Case C-178/20: Judgment of the Court (Fourth Chamber) of 8 July 2021 (request for a preliminary ruling from the Fővárosi Törvényszék — Hungary) — Pharma Expressz Szolgáltató és Kereskedelmi Kft v Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (Reference for a preliminary ruling — Free movement of goods — Medicinal products for human use — Directive 2001/83/EC — Article 5(1), Article 6(1), and Articles 70 to 73 — Medicinal products authorised in a first Member State — Classification as medicinal products not subject to medical prescription — Sale in pharmacies of a second Member State without marketing authorisation in that Member State — National legislation requiring notification to the competent authority and a declaration from that authority on the use of that medicinal product — Article 34 TFEU — Quantitative restriction)
Date: 2021-07-08
Institutions: Court of Justice
Subjects: EU Member State, drug surveillance, drugs classification, free movement of goods, market approval, over-the-counter drug, pharmacy, quantitative restriction








C_2021338EN.01000801.xml










23.8.2021   


EN


Official Journal of the European Union


C 338/8






Judgment of the Court (Fourth Chamber) of 8 July 2021 (request for a preliminary ruling from the Fővárosi Törvényszék — Hungary) — Pharma Expressz Szolgáltató és Kereskedelmi Kft v Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet
(Case C-178/20) (1)

(Reference for a preliminary ruling - Free movement of goods - Medicinal products for human use - Directive 2001/83/EC - Article 5(1), Article 6(1), and Articles 70 to 73 - Medicinal products authorised in a first Member State - Classification as medicinal products not subject to medical prescription - Sale in pharmacies of a second Member State without marketing authorisation in that Member State - National legislation requiring notification to the competent authority and a declaration from that authority on the use of that medicinal product - Article 34 TFEU - Quantitative restriction)
(2021/C 338/09)
Language of the case: Hungarian

Referring court

Fővárosi Törvényszék

Parties to the main proceedings


Applicant: Pharma Expressz Szolgáltató és Kereskedelmi Kft

Defendant: Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet

Operative part of the judgment







1.


Articles 70 to 73 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 read in the light of Article 5(1) and Article 6(1) of that directive are to be interpreted as precluding, subject to the implementation of the derogation provided for in Article 5(1), a medicinal product which can be dispensed without medical prescription in one Member State from also being regarded as a medicinal product which can be dispensed without medical prescription in another Member State, including where, in that State, that medicinal product does not have a marketing authorisation and has not been classified.










2.


A national measure transposing Article 5(1) of Directive 2001/83, as amended by Directive 2012/26, which requires, for dispensing a medicinal product which does not have a marketing authorisation, a medical prescription and a declaration from the competent health authority to ensure that the conditions laid down in that provision are satisfied does not constitute a quantitative restriction or a measure having equivalent effect within the meaning of Article 34 TFEU.






(1)  OJ C 279, 24.8.2020.