The authorisation to take cell samples for therapeutic purposes is issued, suspended or withdrawn under the same conditions as those laid down in article R. 1233-2 and articles R. 1233-4 to R. 1233-6.
To be authorised to carry out cell harvesting for therapeutic purposes, applicant establishments must : 1° Demonstrate that they have an organisation and operating conditions that allow the satisfactory performance of harvesting operations in accordance with the rules of good cell harvesting practice provided for in Article L. 1245-6, and in particular an organisation that allows harvesting for autologous administration and harvesting for allogeneic administration to be carried out separately;…
When the staff of a blood transfusion establishment take blood cell samples in an establishment to make cell therapy preparations for therapeutic purposes, an agreement between the blood transfusion establishment and the health establishment lays down the conditions for carrying out this activity.
Establishments authorised to carry out cell sampling take the necessary steps to ensure that all documents relating to the sampling are kept in accordance with the rules of good cell sampling practice.
Each year, the establishments authorised to carry out cell harvesting transmit to the director of the regional hospitalisation agency and to the director general of the Agence de la biomédecine the information required to evaluate their activity, in accordance with the procedures specified by order of the Minister for Health issued after consultation with the director general of the Agence de la biomédecine.
The provisions of articles R. 1242-6 and R. 1242-7 are applicable to cell harvesting activities authorised under this section.
For the application of the provisions of this chapter, army hospitals and the army blood transfusion centre shall be regarded as public 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.
I.-The provisions of this section apply to the activities mentioned in Article L. 1243-2 relating to the preparation, preservation, distribution or transfer of tissues, their derivatives, cells or cell therapy preparations, whatever their level of processing, used for therapeutic purposes in humans. II – Use for therapeutic purposes includes in particular the research mentioned in article L. 1121-1. In application of article L. 1245-4, the provisions of sub-sections 3 and…
The authorisation provided for in article L. 1243-2 may cover one or more of the activities mentioned in that article.
Establishments or organisations which store and distribute tissues or their derivatives or cell therapy preparations which have been transferred to them by an establishment or organisation authorised to prepare, store, distribute or transfer these products must be authorised, pursuant to Article L. 1243-2, to carry out these storage and distribution activities under the conditions provided for in this section, with the exception of Articles R. 1243-19 and R. 1243-24 which…
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75001, Paris France
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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