Opinion of Mr Advocate General Van Gerven delivered on 5 February 1991

1 Original language: Dutch.

2 The Bundesverwaltungsgericht based itself on academic writings and in particular on Kloesel/Cyran, Kommentar zum AMG, paragraph 4, note 2 (order of the Bundesverwaltungsgericht, p 9)

3 However, it appears from the Bundesverwaltungsgencht's order that as a result of a provisional agreement with the German customs authorities Eurim-Pharm has been able lo date to impon finished medicinal products which do not yet satisfy all the requirements of the AMG The products in question ?-e imported but not cleared for circulation in the Federal Republic. They are placed in a bonded warehouse on Eurim-Pharm's premises at Piding in Upper Bavaria where ihey are labelled to German requirements They arc then cleared by customs after the competent authority (the government of Upper Bavaria), upon application, has issued a customs clearance certificate

4 Observations of the Free State of Bavaria, pp. 2 and 3.

5 See, for example, the judgment in Case 111/76 Officier van Justiţiei van den Hazel [1977] ECR 901.

6 The AMG transposes into German law the Community directives on the production and marketing of medicinal products. Accordingly, in interpreting the terms used in the AMG account must also be taken of the meaning given to them in Community law. It is pointed out that the definition given in Paragraph 4 of the AMG to the term Fertigarzneimitte or finished medicinal product corresponds, not entirely but to a large extent, to the definition given in Article 1(1) of Council Directive 65/65/EEC of 25 January 1965 of the expression proprietary medicinal product (Official Journal, English Special Edition 1965-1966, p 20). However, it is not clear whether a medicinal product which has not yet been provided with the labelling and package leaflet laid down is in fact a proprietary medicinal product within the meaning of Article 1(1) of that directive. Consequently, Community law is unhelpful in this case for the interpretation of the expression Fertigarzneimitte.

7 Order for reference, p. 14.

8 See the ludgmeni in Case 8/74 Dmioiwille (1974] ECK 837

9 See, for example, the judgment in Case C-169/89 Gour-metten? l'ai: de Burg [1990] F.CR 12143 and lhe judgment in Casc 215/87 Schumacher [1989] ECR 617

10 Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down b\law. regulation or administrative action relating to proprietary medicinal products, as amended bv Directives 83/570/EEC, 87/2 l/EEC and 89/341/EĖC, and Council Directive 75/319/EEC of 20 Mav 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, as amended by Directives 83/570/EEC and 89/341/EEC

11 See the ludgment in Schumacher, paragraph 15, cited in note 8

12 Ärtule 13 of Directive 65/65 (labellingI and Article 6 of Directive 75/319 (leaflets enclosed with packaging)

13 Eor example. Article 7 of Directive 75/319 provides as follows Nothwithstanding the provisions of Directive 65/65/EEC, Member States may require that the proprietary medicinal product shall be labelled so as to indicate on the container and/or outer packing and/or on the package leaflet other requirements essential to safety or for the protection of public health, including.

14 See my Opinion delivered on 20 March 1990 in Case C-169/89 Gourmmerie Van dm Burg [1990] ECR I-2143 at I-2151, paragraph 8.

15 Such checks are carried oui as a rule every two years. But there is no reason why the competent authority should not carry out more frequent checks if necessary. At the hearing, Eurim-Pharm stated that over a certain period at least tne competent authority carried out checks on it every two months rather than every two years

16 I would observe, moreover, thai under the provisional arrangements agreed with the German customs authorities (see note 2 above) there are merely rules to the effect that the customs clearance certificate is to be issued after the medicinal products have been repackaged at the premises of the importer, who must hold a manufacturing authorization and an authorization to market the products in the Federal Republic of Germany.