Annexes to COM(2014)319 - Avoid trade diversion into the EU of certain key medicines (codification) - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2014)319 - Avoid trade diversion into the EU of certain key medicines (codification). |
|---|---|
| document | COM(2014)319  |
| date | May 11, 2016 |
(4) Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003 (OJ L 181, 29.6.2013, p. 15).
(5) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).
(6) Directive 2001/83/EC 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).
(7) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
ANNEX I
LIST OF TIERED-PRICED PRODUCTS
| Product | Manufacturer/exporter | Country of destination | Distinctive features | Date of approval | CN/TARIC code (1) |
| TRIZIVIR 750 mg × 60 | GLAXO SMITH KLINE GSK House 980 Great West Road BRENTFORD, MIDDLESEX TW8 9GS United Kingdom | Afghanistan Angola Armenia Azerbaijan Bangladesh Benin Bhutan Botswana Burkina Faso Burundi Cambodia Cameroon Cape Verde Central African Republic Chad Comoros Congo Côte d'Ivoire Democratic Republic of the Congo Djibouti Equatorial Guinea Eritrea Ethiopia Gambia Ghana Guinea Guinea-Bissau Haiti Honduras India Indonesia Kenya Kiribati Kyrgyzstan Laos Lesotho Liberia Madagascar Malawi Maldives Mali Mauritania Moldova Mongolia Mozambique Myanmar/Burma Namibia Nepal Nicaragua Niger Nigeria North Korea Pakistan Rwanda Samoa São Tomé and Príncipe Senegal Sierra Leone Solomon Islands Somalia South Africa Sudan Swaziland Tajikistan Tanzania Timor-Leste Togo Tuvalu Uganda Vanuatu Yemen Zambia Zimbabwe | Distinctive access pack — trilingual text | 19.4.2004 | 3004 90 19 |
| EPIVIR 150 mg × 60 | GLAXO SMITH KLINE GSK House 980 Great West Road BRENTFORD, MIDDLESEX TW8 9GS United Kingdom | Distinctive access pack — trilingual text — red tablets | 3004 90 19 | ||
| RETROVIR 250 mg × 40 | GLAXO SMITH KLINE GSK House 980 Great West Road BRENTFORD, MIDDLESEX TW8 9GS United Kingdom | General export pack (blue) not used in EU. French hospital pack — Francophone markets | 19.4.2004 | 3004 90 19 | |
| RETROVIR 300 mg × 60 | GLAXO SMITH KLINE GSK House 980 Great West Road BRENTFORD, MIDDLESEX TW8 9GS United Kingdom | General export pack (blue) not used in EU. French hospital pack — Francophone markets | 19.4.2004 | 3004 90 19 | |
| RETROVIR 100 mg × 100 | GLAXO SMITH KLINE GSK House 980 Great West Road BRENTFORD, MIDDLESEX TW8 9GS United Kingdom | General export pack (blue) not used in EU. French hospital pack — Francophone markets | 19.4.2004 | 3004 90 19 | |
| COMBIVIR 300/150 mg × 60 | GLAXO SMITH KLINE GSK House 980 Great West Road BRENTFORD, MIDDLESEX TW8 9GS United Kingdom | Distinctive access pack — trilingual text Bottle (rather than blister pack) ‘A22’ embossed red tablets | 3004 90 19 | ||
| EPIVIR ORAL SOLUTION 10 mg/ml 240 ml | GLAXO SMITH KLINE GSK House 980 Great West Road BRENTFORD, MIDDLESEX TW8 9GS United Kingdom | Distinctive access pack — trilingual text | 19.4.2004 | 3004 90 19 | |
| ZIAGEN 300 mg × 60 | GLAXO SMITH KLINE GSK House 980 Great West Road BRENTFORD, MIDDLESEX TW8 9GS United Kingdom | General export pack — not used in EU. French hospital pack — Francophone countries | 20.9.2004 | 3004 90 19 | |
| RETROVIR ORAL SOLUTION 10 mg/ml 200 ml | GLAXO SMITH KLINE GSK House 980 Great West Road BRENTFORD, MIDDLESEX TW8 9GS United Kingdom | Distinctive access pack — Trilingual text | 20.9.2004 | 3004 90 19 |
(1) Only if applicable.
ANNEX II
COUNTRIES OF DESTINATION
Afghanistan
Angola
Armenia
Azerbaijan
Bangladesh
Benin
Bhutan
Botswana
Burkina Faso
Burundi
Cambodia
Cameroon
Cape Verde
Central African Republic
Chad
China
Comoros
Congo
Côte d'Ivoire
Democratic Republic of the Congo
Djibouti
Equatorial Guinea
Eritrea
Ethiopia
Gambia
Ghana
Guinea
Guinea-Bissau
Haiti
Honduras
India
Indonesia
Kenya
Kiribati
Kyrgyzstan
Laos
Lesotho
Liberia
Madagascar
Malawi
Maldives
Mali
Mauritania
Moldova
Mongolia
Mozambique
Myanmar/Burma
Namibia
Nepal
Nicaragua
Niger
Nigeria
North Korea
Pakistan
Rwanda
Samoa
São Tomé and Príncipe
Senegal
Sierra Leone
Solomon Islands
Somalia
South Africa
Sudan
Swaziland
Tajikistan
Tanzania
Timor-Leste
Togo
Turkmenistan
Tuvalu
Uganda
Vanuatu
Vietnam
Yemen
Zambia
Zimbabwe
ANNEX III
PERCENTAGES REFERRED TO IN ARTICLE 3
Percentage referred to in Article 3(a): 25 %
Percentage referred to in Article 3(b): 15 %
ANNEX IV
SCOPE OF DISEASES
HIV/AIDS, malaria, tuberculosis and related opportunistic diseases
ANNEX V
LOGO
The winged staff of Aesculapius with a coiled serpent, in the centre of a circle formed by 12 stars.
ANNEX VI
REPEALED REGULATION WITH LIST OF ITS SUCCESSIVE AMENDMENTS
| Council Regulation (EC) No 953/2003 (OJ L 135, 3.6.2003, p. 5) | |
| Commission Regulation (EC) No 1876/2004 (OJ L 326, 29.10.2004, p. 22) | |
| Commission Regulation (EC) No 1662/2005 (OJ L 267, 12.10.2005, p. 19) | |
| Regulation (EU) No 38/2014 of the European Parliament and of the Council (OJ L 18, 21.1.2014, p. 52) | Only point 3 of the Annex |
ANNEX VII
CORRELATION TABLE
| Regulation (EC) No 953/2003 | This Regulation |
| Articles 1, 2 and 3 | Articles 1, 2 and 3 |
| Article 4(1) | Article 4(1) |
| Article 4(2), introductory wording | Article 4(2), introductory wording |
| Article 4(2)(i) | Article 4(2)(a) |
| Article 4(2)(ii) | Article 4(2)(b) |
| Article 4(2)(iii) | Article 4(2)(c) |
| Article 4(2)(iv) | Article 4(2)(d) |
| Article 4(2)(v) | Article 4(2)(e) |
| Article 4(4) | Article 4(3) |
| Article 4(5) | Article 4(4) |
| Article 4(6) | Article 4(5) |
| Article 4(7) | Article 4(6) |
| Article 4(8) | Article 4(7) |
| Article 4(9) | Article 4(8) |
| Article 5 | Article 5 |
| Article 5a | Article 6 |
| Article 6 | Article 7 |
| Article 7 | Article 8 |
| Article 8 | Article 9 |
| Article 9 | Article 10 |
| Article 10 | Article 11 |
| Article 11 | Article 12 |
| Article 12 | Article 13 |
| — | Article 14 |
| Article 13 | Article 15 |
| Annexes I to V | Annexes I to V |
| — | Annex VI |
| — | Annex VII |