Keywords
Summary

Keywords

1. Preliminary rulings — Questions submitted to the Court — Need for a preliminary ruling and relevance of the questions submitted — Determination by the national court — Possibility for the parties to alter the wording of the questions — Not possible — (EC Treaty, Art. 177)

2. Approximation of laws — Veterinary medicinal products — Prohibitions laid down by Directive 81/851 — Scope — Parallel application of Articles 30 and 36 of the Treaty — Not permissible — (EC Treaty, Arts 30 and 36; Council Directive 81/851, Art. 4, and Council Directives 90/676 and 93/40)

Summary

1. In proceedings under Article 177 of the Treaty, it is solely for the national courts before which actions are brought, and which must bear the responsibility for the subsequent judicial decision, to determine in the light of the particular facts of each case both the need for a preliminary ruling in order to enable them to give judgment and the relevance of the questions which they submit to the Court, without the parties being able to alter the wording of those questions.

2. The prohibition, set out in Article 4 of Directive 81/851 relating to veterinary medicinal products, in its original version and as amended by Directive 90/676, of both the marketing and administration of a medicinal product within the territory of a Member State without prior issue of authorization by the competent authority of that State implies that it is prohibited to import that product for one of those purposes. Consequently, the importation, by a pharmacist in a Member State, of a medicinal product prescribed in that State by a veterinarian in order to cater for a specific need is also covered by the provision in question.

In this regard, although Directive 81/851 describes itself, according to the 11th recital in its preamble, as " one stage in the achievement of the aim of freedom of movement of veterinary medicinal products" , it cannot be inferred from this that, for medicinal products coming within its scope, the directive leaves room for the application of Articles 30 and 36 of the Treaty. The legislature intended by that wording only to signify that the system of multiple national authorizations for the marketing of products, first introduced by Directive 81/851, was destined to be replaced by a system under which account was to be taken of authorizations granted by other Member States (Directive 90/676) and subsequently by a system for the mutual recognition in principle of such authorizations (Directive 93/40).