Part One: General health protection

An establishment or an authorised body may transfer tissues, their derivatives or cells or cell therapy preparations to another establishment or authorised body with a view to their preparation, preservation and distribution by this second establishment or body in accordance with the conditions set out in article R. 1243-26. When they are transferred with a view to distribution, the tissues, their derivatives or the cell therapy preparations comply with the…

Tissues or their derivatives or cell therapy preparations are distributed under the responsibility of the responsible person referred to in Article R. 1243-12 or, where applicable, the person responsible for the activities referred to in Article R. 1243-12 to an identified practitioner, on the basis of a named medical prescription. They may only be distributed if they are recognised as complying with the health safety rules adopted in application of…

When they are distributed or transferred, the tissues, their derivatives, the cells or the cell therapy preparations are accompanied by the documents mentioned in Article R. 1211-19 and Article R. 1211-22-2 and in the rules of good practice provided for in Article L. 1245-6, which ensure their traceability and safety. When distribution is carried out in application of an agreement mentioned in I of Article R. 1243-3-1, these documents may…

Establishments and authorised organisations shall implement a procedure for the recall of tissues or their derivatives or cell therapy preparations in accordance with the rules of good practice provided for in Article L. 1245-6 and including a description of the responsibilities and measures to be taken, including for storage provided under the conditions provided for in Article R. 1243-3-1. The responsible person mentioned in article R. 1243-12 undertakes and coordinates…

By way of derogation from the provisions of this section, where the tissues, their derivatives or the cells or cell therapy preparations are intended for the manufacture of a proprietary medicinal product or a medicinal product manufactured industrially or by a method involving an industrial process, the authorisation provided for in Article L. 5124-3 constitutes authorisation, for the manufacturers of pharmaceutical products mentioned in article R. 5124-2, to carry out…

The establishments or organisations benefiting from the authorisation referred to in Article R. 1243-6 may transfer tissues, their derivatives, cells or cell therapy preparations to a pharmaceutical product manufacturer and to establishments or organisations authorised under Articles L. 4211-9-1, L. 5124-1 or L. 5124-9-1 to manufacture advanced therapy medicinal products prepared on an ad hoc basis in compliance with the ethical and health rules in force, with a view to…

Establishments or organisations benefiting from the authorisation referred to in Article R. 1243-6 may sell tissues, their derivatives, cells or cell therapy preparations to manufacturers of in vitro diagnostic medical devices or ancillary therapeutic products, when these products are intended for the manufacture of: -in vitro diagnostic devices which meet the requirements to which they are subject in order to be placed on the market ; -ancillary therapeutic products which…