# L_2005267EN.01001901.xml

| 12.10.2005 | EN | Official Journal of the European Union | L 267/19 |
| --- | --- | --- | --- |

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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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, |
| --- | --- |

(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).

1

---

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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.’

1

---