C-347/89

3. Paragraph 73(1) of the AMG provides that the importation from other Member 'Do Articles 30 and 36 of the EEC Treaty States of finished medicinal products is preclude provisions which make it prohibited unless: (1) the medicinal products impossible for an undertaking in one are approved for circulation in the Federal Member State to import from another Republic; (2) the recipient of the medicinal Member State finished medicinal products products is a pharmaceutical company, in order to label them locally and provide a wholesaler, a veterinary surgeon or a them with package leaflets in accordance pharmacist. The implementation of that with domestic provisions pursuant to a prohibition on importation is secured by national manufacturing permit.' 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 Legal background and procedure 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'). 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 4. The matter at issue between the parties is Federal Republic of Germany in order first whether when it imports the medicinal to label them and provide them with products in question Eurim-Pharm GmbH package leaflets — in accordance with the does in fact have to present a customs requirements of the Gesetz über den clearance certificate pursuant to Paragraph Verkehr mit Arzneimitteln (Law on trade in 73(6) of the AMG. The Free State of pharmaceutical products, hereinafter Bavaria, the appellant in the main referred to as 'the AMG') as amended by proceedings, argues that it does (but takes

the view that the certificate can be issued applicable. According to the Bundesverwal before the product has been labelled and tungsgericht, this means that Eurim-Pharm provided with a package leaflet: see section has to present a customs clearance 5 below). For its pan, Eurim-Pharm GmbH certificate to the German customs when it maintains that a customs clearance imports the medicinal products in question. certificate is required only for finished That court takes the view that, on this inter medicinal products and that foreign pretation of Paragraph 73 of the AMG, medicinal products whose label and package since such a certificate cannot be issued leaflet are written in a foreign language are until the product has been duly labelled and not (yet) finished products. provided with a package leaflet, Paragraph 73 implies that the importation of medicinal products which are marketed in other

Court). The appeal was dismissed, since the Verwaltungsgerichtshof also took the view that the medicinal products in question were not finished medicinal products and that Paragraph 73 of the AMG was not applicable. The Free State of Bavaria appealed on a point of law to the Bundes verwaltungsgericht, the court which has Consequently, the question is concerned requested the Court of Justice for a solely with the need for a customs clearance preliminary ruling. certificate in so far as it is based on the requirement set out in Paragraph 73(1) of the AMG for medicinal products to be approved for circulation in Germany and not on the requirement laid down therein with regard to the capacity of the recipient. The second requirement is not at issue in As can be inferred from the question, the this case as Eurim-Pharm satisfies it.

They are placed in a bonded warehouse on Eurim-Pharm's premises at Piding in Upper 1 — The Bundesverwaltungsgericht based itself on academic Bavaria where ihey are labelled to German requirements writings and in particular on Kloesel/Cyran, Kommentar They arc then cleared by customs after the competent zum AMG, paragraph 4, note 2 (order of the Bundesver authority (the government of Upper Bavaria), upon waltungsgericht, p 9) application, has issued a customs clearance certificate

6. This observation also applies to the question as to whether the Bundesverwal tungsgericht correctly held that medicinal 5. Before considering the question referred products which have not yet been provided by the Bundesverwaltungsgericht, I should with labelling and a package leaflet as like to draw the Court's attention to the fact required by the AMG are finished medicinal that the Free State of Bavaria, the appellant products within the meaning of Article 4 of in the main proceedings, maintains that in the AMG.

3 legislation. The customs clearance certificate provided for in Paragraph 73(6) 7. When it comes down to it, the question of the AMG may be obtained for products referred by the national court concerns the which have not yet been provided with the interpretation of Article 36 of the EEC proper labelling and package leaflet. Conse Treaty. It is in fact clear — as the national quently, the alleged barrier to trade no 6 court itself admits — that the rules laid longer exists and the question referred to down in Paragraph 73 of the AMG as they the Court for a preliminary ruling is not are interpreted by the Bundesverwaltungs relevant. gericht 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 It is sufficient to observe that, as the Court has consistently held, it is for the national 4 — See, for example, the judgment in Case 111/76 Officier van Justižiei van den Hazel[1977] ECR 901. court and not the Court of Justice to assess 5 — The AMG transposes into German law the Community in the light of the facts whether the directives on the production and marketing of medicinal

3 — Observations of the Free State of Bavaria, pp. 2 and 3. 6 — Order for reference, p. 14.

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9 — Council Directive 65/65/EEC of 2b January 1965 on the 11 — Ärtule 13 of Directive 65/65 (labellingI and Article 6 of approximation of provisions laid down b\ law. regulation Directive 75/319 (leaflets enclosed with packaging) or administrative action relating to proprietary medicinal 12 — Eor example. Article 7 of Directive 75/319 provides as products, as amended bv Directives 83/570/EEC, follows 'Nothwithstanding the provisions of Directive 87/2 l / EEC and 89/341/EĖC, and Council Directive 65/65/EĽC, Member States may require that the 75/319/EEC of 20 Mav 1975 on the approximation of proprietary medicinal product shall be labelled so as to provisions laid down by law, regulation or administrative indicate on the container and/or outer packing and/or on action relating to proprietary medicinal products, as the package leaflet other requirements essential to safety amended by Directives 83/570/EEC and 89/341/EEC or for the protection of public health, including .

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OPINION OF MR VAN GERVEN —CASE C-347/89

second requirement, the requirement of proportionality, there must be a relationship of proportionality between the barrier which This is shown in the first place by is brought about and the objective pursued Paragraph 13(1) of the AMG, which and the actual achievement of that provides, in accordance with Article 16 of n objective. Directive 75/319/EEC, that authorization is required in order to manufacture medicinal products in Germany (which I shall refer to as 'manufacturing authorization').

far. Public health is in fact effectively federal authority. According to Paragraph protected from medicinal products which on 21(3) and Paragraph 4(18) of the AMG, importation have not yet been provided with such authorization (hereinafter referred to the required labelling and package leaflets as 'the marketing authorization') must be by other rules and the related control applied for by any person who markets a measures laid down in the AMG which are medicinal product under his own name.

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with the relevant legal provisions, including importation that it holds a manufacturing the requirements relating to labelling authorization and a marketing author­ (Paragraph 10 of the AMG) and package ization — which is not at issue in this case leaflets (Paragraph 11 of the AMG). Under (see section 4 above) — the competent Paragraph 30(1) of the AMG a marketing German authorities may, by taking samples authorization may be withdrawn or pursuant to Article 64 of the AMG, check suspended if it should appear that the whether the imported medicines have in fact marketing of the medicinal product in been brought into line with the German question would give rise to a breach of the requirements on labelling and package aforementioned legal requirements. leaflets before they are put into circulation. It is therefore not necessary for the purposes of the protection of public health for the customs authorities to check whether medicinal products satisfy the German requirements on labelling and package Lastly, I would refer to Paragraph 64 of the leaflets at the time when they are imported. AMG, which provides that the authority It is sufficient for the customs adminis­ designated to that end must take samples in tration to make sure that the importer, or order to check the manufacture of the firm for which the importer is acting, medicinal products for which a manufac­ holds a manufacturing authorization and a turing authorization has been granted and I4 marketing authorization. to verify whether a marketing authorization has been granted and whether the products satisfy the legal requirements.

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OPINION OF MR VAN GERVEN —CASE C-347/89

12. It appears from the foregoing that the German requirements relating to labelling rules laid down in Paragraph 73 of the and package leaflets but which are in fact AMG which, according to the Bundesver­ imported with the intention of bringing waltungsgericht, prohibit the importation of them into line with those requirements by a the medical products in question is not importer who holds the requisite manufac­ necessary in order to protect public health turing and marketing authorizations. Conse­ against medicinal products which, at the quently, the legislation cannot be justified 15 time of importation, do not satisfy the 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:

'Articles 30 and 36 of the EEC Treaty must be interpreted as precluding legislation preventing a businessman in one Member State from importing from another Member State finished medicinal products which at the time of importation do not yet satisfy the national requirements with regard to labelling and package leaflets when other national rules which comply with Community law and impede trade between Member States guarantee less effectively that the medicinal products in question will satisfy the requirements in question when the goods are put into circulation in the importing Member State.'

15 — 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 authori­ zation and an authorization to market the products in the Federal Republic of Germany.