
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, 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
ANNEX


Product Manufacturer/exporter Country of destination Distinctive features Date of approval CN/TARIC code
‘TRIZIVIR750 mg × 60 
GLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited Kingdom
 AfghanistanAngolaArmeniaAzerbaijanBangladeshBeninBhutanBotswanaBurkina FasoBurundiCambodiaCameroonCape VerdeCentral African RepublicChadComorosCongoCôte d’IvoireDjiboutiDR CongoEast TimorEquatorial GuineaEritreaEthiopiaGambiaGhanaGuineaGuinea BissauHaitiHondurasIndiaIndonesiaKenyaKiribatiKorea (Dem Rep)Kyrgyz RepublicLao People’s DRLesothoLiberiaMadagascarMalawiMaldivesMaliMauritaniaMoldovaMongoliaMozambiqueMyanmarNamibiaNepalNicaraguaNigerNigeriaPakistanRwandaSamoaSao Tome and PrincipeSenegalSierra LeoneSolomon IslandsSomaliaSouth AfricaSudanSwazilandTajikistanTanzaniaTogoTuvaluUgandaVanuatuYemenZambiaZimbabwe Distinctive access pack — tri-lingual text 19.4.2004 3004 90 19
EPIVIR150 mg × 60 
GLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited Kingdom
 Distinctive access pack — tri-lingual text — red tablets  3004 90 19
RETROVIR250 mg × 40 
GLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited Kingdom
 General export pack (blue) not used in EU.French hospital pack — Francophone markets 19.4.2004 3004 90 19
RETROVIR300 mg × 60 
GLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited Kingdom
 General export pack (blue) not used in EU.French hospital pack — Francophone markets 19.4.2004 3004 90 19
RETROVIR100 mg × 100 
GLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited Kingdom
 General export pack (blue) not used in EU.French hospital pack — Francophone markets 19.4.2004 3004 90 19
COMBIVIR300/150 mg × 60 
GLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited Kingdom
 Distinctive access pack — tri-lingual textBottle (rather than blister pack) “A22” embossed red tablets  3004 90 19
EPIVIR ORAL SOLUTION10 mg/ml240 ml 
GLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited Kingdom
 Distinctive access pack — tri-lingual text 19.4.2004 3004 90 19
ZIAGEN300 mg × 60 
GLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited Kingdom
 General export pack — not used in EU.French hospital pack — Francophone countries 20.9.2004 3004 90 19
RETROVIR ORAL SOLUTION10 mg/ml200 ml 
GLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited Kingdom
 Distinctive access packTri-lingual text 20.9.2004 3004 90 19

