Keywords
Summary

Keywords

Free movement of goods – Quantitative restrictions – Measures having equivalent effect – Administrative practice classifying as medicinal products certain vitamin preparations or preparations containing minerals exceeding more than the simple daily amount – Justification – Protection of public health – Absence – Requirement for detailed assessment on a case-by-case basis

(Arts 28 EC and 30 EC; Council Directive 65/65, Art. 1)

Summary

A Member State has failed to fulfil its obligations under Article 28 EC when it automatically classifies as medicinal products vitamin preparations and preparations containing minerals lawfully manufactured or marketed as food supplements in other Member States where they contain either more vitamins other than vitamins A, C, D or K, or more minerals other than those in the chromate group, than the simple daily amount of those nutritive substances, or vitamins A, D or K, irrespective of their content.

Since, in respect of vitamins other than vitamins A, C, D and K and minerals other than those in the chromate group, classification of the preparations concerned, which is based solely on the recommended daily amount, does not fully satisfy the requirement for a classification on the basis of the pharmaceutical properties of each vitamin preparation or preparation containing minerals and, consequently, it does not necessarily follow that all the preparations concerned come within the definition of a ‘function’ medicinal product for the purposes of Directive 65/65 relating to proprietary medicinal products and, in respect of vitamins A, D and K, the practice in question can have the result that preparations containing vitamins A, D or K are classified as medicinal products, although the content of those nutritive substances is too small to be capable of coming within the definition of Directive 65/65, the practice objected to creates a barrier to trade, in so far as vitamin preparations or preparations containing minerals lawfully marketed or produced in other Member States as food supplements cannot be marketed in the Member State in question until they have been subject to the marketing authorisation procedure for medicinal products.

That practice cannot be justified for reasons of protection of the health and life of humans referred to in Article 30 EC, since it does not make a distinction by reference to the different vitamins and minerals added or, in particular, to the level of risk to public health which their addition could entail and, consequently, the automatic nature of that practice does not make it possible to identify and assess a real risk to public health, which requires a detailed assessment on a case-by-case basis of the effects which the addition of the vitamins in question could entail.

(see paras 68, 74, 82, 95-96, 102, operative part)