French Public Health Code
In forceThe application for authorisation to carry out the biological diagnosis provided for in Article R. 2131-26-1 shall be sent to the Director General of the Agence de la biomédecine by the multidisciplinary prenatal diagnosis centre together with a dossier complying with a standard dossier, the content of which is defined by decision of the Director General of the Agence de la biomédecine.
This request must be sent by registered post with acknowledgement of receipt or lodged with the Agency in return for a receipt under the same conditions.
The Director of the Agency will acknowledge receipt of the application for authorisation. Where documents essential to the examination of the application are missing, the acknowledgement of receipt will specify the deadline by which these documents must be supplied.
The decision of the Director General of the Agence de la biomédecine is taken, after obtaining the opinion of the Agency's Steering Committee, within two months of the date on which the application is complete.
The reasoned decision of the Director General of the Agence de la biomédecine is sent to the couple or the unmarried woman and to the multidisciplinary prenatal diagnosis centre, which keeps a copy, under conditions that guarantee confidentiality. In the event of a negative decision, it will indicate the appeal procedures and deadlines.
The couple or unmarried woman must be informed of the possibility of meeting, if they so wish, the doctor or doctors of the multidisciplinary prenatal diagnosis centre mentioned in article R. 2131-26-1.
Where the biological diagnosis referred to in article L. 2131-4-1 is authorised, the two members of the couple or the unmarried woman shall provide one of the practitioners on the multidisciplinary clinical-biological medical team referred to in the first paragraph of article R. 2131-25 with a copy of the authorisation issued by the Director General of the Agence de la biomédecine with a view to carrying out this diagnosis. Prior to the implementation of medically assisted procreation, both members of the couple or the unmarried woman shall reiterate their consent in writing to this practitioner. In this case, the second and third paragraphs of article R. 2131-25 and article R. 2131-26 are applied.
Each member of the couple or the unmarried woman may revoke their consent at any time.
The approved practitioner mentioned in the first paragraph of article R. 2131-24 informs the multidisciplinary prenatal diagnosis centre of the decision taken by the couple or the unmarried woman.
