Keywords
Summary

Keywords

1. Approximation of laws ° Proprietary medicinal products ° Marketing authorization ° Similarity of proprietary medicinal products produced by independent companies under agreements concluded with the same licensor holding a marketing authorization in different Member States ° Parallel importation ° Obligation to grant an authorization ° Lack of similarity ° Need for a new marketing authorization issued in accordance with the conditions of Directive 65/65 ° Licensor established outside the Community ° Not relevant

(Council Directive 65/65, as amended by Directive 87/21, Arts 3 and 4)

2. Approximation of laws ° Proprietary medicinal products ° Directive 65/65 ° Marketing authorization ° Whether the holder of an authorization issued in accordance with the procedure under the directive may rely on Article 5 in order to contest the validity of the authorization issued to a competitor for a proprietary medicinal product with the same name

(Council Directive 65/65, as amended by Directive 87/21, Art. 5)

Summary

1. When the competent authority of a Member State concludes that a proprietary medicinal product covered by a marketing authorization in another Member State and a proprietary medicinal product for which it has already issued a marketing authorization are manufactured by independent companies pursuant to agreements concluded with the same licensor and that those two products, although not identical in all respects, have at least been manufactured according to the same formulation and using the same active ingredient and that they also have the same therapeutic effects, it must treat the imported proprietary medicinal product as being covered by the latter marketing authorization unless there are countervailing considerations relating to the effective protection of the life and health of humans. If the public health authorities of the Member State of importation already have in their possession, as a result of an application for a marketing authorization for the proprietary medicinal product in question, all the pharmaceutical particulars relating to that product and considered to be absolutely necessary for the purpose of checking that the product is effective and not harmful, it is clearly unnecessary, in order to protect the health and life of humans, for those authorities to require a second trader who has imported a proprietary medicinal product satisfying the abovementioned criteria to produce these particulars again.

The fact that the grantor of the licences in respect of the two proprietary medicinal products in question is situated outside the European Community is irrelevant.

However, if the competent national authority concludes that the proprietary medicinal product to be imported does not satisfy the abovementioned criteria, a new marketing authorization is required. That authorization can be issued only in accordance with the conditions laid down in Articles 3 and 4 of Directive 65/65 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, as amended in particular by Directive 87/21. It would, in particular, be contrary to those provisions, which preclude the issue of a marketing authorization unless all the information referred to in Article 4 has been supplied and the tests performed, for the competent authority, in the context of an application for a marketing authorization, to use information supplied by an independent company, without its agreement, in support of an application for a marketing authorization concerning another proprietary medicinal product.

2. The holder of an original marketing authorization issued under the procedure referred to in Directive 65/65 may rely on the provisions of that directive, as amended in particular by Directive 87/21, and specifically on Article 5 thereof, in proceedings before a national court in order to challenge the validity of an authorization issued by the competent national authority on the basis of that directive to one of its competitors for a proprietary medicinal product bearing the same name. The same applies where the authorization, although issued under another procedure laid down at national level, should have been issued on the basis of the directive. Those provisions are sufficiently unconditional and precise for that purpose.