Section 5: Vigilance and urgent safety measures

The provisions of this section apply without prejudice to the provisions of articles R. 1221-22 to R. 1221-52 relating to haemovigilance.

For the purposes of this section, the following definitions shall apply 1° Adverse event, any noxious occurrence in a person who undergoes research involving the human person, whether or not this occurrence is related to the research or to the product to which this research relates; 2° Adverse reaction: any undesirable event occurring in a person who undergoes research involving the human person, when this event is related to the…

The competent authority defined in Article L. 1123-12 implements the vigilance system relating to research involving the human person. Where necessary, it shall take appropriate measures to ensure the safety of persons involved in research involving the human person.

For research involving medicinal products, the Director General of the Agence nationale de sécurité du médicament et des produits de santé ensures that all suspected serious unexpected adverse reactions occurring in France and brought to his attention are recorded and entered into the European database set up by the European Medicines Agency.

The investigator notifies the sponsor without delay from the day on which he becomes aware of all serious adverse events and all adverse reactions and serious incidents occurring in the course of research mentioned in 1° of Article L. 1121-1, with the exception of those identified in the protocol or in the brochure for the investigator as not requiring immediate notification. The investigator notifies these events within an appropriate timeframe,…

For the research mentioned in 1° of Article L. 1121-1 concerning the products mentioned in I of Article R. 1211-29, with the exception of cell therapy preparations, the investigator who has knowledge of the occurrence of an incident or an adverse reaction linked to the product in a person undergoing the research must report this without delay to the sponsor. For the research mentioned in 1° of Article L. 1121-1…

The sponsor shall keep detailed records of all adverse events notified to it by the investigator(s). These records shall be transmitted to the competent authority mentioned in Article L. 1123-12, at its request.

For all research involving humans, the sponsor must pass on to the investigators concerned any information likely to affect the safety of individuals.

For the research mentioned in 1° of Article L. 1121-1 other than that mentioned in Articles R. 1123-54 to R. 1123-58, the sponsor must report to the competent authority any suspected serious unexpected adverse reaction occurring in France and outside national territory, within the following time limits: 1° In the case of a serious unexpected adverse reaction which has resulted in death or which is life-threatening, without delay from the…

For the research mentioned in 1° of Article L. 1121-1 involving the cell therapy preparations defined in Article L. 1243-1, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any suspected serious unexpected adverse reactions occurring in France and outside national territory within the following time limits: 1° In the case of a serious unexpected adverse reaction resulting in death or life-threatening…