French Public Health Code
In forceThe application for authorisation or renewal of authorisation provided for in 12° and 13° of Article L. 5121-1 shall be sent by registered post with acknowledgement of receipt or lodged against receipt with the Director General of the Agence nationale de sécurité du médicament et des produits de santé by the establishments and organisations authorised to carry out the activities mentioned in Article R. 4211-16 .
The application must be accompanied by a file, the content of which is set by order of the Minister for Health on a proposal from the Director General of the National Agency for the Safety of Medicines and Health Products and which includes :
1° Administrative information concerning the applicant establishment or authorised body;
2° Information on the active substances;
3° Information on each stage of the process and in particular the in-process controls;
4° Information on product quality control methods and criteria;
5° Information on pre-clinical data;
6° The proposed therapeutic indications for the gene therapy preparation or xenogenic cell therapy preparation and the results of clinical trials justifying the proposed therapeutic use of the product;
7° For xenogenic cell therapy preparations, information on the source animals used.
The dossier is deemed to be complete if, within one month of receipt, the Director General of the Agence nationale de sécurité du médicament et des produits de santé has not informed the applicant that information is missing by registered letter with acknowledgement of receipt, stating the time limit for providing it.
The Director General of the Agency decides on the application for authorisation after obtaining the opinion of the gene and cell therapy commission provided for in Article R. 1243-38.
