Chapter II: Conditions for the authorisation and operation of health establishments, medical biology laboratories and other organisations

Clinical activities involving medically assisted procreation, with the exception of artificial insemination and ovarian stimulation, may only be carried out in health establishments. Subject to the following paragraph, the biological activities of medically assisted procreation may only be carried out in medical biology laboratories accredited in accordance with the provisions of Chapter I of Title II of Book II of Part Six. The clinical and biological activities of medically assisted…

Any establishment, organisation, health cooperation group or laboratory authorised to carry out medically assisted procreation activities is required to submit an annual activity report to the regional health agency and the Agence de la biomédecine in accordance with the procedures determined by order of the Minister for Health. It is also required to draw up and keep registers relating to the gametes, germinal tissue and embryos it stores.

Any breach of the legislative and regulatory requirements applicable to medically assisted procreation observed in an establishment, organisation, health cooperation group or laboratory, and caused by the latter, will result in the temporary or definitive withdrawal of the authorisations provided for in Article L. 2142-1, under the conditions set out in Article L. 6122-13. The authorisation may also be withdrawn if the prescriptions laid down in the authorisation are violated…

In each establishment, organisation, health cooperation group or laboratory authorised to carry out biological activities for medically assisted procreation, a responsible person is designated, responsible for ensuring compliance with the legislative and regulatory provisions relating to the quality and safety of gametes, germinal tissue and embryos. In medical biology laboratories, the person in charge is the director or deputy director of the laboratory.

The procedures for applying this chapter are determined by decree in the Conseil d’Etat, and in particular : 1° The clinical and biological activities of medically assisted procreation ; 2° The operating and location conditions that must be met by the establishments, organisations, health cooperation groups and laboratories mentioned in the first, second and third paragraphs of Article L. 2142-1 in order to be authorised to carry out medically assisted…