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The authorisation may be suspended or withdrawn in whole or in part, in the cases and under the conditions set out in Article L. 1245-1, by the Director General of the Regional Health Agency, following a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…
To be authorised to carry out organ removal for therapeutic purposes on a deceased person, health establishments must: 1° Have the staff and equipment necessary to establish the fact of death, under the conditions defined in Chapter II of this Title; 2° Demonstrate that their organisation and operating conditions allow for the satisfactory performance of removal operations; 3° Appoint a coordinating doctor for the removal activity, after consultation with the…
To be authorised to carry out organ removal from a living person, health establishments must : 1° Demonstrate that their organisation and operating conditions allow for the satisfactory performance of organ retrieval operations; 2° Have an intensive care unit on site; 3° Have the medical staff and other personnel required to carry out the sampling activity; 4° It must have the premises, and at least one operating theatre, equipped with…
Health establishments authorised to carry out organ removal take the necessary steps to ensure, for a period of thirty years after the donation, that all documents relating to the removal mentioned in the rules of good organ removal practice approved by order of the Minister for Health are kept. In the case of international exchanges of organs, the Agence de la biomédecine is also responsible for keeping these documents.
Each year, health establishments authorised to carry out organ removal for therapeutic purposes send the Director General of the Regional Health Agency and the Director General of the Biomedicine Agency 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 Biomedicine Agency. These establishments shall also send the Director General of…
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75001, Paris France
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is a Registered Trademark of
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182, rue de Rivoli
75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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