Case C-276/15: Judgment of the Court (First Chamber) of 26 October 2016 (request for a preliminary ruling from the Bundesgerichtshof — Germany) — Hecht-Pharma GmbH v Hohenzollern Apotheke, owned by Winfried Ertelt (Reference for a preliminary ruling — Medicinal products for human use — Directive 2001/83/EC — Scope — Article 2(1) — Medicinal products prepared industrially or manufactured by a method involving an industrial process — Point 2 of Article 3 — Officinal formula)
Date: 2016-10-26
Institutions: Court of Justice
Subjects: drug surveillance, market approval, over-the-counter drug, pharmacy








C_2017006EN.01001801.xml










9.1.2017   


EN


Official Journal of the European Union


C 6/18





Judgment of the Court (First Chamber) of 26 October 2016 (request for a preliminary ruling from the Bundesgerichtshof — Germany) — Hecht-Pharma GmbH v Hohenzollern Apotheke, owned by Winfried Ertelt
(Case C-276/15) (1)

((Reference for a preliminary ruling - Medicinal products for human use - Directive 2001/83/EC - Scope - Article 2(1) - Medicinal products prepared industrially or manufactured by a method involving an industrial process - Point 2 of Article 3 - Officinal formula))
(2017/C 006/22)
Language of the case: German

Referring court

Bundesgerichtshof

Parties to the main proceedings


Applicant: Hecht-Pharma GmbH

Defendant: Hohenzollern Apotheke, owned by Winfried Ertelt

Operative part of the judgment

Article 2(1) 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 2011/62/EU of the European Parliament and of the Council of 8 June 2011, must be interpreted as meaning that a medicinal product for human use, such as that at issue in the main proceedings, which, under national legislation, does not require a marketing authorisation by reason of the proven frequency with which it is the subject of medical and dental prescriptions, the essential manufacturing steps for such products are carried out in a pharmacy as part of the normal pharmacy business producing in the course of one day up to 100 packages ready for dispensation and intended for supply under the existing pharmacy operating licence, cannot be regarded as having been prepared industrially or manufactured by a method involving an industrial process, within the meaning of that provision, and consequently does not come within the scope of that directive, subject to the findings of fact which it is for the referring court to make.
However, should those findings lead the referring court to take the view that the medicinal product at issue in the main proceedings has been prepared industrially or manufactured by a method involving an industrial process, the answer must also be that point 2 of Article 3 of Directive 2001/83, as amended by Directive 2011/62, must be interpreted as meaning that it does not preclude provisions such as those laid down in Paragraph 21(2), point 1, of the Law on the marketing of medicinal products, read in conjunction with Paragraph 6(1) of the Regulation on the operation of pharmacies, in so far as those provisions, in essence, require pharmacists to comply with the pharmacopoeia when manufacturing officinal formulae. It is, however, for the referring court to determine whether, on the facts of the case before it, the medicinal product at issue in the main proceedings has been prepared in accordance with the prescriptions of a pharmacopoeia.


(1)  OJ C 294, 7.9.2015.