The blood establishment’s biological qualification laboratory for donations, which is placed under the responsibility of a doctor or pharmacist, must have at least two technicians with the required qualifications as set out in article L. 1222-10 at each site assigned to this activity.
All blood establishments must ensure the continuity of the public transfusion service. When applying for accreditation, and at the request of the inspector from the Agence nationale de sécurité du médicament et des produits de santé, it must provide evidence of compliance with this obligation. For the activities of supply, transfusion advice and, where appropriate, immuno-haematology, the blood establishment must be on call 24 hours a day, in accordance with…
Pursuant to articles L. 1222-1 and L. 1222-1-1, the activities other than transfusion activities that may be carried out within blood establishments are as follows: 1° Among the activities related to blood transfusion : a) Immuno-haematological examinations ; b) Dispensing blood-derived medicinal products; 2° As ancillary activities: a) The collection, preparation, storage, transfer, import and export of blood or its components used for the laboratory reagents mentioned in 4° of…
Medical biology examinations carried out by the Etablissement Français du Sang and the Armed Forces Blood Transfusion Centre, in particular “recipient” immuno-haematology examinations and complex immuno-haemathology examinations, are subject to all the provisions of Book II of Part Six of the Public Health Code.
I. – An order of the Minister for Health and the Minister for Defence, issued on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, specifies the procedures for submitting applications for approval and for amending the approvals provided for in III and VI of article L. 1222-11, as well as the content of the file accompanying each application. II….
I. – Prior written authorisation from the Director General of the Agence nationale de sécurité du médicament et des produits de santé is required for any change to the approval relating to : 1° A new transfusion activity ; 2° The premises in which these activities are carried out and the technical equipment subject to qualification in accordance with the good practices referred to in Article L. 1222-12 , where…
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…
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