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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with the requirements mentioned in the second paragraph of Article R. 1243-62, the authorisation may be suspended or withdrawn by the Minister responsible for research.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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Article R1244-5 of the French Public Health Code

In order to verify the conditions laid down in article L. 1244-2 and to enable the implementation of article L. 1244-6, the organisations, health establishments and health cooperation groups authorised for the activities mentioned in d of 1° and c and d of 2° of article R. 2142-1 keep information on the donor. The donor’s file contains: 1° The donor’s written consent, expressed in application of article L. 1244-2; 2°…

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Article R1244-6 of the French Public Health Code

In order to comply with the provisions of Article L. 1244-4 : 1° For donations made before the first day of the thirteenth month following the promulgation of Law No 2021-1017 of 2 August 2021 on bioethics, the donor file mentioned in Article R. 1244-5 of this Code shall contain the number of children born as a result of the donation; 2° For donations made after the date mentioned in…

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Article R1244-7 of the French Public Health Code

For the application of the provisions of article L. 2143-2, the doctor of the organisation, health establishment or health cooperation group authorised for the activities mentioned in d of 1° and c and d of 2° of article R. 2142-1 collects the data mentioned in article R. 2143-5 and sends it to the Agence de la biomédecine when the donation is used.

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Article R1245-1 of the French Public Health Code

The provisions of this chapter apply to the legal and natural persons mentioned in II of article L. 1245-5 and in article L. 1245-5-1 who, for the purposes mentioned in these articles, bring tissues, their derivatives or cells from the human body, whatever their level of processing and cell therapy preparations, with the exception of gametes, into or out of national territory.

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