Regulation 2006/507 - Conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation 726/2004 - Main contents

EN

Official Journal of the European Union

L 92/6

Before a medicinal product for human use is authorised for placing on the market of one or more Member States, it generally has to undergo extensive studies to ensure that it is safe, of high quality and effective for use in the target population. The rules and procedures for obtaining a marketing authorisation are laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (2) and in Regulation (EC) No 726/2004.

In the case of certain categories of medicinal products, however, in order to meet unmet medical needs of patients and in the interests of public health, it may be necessary to grant marketing authorisations on the basis of less complete data than is normally the case and subject to specific obligations, hereinafter ‘conditional marketing authorisations’. The categories concerned should be medicinal products which aim at the treatment, prevention or medical diagnosis of seriously debilitating or life-threatening diseases, or medicinal products to be used in emergency situations in response to public health threats recognised either by the World Health Organisation or by the Community in the framework of Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community (3), or medicinal products designated as orphan medicinal products in accordance with Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (4).

Although the data upon which an opinion on a conditional marketing authorisation is based may be less complete, the risk-benefit balance, as defined in Article 1(28a) of Directive 2001/83/EC should be positive. Furthermore, the benefits to public health of making the medicinal product concerned immediately available on the market should outweigh the risk inherent in the fact that additional data are still required.

Where conditional marketing authorisations are granted, they should be restricted to situations where only the clinical part of the application dossier is less complete than normal. Incomplete pre-clinical or pharmaceutical data should be accepted only in the case of a product to be used in emergency situations, in response to public health threats.

In order to ensure that the right balance is struck between facilitating access to medicines for patients with unmet medical needs and preventing the authorisation of medicines with an unfavourable risk-benefit profile, it is necessary to make those marketing authorisations subject to specific obligations. The holder should be required to complete or initiate certain studies with a view to confirming that the risk-benefit balance is positive and resolving any questions relating to the quality, safety and efficacy of the product.

Conditional marketing authorisations are distinct from marketing...