Opinion of the Advocate General — ECLI:EU:C:2016:492
Date: 2016-06-30
Language of the case: German
Subject matter: Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: Germany

Summary — Judgment of the Court (First Chamber), 26 October 2016 1. Approximation of laws — Medicinal products for human use — Directive 2001/83 — Scope — Exceptions — Conditions — Cumulative nature (European Parliament and Council Directive 2001/83, as amended by Directive 2011/62, Art. 3, points 1 and 2) 2. Approximation of laws — Medicinal products for human use — Directive 2001/83 — Scope — Medicinal products prepared industrially or manufactured by a method involving an industrial process — Definition — Medicinal product not requiring a marketing authorisation by reason of its frequent prescription and its preparation and dispensation in the pharmacy under the operating licence of that pharmacy — Not included (European Parliament and Council Directive 2001/83, as amended by Directive 2011/62, Art. 2(1)) 3. Approximation of laws — Medicinal products for human use — Directive 2001/83 — Scope — Exceptions — Medicinal product prepared in the pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied to patients served by that pharmacy — Requirement to comply with the prescriptions of a pharmacopoeia — National legislation requiring pharmacists to comply with the pharmacopoeia during the manufacture of officinal formulae — Lawfulness — Condition (European Parliament and Council Directive 2001/83, as amended by Directive 2011/62, Art. 3, point 2) 1. See the text of the decision. (see para. 37) 2. Article 2(1) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2011/62, must be interpreted as meaning that a medicinal product for human use 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. (see para. 41, operative part) 3. Article 3(2) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2011/62, must be interpreted not precluding provisions which, 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. (see para. 42, operative part)