European Union: Parallel Imports - Lack Of Common Origin Of A Parallel Imported Medicinal Product Not Ground To Reject An Application For A Marketing Authorisation On The Basis Of The Simplified Procedure*

Last Updated: 26 November 2004
Article by Morten Göhring

Originally published October 2004

Lack Of Common Origin Of A Parallel Imported Medicinal Product Not Ground To Reject An Application For A Marketing Authorisation On The Basis Of The Simplified Procedure.1

The European Court of Justice ("ECJ") ruled on 1 April 2004 that the competent authority must not reject an application for a marketing authorisation ("MA") for a parallel imported medicinal product on the basis of the simplified procedure solely on the ground that the imported and the reference product do not have a common origin.


The EU Directive 2001/83/EC on the Community code relating to medicinal products for human use provides that no proprietary medicinal product may be placed on the market of a Member State unless a MA has been issued by the competent authority. In order to obtain a MA, the applicant shall provide the competent authority with all particulars and documents necessary to assess the efficacy and safety of the medicinal product at issue.

According to the jurisprudence of the ECJ, however, these rules are subject to exceptions with respect to parallel imported medicinal products. If the imported product is already authorised in the Member State of origin and if an identical or essentially similar medicinal product is authorised in the Member State of destination, the parallel importer is not required to provide the competent authority again with all necessary particulars but may refer to the dossier of the medicinal product that has already been authorised in the State of destination ("simplified procedure").

The ECJ has also clarified the issue of similarity, ruling that two products, which are manufactured by independent companies pursuant to agreements concluded with the same licensor, do not have to be identical in all respects but they should have at least been manufactured according to the same formulation and using the same active ingredient and they should also have the same therapeutic effects (Smith & Nephew, 1996).


The dispute at hand arose from an MA-application which the biggest German parallel importer (Kohlpharma) filed with the competent German authority (BfArM). Kohlpharma requested a MA on the basis of a simplified procedure for the Italian Parkinson pharmaceutical Jumex, referring to the German MA for Movergan. Jumex and Movergan were manufactured and marketed by independent undertakings but both contained the same active ingredient supplied by the same Hungarian manufacturer.

The BfArM rejected the application solely arguing that the two medicinal products did not have a common origin as required by the ECJ jurisprudence. The manufacturers were not part of the same group of undertakings or, at the very least, did not produce the medicinal products under agreements with the same licensor. Kohlpharma appealed against that decision.


The ECJ held that the principles of free movement of goods preclude the application being rejected solely on the ground that the two medicinal products do not have a common origin if, in a case of a parallel import, the assessment of safety and efficacy carried out for the medicinal product which is already authorised can be used in the MA application for the imported product without any risk to public health. According to the ECJ, the rejection of the MA application constitutes a restriction for the free movement of goods. Such a restriction is generally illegitimate unless it is warranted by imperative needs, in particular the protection of public health. Once it has been established that the safety and efficacy assessment carried out for the reference product can, without any risk to the protection of public health, be used in respect of the imported product, rejection of the MA application solely on the ground of a missing common origin is precluded since this criteria is not relevant with respect to the public health.


The ECJ ruling will probably have only a small impact. The competent authority must not reject a MA application solely on the ground of different origins, it will still have to assess whether the safety and efficacy assessment carried out for the reference product can be applied to the application for the imported product without any risk to the protection of public health. Therefore, the authorities will presumably continue to refer to the criteria which the ECJ established in the Smith & Nephewdecision, namely (1) same formulation, (2) same active ingredient and, (3) same therapeutic effects. The authorities will also have to consider that different excipients and essential differences of the Summary of Product Characteristics ("SPC") may indicate that the safety and efficacy assessment cannot be transferred without any risk to the public health.

Finally, the ECJ did not consider the impact of intellectual property rights since the active ingredient was manufactured and supplied by the same undertaking. If the active ingredients are manufactured by different undertakings which do not have any business relationship at all, there may be not exhausted patent rights which prevent a parallel import.

* Case C-112/02 Kohlpharma v. Bundesrepublik Deutschland.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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