Section 1: Prenatal diagnosis.

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 the activities governed by this section and referred to in Article L. 6122-10 , as well as the form and content of the annual report referred to in Article L. 2131-2, are defined by order of the Minister for Health, issued after obtaining the opinion of the Director General of the Agence de la biomédecine.

Authorisation to carry out the tests mentioned in 3° of I of Article R. 2131-1 may only be granted if the health establishment or medical biology laboratory holds authorisation to carry out the tests mentioned in 1° and 2° of II of the same article.