Section 5: Marketing authorisation

The application for marketing authorisation is sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé. It must state : 1° The name and address of the future marketing authorisation holder and, where applicable, those of the company exploiting the proprietary medicinal product, as well as those of the manufacturer where neither the future marketing authorisation holder nor the company exploiting the…

Where an application for marketing authorisation in France is made for a medicinal product which has already been authorised or is the subject of an application for marketing authorisation currently being examined in another Member State of the European Community or a State which is a party to the Agreement on the European Economic Area, without complying with the provisions of Subsection 3a of this Section, the Director General of…

The applicant is responsible for the accuracy and truthfulness of the documents and data supplied to the Agency when the application for marketing authorisation is submitted and during its examination. The applicant must inform the Agency without delay of any new information available or of which he is aware, in particular the results of biomedical studies or research carried out in or outside the European Community or the European Economic…

Where the application for marketing authorisation concerns a generator, it shall also include: 1° A general description of the system and a detailed description of the components of the system likely to affect the composition or quality of the preparation of the daughter nuclide; 2° The qualitative and quantitative characteristics of the eluate or sublimate.

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…