Book II: Donation and use of human body parts and products

Any violation observed in an establishment or organisation, and caused by it, of the legislative and regulatory requirements relating to the removal and transplantation of organs, the removal of tissues and cells, the preservation, preparation, import and export of tissues or cell therapy preparations, as well as the transplantation of these tissues or the administration of these preparations, shall result in the suspension or withdrawal of the authorisations provided for…

Tissues, cells and products of the human body, removed during surgery carried out in the interests of the person operated on, with the exception of cord blood and placental blood cells and cord and placental cells, may be used for therapeutic or scientific purposes, unless he or she objects after being informed of the purposes of such use. Where this person is a minor or an adult subject to a…

Any removal of tissues and cells with a view to donation carried out under the conditions set out in Chapter II of this Title is a medical activity.

For the purposes of this Title, samples taken for grafting or administration in the context of research involving the human person within the meaning of Article L. 1121-1 are considered to be samples taken for therapeutic purposes, without prejudice to the provisions of Title II of Book I of this Part relating to the protection of persons who undergo research involving the human person. In the case of research involving…

I. – Establishments or organisations authorised by the Agence nationale de sécurité du médicament et des produits de santé, in application of article L. 1243-2, may obtain, for therapeutic purposes, tissues, their derivatives and cells from the human body, whatever their level of preparation, as well as cell therapy preparations, prepared and stored in a Member State of the European Union or party to the agreement on the European Economic…

I. – Pharmaceutical establishments and establishments authorised in application of articles L. 4211-9-1 and L. 4211-9-2 may obtain tissues, their derivatives or cells from the human body from a Member State of the European Union or a party to the Agreement on the European Economic Area when these elements or products are intended for the manufacture of proprietary medicinal products, industrially manufactured medicinal products or advanced therapy medicinal products defined…

The rules of good practice which apply to the removal, preparation, preservation, distribution, transfer, transport and use of tissues, cells and cell therapy preparations as well as products of the human body used for therapeutic purposes are defined by decision of the Agence nationale de sécurité du médicament et des produits de santé after obtaining the opinion of the Agence de la biomédecine.