Opinion of Mr Advocate General Van Gerven delivered on 5 February 1991. - Freistaat Bayern v Eurim-Pharm GmbH. - Reference for a preliminary ruling: Bundesverwaltungsgericht - Germany. - Interpretation of Articles 30 and 36 of the EEC Treaty - Importation of medicinal products. - Case C-347/89.



European Court reports 1991 Page I-01747



Opinion of the 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:

"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."

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 ueber 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 part,

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 Bayerisches Verwaltungsgericht (Bavarian Administrative Court) Muenchen, before which the case was heard at first instance, upheld Eurim-Pharm' s argument, whereupon the Free State of Bavaria appealed to the Bayerischer Verwaltungsgerichtshof (Bavarian Higher Administrative 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 Bundesverwaltungsgericht, the court which has requested the Court of Justice for a preliminary ruling.

As can be inferred from the question, the Bundesverwaltungsgericht presupposes, unlike the lower courts, that medicinal products which have not yet been provided with labelling and package leaflets as required by the AMG are none the less finished medicinal products (1) and that Paragraph 73 of the AMG is therefore applicable. According to the Bundesverwaltungsgericht, this means that Eurim-Pharm has to present a customs clearance certificate to the German customs when it imports the medicinal products in question. That court takes the view that, on this interpretation of Paragraph 73 of the AMG, since such a certificate cannot be issued until the product has been duly labelled and provided with a package leaflet, Paragraph 73 implies that the importation of medicinal products which are marketed in other Member States in accordance with the legislation in force there but do not yet fully satisfy the requirements of the AMG at the time of importation is completely precluded. (2) It is for that reason that the Bunderverwaltungsgericht has submitted the above question to the Court for a preliminary ruling.

Consequently, the question is concerned solely with the need for a customs clearance certificate in so far 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 this case as Eurim-Pharm satisfies it. I shall therefore consider solely the first-mentioned requirement.

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. (3) 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.

It is sufficient to observe that, as the Court has consistently held, it is for the national court and not the Court of Justice to assess in the light of the facts whether the preliminary reference is crucial for resolving the dispute at issue in the main proceedings. This holds good a fortiori where, as in this case, an assessment of the relevance of the question referred necessitates the interpretation of national law, namely Paragraph 73(6) of the AMG. The Court' s jurisdiction under Article 177 is confined to the interpretation of Community law and, where appropriate, to considering the validity of Community measures. (4)

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. (5)

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 (6) - 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, (7) and, what is more, one of the most serious kinds as it does not merely impede trade but prevents it completely.

However, under Article 36 of the EEC Treaty "The provisions of Articles 30 to 34 shall not preclude prohibitions or restrictions on imports ... justified on grounds of ... the protection of health and life of humans", provided that they do not "constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States". It must be considered whether the prohibition on imports laid down in Paragraph 73 of the AMG can be justified under Article 36 of the EEC Treaty.

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. (8) 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, (9) 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. (10)

Admittedly, particularly as regards the harmonization of national rules relating to labelling and package leaflets, the Community directives do lay down a number of requirements (11), however, they leave it to the Member States to lay down in national legislation that other requirements essential to safety or for the protection of public health must be indicated. (12) Consequently, there has not yet been full harmonization of all the measures necessary for the protection of public health and hence it is still possible to have recourse to Article 36 of the EEC Treaty as regards such

non-harmonized national provisions.

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.

The test whether the requirement of necessity is satisfied is whether the measure adopted was necessary in order to achieve the objective pursued. This means, first, that the measure adopted must be appropriate in order to achieve the aim pursued, that is to say it must be relevant or pertinent, and, secondly, there must be no alternative to the measure in question which is less restrictive of the free movement of goods. Under the second requirement, the requirement of proportionality, there must be a relationship of proportionality between the barrier which is brought about and the objective pursued and the actual achievement of that objective. (13)

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).

However, to my mind those rules go too far. Public health is in fact effectively protected from medicinal products which on importation have not yet been provided with the required labelling and package leaflets by other rules and the related control measures laid down in the AMG which are in keeping with Community law and are less restrictive of intra-Community trade (see the second aspect of the requirement of necessity). Those other rules and measures afford sufficient guarantees that the medicinal products concerned will be provided with the requisite labelling and leaflet when they are actually placed on the German market.

This is shown in the first place by Paragraph 13(1) of the AMG, which provides, in accordance with Article 16 of Directive 75/319/EEC, that authorization is required in order to manufacture medicinal products in Germany (which I shall refer to as "manufacturing authorization"). It is observed that Paragraph 14(4) of the AMG provides that manufacture also includes (re)packaging and marking (including the insertion of a leaflet). Under Paragraph 18(1) of the AMG a manufacturing authorization may be withdrawn or suspended if the requirements subject to which it was granted are not complied with.

Secondly, I would refer to Paragraph 21(1) of the AMG, which stipulates (in accordance with Article 3 of Directive 65/65/EEC) that a finished medicinal product may not be placed on the market in the Federal Republic of Germany unless it has been authorized by the competent federal authority. According to Paragraph 21(3) and Paragraph 4(18) of the AMG, such authorization (hereinafter referred to as "the marketing authorization") must be applied for by any person who markets a medicinal product under his own name. It should be observed in particular in this connection that, under Paragraph 25(2) of the AMG, a marketing authorization may be refused if the marketing of the medicinal product concerned would be incompatible with the relevant legal provisions, including the requirements relating to labelling (Paragraph 10 of the AMG) and package leaflets (Paragraph 11 of the AMG). Under Paragraph 30(1) of the AMG a marketing authorization may be withdrawn or suspended if it should appear that the marketing of the medicinal product in question would give rise to a breach of the aforementioned legal requirements.

Lastly, I would refer to Paragraph 64 of the AMG, which provides that the authority designated to that end must take samples in order to check the manufacture of medicinal products for which a manufacturing authorization has been granted and to verify whether a marketing authorization has been granted and whether the products satisfy the legal requirements.

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.

In the case of an importer which, like Eurim-Pharm, can prove to the customs on importation that it holds a manufacturing authorization and a marketing authorization - which is not at issue in this case (see section 4 above) - the competent German authorities may, by taking samples pursuant to Article 64 of the AMG, check whether the imported medicines have in fact been brought into line with the German requirements on labelling and package 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 leaflets at the time when they are imported. It is sufficient for the customs administration to make sure that the importer, or the firm for which the importer is acting, holds a manufacturing authorization and a marketing authorization. (14)

The argument that the checks provided for in Paragraph 64 of the AMG would not be sufficiently effective is without foundation. In the case of bulk imports of medicinal products and imported semi-finished products where there is a similar danger to public health, only the checks laid down in Paragraph 64 are stipulated in those cases too. What is more, in the event of a breach of the conditions subject to which the manufacturing authorization and/or the marketing authorization are granted, the competent authority is entitled to withdraw or suspend the relevant authorization, which would be a severe sanction for the importer concerned.

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. (15)

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."

Provisional Text

Translation

OPINION

of Mr Advocate General

Van Gerven

In Case C-374/89

Free State of Bavaria

v

Eurim-Pharm GmbH

(Reference for a preliniary ruling by order of the

Bundesverwaltungsgericht)

Delivered at a sitting on 5 February 1991

Mr President,

Members of the Court,

1.

(*) Original language: Dutch.

(1) 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).

(2) However, it appears from the Bundesverwaltungsgericht' s order that as a result of a provisional agreement with the German customs authorities Eurim-Pharm has been able to date to "import" finished medicinal products which do not yet satisfy all the requirements of the AMG. The products in question are 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 they are labelled to German requirements. They are then cleared by customs after the competent authority (the government of Upper Bavaria), upon application, has issued a customs clearance certificate.

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

(4) See, for example, the judgment in Case 111/76 Officier van Justitie v van den Hazel [1977] ECR 901.

(5) 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 "Fertigarzneimittel" 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 "Fertigarzneimittel".

(6) Order for reference, p. 14.

(7) See the judgment in Case 8/74 Dassonville [1974] ECR 837.

(8) See, for example, the judgment in Case C-169/89 Gourmetterie Van den Burg [1990] ECR I-2143 and the judgment in Case 215/87 Schumacher [1989] ECR 617.

(9) 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, as amended by Directives 83/570/EEC, 87/21/EEC and 89/341/EEC, and 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, as amended by Directives 83/570/EEC and 89/341/EEC.

(10) See the judgment in Schumacher, paragraph 15, cited in note 8.

(11) Article 13 of Directive 65/65 (labelling) and Article 6 of Directive 75/319 (leaflets enclosed with packaging).

(12) For 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 ...".

(13) See my Opinion delivered on 20 March 1990 in Case C-169/89 Gourmetterie Van den Burg [1990] ECR I-2143 at I-2151, paragraph 8.

(14) Such checks are carried out 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 the competent authority carried out checks on it every two months rather than every two years.

(15) I would observe, moreover, that 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.

Translation