Delfarma Sp. z o.o. v Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (C-387/18)

Judgment of 3 Jul 2019

law://eu/cjeu/2018/c-387-18/para_26@2026-11-13

26In the present case, it is common ground that Article 2(7b)(b) of the Law on medicinal products, which requires, for the issue of a parallel import licence for a medicinal product in Poland, that that medicinal product and the medicinal product which has been granted a marketing authorisation in that Member State are both reference medicinal products or both generic medicinal products and which, therefore, prohibits the issue of a parallel import licence for a medicinal product where it is a generic medicinal product while the medicinal product already authorised in that Member State is a reference medicinal product, impedes access to the market concerned of that generic medicinal product and, therefore, constitutes a measure having equivalent effect to a quantitative restriction on imports prohibited by Article 34 TFEU, unless it is justified by considerations relating to the protection of health and life of humans referred to in Article 36 TFEU.

Delfarma Sp. z o.o. v Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (C-387/18)

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