Paranova Läkemedel AB and Others v Läkemedelsverket.
Date: 2003-05-08
22.  It must be noted at the outset 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 (Case C-172/00   Ferring   [2002] ECR I-6891, paragraph 33).
23.  However, such a restriction may be justified by reasons relating to the protection of public health, in accordance with the provisions of Article 30 EC (Ferring  , cited above, paragraph 33).
24.  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.  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 (Ferring  , paragraph 34).
25.  No reason has been put before the Court to justify why the mere fact that a marketing authorisation of reference was withdrawn at the request of its holder should entail the automatic withdrawal of the parallel import licence issued for the medicinal product in question (see, to that effect,   Ferring  , paragraph 35).
26.  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 (Ferring  , paragraph 36).
27.  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 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 (Ferring  , paragraph 37).
28.  Although adequate monitoring of the old version of the medicinal product 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 (Ferring  , paragraph 38).
32.  As the Court has held, such reasons could arise, for example, where there is in fact a risk to public health arising from the coexistence of two versions of the same medicinal product on the market of the importing Member State (Ferring  , paragraph 43).