Article R2151-12-1 of the French Public Health Code
November 4, 2023
Only a legal entity may declare a research protocol involving human embryonic stem cells.
Only a legal entity may declare a research protocol involving human embryonic stem cells.
The declaration of an embryonic stem cell research protocol provided for in Article L. 2151-6 shall be sent to the Director General of the Agence de la biomédecine by any means enabling receipt to be acknowledged and the declaration to be dated. It must be accompanied by a file containing all the information required to verify that the legal conditions have been met. The form and content of this file…
If the Director General of the Agency does not object within two months of the date on which the application is complete, the research protocol may begin. The Agency’s Steering Committee is consulted for its opinion on research protocols aimed at differentiating embryonic stem cells into gametes, obtaining in vitro embryonic development models or inserting these cells into an animal embryo with the aim of transferring it to a female….
All research declared under Article L. 2151-6 is placed under the direction of a responsible person designated by the declaration mentioned in Article R. 2151-12-2. The person responsible for the research sends the Director General of the Agence de la biomédecine a report every two years. The person responsible for the research must send the final report to the Director General of the Agence de la biomédecine as soon as…
Any establishment or organisation wishing to modify a substantial element of the protocol declared under article L. 2151-6 must submit a new dossier. This is examined under the same conditions as the initial declaration.
In the event of a breach of the requirements resulting from III of Article L. 2151-6, the Director General of the Agence de la biomédecine may give formal notice to the establishment or organisation to put an end to the breaches observed and, where appropriate, to submit its observations within a time limit that he/she shall set. If the measures taken are not such as to put an end to…
The provisions of articles R. 2151-12-1 and R. 2151-12-2, and those of articles R. 2151-12-4 to R. 2151-12-6, apply to the declaration and implementation of research protocols conducted on human induced pluripotent stem cells with the aim of differentiating these cells into gametes, obtaining in vitro embryonic development models or inserting these cells into an animal embryo with the aim of transferring it to a female, as mentioned in article…
Any organisation that imports or exports embryonic stem cells must be able to certify that they have been obtained in compliance with the principles mentioned in Articles 16 to 16-8 of the Civil Code, with the prior consent of the persons mentioned in Article R. 2151-4, at the origin of the embryo that was conceived in the context of medically assisted procreation and is no longer the subject of a…
Only organisations may obtain authorisation to import or export embryonic stem cells for research purposes: 1° Holders of the authorisation provided for in Article L. 2151-5 ; 2° Having made the declaration provided for in Article L. 2151-6, without the Director General of the Agence de la biomédecine having objected to the implementation of the protocol, or the declaration provided for in Article L. 2151-9.
The Director General of the Agence de la biomédecine shall authorise the import and export of embryonic stem cells for research purposes, after obtaining the opinion of the Steering Committee. This authorisation is valid for two years. This authorisation is issued for each operation envisaged. The provisions of articles R. 2151-6, R. 2151-9, R. 2151-10 and R. 2151-12 apply to the authorisations provided for in this section.
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is a Registered Trademark of
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75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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