Hecht-Pharma GmbH v Staatliches Gewerbeaufsichtsamt Lüneburg.
Date: 2009-01-15
21. First of all, it should be noted that both Article 2 of Directive 2001/83, in its original version, and Article 2(1) of Directive 2001/83 provide, essentially, that that directive applies to medicinal products for human use intended to be placed on the market in Member States and manufactured industrially.
22. The scope of Directive 2001/83 is thus limited to industrially-produced medicinal products, to the exclusion of products which do not fall under one or other of the definitions of a medicinal product contained in Article 1(2)(a) and (b) of that directive.
26. Thus, Directive 2001/83 does not apply to a product in respect of which it has not been established that it is a medicinal product within the meaning of Article 1(2)(b) of that directive, that is to say, a product in respect of which it has not been scientifically established that it is capable of restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or that it may be used to make a medical diagnosis.
29. Consequently, the answer to the first part of the first question is that Article 2(2) of Directive 2001/83 must be interpreted as meaning that that directive does not apply to a product in respect of which it has not been scientifically established that it is a medicinal product by function, without its being possible to exclude that possibility.
32. In its case-law prior to the amendment of Directive 2001/83 by Directive 2004/27, the Court indicated that, for the purpose of determining whether a product falls within the definition of a medicinal product by function, the national authorities, acting under the supervision of the courts, must decide on a case-by-case basis, taking account of all the characteristics of the product, in particular its composition, its pharmacological properties to the extent to which they can be established in the present state of scientific knowledge, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail ( HLH Warenvertrieb and Orthica , paragraph 51, and Commission  v Germany , paragraph 55).
39. First of all, it should be pointed out that it is apparent from paragraphs 32 and 33 of the present judgment that, for the purpose of determining whether a product falls within the definition of a medicinal product by function within the meaning of Directive 2001/83, the national authorities, acting under the supervision of the courts, must decide on a case-by-case basis, taking account of all the characteristics of the product, in particular its composition, its pharmacological, immunological or metabolic properties, to the extent to which they can be established in the present state of scientific knowledge, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail.
40. It follows that products containing a substance having a physiological effect cannot automatically be classified as medicinal products by function unless the competent administration has made an assessment, with due diligence, of each product individually, taking account, in particular, of that product’s specific pharmacological, immunological or metabolic properties, to the extent to which they can be established in the present state of scientific knowledge.
41. In that regard, it should be borne in mind that the capacity to restore, correct or modify physiological functions should not lead to the classification as medicinal products by function of products which, while having an effect on the human body, do not significantly affect the metabolism and thus do not strictly modify the way in which it functions (see, to that effect, Commission  v Germany , paragraph 60).
42. It follows that, apart from the case of substances or combinations of substances intended for the purpose of making a medical diagnosis, a product cannot be regarded as being a medicinal product by function where, having regard to its composition – including its content in active substances – and if used as intended, it is incapable of appreciably restoring, correcting or modifying physiological functions in human beings.