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Article R1235-6 of the French Public Health Code

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…

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Article R1235-7 of the French Public Health Code

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.

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Article R1235-8 of the French Public Health Code

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….

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Article R1235-9 of the French Public Health Code

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,…

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Article R1235-10 of the French Public Health Code

Authorisations may be modified, suspended or withdrawn in whole or in part by the Minister responsible for research in the event of non-compliance with the provisions of this chapter.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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Article R1235-11 of the French Public Health Code

The list of authorised organisations is regularly updated and communicated by the Minister for Research to the Minister for Customs, the Agence de la biomédecine and the Agence nationale de sécurité du médicament et des produits de santé. This list gives the names and addresses of the establishments and organisations and the type of organs that each of them is authorised to import or export.

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Article R1241-2 of the French Public Health Code

A refusal to remove organs after death, expressed under the conditions set out in Section II of Chapter II of Title III of Book II of this Part, also constitutes a refusal to remove tissues and cells and to collect human body products after death. Where the application for registration so specifies, the refusal may not, however, concern certain tissues.

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Article R1241-2-1 of the French Public Health Code

Tissue and cell samples may only be taken from a deceased person if that person is assisted by mechanical ventilation and retains haemodynamic function. However, tissue and cell samples from a list established by order of the Minister for Health, made on the recommendation of the Director General of the Biomedicine Agency, may be taken from a deceased person with persistent cardiac and respiratory arrest.

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