Article R1222-58-1 of the French Public Health Code
November 5, 2023
The Armed Forces Blood Transfusion Centre must comply with the technical, health and medical conditions defined in articles R. 1222-35 to R. 1222-39.
The Armed Forces Blood Transfusion Centre must comply with the technical, health and medical conditions defined in articles R. 1222-35 to R. 1222-39.
The Armed Forces Blood Transfusion Centre may, except in the cases provided for in article R. 1222-58, export the labile blood products mentioned in article D. 1221-67-1 to foreign armed forces and, after checking that national requirements are met, export other labile blood products prepared in its laboratories, particularly as part of international military cooperation. It informs the Agence nationale de sécurité du médicament et des produits de santé of…
I.-Any violation observed within the Armed Forces Blood Transfusion Centre of the legislative and regulatory requirements applicable to it, as well as the elements mentioned in article L. 1222-11, may result in the modification or temporary or permanent withdrawal of the approval provided for in VI of article L. 1222-11 under the conditions mentioned in this article. II -Modification or withdrawal may only take place after formal notice has been…
In order to ensure better use of resources and means in the field of blood transfusion, agreements concerning the collection of blood and its components and the preparation, storage, transfer and exchange of labile blood products are concluded between the armed forces blood transfusion centre and the Etablissement Français du Sang. These agreements must comply with standard clauses defined by an order of the Minister for Defence and the Minister…
Notwithstanding the provisions of article R. 1221-18, the Armed Forces Blood Transfusion Centre may distribute and supply labile blood products which it alone has available to Armed Forces hospitals for which it is not the referring blood establishment.
Any promotional communication relating to the plasmas referred to in Article L. 1223-3 shall specify the date on which it was drawn up or last revised and shall include at least the following information: 1° The name of the product as it appears in the decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé mentioned in 1° of article L. 1221-8…
The elements contained in the promotional communication of the plasmas mentioned in article L. 1223-3 comply with the information contained in the corresponding part of the decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé mentioned in 1° of article L. 1221-8 and with the recommendations of the Haute Autorité de santé mentioned in article L. 1223-2.
The establishment preparing the product must keep a copy of each promotional communication it issues for a period of three years from the date on which it was last disseminated, and must make this copy available to the Agence nationale de sécurité du médicament et des produits de santé, together with information about the recipients, the method of dissemination and the date on which it was first disseminated.
I. – When one of the plasmas mentioned in Article L. 1223-3 is the subject of a reassessment mentioned in the second paragraph of Article L. 1221-8-2, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall immediately inform the establishment preparing the product. He shall also inform it without delay of the result of this reassessment. II. – If the reassessment requires…
The information contained in the promotional communication is accurate, up-to-date, verifiable and sufficiently complete to enable healthcare professionals to assess the therapeutic value of the product. Quotations, tables and other illustrations borrowed from medical journals or scientific works, which are used in the promotional communication, are faithfully reproduced and the exact source is specified. A promotional communication which reproduces the position taken with regard to a plasma mentioned in article…
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is a Registered Trademark of
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75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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