Chapter I: Collection, preparation and storage of blood, blood components and labile blood products.

Articles in this section · 18

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Article L1221-8

French Public Health CodeIn force
Ask for lawyer reviewed or certified translation

Updated 8 Nov 2023

The following may be prepared from blood or its components:

1° Labile blood products, including in particular whole blood, plasma, the production of which does not involve an industrial process, whatever its purpose, and blood cells of human origin. With the exception of labile blood products intended for research involving the human person, only labile blood products whose list and characteristics are set by decision of the Agence nationale de sécurité du médicament et des produits de santé, after consultation with the president of the Etablissement français du sang and the director of the armed forces blood transfusion centre, and published in the Journal officiel de la République française, may be distributed or supplied for therapeutic purposes.

2° Plasma pastes ;

2° bis Plasma for transfusion purposes, the production of which involves an industrial process governed by Book I of Part Five;

3° Medicinal products derived from the fractionation of plasma, governed by the same Book I;

4° In vitro diagnostic medical devices and their accessories governed by Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 and Title II of Book II of Part Five;

5° Cellular products for therapeutic purposes referred to in Article L. 1243-1 ;

6° (Repealed) ;

7° Excipients for pharmaceutical use and substances used in the manufacture of a medicinal product but not forming part of its composition.

Blood and its components, whether or not they have been collected within the Etablissement Français du Sang, may also be used to carry out quality controls on medical biology examinations and for the production and control of in vitro diagnostic medical devices and their accessories, or to carry out expert assessments and technical controls on products prepared from blood or its components, carried out by the Agence Nationale de Sécurité du Médicament et des Produits de Santé pursuant to 1° of Article L. 5311-2. The principles mentioned in articles L. 1221-3, L. 1221-4 and L. 1221-6 are also applicable in this case.

Mariela Petrova

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Mariela Petrova

Mariela Petrova

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15+ Years In Corporate Practice

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