Section 5: Vigilance and urgent safety measures

For the research referred to in 1° of Article L. 1121-1 concerning medical devices and in vitro diagnostic medical devices, the sponsor must report to the Agence nationale de sécurité du médicament et des produits de santé any suspected serious unexpected adverse reaction and any serious adverse event that may be related to the procedure for using the medical device that occurs in France and outside national territory: 1° In…

For the research mentioned in 1° of Article L. 1121-1 concerning cosmetic products or tattooing products, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any suspicion of a serious adverse reaction occurring in France and outside national territory. The notification must be made without delay and at the latest within seven days of the day on which it came to the…

For the research mentioned in 1° of Article L. 1121-1 involving the products mentioned in I of Article R. 1211-29 with the exception of cell therapy preparations, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any serious adverse reaction and any serious incident occurring in France and outside national territory in the research it is conducting, without delay from the day…

For the research referred to in 1° of Article L. 1121-1 involving labile blood products, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any adverse reaction occurring in a person undergoing such research and any serious incident occurring in France and outside national territory without delay from the day on which he becomes aware of them. Relevant additional information concerning the…

The sponsor shall inform the competent authority and the Committee for the Protection of Individuals without delay of the new facts defined in 12° of Article R. 1123-46 and, where appropriate, of the measures taken. The sponsor shall inform the Director General of the Regional Health Agency without delay of any new facts involving persons with no medical condition who voluntarily lend themselves to research and, where appropriate, of the…

The form, content and procedures for reporting adverse reactions and new facts as defined in Article L. 1123-10 and, where applicable, the procedures for lifting the blind shall be laid down by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) for research falling within its remit.

Once a year for the duration of the research referred to in 1° of Article L. 1121-1 or on request, the sponsor must send the competent authority defined in Article L. 1123-12 and the relevant Data Protection Committee a safety report taking into account all available safety information. This report, the reporting procedures, form and content of which are specified by order of the Minister for Health, issued on a…