BIOS Naturprodukte GmbH v Saarland.
Date: 2009-04-30
18. First of all, it should be pointed out that, for the purpose of determining whether a product falls within the definition of a medicinal product by function for the purposes 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 (Case C‑140/07 Hecht‑Pharma  [2009] ECR I‑0000, paragraph 39).
19. It follows that products containing a substance which has 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 ( Hecht‑Pharma , paragraph 40).
20. The pharmacological, immunological or metabolic properties of a product constitute, in fact, the factor on the basis of which it must be ascertained, in the light of the potential capacities of the product, whether it may, for the purposes of Article 1(2)(b) of Directive 2001/83, be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions (see, to that effect, Case C‑319/05 Commission v Germany  [2007] ECR I‑9811, paragraph 59).
21. 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 ( Hecht‑Pharma , paragraph 41).
22. When that assessment is being made, the normal conditions of use of the product in question should be taken into account (see, to that effect, Case C‑150/00 Commission  v Austria  [2004] ECR I‑3887, paragraph 75), and the fact that it is capable of having a significant physiological effect when used at a higher dosage than that indicated in the instructions or on the packaging is irrelevant in that regard.
23. It follows from the foregoing considerations 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 content and if used as intended, it is incapable of appreciably restoring, correcting or modifying physiological functions in human beings (see, to that effect, Hecht‑Pharma , paragraph 42).
25. In that regard, it should be borne in mind, first, that the fact that the use of a product presents a risk to health is not an indication that it is pharmacologically effective. The risk to health, although it must be taken into consideration in the classification of a product as a medicinal product by function, is none the less an autonomous factor (see Commission  v Germany , paragraph 69).
26. Second, a risk to health is only one aspect of the product which must be taken into consideration by the competent national authorities for the purpose of assessing whether it is a medicinal product within the meaning of Article 1(2)(b) of Directive 2001/83, and cannot be the only determining factor (see, to that effect, Commission  v Austria , paragraph 65).