Book I: Protection and promotion of maternal and child health

Embryos may only be delivered to the person responsible for the research mentioned in Article R. 2151-8 by the holder of the authorisation provided for in Article L. 2151-9, by the practitioner approved in application of Article L. 2131-4-2 or by the practitioner working, in accordance with the fifth paragraph of Article L. 2142-1, in an establishment, laboratory or organisation authorised in application of the same article. The person responsible…

The application for authorisation of an embryo research protocol shall be sent to the Director General of the Agence de la biomédecine by any means capable of establishing a date of receipt. This application must be accompanied by a dossier containing all the information required to verify that the legal conditions have been met, the form and content of which are laid down by decision of the Director General of…

Any decision by the Director General to authorise or refuse research and the opinion of the Steering Committee are forwarded simultaneously to the Ministers for Health and Research, who have a period of one month in which to jointly request a re-examination of the application for authorisation, in application of 1° and 2° of III of article L. 2151-5. When a request for re-examination of an authorised protocol is made…

All research authorised under article L. 2151-5 is placed under the direction of a responsible person designated by the application mentioned in article R. 2151-6. The person responsible for the research sends the Director General of the Agence de la biomédecine an annual report. The final report is sent to the Director General as soon as the research has been completed. These reports shall contain, in particular, information relating to…

Any establishment or organisation wishing to modify a substantial element of the protocol authorised under article L. 2151-5 must submit a new application for authorisation. This application is examined under the same conditions as the initial application.

In the event of a breach of the applicable legislative or regulatory provisions or of the requirements laid down in the authorisation, the Director General of the Agence de la biomédecine may give the establishment or body formal notice to put an end to the breaches observed and, where appropriate, to submit its observations within a period set by the Director General. If the measures taken are not such as…

I.-Establishments and organisations authorised under article L. 2151-5 or the first paragraph of article L. 2151-9 shall keep a register of the embryos they hold. This register mentions : 1° The organisation that supplied the embryos and their identification code after anonymisation ; 2° The title of the research protocol; 3° The name of the person responsible for the research or conservation activity; 4° The number of embryos being researched;…

Any establishment or organisation that carries out embryo research is required to keep the protocol provided for in Article L. 2151-5, the documents attesting to the collection of the consents referred to in Article R. 2151-4, the final research report and the register referred to in I of Article R. 2151-11 for a period of ten years from the end of the research.