Subsection 4: Rules applicable to authorised establishments and organisations

Subject to the provision of the second paragraph relating to blood establishments, the establishment or authorised body shall set up a scientific council or a medico-technical committee, responsible in particular for providing scientific and technical guidance, monitoring activity and results, and proposing and facilitating the implementation of research work in the field of the preparation, preservation and quality control of tissues or their derivatives or cell therapy preparations. Blood transfusion…

An analytical accounting system covering the economic, financial and accounting data relating to the activities mentioned in article R. 1243-1 is set up within the establishment or authorised body.

The authorised establishment or body sends the Director General of the Agence nationale de sécurité du médicament et des produits de santé and the Director General of the Agence de la biomédecine, as well as, where applicable, the Director General of the regional health agency, an annual activity report containing, in particular, updated data on personnel, equipment and any information necessary for the evaluation of all the activities for which…

Authorised establishments or organisations shall make available to the Agence nationale de sécurité du médicament et des produits de santé updated data concerning staff, equipment and any information necessary for the evaluation of all the activities for which they are authorised, including those provided for in Article R. 1243-3-1. They draw up and keep up to date a list of the agreements they have entered into with third parties whose…

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…