CELEX: 62019TA0472
Language: en
Date: 2020-09-23 00:00:00
Title: Case T-472/19: Judgment of the General Court of 23 September 2020 — BASF v Commission (Medicinal products for human use — Marketing authorisation for medicinal products for human use containing omega-3 acid ethyl esters — Variation of the terms of the authorisation — First paragraph of Article 116 of Directive 2001/83/EC — Manifest error of assessment — Proportionality)

16.11.2020   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 390/32
            
         
      Judgment of the General Court of 23 September 2020 — BASF v Commission
      (Case T-472/19) (1)
      
      (Medicinal products for human use - Marketing authorisation for medicinal products for human use containing omega-3 acid ethyl esters - Variation of the terms of the authorisation - First paragraph of Article 116 of Directive 2001/83/EC - Manifest error of assessment - Proportionality)
      (2020/C 390/45)
      Language of the case: English
      
         Parties
      
      
         Applicant: BASF AS (Oslo, Norway) (represented by: E. Wright, Barrister, and H. Boland, lawyer)
      
         Defendant: European Commission (represented by: L. Haasbeek and A. Sipos, acting as Agents)
      
         Re:
      
      Application pursuant to Article 263 TFEU for annulment of Commission Implementing Decision C(2019) 4336 final of 6 June 2019 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, marketing authorisations of medicinal products for human use containing ‘Omega-3 acid ethyl esters’ for oral use in secondary prevention after myocardial infarction.
      
         Operative part of the judgment
      
      The Court:
      
                  1.
               
               
                  Dismisses the action;
               
            
                  2.
               
               
                  Orders BASF AS to pay the costs, including the costs relating to the interlocutory proceedings.
               
            
         (1)  OJ C 305, 9.9.2019.