CELEX: C2005/296/31
Language: en
Date: 2005-11-26 00:00:00
Title: Case C-364/05: Action brought on  27 September 2005  by Commission of the European Communities against the Kingdom of the Netherlands

26.11.2005   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 296/17
            
         Action brought on 27 September 2005 by Commission of the European Communities against the Kingdom of the Netherlands
   (Case C-364/05)
   (2005/C 296/31)
   Language of the case: Dutch
   An action against the Kingdom of the Netherlands was brought before the Court of Justice of the European Communities on 27 September 2005 by the Commission of the European Communities, represented by Michel van Beek, acting as Agent, with an address for service in Luxembourg.
   The applicant claims that the Court should:
   
               —
            
            
               Declare that the Kingdom of the Netherlands,
               by failing to adopt the legislative and administrative measures necessary to comply with Directive 2001/20/EC (1) of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
               by failing to adopt the legislative and administrative measures necessary to comply with Commission Directive 2003/94/EC (2) of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
               or in any event by failing to notify such measures to the Commission
               has failed to fulfil its obligations under those directives;
            
         
               —
            
            
               order the Kingdom of the Netherlands to pay the costs
            
         Pleas in law and main arguments
   The first paragraph of Article 22 of Directive 2001/20 provides that Member States are to bring the necessary legislative and administrative measures for complying with the directive into force by 1 May 2003 and inform the Commission accordingly. In the case of Directive 2003/94, Article 17 sets the deadline at 30 April 2004.
   
      (1)  OJ 2001 L 121, p. 34.
   
      (2)  OJ 2003 L 262, p. 22.