Keywords
Summary

Keywords

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1. Approximation of laws - Proprietary medicinal products - Definition of medicinal product by Directive 65/65 - Classification as medicinal of a product not intended to cure or prevent disease - Conditions - Criteria

(Council Directive 65/65, Art. 1(2) )

2. Approximation of laws - Proprietary medicinal products - Product meeting both the definition of medical product in Directive 65/65 and that of cosmetic product in Directive 76/768 - Subject to the rules of Directive 65/65

(Council Directives 65/65, Art. 1(2), and 76/768, Art. 1(1) )

Summary

1. A product which is not "for treating or preventing disease in human beings or animals" within the meaning of the first subparagraph of Article 1(2) of Directive 65/65 relating to proprietary medicinal products is none the less a medicinal product if it may be administered "with a view to ... restoring, correcting or modifying physiological functions" within the meaning of the second subparagraph of that provision. That phrase must be given a sufficiently broad interpretation to cover all substances capable of having an effect on the actual functioning of the body and include not only products which have a real effect on physiological functions but also those which do not have the advertised effect, the marketing of which may thus be prohibited in order to protect consumers. It cannot, however, encompass substances such as certain cosmetics 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.

It is for the national courts to determine on a case-by-case basis the classification of each product having regard to its pharmacological properties as they may be ascertained in the current state of scientific knowledge, to the way in which it is used, to the extent to which it is sold and to consumers' familiarity with it.

2. Even though it may fall within the definition of cosmetic products given in Article 1(1) of Directive 76/768, a product must nevertheless be treated as a medicinal product as referred to in Article 1(2) of Directive 65/65 relating to proprietary medicinal products and, if it is a proprietary medicinal product, subjected to the corresponding rules, to the exclusion of those governing cosmetic products, if it is presented for treating or preventing disease or if it is intended to be administered with a view to restoring, correcting or modifying physiological functions.

Such a classification is a necessary consequence of the aim, pursued by both directives, of protecting public health, since the rules governing proprietary medicinal products are stricter than those governing cosmetic products, in view of the particular risks to public health which the former may represent and which are generally not displayed by cosmetic products.