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30.4.2004 |
EN |
Official Journal of the European Union |
C 106/8 |
JUDGMENT OF THE COURT
(Sixth Chamber)
of 1 April 2004
in Case C-112/02 (reference for a preliminary ruling from the Oberverwaltungsgericht für das Land Nordrhein-Westfalen): Kohlpharma GmbH v Bundesrepublik Deutschland (1)
(‘Free movement of goods - Medicinal products - Importation - Application for marketing authorisation under a simplified procedure - Common origin’)
(2004/C 106/12)
Language of the case. German
In Case C-112/02: reference to the Court under Article 234 EC by the Oberverwaltungsgericht für das Land Nordrhein-Westfalen (Higher Regional Court for the Land of North Rhine-Westphalia (Germany) for a preliminary ruling in the proceedings pending before that court between Kohlpharma GmbH and Bundesrepublik Deutschland – on the interpretation of Community law, in particular Articles 28 EC and 30 EC – the Court (Sixth Chamber), composed of: C. Gulmann (Rapporteur), acting for the President of the Sixth Chamber, J.N. Cunha Rodrigues, J.-P. Puissochet, R. Schintgen and F. Macken, Judges; A. Tizzano, Advocate General; H.A. Rühl, Principal Administrator, for the Registrar, has given a judgment on 1 April 2004, in which it ruled:
In the case where
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an application for a marketing authorisation for a medicinal product is submitted with reference to a medicinal product that has already been authorised, |
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the medicinal product which is the subject of the application is imported from a Member State in which it has obtained a marketing authorisation, |
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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 and 30 EC preclude the application being rejected solely on the ground that the two medicinal products do not have a common origin.