Article R1222-33 of the French Public Health Code
November 5, 2023
The provisions of this section apply to the Armed Forces Blood Transfusion Centre.
The provisions of this section apply to the Armed Forces Blood Transfusion Centre.
The activities of the Etablissement Français du Sang are carried out in accordance with : 1° The approval referred to in III of Article L. 1222-11 issued by the Agence nationale du médicament et des produits de santé to the Etablissement français du sang or its blood establishments, depending on the geographical area in which the transfusion activities are carried out; 2° The rules applicable to these activities; 3° The…
The collection of blood and its components, their biological qualification, the preparation, processing, distribution and issue of labile blood products are carried out in compliance with the good practices defined by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, taken in application of article L. 1222-12. For each of these activities and on each of the sites where they are…
All blood establishments have the means to ensure the quality control of their products. However, the blood establishment may entrust quality control, under an agreement, either to another blood establishment or to an external laboratory authorised to carry out the corresponding activity; it may also enter into an agreement for the irradiation of the products it prepares with another blood establishment or, where appropriate, with a health establishment.
Each team carrying out whole blood sampling at a fixed or mobile site includes, in addition to the presence of a person mentioned in II of Article R. 1222-17: a) A person authorised to carry out the sampling and meeting the conditions laid down in Article R. 1222-18; b) A nurse if the team consists of more than three people; In the absence of a doctor, a means of communication…
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….
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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