CELEX: 32005R1662
Language: en
Date: 2005-10-11 00:00:00
Title: 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

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.
            
         
               (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
         
      
   
   
      (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).
   
      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
                              
                           
                  
                     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
                              
                           
                  
                     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
                              
                           
                  
                     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
                              
                           
                  
                     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
                              
                           
                  
                     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
                              
                           
                  
                     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
                              
                           
                  
                     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
                              
                           
                  
                     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
                              
                           
                  
                     Distinctive access pack
                     Tri-lingual text
                  
                  
                     20.9.2004
                  
                  
                     3004 90 19
                  
               
      
         (1)  Only if applicable.’