Keywords
Summary

Keywords

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1. Approximation of laws ° Proprietary medicinal products ° Directive 65/65 ° Definition of a medicinal product "by virtue of its presentation" ° Scope

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

2. Community law ° Principles ° Fundamental rights ° Freedom of expression ° Impairment as a result of a definition of medicinal product "by virtue of its presentation" ° None

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

3. Approximation of laws ° Proprietary medicinal products ° Product not covered by the definition of medicinal product laid down by Directive 65/65 ° Submission, by the Member States, to their domestic rules governing medicinal products ° Permissibility ° Limits

(EEC Treaty, Art. 30 et seq.; Council Directive 65/65, Art. 1(2))

Summary

1. A product recommended or described as having prophylactic or therapeutic properties is a medicinal product "by virtue of its presentation" within the meaning of the first subparagraph of Article 1(2) of Directive 65/65 on proprietary medicinal products, even if it is generally regarded as a foodstuff and even if in the current state of scientific knowledge it has no known therapeutic effect.

A product whose therapeutic properties are indicated solely in a publication, such as a brochure, which is sent, at his request, to the purchaser after sale by the manufacturer or the seller of the product or by a third party ° where the third party does not act completely independently of the manufacturer or the seller ° may be categorized as a medicinal product within the meaning of the aforementioned provisions.

2. Freedom of expression, enshrined in Article 10 of the European Convention on Human Rights, which is among the general principles of law the observance of which is ensured by the Court, is not affected by the fact that the publication by a third party, with regard to products which the manufacturer or the seller does not market as medicinal products, of information ascribing to them therapeutic or prophylactic effects may have the effect of bringing those products within the category of medicinal products, as laid down by the definitions set out in Article 1 of Directive 65/65, with all the consequences relating thereto.

3. A product which is not a medicinal product within the meaning of the provisions of Article 1(2) of Directive 65/65 on proprietary medicinal products may, subject to Article 30 et seq. of the Treaty concerning products imported from other Member States, be subject in the domestic law of a Member State to the rules governing medicinal products.