Chapter I: General provisions.

Any proprietary medicinal product or any other medicinal product manufactured industrially or by a method involving an industrial process, as well as any generator, kit or precursor which is not the subject of a marketing authorisation issued by the European Union pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency must, before being placed on the market or distributed free of charge, be the subject of a marketing authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé. The authorisation may be subject to appropriate conditions, in particular the obligation to carry out post-authorisation safety or efficacy studies.

Applicants for authorisation may be exempted from producing certain data and studies under conditions laid down by regulation.

A marketing authorisation may only be issued to an applicant established in a Member State of the European Union or party to the Agreement on the European Economic Area.

The authorisation is granted for a period of five years and may subsequently be renewed, where appropriate, without time limit, under conditions laid down by a decree of the Conseil d'Etat, unless the Agence nationale de sécurité du médicament et des produits de santé decides to renew every five years, on the basis of a reassessment of the positive therapeutic effects of the medicinal product or product with regard to the risks as defined in the first paragraph of Article L. 5121-9. This decree also determines the conditions under which it may lapse.

The authorisation may be modified by the Agence nationale de sécurité du médicament et des produits de santé.

Completion of the formalities provided for in this article does not have the effect of exonerating the manufacturer and, if different, the marketing authorisation holder, from the liability that either of them may incur under the conditions of ordinary law as a result of the manufacture or marketing of the medicinal product or product.