Article R1222-44 of the French Public Health Code
November 5, 2023
Changes other than those subject to authorisation or declaration are described in the annual activity report provided for in article R. 1222-35.
Changes other than those subject to authorisation or declaration are described in the annual activity report provided for in article R. 1222-35.
The Director of the Agence nationale de sécurité du médicament et des produits de santé may ask the applicant for any additional information required to examine the application. The request for additional information sets the time limit within which the Etablissement Français du Sang or the Armed Forces Blood Transfusion Centre must respond. The three-month period provided for an application for approval or modification of approval is suspended until receipt…
The President of the Etablissement Français du Sang or the Director of the Armed Forces Blood Transfusion Centre is notified of the decision of the Director General of the Agence Nationale de Sécurité du Médicament et des Produits de Santé granting approval or authorising modification of the elements of approval by registered letter with acknowledgement of receipt. A copy of this decision is sent to the Minister for Health and,…
The national blood transfusion master plan referred to in article L. 1222-15 is prepared by the Etablissement Français du Sang. It is approved by the Minister for Health, after consultation with the Minister for Defence and the National Steering Council for Regional Health Agencies referred to in article L. 1433-1. The council gives its opinion within two months of receiving the draft plan from the Etablissement Français du Sang. The…
The President of the Etablissement Français du Sang draws up, in compliance with the national master plan mentioned in article L. 1222-15, the regional blood transfusion organisation plans, which specify the procedures for carrying out the blood transfusion activities of the Etablissement Français du Sang in conjunction with health establishments. Each regional blood transfusion organisation plan determines : 1° The fixed collection sites ; 2° Technical facilities for the biological…
The territorial jurisdiction of each regional blood transfusion organisation plan is determined by the President of the Etablissement Français du Sang. Each regional blood transfusion organisation plan is drawn up for a period of five years.
The President of the Etablissement Français du Sang submits the draft regional plan for an opinion, by any means which confers a date of receipt, to each regional health agency concerned and to the Minister for Health, as well as, where an army hospital or other element of the army health service is concerned, to the Minister for Defence. The opinions of the Regional Health Agency, the Minister for Health…
Regional plans may be amended or repealed by decision of the President of the Etablissement Français du Sang in accordance with the procedure set out in Article R. 1222-50. However, the opinion of the Regional Health Agency is not required for amendments to the plans relating to fixed collection sites, technical facilities for the preparation of labile blood products and technical facilities for the biological qualification of donations.
The provisions of this sub-section do not apply to the Armed Forces Blood Transfusion Centre, subject to the provisions of articles R. 1222-47, R. 1222-50 and R. 1222-51.
The Armed Forces Blood Transfusion Centre is part of the Armed Forces Health Service. It is placed under the hierarchical authority of the central director of this service. The Armed Forces Blood Transfusion Centre’s mission is to collect blood and blood components and to prepare, store and distribute the labile blood products required by the armed forces. To this end, the Armed Forces Blood Transfusion Centre : 1° Collects blood…
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