Subsection 3: Role of the Agence nationale de sécurité du médicament et des produits de santé.

The Agence nationale de sécurité du médicament et des produits de santé is responsible for implementing haemovigilance and transfusion safety. It defines the guidelines, leads and coordinates the actions of the various parties involved and ensures compliance with the monitoring procedures organised by this section. Where necessary, it shall take appropriate measures to ensure transfusion safety or refer the matter to the competent authorities. In order to carry out this…

The Agence nationale de sécurité du médicament et des produits de santé provides the Etablissement français du sang and the centre de transfusion sanguine des armées with information relating to the safety and quality of labile blood products resulting from the performance of the vigilance tasks relating to health products mentioned in article R. 1413-61-4.

Each year, the Agence nationale de sécurité du médicament et des produits de santé draws up a summary report on haemovigilance and transfusion safety. This report is sent to the Minister for Health and to the European Commission by 30 June of the following year at the latest.