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Case C-488/20: Judgment of the Court (Third Chamber) of 25 November 2021 (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 TFUE — Free movement of goods — Measure having equivalent effect to a quantitative restriction — Medicinal products for human use — Parallel import of medicinal products — Legislation of a Member State under which a parallel import licence is to expire automatically after one year from the expiry of the marketing authorisation for the reference medicinal product — Protection of the health and life of humans — Proportionality — Directive 2001/83/EC — Pharmacovigilance)
ECLI:EU:UNKNOWN:62020CA0488
62020CA0488
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31.1.2022
Official Journal of the European Union
C 51/13
(Case C-488/20) (*)
(Reference for a preliminary ruling - Articles 34 and 36 TFUE - Free movement of goods - Measure having equivalent effect to a quantitative restriction - Medicinal products for human use - Parallel import of medicinal products - Legislation of a Member State under which a parallel import licence is to expire automatically after one year from the expiry of the marketing authorisation for the reference medicinal product - Protection of the health and life of humans - Proportionality - Directive 2001/83/EC - Pharmacovigilance)
(2022/C 51/16)
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 national legislation under which a parallel import licence for a medicinal product expires automatically after one year from the expiry of the marketing authorisation of reference, without carrying out an examination whether there is any risk to the health and life of humans. The fact that parallel importers are exempt from the obligation to submit periodic safety reports is not a ground which may per se justify the adoption of such a decision.
(*)
Language of the case: Polish.
* * *
(1) OJ C 19, 18.1.2021.
ECLI:EU:C:2021:019