CELEX: C2005/045/09
Language: en
Date: 2005-02-19 00:00:00
Title: Judgment of the Court (Second Chamber) of 9 December 2004 in Case C-36/03 (reference for a preliminary ruling from the High Court of Justice of England and Wales, Queen's Bench Division (Administrative Court)): The Queen, on the application of: Approved Prescription Services Ltd, v Licensing Authority (Medicinal products — Marketing authorisation — Procedures for essentially similar products)

19.2.2005   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 45/5
            
         
      JUDGMENT OF THE COURT
   
   (Second Chamber)
   of 9 December 2004
   in Case C-36/03 (reference for a preliminary ruling from the High Court of Justice of England and Wales, Queen's Bench Division (Administrative Court)): The Queen, on the application of: Approved Prescription Services Ltd, v Licensing Authority
       (1)
   
   (Medicinal products - Marketing authorisation - Procedures for essentially similar products)
   (2005/C 45/09)
   Language of the case: English
   In Case C-36/03: reference for a preliminary ruling under Article 234 EC from the High Court of Justice of England and Wales, Queen's Bench Division (Administrative Court) (United Kingdom), made by order of 23 December 2002, received at the Court on 3 February 2003, in the proceedings between The Queen, on the application of: Approved Prescription Services Ltd, and Licensing Authority, acting by the Medicines and Healthcare products Regulatory Agency, interested party: Eli Lilly & Co. Ltd, – the Court (Second Chamber), composed of: C.W.A. Timmermans, President of the Chamber, C. Gulmann (Rapporteur), J.-P. Puissochet, N. Colneric and J.N. Cunha Rodrigues, Judges; F.G. Jacobs, Advocate General; M. Múgica Arzamendi, Principal Administrator, for the Registrar, has given a judgment on 9 December 2004, in which it has ruled:
   An application for marketing authorisation for a Product C may be made under Article 10(1)(a)(iii) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use where the application seeks to demonstrate that Product C is essentially similar to a Product B, in circumstances where:
   
               —
            
            
               Product B is a new pharmaceutical form of Product A, and
            
         
               —
            
            
               Product A, but not Product B, has been authorised for marketing in the Community for at least the six or ten year period stipulated therein.
            
         
      (1)  OJ C 83 of 5.4.2003.