Practitioner accreditation

The Agence de la biomédecine is responsible for approving practitioners for genetic activities. Analyses to determine a person's genetic characteristics for medical purposes or identification by genetic fingerprinting include :

• cytogenetic analyses, including molecular cytogenetic analyses
• Unlimited molecular genetic analyses
• Molecular genetic analyses for limited use of the molecular biology tool: Hematology; Factors II and V and MTHFR; Hemochromatosis; Pharmacogenetics; HLA genotyping; HPA (Human Platelet Antigen) genotyping.
• Neonatal screening for spinal muscular atrophy (SMA)

Approval is valid for 5 years, and the practitioner may work in any authorized facility.

Each application may concern one or more genetics activities.

Applications for approval for limited genetics must be accompanied by a completed training guide, signed by a practitioner approved for non-limited molecular genetics.

The application for approval must be drawn up in accordance with a standard dossier, the composition of which is laid down by the Agency's General Management.

Applications should preferably be sent electronically to the following address

juridique@biomedecine.mssante.fr (this address can only be used by a healthcare professional)

If you have not received an acknowledgement of receipt from the Legal Department within 72 hours, please contact us at juridique@biomedecine.fr.

The list of practitioners approved by the Agence de la biomédecine is updated regularly.

It is not necessary to apply for new approval if a practitioner wishes to work in another establishment or laboratory. It is the practitioner's responsibility to inform the relevant regional hospital agency and the Agence de la biomédecine :

• of the names of practitioners practicing in his or her establishment or laboratory, prior to implementation of the authorization ;
• the name of any new approved practitioner joining the structure;

The Agence de la biomédecine is responsible for approving practitioners for preimplantation diagnosis and genetics activities. Preimplantation diagnosis includes the following activities:

• Cell sampling of embryos obtained by in vitro fertilization;
• Cytogenetic tests, including molecular tests on embryonic cell(s);
• Molecular genetic tests on embryonic cell(s).

Approval for practitioners to carry out one or more preimplantation diagnostic activities is granted by the General Management of the Agence de la biomédecine, for a period of 5 years.

The decision is notified to the applicant within 2 months of receipt of a complete application file.

The application for approval is based on a standard file, the composition of which is set by the Agence's Director General.

Applications should preferably be sent electronically to the following address

juridique@biomedecine.mssante.fr (this address can only be used by a healthcare professional)

If you have not received an acknowledgement of receipt from the Legal Department within 72 hours, please contact us at juridique@biomedecine.fr.

The list of practitioners approved by the Agence de la biomédecine is updated regularly.

An accredited practitioner may carry out his or her activities in any establishment or laboratory during the 5 years of his or her accreditation, as long as this establishment or laboratory is authorized. It is not necessary to apply for a new accreditation if a practitioner wishes to change structure. However, it is the responsibility of the holder of the authorization (establishment or laboratory) to inform the general management of the Agence de la biomédecine and the management of the relevant Agence régionale de l'hospitalisation:

• of the names of approved practitioners prior to implementation of the authorization,
• any new approved practitioner, prior to taking up his or her post,
• of the cessation of activity of these practitioners.