Section 2: Establishments authorised to collect cells for therapeutic purposes

The authorisation to take cell samples for therapeutic purposes is issued, suspended or withdrawn under the same conditions as those laid down in article R. 1233-2 and articles R. 1233-4 to R. 1233-6.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.