Commission Regulation (EC) No 1662/2005 of 11 October 2005 amending Annex I of Council Regulation (EC) No 953/2003 to avoid trade diversion into the European Union of certain key medicines


Published: 2005-10-11

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L_2005267EN.01001901.xml

12.10.2005   

EN

Official Journal of the European Union

L 267/19

COMMISSION REGULATION (EC) No 1662/2005
of 11 October 2005
amending Annex I of Council 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 medicines (1), and in particular Article 4(4) and (8) thereof,
Whereas:

(1)

The Commission has received modified applications under Article 4 of Regulation (EC) No 953/2003 with respect to Epivir 150 mg × 60 and Combivir 300/150 mg × 60.

(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 replace Annex I to Regulation (EC) No 953/2003,
HAS ADOPTED THIS REGULATION:
Article 1
Annex I to Regulation (EC) No 953/2003 is replaced by the Annex to this Regulation.
Article 2
This regulation enters into force on the day following its publication 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, 11 October 2005.


For the Commission

Peter MANDELSON


Member of the Commission




(1)  OJ L 135, 3.6.2003, p. 5. Regulation as amended by Commission Regulation (EC) No 1876/2004 (OJ L 326, 29.10.2004, p. 22).

ANNEX


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, MIDDX
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
Somalia
South Africa
Sudan
Swaziland
Tajikistan
Tanzania
Togo
Tuvalu
Uganda
Vanuatu
Yemen
Zambia
Zimbabwe
Distinctive access pack — tri-lingual text
19.4.2004
3004 90 19
EPIVIR
150 mg × 60

GLAXO SMITH KLINE
GSK House
980 Great West Road
BRENTFORD, MIDDX
TW8 9GS
United Kingdom
Distinctive access pack — tri-lingual text — red tablets
 
3004 90 19
RETROVIR
250 mg × 40

GLAXO SMITH KLINE
GSK House
980 Great West Road
BRENTFORD, MIDDX
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, MIDDX
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, MIDDX
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, MIDDX
TW8 9GS
United Kingdom
Distinctive access pack — tri-lingual 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, MIDDX
TW8 9GS
United Kingdom
Distinctive access pack — tri-lingual text
19.4.2004
3004 90 19
ZIAGEN
300 mg × 60

GLAXO SMITH KLINE
GSK House
980 Great West Road
BRENTFORD, MIDDX
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, MIDDX
TW8 9GS
United Kingdom
Distinctive access pack
Tri-lingual text
20.9.2004
3004 90 19

(1)  Only if applicable.’