Part One: General health protection

The analyses defined in 1° and 2° of article R. 1131-2 are carried out under the responsibility of a practitioner approved for this purpose under the conditions laid down in article R. 1131-9 and working in one of the establishments or organisations mentioned in article R. 1131-13. The approved practitioner alone is authorised to sign the analysis reports.

The approved practitioner referred to in article R. 1131-6 must be a doctor or pharmacist, holding a diploma of specialised studies in medical biology or an equivalent diploma or, exceptionally, a scientist with specific qualifications or work in the fields of analyses defined in 1° and 2° of article R. 1131-2 . Depending on the category of analyses covered by the application for approval, this approved practitioner must also provide…

When the analyses defined in 1° and 2° of article R. 1131-2 are performed in a medical biology analysis laboratory mentioned in article L. 6211-2, the approved practitioner mentioned in article R. 1131-6 must be the director or deputy director of the laboratory.

The approval of practitioners referred to in Article R. 1131-6 is issued by the Director General of the Agence de la biomédecine, for a period of five years. It may be limited to some of the analyses mentioned in 1° and 2° of Article R. 1131-2. The application for approval shall be made in accordance with a standard dossier drawn up by the Director General of the Agency, which shall…

Renewal of the practitioner’s accreditation is issued by the Director General of the Agence de la biomédecine. Renewal is subject to assessment of the practitioner’s activity, in accordance with the following criteria: 1° Participation by the practitioner in continuing education in the field of genetic characteristics testing ; 2° Obtaining qualifications, carrying out work and publishing during the period of validity of the approval. These criteria are specified by the…

Withdrawal of the approval of the practitioner referred to in article R. 1131-6 is incurred in the event of a breach of the prescriptions provided for in this chapter or in the event of a breach of the terms of the approval. The reasoned decision to withdraw approval is taken by the Director General of the Agence de la biomédecine. The practitioner is informed by registered letter with acknowledgement of…

The Agence de la biomédecine publishes decisions relating to the accreditation of practitioners and the renewal, suspension and withdrawal of this accreditation in the Official Bulletin of the Ministry of Health. It updates the list of approved practitioners and makes it available to the public.