Article R1211-34 of the French Public Health Code
November 5, 2023
After evaluating the information reported to him/her, the Director General of the Agence de la biomédecine analyses the relevance of the corrective measures implemented. If these seem insufficient or inappropriate, he informs the local biovigilance correspondent who reported the event without delay and, if necessary, proposes recommendations. Where appropriate, it draws up recommendations to limit the probability of serious incidents or unexpected adverse reactions occurring, and to reduce their seriousness….
