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Case C-469/21, CGCOF: Judgment of the Court (Seventh Chamber) of 26 January 2023 (request for a preliminary ruling from the Tribunal Supremo — Spain) — Consejo General de Colegios Oficiales de Farmacéuticos de España (CGCOF) v Administracíon General del Estado (Reference for a preliminary ruling — Medicinal products for human use — Delegated Regulation (EU) 2016/161 — Repositories system containing information on safety features — Creation of an interface integrated into the national repository and managed by the public authorities — Obligation to use a specific application for certain medicinal products)
ECLI:EU:UNKNOWN:62021CA0469
62021CA0469
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13.3.2023
Official Journal of the European Union
C 94/7
(Case C-469/21, (1) CGCOF)
(Reference for a preliminary ruling - Medicinal products for human use - Delegated Regulation (EU) 2016/161 - Repositories system containing information on safety features - Creation of an interface integrated into the national repository and managed by the public authorities - Obligation to use a specific application for certain medicinal products)
(2023/C 94/06)
Language of the case: Spanish
Referring court
Parties to the main proceedings
Applicant: Consejo General de Colegios Oficiales de Farmacéuticos de España (CGCOF)
Defendant: Administracíon General del Estado
Operative part of the judgment
1.Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use, in particular Articles 25, 31, 32, 35, 36 and 44 thereof, must be interpreted as not precluding national legislation providing for the creation of an interface, as a tool for accessing the national repository, that is owned and managed by the public authorities.
2.Delegated Regulation 2016/161, in particular Articles 25, 31, 32, 35, 36 and 44 thereof, must be interpreted as not precluding national legislation which (i) requires pharmacies to use an interface owned and managed by the public authorities when they supply medicinal products financed by the national health system and (ii) requires the entity managing the national repository to integrate that interface into the national repository.
(1) OJ C 24, 17.1.2022.