CELEX: 62014CN0452
Language: en
Date: 2014-09-29 00:00:00
Title: Case C-452/14: Request for a preliminary ruling from the Consiglio di Stato (Italy) lodged on 29 September 2014  — Agenzia Italiana del Farmaco (AIFA), Ministry for Health v Doc Generici srl

15.12.2014   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 448/8
            
         Request for a preliminary ruling from the Consiglio di Stato (Italy) lodged on 29 September 2014 — Agenzia Italiana del Farmaco (AIFA), Ministry for Health v Doc Generici srl
   (Case C-452/14)
   (2014/C 448/11)
   Language of the case: Italian
   
      Referring court
   
   Consiglio di Stato
   
      Parties to the main proceedings
   
   
      Applicants: Agenzia Italiana del Farmaco (AIFA), Ministry for Health
   
      Defendant: Doc Generici srl
   
      Questions referred
   
   
               1.
            
            
               Must Article 3(2)(a) of Council Regulation (EC) No 297/95 of 10 February 1995 (1), in the version currently in force, be interpreted as meaning that Type I marketing authorisation variations — and, in particular, in respect of the case in the main proceedings, Type IA variations — where an identical variation affecting several authorisations belonging to the same holder are concerned, are subject to a single fee, to the extent specified therein, or to as many fees as there are authorisations affected by the variation?
            
         
               2.
            
            
               In the circumstances in the present proceedings, may or must, as held by this Chamber, the question be referred to the Court of Justice?
            
         
      (1)  Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (OJ 1995 L 35, 15.2.1995, p. 1).