Subsection 2: National biovigilance system

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 the provisions set out in Article R. 1211-34;

5° May ask the local biovigilance correspondents to carry out any investigations and studies;

6° Carries out epidemiological investigations and studies or has them carried out under its supervision;

7° Drafts, in conjunction with the Agence nationale de sécurité du médicament et des produits de santé and learned societies, the criteria intended to help professionals identify the expected adverse reactions linked to the activities mentioned in 2° of I of Article R. 1211-29. These criteria are established, for each therapeutic indication, on the basis of data from the scientific literature deemed relevant and are made available to healthcare professionals and local biovigilance correspondents. They are set by decision of the Director General of the Agence de la biomédecine. In the absence of such criteria for a therapeutic indication, any adverse reaction is reported to the Agence de la biomédecine;

8° Establishes, in conjunction with the professionals concerned, thresholds above which the frequency of occurrence of incidents and expected adverse reactions requires immediate reporting and declaration. These thresholds are set by decision of the Director General of the Agence de la biomédecine;

9° Establishes a model for the declaration mentioned in 8° of Article R. 1211-30;

10° Establishes the model for the annual report mentioned in 10° of Article R. 1211-37;

11° Establishes and updates the list of local biovigilance correspondents;

12° Draw up an annual report on the biovigilance system based on the annual reports of the local biovigilance correspondents. This report is sent each year to the Minister for Health and to the European Commission by 30 June at the latest. It is also sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé.