Chapter I: General provisions

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…