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Article R2151-16 of the French Public Health Code

November 4, 2023

Any import or export of embryonic stem cells for research purposes, excluding transit and the crossing of customs territory on the occasion of a transfer between two other Member States of the European Union, is subject to the following information being affixed to the outer packaging: 1° The words “embryonic stem cells;”. 2° The designation of the cells concerned; 3° The use for which these cells are intended; 4° For…

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Article R2151-17 of the French Public Health Code

November 4, 2023

Any incident occurring during the transport of embryonic stem cells must be reported to the Director General of the Agence de la biomédecine by the holder of the import or export authorisation. In the event of an incident likely to affect health safety, the Director General of the Agence de la biomédecine shall immediately inform the Director General of the Agence nationale de sécurité du médicament et des produits de…

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Article R2151-18 of the French Public Health Code

November 4, 2023

Any organisation that stores embryos and embryonic stem cells for research purposes must be able to certify that the consents referred to in Article R. 2151-4 have been obtained. Where embryonic stem cells have been imported, the organisation 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…

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Article R2151-19 of the French Public Health Code

November 4, 2023

Subject to the provisions of the second paragraph of Article L. 2151-9, the Director General of the Biomedicine Agency shall authorise the storage of embryos, after obtaining the opinion of the Steering Committee, for a fixed period, which may not exceed five years, renewable under the same conditions. The authorisation shall state the name of the person responsible for the storage activity. Prior to the Director General’s decision, the Agence…

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Article R2151-21 of the French Public Health Code

November 4, 2023

When suspending or withdrawing an authorisation to store embryos, the Director General of the Agence de la biomédecine organises the transfer of these embryos to another organisation authorised to store them in execution, where applicable, of the agreement referred to in Article R. 2151-19. In the event of an incident likely to affect health safety, the Director General of the Agence de la biomédecine shall immediately inform the Director General…

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Article R2151-22 of the French Public Health Code

November 4, 2023

The declaration of embryonic stem cell storage provided for in the sixth paragraph of Article L. 2151-9 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 shall be accompanied by a file designating the person responsible for storage and specifying his or her responsibilities. The file includes a general description of…

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Article R2151-23 of the French Public Health Code

November 4, 2023

Any organisation wishing to change a substantial part of the declared activity must submit a new declaration, which is examined under the same conditions as the initial declaration. The Director General of the Agency may at any time ask the person responsible for conservation to report on the declared activity.

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Article R2212-1 of the French Public Health Code

November 4, 2023

The consultation referred to in Article L. 2212-4 is provided : 1° Either in a family information, consultation or counselling establishment, set up in application of article L. 2311-1 ; 2° Or in a family planning or education centre approved in application of article L. 2311-2 ; 3° Repealed ; 4° Or in a body approved under the conditions laid down in articles R. 2212-2 and R. 2212-3.

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75001, Paris France
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