Chapter III: Preparation, preservation and use of tissues, cells and their derivatives.

With the exception of labile blood products, cellular products for therapeutic purposes are human cells used for autologous or allogeneic therapeutic purposes, whatever their level of transformation, including their derivatives. When these cell products for therapeutic purposes are proprietary medicinal products or other industrially manufactured medicinal products, they are governed by the provisions of Title II of Book I of Part Five. In other cases, they are cell therapy preparations…

The preparation, preservation, distribution and transfer, for autologous or allogeneic therapeutic purposes, of tissues and their derivatives and cell therapy preparations may be carried out by establishments and organisations authorised for this purpose, after obtaining the opinion of the Agence de la biomédecine, by the Agence nationale de sécurité du médicament et des produits de santé, which shall ensure compliance with the provisions of Title I of this Book. The…

Compliance, in establishments authorised under article L. 1243-2, with legislative and regulatory provisions relating to the quality and safety of tissues and their derivatives and cell therapy preparations, is guaranteed by a responsible person appointed under conditions laid down by decree in the Conseil d’Etat. Within the Etablissement Français du Sang, the person in charge has authority over the directors of the blood transfusion establishments to carry out this mission.

Any organisation that has made a prior declaration to the Minister for Research may, for the purposes of its own research programmes, ensure the conservation and preparation for scientific purposes of tissues and cells from the human body as well as the preparation and conservation of organs, blood, its components and derived products. These activities include the creation and use of collections of human biological samples. Where the organisation is…

Any organisation that ensures the conservation and preparation of tissues and cells, organs, blood, its components and derived products, derived from the human body with a view to their transfer for scientific use must hold an authorisation issued by the Minister responsible for research. Where the organisation is a health establishment, the authorisation is issued jointly by the Minister for Research and the Director General of the regional health agency…

Tissue transplants and the administration of cell therapy preparations may only be carried out in health establishments. When these activities are costly or require special arrangements in the interests of public health, they may only be carried out in health establishments authorised for this purpose, after obtaining the opinion of the Agence de la biomédecine, under the conditions laid down in Chapter I of Title II of Book I of…

The granting of the authorisations provided for in articles L. 1243-2 and L. 1243-6 is subject to technical, health or medical conditions and, where necessary, financial conditions, as well as conditions to ensure that it operates in accordance with the general principles set out in Title I of this book.

The regional or inter-regional health plan is drawn up by the competent authority after obtaining the opinion of the Agence de la biomédecine when it concerns haematopoietic cell allograft activity.

An order by the Minister for Health, issued after consultation with the Agence de la biomédecine, the Haute Autorité de santé and representatives of health establishments and medical biology laboratories, defines the rules of good practice for the storage and traceability of human biological samples taken for diagnostic or therapeutic purposes or during an autopsy carried out for medical purposes.

The terms and conditions for the application of this chapter shall be determined by decree in the Conseil d’Etat, and in particular : 1° The high-cost activities or activities requiring special provisions in the interests of public health provided for in article L. 1243-6 ; 2° The conditions and procedures for issuing the authorisations provided for in articles L. 1243-2 and L. 1243-6, as well as the conditions for modification…