CELEX: 62018CA0359
Language: en
Date: 2019-07-29 00:00:00
Title: Case C-359/18 P: Judgment of the Court (Eighth Chamber) of 29 July 2019 — European Medicines Agency v Shire Pharmaceuticals Ireland Ltd, European Commission (Appeal — Regulation (EC) No 141/2000 — Orphan medicinal products — Article 5 — Application for designation of a medicinal product as an ‘orphan medicinal product’ — Validation — Existence of a prior marketing authorisation (MA) for the same medicinal product)

23.9.2019   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 319/17
            
         
      Judgment of the Court (Eighth Chamber) of 29 July 2019 — European Medicines Agency v Shire Pharmaceuticals Ireland Ltd, European Commission
      (Case C-359/18 P) (1)
      
      (Appeal - Regulation (EC) No 141/2000 - Orphan medicinal products - Article 5 - Application for designation of a medicinal product as an ‘orphan medicinal product’ - Validation - Existence of a prior marketing authorisation (MA) for the same medicinal product)
      (2019/C 319/17)
      Language of the case: English
      
         Parties
      
      
         Appellant: European Medicines Agency (represented by: initially by S. Marino, S. Drosos, T. Jabłoński and A. Spina, Agents, and subsequently by S. Marino, S. Drosos and T. Jabłoński, Agents)
      
         Other parties to the proceedings: Shire Pharmaceuticals Ireland Ltd (represented by: G. Castle, Solicitor, D. Anderson QC and M. Birdling, Barrister and by S. Cowlishaw, Solicitor), European Commission (represented by: K. Petersen and A. Sipos, Agents)
      
         Operative part of the judgment
      
      The Court:
      
                  1.
               
               
                  Dismisses the appeal;
               
            
                  2.
               
               
                  Orders the European Medicines Agency (EMA) to bear its own costs and to pay the costs incurred by Shire Pharmaceuticals Ireland Ltd;
               
            
                  3.
               
               
                  Orders the European Commission to bear its own costs.
               
            
         (1)  OJ C 294, 20.8.2018