CELEX: C2004/106/12
Language: en
Date: 2004-04-30 00:00:00
Title: Judgment of the Court (Sixth Chamber) of 1 April 2004 in Case C-112/02 (reference for a preliminary ruling from the Oberverwaltungsgericht für das Land Nordrhein-Westfalen): Kohlpharma GmbH v Bundesrepublik Deutschland (‘Free movement of goods — Medicinal products — Importation — Application for marketing authorisation under a simplified procedure — Common origin’)

30.4.2004   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 106/8
            
         
      JUDGMENT OF THE COURT
   
   (Sixth Chamber)
   of 1 April 2004
   in Case C-112/02 (reference for a preliminary ruling from the Oberverwaltungsgericht für das Land Nordrhein-Westfalen): Kohlpharma GmbH v Bundesrepublik Deutschland
       (1)
   
   (‘Free movement of goods - Medicinal products - Importation - Application for marketing authorisation under a simplified procedure - Common origin’)
   (2004/C 106/12)
   Language of the case. German
   In Case C-112/02: reference to the Court under Article 234 EC by the Oberverwaltungsgericht für das Land Nordrhein-Westfalen (Higher Regional Court for the Land of North Rhine-Westphalia (Germany) for a preliminary ruling in the proceedings pending before that court between Kohlpharma GmbH and Bundesrepublik Deutschland – on the interpretation of Community law, in particular Articles 28 EC and 30 EC – the Court (Sixth Chamber), composed of: C. Gulmann (Rapporteur), acting for the President of the Sixth Chamber, J.N. Cunha Rodrigues, J.-P. Puissochet, R. Schintgen and F. Macken, Judges; A. Tizzano, Advocate General; H.A. Rühl, Principal Administrator, for the Registrar, has given a judgment on 1 April 2004, in which it ruled:
   In the case where
   
            
               an application for a marketing authorisation for a medicinal product is submitted with reference to a medicinal product that has already been authorised,
            
         
            
               the medicinal product which is the subject of the application is imported from a Member State in which it has obtained a marketing authorisation,
            
         
            
               the assessment of safety and efficacy carried out for the medicinal product which is already authorised can be used in the application for a marketing authorisation for the second medicinal product without any risk to public health,
            
         Articles 28 EC and 30 EC preclude the application being rejected solely on the ground that the two medicinal products do not have a common origin.
   
      (1)  OJ C 156 of 29.6.2002.