Criminal proceedings against Johannes Stephanus Wilhelmus Ter Voort.
Date: 1992-10-28
11 Consequently, as the Court has consistently held (see, inter alia, the judgment in Case C-60/89 Monteil and Samanni [1991] ECR I-1547, paragraph 11), the directive thus gives two definitions of medicinal products: a definition "by virtue of their presentation" and a definition "by virtue of their functions". A product is a medicinal product if it falls within either of those definitions.
16 As the Court has consistently held (see, most recently, the judgment in Case C-112/89 Upjohn [1991] ECR I-1703, paragraph 16), the "presentation" criterion used in the first subparagraph of Article 1(2) of Directive 65/65 is designed to catch not only medicinal products having a genuine therapeutic or medical effect but also those which are not sufficiently effective or do not have the effect which their presentation might lead to expect, in order to preserve consumers not only from harmful or toxic medicinal products as such but also from a variety of products used instead of the proper remedies.
17 As the Court has also consistently held (see, inter alia, the judgment in Monteil and Samanni, cited above, paragraph 23), a product is "presented for treating or preventing disease" within the meaning of Directive 65/65 in particular when it is expressly "indicated" or "recommended" as such, possibly by means of labels, leaflets or oral representation.
19 The Court has also held, in the judgments in Case C-369/88 Delattre [1991] ECR I-1487, paragraph 22, and in Monteil and Samanni, cited above, paragraph 17, that, even if it comes within the scope of other, less stringent Community rules, such as the rules on cosmetic products, a product must be held to be a medicinal product and be made subject to the corresponding rules if it is presented as possessing therapeutic or prophylactic properties or if it is intended to be administered with a view to restoring, correcting or modifying physiological functions.
20 No more can the fact that a product is in the nature of a foodstuff prevent it from being categorized as a "medicinal product" within the meaning of the provisions of the first subparagraph of Article 1(2) of Directive 65/65 in so far as the indication or recommendation of its therapeutic or prophylactic properties is in itself of such a kind as to cause it to be regarded as a product presenting the characteristic properties of a therapeutic substance, that is to say, a medicinal product.
26 The conduct, action and approaches of the manufacturer or the seller which disclose his intention to make the product he markets appear to be a medicinal product in the eyes of an averagely well-informed consumer may therefore be conclusive for the purposes of deciding whether a product should be regarded as a medicinal product by virtue of its presentation.
34 As the Court has consistently held (see, inter alia, the judgment in Case C-260/89 Elliniki Radiophonia Tileorassi AE [1991] ECR I-2925, paragraph 41), fundamental rights form an integral part of the general principles of law, the observance of which the Court observes. For that purpose the Court draws inspiration from the constitutional traditions common to the Member States and from the guidelines supplied by international treaties for the protection of human rights on which the Member States have collaborated or of which they are signatories. The European Convention on Human Rights has special significance in that respect. It follows that the Community cannot accept measures which are incompatible with observance of human rights thus recognized and guaranteed.
35 Freedom of expression, as embodied in Article 10 of the European Convention on Human Rights, is among the general principles of law the observance of which is ensured by the Court (judgment in Elliniki Radiophonia Tileorassi AE, cited above, paragraph 44).
41 In the judgment in Case 35/85 Tissier [1986] ECR 1207, paragraph 22, the Court held that, subject to Article 30 et seq. of the Treaty concerning products imported from other Member States, Community law does not affect the right of Member States to subject substances not meeting the Community definition of medicinal product to controls or to require prior authorization in accordance with their own national law on medicinal products.
42 Accordingly, the reply to be given to the fourth question should be that a product which is not a medicinal product within the meaning of the provisions of Article 1(2) of Directive 65/65 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.