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Article L1222-12 of the French Public Health Code

November 8, 2023

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…

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Article L1222-13 of the French Public Health Code

November 8, 2023

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…

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Article L1222-14 of the French Public Health Code

November 8, 2023

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…

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Article L1222-16 of the French Public Health Code

November 8, 2023

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….

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Article L1223-1 of the French Public Health Code

November 8, 2023

Promotional communication relating to plasmas means any form of information, including canvassing, canvassing or inducement intended to promote the prescription, supply, sale or consumption of these products. This definition does not include 1° Information provided, as part of their duties, by staff working for the Etablissement français du sang and the armed forces blood transfusion centre, the blood depots of health establishments and armed forces hospitals, and by haemovigilance and…

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Article L1223-2 of the French Public Health Code

November 8, 2023

The promotional communication defined in article L. 1223-1 must not be misleading or undermine public health protection. It must present the product objectively and encourage its proper use. It must comply with the information contained in the decision of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) establishing the list and characteristics of labile blood…

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Article L1223-3 of the French Public Health Code

November 8, 2023

The only plasmas that may be the subject of promotional communication are those in the production of which no industrial process is involved, mentioned in the second paragraph of article L. 1221-8, if they are included in the decision establishing the list and characteristics of labile blood products mentioned in the same article, and if they are not the subject of a measure provided for in article L. 1221-10-1. Promotional…

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Article L1223-4 of the French Public Health Code

November 8, 2023

Promotional advertising of the plasmas mentioned in article L. 1223-3 to members of the health professions authorised to prescribe or supply these labile blood products or to use them in the exercise of their profession is subject to prior authorisation from the Agence nationale de sécurité du médicament et des produits de santé. This authorisation is valid subject to the inclusion of these plasmas on the list of labile blood…

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Article L1223-5 of the French Public Health Code

November 8, 2023

The applications for authorisation provided for in Article L. 1223-4 are made according to a timetable and during a period determined by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé.

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75001, Paris France
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