Opinion of Mr Advocate General Mancini

Mr President,

Members of the Court,

1. This dispute arises out of an application brought by the Commission under Article 169 of the EEC Treaty against the Federal Republic of Germany. That Member State is said to have infringed Article 30 of the Treaty by reserving the placing of medical preparations on the market to pharmaceutical undertakings having their headquarters in the Federal Republic of Germany.

2. The legislation of which the provision under consideration forms part is very similar to the Belgian Decree of 5 June 1975 which was the subject of the judgment delivered by this Court on 2 March 1983 in Case 155/82. That decree, dealing with the storage, marketing and use of pesticides and phtyo-pharmaceutical products, made the sale of such products subject to an approval which could be obtained only if the person responsible for the marketing was established in Belgium (Article 12). The Commission considered that such a requirement placed manufacturers established in other Member States at a disadvantage by impeding the free movement of goods and this Court accepted its argument and held: The requirement that a representative be established on national territory is not ... such as to provide, with a view to the attainment of the objective of the protection of public health, [a justification for] an exception to the prohibition contained in Article 30 ... and ... constitutes a restriction on intra-Community trade (paragraphs 16 and 17 of the decision).

3. Those considerations, properly developed, are probably sufficient in themselves to demonstrate the illegality under Community law of Paragraph 9 (2) of the AMG. It seems more correct, however, to review the arguments relating to Articles 30 and 36 of the Treaty that the German Government advanced to defend the headquarters requirement.

4. Let us turn to Article 36. Starting from the premise that the procedures for the surveillance of medicinal preparations placed on the market are not harmonized, the German Government relies on that article in four respects. The presence of a representative of the undertaking on the territory of the Federal Republic is, it claims, indispensable for the protection of health because: (a) it enables the competent authorities to obtain all the information necessary for assessing the product before it is placed on the market; (b) it enables them to subject it to further analyses and, if these show that it is harmful, to order its immediate withdrawal after it has been. placed on the market; (c) it facilitates actions for compensation for. damage caused by harmful medicinal preparations; and (d) it ensures the effectiveness of criminal proceedings in the case of an offence against the legislation.

5. In the light of the foregoing considerations, I propose that the Court's decision on the action brought by the Commission of the European Communities against the Federal Republic of Germany by application lodged at the Court Registry on 10 September 1981 should be as follows:

1 Translated from the Italian.