Title IV: Tissues, cells and products

Applicant establishments or organisations appoint a responsible person who ensures compliance with the regulations relating to the quality and safety of tissues or their derivatives or cell therapy preparations, as well as one or more interim responsible persons who, for the period of replacement, are entrusted with the same powers and duties as those conferred on the responsible person and effectively exercise them for the duration of the replacement. The…

The person in charge referred to in Article R. 1243-12 and the interim persons in charge, as well as the person in charge of activities, shall hold diplomas entitling them to practise medicine or pharmacy, or shall hold a doctorate in the life and health sciences. They must have at least two years’ practical experience in the fields of activity defined by this section.

The authorised establishment or body must send the Director General of the Agence nationale de sécurité du médicament et des produits de santé a copy of any instrument appointing the responsible person referred to in Article R. 1243-12 and any interim responsible persons. When the responsible person or the acting responsible person is temporarily or permanently replaced, it shall immediately inform the Director General of the Agence nationale de sécurité…

I.-The applicant establishments or organisations have medical, paramedical and technical staff who carry out their duties under the authority of the person in charge or the person responsible for the activities mentioned in article R. 1243-12. These establishments have at least : 1° A person responsible for preparation. Only persons who, on the one hand, satisfy the conditions for practising medicine or pharmacy, or hold a doctorate in the field…

Applicant establishments or organisations have premises that guarantee the quality and safety of tissues or their derivatives or cell therapy preparations, in accordance with the rules of good practice provided for in article L. 1245-6.

To avoid any risk of cross-contamination, when activities involving the preservation, preparation and transfer for scientific purposes of tissues or their derivatives or of cells are carried out on the same premises as those dedicated to products prepared or preserved for therapeutic purposes, the establishment or organisation applying for authorisation must put in place procedures guaranteeing compliance with health and safety rules, as well as separate circuits according to the…

Applicant establishments or organisations have the equipment described in the rules of good practice provided for in article L. 1245-6, enabling them to guarantee the quality, health safety and traceability of tissues, their derivatives or cells or cell therapy preparations and to reduce the risks, particularly of contamination, for recipients and staff.

The authorised establishment or body shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of the name of one or more medical officers to whom the staff carrying out the activities referred to in article R. 1243-1 may refer on any question relating to the medical activities of this establishment or body, in particular the clinical and biological selection of donors…