Case C-387/18: Request for a preliminary ruling from the Wojewódzki Sąd Administracyjny w Warszawie (Poland) lodged on 12 June 2018 — Delfarma Sp. z o.o. v Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
C2942018EN3210120180612EN0044321321
Request for a preliminary ruling from the Wojewódzki Sąd Administracyjny w Warszawie (Poland) lodged on 12 June 2018 — Delfarma Sp. z o.o. v Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
(Case C-387/18)2018/C 294/44Language 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
Question referred
Does EU law, including without limitation Article 34 and Article 36 of the Treaty on the Functioning of the European Union, preclude national legislation whereby the marketing authorisation in a Member State for a medicinal product imported in parallel cannot be granted quite simply because the medicinal product imported in parallel has been authorised in the Member State of export as a generic medicinal product, namely on the basis of an abridged dossier, whereas in the Member State of import this medicinal product has been authorised as a reference medicinal product, namely on the basis of a full dossier, and the authorisation is refused without examining whether both products are essentially therapeutically identical and without the national authority applying — despite this being possible — for documentation to the appropriate authority in the Member State of export?
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