Important legal notice

61989C0347

European Court reports 1991 Page I-01747

Opinion of the Advocate-General

++++

Mr President,

Members of the Court,

"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.

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

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)

Can the rules be justified under Article 36 of the EEC Treaty?

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.

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.

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)

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,

(*) Original language: Dutch.