The Director General of the Agence de la biomédecine shall give a decision on the application for authorisation of a technique modifying a process included on the list referred to in Article L. 2141-1 within a period of four months. Failing this, the application is deemed to be rejected.
If the Agency’s Steering Committee considers that the proposed modification should be regarded as a new process, the Director General will reject the application. In this case, he may propose to the Minister for Health that the process be included on the list referred to in article L. 2141-1; he will then inform the applicant. If it is accompanied by the reasoned opinion of the guidance council ruling on the conditions set out in article R. 2141-1-1 and the technical file mentioned in article R. 2141-1-3, the proposal is deemed to be an opinion within the meaning of article R. 2141-1-2.
If the Agency’s Steering Committee considers that the proposed modification does not constitute a new process, the Director General authorises or rejects the application depending on whether or not the implementation of the technique improves the efficacy, reproducibility and safety of the existing process. The Director General may also, if he considers it necessary in order to assess the improvement it brings, invite the applicant to apply for authorisation to conduct research involving the human person under the conditions set out in Article R. 1125-14.
If authorisation is granted, the Agence de la biomédecine immediately informs the laboratories, health cooperation groups and organisations authorised to carry out biological activities for medically assisted procreation. Implementation of the new technique complies with the rules of good practice defined by order of the Minister for Health, in application of Article R. 2142-27.