CELEX: 62020CN0488
Language: en
Date: 2020-10-02 00:00:00
Title: Case C-488/20: Request for a preliminary ruling from the Wojewódzki Sąd Administracyjny w Warszawie (Poland) lodged on 2 October 2020 — Delfarma Sp. z o.o. v Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

18.1.2021   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 19/16
            
         
      Request for a preliminary ruling from the Wojewódzki Sąd Administracyjny w Warszawie (Poland) lodged on 2 October 2020 — Delfarma Sp. z o.o. v Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
      (Case C-488/20)
      (2021/C 19/20)
      Language of the case: Polish
      
         Referring court
      
      Wojewódzki Sąd Administracyjny w Warszawie
      
         Parties to the main proceedings
      
      
         Applicant: Delfarma Sp. z o.o.
      
         Defendant: Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
      
         Questions referred
      
      
                  1.
               
               
                  Does Article 34 TFEU preclude national legislation under which a parallel import licence is to expire after one year from the expiry of the marketing authorisation for the reference medicinal product?
               
            
                  2.
               
               
                  In the light of Articles 34 and 36 TFEU, may a national authority adopt a decision of a declaratory nature to the effect that a marketing authorisation for a medicinal product in connection with parallel import is to expire automatically, solely on the ground that the period laid down by law has expired, as from the date on which the marketing authorisation for the reference medicinal product expired, without examining the reasons for the expiry of [the marketing authorisation for] that product or other requirements referred to in Article 36 TFEU relating to the protection of the health and life of humans?
               
            
                  3.
               
               
                  Is the fact that parallel importers are exempt from the obligation to submit periodic safety reports, and the authority consequently has no current data on the benefit/risk of pharmacotherapy, sufficient to adopt a decision of a declaratory nature to the effect that a marketing authorisation for a medicinal product in connection with parallel import is to expire?