Book I: Protection and promotion of maternal and child health

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.

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…

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…