CELEX: 62017TA0733
Language: en
Date: 2019-05-16 00:00:00
Title: Case T-733/17: Judgment of the General Court of 16 May 2019 — GMPO v Commission (Medicinal products for human use — Article 3(1)(b) of Regulation (EC) No 141/2000 — Definition of ‘significant benefit’ — Availability of orphan medicinal products — Article 5(12)(b) of Regulation No 141/2000 — Commission decision to remove a medicinal product from the Register of Orphan Medicinal Products — Error of assessment — Error of law — Legitimate expectations)

8.7.2019   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 230/31
            
         
      Judgment of the General Court of 16 May 2019 — GMPO v Commission
      (Case T-733/17) (1)
      
      (Medicinal products for human use - Article 3(1)(b) of Regulation (EC) No 141/2000 - Definition of ‘significant benefit’ - Availability of orphan medicinal products - Article 5(12)(b) of Regulation No 141/2000 - Commission decision to remove a medicinal product from the Register of Orphan Medicinal Products - Error of assessment - Error of law - Legitimate expectations)
      (2019/C 230/38)
      Language of the case: English
      
         Parties
      
      
         Applicant: GMP-Orphan (GMPO) (Paris, France) (represented by: M. Demetriou QC, E. Mackenzie, Barrister, L. Tsang and J. Mulryne, Solicitors)
      
         Defendant: European Commission (represented by: K. Petersen and A. Sipos, acting as Agents)
      
         Re:
      
      Action pursuant to Article 263 TFEU seeking the partial annulment of Commission Implementing Decision C(2017) 6102 final of 5 September 2017 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Cuprior-trientine’, a medicinal product for human use, in so far as the Commission decided, in Article 5 of that decision, that that medicinal product no longer satisfied the criteria laid down in Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1) to be registered as an orphan medicinal product and that the European Union Register of Orphan Medicinal Products should be updated accordingly.
      
         Operative part of the judgment
      
      The Court:
      
                  1.
               
               
                  
                     Dismisses the action;
                  
               
            
                  2.
               
               
                  
                     Orders GMP-Orphan (GMPO) to pay the costs, including those incurred in the proceedings for interim measures.
                  
               
            
         (1)  OJ C 13, 15.1.2018.