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Article R1243-60 of the French Public Health Code

The application for authorisation consists of a letter signed by the legal representative of the applicant organisation and a supporting file, entered via a teleservice. The letter describes the activity and certifies that the signatory has approved the supporting documents. It is sent via the teleservice to the Minister for Research and, where applicable, to the Director General of the Regional Health Agency. The supporting dossier will only be taken…

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Article R1243-61 of the French Public Health Code

The application is deemed to be complete if, within one month of receipt, the Minister responsible for research or, where applicable, the Director General of the regional health agency, has not informed the applicant of the missing or incomplete information and indicated the deadline for providing it. These authorities inform each other of requests for additional information that they send to the applicant establishment or organisation.

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Article R1243-62 of the French Public Health Code

The decision of the Minister for Research or, where applicable, the joint decision of the Minister for Research and the Director General of the Regional Health Agency is notified to the applicant within three months of the date on which the application is deemed to be complete. If there is no response within this period, this will be deemed to be an implicit rejection decision. The Minister responsible for research…

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Article R1243-63 of the French Public Health Code

Authorisations are issued for a period of five years. Applications for renewal must be accompanied by the supporting documents mentioned in article R. 1243-60 and an activity report. It is made under the same terms and conditions as the initial application.

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Article R1243-64 of the French Public Health Code

Authorised bodies must be able to provide the following information at any time: 1° The nature and number of samples held ; 2° The characteristics of the samples held; 3° How the samples are prepared; 4° The origin of the samples and how they were obtained; 5° Depending on the cases provided for in Article L. 1211-2, details of consent or absence of opposition; 6° The contact details of the…

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Article R1243-65 of the French Public Health Code

Any change to the information contained in the application for authorisation or renewal of authorisation is immediately brought to the attention of the Minister for Research and, where applicable, the Director General of the Regional Health Agency. The latter may request any additional information in order to ensure that the modification in question does not affect compliance with the legislative and regulatory provisions or the requirements mentioned in the second…

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Article R1243-66 of the French Public Health Code

In the event of infringement of legislative and regulatory provisions or failure to comply with the requirements mentioned in the second paragraph of Article R. 1243-62, the authorisation may be suspended or withdrawn by the Minister responsible for research. When the organisation is a health establishment, the decision to suspend or withdraw authorisation is taken jointly by the Minister for Research and the Director General of the Regional Health Agency….

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Article R1243-67 of the French Public Health Code

The provisions of this section apply to the Ministry of Defence establishments mentioned in Article L. 1245-8. For their application, army hospitals are considered to be health establishments. For these hospitals, as for other Ministry of Defence establishments subject to this section, the Minister for Defence exercises the powers of the Director General of the Regional Health Agency. For the application of articles R. 1243-51 and R. 1243-60, the required…

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Article R1244-1 of the French Public Health Code

The layout of the premises and the reception arrangements for donors and recipients are such as to ensure the anonymity of the donation and the confidentiality of activities. A room has been set aside for interviews prior to the donation or provision of gametes.

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Article R1244-2 of the French Public Health Code

The donor’s consent as provided for in article L. 1244-2, as well as the collection or removal of gametes, are preceded by at least one interview with the multidisciplinary clinical-biological medical team mentioned in article L. 2141-2. These interviews make it possible in particular to: 1° Check that the donor meets the conditions laid down in article L. 1244-2; 2° Inform the donor of the legislative and regulatory provisions relating…

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