French Business Law - French Legislation

Article R2131-13 of the French Public Health Code

November 4, 2023

The application for authorisation of the multidisciplinary centre for prenatal diagnosis is submitted by the director of the organisation or health establishment within which the centre is set up. It is made using a standard application form, the composition of which is set by the Director General of the Agence de la biomédecine. This application is sent by the director of the organisation or health establishment to the Director General…

Article R2131-14 of the French Public Health Code

November 4, 2023

The application for authorisation includes the names of the practitioners mentioned in 1° of article R. 2131-12 and the centre’s draft internal regulations.

Article R2131-15 of the French Public Health Code

November 4, 2023

The Agence de la biomédecine publishes decisions relating to authorisations, renewals, suspensions and withdrawals of these authorisations in the Official Bulletin of the Ministry of Health. It updates the list of authorised multidisciplinary prenatal diagnosis centres and makes it available to the public.

Article R2131-15-1 of the French Public Health Code

November 4, 2023

When a multidisciplinary prenatal diagnosis centre authorised in application of Article R. 2131-13 is found to be in breach of the provisions of this chapter, the Director General of the Agence de la biomédecine may, at any time, withdraw the authorisation of this centre after obtaining the opinion of its Steering Committee and informing the Regional Health Agency concerned. In an emergency, the authorisation may, as a precautionary measure, be…

Article R2131-16 of the French Public Health Code

November 4, 2023

The centre may be consulted either directly by the pregnant woman or the couple where a proven risk has been identified in application of III of article L. 2131-1, or by the attending physician who sends the medical file to the centre. In the latter case, the file must contain the written consent of the pregnant woman or the couple to the attending doctor’s action and a certificate stating that…

Article R2131-17 of the French Public Health Code

November 4, 2023

The pregnant woman or the couple will, at her request, be heard by all or some of the members of the multidisciplinary team prior to the consultation mentioned below. The centre will suggest additional investigations or seek specialist external advice if it is necessary to support the diagnosis or prognosis. A doctor from the centre will inform the pregnant woman, the couple or the doctor treating them of the possible…

Article R2131-18 of the French Public Health Code

November 4, 2023

If, at the end of the consultation provided for in article R. 2131-17, it appears to two of the doctors mentioned in 1° of article R. 2131-12 that there is a strong probability that the unborn child is suffering from a particularly serious condition recognised as incurable at the time of diagnosis, and if the pregnant woman so requests, they shall draw up, after the multidisciplinary team has given its…

Article R2131-19 of the French Public Health Code

November 4, 2023

For each request for an opinion relating to a pregnancy in progress, the centre will keep the details of the medical file, the opinions, advice and conclusions of the centre and, where applicable, the date of the voluntary interruption of pregnancy for medical reasons as well as the results of the foetopathological examinations carried out. If the certificates mentioned in articles R. 2131-2, R. 2131-18, R. 2131-23 and R. 2131-26-1…

Article R2131-20 of the French Public Health Code

November 4, 2023

The members of the multidisciplinary team, the composition of which is laid down in article R. 2131-12 , appoint, from among the doctors mentioned in 1° of this article and for a renewable period of two years, a coordinator responsible in particular for overseeing the organisation of the centre’s activities and drawing up the annual activity report provided for in article L. 2131-2. The name of the coordinator and the…

Article R2131-21 of the French Public Health Code

November 4, 2023

The director of the healthcare organisation or institution within which the centre is set up shall declare to the Director General of the Agence de la biomédecine any change in the composition of the centre’s multidisciplinary team. In the event of the departure of a practitioner who was the only one practising one of the disciplines mentioned in Article R. 2131-12, the Director shall designate, within three months, a practitioner…

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Regulatory part

Article R2131-13 of the French Public Health Code

Article R2131-14 of the French Public Health Code

Article R2131-15 of the French Public Health Code

Article R2131-15-1 of the French Public Health Code

Article R2131-16 of the French Public Health Code

Article R2131-17 of the French Public Health Code

Article R2131-18 of the French Public Health Code

Article R2131-19 of the French Public Health Code

Article R2131-20 of the French Public Health Code

Article R2131-21 of the French Public Health Code

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