CELEX: C2005/057/14
Language: en
Date: 2005-03-05 00:00:00
Title: Judgment of the Court (Second Chamber) of 20 January 2005 in Case C-245/03 (reference for a preliminary ruling by the Conseil d'État): Merck, Sharp & Dohme BV v État belge (Directive 89/105/EEC — Medicinal products for human use — Application for entry on a positive list — Nature of the time-limit for responding — Mandatory nature — Consequences of exceeding the time-limit)

5.3.2005   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 57/8
            
         
      JUDGMENT OF THE COURT
   
   (Second Chamber)
   of 20 January 2005
   in Case C-245/03 (reference for a preliminary ruling by the Conseil d'État): Merck, Sharp & Dohme BV v État belge (1)
   
   (Directive 89/105/EEC - Medicinal products for human use - Application for entry on a positive list - Nature of the time-limit for responding - Mandatory nature - Consequences of exceeding the time-limit)
   (2005/C 57/14)
   Language of the case: French
   In Case C-245/03: reference for a preliminary ruling under Article 234 EC from the Conseil d'État (Belgium), by decision of 9 May 2003, received at the Court on 10 June 2003, in the proceedings, between Merck, Sharp & Dohme BV and État belge – the Court (Second Chamber), composed of C.W.A. Timmermans, President of the Chamber, R. Silva de Lapuerta (Rapporteur), C. Gulmann, R. Schintgen and G. Arestis, Judges; A. Tizzano, Advocate General; M. Múgica Arzamendi, Principal Administrator, for the Registrar, has given a judgment on 20 January 2005, in which it has ruled:
   
               1.
            
            
               The time-limit laid down in the first subparagraph of Article 6(1) of Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems is a mandatory time-limit which the national authorities are not entitled to exceed.
            
         
               2.
            
            
               The first subparagraph of Article 6(1) of Directive 89/105 does not impose the automatic entry of a medicinal product on the list of proprietary medicinal products covered by the sickness insurance system where the time-limit laid down in that article is exceeded.
            
         
      (1)  OJ C 213 of 06.09.2003.