The preservation and preparation of organs for scientific purposes are governed by the provisions of Section 2 of Chapter III of Title IV of this Book. These activities include the creation and use of collections of human biological samples as defined in article L. 1243-3, including when these collections are created and used for genetic research purposes.
The importer of organs shall ensure that they have been removed with the donor’s prior consent and without any payment, in whatever form, having been made to the donor. He must be able to justify that he has ensured this.
Any import or export of organs, excluding transit, is subject to the following information being affixed to the package: 1° The words: “elements or products of human origin” ; 2° The designation of the organ, mentioning, where applicable, whether it is a right or left organ; 3° The purpose or purposes, as referred to in Articles L. 1211-1 and L. 1235-1, for which the organ is intended; 4° For import,…
Any establishment or organisation that imports or exports organs for therapeutic purposes, including biomedical research within the meaning of article L. 1121-1, must not disclose any information that could identify the donor or recipient of an organ.
Any establishment or body which imports or exports organs for therapeutic purposes, including biomedical research within the meaning of Article L. 1121-1, shall ensure that these organs have been removed in compliance with standards of protection at least as stringent as the health safety rules mentioned in Article L. 1211-6 and standards of good practice at least equivalent to those provided for in Article L. 1235-5. He must be able…
The list of health establishments authorised to remove or transplant organs in application of articles L. 1233-1 and L. 1234-2 is drawn up and kept up to date by the Director General of the regional health agency responsible for issuing authorisations. This list is sent to the Minister for Health, the Minister for Customs, the Agence nationale de sécurité du médicament et des produits de santé and the Agence de…
Public or private organisations involved in research and using organs for their own research programmes may obtain authorisation to import and export organs for scientific purposes under the conditions laid down in this section. Organisations which have been granted authorisation under article L. 1243-4 may obtain authorisation to import and export organs with a view to their transfer for scientific use, under the conditions laid down in this section.
Four copies of the application for authorisation must be sent to the Minister for Research, together with a dossier, by registered post with acknowledgement of receipt, or handed in against a receipt. The file includes : 1° A copy of the acknowledgement of receipt by the Minister responsible for research of the declaration provided for in Article L. 1243-3 or a copy of the authorisation provided for in Article L….
The Minister responsible for research sends a copy of the application to the Director General of the Agence de la biomédecine and, where the applicant organisation also benefits from an authorisation as provided for in Article L. 1243-2, to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, who give their opinion within one month. If no response is received after this period,…
Authorisations may be modified, suspended or withdrawn in whole or in part by the Minister responsible for research in the event of non-compliance with the provisions of this chapter. Suspension or withdrawal takes place under the conditions laid down in the second paragraph of Article L. 1245-1. In the event of an incident likely to affect health safety, the Minister responsible for research shall immediately inform the Director General of…
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