18.1.2021

EN

Official Journal of the European Union

C 19/16

(Case C-488/20)

(2021/C 19/20)

Language of the case: Polish

Referring court

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?