Section 1: Authorisation system

The clinical and biological activities of medically assisted procreation referred to in Article L. 2142-1 include : 1° The following clinical activities: a) Oocyte retrieval with a view to medically assisted procreation ; b) Sperm retrieval ; c) Embryo transfer with a view to implantation; d) Oocyte retrieval with a view to donation; e) Embryo reception ; f) Oocyte retrieval with a view to their conservation for subsequent medically assisted…

Without prejudice to compliance with the conditions defined in 1° and 2° of Article L. 6122-2, the granting or renewal of authorisation to carry out one or more of the clinical or biological activities of medically assisted procreation defined in Article R. 2142-1 is subject to compliance with the operating rules laid down in this chapter in application of the fourth paragraph of Article L. 2142-1. These rules constitute the…

The authorisation is issued pursuant to Article L. 2142-1, by the Director General of the Regional Health Agency, under the conditions laid down in Articles R. 6122-23 to D. 6122-44-1. The documents in the supporting file provided for in article R. 6122-32 are supplemented or replaced by the documents in a special file, the composition of which is set by order of the Minister for Health, after obtaining the opinion…

When the provisions of the third paragraph of Article L. 6122-10 relating to renewal of authorisation are applied, the application is submitted as provided for in Article R. 6122-28. In this case, the authorisation holder sends a copy of the application to the Director General of the Agence de la biomédecine. When the provisions of the last paragraph of Article L. 6122-13 relating to the continued suspension or withdrawal of…

The form, frequency and content of the periodic evaluation of clinical and biological activities in medically assisted procreation referred to in article L. 6122-10 and the form and content of the annual activity report referred to in article L. 2142-2 are defined by order of the Minister for Health, after obtaining the opinion of the Director General of the Agence de la biomédecine. This annual activity report is accessible to…

The clinical and biological authorisations for medically assisted procreation referred to in the last paragraph of Article L. 2142-1 are combined when the authorisation to carry out the biological activities referred to in b of 2° of Article R. 2142-1 and the authorisation to carry out the clinical activities referred to in a and c and possibly d of 1° of Article R. 2142-1 have been issued respectively: -either to…

Only the centres defined in Article R. 2142-6 which also hold the authorisations to carry out the activities mentioned in e of 1° and g of 2° of Article R. 2142-1 may store embryos intended for reception and carry out their reception. These authorisations may only be issued to public and private not-for-profit health establishments or to the medical biology analysis laboratories mentioned in article L. 6212-1, with regard to…

The holder(s) of the authorisations to carry out the clinical and biological activities necessary for the implementation of in vitro fertilisation as mentioned in article R. 2142-6 shall jointly set up, on the same site, a centre for medically assisted procreation. This centre is located in the health establishment authorised to carry out clinical activities. It includes the multidisciplinary clinical-biological medical team referred to in article L. 2141-2, the composition…

The medically assisted procreation centre keeps, under the joint responsibility of the authorisation holders and in compliance with confidentiality, the following information in the joint medical file mentioned in article R. 2142-8: 1° Indication of the implementation and choice of assisted reproduction technique ; 2° The date of gamete retrieval and the number of oocytes retrieved and prepared during each retrieval; 3° The date of the transfers and the number…