Commission Regulation (EC) No 1876/2004 of 28 October 2004 amending Annex I of Regulation (EC) No 953/2003 to avoid trade diversion into the European Union of certain key medicines
Commission Regulation (EC) No 1876/2004of 28 October 2004amending Annex I of 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., and in particular Article 4(8) thereof,Whereas:(1)The Commission has received applications under Article 4 of Regulation (EC) No 953/2003 with respect to certain pharmaceutical products.(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 add the products concerned to Annex I to Regulation (EC) No 953/2003,HAS ADOPTED THIS REGULATION:
Article 1The products and other details mentioned in the Annex to this Regulation shall be added to Annex I to Regulation (EC) No 953/2003 to avoid trade diversion into the European Union of certain key medicines.
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, 28 October 2004.For the CommissionPascal LamyMember of the CommissionANNEX
Only if applicable."
ProductManufacturer/exporterCountry of destinationDistinctive featuresDate of approvalCN/TARIC code
"TRIZIVIR750 mg × 60Glaxo Smith Kline,GSK House,980 Great West Road,Brentford, Middlesex,TW8 9GS,United KingdomAfghanistanAngolaArmeniaAzerbaijanBangladeshBeninBhutanBotswanaBurkina FasoBurundiCambodiaCameroonCape VerdeCentral African RepublicChadComorosCongoCôte d’IvoireDjiboutiDR CongoEast TimorEquatorial GuineaEritreaEthiopiaGambiaGhanaGuineaGuinea BissauHaitiHondurasIndiaIndonesiaKenyaKiribatiKorea (Dem Rep)Kyrgyz RepublicLao People’s DRLesothoLiberiaMadagascarMalawiMaldivesMaliMauritaniaMoldovaMongoliaMozambiqueMyanmarNamibiaNepalNicaraguaNigerNigeriaPakistanRwandaSamoaSao Tome and PrincipeSenegalSierra LeoneSolomon IslandsDistinctive access pack — trilingual text19.4.200430049019
EPIVIR150 mg × 60Glaxo Smith Kline,GSK House,980 Great West Road,Brentford, Middlesex,TW8 9GS,United KingdomDistinctive access pack — trilingual text19.4.200430049019
RETROVIR250 mg × 40Glaxo Smith Kline,GSK House,980 Great West Road,Brentford, Middlesex,TW8 9GS,United KingdomGeneral export pack (blue) not used in EUFrench hospital pack — Francophone markets19.4.200430049019
RETROVIR300 mg × 60Glaxo Smith Kline,GSK House,980 Great West Road,Brentford, Middlesex,TW8 9GS,United KingdomGeneral export pack (blue) not used in EUFrench hospital pack — Francophone markets19.4.200430049019
RETROVIR100 mg × 100Glaxo Smith Kline,GSK House,980 Great West Road,Brentford, Middlesex,TW8 9GS,United KingdomGeneral export pack (blue) not used in EUFrench hospital pack — Francophone markets19.4.200430049019
COMBIVIR300/150 mg × 60Glaxo Smith Kline,GSK House,980 Great West Road,Brentford, Middlesex,TW8 9GS,United KingdomDistinctive access pack — trilingual textBottle (rather than blister pack) "A22" embossed tablets19.4.200430049019
EPIVIR ORAL SOLUTION10 mg/ml 240 mlGlaxo Smith Kline,GSK House,980 Great West Road,Brentford, Middlesex,TW8 9GS,United KingdomDistinctive access pack — trilingual text19.4.200430049019
ZIAGEN300 mg × 60Glaxo Smith Kline,GSK House,980 Great West Road,Brentford, Middlesex,TW8 9GS,United KingdomSomaliaSouth AfricaSudanSwazilandTajikistanTanzaniaTogoTuvaluUgandaVanuatuYemenZambiaZimbabweGeneral export pack — not used in EUFrench hospital pack — Francophone countries20.9.200430049019
RETROVIR ORAL SOLUTION10 mg/ml200 mlGlaxo Smith Kline,GSK House,980 Great West Road,Brentford, Middlesex,TW8 9GS,United KingdomDistinctive access pack — trilingual text20.9.200430049019
----------------------
Only if applicable."