Judgment of the Court (Fifth Chamber) of 3 July 2019.
Delfarma Sp. z o.o. v Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych.
Request for a preliminary ruling from the Wojewódzki Sąd Administracyjny w Warszawie.
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.
Case C-387/18. (2019)
Language: English

In those circumstances the Wojewódzki Sąd Administracyjny w Warszawie (Regional Administrative Court, Warsaw, Poland) decided to stay the proceedings and to refer the following question to the Court of Justice for a preliminary ruling:
‘Does EU law, and in particular [Articles 34 and 36 TFEU], 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 exportation as an equivalent to a reference medicinal product, namely on the basis of an abridged dossier, whereas in the Member State of importation 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 exportation?’

Legal relationship diagram (Graphviz):
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   "Wojewódzki Sąd Administracyjny w Warszawie (Regional Administrative Court, Warsaw, Poland)"[shape=doubleoctagon];
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   "Wojewódzki Sąd Administracyjny w Warszawie (Regional Administrative Court, Warsaw, Poland)"->"Stay the proceedings"[dir=none];
   "Wojewódzki Sąd Administracyjny w Warszawie (Regional Administrative Court, Warsaw, Poland)"->"Question for a preliminary ruling";
   "Question for a preliminary ruling"->"The Court of Justice";
   "Question for a preliminary ruling"->"Does EU law, and in particular [Articles 34 and 36 TFEU], 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 exportation as an equivalent to a reference medicinal product, namely on the basis of an abridged dossier, whereas in the Member State of importation 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 for documentation to the appropriate authority in the Member State of exportation?"[dir=none];
}