Opinion of Mr Advocate General Lenz

Mr President,

Members of the Court,

Following the oral procedure this afternoon I may assume that the Court is familiar with the facts of this case. Unlike the French Government I agree with the Commission that the questions raised by the tribunal de grande instance are admissible. The Court of Justice has always been prepared to assist the courts of the Member States to overcome difficulties encountered in the application of Community law. Although the Tribunal is not asking for an interpretation of Community law and the statement of grounds contained in its reference is quite terse, it is not difficult to discern from the context as a whole what the national court seeks to ascertain. It would like to know whether Community law contains provisions precluding persons marketing reagents without authorization from being punished and whether the substances manufactured by the accused fall within any concept of Community law and if so which.

The answer to the first question must be that Community law does not contain any such provisions. Definitions of proprietary medicinal products, medicinal products and substances are laid down in Community law in Article 1 of Directive 65/65.

1. Proprietary medicinal products are any ready-prepared medicinal product placed on the market under a special name and in a special pack (Article 1 (1)).

2. Article 1 of Directive 65/65 also contains definitions of medicinal products and substances. However, Community law does not contain any rules on the marketing of such products or substances. Consequently, Member States are in principle at liberty to decide whether and to what extent they wish to regulate the marketing of such products or substances. At the present time Community law contains no provisions prohibiting a Member State from making the marketing of such products or substances subject to certain conditions or from making noncompliance with those conditions a punishable offence.

3. The actual examination of the question whether and under which of the aforesaid definitions the products manufactured by the accused fall is a matter for the national court.

I therefore suggest that the Court should answer the questions raised by the tribunal de grande instance as follows:

Community law contains no provisions preventing a Member State from making it a punishable offence to market proprietary medicinal products, medicinal products or substances without authorization.

The actual examination of the question whether and under which of the aforesaid definitions the substances manufactured by the accused fall is a matter for the national court.

1 Translated from the German.