French Business Law - French Legislation

Article R1221-50 of the French Public Health Code

November 5, 2023

The Agence nationale de sécurité du médicament et des produits de santé and the regional haemovigilance and transfusion safety coordinator simultaneously receive serious incident report forms, adverse reaction report forms for donors and recipients and post-donation information report forms. The Etablissement Français du Sang and the Armed Forces Blood Transfusion Centre each receive their own declaration forms.

Article R1221-51 of the French Public Health Code

November 5, 2023

Decisions by the Director General of the Agence nationale de sécurité des médicaments et des produits de santé, following consultation with the Etablissement français du sang and the Armed Forces Blood Transfusion Centre, set the form and content of serious incident report forms, adverse reaction report forms for donors and recipients and post-donation information report forms, as well as the procedures for their transmission. This decision may define the cases…

Article R1221-52 of the French Public Health Code

November 5, 2023

The provisions of this section shall apply to biomedical research on labile blood products, without prejudice to the provisions of Title II of Book I of Part One of this Code.

Article D1221-53 of the French Public Health Code

November 5, 2023

I.-For the application of the provisions of sections 1 to 4 of this chapter, army hospitals and the army blood transfusion centre are, except in the case of external operations, considered respectively as health establishments and as a blood transfusion establishment. II – For the application of the provisions of sections 1 to 4 of this chapter, the responsibilities of the medical committees of establishments concerning transfusion safety and haemovigilance…

Article R1221-54 of the French Public Health Code

November 5, 2023

With the exception of army pharmacists, pharmacists responsible, in application of article L. 1221-10, for monitoring labile blood products intended for direct therapeutic use in blood establishments must be registered in sections G or H of the national order of pharmacists or in section E if they practise in an overseas department or in the territorial collectivity of Saint-Pierre-et-Miquelon.

Article R1221-55 of the French Public Health Code

November 5, 2023

With the exception of army pharmacists, pharmacists practising in health establishments, when they are responsible for supervising a blood depot mentioned in article R. 1221-20, must, for this activity, be registered in sections G or H of the national order of pharmacists, or in section E if they practise in an overseas department or in the territorial collectivity of Saint-Pierre-et-Miquelon.

Article D1221-56 of the French Public Health Code

November 5, 2023

This section applies to plasma pastes and labile blood products intended for the preparation of health products. It also applies to labile blood products for direct therapeutic use included on the list referred to in 1° of Article L. 1221-8, and to those which are the subject of a biomedical research protocol prior to their inclusion on the aforementioned list. The provisions of this section apply to the Armed Forces…

Article D1221-57 of the French Public Health Code

November 5, 2023

A plasma paste is any intermediate product resulting from the fractionation of plasma, whatever its level of processing, which cannot be used as it is for administration to humans, and which is intended for the preparation of health products.

Article D1221-58 of the French Public Health Code

November 5, 2023

Any importation of a labile blood product or a plasma paste is subject to prior authorisation issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. The import authorisation may be suspended or revoked by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. Except in urgent cases, these decisions may only be taken after…

Article D1221-59 of the French Public Health Code

November 5, 2023

The authorisation referred to in article D. 1221-58 indicates in particular the name and address of the supplier establishment, the natural or legal person responsible for the import and, where applicable, the recipient establishment if it is not the importer, the nature and quantity of the imported product and the intended use. It specifies its period of validity and must be presented during a customs inspection. The import authorisation is…

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French Public Health Code

Article R1221-50 of the French Public Health Code

Article R1221-51 of the French Public Health Code

Article R1221-52 of the French Public Health Code

Article D1221-53 of the French Public Health Code

Article R1221-54 of the French Public Health Code

Article R1221-55 of the French Public Health Code

Article D1221-56 of the French Public Health Code

Article D1221-57 of the French Public Health Code

Article D1221-58 of the French Public Health Code

Article D1221-59 of the French Public Health Code

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French Public Health Code

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