61989J0347

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Free movement of goods - Quantitative restrictions - Measures having equivalent effect - Prohibition on the importation of proprietary medicinal products not packaged in accordance with national law - Intention of the importer, who has been issued with the necessary authorization, to carry out that packaging - Not permissible - Protection of health secured by the relevant Community rules

(EEC Treaty, Arts 30 and 36; Council Directives 65/65 and 75/319)

Articles 30 and 36 of the EEC Treaty preclude national legislation from prohibiting the importation from another Member State of proprietary medicinal products legally marketed in that State for which a marketing authorization has been granted in the importing Member State, simply because they have not been labelled and provided with a package leaflet in accordance with the legal requirements of the importing Member State, although the importer in fact intends to repackage them so as to bring them into line with those requirements with a view to marketing them in the importing Member State and has the manufacturing permit required to that end.

Such a measure is not necessary for the effective protection of human health and life, since the manufacturing and marketing permits issued in accordance with Directives 75/319 and 65/65, which are the only ones required under the Community rules, enable the public authorities to make sure, first, that proprietary medicinal products imported by a parallel importer are identical in point of their composition to products the marketing of which has already been authorized in the national territory and, secondly, that the requirements laid down by national law in relation to the packaging of such products are complied with. The importer holding the manufacturing permit is responsible for ensuring that the imported product complies with the marketing requirements laid down by the law.

In Case C-347/89,

REFERENCE to the Court under Article 177 of the EEC Treaty by the Bundesverwaltungsgericht (Federal Administrative Court) for a preliminary ruling in the proceedings pending before that court between

The Free State of Bavaria

and

Eurim-Pharm GmbH,

on the interpretation of Articles 30 and 36 of the EEC Treaty,

THE COURT (Third Chamber),

composed of: J.C. Moitinho de Almeida, President of the Chamber, F. Grévisse and M. Zuleeg, Judges,

Advocate General: W. Van Gerven,

Registrar: J.A. Pompe, Deputy Registrar,

after considering the written observations submitted on behalf of:

the Free State of Bavaria, by Ulrich Luhmann, Rechtsanwalt, Munich,

Eurim-Pharm, by Wolfgang A. Rehmann, Rechtsanwalt, Munich,

the Commission of the European Communities, by Goetz zur Hausen, Legal Adviser, acting as Agent,

having regard to the Report for the Hearing,

having heard oral argument at the hearing on 12 December 1990 from the appellant in the main proceedings, the respondent in the main proceedings, represented by Wolfgang A. Rehmann, Rechtsanwalt, Munich, and Dietrich Mueller-Roemer, Rechtsanwalt, Bergisch-Gladbach, and the Commission of the European Communities,

after hearing the Opinion of the Advocate General delivered at the sitting on 5 February 1991,

gives the following

Judgment

1 By order dated 3 August 1989 which was received at the Court on 10 November 1989, the Bundesverwaltungsgericht referred to the Court for a preliminary ruling under Article 177 of the EEC Treaty a question on the interpretation of Articles 30 and 36 of the EEC Treaty.

2 The question was raised in proceedings between the Free State of Bavaria and Eurim-Pharm GmbH concerning the importation by the latter into the Federal Republic of Germany of medicinal products which it purchases in other Member States.

3 Eurim-Pharm imports into the Federal Republic of Germany proprietary medicinal products which are lawfully marketed in other Member States but whose packaging does not satisfy the requirements of the State in which they are purchased. It then repackages them so as to comply with the requirements of the German law of 24 August 1976 on medicinal products (Arzneimittelgesetz, hereinafter referred to as "the AMG", Bundesgesetzblatt 1976, p. 2445) and to provide them with a package leaflet required by that law.

4 The customs authorities required Eurim-Pharm to obtain the import certificate required under Paragraph 73 of the AMG before it could carry out those import operations.

5 Paragraph 73(1) of the AMG provides as follows:

"Medicines subject to authorization or registration may be imported into the territory in which this law is applicable

- with the exception of tax-free areas other than the island of Helgoland - only if they have been authorized or registered for circulation in the territory or if they have been exempted from authorization or registration, provided that

(1) if the product is imported from a Member State of the European Community, the recipient must be a pharmaceutical company, a wholesaler, a veterinary surgeon or a pharmacist;

...".

6 In order to enable checks to be carried out to make sure that those requirements are met in the case of the medicinal products being imported, Paragraph 73(6) provides that:

"For the purposes of customs clearance for free circulation, in the case of subparagraph 1 a certificate of the authority responsible for the recipient must be submitted, indicating the type and quantity of the medicinal product and certifying that the conditions set out in subparagraph 1 are met. The competent customs office shall forward the certificate at the declarant' s expense to the authority which drew it up."

7 Eurim-Pharm argued that it was not necessary for it to obtain such a certificate. In its view, only "finished medicinal products" (Fertigarzneimittel) needed a marketing permit within the meaning of Paragraph 4(1) of the AMG. The medicinal products which it imported could not be described as such as they lacked packaging and a package leaflet satisfying the requirements of the AMG, under which it was prohibited to market them in that state in the territory in which that law applied.

8 Eurim-Pharma was successful before the Bayerisches Verwaltungsgericht (Bavarian Administrative Court) and before the Bayerischer Verwaltungsgerichtshof (Bavarian Higher Administrative Court). The Free State of Bavaria, however, appealed on a point of law to the Bundesverwaltungsgericht.

9 The Bundesverwaltungsgericht considered that the medicinal products imported by Eurim-Pharm had to be regarded as being "finished medicinal products" and, as such, subject to the authorization provided for in Paragraph 73 of the AMG. However, the certificate laid down in Paragraph 73(6) could not be issued since, as the medicinal products were packaged and provided with a package leaflet which complied only with the requirements of the exporting Member State, they could not be lawfully imported and marketed in the territory in which the AMG applied.

10 According to the Bundesverwaltungsgericht' s interpretation, medicinal products for which a marketing permit must be obtained according to the AMG may not be imported unless they satisfy in all respects the requirements of the permit issued by the competent authorities. However, a permit may be granted only if the packaging is marked in German with certain particulars laid down in Paragraph 10 of the AMG and the package contains a leaflet, also in German, satisfying the requirements of Paragraph 11 of the Law.

11 Observing that, as a result, the combined provisions of Paragraphs 10, 11, 25 and 73 of the AMG absolutely precluded a pharmaceutical undertaking from importing from other Member States proprietary medicinal products lawfully marketed there in order to repackage them for sale on the German market, the Bundesverwaltungsgericht questioned whether that prohibition on importation was compatible with Articles 30 and 36 of the EEC Treaty.

12 In those circumstances, it referred the following question to the Court for a preliminary ruling:

"Do Articles 30 and 36 of the EEC Treaty preclude provisions which make it impossible for an undertaking in one Member State to import from another Member State finished medicinal products in order to label them locally and provide them with package leaflets in accordance with domestic provisions pursuant to a national manufacturing permit?"

13 Reference is made to the Report for the Hearing for a fuller account of the facts of the case, the course of the procedure and the written observations submitted to the Court, which are mentioned or discussed hereinafter only in so far as is necessary for the reasoning of the Court.

14 The Free State of Bavaria considers that the AMG does not preclude the importation of proprietary pharmaceutical products solely because they are not packaged in accordance with the requirements of Paragraphs 10 and 11 of that law. Once a marketing permit covering the territory in which the Law applies has been issued pursuant to Paragraph 21 of the AMG in respect of the product itself, a parallel importer is entitled to import it with a view to providing it with packaging and a package leaflet which satisfy the requirements of the Law, and then to market it.

15. That view cannot be accepted in view of the Bundesverwaltungsgericht' s interpretation of the Law.

16 The Bundesverwaltungsgericht held, as has already been mentioned, that medicinal products not provided with packaging and a package leaflet satisfying the requirements of the AMG were nevertheless "finished medicinal products" subject to the authorization provided for in Paragraph 73 and that, in the case of such medicinal products, neither that authorization nor a certificate to the effect that authorization had been obtained could be lawfully issued. However, as the Court has consistently held, in proceedings under Article 177 of the EEC Treaty, it may not rule on the interpretation of national laws or regulations (Case 16/83 Prantl [1984] ECR 1299 and Joined Cases 91 and 127/83 Heineken Brouwerijen [1984] ECR 3435) or assess whether questions referred to it by a national court are relevant (see, in particular, Case 52/77 Cayrol v Rivoira [1977] ECR 2261).

17 The Court must therefore answer the Bundesverwaltungsgericht' s question. That court asks whether a national measure is contrary to Articles 30 and 36 of the EEC Treaty in the following circumstances. The measure constitutes an absolute bar to the importation into a Member State of proprietary medicinal products lawfully put into circulation in the Member State of exportation which are the subject in the importing Member State of a marketing authorization, simply because the products in question are not provided with packaging and a package leaflet complying with statutory requirements in the importing Member State, and the importer intends in fact to repackage the products in line with those requirements with a view to selling them on the market of the importing Member State and has the necessary authorizations to do so.

18 In the view of the Free State of Bavaria (which, it is observed, develops its argument in the context of its own interpretation of the AMG which, as has been mentioned above, does not coincide with that of the Bundesverwaltungsgericht), the provisions of the AMG governing authorization to import medicinal products are necessary for the protection of public health. It maintains in particular that parallel imports of proprietary medicinal products entail risks for public health owing to the differences which may exist in respect of a given product depending on the Member State of importation. It follows that checks at the frontier to ascertain that the product being imported is the same as the product for which marketing authorization has been granted in the Federal Republic of Germany are necessary and cannot effectively be replaced by the intermittent checks carried out on the importing pharmaceutical undertaking' s repackaging process pursuant to the manufacturing permit which it has been granted under Paragraph 64 of the AMG. Moreover, the Commission itself has acknowledged that this view is

well-founded, since it abandoned proceedings brought against the Federal Republic of Germany in this connection for failure to fulfil its obligations.

19 The respondent in the main proceedings and Commission maintain that the AMG, as interpreted by the Bundesverwaltungsgericht, constitutes an absolute bar on the importation of proprietary medicinal products which have already been authorized on the German market where the packaging and package leaflet do not satisfy the requirements of Paragraphs 10 and 11 of the AMG, and that this is an excessive restriction in intra-Community trade.

20 They point out that, in any event, the products in question may not be marketed directly in the territory in which the AMG applies but have to be repackaged. Under Paragraph 4(14) of the AMG, repackaging is a manufacturing operation for which authorization is required in accordance with the provisions of Chapter IV of Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (Official Journal 1975 L 147, p. 13) and on the terms laid down in Paragraphs 13 to 20 of the AMG.

21 As a manufacturer, the importing pharmaceutical undertaking is subject to checks carried out by the competent administrative authorities and is responsible for ensuring that not only the packaging but also the content of the medicinal product is in conformity with the AMG and with the marketing authorization. It would be liable to incur severe criminal sanctions if it were to break the provisions of the Law.

22 Eurim-Pharm also argues that the AMG, as interpreted by the Bundesverwaltungsgericht would oblige undertakings to move their packaging process to each of the States from which they import proprietary medicinal products so as to make their packaging satisfy the requirements of the AMG even before they enter the territory in which that law applies.

22 Article 30 of the EEC Treaty prohibits in trade between Member States quantitative restrictions on imports and all measures having equivalent effect. As the Court has consistently held, all trading rules enacted by a Member State which are capable of hindering, directly or indirectly, actually or potentially, intra-Community trade are to be considered as measures having an effect equivalent to quantitative restrictions.

24 A requirement laid down in national legislation for authorization to import certain products constitutes a measure having an effect equivalent to a quantitative restriction on imports.

25 It must therefore be considered whether the measure in question can be justified in the light of Article 36 of the Treaty.

26 On the one hand, the Court has consistently held that the health and the life of humans rank foremost among the property or interests protected by Article 36 and it is for the Member States, within the limits imposed by the Treaty, to decide what degree of protection they intend to assure and in particular how strict the checks to be carried out are to be. On the other hand, Article 36 remains applicable where harmonization of national legislation on the manufacture and marketing of proprietary medicinal products has not been fully achieved (judgment in Case 215/87 Schumacher [1989] ECR 617, paragraph 15).

27 However, it follows from Article 36 that national rules or practices which restrict imports of pharmaceutical products or are capable of doing so are compatible with the Treaty only to the extent to which they are necessary for the effective protection of the health and life of humans. National rules or practices do not qualify for a derogation under Article 36 if the health and life of humans can be protected as effectively using measures which are less restrictive of intra-Community trade.

28 On the view taken by the national court, the importer has a manufacturing permit issued in accordance with the requirements both of Directive 75/319 and of Paragraph 13 of the AMG under which he is authorized to carry on manufacturing operations in respect of the product in question. It is common ground that it needs such a permit in order to carry out operations relating to the packaging of pharmaceutical products, since such operations are covered by the manufacturing of such products under both Article 16(2) of Directive 75/319 and under Paragraph 4(14) of the AMG.

29 As a result, the importing undertaking is subjected, by the competent authorities, to checks provided for in Directive 75/319 and the AMG, the procedures for which are defined in Paragraph 64 of the AMG. If it breaks the law, the undertaking makes itself liable to administrative or criminal sanctions.

30 An undertaking which imports pharmaceutical products from another Member State in order to repackage them must also have, in order to market them, a marketing permit issued under the provisions of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (Official Journal, English Special Edition 1965-1966, p. 20), Directive 75/319 and Paragraph 21 of the AMG.

31 It is common ground that in the Federal Republic of Germany such a permit is an authorization which, simplified in order to take account of the Court' s case-law (judgments in Case 104/75 De Peijper [1976] ECR 613 and in Case 32/80 Officier van Justitie v Kortmann [1981] ECR 251), is issued to the parallel importer in respect of a proprietary medicinal product which has already been placed on the market by the manufacturer or the duly appointed importer.

32 One of the purposes of that permit is to make sure that the composition of proprietary medicinal products imported by a parallel importer is identical to that of products for which a marketing permit has already been issued.

33 The two manufacturing and marketing permits are the only ones required under the Community rules on the free movement of proprietary medicinal products, the aim of which, according to the third and fourth recitals in the preamble to Directive 65/65, is to remove the barriers to trade in proprietary medicinal products within the Community which result from disparities between national provisions. In particular, it must be observed that Directive 75/319 provides, in Article 16(3), for an import permit only in respect of proprietary medicinal products coming from non-member countries.

34 Those two permits enable the public authorities to make sure, first, that proprietary medicinal products imported by a parallel importer are identical in point of their composition to products the marketing of which has already been authorized in the national territory and, secondly, that the requirements laid down by national law in regard to the packaging of such products are complied with. The importer holding the manufacturing permit is responsible for ensuring that the imported product complies with the marketing requirements laid down by the law.

35 Accordingly, the prohibition on the importation of the products in question which according to the national court results from Paragraph 73(1) of the AMG is not necessary for the effective protection of human health and life.

36 It follows that the answer to the question referred by the Bundesverwaltungsgericht must be that Articles 30 and 36 of the EEC Treaty preclude national legislation from prohibiting the importation from another Member State of proprietary medicinal products legally marketed in that State when those products are subject to marketing authorization in the importing Member State and the importer holds a manufacturing permit for the purpose of labelling them and providing them with a package leaflet in accordance with the legislation of the importing Member State.

Costs

37 The costs incurred by the Commission of the European Communities, which has submitted observations to the Court, are not recoverable. Since these proceedings are, in so far as the parties to the main proceedings are concerned, in the nature of a step in the proceedings pending before the national court, the decision on costs is a matter for that court.

On those grounds,

THE COURT (Third Chamber),

in reply to the question submitted to it by the Bundesverwaltungsgericht, by order of 3 August 1989, hereby rules:

Articles 30 and 36 of the EEC Treaty preclude national legislation from prohibiting the importation from another Member State of proprietary medicinal products legally marketed in that State when those products are subject to marketing authorization in the importing Member State and the importer holds a manufacturing permit for the purpose of labelling them and providing them with a package leaflet in accordance with the legislation of the importing Member State.