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
Date: 2004-10-28
Institutions: European Commission
Subjects: customs regulations, customs territory (EU), discriminatory price, export restriction, medicinal product, third country

L 326/22

EN

Official Journal of the European Union

29.10.2004

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
Community,

establishing the European

Having regard to Council Regulation (EC) No 953/2003 of 26
May 2003 to avoid trade diversion into the European Union of
certain key medicines (1), and in particular Article 4(8) thereof,

Whereas:

(1)

(2)

The Commission has received applications under Article
4 of Regulation (EC) No 953/2003 with respect
to
certain pharmaceutical products.

The Commission has determined that the applications
received fulfil
in Regulation
the requirements set out
(EC) No 953/2003 in accordance with the procedure
laid down in Article 5(2) of that Regulation.

(3)

(4)

The applicants have been informed of the Commission
decision to accept their applications.

It is therefore necessary to add the products concerned to
Annex I to Regulation (EC) No 953/2003,

HAS ADOPTED THIS REGULATION:

Article 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.

Article 2

This regulation enters into force on the day following its publi-
cation in the Official Journal of the European Union.

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

(1) OJ L 135, 3.6.2003, p. 5.

29.10.2004

EN

Official Journal of the European Union

L 326/23

ANNEX

Product

Manufacturer/exporter

Country of destination

‘TRIZIVIR
750 mg × 60

EPIVIR
150 mg × 60

RETROVIR
250 mg × 40

RETROVIR
300 mg × 60

RETROVIR
100 mg × 100

COMBIVIR
300/150 mg × 60

Glaxo Smith Kline,
GSK House,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS,
United Kingdom

Glaxo Smith Kline,
GSK House,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS,
United Kingdom

Glaxo Smith Kline,
GSK House,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS,
United Kingdom

Glaxo Smith Kline,
GSK House,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS,
United Kingdom

Glaxo Smith Kline,
GSK House,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS,
United Kingdom

Glaxo Smith Kline,
GSK House,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS,
United Kingdom

EPIVIR ORAL
SOLUTION
10 mg/ml 240 ml

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
features

Date of
approval

CN/TARIC
code (1)

Distinctive access
pack — trilingual
text

19.4.2004

3004 90 19

Distinctive access
pack — trilingual
text

19.4.2004

3004 90 19

General
export
pack (blue) not
used in EU

French
hospital
pack — Franco-
phone markets

General
export
pack (blue) not
used in EU

hospital
French
pack — Franco-
phone markets

export
General
pack (blue) not
used in EU

French
hospital
pack — Franco-
phone markets

Distinctive access
pack — trilingual
text

Bottle (rather
than blister
pack) “A22”
embossed tablets

Distinctive access
pack — trilingual
text

19.4.2004

3004 90 19

19.4.2004

3004 90 19

19.4.2004

3004 90 19

19.4.2004

3004 90 19

19.4.2004

3004 90 19

L 326/24

EN

Official Journal of the European Union

29.10.2004

Product

Manufacturer/exporter

Country of destination

Distinctive
features

Date of
approval

CN/TARIC
code (1)

ZIAGEN
300 mg × 60

RETROVIR
ORAL SOLUTION
10 mg/ml
200 ml

(1) Only if applicable.’

Glaxo Smith Kline,
GSK House,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS,
United Kingdom

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 — Franco-
phone countries

Distinctive access
pack — trilingual
text

20.9.2004

3004 90 19

20.9.2004

3004 90 19