Opinion of Mr Advocate General
Mr President,
Members of the Court,
1. The Bundesverwaltungsgericht (Federal Administrative Court) has referred the following question to the Court for a preliminary ruling:
Legal background and procedure
2. Eurim-Pharm GmbH, the respondent in the main proceedings, is a pharmaceutical company established in the Federal Republic of Germany. As a parallel importer it purchases in other Member States medicinal products which are lawfully marketed there. It then imports those products into the Federal Republic of Germany in order first to label them and provide them with package leaflets — in accordance with the requirements of the Gesetz über den Verkehr mit Arzneimitteln (Law on trade in pharmaceutical products, hereinafter referred to as the AMG) as amended by the Gesetz zur Neuordnung des Arzneimittelrechts of 24 August 1976 (Law recasting the legislation on pharmaceutical products) — following which they may be sold on the German market.
3. Paragraph 73(1) of the AMG provides that the importation from other Member States of finished medicinal products is prohibited unless: (1) the medicinal products are approved for circulation in the Federal Republic; (2) the recipient of the medicinal products is a pharmaceutical company, a wholesaler, a veterinary surgeon or a pharmacist. The implementation of that prohibition on importation is secured by Paragraph 73(6) of the AMG, according to which, when finished medicinal products are imported from other Member States, a certificate must be presented to the customs administration mentioning the nature and quantity of the medicinal products and certifying that they satisfy the requirements of Paragraph 73(1) (which I shall refer to as the customs clearance certificate).
4. The matter at issue between the parties is whether when it imports the medicinal products in question Eurim-Pharm GmbH does in fact have to present a customs clearance certificate pursuant to Paragraph 73(6) of the AMG. The Free State of Bavaria, the appellant in the main proceedings, argues that it does (but takes the view that the certificate can be issued before the product has been labelled and provided with a package leaflet: see section 5 below). For its pan, Eurim-Pharm GmbH maintains that a customs clearance certificate is required only for finished medicinal products and that foreign medicinal products whose label and package leaflet are written in a foreign language are not (yet) finished products.
The interpretation of German law and the Court's jurisdiction under Article 177 of the EEC Treaty
5. Before considering the question referred by the Bundesverwaltungsgericht, I should like to draw the Court's attention to the fact that the Free State of Bavaria, the appellant in the main proceedings, maintains that in actual fact the issue before the national court does not arise. As has already been mentioned, the Free State of Bavaria argues that although Paragraph 73 of the AMG does make the circulation of medicinal products imported into the Federal Republic of Germany subject to authorization, it does not require imported medicinal products already to be provided with labelling (and a package leaflet) complying with the German legislation. The customs clearance certificate provided for in Paragraph 73(6) of the AMG may be obtained for products which have not yet been provided with the proper labelling and package leaflet. Consequently, the alleged barrier to trade no longer exists and the question referred to the Court for a preliminary ruling is not relevant.
6. This observation also applies to the question as to whether the Bundesverwaltungsgericht correctly held that medicinal products which have not yet been provided with labelling and a package leaflet as required by the AMG are finished medicinal products within the meaning of Article 4 of the AMG. That question likewise primarily relates to the interpretation of German law, which is not within the jurisdiction of the Court of Justice.
Can the rules be justified under Article 36 of the EEC Treaty?
7. When it comes down to it, the question referred by the national court concerns the interpretation of Article 36 of the EEC Treaty. It is in fact clear — as the national court itself admits — that the rules laid down in Paragraph 73 of the AMG as they are interpreted by the Bundesverwaltungsgericht prohibit the importation of medicinal products which do not (yet) satisfy all the requirements laid down in the AMG, including those relating to labelling and package leaflets. Consequently, the rules constitute a measure having equivalent effect to a quantitative restriction on imports within the meaning of Article 30 of the EEC Treaty, and, what is more, one of the most serious kinds as it does not merely impede trade but prevents it completely.
8. As the Court has consistently held, the Member States may no longer rely on Article 36 of the EEC Treaty in order to justify measures which impede trade where Community directives provide for complete harmonization of all the measures necessary for the protection of the interests listed in that article. As far as the production and marketing of medicinal products are concerned, the Community has already manifestly made substantial efforts with a view to the harmonization of the relevant national legislation, with the result that it may be asked whether the harmonization already achieved does not preclude recourse to Article 36 of the EEC Treaty. In the judgment delivered on 7 March 1989 in Schumacher the Court answered that question in the negative when it held that harmonization of national legislation on the manufacture and marketing of proprietary medicinal products has not yet been fully achieved.
9. In order for a prohibition on importation which is incompatible with Article 30 of the EEC Treaty to be justified under Article 36 of the Treaty, it must satisfy the requirements of necessity and proportionality embodied therein.
10. As far as the requirement of necessity is concerned, which is the only one which has to be considered in this case, as we shall see later, it is observed that to market in Germany medicinal products which do not satisfy the German requirements on labelling and package leaflets is without doubt a potential threat to public health. The rules set out in Paragraph 73 of the AMG, which, according to the interpretation given to them by the Bundesverwaltungsgericht, prohibit the importation of such medicinal products, are consequently apt to protect public health (see the first aspect of the requirement of necessity).
11. Medicinal products which on importation do not satisfy the legal requirements relating to labelling and package leaflets but are imported with the intention of bringing them into line with the requirements before marketing them are subject to the detailed rules set out in Paragraphs 13 and 21 of the AMG and to the checks laid down in Paragraph 64 of the AMG. The combination of those provisions affords sufficient guarantees that, at the time when the medicinal products are marketed, they will satisfy all the requirements of the AMG and hence will pose no danger to public health.
12. It appears from the foregoing that the rules laid down in Paragraph 73 of the AMG which, according to the Bundesverwaltungsgericht, prohibit the importation of the medical products in question is not necessary in order to protect public health against medicinal products which, at the time of importation, do not satisfy the German requirements relating to labelling and package leaflets but which are in fact imported with the intention of bringing them into line with those requirements by a importer who holds the requisite manufacturing and marketing authorizations. Consequently, the legislation cannot be justified under Article 36 of the EEC Treaty.
13. In view of the foregoing considerations, I propose that the question referred by the national court for a preliminary ruling should be answered as follows:
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.