Hecht-Pharma GmbH v Hohenzollern Apotheke, Winfried Ertelt.
Date: 2016-10-26
29


It should be recalled, in this regard, that Article 2(1) of Directive 2001/83 makes a positive determination of the scope of that directive, by providing that it is to apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process, while Article 3, points 1 and 2, of that directive provides for certain exceptions to its scope. It follows that, in order to come within the scope of Directive 2001/83, the product in question, first, must satisfy the conditions laid down in Article 2(1) of that directive and, secondly, must not come within one of the exceptions expressly provided for in Article 3 thereof (judgment of 16 July 2015, Abcur, C‑544/13 and C‑545/13, EU:C:2015:481, paragraphs 38 and 39).
31


With regard to the question whether Article 2(1) of Directive 2001/83 must be interpreted as meaning that a medicinal product for human use, such as that at issue in the main proceedings, can be regarded as having been prepared industrially or manufactured by a method involving an industrial process within the meaning of that provision and consequently comes within the scope of that directive, the Court has already held that, having regard to the objective of protection of public health pursued by the EU rules on medicinal products for human use, the terms ‘prepared industrially’ and ‘manufactured by a method involving an industrial process’ cannot be interpreted narrowly. Those terms must therefore include, at the very least, any preparation or manufacture involving an industrial process (judgment of 16 July 2015, Abcur, C‑544/13 and C‑545/13, EU:C:2015:481, paragraph 50).
32


An industrial process differs from an artisanal process in the means of production used and, consequently, in the quantities produced. The Court has thus held that an industrial process is characterised in general by a succession of operations, which may, in particular, be mechanical or chemical, in order to obtain a significant quantity of a standardised product (judgment of 16 July 2015, Abcur, C‑544/13 and C‑545/13, EU:C:2015:481, paragraph 50).
37


Pursuant to point 2 of Article 3 of Directive 2001/83, that directive does not apply to any ‘medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by the pharmacy in question (commonly known as the officinal formula)’. It is clear from the wording of that provision that the implementation of the exception for which it provides is subject to the fulfilment of a set of conditions concerning the medicinal products in question. Those products must be prepared ‘in a pharmacy’, ‘in accordance with the prescriptions of a pharmacopoeia’ and ‘intended to be supplied directly to the patients served by the pharmacy in question’. Those conditions are also cumulative, with the result that the exception provided for in that provision cannot be applied if one of them is not satisfied (judgment of 16 July 2015, Abcur, C‑544/13 and C‑545/13, EU:C:2015:481, paragraph 66).