Judgment — ECLI:EU:C:2009:278
Date: 2009-04-30
Language of the case: German
Court formation: Fifth Chamber
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws
Concepts: Medicinal products by function
Procedure: Reference for a preliminary ruling
Origin: Germany

Summary of the Judgment Approximation of laws – Medicinal products for human use – Directive 2001/83 – Classification of a product as a medicinal product by function – Criteria (European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Art. 1(2)) Article 1(2) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27 must, apart from the case of substances or combinations of substances intended for the purpose of making a medical diagnosis, be interpreted as meaning that a product which includes in its composition a substance which has a physiological effect when used in a particular dosage is not a medicinal product by function where, having regard to its content in active substances and under normal conditions of use, it constitutes a risk to health without, however, being capable of restoring, correcting or modifying physiological functions in human beings. The pharmacological, immunological or metabolic properties of a product constitute 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. The capacity to restore, correct or modify physiological functions should not, however, 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. When that assessment is being made, the normal conditions of use of the product in question should be taken into account, 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. This conclusion is not invalidated by the fact that the product in question, under normal conditions of use, may involve a risk to health. The fact that the use of a product presents a risk to health is not an indication that it is pharmacologically effective. (see paras 20-25, 27, operative part)