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Case C-387/18: Judgment of the Court (Fifth Chamber) of 3 July 2019 (request for a preliminary ruling from the Wojewódzki Sąd Administracyjny w Warszawie — Poland) — Delfarma sp. z o.o. v Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Reference for a preliminary ruling — Articles 34 and 36 TFEU — Free movement of goods — Measure having equivalent effect to a quantitative restriction — Protection of health and life of humans — Parallel import of medicinal products — Reference medicinal products and generic medicinal products — Requirement that the imported medicinal product and that which has been granted a marketing authorisation in the Member State of importation are both reference medicinal products or are both generic medicinal products)
ECLI:EU:UNKNOWN:62018CA0387
62018CA0387
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Official Journal of the European Union
C 305/23
(Case C-387/18) (<span class="super note-tag">1</span>)
(Reference for a preliminary ruling - Articles 34 and 36 TFEU - Free movement of goods - Measure having equivalent effect to a quantitative restriction - Protection of health and life of humans - Parallel import of medicinal products - Reference medicinal products and generic medicinal products - Requirement that the imported medicinal product and that which has been granted a marketing authorisation in the Member State of importation are both reference medicinal products or are both generic medicinal products)
(2019/C 305/28)
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
Operative part of the judgment
Articles 34 and 36 TFEU must be interpreted as precluding the legislation of a Member State, such as that at issue in the main proceedings, which requires, for the issue of a parallel import licence for a medicinal product, 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 any parallel import licence for a medicinal product where it is a generic medicinal product whereas the medicinal product previously authorised in that Member State is a reference medicinal product.
(<span class="note">1</span>) OJ C 294, 20.8.2018.