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
Date: 2005-10-11
Institutions: European Commission
Subjects: customs regulations, customs territory (EU), discriminatory price, export restriction, medicinal product

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
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(4) and (8)
thereof,

Whereas:

(EC) No 953/2003 in accordance with the procedure
laid down in Article 5(2) of that Regulation.

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

It is therefore necessary to replace Annex I to Regulation
(EC) No 953/2003,

(3)

(4)

HAS ADOPTED THIS REGULATION:

Article 1

(1)

(2)

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.

Annex I to Regulation (EC) No 953/2003 is replaced by the
Annex to this Regulation.

Article 2

The Commission has determined that the applications
in Regulation
the requirements set out
received fulfil

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, 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).

L 267/20

EN

Official Journal of the European Union

12.10.2005

Product

Manufacturer/exporter

Country of destination

Distinctive features

Date of approval

CN/TARIC code (1)

ANNEX

‘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

EPIVIR ORAL
SOLUTION
10 mg/ml
240 ml

ZIAGEN
300 mg × 60

GLAXO SMITH KLINE
GSK House
980 Great West Road
BRENTFORD, MIDDX
TW8 9GS
United Kingdom

GLAXO SMITH KLINE
GSK House
980 Great West Road
BRENTFORD, MIDDX
TW8 9GS
United Kingdom

GLAXO SMITH KLINE
GSK House
980 Great West Road
BRENTFORD, MIDDX
TW8 9GS
United Kingdom

GLAXO SMITH KLINE
GSK House
980 Great West Road
BRENTFORD, MIDDX
TW8 9GS
United Kingdom

GLAXO SMITH KLINE
GSK House
980 Great West Road
BRENTFORD, MIDDX
TW8 9GS
United Kingdom

GLAXO SMITH KLINE
GSK House
980 Great West Road
BRENTFORD, MIDDX
TW8 9GS
United Kingdom

GLAXO SMITH KLINE
GSK House
980 Great West Road
BRENTFORD, MIDDX
TW8 9GS
United Kingdom

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

Distinctive access pack —
tri-lingual text

19.4.2004

3004 90 19

Distinctive access pack —
tri-lingual text — red tablets

3004 90 19

General export pack (blue)
not used in EU.
French hospital pack —
Francophone markets

General export pack (blue)
not used in EU.
French hospital pack —
Francophone markets

General export pack (blue)
not used in EU.
French hospital pack —
Francophone markets

Distinctive access pack —
tri-lingual text
than blister
(rather
Bottle
“A22” embossed red
pack)
tablets

19.4.2004

3004 90 19

19.4.2004

3004 90 19

19.4.2004

3004 90 19

3004 90 19

Distinctive access pack —
tri-lingual text

19.4.2004

3004 90 19

General export pack — not
used in EU.
French hospital pack —
Francophone countries

20.9.2004

3004 90 19

12.10.2005

EN

Official Journal of the European Union

L 267/21

Product

Manufacturer/exporter

Country of destination

Distinctive features

Date of approval

CN/TARIC code (1)

Distinctive access pack
Tri-lingual text

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

Sierra Leone
Solomon Islands
Somalia
South Africa
Sudan
Swaziland
Tajikistan
Tanzania
Togo
Tuvalu
Uganda
Vanuatu
Yemen
Zambia
Zimbabwe

(1) Only if applicable.’