Ferring Arzneimittel GmbH v Eurim-Pharm Arzneimittel GmbH.
Date: 2002-09-10
19 According to the principles laid down in Directive 65/65, no medicinal product may be placed on the market for the first time in a Member State unless a marketing authorisation has been issued in accordance with the directive by the competent authority of that State. Applications for marketing authorisations for a medicinal product submitted by the person responsible for placing it on the market must contain the information and be accompanied by the documents listed in Article 4 of the directive, even where the medicinal product concerned is already the subject of an authorisation issued by the competent authority of another Member State (Case C-94/98 Rhône-Poulenc Rorer and May & Baker [1999] ECR I-8789, paragraph 23).
21 Those rules, as interpreted by the Court, mean in particular that an operator who has bought a medicinal product lawfully marketed in one Member State under a marketing authorisation issued in that State can import that medicinal product into another Member State where he already has a marketing authorisation without having to obtain such an authorisation in accordance with Directive 65/65, and without having to provide information about the verification, prescribed by the directive, of efficacity and non-toxicity of the medicinal product.  It is not necessary for the protection of public health to subject parallel importers to such requirements, as the competent authorities of the Member State of importation already have all the information necessary to carry out that verification (see in particular Case 104/75 De Peijper [1976] ECR 613, paragraphs 21 and 36 and Case C-201/94 Smith & Nephew and Primecrown [1996] ECR I-5819, paragraph 22).
33 It is common ground that the cessation of the validity of a parallel import licence following the withdrawal of the marketing authorisation of reference constitutes a restriction on the free movement of goods contrary to Article 28 EC, unless it is justified by reasons relating to the protection of public health, in accordance with the provisions of Article 30 EC.
34 It is for the national authorities responsible for the operation of the legislation governing the production and marketing of medicinal products - legislation which, as is made clear in the first recital of Directive 65/65, has as its primary objective the safeguarding of public health - to ensure that it is fully complied with.  Nevertheless, the principle of proportionality, which is the basis of the last sentence of Article 30 EC, requires that the power of the Member States to prohibit imports of products from other Member States be restricted to what is necessary in order to achieve the aims concerning the protection of health that are legitimately pursued (see Case 174/82 Sandoz [1983] ECR 2445, paragraph 18).  Thus, national legislation or practice cannot benefit from the derogation laid down in Article 30 EC when the health and life of humans can be protected equally effectively by measures less restrictive of intra-Community trade.
35 In a situation such as that in point in the main proceedings in which, at the request of its holder, a marketing authorisation of reference is withdrawn for reasons other than the protection of public health there do not appear, as the Swedish Government and the Commission in particular have pointed out, to be any reasons to justify the automatic cessation of the validity of the parallel import licence.
36 First, it must be observed that the withdrawal of a marketing authorisation of reference does not mean in itself that the quality, efficacity and non-toxicity of the old version is called into question.  In that respect it must be noted that that version continues to be lawfully marketed in the Member State of exportation under the marketing authorisation issued in that State.
37 Next, although the competent authorities of the Member State of importation can, and indeed must, adopt the measures necessary for the purpose of verifying the quality, efficacity and non-toxicity of the old version of the medicinal product, it does not appear from the information before the Court that that objective cannot be attained by other measures having a less restrictive effect on the import of medicinal products than the automatic cessation of the validity of the parallel import licence in consequence of the withdrawal of the marketing authorisation of reference.
38 Although adequate monitoring of the old version remains necessary and may in certain cases mean that information is requested from the importer, it must be pointed out that pharmacovigilance satisfying the relevant requirements of Directive 75/319 as amended can ordinarily be guaranteed for medicinal products that are the subject of parallel imports, such as those in question in the main proceedings, through cooperation with the national authorities of the other Member States by means of access to the documents and data produced by the manufacturer or other companies in the same group, relating to the old version in the Member States in which that version is still marketed on the basis of a marketing authorisation still in force (see Rhône-Poulenc Rorer and May & Baker, cited above, paragraph 46).
43 As to the fourth question, concerning the fact that two versions of the same medicinal product on the market of the Member State of importation entails the risk of improper conservation of the old version, it must be held that if it can be demonstrated that there is in fact a risk to public health arising from the coexistence of the two versions such a risk may justify restrictions on the importation of the old version.