Subsection 2: National biovigilance system

The players involved in the biovigilance system are: 1° The Agence de la biomédecine; 2° The Agence nationale de sécurité du médicament et des produits de santé; 3° The following establishments or organisations: a) Establishments and organisations authorised to carry out sampling and collection activities pursuant to Articles L. 1233-1, L. 1242-1 and L. 2323-1; b) Establishments and organisations authorised to carry out the activities of preparation, treatment, conservation, distribution,…

The Agence de la biomédecine is responsible for implementing the biovigilance system. Within this framework, the Agency: 1° Leads and coordinates the actions of the various parties involved; 2° Ensures compliance with the procedures organised by this section; 3° Evaluates the information reported to it, including the results of investigations carried out by the local biovigilance correspondent and the corrective measures put in place; 4° After evaluating this information, implements…

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….