Subsection 1: Organisations preserving and preparing tissues and cells from the human body for their own research programmes

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R1243-49R1243-50R1243-51R1243-52R1243-53R1243-54R1243-55R1243-56

Article R1243-51

French Public Health CodeIn force
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Updated 5 Nov 2023

The declaration is made up of a letter signed by the legal representative of the applicant organisation and a supporting file, entered using a teleservice. The letter describes the activity and certifies that the signatory has approved the supporting file. 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 into account once this letter has been received.

The procedures for entering the supporting file using the teleservice and the model supporting file are set by order of the Minister for Research. The file includes in particular

1° The identity of the scientist(s) responsible for the declared activities; if there is more than one scientist responsible, a coordinating scientist is appointed;

2° A description of the premises, equipment and materials used for each of the activities;

3° A description of the samples or collections, where they come from and how they were obtained;

4° The conditions for informing the persons from whom the biological elements are obtained and, depending on the cases provided for in Article L. 1211-2, the procedures for obtaining consent or the procedures for verifying the absence of opposition;

5° If storage or preparation activities for therapeutic purposes are carried out on the same site, details of the means intended to avoid the risk of contamination.

The Minister responsible for research sends the Agence nationale de sécurité du médicament et des produits de santé the name of each organisation that has declared activities of preservation or preparation for scientific purposes of tissues and cells from the human body carried out on the same site as activities of the same nature carried out for therapeutic purposes. If he considers it necessary, the Director General of the Agency may request that the files of declaring organisations whose names he has received be sent to him. The files forwarded to him shall include details provided by the reporting body of the measures taken to avoid the risk of contamination.

Mariela Petrova

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Mariela Petrova

Mariela Petrova

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15+ Years In Corporate Practice

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