French Public Health Code
In forceI.-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 Etablissement Français du Sang, under the authority of a doctor or pharmacist, and in accordance with the geographical and technical fields of activity and the procedures for carrying out these activities determined by its board of directors.
III -The Etablissement Français du Sang must be approved by the Agence Nationale de Sécurité du Médicament et des Produits de Santé for its various transfusion activities.
IV - The activity of supplying labile blood products is carried out, under the authority of a doctor or pharmacist, by the French Blood Establishment and by health establishments or army hospitals.
V.-The approval referred to in III is issued for an unlimited period. It is subject to geographical, technical, medical and health conditions defined by decree in the Conseil d'Etat.
VI -The Armed Forces Blood Transfusion Centre may :
1° After approval from the Agence nationale de sécurité du médicament et des produits de santé, collect, biologically qualify donations and prepare, distribute and issue labile blood products. Approval is granted for an unlimited period. A Conseil d'Etat decree specifies the geographical, technical, medical and health conditions, taking into account the specific features of the armed forces blood transfusion centre;
2° Be authorised, in order to meet specific national defence or security needs, to manufacture, by way of derogation from article L. 5124-14, import, export and use blood-derived medicinal products as defined in 18° of article L. 5121-1. These activities are carried out under the responsibility of a pharmacist covered by article L. 4138-2 of the Defence Code, designated by the Minister for Defence, who acts as the responsible pharmacist.
For the performance of these activities, the Armed Forces Blood Transfusion Centre is subject to articles L. 5124-2, with the exception of the first paragraph, L. 5124-3, L. 5124-4, with the exception of the last paragraph, L. 5124-5, L. 5124-6, L. 5124-11 and L. 5124-18 of the present code.
