Case C-112/02

Kohlpharma GmbH

v

Bundesrepublik Deutschland

(Reference for a preliminary ruling from the Oberverwaltungsgericht für das Land Nordrhein-Westfalen)

(Free movement of goods – Medicinal products – Importation – Application for marketing authorisation under a simplified procedure – Common origin)

Summary of the Judgment

Free movement of goods – Quantitative restrictions – Measures having equivalent effect – Medicinal products – Application for a marketing authorisation with reference to a medicinal product that has already been authorised – Possibility of transposing the safety and efficacy assessment carried out for that medicinal product without any risk to public health – Rejection of the application because the medicinal products do not have a common origin – Not permissible – Justification – None

(Arts 28 EC and 30 EC)

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 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, that is, that their manufacturers are not part of the same group of undertakings and they do not produce those medicinal products under agreement with the same licensor.

In such circumstances, the restriction on the free movement of goods between Member States which results from the refusal to issue a marketing authorisation to the second medicinal product cannot be justified on grounds of protecting public health if that refusal is based solely on the fact that the two medicinal products do not have the same origin. A common origin may indeed constitute an important element in establishing that 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. The absence of a common origin for the two medicinal products does not, however, in itself constitute a ground for refusing a marketing authorisation to the second medicinal product.

(see paras 15-18, 21, operative part)

JUDGMENT OF THE COURT (Sixth Chamber)
1 April 2004(1)

(Free movement of goods – Medicinal products – Importation – Application for marketing authorisation under a simplified procedure – Common origin)

In Case C-112/02,

REFERENCE to the Court under Article 234 EC by the Oberverwaltungsgericht für das Land Nordrhein-Westfalen (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,

Advocate General: A. Tizzano,
Registrar: H.A. Rühl, Principal Administrator,

after considering the written observations submitted on behalf of:

– Kohlpharma GmbH, by W.A. Rehmann, Rechtsanwalt,

– the Commission of the European Communities, by H. Støvlbæk and S. Fries, acting as Agents,

after hearing the oral observations of Kohlpharma GmbH, represented by W.A. Rehmann; of the Bundesinstitut für Arzneimittel und Medizinprodukte, represented by M. Wagner and A. von Hagen, acting as Agents; and of the Commission, represented by H. Støvlbæk and S. Fries, at the hearing on 13 March 2003,

after hearing the Opinion of the Advocate General at the sitting on 11 September 2003,

gives the following

Judgment

1 By order of 14 March 2002, received at the Court on 27 March 2002, the Oberverwaltungsgericht für das Land Nordrhein-Westfalen (Higher Administrative Court of North Rhine-Westphalia) referred to the Court for a preliminary ruling under Article 234 EC a question on the interpretation of Community law, in particular Articles 28 EC and 30 EC.

2 That question has arisen in proceedings between Kohlpharma GmbH (‘Kohlpharma’) and the Federal Republic of Germany concerning marketing authorisation for a medicinal product imported from Italy.

Main proceedings

3 The company Chiesi Farmaceutici SpA (hereinafter ‘Chiesi’) produces and markets the medicinal product Jumex in Italy under a marketing authorisation which it was granted in that country. That medicinal product is manufactured from the active ingredient selegiline hydrochloride. The company Orion Pharma GmbH (hereinafter ‘Orion’) produces and markets the medicinal product Movergan in Germany under a marketing authorisation issued to it in that country. Movergan is manufactured using the same active ingredient as that in Jumex.

4 TTheThe active ingredient used by Chiesi and Orion is supplied by the undertaking Chinoin Pharmaceutical and Chemical Works Co. Ltd (hereinafter ‘Chinoin’), established in Hungary. While Chiesi has a licensing agreement with Chinoin, Orion receives its supplies, either directly or through Finland, under a supply agreement between Chinoin and Orion Corp. Finland.

5 Kohlpharma applied to the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Medicinal Products, hereinafter ‘the Bundesinstitut’) for marketing authorisation for the medicinal product Jumex, for the purpose of importing it into Germany. It referred to the medicinal product Movergan, which is already authorised in Germany, and requested that the marketing authorisation for that medicinal product be extended to Jumex.

6 ThThe Bundesinstitut rejected that application, citing the judgment in Case C-201/94 Smith & Nephewand Primecrown [1996] ECR I-5819. That judgment, the Bundesinstitut argued, establishes that the extension to an imported medicinal product of a marketing authorisation already issued to another medicinal product in the State of importation is subject to the condition that the two medicinal products have a common origin, that is, that their manufacturers are part of the same group of undertakings or, at the very least, that they produce those medicinal products under agreements with the same licensor.

7 Kohlpharma appealed against that rejection decision to the Oberverwaltungsgericht, arguing that the medicinal product to be imported and that already authorised in the Member State of importation could not be required to have a common origin. In the case-law relating to parallel imports, it submitted, the Court did not establish the condition of identity of origin as a binding principle but merely took it into account, since the conditions of identity of products and of origin were in fact both satisfied in the cases which had been referred to it for a preliminary ruling.

8 In those circumstances, the Oberverwaltungsgericht für das Land Nordrhein-Westfalen decided, by order of 14 March 2002, to stay proceedings and to refer the following question to the Court for a preliminary ruling:

‘Is it justified under Article 30 EC or other Community law for the competent German authority to obstruct the parallel import of a medic