Part Two: Family, maternal and child health

The Minister for Health shall register a procedure on the list mentioned in Article L. 2141-1, on his own initiative or at the request of an establishment, laboratory, health cooperation group or body mentioned in Article R. 2141-1-6, after consulting the Agence de la biomédecine. The latter must give its opinion within four months, accompanied by the reasoned opinion of its Steering Committee and the technical file mentioned in Article…

I.-In order to verify compliance with the conditions mentioned in Article R. 2141-1-1, the Agence de la biomédecine shall compile a technical file specifying : 1° The characterisation or nature of the process ; 2° The procedures and operating methods involved and identification of the critical stages; 3° An analysis of the foreseeable risks and, where appropriate, a justification of the additional constraints of the process studied compared to the…

I.- Biological processes included on the list referred to in Article L. 2141-1 shall be reassessed by the Agence de la biomédecine in the light of the criteria referred to in Article R. 2141-1-1 and the results observed, in accordance with a programme determined by the Agence. If, following this reassessment, it appears that a procedure no longer fulfils the conditions laid down in Article R. 2141-1-1 or presents a…

A technique modifying a process included on the list mentioned in Article L. 2141-1 may only be implemented after authorisation by the Agence de la biomédecine. The technique is authorised if, without constituting a new process, it improves the efficacy, reproducibility and safety of the process it modifies.

The application for authorisation of a technique modifying a process included on the list mentioned in article L. 2141-1 may be submitted by any health establishment, medical biology laboratory, health cooperation group or organisation authorised to carry out medically assisted procreation activities in application of article L. 2142-1. The applicant attaches to its application a file containing all the information required to assess the technique, the model for which is…

When authorisation is sought for a technique that modifies a procedure on the list mentioned in Article L. 2141-1 , the Director General of the Agence de la biomédecine refers the matter to the Agency’s Orientation Board. The latter gives a reasoned opinion on the nature and interest of the proposed modification and assesses in particular, in the light of the technical dossier for the process for which the modification…

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…

The Director General of the Agence de la biomédecine may at any time suspend or withdraw authorisation for the implementation of a technique if the conditions laid down in this section are no longer satisfied or for any public health reason. Suspension for a period of more than three months and withdrawal are decided after obtaining the opinion of the Agency’s Steering Committee. Reasons must be given for the decision…