Paragraph 2: Conditions for authorising laboratories

The analyses mentioned in 1° and 2° of Article R. 1131-2 may only be performed in the medical biology laboratories of public health establishments, the laboratories of cancer centres, the medical biology analysis laboratories mentioned in Article L. 6211-2 and the medical biology analysis laboratories of the Etablissement Français du Sang (French Blood Establishment) authorised under the conditions defined in Articles R. 1131-14 et seq. These analyses may also be…

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 R. 1131-13, to perform the analyses mentioned in 1° and 2° of Article R. 1131-2 is subject to compliance with the rules laid down in this paragraph. These rules constitute the establishment conditions and the technical operating conditions provided for in 3° of article L. 6122-2….

The authorisation provided for in Article R. 1131-13 is issued for a period of five 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 Conference on Health and Autonomy 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…

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 this application to the Director General of the Agence de la biomédecine.

In the event of failure to comply with the legislative and regulatory provisions of this Title and Books I and II of Part Six of this Code, or breach of the conditions laid down in the authorisation, the authorisation may be suspended or withdrawn under the conditions set out in Article L. 6122-13. When the provisions of the last paragraph of this article relating to the continued suspension or withdrawal…

The holder of the authorisation referred to in Article R. 1131-13 is required to declare to the competent regional health agency and to the Agence de la biomédecine, the names of the approved practitioners prior to implementation of the authorisation, as well as the name of any new approved practitioner prior to taking up their post. It is also required to inform the Regional Health Agency and the Agence de…