The Director General of the Agency shall, where appropriate, forward to the Minister for Research, within the two-month time limit laid down in Article R. 1232-18, any information in his possession which is likely to make it possible to assess the need for the sample or the relevance of the research.
Implementation of the protocol may begin on expiry of the two-month period following issue of the acknowledgement of receipt, unless the Minister responsible for research decides to prohibit implementation in application of article L. 1232-3, after the establishment or organisation has been given the opportunity to present its observations within a specified period which may not exceed one month.
The Director General of the Agence de la biomédecine must be informed of any change in the information contained in the file during the implementation of the protocol. The latter will inform the Minister for Research.
The establishment or organisation must be able to provide the following information at any time, at the request of the Minister for Research or the Director General of the Agence de la biomédecine: 1° The number and nature of the organs removed ; 2° The place and date of removal; 3° Any document attesting, in the cases provided for in Articles L. 1232-1 and L. 1232-2, to the absence of…
Implementation of the protocol is suspended or prohibited if the conditions that justified its authorisation are no longer met and after the establishment or organisation has been invited to present its observations. The Minister for Research and the Agence de la biomédecine inform each other of any facts that may justify a decision to suspend or prohibit the implementation of a protocol in application of article L. 1232-3.
Prior to any suspension or prohibition decision, the Minister in charge of research will give formal notice to the establishment or organisation responsible for implementing the protocol to put an end to its failings or to submit its observations within a specified period. The period of suspension may not exceed one year. The Director General of the Agence de la biomédecine is notified of the suspension or prohibition decision.
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…
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