Subsection 2: Vigilance relating to health products

Vigilance relating to health products includes haemovigilance, pharmacovigilance, addictovigilance, materialovigilance and reactovigilance, as provided for in articles L. 1221-13, L. 5121-22, L. 5133-1, L. 5212-2 and L. 5222-3 respectively.

Vigilance missions relating to health products are carried out at national level by the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products), which oversees and coordinates these vigilance missions under the conditions set out in Article R. 5311-2.

Vigilance missions relating to health products are carried out at regional level, by the regional pharmacovigilance centres, the centres for evaluation and information on pharmacodependence and addictovigilance, the regional haemovigilance and transfusion safety coordinators, and the regional materialovigilance and reactovigilance coordinators mentioned respectively in articles R. 5121-158, R. 5132-104, R. 1221-32 and R. 5212-7, and coordinated within the regional vigilance and support networks mentioned in article R. 1413-62. The centres…

I.-The tasks of the centres and coordinators mentioned in Article R. 1413-61-3 consist of : 1° Collecting and processing, each in their own field of competence and expertise, alerts relating to each of the vigilance procedures for health products, with a view to forwarding them to the Agence nationale de sécurité du médicament et des produits de santé (French Agency for the Safety of Medicines and Health Products) and carrying…

The centres and coordinators referred to in article R. 1413-61-3 are hosted by one or more health establishments or placed under the authority of the Director General of the Regional Health Agency where this is justified by their tasks.

I.-The Director General of the Regional Health Agency organises vigilance missions relating to health products at regional level. To this end: 1° After obtaining the opinion of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, he shall designate one or more health establishments to house the centres and coordinators referred to in Article R. 1413-61-3 ; 2° He shall organise the pooling…