French Business Law - French Legislation

Article R1243-24 of the French Public Health Code

November 5, 2023

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…

Article R1243-25 of the French Public Health Code

November 5, 2023

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…

Article R1243-26 of the French Public Health Code

November 5, 2023

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…

Article R1243-27 of the French Public Health Code

November 5, 2023

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…

Article R1243-29 of the French Public Health Code

November 5, 2023

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…

Article R1243-30 of the French Public Health Code

November 5, 2023

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…

Article R1243-31 of the French Public Health Code

November 5, 2023

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…

Article R1243-32 of the French Public Health Code

November 5, 2023

For the application of the provisions of sub-sections 1 to 4, army hospitals and the army blood transfusion centre shall be considered as health establishments and a blood transfusion establishment respectively. For these hospitals and for this centre, the Minister for Defence exercises the powers of the Director General of the Regional Health Agency.

Article R1243-49 of the French Public Health Code

November 5, 2023

The provisions of this sub-section apply to organisations carrying out the conservation and preparation for scientific purposes of tissues and cells from the human body and their derivatives when these activities are carried out for the needs of their own research programmes, whatever the purpose for which the sample was taken. The activities mentioned in the previous paragraph include the creation and use of collections of human biological samples as…

Article R1243-50 of the French Public Health Code

November 5, 2023

Where the activities referred to in article R. 1243-49 are carried out in separate locations, the organisation may submit several declarations, determining the scope covered by each of them.

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Article R1243-24 of the French Public Health Code

Article R1243-25 of the French Public Health Code

Article R1243-26 of the French Public Health Code

Article R1243-27 of the French Public Health Code

Article R1243-29 of the French Public Health Code

Article R1243-30 of the French Public Health Code

Article R1243-31 of the French Public Health Code

Article R1243-32 of the French Public Health Code

Article R1243-49 of the French Public Health Code

Article R1243-50 of the French Public Health Code

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