzneimittel plastic bottle with a 3K nasal spray, solution YES YES YES

spray GmbH&Co., system and protective cap,

Saarbrucken, Germany supplied in a box

Solvay

capsules (soft, Pharmaceuticals 28 capsules in a plastic Omacor YES YES YES

transparent, gelatinous) GmbH, Neustadt, bottle

Germany

10 glass bottles with 100 mL Fresenius Kabi Austria

Omegaven emulsion for infusion of emulsion (10x100 mL), YES YES

GmbH, Graz, Austria supplied in a box

10 glass bottles with 50 mL Fresenius Kabi Austria

Omegaven emulsion for infusion of emulsion (10x50 mL), YES YES

GmbH, Graz, Austria supplied in a box

Farmal d.d., Branitelja 14 (2x7) capsules in a

gastric-resistant domovinskog rata 8, Omezol capsules 20 mg OPA/Al/PVC//Al blister, YES YES

capsules, hard Ludbreg, Republic of supplied in a box

Croatia

Astellas Pharma Box with 3x10 prolonged

prolonged-release Europe B.V., Omnic 0.4 mg release capsules in an YES YES

capsules Elisabethhof 19, Al/polypropylene blister

Leiderdorp, the Netherlands

Amersham Health IDA

Business Park, 10 bottles containing 10 mL Omnipaque 240 solution solution for injection YES YES

Carrigtwohill, Co. Cork, of solution, supplied in a box

Republic of Ireland

Amersham Health IDA

solution for Business Park, 10 bottles containing 100 mL Omnipaque 300 solution YES YES

injection/infusion Carrigtwohill, Co. Cork, of solution, supplied in a box

Republic of Ireland

Amersham Health IDA

solution for Business Park, 10 bottles containing 50 mL Omnipaque 300 solution YES YES

injection/infusion Carrigtwohill, Co. Cork, of solution, supplied in a box

Republic of Ireland

Amersham Health IDA

Business Park, 10 bottles containing 10 mL Omnipaque 300 solution solution for injection YES YES

Carrigtwohill, Co. Cork, of solution, supplied in a box

Republic of Ireland

Amersham Health IDA

Business Park, 6 bottles with 200 mL of Omnipaque 350 solution solution for injection YES YES

Carrigtwohill, Co. Cork, solution, supplied in a box

Republic of Ireland

Amersham Health IDA

Business Park, 25 bottles each with 20 mL Omnipaque 350 solution solution for injection YES YES

Carrigtwohill, Co. Cork, of solution, supplied in a box

Republic of Ireland

Amersham Health IDA

Business Park, 10 bottles containing 50 mL Omnipaque 350 solution solution for injection YES YES

Carrigtwohill, Co. Cork, of solution, supplied in a box

Republic of Ireland

Amersham Health IDA

solution for Business Park, 10 bottles containing 100 mL Omnipaque 350 solution YES YES

injection/infusion Carrigtwohill, Co. Cork, of solution, supplied in a box

Republic of Ireland

GE Healthcare

Republic of Ireland,

Omniscan 0.5 mmol/mL Carrigtwohill, Co. Cork, 10 glass bottles with 20 mL solution for injection YES YES

solution for injection Republic of Ireland; GE of solution, supplied in a box

Healthcare AS,

Nydalen, Oslo, Norway

GE Healthcare

Republic of Ireland,

Omniscan 0.5 mmol/mL Carrigtwohill, Co. Cork, 10 glass bottles with 10 mL solution for injection YES YES

solution for injection Republic of Ireland; GE of solution, supplied in a box

Healthcare AS,

Nydalen, Oslo, Norway

Omniscan 0.5 mmol/mL 10 plastic syringes with 20

GE Healthcare AS, solution for injection (presolution for injection mL of solution, supplied in a YES YES

Nydalen, Oslo, Norway filled syringe) box

Omniscan 0.5 mmol/mL 10 plastic syringes with 10

GE Healthcare AS, solution for injection (presolution for injection mL of solution, supplied in a YES YES

Nydalen, Oslo, Norway filled syringe) box

GE Healthcare

Republic of Ireland, Omniscan 0.5 mmol/mL

Carrigtwohill, Co. Cork, 10 plastic syringes with 5 mL solution for injection (presolution for injection YES YES

Republic of Ireland; GE of solution, supplied in a box filled syringe)

Healthcare AS,

Nydalen, Oslo, Norway

Alcon Couvreur N.V., Plastic bottle (low density

Rijksweg 14, Puurs, polyethylene) with a dropper

Opatanol 1 mg/mL eye Belgium; Alcon Cusi and a stopper eye drops YES YES

drops S.A., Camil Fabra 58, (polypropylene) containing 5

El Masnou, Barcelona, mL of solution, supplied in a

Spain box

Lek farmacevtska 10 mL of solution in a plastic Operil 0.05% nasal drops nasal drops YES YES YES

družba d.d., bottle with a dropper, Verovškova 57, supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d., 10 mL of solution in a plastic

Operil 0.05% nasal spray nasal spray (solution) Verovškova 57, box with atomizer extension, YES YES YES

Ljubljana, Republic of supplied in a box

Slovenia

Lek farmacevtska

družba d.d., 10 mL of solution in a plastic Operil P 0.025% nasal

nasal drops Verovškova 57, bottle with a dropper, YES YES YES drops

Ljubljana, Republic of supplied in a box

Slovenia

Lek farmacevtska

družba d.d., 10 mL of solution in a plastic Operil P 0.025% nasal

nasal spray (solution) Verovškova 57, box with atomizer extension, YES YES YES spray

Ljubljana, Republic of supplied in a box

Slovenia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 30 (3x10) tablets in a blister Optimon 10 mg tablets tablets YES YES

Zagreb, Republic of (PVC/Al), supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 30 (3x10) tablets in ablister Optimon 20 mg tablets tablets YES YES

Zagreb, Republic of (PVC/Al), supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 30 (3x10) tablets in a blister Optimon 5 mg tablets tablets YES YES

Zagreb, Republic of (PVC/Al), supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

30 (3x10) tablets in a blister

Optimon Plus 10/12.5 mg grada Vukovara 49,

tablets (PVC/PVDC/Al), supplied in YES YES

tablets Zagreb, Republic of

a box

Croatia

Pliva Croatia Ltd., Ulica

30 (3x10) tablets in a blister

Optimon Plus 20/12.5 mg grada Vukovara 49,

tablets (PVC/PVDC/Al), supplied in YES YES

tablets Zagreb, Republic of

a box

Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 14 (1x14) tablets in a blister, Ormidol 100 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 tablets (3x10) in a PVC/Al Ormidol 25 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 tablets (3x10) in a PVC/Al Ormidol 50 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Krka d.d., Novo Mesto,

Republic of Slovenia in

cooperation with 30 g of cream in a tube, Oronazol cream cream YES YES

Janssen supplied in a box

Pharmaceutica,

Beerse, Belgium

Janssen

100 mL of shampoo in a

Pharmaceutica NV,

Oronazol shampoo shampoo plastic bottle, supplied in a YES YES YES

Turnhouseweg 30,

box

Beerse, Belgium

Krka d.d., Novo Mesto,

Republic of Slovenia in

20 tablets in an amber glass

cooperation with

Oronazol tablets tablets bottle, supplied in a carton YES YES

Janssen

box

Pharmaceutica,

Beerse, Belgium Jadran - Galenski

laboratorij d.d., Pulac 14 capsules in a plastic bottle Ortalox 10 mg capsules YES YES

bb, Rijeka, Republic of (HDPE), supplied in a box

Croatia

Jadran - Galenski

laboratorij d.d., Pulac 14 capsules in a plastic bottle Ortalox 20 mg capsules YES YES

bb, Rijeka, Republic of (HDPE), supplied in a box

Croatia

Lek farmacevtska

družba d.d., 7 capsules in an amber glass

Ortanol 20 mg capsules capsules Verovškova 57, YES YES bottle, supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d., 7 (1x7) capsules in a blister,

Ortanol 40 mg capsules capsules Verovškova 57, YES YES supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d., 7 (1x7) capsules in a blister,

Ortanol S 10 mg capsules capsules Verovškova 57, YES YES supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d., 28 (4x7) capsules in a blister,

Ortanol S 10 mg capsules capsules Verovškova 57, YES YES supplied in a box

Ljubljana, Republic of

Slovenia

Les Laboratories

granules for oral Servier Industrie, 905 7 bags (paper/PE/Al/PE) with Osseor 2 g YES YES YES

suspension route de Saran, 45520 granules, supplied in a box

Gidy, France

powder and diluent for Industria Farmaceutica Vial with powder and vial with

OVITRELLE 250 mg preparation of solution for Serono S.p.A., Bari, diluent with 1 mL of Water for YES YES YES

injection Italy Injection, supplied in a box

Industria Farmaceutica One glass syringe with OVITRELLE 250 solution for injection in a

Serono S.p.A., Bari, needle in a plastic container, YES YES YES micrograms/0.5 mL syringe

Italy supplied in a box

Powder for solution for Pliva Croatia Ltd., Ulica

infusion in a glass bottle (50 powder for solution for grada Vukovara 49,

Oxaliplatin Pliva 100 mg mL) with a rubber stopper, YES YES infusion Zagreb, Republic of

aluminium ring and plastic Croatia

cap, supplied in a box

Powder for solution for Pliva Croatia Ltd., Ulica

infusion in a glass bottle (26 powder for solution for grada Vukovara 49,

Oxaliplatin Pliva 50 mg mL) with a rubber stopper, YES YES infusion Zagreb, Republic of

aluminium ring and plastic Croatia

cap, supplied in a box

Bosnalijek d.d.,

Jukićeva 53, Sarajevo,

Oxetin film coated tablets Bosnia and 20 (2x10) tablets in PVC/Al film coated tablets YES YES

20 mg Herzegovina in blister, supplied in a box

cooperation with JMP,

Jordan

Mundipharma Gm.b.H.,

Limburg, Germany and 30 tablets (3x10) in a PVC/Al

OxyContin 10 mg prolonged-release tablets Mundipharma YES YES blister, supplied in a box

GES.m.b.H., Vienna,

Austria

Mundipharma Gm.b.H.,

Limburg, Germany and 30 tablets (3x10) in a PVC/Al

OxyContin 20 mg prolonged-release tablets Mundipharma YES YES blister, supplied in a box

GES.m.b.H., Vienna,

Austria

Mundipharma Gm.b.H., 30 tablets (3x10) in a PVC/Al

OxyContin 40 mg prolonged-release tablets Limburg, Germany and YES YES blister, supplied in a box

Mundipharma GES.m.b.H., Vienna,

Austria

Mundipharma Gm.b.H.,

Limburg, Germany and 30 tablets (3x10) in a PVC/Al

OxyContin 80 mg prolonged-release tablets Mundipharma YES YES blister, supplied in a box GES.m.b.H., Vienna,

Austria

Bard Pharmaceuticals 56 (4x14) tablets in a PVC/Al

OxyContin tablets 10 mg prolonged release tablets Ltd., Cambridge, Great YES YES blister, supplied in a box Britain

Bard Pharmaceuticals 56 (4x14) tablets in a PVC/Al

OxyContin tablets 20 mg prolonged release tablets Ltd., Cambridge, Great YES YES blister, supplied in a box Britain

Bard Pharmaceuticals 56 (4x14) tablets in a PVC/Al

OxyContin tablets 40 mg prolonged release tablets Ltd., Cambridge, Great YES YES blister, supplied in a box Britain

Bard Pharmaceuticals 56 (4x14) tablets in a PVC/Al

OxyContin tablets 80 mg prolonged release tablets Ltd., Cambridge, Great YES YES blister, supplied in a box Britain

Ebewe Pharma Ges.

Paclitaxel Ebewe 150 concentrate of solution m.b.H. Nfg. KG, 25 mL of solution in a glass

YES YES mg/25 mL for infusion Mondseestrasse 11, bottle, supplied in a box

Unterach, Austria

Ebewe Pharma Ges.

Paclitaxel Ebewe 30 mg/5 concentrate of solution m.b.H. Nfg. KG, 5 mL of solution in a glass

YES YES mL for infusion Mondseestrasse 11, bottle, supplied in a box

Unterach, Austria

Pliva Croatia Ltd., Ulica

Paclitaxel Pliva 100 concentrate for solution grada Vukovara 49,

One glass vial in a box YES YES mg/16.7 mL for infusion Zagreb, Republic of

Croatia

Pliva Croatia Ltd., Ulica

Paclitaxel Pliva 30 mg/5 concentrate for solution grada Vukovara 49,

One glass vial in a box YES YES mL for infusion Zagreb, Republic of

Croatia

50 mL of solution

Pliva Croatia Ltd., Ulica concentrate in a glass bottle

PACLITAXEL PLIVA 300 concentrate of solution grada Vukovara 49, (multy dose vial) with a

YES YES mg/50 mL for infusion Zagreb, Republic of rubber stopper, an aluminium

Croatia cap and a protective lid,

supplied in a box

16.7 mL of concentrate for

infusion solution in a clear

Pharmachemie B.V., glass bottle with teflonconcentrate of solution

Paclitaxin 6 mg/mL Haarlem, the coated rubber (bromobutyl) YES YES YES YES for infusion

Netherlands stopper and aluminium ring

with plastic (PP) lid,

supplied in a box

5 mL of solution for infusion

concentrate in a colourless

Pharmachemie B.V., glass bottle with a rubber concentrate of solution

Paclitaxin 6 mg/mL Haarlem, the (bromobutyl) stopper coated YES YES YES YES for infusion

Netherlands 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

Pharmachemie B.V., glass bottle with rubber concentrate of solution

Paclitaxin 6 mg/mL Haarlem, the (bromobutyl) stopper coated YES YES YES YES for infusion

Netherlands with teflon and Al ring with

plastic (PP) lid, supplied in a

box

50 mL of solution for infusion

Pharmachemie B.V., concentrate in a colourless concentrate of solution

Paclitaxin 6 mg/mL Haarlem, the glass bottle with a rubber YES YES YES YES for infusion

Netherlands (bromobutyl) stopper coated

with Teflon and an aluminium

ring with a plastic (PP) lid,

supplied in a box

Mundipharma 56 (4x14) capsules in a Palladone SR capsules 16 prolonged-release

Ges.m.b.H., Vienna, blister (PVDC/PVC//Al), YES YES mg capsules

Austria supplied in a box

Mundipharma 56 (4x14) capsules in a Palladone SR capsules 4 prolonged-release

Ges.m.b.H., Vienna, blister (PVDC/PVC//Al), YES YES mg capsules

Austria supplied in a box

Mundipharma 56 (4x14) capsules in a Palladone SR capsules 8 prolonged-release

Ges.m.b.H., Vienna, blister (PVDC/PVC//Al), YES YES mg capsules

Austria supplied in a box

Pamitor 15 mg/mL One clear glass ampoule concentrate for infusion Torrex-Pharma GmbH,

concentrate for infusion containing 4 mL of solution, YES YES solution Vienna, Austria

solution supplied in a box

Pamitor 15 mg/mL Polyethylene ampoule concentrate of solution Torrex-Pharma GmbH,

concentrate of solution for containing 2 mL of solution, YES YES for infusion Vienna, Austria

infusion supplied in a box

Pamitor 15 mg/mL A clear glass ampoule concentrate for infusion Torrex-Pharma GmbH,

concentrate for infusion containing 6 mL of solution, YES YES solution Vienna, Austria

solution supplied in a box

Pamitor 15 mg/mL Polyethylene ampoule concentrate of solution Torrex-Pharma GmbH,

concentrate of solution for containing 4 mL of solution, YES YES for infusion Vienna, Austria

infusion supplied in a box

Pamitor15 mg/mL Polyethylene ampoule concentrate of solution Torrex-Pharma GmbH,

concentrate of solution for containing 6 mL of solution, YES YES for infusion Vienna, Austria

infusion supplied in a box

Pamitor15 mg/mL One clear glass ampoule concentrate for infusion Torrex-Pharma GmbH,

concentrate for infusion containing 2 mL of solution, YES YES solution Vienna, Austria

solution supplied in a box

GlaxoSmithKline

Dungarvan Ltd.,

Knockbrack, 12 (1x12) tablets in a PVC/Al Panadol film coated tablets YES YES YES

Dungarvan, Co. blister, supplied in a box

Waterford, Republic of

Ireland

300 mL of suspension in an Glaxo Wellcome

amber glass bottle with a Production, Avenue du

plastic temper-evident Panadol Baby oral suspension General de Gaulle, YES YES YES

stopper and a plastic Herouville Saint Clair,

measuring device (0.5 mL to France

8 mL), supplied in a box

Glaxo Wellcome 100 mL of suspension in an

Production, Avenue du amber glass bottle with

Panadol Baby oral suspension General de Gaulle, plastic temper-proof closure YES YES YES

Herouville Saint Clair, and plastic dispenser (0.5 mL

France to 8 mL), supplied in a box

GlaxoSmithKline

Dungarvan Ltd.,

12 (1x12) tablets in PVC/Al

Knockbrack,

Panadol Extra film coated tablets blister, supplied in a carton YES YES YES

Dungarvan, Co.

box

Waterford, Republic of

Ireland

GlaxoSmith Kline

10 (1x10) tablets in a PVC/AI

Panadol Rapid film coated tablets Dungarvan Limited, YES YES YES

blister, supplied in a box

Republic of Ireland

capsules (with gastric Krka d.d., Šmarješka 20 capsules in an amber

Panaze 10000 capsules resistant microfilm cesta 6, Novo mesto, glass bottle, supplied in a YES YES

tablets) Republic of Slovenia box

2 mL of solution in a glass

Pancuronium injection BP solution for intravenous Rotexmedica GmbH, ampoule, 10 ampoules in a YES YES

4 mg injection Trittau, Germany box

Solvay

Pharmaceuticals 50 (2x25) tablets in a blister, Pankreoflat coated tablets YES YES YES

GmbH, Hannover, supplied in a box

Germany Jadran - Galenski 25 grams of cream in an laboratorij d.d., Pulac

Pantexol cream cream aluminium tube with plastic YES YES YES bb, Rijeka, Republic of

cap, supplied in a box Croatia

Jadran - Galenski

25 grams of ointment in an

laboratorij d.d., Pulac

Pantexol ointment ointment aluminium tube with plastic YES YES YES

bb, Rijeka, Republic of

cap, supplied in a box

Croatia

Jadran - Galenski 150 mL of syrup in an amber

Paracetamol JADRAN laboratorij d.d., Pulac glass bottle and a plastic syrup YES YES YES

syrup 150 mL bb, Rijeka, Republic of measuring glass, supplied in

Croatia a box

Paraplatin 150 mg/15 mL Bristol-Myers Squibb 15 mL of concentrate for concentrate of solution

concentrate for solution for S.r.l., Sermoneta, infusion solution in a glass YES YES for infusion

infusion Latina, Italy bottle, supplied in a box

Paraplatin 50 mg/5 mL Bristol-Myers Squibb 5 mL of solution for infusion concentrate of solution

concentrate for solution for S.r.l., Sermoneta, concentrate in a glass bottle, YES YES for infusion

infusion Latina, Italy supplied in a box

Box with one pre-filled Baxter AG,

syringe and a needle with

Partobulin SDF 1250 IU solution for injection Industriestrasse 67, A- YES one dose of 250 ug (1250 IU) 1220 Vienna, Austria

of preparation

Merz Pharma GmbH & 6 (1x6) pessaries in a

Patentex Oval N pessary Co KGaA, Frankfurt PVC/PVDC/PE strip, YES YES YES

am Main, Germany supplied in a box

N.V. Organon, Oss, the

Netherlands; Organon 50 ampoules with 2 mL of Pavulon 4 mg=2 mL solution for injection YES YES

S.A., Eragny Sur Epte, solution, supplied in a box

France

PEDIACEL vaccine

against diphtheria, tetanus, 0.5-mL of suspension in a

pertussis (acellular, five glass bottle (glass type I,

Sanofi Pasteur Limited, component), poliomyelitis suspension for injection Ph.Eur), with a bromobutyl YES

Toronto, Canada (inactivated) and stopper that does not contain

Haemofilus influenzae type latex, supplied in a box

B (conjugated), absorbed

F. Hoffmann-La Roche PEGASYS 135

Ltd., Box with 1 syringe containing micrograms of solution for

solution for injection Grenzacherstrasse 0.5 mL of solution and a YES YES YES YES injection in pre-filled

124, Basel, needle syringe

Switzerland

F. Hoffmann-La Roche PEGASYS 180

Ltd., Box with 1 syringe containing micrograms of solution for

solution for injection Grenzacherstrasse 0.5 mL of solution and a YES YES YES YES injection in pre-filled

124, Basel, needle syringe

Switzerland

Vial containing powder and

ampoule with diluent for Schering-Plough

solution for injection (Water

PegIntron 100 ug powder powder and diluent for (Brinny) Company, for Injection), one syringe for and diluent for injection preparation of solution for Innishannon, County YES YES YES

injection, two needles for

solution injection Cork, Republic of injection and one absorbent Ireland

cotton-wool roll, supplied in a

box

Syringe with cartridge

Schering-Plough containing powder and PegIntron 100 ug powder

powder and diluent for (Brinny) Company, diluent for solution for and diluent for solution for

solution for injection in a Innishannon, County injection (Water for injection), YES YES YES injection in syringe with

cartridge Cork, Republic of one injection needle and two cartridge

Ireland absorbent cotton wool rolls,

supplied in a box

Vial containing powder and Schering-Plough

ampoule with diluent for PegIntron 120 ug powder powder and diluent for (Brinny) Company,

solution for injection (Water

and diluent for injection preparation of solution Innishannon, County YES YES YES for Injection), one syringe for solution for injection Cork, Republic of

injection, two needles for Ireland

injection and one absorbent cotton-wool roll, supplied in a

box

Syringe with cartridge

Schering-Plough containing powder and PegIntron 120 ug powder

powder and diluent for (Brinny) Company, diluent for solution for and diluent for solution for

solution for injection in a Innishannon, County injection (Water for injection), YES YES YES injection in syringe with

cartridge Cork, Republic of one injection needle and two cartridge

Ireland absorbent cotton wool rolls,

supplied in a box

Vial containing powder and

ampoule with diluent for Schering-Plough

solution for injection (Water PegIntron 150 ug powder powder and diluent for (Brinny) Company,

for Injection), one syringe for and diluent for injection preparation of solution for Innishannon, County YES YES YES

injection, two needles for solution injection Cork, Republic of

injection and one absorbent Ireland

cotton-wool roll, supplied in a

box

Syringe with cartridge

Schering-Plough containing powder and PegIntron 150 ug powder

powder and diluent for (Brinny) Company, diluent for solution for and diluent for solution for

solution for injection in a Innishannon, County injection (Water for injection), YES YES YES injection in syringe with

cartridge Cork, Republic of one injection needle and two cartridge

Ireland absorbent cotton wool rolls,

supplied in a box

Vial containing powder and

ampoule with diluent for Schering-Plough

solution for injection (Water PegIntron 50 ug powder powder and diluent for (Brinny) Company,

for Injection), one syringe for and diluent for injection preparation of solution for Innishannon, County YES YES YES

injection, two needles for solution injection Cork, Republic of

injection and one absorbent Ireland

cotton-wool roll, supplied in a

box

Syringe with cartridge

Schering-Plough containing powder and PegIntron 50 ug powder

powder and diluent for (Brinny) Company, diluent for solution for and diluent for solution for

solution for injection in a Innishannon, County injection (Water for injection), YES YES YES injection in syringe with

cartridge Cork, Republic of one injection needle and two cartridge

Ireland absorbent cotton wool rolls,

supplied in a box

Vial containing powder and

ampoule with diluent for Schering-Plough

solution for injection (Water PegIntron 80 ug powder powder and diluent for (Brinny) Company,

for Injection), one syringe for and diluent for injection preparation of solution for Innishannon, County YES YES YES

injection, two needles for solution injection Cork, Republic of

injection and one absorbent Ireland

cotton-wool roll, supplied in a

box

Syringe with cartridge

Schering-Plough containing powder and PegIntron 80 ug powder

powder and diluent for (Brinny) Company, diluent for solution for and diluent for solution for

solution for injection in a Innishannon, County injection (Water for injection), YES YES YES injection in syringe with

cartridge Cork, Republic of one injection needle and two cartridge

Ireland absorbent cotton wool rolls,

supplied in a box

Pliva Croatia Ltd., Ulica 50 colourless glass bottles

powder for solution for grada Vukovara 49, Penbritin injection 1 g with powder, supplied in a YES YES

injection Zagreb, Republic of box

Croatia

Pliva Croatia Ltd., Ulica 50 colourless glass bottles

powder for solution for grada Vukovara 49, Penbritin injection 500 mg with powder, supplied in a YES YES

injection Zagreb, Republic of box

Croatia

Pliva Croatia Ltd., Ulica 20 (2x10) film coated tablets

film coated tablets with grada Vukovara 49, Pentamon in a (PVC/Al) blister, supplied YES YES

prolonged-release Zagreb, Republic of in a box

Croatia

28 (4x7) suppositories in an

Ferring A/S, Vanlose,

Pentasa 1 g suppositories suppositories aluminium blister, supplied in YES YES

Denmark

a box

7 individually packed

containers (in bags) with 100

Ferring-Lečiva a.s., mL of suspension and an Pentasa 1 g suspension suspension for rectal

Jesenice u Prahy, application attachment, in a YES YES for rectal administration administration

Czech Republic protective bag and 7 plastic

hygiene bags, supplied in a

box

Ferring A/S, Vanlose,

Denmark; Ferring 100 (10x10) tablets in

Pentasa 500 mg tablets prolonged release tablets Intercontinental Center auminum blisters, supplied in YES YES

SA, St-Prex, a box

Switzerland

PENTAXIM, diphtheria,

Box with a glass bottle with

tetanus, pertussis powder and suspension Sanofi Pasteur S.A., 2 powder and a glass syringe

(acellular), poliomyelitis for suspension for avenue Pont Pasteur, with 0.5 mL of suspension YES

(inactivated), and injection Lyon, France with a needle and a needle

Haemophilus influenzae protection

type B conjugated vaccine

Krka d.d., Šmarješka 5 mL of solution for injection PENTILIN solution for

solution for injection cesta 6, Novo mesto, in a glass ampoule, 5 YES YES injection 100 mg/5 mL

Republic of Slovenia ampoules in a box

Krka d.d., Šmarješka 20 (2x10) prolonged-release

PENTILIN tablets 400 mg prolonged-release tablets cesta 6, Novo mesto, tablets in PVC/Al blister, YES YES

Republic of Slovenia supplied in a box

Pliva Croatia Ltd., Ulica

10 (1x10) film coated tablets

grada Vukovara 49,

Peptoran 75 tablets film coated tablets in a OPA/Al/PVC//Al blister, YES YES YES

Zagreb, Republic of

supplied in a box

Croatia

One glass vial with 100 mL of Bristol-Myers Squibb,

solution for infusion, 12 vials 304, avenue du Dr

Perfalgan 10 mg/mL solution for infusion in a transparent protective YES YES YES YES

Jean Bru, Agen,

container (polyethylene with

France

thermo film)

One glass vial with 50 mL of Bristol-Myers Squibb,

solution for infusion, 12 vials 304, avenue du Dr

Perfalgan 10 mg/mL solution for infusion in a transparent protective YES YES YES YES

Jean Bru, Agen,

container (polyethylene with

France

thermo film)

Boehringer Ingelheim 50 coated tablets in a white

Persantin 75 mg coated France, 12, Rue Andre plastic container (PP) with a coated tablets YES YES

tablets Huet, Reims, Cedex, white stopper (PE), supplied

France in a box

Lek farmacevtska

družba d.d., Box with 40 sugar coated Persen sugar-coated

sugar-coated tablets Verovškova 57, tablets (blister, 4x10 sugar YES YES tablets

Ljubljana, Republic of coated tablets)

Slovenia

Lek farmacevtska 20 (2x10) capsules in a

Persen forte capsules capsules, hard družba d.d., Ljubljana, (PVC/PCTFE//Al) blister, YES YES

Republic of Slovenia supplied in a box

Lek farmacevtska

družba d.d.,

Box with 20 capsules (blister,

Persen forte capsules capsules Verovškova 57, YES YES

2x10 capsules)

Ljubljana, Republic of

Slovenia

Lek farmacevtska 40 (4x10) coated tablets in a

Persen tablets coated tablets družba d.d., Ljubljana, blister (PVC/TE/PVDC//Al), YES YES

Republic of Slovenia supplied in a box

Pliva Croatia Ltd., Ulica 5 ampoules with powder and powder (lyophilisate) and

Phenobarbiton sodium grada Vukovara 49, 5 ampoules each with 2 mL diluent for preparation of YES YES

injection Zagreb, Republic of of solvent (water for injections

Croatia injection), supplied in a box Pliva Croatia Ltd., Ulica 10 (1x10) tablets in an

PHENOBARBITON PLIVA grada Vukovara 49, tablets orange blister (PVC/Al), YES YES

100 mg tablets Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 30 (3x10) tablets in an

PHENOBARBITON grada Vukovara 49, tablets orange blister (PVC/Al), YES YES

PLIVA15 mg tablets Zagreb, Republic of supplied in a box

Croatia

Alkaloid AD - Skopje, 20 capsules in an amber

PHOLCODIN 10 mg Bulevar Aleksandar capsules glass bottle, supplied in a YES YES

capsules Makedonski 12, box

Skopje, FYROM

150 mL of solution in an Alkaloid AD - Skopje,

amber glass bottle with PHOLCODIN 15 mg/15 Bulevar Aleksandar

oral solution plastic closure and 15-mL YES YES mL oral solution Makedonski 12,

plastic dispenser, supplied in Skopje, FYROM

a box

60 mL of solution in an Alkaloid AD - Skopje,

amber glass bottle with a

PHOLCODIN 4 mg/5 mL Bulevar Aleksandar oral solution plastic stopper and a plastic YES YES

oral solution for children Makedonski 12, measuring unit of 2.5 mL, Skopje, FYROM

supplied in a box

Solvay

28 (1x28) film coated tablets

Pharmaceuticals

Physiotens 0.2 film coated tablets in a PVC/PVDC/Al blister, YES YES

S.A.S., Châtillon sur

supplied in a box

Chalaronne, France

Solvay

28 (1x28) film coated tablets

Pharmaceuticals

Physiotens 0.4 film coated tablets in a PVC/PVDC/Al blister, YES YES

S.A.S., Châtillon sur

supplied in a box

Chalaronne, France

Jadran -Galenski

laboratorij d.d., Rijeka

28 (4x7) tablets in a blister,

Pigrel film coated tablets in cooperation with YES YES

supplied in a box

Krka Farma d.o.o.,

Zagreb

Bosnalijek d.d.,

60 mL of lotion in an amber

Jukićeva 53, Sarajevo,

Pilfud 2% lotion lotion glass bottle, supplied in a YES YES YES

Bosnia and

box

Herzegovina

Bosnalijek d.d., 60 mL of solution in a plastic

Jukićeva 53, Sarajevo, bag with a spray pump and a Pilfud 5% lotion skin spray, solution YES YES YES

Bosnia and temper-evident stopper,

Herzegovina supplied in a box

LEK S.A., Stryków,

28 (7x4) tablets in a strip ,

Piramil 1.25 mg tablets tablets Poland; LEK S.A., YES YES

supplied in a box

Warszawa, Poland

LEK S.A., Stryków,

28 (7x4) tablets in a blister,

Piramil 10 mg tablets tablets Poland; LEK S.A., YES YES

supplied in a box

Warszawa, Poland

LEK S.A., Stryków,

28 (7x4) tablets in a blister,

Piramil 2.5 mg tablets tablets Poland; LEK S.A., YES YES

supplied in a box

Warszawa, Poland

LEK S.A., Stryków,

28 (7x4) tablets in a blister,

Piramil 5 mg tablets tablets Poland; LEK S.A., YES YES

supplied in a box

Warszawa, Poland

Trešnjevka laboratorij

"Planinski čaj" - herbal d.o.o., Jukićeva 32, 75 g of tea in a plastic (PP) herbal laxative tea YES YES

laxative tea Zagreb, Republic of bag, supplied in a box

Croatia

20 mL of infusion solution

Platinex 10 mg/20 mL Bristol-Myers Squibb concentrate for infusion concentrate in an amber

concentrate for infusion S.r.l., Sermoneta, YES YES solution glass bottle, supplied in a

solution Latina, Italy box

100 mL of concentrate for

Platinex 50 mg/100 mL Bristol-Myers Squibb concentrate for infusion infusion solution in an amber

concentrate for infusion S.r.l., Sermoneta, YES YES solution glass bottle, supplied in a

solution Latina, Italy box

Sanofi Winthrop

28 (2x14) film coated tablets

Industrie, Ambares et

Plavix film coated tablets in a blister (Al/Al), supplied in YES YES YES

Lagrave, Carbon Blanc

a box

Cedex, France

Pliva Croatia Ltd., Ulica

10 (1x10) film coated tablets

grada Vukovara 49,

PLICET EFFECT tablets film coated tablets in an orange PVC/PVDC//Al YES YES YES

Zagreb, Republic of

blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

100 mL of syrup in an amber

grada Vukovara 49,

Plicet syrup syrup glass bottle and a 5-mL YES YES YES

Zagreb, Republic of

spoon, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 20 (2x10) tablets in PVC/Al Plicet tablets tablets YES YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 10 (1x10) tablets in a PVC/Al Plicet tablets tablets YES YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 20 grams of cream in an

grada Vukovara 49, Plimycol cream cream aluminium tube, supplied in a YES YES

Zagreb, Republic of box

Croatia

Pliva Croatia Ltd., Ulica 10 (1x10) tablets in an

grada Vukovara 49, orange blister PLIVADON tablets YES YES YES

Zagreb, Republic of (PVC/PVDC//Al), supplied in

Croatia a box

Pliva Croatia Ltd., Ulica

1-mL of solution for injection

PLIVIT B1 injection 100 grada Vukovara 49,

solution for injection in a glass ampoule, 50 YES YES

mg Zagreb, Republic of

ampoules in a box

Croatia

Pliva Croatia Ltd., Ulica

2 mL of solution for injection

PLIVIT B1 injection 250 grada Vukovara 49,

solution for injection in a glass ampoule , 50 YES YES

mg Zagreb, Republic of

ampoules in a box

Croatia

Pliva Croatia Ltd., Ulica

20 (2x10) tablets in a blister

grada Vukovara 49,

PLIVIT B1 tablets tablets (PVC/PVDC//Al), supplied in YES YES YES

Zagreb, Republic of

a box

Croatia

Pliva Croatia Ltd., Ulica

5 mL of solution for injection

PLIVIT B6 injection 250 grada Vukovara 49,

solution for injection in an amber glass ampoule, YES YES

mg Zagreb, Republic of

50 ampoules in a box

Croatia

Pliva Croatia Ltd., Ulica

2 mL of solution for injection

grada Vukovara 49,

PLIVIT B6 injection 50 mg solution for injection in an amber glass ampoule , YES YES

Zagreb, Republic of

50 ampoules in a box

Croatia

Pliva Croatia Ltd., Ulica

20 (2x10) tablets in a blister

grada Vukovara 49,

PLIVIT B6 tablets tablets (PVC/PVDC//Al), supplied in YES YES YES

Zagreb, Republic of

a box

Croatia

Pliva Croatia Ltd., Ulica 10 effervescent tablets in a PLIVIT C 1000 mg sugargrada

Vukovara 49, polypropylene tube (cap with free effervescent tablets, effervescent tablets YES YES YES

Zagreb, Republic of silicagel and tamper-proof lemon flavoured

Croatia ring), supplied in a box

Pliva Croatia Ltd., Ulica 10 effervescent tablets in a PLIVIT C 1000 mg sugargrada

Vukovara 49, polypropylene tube (cap with free effervescent tablets, effervescent tablets YES YES YES

Zagreb, Republic of silicagel and tamper-proof lemon flavoured

Croatia ring), supplied in a box

Pliva Croatia Ltd., Ulica 30 (3x10) tablets in a

grada Vukovara 49, PLIVIT C tablets 50 mg tablets PVC/PVDC//Al blister, YES YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 20 (2x10) tablets in a blister

PLIVIT C tablets 500 mg tablets grada Vukovara 49, (PVC/PVDC//Al), supplied in YES YES YES

Zagreb, Republic of a box Croatia

Pliva Croatia Ltd., Ulica 10 (1x10) prolonged-release

PLIVIT C 500 mg film coated prolongedgrada Vukovara 49, film coated tablets in a

YES YES YES prolonged-release tablets release tablets Zagreb, Republic of PVC/PVDC//Al blister,

Croatia supplied in a box

Pliva Croatia Ltd., Ulica 10 mL of solution in an

grada Vukovara 49, amber glass bottle with Plivit D3 oral drops, solution YES YES

Zagreb, Republic of plastic dropper attachment,

Croatia supplied in a box

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 3 vaginal tablets in a blister, Plymicol vaginal tablets vaginal tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

PNEUMO 23 Sanofi Pasteur S.A., 2 Box with 1 glass syringe

Pneumococcal solution for injection avenue Pont Pasteur, containing 0.5 mL of vaccine YES

polysaccharide vaccine Lyon, France and a needle with protection

Poliosabin (Oral) trovalent

GlaxoSmithKline live, attenuated vaccine

Biologicals s.a., Rue Box with 25 plastic tubes with against poliomyelitis, oral suspension YES

de lInstitut 89, one vaccine dose Sabin strain, stabilized in

Rixensart, Belgium MgCl

Pliva Croatia Ltd., Pollinex tree, extract of One 1.5 mL of suspension in

Zagreb, Republic of birch, hazel and alder tree suspension for a glass vial, 3 glass syringes

Croatia and Allergy YES pollen for specific subcutaneous injection and 4 needles for injection,

Therapeutics Ltd., immunotherapy supplied in a box

Worthing, Great Britain

Pliva Croatia Ltd., Pollinex tree, extract of 3 red glass syringes each

Zagreb, Republic of birch, hazel and alder tree suspension for containing 0.5 mL of

Croatia and Allergy YES pollen for specific subcutaneous injection suspension and 4 needles for

Therapeutics Ltd., immunotherapy injection, supplied in a box

Worthing, Great Britain

Pliva Croatia Ltd., Pollinex tree, extract of 3 glass syringes each

Zagreb, Republic of birch, hazel and alder tree suspension for containing 0.5 mL of

Croatia and Allergy YES pollen for specific subcutaneous injection suspension and 4 needles for

Therapeutics Ltd., immunotherapy injection, supplied in a box

Worthing, Great Britain

Pliva Croatia Ltd., 3 glass bottles each Pollinex tree, extract of

Zagreb, Republic of containing 1 mL of birch, hazel and alder tree suspension for

Croatia and Allergy suspension, 5 syringes and 6 YES pollen for specific subcutaneous injection

Therapeutics Ltd., needles for injection, immunotherapy

Worthing, Great Britain supplied in a box

Pliva Croatia Ltd., Pollinex tree, extract of One 1.5 mL of suspension in

Zagreb, Republic of birch, hazel and alder tree suspension for a glass vial, 3 glass syringes

Croatia and Allergy YES pollen for specific subcutaneous injection and 4 needles for injection,

Therapeutics Ltd., immunotherapy supplied in a box

Worthing, Great Britain

Pliva Croatia Ltd., 4 glass syringes each

Pollinex grass and rye, Zagreb, Republic of suspension for containing 0.5 mL of

extract of grass and rye for Croatia and Allergy YES subcutaneous injection suspension and 4 needles for

specific immunotherapy Therapeutics Ltd., injection, supplied in a box Worthing, Great Britain

Pliva Croatia Ltd., 4 glass bottles each

Pollinex grass and rye, Zagreb, Republic of containing 1 mL of suspension for

extract of grass and rye for Croatia and Allergy suspension, 5 syringes and 6 YES subcutaneous injection

specific immunotherapy Therapeutics Ltd., needles for injection,

Worthing, Great Britain supplied in a box

Pliva Croatia Ltd., 5 glass syringes each

Pollinex grass and rye, Zagreb, Republic of suspension for containing 0.5 mL of

extract of grass and rye for Croatia and Allergy YES subcutaneous injection suspension and 4 needles for

specific immunotherapy Therapeutics Ltd., injection, supplied in a box Worthing, Great Britain

Lek farmacevtska

družba d.d.,

28 (4x7) capsules in a blister,

Portal 20 mg capsules capsules Verovškova 57, YES YES

supplied in a box

Ljubljana, Republic of

Slovenia Lek farmacevtska

družba d.d.,

14 (2x7) capsules in a blister,

Portal 20 mg capsules capsules Verovškova 57, YES YES

supplied in a box

Ljubljana, Republic of

Slovenia

Belupo, lijekovi i

20 bags (PET/Al/PE) with à

kozmetika d.d., Ulica

Portalak syrup syrup 15 mL of syrup, supplied in a YES YES YES

Danica 5, Koprivnica,

box

Republic of Croatia

Belupo, lijekovi i

5 (PET/Al/PE) bags each

kozmetika d.d., Ulica

Portalak syrup syrup with 15 mL of syrup, supplied YES YES YES

Danica 5, Koprivnica,

in a box

Republic of Croatia

Belupo, lijekovi i

250-mL of syrup in a plastic

kozmetika d.d., Ulica

Portalak syrup syrup bottle with screw cap, YES YES YES

Danica 5, Koprivnica,

supplied in a box

Republic of Croatia

Pliva Croatia Ltd., Ulica 50 sugar coated tablets

Prazine sugar-coated grada Vukovara 49, sugar-coated tablets (5x10) in a blister, supplied in YES YES

tablets 100 mg Zagreb, Republic of a box

Croatia

Pliva Croatia Ltd., Ulica 50 sugar coated tablets

Prazine sugar-coated grada Vukovara 49, sugar-coated tablets (5x10) in a blister, supplied in YES YES

tablets 25 mg Zagreb, Republic of a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, Box with 10 ampoules with 2 Prazine injection 100 mg solution for injection YES YES

Zagreb, Republic of mL of solution

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, Box with 10 ampoules with 1 Prazine injection 50 mg solution for injection YES YES

Zagreb, Republic of mL of solution

Croatia

Les Laboratories

Servier Industrie, 905 60 (2x30) tablets in a PVX/Al Preductal film coated tablets YES YES

route de Saran, 45520 blister, supplied in a box

Gidy, France

Krka d.d., Novo mesto,

Republic of Slovenia; 30 (3x10) tablets in

PRENESSA tablets 4 mg tablets KRKA Polska PVC/PE/PVDC//Al blister, YES YES YES YES

Sp.z.o.o., Warszawa, supplied in a box

Poland

One glass vial with 0.5 mL of

Prevenar S. Pneumoniae John Wyeth & Brother vaccine suspension, one

saccharide conjugated suspension for injection Ltd., Hants, Great YES syringe and two needles, vaccine, absorbed Britain

supplied in a box

Prevenar, saccharide,

John Wyeth & Brother 10 syringes with 0.5 mL of conjugated and absorbed

suspension for injection Ltd., Hants, Great vaccine suspension, supplied YES vaccine against S.

Britain in a box pneumoniae

Prevenar S. Pneumoniae John Wyeth & Brother One syringe with 0.5 mL of

saccharide conjugated suspension for injections Ltd., Hants, Great vaccine suspension, supplied YES

vaccine, absorbed Britain in a box

One syringe with 0.5 mL of

Prevenar S. Pneumoniae John Wyeth & Brother vaccine suspension, with saccharide conjugated suspension for injections Ltd., Hants, Great YES

separate needle, supplied in

vaccine, absorbed Britain a box

Prevenar S. Pneumoniae John Wyeth & Brother One glass vial with 0.5 mL of

saccharide conjugated suspension for injection Ltd., Hants, Great vaccine suspension, supplied YES

vaccine, absorbed Britain in a box

Les Laboratoires

Servier Industrie, Gidy,

France; Servier

30 (1x30) tablets in a blister

Prexanil 4 mg tablets Republic of Ireland YES YES

(PVC/Al), supplied in a box

Industries Ltd.,

Arcklow, Co. Wicklow,

Republic of Ireland Les Laboratoires

Servier Industrie, Gidy,

France; Servier

30 (1x30) tablets in a blister

PREXANIL 8 mg tablets tablets Republic of Ireland YES YES

(PVC/Al), supplied in a box

Industries Ltd.,

Arcklow, Co. Wicklow,

Republic of Ireland

Les Laboratoires

Servier Industrie, Gidy,

France; Servier

30 (1x30) tablets in a blister

Prexanil Combi tablets Republic of Ireland YES YES

(PVC/Al), supplied in a box

Industries Ltd.,

Arcklow, Co. Wicklow,

Republic of Ireland

Schering GmbH und

20 tablets in an amber glass

Co. Produktions KG,

Primolut-Nor tablets tablets bottle, supplied in a carton YES YES

Doebereinerstrasse 20,

box

Weimar, Germany

Fitofarmacija d.o.o.,

14 bags each containing 5 g

Primus tea tea Zagreb, Republic of YES YES

of tea, supplied in a box

Croatia

Merck Sharp & Dohme

B.V., Waarderweg 39, 28 (2x14) tablets in a blister, Prinivil 10 mg tablets tablets YES YES

Postbus 581, Haarlem, supplied in a box

the Netherlands

Merck Sharp & Dohme

B.V., Waarderweg 39, 28 (2x14) tablets in a blister, Prinivil 20 mg tablets tablets YES YES

Postbus 581, Haarlem, supplied in a box

the Netherlands

Merck Sharp & Dohme

B.V., Waarderweg 39, 28 (2x14) tablets in a blister, Prinivil 5 mg tablets tablets YES YES

Postbus 581, Haarlem, supplied in a box

the Netherlands

Merck Sharp & Dohme

Prinzide 20/12.5 mg B.V., Waarderweg 39, 28 (2x14) tablets in a PVC/Al tablets YES YES

tablets Postbus 581, Haarlem, blister, supplied in a box

the Netherlands

Vial containing single dose of

lyophilised vaccine (powder),

PRIORIX, combined, live GlaxoSmithKline syringe with pre-filled 0.5 mL lyophilized vaccine against powder and diluent for Biologicals s.a., Rue

of diluent, Water for YES YES YES YES morbilli, parotitis and solution for injection de lInstitut 89,

injection, and two needles

rubella Rixensart, Belgium with protective caps, supplied

in a box

SmithKline Beecham

28 (4x7) tablets in a blister

Pharmaceuticals,

PRITOR 40 mg tablets tablets (PA/Al/PVC//Al), supplied in YES YES YES YES

Crawley, West Sussex,

a box

Great Britain

SmithKline Beecham

28 (4x7) tablets in a blister

Pharmaceuticals,

PRITOR 80 mg tablets tablets (PA/Al/PVC//Al), supplied in YES YES YES YES

Crawley, West Sussex,

a box

Great Britain

SmithKline Beecham

28 (4x7) tablets in a blister

PritorPlus 40/12.5 mg Pharmaceuticals,

tablets (OPA/Al/PVC/Al blister), YES YES YES

tablets Crawley, West Sussex,

supplied in a box

Great Britain

SmithKline Beecham

28 (4x7) tablets in a blister

PritorPlus 80/12.5 mg Pharmaceuticals,

tablets (OPA/Al/PVC/Al blister), YES YES YES

tablets Crawley, West Sussex,

supplied in a box

Great Britain

Les Laboratoires

Servier Industrie, 905

route de Saran, 45520 29 (2x14) film coated tablets Procoralan 5 mg film

film coated tablets Gidy, France; Servier in a PVC/Al blister, supplied YES YES YES YES coated tablets

(Republic of Ireland) in a carton box

Industries Ltd., Gorey

Road, Arklow, Co.

Wicklow, Republic of

Ireland;

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 Ltd., Gorey

30 (2x14) film coated tablets

Procoralan 7.5 mg film Road, Arklow, Co.

film coated tablets in a PVC/Al blister, supplied YES YES YES YES

coated tablets Wicklow, Republic of

in a carton box

Ireland;

Przedsiebiorstwo

Farmaceutyczne

Anpharm S.A., Ul.

Annopol 603-236,

Warszava, Poland

STADA Arzneimittel 20 grams of ointment in an

Proctosan ointment AG, Stadtstraße 2-18, aluminum tube with a plastic YES YES YES

Bad Vilbel, Germany cap, supplied in a box

STADA Arzneimittel 10 (2x5) suppositories in a

Proctosan forte suppositories AG, Stadtstraße 2-18, strip (PVC/LDPE foil), YES YES YES

Bad Vilbel, Germany supplied in a box

10 mL of solution in an Alkaloid AD - Skopje,

amber glass bottle and Bulevar Aleksandar

Proculin eye drops, solution plastic sterile dropper YES YES

Makedonski 12,

attachment in a protective

Skopje, FYROM

plastic bag, supplied in a box

Pro. Med.CS Praha

Pro-famosal 20 mg coated tablets a.s., Prag, Czech Box with 20 tablets (blister) YES YES

Republic

Pro. Med.CS Praha

Pro-famosal 20 mg coated tablets a.s., Prag, Czech Box with 20 tablets (blister) YES YES

Republic

Pro. Med.CS Praha

Pro-famosal 40 mg coated tablets a.s., Prag, Czech Box with 10 tablets (blister) YES YES

Republic

Pro. Med.CS Praha

Pro-famosalL 40 mg coated tablets a.s., Prag, Czech Box with 10 tablets (blister) YES YES

Republic

30 (3x10) capsules in a Astellas Republic of

blister (PVC/PVDC//Al), in Ireland Co. Ltd.,

Prograf capsules 0.5 mg capsules, hard protective aluminum YES YES YES

Killorglin, Republic of envelope with desiccant,

Ireland supplied in a box

Astellas Republic of 60 (6x10) capsules in a

Ireland Co. Ltd., blister, in protective Prograf capsules 1 mg capsules YES YES YES

Killorglin, Republic of aluminium foil, supplied in a

Ireland box

Astellas Republic of 30 (3x10) capsules in a

Ireland Co. Ltd., blister, in protective Prograf capsules 5 mg capsules YES YES YES

Killorglin, Republic of aluminum envelope, supplied

Ireland in a box

Jadran - Galenski

Prolax suppositories for laboratorij d.d., Pulac 10 (2x5) suppositories in a suppositories YES YES YES

children bb, Rijeka, Republic of Al/PE strip, supplied in a box

Croatia

Jadran - Galenski

Prolax suppositories for laboratorij d.d., Pulac 10 (2x5) suppositories in a suppositories YES YES YES

children bb, Rijeka, Republic of Al/PE strip, supplied in a box

Croatia

Propafenon Alkaloid 150 Alkaloid AD - Skopje, 50 tablets in an amber glass film coated tablets YES YES

mg film coated tablets Bulevar Aleksandar bottle with an aluminium

Makedonski 12, stopper, supplied in a box

Skopje, FYROM

Alkaloid AD - Skopje, Propafenon Alkaloid 35 10 (2x5) ampoules each

Bulevar Aleksandar mg/10 mL solution for solution for injection containing 10 mL of solution, YES YES

Makedonski 12, injection supplied in a box

Skopje, FYROM

Genericon Pharma

50 (5x10) film coated tablets

Propafenon Genericon Ges.m.b.H.,

film coated tablets in a blister (PVC/Al), supplied YES YES

150 mg film coated tablets Hafnerstrasse 211,

in a box

Graz, Austria

Genericon Pharma

50 (5x10) film coated tablets

Propafenon Genericon Ges.m.b.H.,

film coated tablets in a blister (PVC/Al), supplied YES YES

300 mg film coated tablets Hafnerstrasse 211,

in a box

Graz, Austria

Merck Sharp & Dohme

B.V., Waarderweg 39, 28 (4x7) tablets in a Alu/Alu Propecia 1 mg film coated tablets YES YES

Postbus 581, Haarlem, blister, supplied in a box

the Netherlands

Alkaloid AD - Skopje,

20 tablets in an amber glass

Propiltiouracil Alkaloid 50 Bulevar Aleksandar

tablets bottle, supplied in a carton YES YES

mg Makedonski 12,

box

Skopje, FYROM

Lek farmacevtska

družba d.d., Propranolol Lek 40 mg 50 tablets in a glass bottle,

tablets Verovškova 57, YES YES tablets supplied in a box

Ljubljana, Republic of

Slovenia

Merck Sharp & Dohme

B.V., Waarderweg 39, 28 (2x14) tablets in a blister, Proscar 5 mg film coated tablets YES YES

Postbus 581, Haarlem, supplied in a box

the Netherlands

Engelhard Arzneimittel 10 effervescent tablets in a

Prospan acute GmbH & Co.KG, plastic tube (desiccant in effervescent tablets YES YES

effervescent tablets Niederdorfelden, polyethylene cap), supplied

Germany in a box

Engelhard Arzneimittel

GmbH & Co.KG, 30 bags each with 5 mL of Prospan Liquid oral solution YES YES

Niederdorfelden, solution, supplied in a box

Germany

100 mL of solution in an

Engelhard Arzneimittel amber glass bottle with

GmbH & Co.KG, plastic extensionattachment, Prospan oral solution oral solution YES YES

Niederdorfelden, screw cap and 10 mL

Germany measuring glass, supplied in

a box

Belupo, lijekovi i 20 (1x20) tablets in a

kozmetika d.d., Ulica Prospera 1 mg tablets tablets PVC/PE/PVDC/Al blister, YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i 20 (1x20) tablets in a

kozmetika d.d., Ulica Prospera 2 mg tablets tablets PVC/PE/PVDC/Al blister, YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i 20 (1x20) tablets in a

kozmetika d.d., Ulica Prospera 3 mg tablets tablets PVC/PE/PVDC/Al blister, YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i 20 (1x20) tablets in a

kozmetika d.d., Ulica Prospera 4 mg tablets tablets PVC/PE/PVDC/Al blister, YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i 28 (1x28) tablets in a

kozmetika d.d., Ulica transparent blister Protecta 10 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, (PVC/PE/PVDC//Al),

Republic of Croatia supplied in a box Belupo, lijekovi i 28 (2x14) tablets in a

kozmetika d.d., Ulica transparent blister Protecta 20 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, (PVC/PE/PVDC//Al),

Republic of Croatia supplied in a box

Belupo, lijekovi i 29 (2x14) tablets in a

kozmetika d.d., Ulica transparent blister Protecta 40 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, (PVC/PE/PVDC//Al),

Republic of Croatia supplied in a box

Pfizer Italia S.r.l.,

30 (3x10) tablets in a blister

PROVERA tablets 10 mg tablets Marina De Tronto, YES YES

(PVC/Al), supplied in a box

Ascoli Piceno, Italy

Pfizer Italia S.r.l., 24 tablets in an amber glass

PROVERA tablets 5 mg tablets Marina De Tronto, bottle with plastic cap, YES YES

Ascoli Piceno, Italy supplied in a box

Eli Lilly and Company 14 (1x14) capsules in a

Limited, Basingstoke, Prozac 20 mg capsules capsules blister (PVC/Al), supplied in a YES YES

Hampshire, Great box

Britain

Lilly, S.A., Avendia de

14 (1x14) tablets in a blister

Prozac dispersible tablets la Industria 30,

freely dispersible tablets (PVC/PE/Aclar//Al), supplied YES YES

20 mg Alcobendas, Madrid,

in a box

Spain

Lilly, S.A., Avendia de

la Industria 30,

70 mL of oral solution in an

Alcobendas, Madrid,

amber glass bottle and a

Prozac Liquid 20 mg/5 mL Spain; Patheon

oral solution plastic measuring cup (with a YES YES

oral solution France, 40, boulevard

5 mL graduate line), supplied

de Champaret,

in a box

Bourgoin-Jallieu,

France

Dr. August Wolff 100 grams of solution in a

GmbH & Co. plastic (HDPE) bottle with Psorimed dermal solution YES YES

Arzneimittel, Bielefeld, applicator-shaped PP cap,

Germany supplied in a box

F. Hoffmann-La Roche

2.5 mL of solution in a plastic

Ltd.,

(polyethylene) ampoule, 6

Pulmozyme solution for inhalation Grenzacherstrasse YES YES

ampoules in a protective foil,

124, Basel,

supplied in a box

Switzerland

Cedevita d.o.o.,

Purisan granules granules Zagreb, Republic of 14 bags in a box YES YES

Croatia

Krka d.d., Šmarješka 100 tablets in an amber PYRAZINAMID Krka

tablets cesta 6, Novo mesto, glass bottle with aluminum YES YES tablets 500 mg

Republic of Slovenia cap, supplied in a box

Farmal d.d., Branitelja 28 (4x7) tablets in a

domovinskog rata 8, Ramipril 10 mg tablets tablets Al/OPA/PVC/Al blister, YES YES

Ludbreg, Republic of supplied in a box

Croatia

Farmal d.d., Branitelja 28 (4x7) tablets in a

domovinskog rata 8, Ramipril 2.5 mg tablets tablets Al/OPA/PVC/Al blister, YES YES

Ludbreg, Republic of supplied in a box

Croatia

Farmal d.d., Branitelja 28 (4x7) tablets in a

domovinskog rata 8, Ramipril 5 mg tablets tablets Al/OPA/PVC/Al blister, YES YES

Ludbreg, Republic of supplied in a box

Croatia

Farmal d.d., Branitelja 28 (4x7) tablets in a

Ramipril H 2.5mg/12.5 mg domovinskog rata 8, tablets Al/OPA/PVC/Al blister, YES YES

tablets Ludbreg, Republic of supplied in a box

Croatia

Farmal d.d., Branitelja 28 (4x7) tablets in a

Ramipril H 5 mg/25 mg domovinskog rata 8, tablets Al/OPA/PVC/Al blister, YES YES

tablets Ludbreg, Republic of supplied in a box

Croatia Pliva Croatia Ltd., Ulica 30 (3x10) tablets in a blister

RAMIPRIL PLIVA 10 mg grada Vukovara 49, tablets (Al/OPA//PVC/Al), supplied in YES YES

tablets Zagreb, Republic of a box

Croatia

Pliva Croatia Ltd., Ulica

30 (3x10) tablets in a blister

RAMIPRIL PLIVA 2.5 mg grada Vukovara 49,

tablets (Al/OPA//PVC/Al), supplied in YES YES

tablets Zagreb, Republic of

a box

Croatia

Pliva Croatia Ltd., Ulica

30 (3x10) tablets in a blister

RAMIPRIL PLIVA 5 mg grada Vukovara 49,

tablets (Al/OPA//PVC/Al), supplied in YES YES

tablets Zagreb, Republic of

a box

Croatia

Pliva Croatia Ltd., Ulica

30 (3x10) tablets in a blister

RAMIPRIL PLUS PLIVA grada Vukovara 49,

tablets (Al/OPA//PVC/Al), supplied in YES YES

2.5/12.5 mg tablets Zagreb, Republic of

a box

Croatia

Pliva Croatia Ltd., Ulica

30 (3x10) tablets in a blister

RAMIPRIL PLUS PLIVA grada Vukovara 49,

tablets (Al/OPA//PVC/Al), supplied in YES YES

5/25 mg tablets Zagreb, Republic of

a box

Croatia

Pro. Med.CS Praha

20 (2x10) tablets in a blister,

Ranisan 150 mg film coated tablets a.s., Prague, Czech YES YES

supplied in a box

Republic

Pro. Med.CS Praha

60 (6x10) tablets in a blister

Ranisan 150 mg film coated tablets a.s., Prague, Czech YES YES

(Al/Al), supplied in a box

Republic

Pro. Med.CS Praha

20 (2x10) tablets in a blister

Ranisan 150 mg film coated tablets a.s., Prague, Czech YES YES

(Al/Al), supplied in a box

Republic

Pro. Med.CS Praha

30 (3x10) tablets in a blister

Ranisan 150 mg film coated tablets a.s., Prague, Czech YES YES

(Al/Al), supplied in a box

Republic

Pro. Med.CS Praha

10 (1x10) tablets in a blister,

Ranisan 75 mg film coated tablets a.s., Prague, Czech YES YES YES

supplied in a box

Republic

Pro. Med.CS Praha

10 (1x10) tablets in a Al/Al

Ranisan 75 mg film coated tablets a.s., Prague, Czech YES YES YES

blister, supplied in a box

Republic

Farmal d.d., Ludbreg,

Republic of Croatia in 5 ampoules each with 2 mL Ranital injection 50 mg/2

solution for injection cooperation with Lek of water for injection in a YES YES mL

d.d., Ljubljana, blister, supplied in a box

Republic of Slovenia

Farmal d.d., Ludbreg,

Republic of Croatia in 20 (2x10 tablets in Al/Al

Ranital tablets 150 mg film coated tablets cooperation with Lek YES YES blister, supplied in a box

d.d., Ljubljana,

Republic of Slovenia

Farmal d.d., Ludbreg,

Republic of Croatia in

30 (3x10) tablets in a Al/Al

Ranital tablets 300 mg film coated tablets cooperation with Lek YES YES

blister, supplied in a box

d.d., Ljubljana,

Republic of Slovenia

Pliva Croatia Ltd., Ulica

Ranitidin Europharma grada Vukovara 49, 5 ampoules each with 2 mL solution for injection YES YES

injection 50 mg/2 mL Zagreb, Republic of of solution, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

Ranitidin Europharma grada Vukovara 49, 20 (2x10) tablets in a blister, film coated tablets YES YES

tablets 150 mg Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

Ranitidin Europharma grada Vukovara 49, 10 (1x10) tablets in a blister, film coated tablets YES YES

tablets 300 mg Zagreb, Republic of supplied in a box

Croatia Jadran - Galenski

laboratorij d.d., Pulac 20 (2x10) tablets in a blister, Ranix 150 film tablets YES YES

bb, Rijeka, Republic of supplied in a box

Croatia

Jadran - Galenski

laboratorij d.d., Pulac 10 (1x10) tablets in a blister, Ranix 300 film tablets YES YES

bb, Rijeka, Republic of supplied in a box

Croatia

Jadran - Galenski 5 amber glass ampoules with

solution forintramuscular laboratorij d.d., Pulac Ranix injection 2 mL of solution, supplied in YES YES

and intravenous injection bb, Rijeka, Republic of a box

Croatia

Wyeth

Pharmaceuticals, New 30 (3x10) tablets in a Rapamune 1 mg coated

coated tablets Lane, Havant, PVC/PE/Aclar/Al blister, YES YES YES tablets

Hampshire P09 2NG, supplied in a box

Great Britain

2 glass bottles with 10 units Roche Diagnostics

Rapilysin 10 U powder and of powder, 2 pre-filled powder and diluent for GmbH, Sandhofeer

diluent for injection syringes with 10 mL of YES YES YES YES solution for injection Strasse 116, D-68305

solution diluent, 2 reconstitution kits

Mannheim, Germany

and 2 injection needles

Laboratories Serono One glass vial with powder, a

S.A., Aubonne, syringe with 1.3 mL of powder and diluent for

Raptiva 100 mg/mL Switzerland i Industria diluent, a reconstitution YES YES YES solution for injection

Farmaceutica Serono needle and an injection

S.p.A., Rome, Italy needle, supplied in a box

Krka d.d., Šmarješka 32 (3x10) tablets in a prolonged-release film

RAWEL SR cesta 6, Novo mesto, PVC/PVDC//Al blister, YES YES YES YES coated tablets

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 60 (6x10) tablets in a film coated tablets with

RAWEL SR cesta 6, Novo mesto, PVC/PVDC//Al blister, YES YES YES YES prolonged-release

Republic of Slovenia supplied in a box

Schering-Plough Labo

84 (7x12) capsules in a

REBETOL 200 mg hard N.V. Industrepark 30,

hard capsules blister (PVC/PE/PVDC//Al), YES YES YES YES

capsules Heist-op-den-Berg,

supplied in a box

Belgium

Schering-Plough Labo 100 mL of oral solution in an

REBETOL 40 mg/mL oral N.V. Industrepark 30, amber glass bottle with oral solution YES YES YES YES

solution Heist-op-den-Berg, temper-proof plastic closure,

Belgium 1 glass bottle in a box

Industria Farmaceutica Pre-filled 1-mL glass syringe

Serono S.p.A., Bari, with fixed stainless steel Rebif 22 micrograms -

solution for injection Italy i Laboratories needle containing a single YES YES solution for injection

Serono S.A., Aubonne, 0.5 mL dose of solution for

Switzerland injection, supplied in a box

Industria Farmaceutica Pre-filled 1-mL glass syringe

Serono S.p.A., Bari, with fixed stainless steel Rebif 44 micrograms -

solution for injection Italy; Laboratories needle containing a single YES YES solution for injection

Serono S.A., Aubonne, 0.5 mL dose of solution for

Switzerland injection, supplied in a box

30 mL bottle with lyophilized

drug, bottle with 10 mL of

lyophilisate and solvent solvent (water for injection), Baxter S.A, Hyland

for preparation of sterile double needle for Recombinate 1000 IU Immuno, Lessines, YES

intravenous solution dissolution, sterile filter Belgium

(injections/infusion) needle, sterile mini infusion

kit, disposable sterile syringe,

supplied in a box

30 mL bottle with lyophilized

drug, bottle with 10 mL of

solvent (water for injection), lyophilisate and solvent Baxter S.A, Hyland

sterile double needle for

Recombinate 250 IU for intravenous solution Immuno, Lessines, YES dissolution, sterile filter

(injections/infusion) Belgium

needle, sterile mini infusion

kit, disposable sterile syringe,

supplied in a box 30 mL bottle with lyophilized

drug, bottle with 10 mL of

lyophilisate and solvent solvent (water for injection), Baxter S.A, Hyland

for preparation of i.v. sterile double needle for Recombinate 500 IU Immuno, Lessines, YES

solution dissolution, sterile filter Belgium

(injections/infusion) needle, sterile mini infusion

kit, disposable sterile syringe,

supplied in a box

Trommsdorff GmbH & 4 suppositories in a white Rectodelt 100 mg

suppositories Co.KG Arzneimittel, non-transparent strip YES YES suppositories

Alsdorf, Germany (PVC/PE), supplied in a box

Abbott GmbH & Co. 28 (2x14) capsules in a

Reductil 10 mg capsules capsules KG, Ludwigshafen, YES YES blister, supplied in a box

Germany

Abbott GmbH & Co. 28 (2x14) capsules in a

Reductil 15 mg capsules capsules KG, Ludwigshafen, YES YES blister, supplied in a box

Germany

Alkaloid AD, Skopje, solution for intramuscular 30 ampoules (6 x 5 on a

FYROM in cooperation Reglan injection injection and intravenous plastic pad) with 2 mL of YES YES

with Sanofiinfusion solution, supplied in a box

Synthelabo, France

Alkaloid AD - Skopje, 120 mL of solution in an

Bulevar Aleksandar REGLAN solution oral solution amber glass bottle with YES YES

Makedonski 12,

dispenser, supplied in a box

Skopje, FYROM

Alkaloid AD, Skopje,

FYROM in cooperation 40 tablets in an amber glass Reglan tablets tablets YES YES

with Sanofibottle, supplied in a box

Synthelabo, France

GlaxoWellcome

5 rotadisk blisters (PVC/Al)

Production, Evreux,

each with 4 doses of powder,

France and

Relenza inhalation powder, dosed in a plastic box with 1 YES YES YES

GlaxoSmithKline

diskhaler (applicator),

Australia Pty Ltd.,

supplied in a box

Australia

Centocor B.V., Remicade powder for powder for preparation of

Einsteinweg 101, 2333 One glass vial with powder concentrate of infusion concentrate for infusion YES YES

CB Leiden, the supplied in a box solution solution

Netherlands

Genzyme Limited

Great Britain; Renagel 800 mg film

film coated tablets Genzyme Republic of 180 tablets in a plastic bottle YES YES YES YES coated tablets

Ireland Limited,

Republic of Ireland

Bayer Sante Familiale,

24 (4x6) tablets in a blister,

Rennie chewing tablets 33 rue de L'industrie, YES YES YES

supplied in a box

74240 Gaillard, France

Replagal 1 mg/1 mL 5-mL glass bottle with 3.5-mL concentrate for infusion TKT Europe AB,

concentrate for infusion of concentrate supplied in a YES YES YES YES solution Danderyd, Sweden

solution box

Replagal 1 mg/1 mL 3-mL glass bottle with 1-mL concentrate for infusion TKT Europe AB,

concentrate for solution for of concentrate supplied in a YES YES YES YES solution Danderyd, Sweden

infusion box

SmithKline Beecham

Pharmaceuticals, 210 tablets in a PVC/PVDC Requip 0.25 mg tablets film coated tablets YES YES

Crawley, West Sussex, blister, supplied in a box

Great Britain

SmithKline Beecham

Pharmaceuticals, 21 tablets in a PVC/PVDC Requip 1 mg tablets film coated tablets YES YES

Crawley, West Sussex, blister, supplied in a box

Great Britain

SmithKline Beecham

Pharmaceuticals, 21 tablets in a PVC/PVDC Requip 2 mg tablets film coated tablets YES YES

Crawley, West Sussex, blister, supplied in a box

Great Britain SmithKline Beecham

Pharmaceuticals, 21 tablets in a PVC/PVDC Requip 5 mg tablets film coated tablets YES YES

Crawley, West Sussex, blister, supplied in a box

Great Britain

Krka d.d., Šmarješka 30 tablets in an amber glass Retafer 100 mg film coated

film coated tablets cesta 6, Novo mesto, bottle with an aluminium YES YES tablets

Republic of Slovenia stopper, supplied in a box

Pfizer PGM, Poce sur 90 (6x15) tablets in a blister Revatio 20 mg tablets film coated tablets YES YES YES YES

Cisse, France (PVC/Al), supplied in a box

28 (4x7) tablets in a white

Bristol-Myers Squibb, nontransparent Revia film coated tablets YES YES

Epernon, France PVC/PE/Aclar/Al blister,

supplied in a box

Aventis Boehring

Box with 1 ampoule with 1.5

solution for intramuscular GmbH, Emil-von

Rhesogamma P mL of solution (not less than YES

injection Behring Strasse 76,

300 µg = 1500 IU)

Marburg, Germany

Lyophilisate in a glass bottle lyophilisate and diluent

Octapharma AB, (8 mL) and 2 mL of solvent Rhesonativ 1250 IU for preparation of solution YES

Stockholm, Sweden (water for injection) in an for i.m. injection

ampoule, supplied in a box

100 mL of syrup in an amber Bosnalijek d.d.,

glass bottle with plastic cap Jukićeva 53, Sarajevo,

RHINOSTOP syrup syrup and a 5-mL plastic YES YES YES Bosnia and

measuring spoon, supplied in Herzegovina

a box

Bosnalijek d.d., 10 (1x10) tablets in a

Jukićeva 53, Sarajevo, RHINOSTOP tablets tablets Al/PVC blister, supplied in a YES YES YES

Bosnia and box

Herzegovina

500 mL in a glass infusion

Hrvatski zavod za bottle with a chlorobutyl Ringer's solution for

solution for intravenous transfuzijsku medicinu, stopper protected with an intravenous infusion, 500 YES YES

infusion Petrova 3, Zagreb, aluminium cap with a plastic mL

Republic of Croatia lid (10 bottles with plastic

holders, supplied in a box)

B. Braun Melsungen

10 polyethylene bottles with

AG, Carl-Braun-Straße

Ringer’s solution solution for infusion 1000 mL of solution, supplied YES YES

1, Melsungen,

in a box

Germany

B. Braun Melsungen

10 polyethylene bottles with

AG, Carl-Braun-Straße

Ringer’s solution solution for infusion 500 mL of solution, supplied YES YES

1, Melsungen,

in a box

Germany

Baxter S.A., Belgium;

10 plastic Viaflo bags with

Baxter Healthcare Ltd,

1000 mL of infusion solution,

Ringer’s solution Viaflo solution for infusion Great Britain; Bieffe YES YES

in a protective bag, supplied

Medital Sabinanigo,

in a box

Spain

Baxter S.A., Belgium;

20 plastic Viaflo bags with

Baxter Healthcare Ltd,

500 mL of infusion solution,

Ringer’s solution Viaflo solution for infusion Great Britain; Bieffe YES YES

in a protective bag, supplied

Medital Sabinanigo,

in a box

Spain

100 mL of syrup in a 125 mL Pliva Croatia Ltd., Ulica

amber glass bottle with grada Vukovara 49,

Rinolan syrup syrup aluminum cap and a 5-mL YES YES

Zagreb, Republic of

plastic (poylethyrene) spoon,

Croatia

supplied in a box

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 10 (1x10) tablets in a PVC/Al Rinolan tablets tablets YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Janssen 100 mL of oral solution in an Rispolept 1 mg/mL

oral solution Pharmaceutica NV, amber glass bottle with YES YES solution for oral use

Turnhouseweg 30, temper-prooft plastic closure Beerse, Belgium and pipette, supplied in a box

65.6 mg of powder

Cilag AG, (microspheres) in a glass

Schaffhausen, bottle, 2 mL of solvent in a prolonged-release

Switzerland for syringe, 2 needles for Rispolept Consta 25 mg suspension for i.m. YES YES

Janssen preparation of suspension injections

Pharmaceutica N.V., and 1 needle for i.v.

Beerse, Belgium administration, in a plastic

container, supplied in a box

98.4 mg of powder

(microspheres) in a glass Cilag AG,

bottle, 2 mL of solvent in a Schaffhausen, prolonged-release syringe, 2 needles for

Switzerland for Rispolept Consta 37.5 mg suspension for i.m. preparation of suspension YES YES

Janssen injections and a needle for i.v.

Pharmaceutica N.V., administration, inserted into a

Beerse, Belgium plastic container, supplied in

a box

131.2 mg powder

(microsphere) in a glass Cilag AG,

bottle, 2 mL of diluent in a Schaffhausen, prolonged-release syringe, 2 needles for

Switzerland for Rispolept Consta 50 mg suspension for i.m. suspension preparation and YES YES

Janssen injection one needle for intramuscular

Pharmaceutica N.V.,

administration, inserted in a

Beerse, Belgium

plastic container, supplied in

a box

Janssen-Cilag S.p.A., 20 (2x10) tablets in a blister

Rispolept tablets 1 mg film coated tablets Borgo San Michele, (PVC/PE/PVDC//Al) , YES YES

Latina, Italy supplied in a box

Janssen-Cilag S.p.A., 60 (6x10) tablets in a blister

Rispolept tablets 2 mg film coated tablets Borgo San Michele, (PVC/PE/PVDC//Al), YES YES

Latina, Italy supplied in a box

Janssen-Cilag S.p.A., 60 (6x10) tablets in a blister

Rispolept tablets 3 mg film coated tablets Borgo San Michele, (PVC/PE/PVDC//Al), YES YES

Latina, Italy supplied in a box

Janssen-Cilag S.p.A., 60 (6x10) tablets in a blister

Rispolept tablets 4 mg film coated tablets Borgo San Michele, (PVC/PE/PVDC//Al), YES YES

Latina, Italy supplied in a box

Lek farmacevtska

družba d.d., 20 (2x10) tablets in

Rispolux 1 mg film coated tablets Verovškova 57, PVC/PE/PVDC/Al blister, YES YES YES

Ljubljana, Republic of supplied in a box

Slovenia

Lek farmacevtska

družba d.d., 20 (2x10) tablets in

Rispolux 2 mg film coated tablets Verovškova 57, PVC/PE/PVDC/Al blister, YES YES YES

Ljubljana, Republic of supplied in a box

Slovenia

Lek farmacevtska

družba d.d., 20 (2x10) tablets in

Rispolux 3 mg film coated tablets Verovškova 57, PVC/PE/PVDC/Al blister, YES YES YES

Ljubljana, Republic of supplied in a box

Slovenia

Lek farmacevtska

družba d.d., 20 (2x10) tablets in

Rispolux 4 mg film coated tablets Verovškova 57, PVC/PE/PVDC/Al blister, YES YES YES

Ljubljana, Republic of supplied in a box

Slovenia

Pliva Croatia Ltd., Ulica 20 (2x10) film coated tablets

grada Vukovara 49, Risset tablets 1 mg film coated tablets in an orange PVC/PVDC/A1 YES YES

Zagreb, Republic of

blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 20 (2x10) film coated tablets

Risset tablets 2 mg film coated tablets grada Vukovara 49, in an orange PVC/PVDC/A1 YES YES

Zagreb, Republic of blister, supplied in a box Croatia

Pliva Croatia Ltd., Ulica 20 (2x10) film coated tablets

grada Vukovara 49, Risset tablets 3 mg film coated tablets in an orange PVC/PVDC/A1 YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 20 (2x10) film coated tablets

grada Vukovara 49, Risset tablets 4 mg film coated tablets in an orange PVC/PVDC/A1 YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

F. Hoffmann-La Roche

Ltd., 50 tablets in an amber glass

Rivotril 0.5 mg tablets tablets Grenzacherstrasse bottle with a plastic (PE) YES YES

124, Basel, stopper, supplied in a box

Switzerland

F. Hoffmann-La Roche

Ltd., 30 tablets in an amber glass

Rivotril 2 mg tablets tablets Grenzacherstrasse bottle with a plastic (PE) YES YES

124, Basel, stopper, supplied in a box

Switzerland

F. Hoffmann-La Roche

Ltd., 30 (3x10) soft capsules in a Roaccutane soft capsules

soft capsules Grenzacherstrasse blister (PVC/PE/PVDC//Al), YES YES 10 mg

124, Basel, supplied in a box

Switzerland

F. Hoffmann-La Roche

Ltd., 100 (5x20) capsules in

Rocaltrol 0.25 µg capsules soft capsules Grenzacherstrasse PVC/Al blister, supplied in a YES YES

124, Basel, box

Switzerland

F. Hoffmann-La Roche

Ltd., 100 (5x20) capsules in a

Rocaltrol 0.5 µg capsules soft capsules Grenzacherstrasse PVC/Al blister, supplied in a YES YES

124, Basel, box

Switzerland

F. Hoffmann-La Roche 2 g of powder in a vial and

powder for preparation of Ltd., 3.5 mL of diluent (Water for

Rocephin 1 g i.m. solution for intramuscular Grenzacherstrasse YES YES

Injection) in an ampoule, injection 124, Basel,

supplied in a box Switzerland

F. Hoffmann-La Roche 1 g of powder in a vial and

powder for preparation of Ltd., 10mL of diluent (Water for

Rocephin 1 g i.v. solution for intravenous Grenzacherstrasse YES YES

Injection) in an ampoule, injection 124, Basel,

supplied in a box Switzerland

F. Hoffmann-La Roche One 50 mL glass vial for

Ltd., Rocephin 2g powder for powder for solution for infusion containing

Grenzacherstrasse YES YES infusion solution infusion (for i.v. use) powder,with rubber cap,

124, Basel, supplied in a vial

Switzerland

F. Hoffmann-La Roche One glass syringe containing

Ltd., 0.5 mL of solution, closed solution for injection (for

Roferon-A 3 MIU/0.5 mL Grenzacherstrasse with protective cap and a YES YES single s.c. administration)

124, Basel, needle (in a plastic

Switzerland container), supplied in a box

F. Hoffmann-La Roche One glass syringe with 0.5

Ltd., mL of solution closed with a solution for injection (for

Roferon-A 4.5 MIU/0.5 mL Grenzacherstrasse protective cap and one YES YES single s.c. administration)

124, Basel, needle (in a plastic

Switzerland container), supplied in a box

F. Hoffmann-La Roche One glass syringe with 0.5

Ltd., mL of solution closed with a solution for injection (for

Roferon-A 6 MIU/0.5 mL Grenzacherstrasse protective cap and one YES YES single s.c. administration)

124, Basel, needle (in a plastic

Switzerland container), supplied in a box F. Hoffmann-La Roche One glass syringe with 0.5

Ltd., mL of solution closed with a solution for injection (for

Roferon-A 9 MIU/0.5 mL Grenzacherstrasse protective cap and one YES YES single s.c. administration)

124, Basel, needle (in a plastic

Switzerland container), supplied in a box

Belupo, lijekovi i

kozmetika d.d., Ulica 7 (1 x7) pessaries in an ROJAZOL 200 mg pessary pessary YES YES

Danica 5, Koprivnica, Al/PE strip, supplied in a box

Republic of Croatia

Belupo, lijekovi i 30 g of cream in an

kozmetika d.d., Ulica ROJAZOL cream cream aluminium tube with a plastic YES YES

Danica 5, Koprivnica,

stopper, supplied in a box

Republic of Croatia

Belupo, lijekovi i 40 g of oral gel in an

kozmetika d.d., Ulica aluminium tube with a 5 mL ROJAZOL oral gel oral gel YES YES

Danica 5, Koprivnica, plastic measuring spoon,

Republic of Croatia supplied in a box

A.C.R.A.F. S.p.A., Via

4 bags (2x2), each with 9.44

granules for vaginal Vecchia del Pinocchio,

Rosalgin granules g of granulate, supplied in a YES YES

solution 22, 60131 Ancona,

box

Italy

A.C.R.A.F. S.p.A., Via 140 mL of solution in a

Vecchia del Pinocchio, plastic bottle with plastic Rosalgin solution vaginal solution YES YES

22, 60131 Ancona, applicator attachment, 5

Italy bottles in a carton box

ROWA

PHARMACEUTICALS 30 (3x10) capsules in a

ROWAchol capsules capsules LTD., Newtown, YES YES blister, supplied in a box

Bantry, Co. Cork,

Republic of Ireland

ROWA

PHARMACEUTICALS 30 (3x10) capsules in a

ROWAtinex capsules capsules LTD., Newtown, YES YES blister, supplied in a box

Bantry, Co. Cork,

Republic of Ireland

Jadran - Galenski

laboratorij d.d., Pulac 25 grams of cream in an Al Rozamet 1% cream cream YES YES

bb, Rijeka, Republic of tube, supplied in a carton box

Croatia

Belupo, lijekovi i 50 coated tablets in an

RUDAKOL 135 mg coated kozmetika d.d., Ulica amber glass bottle with an coated tablets YES YES

tablets Danica 5, Koprivnica, aluminium stopper, supplied

Republic of Croatia in a box

Bayer HealthCare AG,

20 (2x10) chewing tablets in

Rupurut chewing tablets chewing tablets 51368 Leverkusen, YES YES YES

a blister, supplied in a box

Germany

Krka d.d., Šmarješka 20 (2x10) tablets in a blister Rutacid chewing tablets

chewing tablets cesta 6, Novo mesto, (PVC/PVDC-Al), supplied in YES YES YES 500 mg

Republic of Slovenia a box

Abbott GmbH & Co. 50 (5x10) film coated tablets Rytmonorm 150 mg film

film coated tablets KG, Ludwigshafen, in a blister (PVC/Al or PP/Al) YES YES tablets

Germany , supplied in a box

Abbott GmbH & Co. 50 (5x10) film coated tablets Rytmonorm 300 mg film

film coated tablets KG, Ludwigshafen, in a blister (PVC/Al or PP/Al), YES YES tablets

Germany supplied in a box

Ebewe Pharma Ges.

20 mL of injection solution in

Rytmonorm solution for m.b.H. Nfg. KG,

solution for injection a glass ampoule, 5 ampoules YES YES

injection Mondseestrasse 11,

supplied in a box

Unterach, Austria

Salazopyrin EN tablets Pfizer Health AB, 100 tablets in a polyethylene gastric-resistant tablets YES YES

500 mg Uppsala, Sweden bottle, supplied in a box

dr. Falk Pharma 30 (6x5) suppositories in a Salofalk suppositories 250

suppositories GmbH, Freiburg, strip (PVC/LDPE), supplied YES YES mg

Germany in a box

Salofalk suppositories 500 dr. Falk Pharma 30 (6x5) suppositories in a suppositories YES YES

mg GmbH, Freiburg, strip (PVC/LDPE), supplied

Germany in a box

7 plastic containers each with

Salofalk suspension for dr. Falk Pharma 60 mL of suspension (with suspension for rectal

rectal administration 4 g/60 GmbH, Freiburg, attachment for rectal YES YES administration

mL Germany administration) in a protective

blister, supplied in a box

dr. Falk Pharma 100 (10x10) tablets in a

Salofalk 250 mg tablets gastric-resistant tablets GmbH, Freiburg, PVC/PVDC//Al blister, YES YES

Germany supplied in a box

dr. Falk Pharma 100 (10x10) tablets in a

Salofalk 500 mg tablets gastric-resistant tablets GmbH, Freiburg, PVC/PVDC//Al blister, YES YES

Germany supplied in a box

Pliva Croatia Ltd., Ulica 250-mL of solution for

grada Vukovara 49, infusion in a plastic bottle for Salviamin L8b.UH solution for infusion YES YES

Zagreb, Republic of infusion, 10 bottles and

Croatia plastic bottle holders in a box

Pliva Croatia Ltd., Ulica 500 mL of solution for

grada Vukovara 49, infusion in a glass infusion Salviamin L8b.UH solution for infusion YES YES

Zagreb, Republic of bottle, 10 bottles and plastic

Croatia bottle holders in a box

Pliva Croatia Ltd., Ulica 500 mL of solution for

grada Vukovara 49, Salviamin LX6 solution for infusion infusion in a glass infusion YES YES

Zagreb, Republic of bottle, 10 bottles in a box

Croatia

Novartis Pharma Stein 10 ampoules containing 5 mL

Sandimmun 50 mg/mL concentrate for AG, of concentrate for infusion, YES YES

concentrate for infusion intravenous infusion Schaffhauserstrasse, supplied in a box

Stein, Switzerland

Novartis Pharma Stein

Sandimmun Neoral 100 AG, 50 (10x5) capsules in an Al soft gelatinous capsules YES YES

mg capsules Schaffhauserstrasse, blister, supplied in a box

Stein, Switzerland

Novartis Pharma Stein

Sandimmun Neoral AG, 50 (10x5) capsules in an Al soft gelatinous capsules YES YES

capsules 25 mg Schaffhauserstrasse, blister, supplied in a box

Stein, Switzerland

Novartis Pharma Stein

Sandimmun Neoral AG, 50 (10x5) capsules in an Al soft gelatinous capsules YES YES

capsules 50 mg Schaffhauserstrasse, blister, supplied in a box

Stein, Switzerland

50 mL of solution in an Novartis Pharma

Sandimmun Neoral 100 amber glass bottle with a oral solution S.A.S., Huningue YES YES

mg/mL oral solution measuring kit (in a protective

Cedex, France container), supplied in a box

Novartis Pharma Stein 5 ampoules each with 1 mL

Sandostatin 0.05 mg AG, solution for injection of solution for injection, YES YES

injection Schaffhauserstrasse, supplied in a box

Stein, Switzerland

Novartis Pharma Stein 5 ampoules each with 1 mL

Sandostatin 0.1 mg AG, solution for injection of solution for injection, YES YES

injection Schaffhauserstrasse, supplied in a box

Stein, Switzerland

Novartis Pharma Stein 5 ampoules each with 1 mL

Sandostatin 0.5 mg AG, solution for injection of solution for injection, YES YES

injection Schaffhauserstrasse, supplied in a box

Stein, Switzerland

Vial with powder, pre-filled

syringe with 2.5 mL of diluent

Novartis Pharma Stein for suspension, and two

powder and diluent for AG, needles (1.1x40 mm, 19 G x Sandostatin LAR 10 mg YES YES

suspension for injection Schaffhauserstrasse, 1 1/2'') in individual

Stein, Switzerland packages, inserted into

protective plastic container,

supplied in a carton box Vial with powder, pre-filled

syringe with 2.5 mL of diluent

Novartis Pharma Stein for suspension, two needles

powder and diluent for AG, (1.1x40 mm, 19 G x 1 1/2'') in Sandostatin LAR 20 mg YES YES

suspension for injection Schaffhauserstrasse, individual packages, inserted

Stein, Switzerland into a protective plastic

container, supplied in a

carton box

Vial with powder, pre-filled

syringe with 2.5 mL of diluent

Novartis Pharma Stein for suspension, two needles

powder and diluent for AG, (1.1x40 mm, 19 G x 1 1/2'') in Sandostatin LAR 30 mg YES YES

suspension for injection Schaffhauserstrasse, individual packages, inserted

Stein, Switzerland into a protective plastic

container, supplied in a

carton box

Lek farmacevtska

družba d.d.,

20 (2x10) tablets in PVC/Al

Sanval 10 mg tablets film coated tablets Verovškova 57, YES YES

blister, supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d.,

20 (2x10) tablets in PVC/Al

Sanval 10 mg tablets film coated tablets Verovškova 57, YES YES

blister, supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska

družba d.d.,

20 (2x10) tablets in PVC/Al

Sanval 5 mg tablets film coated tablets Verovškova 57, YES YES

blister, supplied in a box

Ljubljana, Republic of

Slovenia

Bayer Sante Familiale,

10 (1x10) tablets in a PVC/Al

Saridon tablets 33 rue de L'industrie, YES YES YES

blister, supplied in a box

74240 Gaillard, France

Krka d.d., Šmarješka 20 capsules in an amber

Seldiar capsules capsules cesta 6, Novo mesto, glass bottle, supplied in a YES YES

Republic of Slovenia box

Krka d.d., Šmarješka 31 (3x10) lozenges in a

Septolete lozenges cesta 6, Novo mesto, YES YES YES blister, supplied in a box

Republic of Slovenia

Krka d.d., Šmarješka 32 (3x10) lozenges in a

Septolete D lozenges cesta 6, Novo mesto, YES YES YES blister, supplied in a box

Republic of Slovenia

Krka d.d., Šmarješka 18 (2x9) lozenges in a blister

Septolete wild cherry lozenges cesta 6, Novo mesto, (PVC/PVDC-Al), supplied in YES YES YES

Republic of Slovenia a box

Krka d.d., Šmarješka 18 (2x9) lozenges in a blister

Septolete lemon lozenges cesta 6, Novo mesto, (PVC/PVDC-Al), supplied in YES YES YES

Republic of Slovenia a box

Krka d.d., Šmarješka 30 (3x10) lozenges in a

Septolete Plus lozenges lozenges cesta 6, Novo mesto, blister (PVC/PVDC-Al), YES YES YES

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 18 (2x9) lozenges in a blister

Septolete green apple lozenges cesta 6, Novo mesto, (PVC/PVDC-Al), supplied in YES YES YES

Republic of Slovenia a box

H. Lundbeck A/S,

28 (4x7) tablets in a blister

Serdolect 12 mg film Ottilavej 9,

film coated tablets (PVC/PVdC/Al), supplied in a YES YES YES

coated tablets Copenhagen-Valby,

box

Denmark

H. Lundbeck A/S,

28 (4x7) tablets in a blister

Serdolect 16 mg film Ottilavej 9,

film coated tablets (PVC/PVdC/Al), supplied in a YES YES YES

coated tablets Copenhagen-Valby,

box

Denmark

H. Lundbeck A/S,

28 (4x7) tablets in a blister

Serdolect 20 mg film Ottilavej 9,

film coated tablets (PVC/PVdC/Al), supplied in a YES YES YES

coated tablets Copenhagen-Valby,

box

Denmark

H. Lundbeck A/S,

31 (3x10) tablets in a

Serdolect 4 mg film coated Ottilavej 9,

film coated tablets PVC/PVdC/Al blister, YES YES YES

tablets Copenhagen-Valby,

supplied in a box

Denmark

60 doses of powder in an Glaxo Wellcome

aluminium blister (with

Seretide 100 discus inhalation powder Operations, Greenford, YES YES YES protective foil) in a plastic Great Britain

housing, supplied in a box

One metal container (120

Glaxo Wellcome doses) with metering valve in

Seretide 125 Inhaler inhalation aerosol Production, Evreux, plastic atomizer for oral YES YES YES

France administration, supplied in a

box

60 doses of powder in an Glaxo Wellcome

aluminium blister (with

Seretide 250 diskus inhalation powder Operations, Greenford, YES YES YES protective foil) in a plastic Great Britain

housing, supplied in a box

One metal container (120

Glaxo Wellcome doses) with metering valve in

Seretide 250 Inhaler inhalation aerosol Production, Evreux, plastic atomizer for oral YES YES YES

France administration, supplied in a

box

One metal container (120

Glaxo Wellcome doses) with metering valve in

Seretide 50 Inhaler inhalation aerosol Production, Evreux, plastic atomizer for oral YES YES YES

France administration, supplied in a

box

60 doses of powder in an Glaxo Wellcome

aluminium blister (with

Seretide 500 diskus inhalation powder Operations, Greenford, YES YES YES protective foil) in a plastic Great Britain

housing, supplied in a box

Glaxo Wellcome 60 doses of powder in an

Serevent Discus inhalation powder Production, Evreux, aluminium blister, in a plastic YES YES

France housing, supplied in a box

GlaxoSmithKline

Pharmaceuticals S.A.,

120 doses in a metal

Ul. Grunwaldzka 189,

inhalation aerosol (aluminum) bottle with

Serevent Inhaler Poznan, Polish Glaxo YES YES

(suspension) metering valve in plastic

Wellcome Production,

nebulizer, supplied in a box

23 Rue Lavoisier,

Evreux, France

AstraZeneca UK

Limited, Silk Road SEROQUEL tablets 100 60 tablets (6x10) in a blister,

film coated tablets Business Park, YES YES YES mg supplied in a box

Macclesfield, Cheshire,

Great Britain

AstraZeneca UK

Limited, Silk Road SEROQUEL tablets 200 60 tablets (6x10) in a blister,

film coated tablets Business Park, YES YES YES mg supplied in a box

Macclesfield, Cheshire,

Great Britain

AstraZeneca UK

Limited, Silk Road 60 tablets (6x10) in a blister,

SEROQUEL tablets 25 mg film coated tablets Business Park, YES YES YES supplied in a box

Macclesfield, Cheshire,

Great Britain

AstraZeneca UK

Limited, Silk Road

60 (6x10) tablets in a blister

Seroquel tablets 300 mg film coated tablets Business Park, YES YES YES

(PVC/Al), supplied in a box

Macclesfield, Cheshire,

Great Britain

Belupo lijekovi i

kozmetika d.d.,

Koprivnica, Republic of 30 (3x10) tablets in a blister, Seroxat 20 mg tablets film coated tablets YES YES

Croatia in cooperation supplied in a box

with GlaxoSmithKline,

Great Britain Belupo lijekovi i

kozmetika d.d.,

Koprivnica, Republic of 30 (3x10) tablets in a blister, Seroxat 30 mg tablets film coated tablets YES YES

Croatia in cooperation supplied in a box

with GlaxoSmithKline,

Great Britain

Belupo lijekovi i

kozmetika d.d.,

150 mL of suspension in an

Koprivnica, Republic of

Seroxat oral suspension oral suspension amber glass bottle, supplied YES YES

Croatia in cooperation

in a box

with GlaxoSmithKline,

Great Britain

Pliva Croatia Ltd., Ulica

Setronon injection 4 mg/2 grada Vukovara 49, Box with 5 ampoules solution for injection YES YES

mL Zagreb, Republic of containing 2 mL of solution

Croatia

Pliva Croatia Ltd., Ulica

Setronon injection 8 mg/4 grada Vukovara 49, Box with 5 ampoules solution for injection YES YES

mL Zagreb, Republic of containing 4 mL of solution

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, Setronon tablets 4 mg film tablets Box with 10 tablets (blister) YES YES

Zagreb, Republic of

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, Setronon tablets 8 mg film tablets Box with 10 tablets (blister) YES YES

Zagreb, Republic of

Croatia

Brown polyethylene bottle Abbott Laboratories

with 250 mL of solution and a

Sevorane inhalate, solution Ltd., Queenborough, YES YES temper-evident stopper,

Great Britain supplied in a box

Bard Pharmaceuticals 56 (4x14) tablets in a

Sevredol 10 mg film Ltd., Milton Road, film coated tablets PVC/PVDC/Al blister, YES YES

coated tablets Cambridge, Great supplied in a box

Britain

Mundipharma Gm.b.H.,

Limburg, Germany and 30 (3x10) tablets in a Sevredol 10 mg film

film coated tablets Mundipharma PVC/PVdC/Al blister, YES YES coated tablets

GES.m.b.H., Vienna, supplied in a box

Austria

Bard Pharmaceuticals 56 (4x14) tablets in a

Sevredol 20 mg film Ltd., Milton Road, film coated tablets PVC/PVDC/Al blister, YES YES

coated tablets Cambridge, Great supplied in a box

Britain

Mundipharma Gm.b.H.,

Limburg, Germany and 31 (3x10) tablets in a Sevredol 20 mg film

film coated tablets Mundipharma PVC/PVdC/Al blister, YES YES coated tablets

GES.m.b.H., Vienna, supplied in a box

Austria

Belupo, lijekovi i

150 mL of suspension in an

Silapen 1000 oral kozmetika d.d., Ulica

oral suspension amber glass bottle, supplied YES YES

suspension Danica 5, Koprivnica,

in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 15 tablets in a plastic bottle, Silapen 1000 tablets tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 30 tablets in a blister, Silapen 1500 tablets tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i 30 (3x10) capsules in a

kozmetika d.d., Ulica Silymarin capsules capsules PVC/Al blister, supplied in a YES YES

Danica 5, Koprivnica, box

Republic of Croatia Cipla Ltd., MIDC

Industrial Area, 20 (2x10) tablets in a blister

Simcard 10 film coated tablets Kurkumbh, Pune, (white PVC/PVDC/Al), YES YES

Maharashtra State, supplied in a box

India

Cipla Ltd., MIDC

Industrial Area, 20 (2x10) tablets in a blister

Simcard 20 film coated tablets Kurkumbh, Pune, (white PVC/PVDC/Al), YES YES

Maharashtra State, supplied in a box

India

Cipla Ltd., MIDC

Industrial Area, 28 (2x14) tablets in a blister

Simcard 40 film coated tablets Kurkumbh, Pune, (white PVC/PVDC/Al), YES YES

Maharashtra State, supplied in a box

India

Simdax 2.5 mg/mL Orion Corporation One glass vial with 5 mL of concentrate for solution

concentrate for solution for ORION PHARMA, solution concentrate, YES YES YES for infusion

infusion Espoo, Finland supplied in a box

Vial containing medicinal Novartis Pharma Stein powder and solvent for product (powder) and

AG, Simulect 10 mg preparation of solution for ampoule with 5mL of diluent YES YES

Schaffhauserstrasse, injection or infusion (Water for Injection), supplied

Stein, Switzerland in a box

Vial containing medicinal Novartis Pharma Stein powder and solvent for product (powder) and

AG, Simulect 20 mg preparation of solution for ampoule with 5mL of diluent YES YES

Schaffhauserstrasse, injection or infusion (Water for Injection), supplied

Stein, Switzerland in a box

Lek farmacevtska

družba d.d., Ljubljana,

Republic of Slovenia, Simvastatin Lek 10 mg film 28 (2x14) tablets in a PVC/Al

film coated tablets LEK S.A., Warszawa, YES YES YES coated tablets blister, supplied in a box

Poland and Salutas

Pharma GmbH,

Barleben, Germany

Lek farmacevtska

družba d.d., Ljubljana,

Republic of Slovenia, Simvastatin Lek 20 mg film 28 (2x14) tablets in a PVC/Al

film coated tablets LEK S.A., Warszawa, YES YES YES coated tablets blister, supplied in a box

Poland and Salutas

Pharma GmbH,

Barleben, Germany

Lek farmacevtska

družba d.d., Ljubljana,

Republic of Slovenia, Simvastatin Lek 40 mg film 28 (2x14) tablets in a PVC/Al

film coated tablets LEK S.A., Warszawa, YES YES YES coated tablets blister, supplied in a box

Poland and Salutas

Pharma GmbH,

Barleben, Germany

Jadran - Galenski 20 (2x10) film coated tablets

Simvax 10 mg film coated laboratorij d.d., Pulac film coated tablets in a (PVC/PVDC/Al) blister, YES YES tablets bb, Rijeka, Republic of

supplied in a box Croatia

Jadran - Galenski 28 (1x28) film coated tablets

Simvax 10 mg film coated laboratorij d.d., Pulac film coated tablets in a PVC/PVDC/Al blister, YES YES tablets bb, Rijeka, Republic of

supplied in a box Croatia

Jadran - Galenski 20 (2x10) film coated tablets

Simvax 20 mg film coated laboratorij d.d., Pulac film coated tablets in a (PVC/PVDC/Al) blister, YES YES tablets bb, Rijeka, Republic of

supplied in a box Croatia

Jadran - Galenski 20 (2x10) film coated tablets

Simvax 40 mg film coated laboratorij d.d., Pulac film coated tablets in a (PVC/PVDC/Al) blister, YES YES tablets bb, Rijeka, Republic of

supplied in a box Croatia

Sinecod 50 film coated Novartis Saglik, Turkey 10 (1x10) tablets in a blister, film coated tablets YES YES

tablets za Novartis Consumer supplied in a box

Health S.A.,

Switzerland

Novartis Consumer

20 mL of solution in a plastic

Health S.A., Route de l'

Sinecod oral drops oral drops, solution bottle with dropper YES YES

Etraz, Nyon,

attachment, supplied in a box

Switzerland

Novartis Consumer 200 mL of syrup in an amber

Health S.A., Route de l' glass bottle and a plastic Sinecod syrup syrup YES YES

Etraz, Nyon, measuring vessel, supplied

Switzerland in a box

Merck Sharp & Dohme 100 tablets in an amber

B.V., Waarderweg 39, Sinemet CR tablets controlled-release tablets glass bottle, supplied in a YES YES

Postbus 581, Haarlem, box

the Netherlands

Merck Sharp & Dohme

B.V., Waarderweg 39, 100 (10x10) tablets in a Sinemet tablets tablets YES YES

Postbus 581, Haarlem, blister, supplied in a box

the Netherlands

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 10 (1x10) tablets in a PVC/AI SINERSUL forte tablets tablets YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 100 mL of syrup in an amber

grada Vukovara 49, glass bottle with aluminum SINERSUL syrup syrup YES YES

Zagreb, Republic of cap and a 5-mL plastic

Croatia spoon, supplied in a box

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 20 (2x10) tablets in a blister SINERSUL tablets tablets YES YES

Zagreb, Republic of (PVC/Al), supplied in a box

Croatia

Merck Sharp & Dohme 28 (2x14) tablets in a

Singulair 10 mg film B.V., Waarderweg 39, film coated tablets PA/PVC/Al blister, supplied YES YES

coated tablets Postbus 581, Haarlem, in a box

the Netherlands

Merck Sharp & Dohme 28 (2x14) tablets in a

Singulair junior 5 mg B.V., Waarderweg 39, chewing tablets PA/PVC/Al blister, supplied YES YES

chewing tablets Postbus 581, Haarlem, in a box

the Netherlands

Merck Sharp & Dohme 28 aluminum bags each

Singulair mini 4 mg oral B.V., Waarderweg 39, granules for oral solution containing 500 mg of YES YES

granules Postbus 581, Haarlem, granules, supplied in a box the Netherlands

Merck Sharp & Dohme 28 (2x14) tablets in a

Singulair mini 4 mg B.V., Waarderweg 39, chewing tablets PA/PVC/Al blister, supplied YES YES

chewing tablets Postbus 581, Haarlem, in a box

the Netherlands

Berlin-Chemie AG

(Menarini Group), 39 (3x10) tablets in a PVC/Al Siofor 500 film coated tablets YES YES

Glienicker Weg 125, blister, supplied in a box

Berlin, Germany

Berlin-Chemie AG

(Menarini Group), 30 (2x15) tablets in a PVC/Al Siofor 850 film coated tablets YES YES

Glienicker Weg 125, blister, supplied in a box

Berlin, Germany

Trešnjevka laboratorij

220 mL of syrup in an amber

d.o.o., Jukićeva 32,

Iceland lichen syrup syrup glass bottle with aluminum YES YES

Zagreb, Republic of

cap, supplied in a box

Croatia

Intendis Manufacturing 30 g of cream in an

Skinoren cream cream S.p.A., Segrate, aluminium tube, supplied in a YES YES

Milano, Italy box

Intendis Manufacturing 30 g of cream in an

Skinoren cream cream S.p.A., Segrate, aluminium tube, supplied in a YES YES

Milano, Italy box

Alkaloid AD - Skopje, 36 (3x10) tablets in a PVC/Al Skopryl 10 mg tablets YES YES

Bulevar Aleksandar blister, supplied in a box Makedonski 12,

Skopje, FYROM

Alkaloid AD - Skopje,

Bulevar Aleksandar 37 (3x10) tablets in a PVC/Al Skopryl 20 mg tablets YES YES

Makedonski 12, blister, supplied in a box

Skopje, FYROM

B. Braun Melsungen Compound sodium lactate 1000 mL of infusion solution

AG, Carl-Braun-Straße solution (Hartmann's solution for infusion in a plastic bottle (10 bottles YES YES

1, Melsungen, solution) in a box)

Germany

B. Braun Melsungen Compound sodium lactate 500 mL of solution for

AG, Carl-Braun-Straße solution (Hartmann's solution for infusion infusion in a plastic bottle (10 YES YES

1, Melsungen, solution) bottles in a box)

Germany

30 bags (LDPE/Al/paper) Beaufor Ipsen powder for preparation of each with 3.76 g of powder Smecta Industrie, Dreux, YES YES YES

oral suspension for oral suspension, supplied France

in a box

10 bags (LDPE/Al/paper) Beaufor Ipsen powder for oral each containing 3.76 g of Smecta Industrie, Dreux, YES YES YES

suspension powder for oral suspension, France

supplied in a box

Plastic bag ("Excel")

containing 100 mL of

emulsion for infusion with two

attachments for drug

SMOFlipid 20% emulsion Fresenius Kabi AB, administration and for emulsion for infusion YES YES YES

for infusion Uppsala, Sweden 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

attachments for drug

SMOFlipid 20% emulsion Fresenius Kabi AB, administration and for emulsion for infusion YES YES YES

for infusion Uppsala, Sweden infusion, one small bag

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

SMOFlipid 20% emulsion Fresenius Kabi AB, administration and for emulsion for infusion YES YES YES

for infusion Uppsala, Sweden infusion, one small bag

containing oxygen absorber,

and one bag with solution for

packaging airtightness

control

Glass infusion bottle with 500

mL of emulsion (with rubber

SMOFlipid 20% emulsion Fresenius Kabi Austria emulsion for infusion stopper, aluminum ring and YES YES YES

for infusion GmbH, Graz, Austria plastic protective cap), 10

bottles in a carton box

Glass infusion bottle with 250

mL emulsion (with rubber

SMOFlipid 20% emulsion Fresenius Kabi Austria emulsion for infusion stopper, aluminum ring and YES YES YES

for infusion GmbH, Graz, Austria plastic protective cap), 10

bottles in a carton box

Glass infusion bottle with 100

mL of emulsion (with rubber

SMOFlipid 20% emulsion Fresenius Kabi Austria emulsion for infusion stopper, aluminum ring and YES YES YES

for infusion GmbH, Graz, Austria plastic protective cap), 10

bottles in a carton box Glaxo Wellcome 12 (1x12) capsules in a

SOLPADEINE capsules capsules Production, Mayenne, PVC/Al blister, supplied in a YES YES YES

France box

GlaxoSmithKline

Dungarvan Ltd., 12 (3x4) effervescent tablets

SOLPADEINE Knockbrack, in multilayer strip packing effervescent tablets YES YES YES

effervescent tablets Dungarvan, Co. (paper/PE/Al/PE), supplied in

Waterford, Republic of a box

Ireland

GlaxoSmithKline

Dungarvan Ltd.,

Knockbrack, 12 (1x12) tablets in PVC/Al SOLPADEINE tablets tablets YES YES YES

Dungarvan, Co. blister, supplied in a box

Waterford, Republic of

Ireland

Glass bottle with lyophilisate Pfizer Manufacturing

Solu-Cortef injection 100 lyophilisate and diluent in a lower part and solvent (2

Belgium NV, Rijksweg YES YES mg for solution for injection mL) in the upper part,

12, Puurs, Belgium supplied in a box

Pliva Croatia Ltd., Ulica 10 glass bottles with à 20 mL

grada Vukovara 49, of solution for injection (with Soludeks 1 solution for injection YES YES

Zagreb, Republic of rubber stopper and aluminum

Croatia cap), supplied in a box

10 glass nfusion bottles each Pliva Croatia Ltd., Ulica

contiaining 500 mL of grada Vukovara 49,

Soludeks 40 solution for infusion infusion solution and plastic YES YES

Zagreb, Republic of

holders for infusion bottles,

Croatia

supplied in a box

11 glass nfusion bottles each Pliva Croatia Ltd., Ulica

contiaining 500 mL of grada Vukovara 49,

Soludeks 70 solution for infusion infusion solution and plastic YES YES

Zagreb, Republic of

holders for infusion bottles,

Croatia

supplied in a box

Glass bottle with lyophilisate

Pfizer Manufacturing in a lower part and solvent SOLU-MEDROL injection lyophilisate and diluent

Belgium NV, Rijksweg (15.60 mL for reconstitution YES YES 1000 mg for solution for injection

12, Puurs, Belgium of lyophilisate), supplied in a

box

Glass bottle with lyophilisate Pfizer Manufacturing

SOLU-MEDROL injection lyophilisate and diluent in a lower part and solvent (2

Belgium NV, Rijksweg YES YES 125 mg for solution for injection mL) in the upper part,

12, Puurs, Belgium supplied in a box

Glass bottle with lyophilisate Pfizer Manufacturing

SOLU-MEDROL injection lyophilisate and diluent in a lower part and solvent (4

Belgium NV, Rijksweg YES YES 250 mg for solution for injection mL) in the upper part,

12, Puurs, Belgium supplied in a box

Glass bottle with lyophilisate Pfizer Manufacturing

SOLU-MEDROL injection lyophilisate and diluent in a lower part and solvent

Belgium NV, Rijksweg YES YES 40 mg for solution for injection (1mL) in the upper part,

12, Puurs, Belgium supplied in a box

Glass bottle with lyophilisate

Pfizer Manufacturing in a lower part and solvent SOLU-MEDROL injection lyophilisate and diluent

Belgium NV, Rijksweg (7.8 mL for reconstitution of YES YES 500 mg for solution for injection

12, Puurs, Belgium lyophilisate), supplied in a

box

Glass bottle of 6 mL with

powder and a glass bottle Pfizer Manufacturing

SOMAVERT injection 10 powder and diluent for with 8 mL of water for

Belgium NV, Rijksweg YES YES YES YES mg solution for injection injection 30 bottles with

12, Puurs, Belgium

powder and 30 bottles with

solvent, supplied in a box

Glass bottle of 6 mL with

powder and a glass bottle Pfizer Manufacturing

SOMAVERT injection 15 powder and diluent for with 8 mL of water for

Belgium NV, Rijksweg YES YES YES YES mg solution for injection injection 30 bottles with

12, Puurs, Belgium

powder and 30 bottles with

solvent, supplied in a box

Glass bottle of 6 mL with

powder and a glass bottle Pfizer Manufacturing

SOMAVERT injection 20 powder and diluent for with 8 mL of water for

Belgium NV, Rijksweg YES YES YES YES mg solution for injection injection 30 bottles with

12, Puurs, Belgium powder and 30 bottles with

solvent, supplied in a box

Glass bottle of 6 mL with

powder and a glass bottle Pfizer Manufacturing

SOMAVERT injection 20 powder and diluent for with 8 mL of water for

Belgium NV, Rijksweg YES YES YES YES mg solution for injection injection 1 bottle with powder

12, Puurs, Belgium and 1 bottle with solvent,

supplied in a box

Jadran - Galenski

laboratorij d.d., Pulac 28 (2x14) tablets in a PVC/Al Sonalia 50 mg film coated tablets YES YES

bb, Rijeka, Republic of blister, supplied in a box

Croatia

Gödecke GmbH,

Mooswaldalle 1,

Freiburg, Germany;

Heinrich Mack Nacf.

GmbH&Co.KG, 14 (2x7) tablets in a

Sortis 10 mg tablets film coated tablets Heinrich Mack Strasse (PA/Al/PVC//Al) blister, YES YES

35, Illertisen, Germany; supplied in a box

Pfizer Italia 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, 15 (2x7) tablets in a

Sortis 20 mg tablets film coated tablets Heinrich Mack Strasse (PA/Al/PVC//Al) blister, YES YES

35, Illertisen, Germany; supplied in a box

Pfizer Italia 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, 16 (2x7) tablets in a

Sortis 40 mg tablets film coated tablets Heinrich Mack Strasse (PA/Al/PVC//Al) blister, YES YES

35, Illertisen, Germany; supplied in a box

Pfizer Italia 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, 17 (2x7) tablets in a

Sortis 80 mg tablets film coated tablets Heinrich Mack Strasse (PA/Al/PVC//Al) blister, YES YES

35, Illertisen, Germany; supplied in a box

Pfizer Italia S.r.l.,

Strada statale 156, km

50, Borgo san Michele,

Latina, Italy

Lek farmacevtska 50 (5x10) amber glass

družba d.d., ampoules with 5 mL of Spasmex 0.2 mg/5 mL

solution for injection Verovškova 57, solution for injection in a YES YES injection

Ljubljana, Republic of plastic container, supplied in

Slovenia a box

Spasmex forte 5 mg Lek farmacevtska 20 (2x10) tablets in a blister tablets YES YES

tablets družba d.d., (PVC/PVDC//Al), supplied in

Verovškova 57, a box

Ljubljana, Republic of

Slovenia

Boehringer Ingelheim 30 capsules (3 blisters with

Spiriva 18 micrograms, Pharma GmbH & Co. 10 (2x5) capsules) in a blister inhalation powder, hard

inhalation powder, hard KG, Binger Strasse (Al/PVC/Al) and an inhaler YES YES YES capsules

capsule 173, Ingelheim am (HandiHaler), supplied in a

Rhein, Germany box

Orion Corporation 100 tablets in a plastic Stalevo 100 mg/25 mg/200

film coated tablets ORION PHARMA, (HDPE) bottle, supplied in a YES YES YES mg

Espoo, Finland box

Orion Corporation 100 tablets in a plastic Stalevo 150 mg/37.5

film coated tablets ORION PHARMA, (HDPE) bottle, supplied in a YES YES YES mg/200 mg

Espoo, Finland box

Orion Corporation 100 tablets in a plastic Stalevo 50 mg/12.5

film coated tablets ORION PHARMA, (HDPE) bottle, supplied in a YES YES YES mg/200 mg

Espoo, Finland box

One glass vial with a single

dose of lyophilized vaccine

STAMARIL, attenuated Sanofi Pasteur S.A., 2 powder and diluent for and a pre-filled glass syringe

vaccine against yellow avenue Pont Pasteur, YES suspension for injection with fixed needle containing

fever , 1 dose Lyon, France

0.5mL of diluent, supplied in

a box

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 28 (2x14) tablets in a blister, Starcitin tablets 10 mg film tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 28 (2x14) tablets in a blister, Starcitin tablets 20 mg film tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 28 (4x7) tablets in a blister, Starcitin tablets 40 mg film tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, Box with 20 tablets (blister, Statex 20 film tablets YES YES

Zagreb, Republic of 2x10 tbl.)

Croatia

Wyeth Medica

21 (1x21) tablets in PVC/Al

Stediril-d sugar coated Republic of Ireland,

sugar coated tablets blister, supplied in a carton YES YES

tablets Newbridge, Republic of

box

Ireland

Wyeth Medica

Republic of Ireland,

Newbridge, Republic of 21 (1x21) tablets in PVC/Al Stediril-m sugar coated

sugar coated tablets Ireland or Haupt blister, supplied in a carton YES YES tablets

Pharma Munster box

GmbH, Munster, SR

Germany

Wyeth Medica

Republic of Ireland,

Newbridge, Republic of 21 (1x21) tablets in PVC/Al Stediril-m sugar coated

sugar coated tablets Ireland or Haupt blister, supplied in a carton YES YES tablets

Pharma Munster box

GmbH, Munster, SR

Germany

Merck Sharp & Dohme 30 capsules in a HDPE bottle

B.V., Waarderweg 39, Stocrin 100 mg capsules capsules with a PP stopper, supplied YES YES YES YES

Postbus 581, Haarlem, in a box

the Netherlands

Merck Sharp & Dohme 90 tablets in a plastic (HDPE)

STOCRIN 200 mg film B.V., Waarderweg 39, film coated tablets bottle with a temper-evident YES YES YES YES

coated tablets Postbus 581, Haarlem, stopper, supplied in a box the Netherlands

Merck Sharp & Dohme

90 capsules in a HDPE bottle

B.V., Waarderweg 39,

Stocrin 200 mg capsules capsules with a PP stopper, supplied YES YES YES YES

Postbus 581, Haarlem,

in a box

the Netherlands

Merck Sharp & Dohme 30 tablets in a plastic (HDPE)

STOCRIN 50 mg film B.V., Waarderweg 39, bottle with a temper-evident film coated tablets YES YES YES YES

coated tablets Postbus 581, Haarlem, stopper and desiccant,

the Netherlands supplied in a box

Merck Sharp & Dohme

30 capsules in a HDPE bottle

B.V., Waarderweg 39,

Stocrin 50 mg capsules capsules with a PP stopper, supplied YES YES YES YES

Postbus 581, Haarlem,

in a box

the Netherlands

Merck Sharp & Dohme 30 tablets in a plastic (HDPE)

STOCRIN 600 mg film B.V., Waarderweg 39, bottle with a temper-evident film coated tablets YES YES YES YES

coated tablets Postbus 581, Haarlem, stopper and desiccant,

the Netherlands supplied in a box

Bosnalijek d.d., 200 mL of solution in an

Jukićeva 53, Sarajevo, amber glass bottle with STOMATIDIN solution solution YES YES YES

Bosnia and aluminum cap, supplied in a

Herzegovina carton box

Eli Lilly and Company 7 (1x7) capsules in a

STRATTERA 10 mg hard Limited, Basingstoke, capsules, hard PVC/PE/PCTFE/Al blister, YES YES YES YES

capsules Hampshire, Great supplied in a box

Britain

Eli Lilly and Company 7 (1x7) capsules in a

STRATTERA 18 mg hard Limited, Basingstoke, capsules, hard PVC/PE/PCTFE/Al blister, YES YES YES YES

capsules Hampshire, Great supplied in a box

Britain

Eli Lilly and Company 28 (2x14) capsules in a

STRATTERA 25 mg hard Limited, Basingstoke, capsules, hard PVC/PE/PCTFE/Al blister, YES YES YES YES

capsules Hampshire, Great supplied in a box

Britain

Eli Lilly and Company 28 (2x14) capsules in a

STRATTERA 40 mg hard Limited, Basingstoke, capsules, hard PVC/PE/PCTFE/Al blister, YES YES YES YES

capsules Hampshire, Great supplied in a box

Britain

Eli Lilly and Company 28 (2x14) capsules in a

STRATTERA 60 mg hard Limited, Basingstoke, capsules, hard PVC/PE/PCTFE/Al blister, YES YES YES YES

capsules Hampshire, Great supplied in a box

Britain

Reckitt Benckiser

Healthcare

STREPSILS sugar-free International Ltd., 16 lozenges (2x8) in a blister, lozenges YES YES YES

lozenges, lemon flavour Thane Road, supplied in a box

Nottingham, Great

Britain

Reckitt Benckiser

Healthcare

Strepsils sugar-free International Ltd., 16 (2x8) lozenges in a blister, lozenges YES YES YES

lozenges, lemon flavour Thane Road, supplied in a box

Nottingham, Great

Britain

Reckitt Benckiser

Healthcare 24 (2X12) lozenges in a

Strepsils lozenges - honey International Ltd., lozenges blister (PVC/PVDC-Al), YES YES YES

and lemon Thane Road, supplied in a box

Nottingham, Great

Britain

Reckitt Benckiser

Healthcare 12 (1x12) lozenges in

Strepsils honey and lemon International Ltd., lozenges PVC/PVDC-Al blister, YES YES YES

lozenges Thane Road, supplied in a tin box

Nottingham, Great

Britain

Reckitt Benckiser Strepsils honey and lemon 12 (1x12) lozenges in a

lozenges Healthcare YES YES YES lozenges blister, supplied in a tin box

International Ltd., Thane Road,

Nottingham, Great

Britain

Reckitt Benckiser

Healthcare

Strepsils lozenges - International Ltd., 24 (2X12) lozenges in a lozenges YES YES YES

menthol and eucalyptus Thane Road, blister, supplied in a box

Nottingham, Great

Britain

Reckitt Benckiser

Healthcare 24 (2X12) lozenges in a

Strepsils lozenges - International Ltd., lozenges blister (PVC/PVDC-Al), YES YES YES

menthol and eucalyptus Thane Road, supplied in a box

Nottingham, Great

Britain

Reckitt Benckiser

Healthcare 24 (2X12) lozenges in a

Strepsils lozenges - International Ltd., lozenges blister (PVC/PVDC-Al), YES YES YES

orange with vitamin C Thane Road, supplied in a box

Nottingham, Great

Britain

Reckitt Benckiser

Healthcare

Strepsils lozenges - International Ltd., 24 (2X12) lozenges in a lozenges YES YES YES

orange with vitamin C Thane Road, blister, supplied in a box

Nottingham, Great

Britain

Reckitt Benckiser

Healthcare

International Ltd., 24 (2X12) lozenges in a Strepsils original lozenges lozenges YES YES YES

Thane Road, blister, supplied in a box

Nottingham, Great

Britain

Reckitt Benckiser

Healthcare

International Ltd., 24 (2X12) lozenges in a Strepsils original lozenges lozenges YES YES YES

Thane Road, blister, supplied in a box

Nottingham, Great

Britain

Reckitt Benckiser

Healthcare

International Ltd., 24 (2X12) lozenges in a Strepsils Plus lozenges lozenges YES YES YES

Thane Road, blister, supplied in a box

Nottingham, Great

Britain

Reckitt Benckiser

Healthcare 24 (2X12) lozenges in a

International Ltd., Strepsils Plus lozenges lozenges blister (PVC/PVDC-Al), YES YES YES

Thane Road, supplied in a box

Nottingham, Great

Britain

Plastic bag ("Excel")

containing 500 mL of

emulsion for infusion with two

attachments for drug

Fresenius Kabi AB, administration and for Structolipid 20% emulsion for infusion YES YES YES

Uppsala, Sweden infusion, one small bag

containing oxygen absorber,

and one bag with solution for

packaging airtightness

control

Plastic bag ("Excel")

containing 250 mL of

Fresenius Kabi AB, emulsion for infusion with two Structolipid 20% emulsion for infusion YES YES YES

Uppsala, Sweden attachments for drug

administration and for

infusion, one small bag containing oxygen absorber,

and one bag with solution for

packaging airtightness

control

Krka d.d., Novo mesto,

Republic of Slovenia in

cooperation with 50 (5x10) tablets in a PVC/Al Stugeron forte tablets tablets YES YES

Janssen blister, supplied in a box

Pharmaceutica,

Beerse, Belgium

Reckitt Benckiser

Healthcare (UK)

7 (1x7) tablets in a

Subutex 0.4 mg sublingual Limited, East

sublingual tablets PVC/PVDC-Al blister, YES YES YES

tablets Yorkshire, Great Britain

supplied in a box

for Schering-Plough

Corporation, USA

Reckitt Benckiser

Healthcare (UK)

7 (1x7) tablets in a

Subutex sublingvalne Limited, East

sublingual tablets PVC/PVDC-Al blister, YES YES YES

tablets 2 mg Yorkshire, Great Britain

supplied in a box

for Schering-Plough

Corporation, USA

Reckitt Benckiser

Healthcare

Subutex sublingvalne International Ltd., sublingual tablets 7 tablets, supplied in a box YES YES YES

tablets 8 mg Thane Road,

Nottingham, Great

Britain

Reckitt Benckiser

Healthcare (UK)

7 (1x7) tablets in a

Subutex sublingvalne Limited, East

sublingual tablets PVC/PVDC-Al blister, YES YES YES

tablets 8 mg Yorkshire, Great Britain

supplied in a box

for Schering-Plough

Corporation, USA

Pliva Croatia Ltd., Ulica 10 mL of solution in a PE

grada Vukovara 49, bottle with dropper Sulfasol 4% eye drops, solution YES YES

Zagreb, Republic of attachment and PP cap,

Croatia supplied in a box

Belupo, lijekovi i

kozmetika d.d., Ulica 20 (1x20) tablets in a PVC/Al Sulotrim 100/20 mg tablets tablets YES YES

Danica 5, Koprivnica, blister, supplied in a box

Republic of Croatia

Belupo, lijekovi i 20 tablets in an amber glass

kozmetika d.d., Ulica Sulotrim 400/80 mg tablets tablets bottle, supplied in a carton YES YES

Danica 5, Koprivnica, box

Republic of Croatia

Belupo, lijekovi i 20 tablets in an amber glass

Sulotrim Forte 800/160 mg kozmetika d.d., Ulica tablets bottle, supplied in a carton YES YES tablets Danica 5, Koprivnica,

box Republic of Croatia

Belupo, lijekovi i 100 mL of suspension in an

kozmetika d.d., Ulica amber glass bottle and a Sulotrim oral suspension oral suspension YES YES

Danica 5, Koprivnica, plastic measuring spoon,

Republic of Croatia supplied in a box

Belupo, lijekovi i 2 mL of solution for injection

Sulpirid 100 mg/2 mL kozmetika d.d., Ulica solution for injection in a glass ampoule, 6 YES YES injection Danica 5, Koprivnica,

ampoules in a box Republic of Croatia

Belupo, lijekovi i 12 capsules in a plastic bottle

kozmetika d.d., Ulica Sulpirid 200 mg capsules capsules with closure, supplied in a YES YES

Danica 5, Koprivnica, box

Republic of Croatia

Belupo, lijekovi i

30 (2x15) capsules in a

kozmetika d.d., Ulica

Sulpirid 50 mg capsules capsules PVC/Al blister, supplied in a YES YES

Danica 5, Koprivnica,

box

Republic of Croatia

One HDPE bottle with

Pliva Croatia Ltd., Ulica

powder, one plastic spoon

powder for preparation of grada Vukovara 49,

Sumamed forte syrup and one plastic syringe for YES YES

oral suspension Zagreb, Republic of

dose delivery, supplied in a

Croatia

box

Pliva Croatia Ltd., Ulica

powder for solution for grada Vukovara 49, 5 glass bottles with powder, Sumamed injection YES YES

infusion Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 6 (1x6) capsules in a

grada Vukovara 49, Sumamed capsules capsules PVC/PVDC//Al blister, YES YES

Zagreb, Republic of

supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

Sumamed S capsules 250 grada Vukovara 49, capsules Box with 4 capsules (blister) YES YES

mg Zagreb, Republic of

Croatia

Pliva Croatia Ltd., Ulica

Sumamed S tablets 500 grada Vukovara 49, Box with 2 film tablets film tablets YES YES

mg Zagreb, Republic of (blister)

Croatia

One HDPE bottle with Pliva Croatia Ltd., Ulica

powder, one plastic spoon powder for preparation of grada Vukovara 49,

Sumamed syrup and one plastic syringe for YES YES oral suspension Zagreb, Republic of

dose delivery, supplied in a Croatia

box

One HDPE bottle with Pliva Croatia Ltd., Ulica

powder, one plastic spoon powder for preparation of grada Vukovara 49,

Sumamed syrup 1200 and one plastic syringe for YES YES oral suspension Zagreb, Republic of

dose delivery, supplied in a Croatia

box

One HDPE bottle with Pliva Croatia Ltd., Ulica

powder, one plastic spoon powder for preparation of grada Vukovara 49,

Sumamed syrup 1200 XL and one plastic syringe for YES YES oral suspension Zagreb, Republic of

dose delivery, supplied in a Croatia

box

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 6 (1x6) tablets in a PVC/Al Sumamed tablets 125 mg film coated tablets YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 4 (1x3) tablets in a PVC/Al Sumamed tablets 500 mg film coated tablets YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 200 mL of syrup in an amber

grada Vukovara 49, glass bottle with aluminum Supremin syrup YES YES

Zagreb, Republic of cap and a 5-mL polystyrene

Croatia spoon, supplied in a box

Pfizer Italia S.r.l., 30 capsules in a plastic

Sutent 12.5 mg capsules capsules, hard Marina del Tronto, (HDPE) bottle with a plastic YES YES YES YES

Ascoli Piceno, Italy stopper, supplied in a box

Pfizer Italia S.r.l., 30 capsules in a plastic

Sutent 25 mg capsules capsules, hard Marina del Tronto, (HDPE) bottle with a plastic YES YES YES YES

Ascoli Piceno, Italy stopper, supplied in a box

Pfizer Italia S.r.l., 30 capsules in a plastic

Sutent 50 mg capsules capsules, hard Marina del Tronto, (HDPE) bottle with a plastic YES YES YES YES

Ascoli Piceno, Italy stopper, supplied in a box

AstraZeneca 120 doses in a plastic inhaler

Symbicort Turbuhaler Södertälje, Sweden or inhalation powder with mouthpiece, supplied in YES YES

160/4.5 µg AstraZeneca GmbH, a box

Plankstadt, Germany

AstraZeneca AB, S-

151-85 Södertälje, 60 doses in a plastic inhaler Symbicort Turbuhaler

inhalation powder Sweden; AstraZeneca with a mouthpiece, supplied YES YES 160/4.5 µg

GmbH, D-68721 in a box

Plankstadt, Germany AstraZeneca AB, S-

151-85 Södertälje, 60 doses in a plastic inhaler Symbicort Turbuhaler

inhalation powder Sweden; AstraZeneca with a mouthpiece, supplied YES YES 320/9 µg

GmbH, D-68721 in a box

Plankstadt, Germany

AstraZeneca AB, S-

151-85 Södertälje, 60 doses in a plastic inhaler Symbicort Turbuhaler

inhalation powder Sweden; AstraZeneca with a mouthpiece, supplied YES YES 80/4.5 µg

GmbH, D-68721 in a box

Plankstadt, Germany

AstraZeneca

120 doses in a plastic inhaler

Symbicort Turbuhaler Södertälje, Sweden or

inhalation powder with mouthpiece, supplied in YES YES

80/4.5 µg AstraZeneca GmbH,

a box

Plankstadt, Germany

Abbott S.p.A., Via Box with one bottle with 100

Synagis 100 mg powder lyophilisate and diluent Pontina 52, I-04010 mg of preparation, 1 mL of

YES YES YES and diluent for injections for preparation of solution Campoverde di Aprilia solvent in an ampoule and a

(Latina), Italy leaflet

Abbott S.p.A., Via

Box with one bottle with 50

Synagis 50 mg powder lyophilisate and diluent Pontina 52, I-04010

mg of preparation and 1 mL YES YES YES

and diluent for injections for preparation of solution Campoverde di Aprilia

of solvent in an ampoule

(Latina), Italy

Pliva Croatia Ltd.,

Zagreb, Republic of 2 mL of solution for injecion

Synopen injection solution for injection Croatia in cooperation in an ampoule, 10 ampoules YES YES

with Novartis, Basel, in a box

Switzerland

Pliva Croatia Ltd.,

Zagreb, Republic of

20 grams of ointment in an Al

Synopen ointment ointment Croatia in cooperation YES YES

tube, supplied in a box

with Novartis, Basel,

Switzerland

Novartis Pharma Stein solution for

AG, Box with 10 ampoules with 1 Syntocinon 5 IU injection intramuscular/intravenous YES YES

Schaffhauserstrasse, mL of solution injection

Stein, Switzerland

Novartis Pharma

S.A.S., Huningue Bottle with 5 mL of solution

Syntocinon aerosol nasal aerosol Cedex, France for with a spray attachment, YES YES

Novartis Pharma AG, supplied in a box

Basel, Switzerland

Belupo, lijekovi i 100 mL of syrup in an amber

kozmetika d.d., Ulica glass bottle and a 5-mL Tabex forte syrup syrup YES YES YES

Danica 5, Koprivnica, plastic measuring spoon,

Republic of Croatia supplied in a box

Belupo, lijekovi i 100 mL of syrup in an amber

kozmetika d.d., Ulica glass bottle and a 5-mL Tabex syrup syrup YES YES YES

Danica 5, Koprivnica, plastic measuring spoon,

Republic of Croatia supplied in a box

One collagen sponge for

Nycomed Austria wound dressing (2.5x3.0x0.5

TachoComb 2.5x3.0x0.5 spongy absorbent wound GmbH, St. Petercm) in a double package

YES cm dressing Strasse 25, Linz, (plastic foil/alufoil) and a

Austria silicagel bag, supplied in a

box

One collagen sponge for

Nycomed Austria wound dressing (9.5x4.8x0.5

TachoComb 9.5x4.8x0.5 spongy absorbent wound GmbH, St. Petercm) in a double package

YES cm dressing Strasse 25, Linz, (plastic foil/alufoil) and a

Austria silicagel bag, supplied in a

box

One collagen sponge for Nycomed Austria

wound dressing (2.5x3.0x0.5 spongy absorbent wound GmbH, St. Peter

TachoSil 2.5x3.0x0.5 cm cm) in a double package YES dressing Strasse 25, Linz,

(blister) and a silicagel bag, Austria

supplied in a box One collagen sponge for

Nycomed Austria

wound dressing (9.5x4.8x0.5

spongy absorbent wound GmbH, St. Peter

TachoSil 9.5x4.8x0.5 cm cm) in a double package YES

dressing Strasse 25, Linz,

(blister) and a silicagel bag,

Austria

supplied in a box

Laboratoires Fournier 60 (6x10) soft capsules in a

Tadenan capsules, soft S.A., Fontaine Les blister (PVC/Al), supplied in a YES YES

Dijon, France box

10 mL of suspension (200 Lek farmacevtska

inhalation doses) in a brown družba d.d.,

glass bottle with a plastic

Tafen 50 µg nasal spray nasal spray, suspension Verovškova 57, YES YES atomizer pump and plastic Ljubljana, Republic of

protective cap, supplied in a Slovenia

box

Lek d.d., Ljubljana,

One cartridge with 2.18 g of

Republic of Slovenia in

Tafen Novolizer 200 µg powder on average (teh

inhalation powder cooperation with YES YES

inhalation powder cartridge contains 200 doses

Sofotec GmbH &

of powder), supplied in a box

Co.KG, Germany

Lek d.d., Ljubljana, One inhaler and one

Republic of Slovenia in cartridge with approx. 2.18 g Tafen Novolizer 200 µg

inhalation powder cooperation with of powder (the cartridge YES YES powder for inhalation

Sofotec GmbH & contains 200 doses of

Co.KG, Germany powder), supplied in a box

Krka d.d., Šmarješka Tagren 250 mg film coated 40 (3x10) tablets in a PVC/Al

film coated tablets cesta 6, Novo mesto, YES YES tablets blister, supplied in a box

Republic of Slovenia

30 g of powder for oral

suspension in a glass bottle

with a plastic temper-evident F. Hoffmann-La Roche

stopper, a plastic measuring Ltd.,

Tamiflu 12 mg/mL powder powder for preparation of cup for solvent, a plastic

Grenzacherstrasse YES YES YES YES for oral suspension oral suspension attachment affixed to the

124, Basel,

bottle and a plastic syringe

Switzerland

for application of oral

suspension, supplied in a

box

F. Hoffmann-La Roche

Ltd., Tamiflu 75 mg hard 10 (1x10) capsules in a

hard capsules Grenzacherstrasse YES YES YES YES capsules blister, supplied in a box

124, Basel,

Switzerland

Belupo, lijekovi i 30 (2x15) capsules in a

Tamosin 0.4 mg extendedprolonged-release kozmetika d.d., Ulica

PVC/PVDC//Al blister, YES YES release capsules capsules, hard Danica 5, Koprivnica,

supplied in a box Republic of Croatia

30 mL of solution in an

amber glass bottle with a Beaufor Ipsen

Tanakan 40 mg/mL oral plastic stopper and 1 mL oral solution Industrie, Dreux, YES YES

solution measuring plastic syringe

France with a protective casing,

supplied in a box

Beaufor Ipsen 90 (6x15) film coated tablets Tanakan film coated

film coated tablets Industrie, Dreux, in a PVC/Al blister, supplied YES YES tablets

France in a box

10 individually paper A.C.R.A.F. S.p.A., Via

wrapped lozenges in a Vecchia del Pinocchio,

Tantum Lemon lozenges lozenges protective PE/paper/Al YES YES YES 22, 60131 Ancona,

wrapping, 20 (2x10) Italy

lozenges in a box

1000 mL of solution in a Sanochemia

Tantum Verde gargling plastic bottle with temperoromucosal solution Pharmazeutika AG, YES YES YES

solution proof closure and metering

Neufeld/Leitha, Austria pump, supplied in a box

Sanochemia 1000 mL of solution in a Tantum Verde gargling

oromucosal solution Pharmazeutika AG, plastic bottle with temper YES YES YES solution

Neufeld/Leitha, Austria proof closure, supplied in a box

150 mL of solution in a Sanochemia

Tantum Verde gargling plastic bottle with temperoromucosal solution Pharmazeutika AG, YES YES YES

solution proof closure and atomizer

Neufeld/Leitha, Austria pump, supplied in a box

150 mL of solution in a Sanochemia

Tantum Verde gargling plastic bottle with temperoromucosal solution Pharmazeutika AG, YES YES YES

solution proof closure cap, supplied in

Neufeld/Leitha, Austria a box

Sanochemia 60 mL of solution in a glass Tantum Verde gargling

oromucosal solution Pharmazeutika AG, bottle with a temper--evident YES YES YES solution

Neufeld/Leitha, Austria stopper, supplied in a box

11 individually paper A.C.R.A.F. S.p.A., Via

wrapped lozenges in a Vecchia del Pinocchio,

Tantum Verde lozenges lozenges protective PE/paper/Al YES YES YES 22, 60131 Ancona,

wrapping, 20 (2x10) Italy

lozenges in a box

A.C.R.A.F. S.p.A., Via

30 mL of solution in a plastic

Tantum Verde spray Vecchia del Pinocchio,

oromucosal spray bottle with a spray YES YES YES

0.15% 22, 60131 Ancona,

attachment, supplied in a box

Italy

A.C.R.A.F. S.p.A., Via

15 mL of solution in a plastic

Tantum Verde spray Vecchia del Pinocchio,

oromucosal spray bottle with nebullizer YES YES YES

0.30% 22, 60131 Ancona,

attachment, supplied in a box

Italy

Krka d.d., Šmarješka 60 (6x10) capsules in a prolonged release

TANYZ 0.4 mg cesta 6, Novo mesto, PVC/PE/PVDC/Al blister, YES YES YES YES capsules

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 30 (3x10) capsules in a prolonged-release

TANYZ 0.4 mg cesta 6, Novo mesto, PVC/PE/PVDC/Al blister, YES YES YES YES capsules

Republic of Slovenia supplied in a box

F. Hoffmann-La Roche

Ltd., 30 (3x10) film coated tablets Tarceva 100 mg film

film coated tablets Grenzacherstrasse in a blister (PVC/Al) , YES YES YES coated tablets

124, Basel, supplied in a box

Switzerland

F. Hoffmann-La Roche

Ltd., 30 (3x10) film coated tablets Tarceva 150 mg film

film coated tablets Grenzacherstrasse in a blister (PVC/Al), supplied YES YES YES coated tablets

124, Basel, in a box

Switzerland

F. Hoffmann-La Roche

Ltd., 30 (3x10) film coated tablets Tarceva 25 mg film coated

film coated tablets Grenzacherstrasse in a blister (PVC/Al) , YES YES YES tablets

124, Basel, supplied in a box

Switzerland

Belupo, lijekovi i

kozmetika d.d., Ulica 7 capsules in an amber glass Target 10 capsules YES YES YES

Danica 5, Koprivnica, bottle, supplied in a box

Republic of Croatia

Belupo, lijekovi i 14 capsules in an amber

kozmetika d.d., Ulica Target Plus capsules capsules glass bottle, supplied in a YES YES

Danica 5, Koprivnica, box

Republic of Croatia

Vial with powder and powder for preparation of Gruppo Lepetit S.p.A,

Targocid 200 mg ampoule with diluent YES YES solution for injection Anagni, Italy

supplied in a box

Vial with powder and powder for preparation of Gruppo Lepetit S.p.A,

Targocid 400 mg ampoule with diluent YES YES solution for injection Anagni, Italy

supplied in a box

Abbott GmbH & Co. 28 capsules (2x14) in a

Tarka capsules KG, Ludwigshafen, PVC/Al blister , supplied in a YES YES

Germany box

Abbott GmbH & Co. 28 (2x14) modified-release Tarka 180 mg/2 mg tablets modified-release tablets YES YES

KG, Ludwigshafen, tablets in a blister Germany (PVC/PVDC//Al) , supplied in

a box

28 (2x14) modified-release Abbott GmbH &

TARKA 240 mg/2 mg tablets in a blister modified-release tablets Co.KG., Ludwigshafen, YES YES

tablets (PVC/PVDC//Al) , supplied in

Germany a box

28 (2x14) modified-release Abbott GmbH &

TARKA 240 mg/4 mg tablets in a blister modified-release tablets Co.KG., Ludwigshafen, YES YES

tablets (PVC/PVDC//Al) , supplied in

Germany a box

Aventis Pharma

Deutschland GmbH,

10 tablets in a blister,

Tavanic 250 mg tablets film tablets Brunningstrasse 50, YES YES YES

supplied in a box

Frankfurt am Main,

Germany

Aventis Pharma

Deutschland GmbH,

10 tablets in a blister,

Tavanic 500 mg tablets film tablets Brunningstrasse 50, YES YES YES

supplied in a box

Frankfurt am Main,

Germany

Aventis Pharma

Deutschland GmbH, solution for intravenous 100 mL of solution in a glass Tavanic i.v. 500 mg Brunningstrasse 50, YES YES YES

infusion bottle, supplied in a box Frankfurt am Main,

Germany

Bristol Myers-Squibb One glass vial with 16.7 mL Taxol injection 100 mg / concentrate for solution

S.r.I., Sermoneta, of solution concentrate, YES YES YES 16.7 mL for infusion

Latina, Italy supplied in a carton box

Bristol Myers-Squibb One glass vial with 5 mL of Taxol injection 30 mg / 5 concentrate for solution

S.r.I., Sermoneta, solution concentrate, YES YES YES mL for infusion

Latina, Italy supplied in a carton box

Bristol Myers-Squibb One glass vial with 50 mL of Taxol injection 300 mg / 50 concentrate for solution

S.r.I., Sermoneta, solution concentrate, YES YES YES mL for infusion

Latina, Italy supplied in a carton box

One glass vial with 0.5 mL of Aventis Pharma

concentrate and one glass concentrate for solution Dagenham,

Taxotere 20 mg vial containing 1.5 mL of YES YES for infusion Dagenham, Essex,

diluent in a blister, supplied Great Britain

in a box

Aventis Pharma One glass vial with 2 mL of

concentrate for solution Dagenham, concentrate and one glass Taxotere 80 mg YES YES

for infusion Dagenham, Essex, vial with 6mL of diluent in a

Great Britain blister, supplied in a box

Clear glass 72-mL bottle with

Wyeth Lederle S.p.A., 4.5 g of lyophilisate equipped

powder for preparation of Catania, Italy; Wyeth with a grey bromobutyl Tazocin 4.5 g injection for

solution for injection or Laboratories, New stopper and flip-off cap of YES YES intravenous use

infusion Lane, Havant, Great aluminum and plastic

Britain coloured pink, supplied in a

box

Guerbet, Cedex, Vial with 50 mL of solution, Telebrix 35 solution for injection YES YES

France supplied in a box

Aventis Pharma

Deutschland GmbH,

10 tablets in a blister,

Telfast 120 mg film coated tablets Brunningstrasse 50, YES YES

supplied in a box

Frankfurt am Main,

Germany

Aventis Pharma

Deutschland GmbH,

10 tablets in a blister,

Telfast 180 mg film coated tablets Brunningstrasse 50, YES YES

supplied in a box

Frankfurt am Main,

Germany

Aventis Pharma S.p.A., 60 (4x15) tablets in a blister,

Telfast 30 mg film coated tablets S.S. 17 KM 22, YES YES supplied in a box

Scoppito, Italy Schering-Plough Labo 5 capsules in a glass bottle N.V. Industrepark 30,

Temodal capsules 100 mg capsules, hard with a plastic stopper, YES YES

Heist-op-den-Berg, supplied in a box

Belgium

Schering-Plough Labo 5 capsules in a glass bottle

N.V. Industrepark 30, Temodal capsules 20 mg capsules, hard with a plastic stopper, YES YES

Heist-op-den-Berg, supplied in a box

Belgium

Schering-Plough Labo 5 capsules in a glass bottle

N.V. Industrepark 30, Temodal capsules 250 mg capsules, hard with a plastic stopper, YES YES

Heist-op-den-Berg, supplied in a box

Belgium

Schering-Plough Labo 5 capsules in a glass bottle

N.V. Industrepark 30, Temodal capsules 5 mg capsules, hard with a plastic stopper, YES YES

Heist-op-den-Berg, supplied in a box

Belgium

powder for preparation of Pliva Krakow, Krakow, 5 (10 mL) glass bottles with

Tenicef 0.5 g injection solution for i.v. and i.m. YES YES Poland powder, supplied in a box

injection

powder for preparation of Pliva Krakow, Krakow, 5 (15 mL) glass bottles with

Tenicef 1g injection solution for i.v. and i.m. YES YES Poland powder, supplied in a box

injection

powder for preparation of Pliva Krakow, Krakow, 5 (15 mL) glass bottles with

Tenicef 2g injection injection/infusion solution YES YES Poland powder, supplied in a box

for i.v. use

AstraZeneca UK

Limited, Silk Road 28 (2x14) film coated tablets

Tenormin 100 mg tablets film coated tablets Business Park, in a blister (PVC/PVDC//Al), YES YES

Macclesfield, Cheshire, supplied in a box

Great Britain

AstraZeneca UK

Limited, Silk Road 29 (2x14) film coated tablets

Tenormin 50 mg tablets film coated tablets Business Park, in a blister (PVC/PVDC//Al), YES YES

Macclesfield, Cheshire, supplied in a box

Great Britain

Krka d.d., Novo Mesto,

Republic of Slovenia; 30 (3x10) tablets in a blister,

Tenox 10 mg tablets tablets Krka Farma d.o.o., YES YES supplied in a box

DPC Jastrebarsko,

Republic of Croatia

Krka d.d., Novo Mesto,

Republic of Slovenia; 30 (3x10) tablets in a blister,

Tenox 5 mg tablets tablets Krka Farma d.o.o., YES YES supplied in a box

DPC Jastrebarsko,

Republic of Croatia

Lek farmacevtska Teolin retard 125 mg 40 tablets in a glass bottle,

prolonged-release tablets družba d.d., Ljubljana, YES YES tablets supplied in a carton box

Republic of Slovenia

Lek farmacevtska 40 (4x10) tablets in a PVC/Al Teolin retard 300 mg

prolonged-release tablets družba d.d., Ljubljana, blister, supplied in a carton YES YES tablets

Republic of Slovenia box

Krka d.d., Novo mesto,

Šmarješka cesta 6, Teotard 200 mg 40 (4x10) capsules in a

prolonged-release Republic of Slovenia in prolonged-release blister (PVC/Al), supplied in a YES YES

capsules, hard cooperation with capsules box

Astellas Pharma

GmbH, Germany

Krka d.d., Novo mesto,

Šmarješka cesta 6, 40 (4x10) capsules in a

Teotard capsules prolonged-release Republic of Slovenia in blister (PVC/Al), supplied in a YES YES

prolonged-release 350 mg capsules, hard cooperation with box

Astellas Pharma

GmbH, Germany

Les Laboratories 30 (1x30) tablets in a

Servier Industrie, 905 Tertensif film coated tablets PVC/Alu blister , supplied in YES YES

route de Saran, 45520 a box

Gidy, France Les Laboratories

sustained-release film Servier Industrie, 905 Box with 30 tablets (2x15) in Tertensif SR YES YES

tablets route de Saran, 45520 a blister

Gidy, France

Imunološki zavod d.d.,

Tetanus antitoxin (equine) solution for parenteral Rockefellerova 2, Box with 1 ampoule with

YES 1500 IU use Zagreb, Republic of 1500 IU of preparation

Croatia

Imunološki zavod d.d.,

Tetanus antitoxin (equine) solution for parenteral Rockefellerova 2, Box with 50 ampoules each

YES 1500 IU use Zagreb, Republic of with 1500 IU of preparation

Croatia

Imunološki zavod d.d.,

Tetanus antitoxin (equine) solution for parenteral Rockefellerova 2, Box with 50 ampoules each

YES 3000 IU use Zagreb, Republic of with 3000 IU of preparation

Croatia

Imunološki zavod d.d.,

Tetanus antitoxin (equine) solution for parenteral Rockefellerova 2, Box with 1 ampoule with

YES 3000 IU use Zagreb, Republic of 3000 IU of preparation

Croatia

TETRAct - HIB, combined lyophilisate and

Box with 1 bottle containing

diphtheria, tetanus, suspension for Sanofi Pasteur S.A., 2 lyophilisate and 1 glass pertussis and preparation of avenue Pont Pasteur, YES

syringe with 0.5 mL of

Haemophilus influenzae suspension for i.m. and Lyon, France suspension

type B vaccine deep subcutaneoud use

TETRAXIM diphtheria,

tetanusa, pertussis Sanofi Pasteur S.A., 2 Glass syringe with a needle

(acellular) and suspension for injections avenue Pont Pasteur, containing 0.5 mL of YES

poliomyelitis (inactivated) Lyon, France suspension for injections

vaccine , absorbed

Solvay 30 (2x14) film coated tablets

Pharmaceuticals B.V., TEVETEN 600 mg film coated tablets in a blister (PVC/Aclar//Al), YES YES

Weesp, the supplied in a box

Netherlands

Solvay

Pharmaceuticals B.V., 28 (2x14) tablets in a blister

TEVETEN 600 mg film coated tablets C.J. van Houtenlaan (PVC/Aclar/Al), supplied in a YES YES YES

36, 1381 CP Weesp, box

the Netherlands

Solvay

Pharmaceuticals

28 (2x14) tablets in a

GmbH, Hannover,

nontransparent

Teveten plus film coated tablets Germany Solvay YES YES YES

PVC/Aclar/Alu blister,

Pharmaceuticals B.V.,

supplied in a box

Weesp, the

Netherlands

Genzyme Ltd., 37 Clear type I glass 5-mL vials

Thyrogen 0.9 mg powder powder for solution for Hollands Road, with siliconized butyl stopper

YES YES YES YES for solution for injection injection Haverhill, Suffolk CB9 with tamper proof flip-off cap,

8PU, Great Britain supplied in a box

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 40 (4x10) capsules in blister TIAREN capsules YES YES

Zagreb, Republic of (PVC/Al), supplied in a box

Croatia

Merck Sharp & Dohme 5 (115 mL) glass bottles with

powder for preparation of B.V., Waarderweg 39, Tienam i.v. Infusion powder for solution for YES YES

solution for infusion Postbus 581, Haarlem,

infusion, supplied in a box

The Nederlands

Jadran - Galenski

laboratorij d.d., Pulac Box with 5 mL of solution in a Timalen 0.25% eyel drops eye drops YES YES

bb, Rijeka, Republic of plastic bottle with a dropper

Croatia

Jadran - Galenski

laboratorij d.d., Pulac Box with 5 mL of solution in a Timalen 0.5% eyel drops eye drops YES YES

bb, Rijeka, Republic of plastic bottle with a dropper

Croatia Pliva Croatia Ltd., Ulica 40 (4x10) lozenges in an

grada Vukovara 49, orange blister

TINIDIL sublingual tablets YES YES Zagreb, Republic of (PVC/PVDC//Al), supplied in

Croatia a box

Belupo, lijekovi i 60 (3x20) tablets in a blister

kozmetika d.d., Ulica TIRAMAT 100 mg tablets film coated tablets (PVC/PE/PVDC//AI), YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i 60 (5x12) tablets in a blister

kozmetika d.d., Ulica TIRAMAT 200 mg tablets film coated tablets (PVC/PE/PVDC//AI), YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i 60 (2x30) tablets in a blister

kozmetika d.d., Ulica TIRAMAT 25 mg tablets film coated tablets (PVC/PE/PVDC-Al), supplied YES YES

Danica 5, Koprivnica, in a box

Republic of Croatia

Belupo, lijekovi i 60 (2x30) tablets in a blister

kozmetika d.d., Ulica TIRAMAT 50 mg tablets film coated tablets (PVC/PE/PVDC-Al), supplied YES YES

Danica 5, Koprivnica, in a box

Republic of Croatia

5 glass bottles: Tissucol

lyophilisate, 1 mL of aprotinin lyophilisates for

Baxter AG, solution, Trombin 4 preparation of two

Tissucol kit 1.0 mL Industriestrasse 67, A- lyophilisate, trombin 500 YES component fibrin

1220 Vienna, Austria lyophilisate, 1 mL of calcium adhesives

chloride solution; application

kit (Duploject)

5 glass bottles: Tissucol

lyophilisate, 2 mL of aprotinin lyophilisates for

Baxter AG, solution, Trombin 4 preparation of two

Tissucol kit 2.0 mL Industriestrasse 67, A- lyophilisate, trombin 500 YES component fibrin

1220 Vienna, Austria lyophilisate, 2 mL of calcium adhesive

chloride solution; application

kit (Duploject)

5 glass bottles: Tissucol

lyophilisate, 5 mL of aprotinin lyophilisates for

Baxter AG, solution, Trombin 4 preparation of two

Tissucol kit 5.0 mL Industriestrasse 67, A- lyophilisate, trombin 500 YES component fibrin

1220 Vienna, Austria lyophilisate, 5 mL of calcium adhesive

chloride solution; application

kit (Duploject)

5 mL of suspension in a

polyethylene bottle with a Alcon-Couvreur s.a.,

TOBRADEX eye drops, drop tainer and an LDPE eye drops, suspension Rijksweg 14, Puurs, YES YES

suspension dropper with a PP temper

Belgium evident screw cap, supplied

in a box

Alcon-Couvreur s.a., 3.5 g of ointment in an

TOBRADEX eye ointment eye ointment Rijksweg 14, Puurs, aluminum tube, supplied in a YES YES

Belgium box

Alcon-Couvreur s.a., 5 mL of solution in a plastic

Tobrex eye drops eye drops, solution Rijksweg 14, Puurs, bottle with a dropper, YES YES

Belgium supplied in a box

Alcon-Couvreur s.a., 3.5 g of ointment in an

Tobrex eye ointment eye ointment Rijksweg 14, Puurs, aluminum tube, supplied in a YES YES

Belgium box

Pliva Croatia Ltd., Ulica 20 (2x10) tablets in a blister

grada Vukovara 49, TONOCARDIN 2 mg tablets (PVC/PVDC//Al), supplied in YES YES

Zagreb, Republic of a box

Croatia

Pliva Croatia Ltd., Ulica 23 (2x10 tablets in

grada Vukovara 49, TONOCARDIN 4 mg tablets PVC/PVDC/Al blister, YES YES

Zagreb, Republic of supplied in a box

Croatia

Cilag AG, 60 (6x10) tablets in a blister,

Topamax 100 mg tablets film coated tablets Schaffhausen, YES YES supplied in a box

Switzerland Cilag AG, 60 (6x10) tablets in a blister,

Topamax 200 mg tablets film coated tablets Schaffhausen, YES YES supplied in a box

Switzerland

Cilag AG, 60 (6x10) tablets in a blister,

Topamax 25 mg tablets film coated tablets Schaffhausen, YES YES supplied in a box

Switzerland

Cilag AG, 60 (6x10) tablets in a blister,

Topamax 50 mg tablets film coated tablets Schaffhausen, YES YES supplied in a box

Switzerland

Krka d.d., Novo mesto,

Republic of Slovenia in 6 (1x6) suppositories in a Torecan suppositories 6.5

suppositories cooperation with strip (Al/LDPE), supplied in a YES YES mg

Novartis Pharma Ltd., box

Switzerland

Krka d.d., Novo mesto, 1-mL of solution for injection

Republic of Slovenia in Torecan solution for solution for injection (for in a glas ampoule ; 50 (5x10)

cooperation with YES YES injection 6.5 mg/1 mL i.m., i.v. and s.c.use) ampoules in a blister,

Novartis Pharma Ltd., supplied in a box

Switzerland

Krka, d.d., Novo

mesto, Republic of 20 (2x10) tablets in a blister Torendo 1-mg film coated

film coated tablets Slovenia or Krka(PVC/PE/PVDC//Al), YES YES tablets

Farma d.o.o., Zagreb, supplied in a box

Republic of Croatia

Krka Farma d.o.o., 20 (2x10) tablets in a blister

Torendo 2-mg film coated Radnička cesta 48, film coated tablets (PVC/PE/PVDC//Al), YES YES

tablets Zagreb, Republic of supplied in a box

Croatia

Krka Farma d.o.o., 20 (2x10) tablets in a blister

Torendo 3-mg film coated Radnička cesta 48, film coated tablets (PVC/PE/PVDC//Al), YES YES

tablets Zagreb, Republic of supplied in a box

Croatia

Krka Farma d.o.o., 20 (2x10) tablets in a blister

Torendo 4-mg film coated Radnička cesta 48, film coated tablets (PVC/PE/PVDC//Al), YES YES

tablets Zagreb, Republic of supplied in a box

Croatia

100 mL of solution in an

Krka d.d., Šmarješka amber glass bottle with Torendo oral solution 1

oral solution cesta 6, Novo mesto, plastic (PP) cap and 3 mL YES YES mg/1 mL

Republic of Slovenia metered-dose syringe,

supplied in a box

Krka Farma d.o.o., 28 (4x7) tablets in a blister

Torendo Q-Tab 0.5-mg Radnička cesta 48, orodispersible tablets (OPA/Al/PVC//Al), supplied in YES YES

orodispersible tablets Zagreb, Republic of a box

Croatia

Krka Farma d.o.o., 28 (4x7) tablets in a blister

Torendo Q-Tab 1-mg Radnička cesta 48, orodispersible tablets (OPA/Al/PVC//Al), supplied in YES YES

orodispersible tablets Zagreb, Republic of a box

Croatia

Krka Farma d.o.o., 28 (4x7) tablets in a blister

Torendo Q-Tab 2-mg Radnička cesta 48, orodispersible tablets (OPA/Al/PVC//Al), supplied in YES YES

orodispersible tablets 2 mg Zagreb, Republic of a box

Croatia

Ferring GmbH,

Wittland 1, Kiel,

Tractocile 7.5 mg/mL Germany; Ferring 5 mL of concentrate in a concentrate of solution

concentrate of solution for International Center glass bottle, supplied in a YES YES for infusion

infusion SA, Chemin de la box

Vergognausaz,

Switzerland

Ferring GmbH,

Wittland 1, Kiel,

Germany; Ferring Tractocile 7.5 mg/mL, 0.9-mL of solution in a glass

solution for injection International Center YES YES solution for injection bottle, supplied in a box

SA, Chemin de la

Vergognausaz,

Switzerland Farmal d.d., Branitelja 28 (2x14) tablets in a domovinskog rata 8,

TRALIN tablets 100 mg film coated tablets PVC/PVDC/Al blister, YES YES

Ludbreg, Republic of supplied in a box

Croatia

Farmal d.d., Branitelja

28 (2x14) tablets in a

domovinskog rata 8,

TRALIN tablets 50 mg film coated tablets PVC/PVDC/Al blister, YES YES

Ludbreg, Republic of

supplied in a box

Croatia

Farmal d.d., Branitelja

Tramadol injection 100 domovinskog rata 8, 5 ampoules each with 2 mL solution for injection YES YES mg/2 mL Ludbreg, Republic of of solution, supplied in a box

Croatia

Farmal d.d., Branitelja

Tramadol injection 50 domovinskog rata 8, 5 ampoules each with 1 mL solution for injection YES YES mg/mL Ludbreg, Republic of of solution, supplied in a box

Croatia

Farmal d.d., Branitelja 10 mL of solution in an

domovinskog rata 8, amber glass bottle with Tramadol kapi 100 mg/mL oral drops, solution YES YES

Ludbreg, Republic of dropper attachment and

Croatia plastic cap, suplied in a box

Farmal d.d., Branitelja

20 (2x10) capsules in a

domovinskog rata 8,

Tramadol capsules 50 mg capsules blister (PVC/Al), supplied in a YES YES

Ludbreg, Republic of

box

Croatia

Farmal d.d., Branitelja

Tramadol suppositories domovinskog rata 8, 5 suppositories in an Al/PE suppositories YES YES 100 mg Ludbreg, Republic of pack, supplied in a box

Croatia

Tramal 100 mg solution for Grünenthal GmbH, 5 ampoules with 2 mL of solution for injection YES YES

injection Stolberg, Germany solution, supplied in a box

Tramal 50 mg solution for Grünenthal GmbH, 5 ampoules with 1 mL of solution for injection YES YES

injection Stolberg, Germany solution, supplied in a box

Grünenthal GmbH, 5 suppositories in a strip, Tramal suppositories suppositories YES YES

Stolberg, Germany supplied in a box

96 mL of solution in an

Grünenthal GmbH, amber glass bottle with a Tramal drops 96 mL solution, oral drops YES YES

Stolberg, Germany metering pump, supplied in a

box

10 mL of solution in an

Tramal kapi, solution for Grünenthal GmbH, solution, oral drops amber glass bottle, supplied YES YES

oral drops Stolberg, Germany in a box

Grünenthal GmbH, 20 (2x10) capsules in a Tramal capsules capsules YES YES

Stolberg, Germany blister, supplied in a box

Tramal retard tablets 100 film coated tablets with Grünenthal GmbH, Box with 30 tablets in a

YES YES mg prolonged-release Stolberg, Germany blister

Tramal retard tablets 150 film coated tablets with Grünenthal GmbH, Box with 30 tablets in a

YES YES mg prolonged-release Stolberg, Germany blister

Tramal 200 mg retard prolonged-release film Grünenthal GmbH, 30 tablets in a blister,

YES YES tablets coated tablets Stolberg, Germany supplied in a box

Mundipharma Gm.b.H.,

Limburg, Germany and

50 (5x10) tablets in a blister

Tramundin retard prolonged release tablets Mundipharma YES YES

(PVC/Al) , supplied in a box

GES.m.b.H., Vienna,

Austria

Grünenthal GmbH, One transdermal patch in a

Zieglerstrasse 6, D- multilayer bag Transtec 35 µg/h transdermal patch YES YES YES

52078 Aachen, (paper/PE/Al/surlin), 4

Germany patches in a carton box

Grünenthal GmbH, One transdermal patch in a

Zieglerstrasse 6, D- multilayer bag Transtec 35 µg/h transdermal patch YES YES YES

52078 Aachen, (paper/PE/Al/surlin), 16

Germany patches in a carton box

Grünenthal GmbH, One transdermal patch in a

Transtec 52.5 µg/h transdermal patch Zieglerstrasse 6, D- multilayer bag YES YES YES

52078 Aachen, (paper/PE/Al/surlin), 4 Germany patches in a carton box

Grünenthal GmbH, One transdermal patch in a

Zieglerstrasse 6, D- multilayer bag Transtec 70 µg/h transdermal patch YES YES YES

52078 Aachen, (paper/PE/Al/surlin), 4

Germany patches in a carton box

Alcon Couvreur N.V.,

Rijksweg 14, Puurs, 2.5 mL of solution in a

Travatan 40 µg/mL eyel Belgium; Alcon Cusi polypropylene bottle with eye drops YES YES

drops, solution S.A., Camil Fabra 58, dropper attachment, in foil,

El Masnou, Barcelona, supplied in a box

Spain

Intendis Manufacturing

Travocort cream cream S.p.A., Segrate, 15 g of cream in an Al tube YES YES

Milano, Italy

Aventis Pharma S.p.A., modified-release film 20 (2x10) tablets in a blister, Trental 400 mg tablets S.S. 17 KM 22, YES YES

coated tablets supplied in a box Scoppito, Italy

33 (3x10) film coated tablets Laboratoires Fournier

in a blister Tricor 145 mg film coated tablets S.A., Fontaine Les YES YES YES YES

(PVC/PE/PVDC/Al), supplied Dijon, France

in a box

34 (3x10) film coated tablets Laboratoires Fournier

in a blister Tricor 160 mg film coated tablets S.A., Fontaine Les YES YES YES YES

(PVC/PE/PVDC/Al), supplied Dijon, France

in a box

Schering-Plough Labo

15 g of cream in an

N.V. Industrepark 30,

Triderm cream cream aluminum tube, supplied in a YES YES

Heist-op-den-Berg,

box

Belgium

Schering-Plough

15 g of cream in an

Farma, Lda, Casal do

Triderm ointment ointment aluminum tube, supplied in a YES YES

Colaride, Agualva

box

Cacem, Portugal

Novartis Farma S.p.A., 50 (5x10) tablets in a blister Trileptal 150 mg film

film coated tablets Torre Annunziata (PVC/PE/PVDC/Al), supplied YES YES YES coated tablets

(Napoli), Italy in a box

Novartis Farma S.p.A., 50 (5x10) tablets in a blister Trileptal 300 mg film

film coated tablets Torre Annunziata (PVC/PE/PVDC/Al), supplied YES YES YES coated tablets

(Napoli), Italy in a box

250-mL of oral suspension in

an amber glass bottle with

plastic temper-proof closure, Novartis Pharma

Trileptal 60 mg/mL oral 10-mL plastic syringe for oral suspension S.A.S., Huningue YES YES YES

suspension administration of oral

Cedex, France

suspension and a plastic

bottle attachment, supplied in

a box

Novartis Farma S.p.A., 50 (5x10) tablets in a blister Trileptal 600 mg film

film coated tablets Torre Annunziata (PVC/PE/PVDC/Al), supplied YES YES YES coated tablets

(Napoli), Italy in a box

1-mL of concentrate for the Merck KGaA, concentrate for solution solution for infusion in a

Trinitrosan 5 mg Frankfurter Straße 250, YES YES for infusion glass ampoule, 5 ampoules

Darmstadt, Germany in a box

21 (1x21) tablets (7 white, 7 Cilag AG,

pink and 7 orange) in a

Trinovum tablets tablets Schaffhausen, YES YES blister (PVC/Al), supplied in a

Switzerland box

21 coated tablets (6 red Schering AG,

brown, 5 white and 10 dar

Triquilar coated tablets Muellerstrasse 170- YES YES yellow) in blister (PVC/Al), 178, Berlin, Germany

supplied in a box

Novo Nordisk A/S, 28 (12 blue, 10 white, 6 red)

Trisequens film coated tablets Novo Allé, DK-2880 tablets in a plastic calendar YES YES

Bagsvaerd, Denmark dial pack (dispenser with

marked days of the week),

supplied in a box

Aventis Pharma S.p.A.,

28 (2x14) tablets in a blister,

Tritace 1.25 tablets S.S. 17 KM 22, YES YES

supplied in a box

Scoppito, Italy

Aventis Pharma S.p.A.,

28 (2x14) tablets in a blister,

Tritace 2.5 tablets S.S. 17 KM 22, YES YES

supplied in a box

Scoppito, Italy

Aventis Pharma S.p.A.,

28 (2x14) tablets in a blister,

Tritace 5 tablets S.S. 17 KM 22, YES YES

supplied in a box

Scoppito, Italy

Aventis Pharma S.p.A., 28 (2x14) tablets in a green

Tritazide 2.5 mg/12.5 mg tablets S.S. 17 KM 22, blister (PVC/Al), supplied in a YES YES

Scoppito, Italy box

Aventis Pharma S.p.A., 28 (2x14) tablets in a green

Tritazide 5 mg/25 mg tablets S.S. 17 KM 22, blister (PVC/Al), supplied in a YES YES

Scoppito, Italy box

Merck Sharp & Dohme

5 mL of solution in a plastic

B.V., Waarderweg 39,

Trusopt eye drops eye drops container OCUMETER YES YES

Postbus 581, Haarlem,

PLUS, supplied in a box

the Netherlands

Box with 1 glass bottle Tuberkulin PPD RT 23 SSI solution for intradermal Statens Serum Institut,

containing 1.5 mL of YES 10 T.U./0.1 mL use Copenhagen, Denmark

tuberculin of 10 T.U./0.1 mL

Box with 1 glass bottle Tuberkulin PPD RT 23 SSI solution for intradermal Statens Serum Institut,

containing 1.5 mL of YES 2 T.U./0.1 mL use Copenhagen, Denmark

tuberculin of 2 T.U./0.1 mL

Box with 1 glass bottle Tuberkulin PPD RT 23 SSI solution for intradermal Statens Serum Institut,

containing 5 mL of tuberculin YES 2 T.U./0.1 mL use Copenhagen, Denmark

of 2 T.U../0.1 mL

Lek farmacevtska Tulip 10 mg film coated 30 (3x10) tablets in a blister,

film coated tablets družba d.d., Ljubljana, YES YES tablets supplied in a box

Republic of Slovenia

Lek farmacevtska

družba d.d., Tulip 10 mg film coated 60 tablets (6x10) in a blister,

film-tablets Verovškova 57, YES YES tablets supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska Tulip 20 mg film coated 30 (3x10) tablets in a blister,

film coated tablets družba d.d., Ljubljana, YES YES tablets supplied in a box

Republic of Slovenia

Lek farmacevtska

družba d.d., Tulip 20 mg film coated 60 tablets (6x10) in a blister,

film-tablets Verovškova 57, YES YES tablets supplied in a box

Ljubljana, Republic of

Slovenia

Lek farmacevtska 30 (3x10) tablets in a blister Tulip 40 mg film coated

film coated tablets družba d.d., Ljubljana, (Al/PVC//PVC//Al), supplied YES YES tablets

Republic of Slovenia in a box

20 (1x20) sugar-coated Tusidil sugar coated AD JAKA 80 Radoviš,

sugar coated tablets tablets in a A-PVC blister, YES YES tablets Radoviš, FYROM

supplied in a box

60 mL of syrup in an amber AD JAKA 80 Radoviš,

Tusidil syrup for children syrup glass bottle, supplied in a YES YES

Radoviš, FYROM box

Jadran - Galenski

150 mL of syrup in a dark

laboratorij d.d., Pulac

Tusifan syrup 1 mg/mL syrup brown plastic bottle, supplied YES YES YES

bb, Rijeka, Republic of

in a box

Croatia

Jadran - Galenski

150 mL of syrup in a dark

laboratorij d.d., Pulac

Tusifan syrup 3 mg/mL syrup brown plastic bottle, supplied YES YES YES

bb, Rijeka, Republic of

in a box

Croatia

GlaxoSmithKline Pre-filled glass syringe

TWINRIX Adult suspension for injection Biologicals s.a., Rue containing a single dose of YES

de lInstitut 89, the vaccine (1 mL of Rixensart, Belgium suspension) with plunge

stopper and needle, supplied

in a carton box

Pre-filled glass syringe

GlaxoSmithKline containing a single dose of

Biologicals s.a., Rue the vaccine (0.5 mL of TWINRIX Paediatric suspension for injection YES

de lInstitut 89, suspension) with plunge

Rixensart, Belgium stopper and needle, supplied

in a carton box

Box with 1 glass syringe TYPHIM Vi, thyphoid Sanofi Pasteur S.A., 2

solution for intramuscular containing 1 dose of vaccine polysaccharide vaccine, avenue Pont Pasteur, YES

and subcutaneous use (0.5 mL) and a needle with a purified Lyon, France

needle protection

Krka d.d., Šmarješka 20 (2x10) tablets in a blister,

Ulfamid tablets 20 mg film coated tablets cesta 6, Novo mesto, YES YES supplied in a box

Republic of Slovenia

Krka d.d., Šmarješka 10 (1x10) tablets in a blister,

Ulfamid tablets 40 mg film coated tablets cesta 6, Novo mesto, YES YES supplied in a box

Republic of Slovenia

14 capsules in a plastic Krka d.d., Šmarješka gastric-resistant (HDPE) bottle with plastic Ultop capsules 20 mg cesta 6, Novo mesto, YES YES

capsules, hard PP cap and desiccant, Republic of Slovenia

supplied in a box

28 capsules in a plastic Krka d.d., Šmarješka gastric-resistant (HDPE) bottle with plastic Ultop capsules 20 mg cesta 6, Novo mesto, YES YES

capsules, hard (PP) closure and desiccant, Republic of Slovenia

supplied in a box

Krka d.d., Šmarješka 14 capsules in a plastic bottle

Ultop capsules 40 mg capsules cesta 6, Novo mesto, (with desiccant), supplied in YES YES

Republic of Slovenia a box

Colourless glass bottle with Krka d.d., Šmarješka

Ultop powder for solution powder for solution for lyophilisate (closed with a cesta 6, Novo mesto, YES YES

for infusion 40 mg infusion rubber stopper and Al ring), Republic of Slovenia

supplied in a box

Krka d.d., Šmarješka 28 capsules in a plastic bottle

Ultop S capsules 10 mg capsules cesta 6, Novo mesto, (with desiccant), supplied in YES YES

Republic of Slovenia a box

Intendis Manufacturing 10 suppositories in a strip

Ultraproct suppositories suppositories SpA, Segrate, Milano, (Al/LDPE foil), supplied in a YES YES

Italy box

Intendis Manufacturing 30 g of ointment in an

Ultraproct oitment rectal ointment SpA, Segrate, Milano, aluminium tube with a plastic YES YES

Italy applicator, supplied in a box

Schering AG, 10 infusion bottles each with Ultravist 240 solution for

solution for infusion Muellerstrasse 170- 50 mL of solution, supplied in YES YES infusion

178, Berlin, Germany a box

Schering AG, 10 infusion bottles each with Ultravist 300 solution for

solution for infusion Muellerstrasse 170- 100 mL of solution, supplied YES YES infusion

178, Berlin, Germany in a box

Schering AG, 10 infusion bottles each with Ultravist 300 solution for

solution for infusion Muellerstrasse 170- 50 mL of solution, supplied in YES YES infusion

178, Berlin, Germany a box

Schering AG, 10 ampoules each containing Ultravist 300 solution for

solution for injection Muellerstrasse 170- 20 mL of solution, supplied in YES YES injection

178, Berlin, Germany a box

Schering AG, 10 infusion bottles each with Ultravist 370 solution for

solution for infusion Muellerstrasse 170- 100 mL of solution, supplied YES YES infusion

178, Berlin, Germany in a box

Schering AG, Ultravist 370 solution for 200 mL in a glass bottle for

solution for infusion Muellerstrasse 170- YES YES infusion infusion, 10 bottles in a box

178, Berlin, Germany

Schering AG, 500 mL of solution in a glass Ultravist 370 solution for

solution for infusion Muellerstrasse 170- infusion bottle, 8 bottles in a YES YES infusion

178, Berlin, Germany box

Ultravist 370 solution for Schering AG, 10 infusion bottles each with

solution for infusion YES YES

14509/11 WS/jj 390

178, Berlin, Germany a box

Schering AG, 10 ampoules each containing Ultravist 370 solution for

solution for injection Muellerstrasse 170- 30 mL of solution, supplied in YES YES injection

178, Berlin, Germany a box

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 14 (2x7) capsules in a blister, Ulzol capsules YES YES

Zagreb, Republic of supplied in a box

Croatia

Bristol-Myers Squibb,

20 (2x10) film coated tablets

UPFEN 200 mg film 304, avenue du Dr

film coated tablets in a PVC-Al blister, supplied YES YES YES

coated tablets Jean Bru, Agen,

in a box

France

Bristol-Myers Squibb,

304, avenue du Dr.

2 plastic tubes each with 10

Jean Bru, Agen,

UPFEN 200 mg effervescent tablets, supplied

effervescent tablets France; Bristol-Myers YES YES YES

effervescent tablets in a box (desiccant in the

Squibb, 979 Avenue

plastic cap)

des Pyrenees, Le

Passage, France

Bristol-Myers Squibb,

304, avenue du Dr.

10 effervescent tablets in a

Jean Bru, Agen,

polypropylene tube

UPSARIN plus vitamin C effervescent tablets France; Bristol-Myers YES YES YES

(desiccant in polyethylene

Squibb, 979 Avenue

cap), supplied in a box

des Pyrenees, Le

Passage, France

Bristol-Myers Squibb,

304, avenue du Dr.

10 effervescent tablets in a

Jean Bru, Agen,

polypropylene tube

Upsavit vitamin C 1000 mg effervescent tablets France; Bristol-Myers YES YES YES

(desiccant in polyethylene

Squibb, 979 Avenue

cap), supplied in a box

des Pyrenees, Le

Passage, France

Baxter Oncology solution for intravenous 15 (3x5) ampoules with 4 mL Uromitexan injection GmbH, Kantstrasse 2, YES YES

injection of solution, supplied in a box Halle, Germany

Belupo, lijekovi i 30 (3x10) capsules in a

kozmetika d.d., Ulica Urosal M plus capsules capsules, soft PVC/Al blister, supplied in a YES YES

Danica 5, Koprivnica, box

Republic of Croatia

dr. Falk Pharma 100 (4 x 25) tablets in

Ursofalk capsules capsules GmbH, Freiburg, PVC//Al blister, supplied in a YES YES

Germany box

Belupo, lijekovi i

kozmetika d.d., Ulica Bottle with 100 tablets, Urutal 8 mg tablets tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i 60 (3x20) tablets in a

kozmetika d.d., Ulica Urutal forte 16 mg tablets tablets PVC/PVDC/Al blister, YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Laboratoires Besins

International, 30 (2x15) capsules in a

UTROGESTAN 100 mg Montrouge, France; capsules, soft PVC/Al blister, supplied in a YES YES

capsules Besins International box

Belgique S.A.,

Drogenbos, Belgium

Cedevita d.o.o.,

Polypropylene bag with 50 g,

Uvin H Forte tea blend tea blend Zagreb, Republic of YES YES

supplied in a carton box

Croatia

Cedevita d.o.o., 25 filter bags (microcrystal Uvin H Forte tea blend in

tea blend in filter bags Zagreb, Republic of cellulose) each with 1.5 g of YES YES filter bags

Croatia tea blend, supplied in a box

Cedevita d.o.o., 14 bags (paper/Al/PE) each Uvin H Forte granules granules YES YES

Zagreb, Republic of containing 5 g of granules, Croatia supplied in a box

15 (3x5) applicators each Novo Nordisk A/S,

with one vaginal tablet, in

Vagifem vaginal tablets Novo Allé, DK-2880 YES YES blister packs, supplied in a Bagsvaerd, Denmark

box

Dr. August Wolff

GmbH & Co. 7 vaginal tablets in a strip, Vagisan vaginal tablets YES YES

Arzneimittel, Bielefeld, supplied in a box

Germany

Belupo, lijekovi i

kozmetika d.d., Ulica 28 (1x28) tablets in a blister, Vaira 10 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i

kozmetika d.d., Ulica 28 (1x28) tablets in a blister, Vaira 5 mg tablets film coated tablets YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

F. Hoffmann-La Roche

Ltd., 60 tablets in a plastic (HDPE) Valcyte 450 mg film coated

film coated tablets Grenzacherstrasse bottle, supplied in a carton YES YES YES tablets

124, Basel, box

Switzerland

Merck Sharp & Dohme Vaqta 25 IU/0.5 mL Box with 1 glass bottle

B.V., Waarderweg 39, (purified, inactivated suspension for injections containing 0.5 mL of YES

Postbus 581, Haarlem, hepatitis A vaccine) suspension

the Netherlands

Merck Sharp & Dohme Vaqta 50 IU/1 mL (purified, Box with 1 glass bottle

B.V., Waarderweg 39, inactivated hepatitis A suspension for injections containing 0.5 mL of YES

Postbus 581, Haarlem, vaccine) suspension

the Netherlands

Krka d.d., Šmarješka 30 (3x10) tablets in a Vasilip film coated tablets

film coated tablets cesta 6, Novo mesto, PVC/PE/PVDC//Al blister, YES YES

10 mg

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 20 (2x10) tablets in a blister Vasilip 10 mg film-coated

film coated tablets cesta 6, Novo mesto, PVC/PE/PVDC/PE/PVC//Al), YES YES

tablets

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 31 (3x10) tablets in a Vasilip film coated tablets

film coated tablets cesta 6, Novo mesto, PVC/PE/PVDC//Al blister, YES YES

20 mg

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 20 (2x10) tablets in a blister Vasilip 20 mg film-coated

film coated tablets cesta 6, Novo mesto, PVC/PE/PVDC/PE/PVC//Al), YES YES

tablets

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 32 (3x10) tablets in a Vasilip film coated tablets

film coated tablets cesta 6, Novo mesto, PVC/PE/PVDC//Al blister, YES YES

40 mg

Republic of Slovenia supplied in a box

Krka d.d., Šmarješka 28 (4x7) tablets in a blister Vasilip film coated tablets

film coated tablets cesta 6, Novo mesto, PVC/PE/PVDC/PE/PVC//Al), YES YES

40 mg

Republic of Slovenia supplied in a box

Alkaloid AD - Skopje,

Bulevar Aleksandar 30 tablets in an amber glass Vasoflex 1 mg tablets YES YES

Makedonski 12, bottle, supplied in a box

Skopje, FYROM

Pre-filled glass syringe (glass

type I) with a needle and a

VAXIGRIP - inactivated chlorobromobutyl or

Sanofi Pasteur S.A., vaccine against influenza suspension for injection chlorobutyl stopper, YES

Lyon, France (fragmented) containing single dose (0.5

mL) of suspension for

injection, supplied in a box

Pre-filled glass syringe with a

VAXIGRIP inactivated Sanofi Pasteur S.A., 2 needle containing a single

vaccine against influenza suspension for injection avenue Pont Pasteur, dose (0.5 mL) of the YES

(fragmented) Lyon, France suspension for injection,

supplied in a box Pre-filled glass syringe with

VAXIGRIP Pediatric use -

Sanofi Pasteur S.A., 2 needle containing a single inactivated vaccine against

suspension for injection avenue Pont Pasteur, dose (0.25 mL) of YES influenza (fragmented) for

Lyon, France suspension for injection, children

supplied in a box

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 28 (2x14) tablets in a blister, Velafax tablets 37.5 mg tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 28 (2x14) tablets in a blister, Velafax tablets 75 mg tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 28 (2x14) capsules in a

Velafax XL capsules 150 prolonged-release grada Vukovara 49, transparent blister (PVC/Al) , YES YES

mg capsules, hard Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 28 (2x14) capsules in a

Velafax XL capsules 75 prolonged-release grada Vukovara 49, transparent blister (PVC/Al) , YES YES

mg capsules, hard Zagreb, Republic of supplied in a box

Croatia

Janssen 10-mL glass vial containing

Velcade powder for powder for solution for Pharmaceutica NV, 38.5 mg of powder for

YES YES YES solution for injection injection Turnhouseweg 30, solution for injection,

Beerse, Belgium supplied in a box

Vifor International Inc.,

Venofer 100 mg/5 mL St. Gallen, Switzerland

5 ampoules each with 5 mL solution for intravenous solution for injection for Lek farmacevtska YES YES

of solution, supplied in a box injection družba d.d. Ljubljana,

Republic of Slovenia

Schering AG, Berlin, 3-mL glass ampoule

Germany and VENTAVIS 10 µg/mL containing 2 mL of solution

solution for atomizer BERLIMED S.A., YES YES YES solution for atomizer for nebulizer, 100 ampoules

Alcala de Henares, in a box

Madrid, Spain

Pliva Croatia Ltd., Ulica 10 mL of solution in an

grada Vukovara 49, Ventolin inhalation solution nebulisation solution amber glass bottle with YES YES

Zagreb, Republic of plastic cap, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica 200 mL of syrup in an amber

grada Vukovara 49, glass bottle with aluminum Ventolin syrup syrup YES YES

Zagreb, Republic of cap and plastic measuring

Croatia spoon, supplied in a box

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 60 (2x30) tablets in a blister Ventolin tablets tablets YES YES

Zagreb, Republic of (PVC/Al), supplied in a box

Croatia

5 mL of solution in a glass solution for injection (for Bristol-Myers Squibb

Vepesid injection 100 mg/5 bottle, supplied in a box (10 preparation of i.v. S.r.l., Sermoneta, YES YES

mL boxes in a collective carton infusion) Latina, Italy

packaging)

Bristol-Myers Squibb 10 capsules in an amber

Vepesid capsules 100 mg capsules S.r.l., Sermoneta, glass bottle, supplied in a YES YES

Latina, Italy box

Bristol-Myers Squibb 20 capsules in an amber

Vepesid capsules 50 mg capsules S.r.l., Sermoneta, glass bottle, supplied in a YES YES

Latina, Italy box

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 14 (1x14) tablets in a blister, Verbinaf 125 mg tablets tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 14 (1x14) tablets in a blister, Verbinaf 250 mg ablets tablets YES YES

Zagreb, Republic of supplied in a box

Croatia Krka d.d., Novo mesto,

Republic of Slovenia in 30 mL of suspension in an

Vermox 100 mg/5 mL oral cooperation with amber glass bottle with a 5 oral suspension YES YES

suspension Janssen mL plastic measuring spoon,

Pharmaceutica, supplied in a box

Beerse, Belgium

Krka d.d., Novo mesto,

Republic of Slovenia in

cooperation with 6 (1x6) tablets in a strip Vermox tablets 100 mg tablets YES YES

Janssen (Al/PE), supplied in a box

Pharmaceutica,

Beerse, Belgium

Krka d.d., Šmarješka 23 (2x10) tablets in a

Verolax Senna film coated tablets cesta 6, Novo mesto, PVC/PVD//Al) blister, YES YES

Republic of Slovenia supplied in a box

F. Hoffmann-La Roche

Ltd., 100 soft capsules in a brown Vesanoid soft capsules 10

soft capsules Grenzacherstrasse plastic bottle, supplied in a YES YES mg

124, Basel, box

Switzerland

One glass vial with rubber

VFEND 200 mg powder for powder for solution for Pfizer PGM, Pocé-surcap and aluminum ring,

YES YES YES solution for infusion infusion Cisse, France containing powder, supplied

in a box

45 g of powder for oral

suspension in a plastic bottle

with a temper-evident

stopper, a plastic measuring

VFEND 40 mg/mL powder powder for oral Pfizer PGM, Pocé-surcup for solvent (23 mL), a

YES YES YES for oral suspension suspension Cisse, France plastic attachment for bottle

neck and a plastic syringe for

administration of oral

suspension, supplied in a

box

Heinrich Mack Nachf.

28 (2x14) tablets in a blister

VFEND tablets 200 mg film coated tablets GmbH & Co., YES YES YES

(PVC/Al), supplied in a box

Illertissen, Germany

Heinrich Mack Nachf.

28 (2x14) tablets in a blister

VFEND tablets 50 mg film coated tablets GmbH & Co., YES YES YES

(PVC/Al), supplied in a box

Illertissen, Germany

One (1x1) film coated tablet Pfizer PGM, Poce-sur

Viagra tablets 100 mg film coated tablets in a blister (PVC/Al), supplied YES YES YES

Cisse, France in a box

One (1x1) film coated tablet Pfizer PGM, Poce-sur

Viagra tablets 25 mg film coated tablets in a blister (PVC/Al) supplied YES YES YES

Cisse, France in a box

One (1x1) film coated tablet Pfizer PGM, Poce-sur

Viagra tablets 50 mg film coated tablets in a blister (PVC/Al) supplied YES YES YES

Cisse, France in a box

30 (3x10) capsules in a gastric-resistant Bristol-Myers Squibb,

Videx capsules 125 mg PVC/PE/ACLAR/Al blister, YES YES YES YES capsules, hard Meymac, France

supplied in a carton box

30 (3x10) capsules in a gastric-resistant Bristol-Myers Squibb,

Videx capsules 250 mg PVC/PE/ACLAR/Al blister, YES YES YES YES capsules, hard Meymac, France

supplied in a carton box

30 (3x10) capsules in a gastric-resistant Bristol-Myers Squibb,

Videx capsules 400 mg PVC/PE/ACLAR/Al blister, YES YES YES YES capsules, hard Meymac, France

supplied in a carton box

Pliva Croatia Ltd., Ulica 30 (3x10) tablets in an

grada Vukovara 49, Vilpin 10 mg tablets tablets orange PVC/PVDC//Al, YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

30 (3x10) tablets in a blister

grada Vukovara 49,

Vilpin 5 mg tablets tablets (orange PVC/PVDC//Al) , YES YES

Zagreb, Republic of

supplied in a box

Croatia

Pfizer (Perth) Pty 1-mL of solution for injection

solution for injection (for

Vincristine injection 1 mg Limited, Bentley WA, in a plastic bottle, 5 bottles in YES YES

intravenous use)

Australija a box

F. Hoffmann-La Roche 270 film-coated tablets in a

Ltd., VIRACEPT 250 mg film plastic (HDPE) bottle with

film coated tablets Grenzacherstrasse YES YES YES coated tablets child resistant closure,

124, Basel,

supplied in a box

Switzerland

Boehringer Ingelheim

Pharma GmbH & Co.

KG, Ingelheim am 60 (6x10) tablets in a blister

Viramune tablets 200 mg tablets Rhein, Germany and YES YES YES (PVC/Al), supplied in a box

Boehringer Ingelheim

Ellas A.E., Atika,

Greece

Krka d.d., Šmarješka 5 g of cream in a tube,

Virolex cream cream cesta 6, Novo mesto, YES YES supplied in a box

Republic of Slovenia

Krka d.d., Novo Mesto, Virolex lyophilisate for lyophilisate for 5 glass bottles each with 250

Republic of Slovenia in preparation of infusion preparation of solution for mg of lyophilisate, supplied in YES YES

cooperation with Glaxo solution infusion a box

SmithKline

Krka d.d., Šmarješka 4.5 g of ointment in a tube,

Virolex eye ointment eye ointment cesta 6, Novo mesto, YES YES supplied in a box Republic of Slovenia

Krka d.d., Šmarješka 20 (2x10) tablets in a blister,

Virolex tablets tablets cesta 6, Novo mesto, YES YES supplied in a box Republic of Slovenia

GE Healthcare Gass bottle (with rubber

Republic of Ireland, stopper, aluminum ring and

Carrigtwohill, Co. Cork, Visipaque 270 mgI/mL solution for injection plastic protective cap) YES YES

Republic of Ireland; GE containing 50 mL of solution,

Healthcare AS, 10 ampoules in a box

Nydalen, Oslo, Norway

GE Healthcare Gass bottle (with rubber

Republic of Ireland, stopper, aluminum ring and

Carrigtwohill, Co. Cork, plastic protective cap) Visipaque 270 mgI/mL solution for injection YES YES

Republic of Ireland; GE containing 100 mL of

Healthcare AS, solution, 10 ampoules in a

Nydalen, Oslo, Norway box

GE Healthcare Plastic (polypropylene) bottle

Republic of Ireland, containing 50 mL of solution

Carrigtwohill, Co. Cork, with a rubber stopper and Visipaque 270 mgI/mL solution for injection YES YES

Republic of Ireland; GE plastic (polypropylene)

Healthcare AS, closure with protective ring

Nydalen, Oslo, Norway and cap, 10 bottles in a box

GE Healthcare Plastic (polypropylene) bottle

Republic of Ireland, containing 100 mL of solution

Carrigtwohill, Co. Cork, with a rubber stopper and Visipaque 270 mgI/mL solution for injection YES YES

Republic of Ireland; GE plastic (polypropylene)

Healthcare AS, closure with protective ring

Nydalen, Oslo, Norway and cap, 10 bottles in a box

GE Healthcare Plastic (polypropylene) bottle

Republic of Ireland, containing 100 mL of solution

Carrigtwohill, Co. Cork, with a rubber stopper and Visipaque 320 mgI/mL solution for injection YES YES

Republic of Ireland; GE plastic (polypropylene)

Healthcare AS, closure with protective ring

Nydalen, Oslo, Norway and cap, 10 bottles in a box

GE Healthcare Glass bottle (with rubber

Republic of Ireland, stopper, aluminum ring and

Carrigtwohill, Co. Cork, Visipaque 320 mgI/mL solution for injection plastic cap) containing 200 YES YES

Republic of Ireland; GE mL of solution, 6 bottles in a

Healthcare AS, box

Nydalen, Oslo, Norway

GE Healthcare Glass bottle (with rubber

Visipaque 320 mgI/mL solution for injection Republic of Ireland, stopper, aluminum ring and YES YES

Carrigtwohill, Co. Cork, plastic protective cap) Republic of Ireland; GE containing 100 mL of

Healthcare AS, solution, 10 ampoules in a

Nydalen, Oslo, Norway box

GE Healthcare Glass bottle (with rubber

Republic of Ireland,

stopper, aluminum ring and

Carrigtwohill, Co. Cork,

Visipaque 320 mgI/mL solution for injection plastic protective cap) YES YES

Republic of Ireland; GE

containing 50 mL of solution,

Healthcare AS,

10 ampoules in a box

Nydalen, Oslo, Norway

GE Healthcare Plastic (polypropylene) bottle

Republic of Ireland, containing 500 mL of solution

Carrigtwohill, Co. Cork, with a rubber stopper and Visipaque 320 mgI/mL solution for injection YES YES

Republic of Ireland; GE plastic (polypropylene)

Healthcare AS, closure with protective ring

Nydalen, Oslo, Norway and cap, 6 bottles in a box

GE Healthcare Plastic (polypropylene) bottle

Republic of Ireland, containing 200 mL of solution

Carrigtwohill, Co. Cork, with a rubber stopper and Visipaque 320 mgI/mL solution for injection YES YES

Republic of Ireland; GE plastic (polypropylene)

Healthcare AS, closure with protective ring

Nydalen, Oslo, Norway and cap, 10 bottles in a box

GE Healthcare Plastic (polypropylene) bottle

Republic of Ireland, containing 50 mL of solution

Carrigtwohill, Co. Cork, with a rubber stopper and Visipaque 320 mgI/mL solution for injection YES YES

Republic of Ireland; GE plastic (polypropylene)

Healthcare AS, closure with protective ring

Nydalen, Oslo, Norway and cap, 10 bottles in a box

GE Healthcare

Republic of Ireland, Plastic (polypropylene) bottle

Carrigtwohill, Co. Cork, containing 20 mL of solution, Visipaque 320 mgI/mL solution for injection YES YES

Republic of Ireland; GE with a plastic twist-off cap, 10

Healthcare AS, bottles in a box

Nydalen, Oslo, Norway

Allergan

Pharmaceuticals

5 mL of solution in a plastic

Vistagan Liquifilm 0.5 % Republic of Ireland,

eye drops, solution bottle with a dropper, YES YES

eye drops Castlebar Road,

supplied in a box

Westport, Co Mayo,

Republic of Ireland

One glass vial containing Novartis Pharma powder for solution for powder with rubber stopper Visudyne S.A.S., Huningue YES YES YES

infusion and aluminum ring, supplied Cedex, France

in a box

Krka d.d., Šmarješka Vitamin B12 Krka solution 100 ampoules with 1 mL of

solution for injection cesta 6, Novo mesto, YES YES for injection 100 µg/1 mL solution, supplied in a box

Republic of Slovenia

Krka d.d., Šmarješka Vitamin B12 Krka solution 100 ampoules with 1 mL of

solution for injection cesta 6, Novo mesto, YES YES for injection 500 µg/1 mL solution, supplied in a box

Republic of Slovenia

STADA Arzneimittel 30 (3x10) tablets in a

Vitopril 10 mg tablets AG, Stadtstraße 2-18, PVC/PVdC/Alu blister, YES YES

Bad Vilbel, Germany supplied in a box

STADA Arzneimittel 31 (3x10) tablets in a

Vitopril 20 mg tablets AG, Stadtstraße 2-18, PVC/PVdC/Alu blister, YES YES

Bad Vilbel, Germany supplied in a box

STADA Arzneimittel 32 (3x10) tablets in a

Vitopril 5 mg tablets AG, Stadtstraße 2-18, PVC/PVdC/Alu blister, YES YES

Bad Vilbel, Germany supplied in a box

Jadran - Galenski 10 mL of nasal drops in a

laboratorij d.d., Pulac clear plastic (PE) bottle with Vizol eyel drops solution eye drops, solution YES YES YES

bb, Rijeka, Republic of a dropper attachment,

Croatia supplied in a box

Alkaloid AD - Skopje, 50 colourless glass

Water for Injection, Bulevar Aleksandar ampoules with 5 mL of water diluent for parenteral use YES YES

Alkaloid Makedonski 12, for injection, supplied in a

Skopje, FYROM box Baxter S.A., Belgium;

Baxter Healthcare Ltd,

20 plastic Viaflo bags with

Great Britain; Bieffe

500 mL of infusion solution,

Water for Injections Viaflo diluent for parenteral use Medital Sabinanigo, YES YES

in a protective bag, supplied

Spain; Baxter

in a box

Healthcare S.A.,

Republic of Ireland

Baxter S.A., Belgium;

Baxter Healthcare Ltd,

30 plastic Viaflo bags with

Great Britain; Bieffe

250 mL of water for injection

Water for Injection, Viaflo diluent for parenteral use Medital Sabinanigo, YES YES

in a protective bag, supplied

Spain; Baxter

in a box

Healthcare S.A.,

Republic of Ireland

Novartis Consumer

Health S.A., Route de l'

Etraz, Nyon,

Switzerland Novartis 50 g of gel in an aluminium Voltaren Emulgel 1 % gel YES YES YES

Pharma Produktions tube, supplied in a box

GmbH, Oflinger

Strasse 44, Wehr,

Germany

Pliva Croatia Ltd., Ulica

grada Vukovara 49, Box with 20 tablets (blister, Voltaren forte film coated tablets YES YES

Zagreb, Republic of 2x10 tbl.)

Croatia

Pliva Croatia Ltd., Ulica

5 ampoules each with 3 mL

grada Vukovara 49,

Voltaren injection solution for injection of solution for injection, YES YES

Zagreb, Republic of

supplied in a box

Croatia

Pliva Croatia Ltd.,

10 (1x10) film coted tablets in

Zagreb, Republic of

a PVC//Al ili

Voltaren rapid coated tablets Croatia in cooperation YES YES

PVC/PE/PVDC//Al blister,

with Novartis Pharma

supplied in a box

AG, Basel, Switzerland

Fresenius Kabi 500 mL of solution in a Voluven 6% solution for

solution for infusion Deutschland GmbH, transparent plastic bag YES YES YES infusion

Germany (Freeflex), 15 bags in a box

Fresenius Kabi Voluven 6% solution for 500 mL of solution in a glass

solution for infusion Deutschland GmbH, YES YES YES infusion bottle, 10 bottles in a box

Germany

2.5 mL of solution in a 5 mL

Pfizer Manufacturing plastic (LDPE) bottle with

Xalacom eye drops, solution Belgium NV, Rijksweg dropper attachment and YES YES YES

12, Puurs, Belgium plastic (HDPE) temper-proof

closure, supplied in a box

2.5 mL eye drops, solution in Pfizer Manufacturing

a 5 mL plastic bottle with Xalatan eye drops, solution Belgium NV, Rijksweg YES YES

dropper attachment, supplied 12, Puurs, Belgium

in a box

Pfizer Manufacturing

Belgium NV, Rijksweg

12, Puurs, Belgium; 30 (3x10) tablets in a

Xanax SR 0.5 mg tablets modified release tablets Pfizer Italia; s.r.l. PA/Al//Al blister, supplied in a YES YES

Localita Marino del box

Tronto, Ascoli Piceno,

Italy

Pfizer Manufacturing

Belgium NV, Rijksweg

12, Puurs, Belgium; 31 (3x10) tablets in a

Xanax SR 1 mg tablets modified release tablets Pfizer Italia; s.r.l. PA/Al//Al blister, supplied in a YES YES

Localita Marino del box

Tronto, Ascoli Piceno,

Italy

Pfizer Manufacturing

33 (3x10) tablets in a PVC/Al

Xanax SR tablets 2 mg modified release tablets Belgium NV, Rijksweg YES YES

blister , supplied in a box

12, Puurs, Belgium;

Pfizer Italia s.r.l.

Localita Marino del

Tronto, Ascoli Piceno,

Italy

Pfizer Manufacturing

Belgium NV, Rijksweg

12, Puurs, Belgium; 31 (3x10) tablets in a PVC/Al

Xanax tablets 0.25 mg tablets Pfizer Italia s.r.l. YES YES blister , supplied in a box

Localita Marino del

Tronto, Ascoli Piceno,

Italy

Pfizer Manufacturing

Belgium NV, Rijksweg

12, Puurs, Belgium; 32 (3x10) tablets in a PVC/Al

Xanax tablets 0.5 mg tablets Pfizer Italia s.r.l. YES YES blister , supplied in a box

Localita Marino del

Tronto, Ascoli Piceno,

Italy

F. Hoffmann-La Roche

Ltd., 60 (6x10) tablets in a blister XELODA 150 mg film

film coated tablets Grenzacherstrasse (PVC/PE/PVDC//Al), YES YES YES YES coated tablets

124, Basel, supplied in a box

Switzerland

F. Hoffmann-La Roche

Ltd., 120 (12x10) tablets in a XELODA 500 mg film

film coated tablets Grenzacherstrasse blister (PVC/PE/PVDC//Al), YES YES YES YES coated tablets

124, Basel, supplied in a box

Switzerland

F. Hoffmann-La Roche

Ltd.,

42 (2x21) capsules in a

Xenical capsules Grenzacherstrasse YES YES

blister, supplied in a box

124, Basel,

Switzerland

Lilly Pharma Fertigung One glass vial with 20 mg of

Xigris 20 mg powder for powder for solution for und Distribution GmBH medicinal product, supplied YES YES

solution for infusion infusion & Co. KG, Giessen, in a box

Germany

Lilly Pharma Fertigung

One glass vial with 5 mg of

Xigris 5 mg powder for powder for solution for und Distribution GmBH

medicinal product, supplied YES YES

solution for infusion infusion & Co. KG, Giessen,

in a box

Germany

Novartis Pharma Stein One glass vial with powder

powder and diluent for AG, and one glass ampoule with Xolair 150 mg YES YES YES

solution for injection Schaffhauserstrasse, 2 mL of Water for Injection,

Stein, Switzerland supplied in a box

Novartis Pharma Stein One glass vial with powder

powder and diluent for AG, and a glass ampoule with 2 Xolair 75 mg YES YES YES

solution for injection Schaffhauserstrasse, mL of Water for Injection,

Stein, Switzerland supplied in a box

10 (1x10) film coted tablets in Xorimax 125 mg film Sandoz GmbH, Kundl,

film coated tablets a PA/Al/PE//Al blister or an YES YES YES coated tablets Austria

Al/PE strip, supplied in a box

10 (1x10) film coted tablets in Xorimax 250 mg film Sandoz GmbH, Kundl,

film coated tablets a PA/Al/PE//Al) blister or an YES YES YES coated tablets Austria

Al/PE strip , supplied in a box

10 (1x10) film coted tablets in Xorimax 500 mg film Sandoz GmbH, Kundl,

film coated tablets a PA/Al/PE//Al) blister or an YES YES YES coated tablets Austria

Al/PE strip , supplied in a box

200 mL of oral solution in a

glass bottle with temper

XYZAL 0.5 mg/mL oral UCB Pharma S.p.A., oral solution proof closure and a 10-mL YES YES YES

solution Pianezza, Italy plastic nebulizer, supplied in

a box

UCB Pharma S.p.A., Xyzal 5 mg film coated 10 (1x10) tablets in a Al/Al

film coated tablets Via Praglia 15, I-10044 YES YES YES tablets blister, supplied in a box

Pianezza (TO), Italy Schering AG, 21 (1x21) film-coated tablets

Yasmin film tablets film coated tablets Muellerstrasse 170- YES YES YES in a blister, supplied in a box

178, Berlin, Germany

Krka d.d., Šmarješka 28 (4x7) tablets in a blister Yasnal film coated tablets

film coated tablets cesta 6, Novo mesto, (OPA/Al/PVC//Al), supplied in YES YES 10 mg

Republic of Slovenia a box

Krka d.d., Šmarješka 28 (4x7) tablets in a blister Yasnal film coated tablets

film coated tablets cesta 6, Novo mesto, (PVC/Al/OPA//Al), supplied in YES YES 5 mg

Republic of Slovenia a box

5 mL of solution in a white

plastic (LDPE) bottle with a EXCELVISION,

Zaditen eye drops, solution dropper and a plastic (HDPE) YES YES YES Annonay, France

stopper with a safety ring,

supplied in a box

20 (5x4) single-dose plastic

(LDPE) containers with 0.4 EXCELVISION,

Zaditen SDU eye drops, solution mL of solution in a protective YES YES YES Annonay, France

package (PVC/Al/PA-

Al/papir), supplied in a box

Jadran-Galenski

laboratorij d.d., Rijeka, 28 (4x7) tablets in a

Hrvatska in Zalasta 10 mg tablets tablets OPA/Al/PVC-Al blister , YES YES

cooperation with Krka supplied in a box

d.d., Novo mesto,

Republic of Slovenia

Jadran-Galenski

laboratorij d.d., Rijeka, 28 (4x7) tablets in a

Hrvatska in Zalasta 5 mg tablets tablets OPA/Al/PVC-Al blister , YES YES

cooperation with Krka supplied in a box

d.d., Novo mesto,

Republic of Slovenia

Krka Farma d.o.o., 28 (4x7) tablets in a

Radnička cesta 48, Zalasta Q-Tab 10 mg orodispersible tablets OPA/Al/PVC//Al blister, YES YES

Zagreb, Republic of supplied in a box

Croatia

Krka Farma d.o.o., 28 (4x7) tablets in a

Radnička cesta 48, Zalasta Q-Tab 15 mg orodispersible tablets OPA/Al/PVC//Al blister, YES YES

Zagreb, Republic of supplied in a box

Croatia

Krka Farma d.o.o., 28 (4x7) tablets in a

Radnička cesta 48, Zalasta Q-Tab 20 mg orodispersible tablets OPA/Al/PVC//Al blister, YES YES

Zagreb, Republic of supplied in a box

Croatia

Krka Farma d.o.o., 28 (4x7) tablets in a

Radnička cesta 48, Zalasta Q-Tab 5 mg orodispersible tablets OPA/Al/PVC//Al blister, YES YES

Zagreb, Republic of supplied in a box

Croatia

Grünenthal GmbH,

Zieglerstrasse 6, D- 10 tablets in a blister, Zaldiar 37.5 mg/325 mg film coated tablets YES YES

52078 Aachen, supplied in a box

Germany

Belupo, lijekovi i 7 capsules in a

kozmetika d.d., Ulica Zan 10 mg capsules capsules PVC/PVDC/Al blister, YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Belupo, lijekovi i 7 capsules in a

kozmetika d.d., Ulica Zan 5 mg capsules capsules PVC/PVDC/Al blister, YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Glaxo Operations UK

Ltd. (trading as Glaxo

Wellcome Operations),

28 (2x14) tablets in a blister

Hertfordshire, Great

Zeffix tablets film coated tablets (PVC/PA/Al), supplied in a YES YES YES YES

Britain,

box

GlaxoSmithKline

Pharmaceuticals S.A.,

Poznan, Poland Heinrich Mack Nachf.

GmbH & Co. (Pfizer Box with 30 capsules (blister, ZELDOX 20 mg capsules capsules YES YES

grupa), Illertissen, 3x10 capsules)

Germany

Heinrich Mack Nachf.

GmbH & Co. (Pfizer Box with 30 capsules (blister, ZELDOX 40 mg capsules capsules YES YES

grupa), Illertissen, 3x10 capsules)

Germany

Heinrich Mack Nachf.

GmbH & Co. (Pfizer Box with 30 capsules (blister, ZELDOX 60 mg capsules capsules YES YES

grupa), Illertissen, 3x10 capsules)

Germany

Heinrich Mack Nachf.

GmbH & Co. (Pfizer Box with 30 capsules (blister, ZELDOX 80 mg capsules capsules YES YES

grupa), Illertissen, 3x10 capsules)

Germany

Abbott S.p.A., Via

5 glass ampoules each with

Zemplar 5 µg/mL solution Pontina 52, I-04010

solution for injection 1 mL of solution, supplied in YES YES YES

for injection Campoverde di Aprilia

a carton box

(Latina), Italy

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 7 capsules in a PVC/Al Zenafluk capsules 100 mg capsules YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, One capsule in a PVC/Al Zenafluk capsules 150 mg capsules YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 7 capsules in a PVC/Al Zenafluk capsules 200 mg capsules YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 7 capsules in a PVC/Al Zenafluk capsules 50 mg capsules YES YES

Zagreb, Republic of blister, supplied in a box

Croatia

F. Hoffmann-La Roche

Ltd., Bottle with 5 mL of concentrate for infusion

Zenapax Grenzacherstrasse concentrate, supplied in a YES YES YES solution

124, Basel, box

Switzerland

Bristol-Myers Squibb, 56 (4x14) capsules in a Zerit capsules 30 mg capsules YES YES

Meymac, France blister, supplied in a box

Bristol-Myers Squibb, 56 (4x14) capsules in a Zerit capsules 40 mg capsules YES YES

Meymac, France blister, supplied in a box

Glaxo Wellcome 60 (6x10) tablets in a blister,

Ziagen tablets film coated tablets Operations, Greenford, YES YES supplied in a box

Great Britain

Granules for 100 mL of

Glaxo Wellcome suspension in a glass bottle, Zinnat suspension 125 granules for oral

Operations, Greenford, with a plastic spoon and a YES YES mg/5mL suspension

Great Britain measuring device, supplied

in a box

Glaxo Wellcome

10 tablets in a blister,

Zinnat 125 mg tablets film coated tablets Operations, Greenford, YES YES

supplied in a box

Great Britain

Glaxo Wellcome

10 tablets in a blister,

Zinnat 250 mg tablets film coated tablets Operations, Greenford, YES YES

supplied in a box

Great Britain

Glaxo Wellcome

10 tablets in a blister,

Zinnat 500 mg tablets film coated tablets Operations, Greenford, YES YES

supplied in a box

Great Britain

Pliva Croatia Ltd., Ulica

28 (2x14) tablets in a

grada Vukovara 49,

Zipantola tablets 20 mg gastric-resistant tablets OPA/Al/PVC//Al blister, YES YES

Zagreb, Republic of

supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 14 (1x14) tablets in a blister, Zipantola 40 mg tablets gastric-resistant tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

solution for intravenous GlaxoSmithKline 5 ampoules with 2 mL of Zofran injection 4 mg YES YES

injection S.p.A., Parma, Italy solution, supplied in a box

solution for intravenous GlaxoSmithKline 5 ampoules with 4 mL of Zofran injection 8 mg YES YES

injection S.p.A., Parma, Italy solution, supplied in a box

Glaxo Wellcome S.A.,

Aranda de Duero,

Spain; 10 tablets in a blister,

Zofran 4 mg tablets tablets YES YES

GlaxoSmithKline supplied in a box

Pharmaceuticals S.A.,

Poznan, Poland

Glaxo Wellcome S.A.,

Aranda de Duero,

Spain; 10 tablets in a blister,

Zofran 8 mg tablets tablets YES YES

GlaxoSmithKline supplied in a box

Pharmaceuticals S.A.,

Poznan, Poland

AstraZeneca UK Implant for s.c. administration

Limited, Silk Road in a syringe with a safety

Zoladex 3.6 mg subcutaneous implant Business Park, system (SafeSystem TM), in YES YES

Macclesfield, Cheshire, a sterile protective casing,

Great Britain supplied in a carton box

AstraZeneca UK Implant for s.c. administration

Limited, Silk Road in a syringe with a safety

Zoladex LA 10.8 mg subcutaneous implant Business Park, system (SafeSystem TM), in YES YES

Macclesfield, Cheshire, a sterile protective casing,

Great Britain supplied in a carton box

Pfizer Italia S.r.l., 28 (2x14) tablets in a blister

Zoloft tablets 100 mg film coated tablets Borgo San Michele, YES YES

(PVC/Al), supplied in a box Latina, Italy

Pfizer Italia S.r.l., 28 (2x14) tablets in a blister

Zoloft tablets 50 mg film coated tablets Borgo San Michele, YES YES

(PVC/Al), supplied in a box Latina, Italy

Belupo, lijekovi i 28 (2x14) tablets in a blister

kozmetika d.d., Ulica Zoltex 20 mg tablets gastric-resistant tablets (PA/Al/PVC//Al), supplied in YES YES

Danica 5, Koprivnica, a box

Republic of Croatia

Belupo, lijekovi i 14 (2x7) tablets in a

kozmetika d.d., Ulica Zoltex 40 mg tablets gastric-resistant tablets PA/Al/PVC//Al blister, YES YES

Danica 5, Koprivnica, supplied in a box

Republic of Croatia

Novartis Pharma Stein Zometa 4 mg/5 mL 5 mL of solution concentrate

concentrate of solution AG, concentrate for solution for in a plastic bottle, supplied in YES YES

for infusion Schaffhauserstrasse, infusion a box

Stein, Switzerland

AstraZeneca UK

Limited, Silk Road 6 (1x6) tablets in a blister

Zomig Rapimelt orodispersible tablets Business Park, (PVC/Al-Al/paper), supplied YES YES

Macclesfield, Cheshire, in a box

Great Britain

3 (1x3) tablete in a blister Astra Zeneca UK

Zomig tablets 2.5 mg film coated tablets (Alu/PA-Alu/PVC), supplied YES YES

Limited, Great Britain in a box

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 20 (2x10) tablets in a blister, Zonadin 10 mg tablets film tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pliva Croatia Ltd., Ulica

grada Vukovara 49, 20 (2x10) tablets in a blister, Zonadin 5 mg tablets film tablets YES YES

Zagreb, Republic of supplied in a box

Croatia

Pierre Fabre 15 g of gel in an aluminum Zorac 0.05% gel gel YES YES

Medicament tube, supplied in a box Production, France

Pierre Fabre

15 g of gel in an aluminum

Zorac 0.1 % gel gel Medicament YES YES

tube, supplied in a box

Production, France

Glaxo Operations UK 2 grams of cream in an

Zovirax cream Ltd, Durham, Great aluminum tube with plastic YES YES YES

Britain cap, supplied in a box

GlaxoSmithKline

Pharmaceuticals S.A., 60 (6x10) tablets in an Al/Al Zyban prolonged release tablets YES YES

Ul. Grunwaldzka 189, blister, supplied in a box

Poznan, Poland

KRKA FARMA d.o.o.,

DPC Jastrebarsko, Zyllt film coated tablets 75 14 (2x7) tablets in a blister,

film coated tablets Cvetkovići bb, YES YES mg supplied in a box

Jastrebarsko, Republic

of Croatia

Lilly Pharma Fertigung

5-mL glass vial with powder

powder for solution for und Distribution GmbH

Zyprexa 10 mg injection for solution for injection, YES YES

injection & Co. KG, Giessen,

supplied in a box

Germany

Eli Lilly and Company

Zyprexa 10 mg coated Limited, Basingstoke, 28 (4x7) tablets in a Alu/Alu film coated tablets YES YES

tablets Hampshire, Great blister, supplied in a box

Britain

Eli Lilly and Company

Zyprexa 15 mg coated Limited, Basingstoke, 28 (4x7) tablets in a Alu/Alu film coated tablets YES YES

tablets Hampshire, Great blister, supplied in a box

Britain

Eli Lilly and Company

Zyprexa 2.5 mg coated Limited, Basingstoke, 28 (4x7) tablets in a Alu/Alu film coated tablets YES YES

tablets Hampshire, Great blister, supplied in a box

Britain

Eli Lilly and Company

Zyprexa 5 mg coated Limited, Basingstoke, 28 (4x7) tablets in a Alu/Alu film coated tablets YES YES

tablets Hampshire, Great blister, supplied in a box

Britain

Eli Lilly and Company

Zyprexa 7.5 mg coated Limited, Basingstoke, 56 (8x7) tablets in an Al/Al film coated tablets YES YES

tablets Hampshire, Great blister, supplied in a box

Britain

Eli Lilly and Company

Zyprexa Velotab 10 mg Limited, Basingstoke, 28 (4x7) tablets in a blister, orodispersible tablets YES YES

orodispersible tablets Hampshire, Great supplied in a box

Britain

Eli Lilly and Company

Zyprexa Velotab 5 mg Limited, Basingstoke, 28 (4x7) tablets in a blister, orodispersible tablets YES YES

orodispersible tablets Hampshire, Great supplied in a box

Britain

66 g granules in an amber Pharmacia & Upjohn

glass bottle of 240 mL with a Company, Michigan,

Zyvoxid granules for oral granules for oral plastic temper-evident

USA and Pfizer YES YES YES suspension 20 mg/mL suspension stopper and a plastic

Manufacturing Belgium

measuring spoon (2.5 mL/5

NV, Puurs, Belgium

mL), supplied in a box

300 mL of solution in a

Zyvoxid 2 mg/mL solution Fresenius Kabi Norge, plastic infusion bag, in a solution for infusion YES YES YES

for infusion Halden, Norway protective aluminium casing.

10 bags per box.

Pharmacia & Upjohn

Company, Michigan,

10 (1x10) tablets in a PVC/Al

Zyvoxid tablets 600 mg film coated tablets USA and Pfizer YES YES YES

blister, supplied in a box

Manufacturing Belgium

NV, Puurs, Belgium

_____________________

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Contents

1.

Kerngegevens

2.

Text

THE EUROPEAN UNION

14509/11

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

Rules on competition