Book I: Pharmaceutical products

The application provided for in Article R. 5121-21 must be accompanied by a dossier containing the following information and documents, updated as necessary, presented in accordance with the order referred to in Article R. 5121-11: 1° Chemical, pharmaceutical and biological data ; 2° The results of pre-clinical tests and clinical trials; 3° A summary describing the pharmacovigilance system of the future authorisation holder or of the company exploiting the proprietary…

By way of derogation from 2° of Article R. 5121-25, for the medicinal products mentioned in this article, the dossier attached to the marketing authorisation application is compiled under the following conditions: 1° Where the applicant demonstrates, by reference to appropriate bibliographical documentation, that the application relates to a medicinal product whose active substance or substances have been in well-established medical use for at least ten years in France, in…

The dossiers provided in support of the application for authorisation of the medicinal products mentioned in articles R. 5121-25 and R. 5121-26 are considered to contain all the necessary and sufficient data for the evaluation of these medicinal products within the meaning of article L. 5121-1.

By way of derogation from 2° of Article R. 5121-25, for the medicinal products mentioned in this Article, the dossier attached to the marketing authorisation application is compiled under the following conditions: 1° Where the application concerns a generic medicinal product of a reference medicinal product which is or has been authorised for at least eight years in France, the dossier submitted in support of the application includes, in addition…

For the application of the provisions of 1° of Article R. 5121-28, the Director General of the Agence française de sécurité sanitaire des produits de santé may exempt the applicant for a marketing authorisation for a generic medicinal product from providing the bioavailability studies provided for in Article L. 5121-1 in the following cases: 1° Its dossier is a simple duplicate of the marketing authorisation dossier for the reference medicinal…

When an application for authorisation concerns a generic medicinal product of a reference medicinal product which has not been authorised in France, the applicant must indicate the Member State of the European Community or party to the Agreement on the European Economic Area in which this reference medicinal product is or has been authorised. In this case, the Director General of the Agence nationale de sécurité du médicament et des…

When it is informed by the holder of a marketing authorisation for a medicinal product granted under 1°, 2° or 3° of article R. 5121-28, prior to the marketing of the medicinal product or speciality concerned, of the fact that for some of the indications, pharmaceutical forms or strengths of the reference medicinal product or speciality the intellectual property rights have not expired, the Director General of the Agency shall…

For the application of 1° of Article R. 5121-26, where reference is made to published scientific literature, experts must justify the use of this bibliographical documentation and demonstrate that it meets the requirements of the protocols adopted pursuant to Article R. 5121-11, taking into account in particular the pharmaceutical form and the constituents of the excipient.

For the application of 5° of article R. 5121-28, when reference is made to published literature recognised in the tradition of homeopathic medicine practised in France, experts justify, on the basis of the documentation provided: 1° The homeopathic use of the strains used and their traditional use in the claimed indication; 2° The safety of the homeopathic medicinal product, particularly with regard to the degree of dilution of each of…