Subsection 2: Conditions for authorising establishments performing pre-implantation diagnosis

The authorisation to practise pre-implantation diagnosis issued to an establishment pursuant to Article L. 2131-4 covers all three activities mentioned in Article R. 2131-22-2. The establishment is authorised, for a period of five years, by the Director General of the Agence de la biomédecine to carry out each of these activities, after receiving the opinion of the Agency’s Orientation Council in accordance with article L. 1418-4. Where an establishment has…

The application for authorisation must be drawn up in accordance with a standard dossier, the composition of which is set by the Director General of the Agence de la biomédecine. This application is sent by the director of the establishment to the Director General of the Agence de la biomédecine by registered post with acknowledgement of receipt, or lodged with the Agence under the same conditions. This application must be…

To obtain authorisation to carry out the activity mentioned in 1° of article R. 2131-22-2, establishments must be authorised, in application of article L. 2142-1 and under the conditions set out in articles R. 2142-1 et seq, to carry out in vitro fertilisation with micro-manipulation. To obtain the authorisations corresponding to the activities mentioned in 2° and 3° of article R. 2131-22-2, the establishments must be authorised in application of…

Embryo retrieval may only be carried out in the room used exclusively for in vitro fertilisation mentioned in article R. 2142-26.

Any establishment authorised to carry out pre-implantation diagnosis in application of article R. 2131-27 is required to submit an annual activity report to the regional health agency and the Agence de la biomédecine, the form and content of which are defined by order of the Minister for Health, made after obtaining the opinion of the Director General of the Agence de la biomédecine.

Establishments authorised in application of article R. 2131-27 keep information relating to diagnoses carried out under conditions that guarantee confidentiality.

Where breaches of the provisions of this chapter are observed in an establishment authorised to carry out pre-implantation diagnosis pursuant to Article R. 2131-27, the Director General of the Agence de la biomédecine may, at any time, withdraw the authorisation of this establishment after obtaining the opinion of its Steering Committee and informing the Regional Health Agency concerned. In an emergency, the authorisation may, as a precautionary measure, be suspended…