Judgment_paragraph 6. · Criminal proceedings against Leendert van Bennekom (227/82)

6.According to the Italian Government, vitamin preparations (whether they be of high or of low concentration) fall within the definition of “medicinal product” laid down by Directive 65/65/EEC. The Italian Government believes that the first branch of the Community definition covers not only substances or combinations of substances whose labels state explicitly that they possess curative or preventive properties, but also cases where the method of presentation, objectively considered, inevitably leads to the belief that those substances have curative or preventive properties. Thus, if a substance is presented in the form of a bottle containing an injection, a suppository, a capsule or other form, that form of presentation, objectively considered, in conjunction with information relating to the composition and dose, would necessarily lead to the belief that that substance has therapeutic properties. In the eyes of the consumer, it is immaterial whether a curative or preventive property is expressly indicated or stated or whether it appears objectively from the method of presentation and, consequently, from the manner in which the substance is administered.In the interpretation of the second branch of the Community definition, contrary to the view which the accused and the national court appear to take, importance may not be attached to the purely subjective purpose (for example purely dietary) which the manufacturer or the consumer of the vitamin preparations may set out to achieve. The purpose of that second branch should, on the contrary, be considered in an objective manner, namely as a result which may be achieved by means of the administration of those substances. For that reason, and because of their indisputable therapeutic effect, vitamin preparations are also included in the definition of “medicinal product” which appears in the second branch of the Community definition.In any case, even if vitamin preparations are not proprietary medicinal products within the meaning of the directive, their free circulation may encounter legitimate barriers (such as controls, permits, registration and others) for obvious reasons relating to the protection of public health within the meaning of Article 36 of'the EEC Treaty (judgment of the Court of 20 May 1976 in Case 104/75 de Peijper [1976] ECR 613; judgment of 5 February 1981 in Case 53/80 Officier van Justitie v Koninklijk Kaasfabriek Eyssen £K[1981] ECR 409 and judgment of 17 December 1981 in Case 272/80 Frans-Nederlandse Maatschappij voor Biologische Producten BV [1981] ECR 3277).