Subsection 3: Conditions for authorising and operating public health establishments and medical biology analysis laboratories

Without prejudice to the conditions defined in 1° and 2° of Article L. 6122-2, the granting or renewal of the authorisation, mentioned in Article L. 2131-1, granted to public health establishments and medical biology laboratories to carry out one or more of the biological activities listed in I and II of Article R. 2131-1, is subject to compliance with the rules laid down in this section of this chapter. These…

In order to obtain the authorisation referred to in Article R. 2131-5-5, the public health establishment or medical biology laboratory must have the equipment necessary to carry out these activities under conditions that guarantee their quality and safety, as defined by the rules of good practice provided for in Article R. 2131-2-2. It must also have a room for interviews with families concerned by prenatal diagnosis.

The authorisation provided for in Article R. 2131-5-5 is issued for a period of seven years, under the conditions laid down in Articles R. 6122-23 to R. 6122-44. However, before taking the opinion of the specialised commission of the Regional Health and Autonomy Conference competent for the health sector, the Regional Health Agency shall, by virtue of 12° of Article L. 1418-1, obtain the opinion of the Agence de la…

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.