French Public Health Code
In forceThe authorisation is issued pursuant to Article L. 2142-1, by the Director General of the Regional Health Agency, under the conditions laid down in Articles R. 6122-23 to D. 6122-44-1.
The documents in the supporting file provided for in article R. 6122-32 are supplemented or replaced by the documents in a special file, the composition of which is set by order of the Minister for Health, after obtaining the opinion of the Director General of the Agence de la biomédecine. This file includes in particular:
1° Information on the procedures used to collect, prepare, preserve and make available gametes, germ tissue or embryos;
2° A copy of the agreements between the applicant and the external third party involved in the implementation of medically assisted procreation. These agreements specify the responsibilities of each party as well as the procedures to be followed by external third parties to meet quality and health safety requirements;
3° Documents proving the competence of practitioners, as provided for in articles R. 2142-10 and R. 2142-11.
Before taking the opinion of the specialised commission of the Regional Health and Autonomy Conference competent for the health sector, the Regional Health Agency obtains the opinion of the Agence de la biomédecine, pursuant to 12° of Article L. 1418-1, on the application for authorisation and, where applicable, on the application for renewal. In giving its opinion, the Agence de la biomédecine may in particular take into account the projected activity declared by the applicant in the light of regional activity data, the guarantees of continuity of the activity envisaged or already implemented, the agreements with the third parties involved and the results of any assessment carried out in application of 4° of Article L. 1418-1.
When the application for authorisation concerns one or more biological activities mentioned in 2° of Article R. 2142-1, the Agence de la biomédecine gives its opinion in particular on the processes mentioned in the third paragraph.
The Director General of the Agence de la biomédecine shall forward his opinion to the Director General of the Agence régionale de santé within two months of the date of receipt of the dossier.
Any change to the information contained in the initial authorisation must be the subject of an amending authorisation.
The Agence de la biomédecine is informed by the Agence régionale de santé of authorisations granted and refused, as well as decisions relating to their renewal and decisions taken in application of the procedure provided for in Article L. 6122-10.
The Agence de la biomédecine keeps an up-to-date list of authorised health establishments, organisations, health cooperation groups and medical biology laboratories and makes it available to the public.
Where external third parties are involved in the implementation of medically assisted procreation, the application for authorisation must be accompanied by a copy of the agreement(s) signed between the external third party or the establishment, organisation, health cooperation group or laboratory. These agreements specify the responsibilities of each party and the procedures to be followed by external third parties to meet quality and health safety requirements.
Authorised establishments, organisations, health cooperation groups or laboratories must keep an up-to-date list of all agreements entered into with external third parties.
