Section 1: Authorisation procedure

For the application of the provisions of this section, samples taken in the context of biomedical research as defined in Article L. 1121-1 shall be regarded as samples taken for therapeutic purposes.

The authorisation to remove organs for therapeutic purposes is issued for a period of five years by the Director General of the Regional Health Agency, after obtaining the opinion of the Director General of the Biomedicine Agency. It specifies the type of organs that the establishment is authorised to harvest. It may be renewed under the same conditions.

Authorisation to remove organs for therapeutic purposes from a living person may only be granted to health establishments which, on the same site as the one from which the organs are to be removed, transplant the organs for which authorisation is requested.

The authorisation may be suspended or withdrawn in whole or in part, in the cases and under the conditions set out in Article L. 1245-1, by the Director General of the Regional Health Agency, following a reasoned opinion from the Director General of the Agence de la biomédecine. In the event of an emergency as provided for in the second paragraph of Article L. 1245-1, the temporary suspension of the…

Five copies of the application for authorisation or renewal of the authorisation must be sent by registered post with acknowledgement of receipt to the Director General of the Regional Health Agency. It may also be submitted against a receipt. Applications for renewal of the authorisation must be sent to the Director General of the Regional Health Agency seven months before the expiry date of the authorisation. The application for authorisation…

The Director General of the Regional Health Agency will notify the applicant of his decision within six months of the date on which the complete application was sent to him. If no decision is taken within this period, the application for authorisation will be rejected. The Director General of the Regional Health Agency draws up and updates a list of authorised health establishments in the region; it is sent to…