Keywords
Summary

Keywords

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

(EC Treaty, Arts 30 and 36 (now, after amendment, Arts 28 EC and 30 EC; Council Directive 65/65, Art. 1)

Summary

A Member State has failed to fulfil its obligations under Article 30 of the Treaty (now, after amendment, Article 28 EC) when it automatically classifies as medicinal products vitamin preparations lawfully manufactured or marketed as food supplements in other Member States where they contain three times more vitamins, other than vitamins A and D, than the daily amount recommended by the national food association.

Since such a classification, which is based solely on the recommended daily amount, does not fully satisfy the requirement for a classification on the basis of the pharmacological properties of each vitamin preparation and, consequently, it does not necessarily follow that all preparations concerned come within the definition of a ‘function’ medicinal product for the purposes of Directive 65/65 relating to proprietary medicinal products, that practice creates a barrier to trade, in so far as vitamin preparations 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 36 of the Treaty (now, after amendment, Article 30 EC), since it does not make a distinction by reference to the different vitamins 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 62, 65, 78-79, 83, operative part)