Kohlpharma GmbH v Bundesrepublik Deutschland.
Date: 2004-04-01
11. In that context, in order to give a useful answer to the question referred for a preliminary ruling, the Court can take as a basis the premiss that, for the purposes of assessing their safety and efficacy, the two medicinal products do not differ significantly.
14. It is for the competent national authorities, before they issue a marketing authorisation, to ensure that the primary objective of the Community legislation, namely the safeguarding of public health, is fully complied with. Nevertheless, the principle of proportionality requires that, in order to protect the free movement of goods, the legislation in question be applied within the limit of what is necessary in order to achieve the aim of protecting health that is legitimately being pursued (see, to that effect, Case C-172/00 Ferring [2002] ECR I-6891, paragraph 34).
16. In a situation such as that in the main proceedings, the problem confronting the competent authorities as regards marketing authorisations for medicinal products is whether, as is claimed by the applicant for a marketing authorisation, the safety and efficacy assessment carried out for the medicinal product which has already been authorised can indeed be applied to the application for a marketing authorisation for the second medicinal product without any risk to the protection of public health.
17. In that regard, a common origin of the two medicinal products may constitute an important element in establishing that such is the case.
19. In circumstances such as those in the main proceedings, which are characterised by the fact that an active ingredient is sold to two different manufacturers established in two Member States, the applicant for marketing authorisation for the second medicinal product may, for the purpose of assessing its safety and efficacy, demonstrate by means of available or accessible information that the medicinal product to be imported does not differ significantly from the medicinal product which is already authorised.
20. When, in particular in the case of an importer, the applicant does not have access to all the necessary information but provides data that make it at least plausible that the two medicinal products do not differ significantly for the purpose of assessing their safety and efficacy, the competent authorities must act in such a way that their decision as to whether to extend to the second medicinal product the marketing authorisation granted to the first one is taken on the basis of the fullest information possible, including information which is available to them or which they could have obtained through cooperation with the health authorities in other Member States.
21. The answer to the question must therefore be that, in the case where
– an application for a marketing authorisation for a medicinal product is submitted with reference to a medicinal product that has already been authorised,
– the medicinal product which is the subject of the application is imported from a Member State in which it has obtained a marketing authorisation,
– the the the assessment of safety and efficacy carried out for the medicinal product which is already authorised can be used in the application for a marketing authorisation for the second medicinal product without any risk to public health,
Articles 28 EC et 30 EC  preclude  the appli the application being rejected solely on the ground that the two medicinal products do not have a common origin.