CELEX: 62011CN0535
Language: en
Date: 2011-10-20 00:00:00
Title: Case C-535/11: Reference for a preliminary ruling from the Landgericht Hamburg (Germany) lodged on 20 October 2011 — Novartis Pharma GmbH v Apozyt GmbH

14.1.2012   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 13/5
            
         Reference for a preliminary ruling from the Landgericht Hamburg (Germany) lodged on 20 October 2011 — Novartis Pharma GmbH v Apozyt GmbH
   (Case C-535/11)
   2012/C 13/10
   Language of the case: German
   
      Referring court
   
   Landgericht Hamburg
   
      Parties to the main proceedings
   
   
      Claimant: Novartis Pharma GmbH
   
      Defendant: Apozyt GmbH
   
      Question referred
   
   Does the term ‘developed’ in the introductory sentence of the Annex to Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (1) extend to processes in which portions only of a medicinal product which has been developed and produced on a ready-to-use basis in accordance with the above procedures are drawn off into another container, after being prescribed and ordered at the time concerned by a doctor, if as a result of the process the composition of the medicinal product is not modified, and therefore in particular to the production of pre-filled syringes which have been filled with a medicinal product which is authorised under the regulation?
   
      (1)  OJ 2004 L 136, p. 1.