(Case C-387/18)

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

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?