Subsection 3: Person responsible.

The person responsible for compliance, within the Etablissement Français du Sang, with the regulations relating to the quality and safety of blood products referred to in Article L. 1222-2 is responsible for : – ensuring that each unit of blood or blood components, whatever its intended use, is collected, tested and, when intended for transfusion, prepared, stored, distributed or issued in accordance with the legislative and regulatory provisions in force;…

The person in charge must satisfy the conditions for practising medicine or pharmacy and have at least two years’ practical experience in the field of blood transfusion in one or more blood transfusion establishments.

The President of the Etablissement Français du Sang appoints one or more interim persons in charge at the same time as the person in charge. For the period of the replacement, the interim person in charge is granted the same powers and responsibilities as those granted to the person in charge and must exercise them effectively for the duration of the replacement. The temporary responsible person must meet the conditions…

The President of the Etablissement Français du Sang shall send the Director General of the Agence Nationale de Sécurité du Médicament et des Produits de Santé a copy of any instrument appointing the person in charge and the interim persons in charge. When the person in charge is temporarily replaced, the President of the Etablissement Français du Sang shall immediately inform the Director General of the Agency of the name…

For the application of this sub-section to the Armed Forces Blood Transfusion Centre, the responsibilities and tasks assigned to the person in charge are carried out by the Director of the Centre.