Book II: Donation and use of human body parts and products

The procedures for applying the provisions of this chapter shall be determined, where necessary and unless otherwise provided, by decree in the Conseil d’Etat, and in particular : 1° The procedures for organising and operating the Etablissement Français du Sang and the conditions for exercising the supervision and financial control of the State; 2° The qualifications of the establishment’s staff for the categories it determines, and of the person in…

I.-The geographical and technical areas of activity of the Etablissement Français du Sang are determined by it, in accordance with the provisions relating to the national blood transfusion master plan. II – Apart from the collection of blood or its components mentioned in article L. 1221-2, the biological qualification of donations, the preparation of labile blood products and their distribution may only be carried out, subject to VI, within the…

The Etablissement Français du Sang, the Armed Forces Blood Transfusion Centre, for the activities of collection, biological qualification of the donation, preparation, distribution, delivery of labile blood products and their quality control, as well as the health establishments authorised to store and deliver labile blood products, must adopt good practices, the principles of which are defined by decision of the Agence Nationale de Sécurité du Médicament et des Produits de…

Any violation observed within the Etablissement français du sang, and caused by it, of the legislative or regulatory requirements applicable to it, as well as the elements mentioned in article L. 1222-11 or the terms of any approval or authorisation decision provided for by this code, may result in the temporary or permanent modification or withdrawal of the approval or authorisation. Modification or withdrawal by the Director General of the…

The national blood transfusion master plan sets out the principles governing the organisation of blood transfusion in order to guarantee national self-sufficiency and health safety, in particular the principles relating to: 1° The collection of blood and its components ; 2° The preparation of labile blood products, their quality control, their distribution throughout the country and the biological qualification of donations; 3° Performing immuno-haematology tests on recipients, providing transfusion advice…

The national blood transfusion master plan is drawn up by the Minister for Health, after consultation with the Minister for Defence, on the basis of the project prepared by the Etablissement Français du Sang.

The following are determined by decree in the Conseil d’Etat: 1° The status of the armed forces blood transfusion centre, as well as the conditions for granting, modifying and withdrawing the approval of the armed forces blood transfusion centre mentioned in article L. 1222-11 ; 2° After obtaining the opinion of the President of the Etablissement Français du Sang (French Blood Establishment) under the conditions laid down in Article L….