REGULATION (EU) 2016/793 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 11 May 2016
to avoid trade diversion into the European Union of certain key medicines
(codification)
Article 1
Article 2
Article 3
Article 4
Article 5
Article 6
Article 7
Article 8
Article 9
Article 10
Article 11
Article 12
Article 13
Article 14
Article 15
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 |
|
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 |
|
Distinctive access pack — trilingual text — red tablets |
|
3004 90 19 |
|||||||
RETROVIR 250 mg × 40 |
|
General export pack (blue) not used in EU. French hospital pack — Francophone markets |
19.4.2004 |
3004 90 19 |
|||||||
RETROVIR 300 mg × 60 |
|
General export pack (blue) not used in EU. French hospital pack — Francophone markets |
19.4.2004 |
3004 90 19 |
|||||||
RETROVIR 100 mg × 100 |
|
General export pack (blue) not used in EU. French hospital pack — Francophone markets |
19.4.2004 |
3004 90 19 |
|||||||
COMBIVIR 300/150 mg × 60 |
|
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 |
|
Distinctive access pack — trilingual text |
19.4.2004 |
3004 90 19 |
|||||||
ZIAGEN 300 mg × 60 |
|
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 |
|
Distinctive access pack — Trilingual text |
20.9.2004 |
3004 90 19 |
ANNEX II
COUNTRIES OF DESTINATION
ANNEX III
PERCENTAGES REFERRED TO IN ARTICLE 3
ANNEX IV
SCOPE OF DISEASES
ANNEX V
LOGO
ANNEX VI
REPEALED REGULATION WITH LIST OF ITS SUCCESSIVE AMENDMENTS
Council Regulation (EC) No 953/2003 |
|
Commission Regulation (EC) No 1876/2004 |
|
Commission Regulation (EC) No 1662/2005 |
|
Regulation (EU) No 38/2014 of the European Parliament and of the Council |
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 |