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
Commission Regulation (EC) No 1662/2005of 11 October 2005amending 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 medicinesOJ 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)., 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 1Annex I to Regulation (EC) No 953/2003 is replaced by the Annex to this Regulation.
Article 2This 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 CommissionPeter MandelsonMember of the CommissionANNEX
Only if applicable."
ProductManufacturer/exporterCountry of destinationDistinctive featuresDate of approvalCN/TARIC code
"TRIZIVIR750 mg × 60GLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited KingdomAfghanistanAngolaArmeniaAzerbaijanBangladeshBeninBhutanBotswanaBurkina FasoBurundiCambodiaCameroonCape VerdeCentral African RepublicChadComorosCongoCôte d’IvoireDjiboutiDR CongoEast TimorEquatorial GuineaEritreaEthiopiaGambiaGhanaGuineaGuinea BissauHaitiHondurasIndiaIndonesiaKenyaKiribatiKorea (Dem Rep)Kyrgyz RepublicLao People’s DRLesothoLiberiaMadagascarMalawiMaldivesMaliMauritaniaMoldovaMongoliaMozambiqueMyanmarNamibiaNepalNicaraguaNigerNigeriaPakistanRwandaSamoaSao Tome and PrincipeSenegalSierra LeoneSolomon IslandsSomaliaSouth AfricaSudanSwazilandTajikistanTanzaniaTogoTuvaluUgandaVanuatuYemenZambiaZimbabweDistinctive access pack — tri-lingual text19.4.200430049019
EPIVIR150 mg × 60GLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited KingdomDistinctive access pack — tri-lingual text — red tablets30049019
RETROVIR250 mg × 40GLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited KingdomGeneral export pack (blue) not used in EU.French hospital pack — Francophone markets19.4.200430049019
RETROVIR300 mg × 60GLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited KingdomGeneral export pack (blue) not used in EU.French hospital pack — Francophone markets19.4.200430049019
RETROVIR100 mg × 100GLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited KingdomGeneral export pack (blue) not used in EU.French hospital pack — Francophone markets19.4.200430049019
COMBIVIR300/150 mg × 60GLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited KingdomDistinctive access pack — tri-lingual textBottle (rather than blister pack) "A22" embossed red tablets30049019
EPIVIR ORAL SOLUTION10 mg/ml240 mlGLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited KingdomDistinctive access pack — tri-lingual text19.4.200430049019
ZIAGEN300 mg × 60GLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited KingdomGeneral export pack — not used in EU.French hospital pack — Francophone countries20.9.200430049019
RETROVIR ORAL SOLUTION10 mg/ml200 mlGLAXO SMITH KLINEGSK House980 Great West RoadBRENTFORD, MIDDXTW8 9GSUnited KingdomDistinctive access packTri-lingual text20.9.200430049019
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Only if applicable."