Commission Regulation (EC) No 1876/2004 of 28 October 2004 amending Annex I of Regulation (EC) No 953/2003 to avoid trade diversion into the European Union of certain key medicines
EU Regulation No 1876/2004 · Adopted 28 October 2004 · Extends to United Kingdom
Commission Regulation (EC) No 1876/2004
of 28 October 2004
amending Annex I of Regulation (EC) No 953/2003 to avoid trade diversion into the European Union of certain key medicines
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicinesf1, and in particular Article 4(8) thereof,
Whereas:
(1)
The Commission has received applications under Article 4 of Regulation (EC) No 953/2003 with respect to certain pharmaceutical products.
(2)
The Commission has determined that the applications received fulfil the requirements set out in Regulation (EC) No 953/2003 in accordance with the procedure laid down in Article 5(2) of that Regulation.
(3)
The applicants have been informed of the Commission decision to accept their applications.
(4)
It is therefore necessary to add the products concerned to Annex I to Regulation (EC) No 953/2003,
HAS ADOPTED THIS REGULATION:
Annotations to the whole text
Footnotes
Contents
1
The products and other details mentioned in the Annex to this Regulation shall be added to Annex I to Regulation (EC) No 953/2003 to avoid trade diversion into the European Union of certain key medicines.
2
This regulation enters into force on the day following its publication in the Official Journal of the European Union.
Signature
It shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 October 2004.
For the Commission
Pascal Lamy
Member of the Commission
Only if applicable.’
Product Manufacturer/exporter Country of destination Distinctive features Date of approval CN/TARIC codef1 ‘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
Djibouti
DR Congo
East Timor
Equatorial Guinea
Eritrea
Ethiopia
Gambia
Ghana
Guinea
Guinea Bissau
Haiti
Honduras
India
Indonesia
Kenya
Kiribati
Korea (Dem Rep)
Kyrgyz Republic
Lao People’s DR
Lesotho
Liberia
Madagascar
Malawi
Maldives
Mali
Mauritania
Moldova
Mongolia
Mozambique
Myanmar
Namibia
Nepal
Nicaragua
Niger
Nigeria
Pakistan
Rwanda
Samoa
Sao Tome and Principe
Senegal
Sierra Leone
Solomon Islands
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 19.4.2004 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 tablets
19.4.2004 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
Somalia
South Africa
Sudan
Swaziland
Tajikistan
Tanzania
Togo
Tuvalu
Uganda
Vanuatu
Yemen
Zambia
Zimbabwe
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