French Business Law - French Legislation

Article R2131-5-5 of the French Public Health Code

November 4, 2023

Without prejudice to the conditions defined in 1° and 2° of Article L. 6122-2, the granting or renewal of the authorisation, mentioned in Article L. 2131-1, granted to public health establishments and medical biology laboratories to carry out one or more of the biological activities listed in I and II of Article R. 2131-1, is subject to compliance with the rules laid down in this section of this chapter. These…

Article R2131-6 of the French Public Health Code

November 4, 2023

In order to obtain the authorisation referred to in Article R. 2131-5-5, the public health establishment or medical biology laboratory must have the equipment necessary to carry out these activities under conditions that guarantee their quality and safety, as defined by the rules of good practice provided for in Article R. 2131-2-2. It must also have a room for interviews with families concerned by prenatal diagnosis.

Article R2131-7 of the French Public Health Code

November 4, 2023

The authorisation provided for in Article R. 2131-5-5 is issued for a period of seven years, under the conditions laid down in Articles R. 6122-23 to R. 6122-44. However, before taking the opinion of the specialised commission of the Regional Health and Autonomy Conference competent for the health sector, the Regional Health Agency shall, by virtue of 12° of Article L. 1418-1, obtain the opinion of the Agence de la…

Article R2131-8 of the French Public Health Code

November 4, 2023

When the provisions of the third paragraph of Article L. 6122-10 relating to renewal of authorisation are applied, the application is submitted as provided for in Article R. 6122-28. In this case, the authorisation holder sends a copy of the application to the Director General of the Agence de la biomédecine. When the provisions of the last paragraph of Article L. 6122-13 relating to the continued suspension or withdrawal of…

Article R2131-9 of the French Public Health Code

November 4, 2023

The form, frequency and content of the periodic evaluation of the activities governed by this section and referred to in Article L. 6122-10 , as well as the form and content of the annual report referred to in Article L. 2131-2, are defined by order of the Minister for Health, issued after obtaining the opinion of the Director General of the Agence de la biomédecine.

Article R2131-9-1 of the French Public Health Code

November 4, 2023

Authorisation to carry out the tests mentioned in 3° of I of Article R. 2131-1 may only be granted if the health establishment or medical biology laboratory holds authorisation to carry out the tests mentioned in 1° and 2° of II of the same article.

Article R2131-10 of the French Public Health Code

November 4, 2023

Only centres that have received the authorisation referred to in VIII of Article L. 2131-1, issued by decision of the Director General of the Agence de la biomédecine after consultation with the Agency’s Orientation Council, may be designated as multidisciplinary prenatal diagnosis centres. The duration of the authorisation is five years.

Article R2131-10-1 of the French Public Health Code

November 4, 2023

In addition to the responsibilities conferred on them by Articles L. 2131-4 and L. 2213-1, the multidisciplinary centres for prenatal diagnosis are responsible for: 1° To promote access to all prenatal diagnosis activities and to ensure their implementation by constituting a centre of clinical and biological expertise at the service of patients and practitioners ; 2° To give advice and opinions on diagnosis, treatment and prognosis to clinicians and biologists…

Article R2131-11 of the French Public Health Code

November 4, 2023

The authorisation of a centre, as provided for in article L. 2131-5, is subject to the following conditions: 1° The centre must operate within a public or private health organisation or establishment of collective interest, on a site with an obstetrics unit ; 2° It must form a multidisciplinary team, the composition of which is defined in article R. 2131-12 ; 3° It must carry out all the tasks defined…

Article R2131-12 of the French Public Health Code

November 4, 2023

Each centre consists of : 1° A team of practitioners comprising at least : a) A doctor practising on the site mentioned in 1° of article R. 2131-11, holding a diploma of specialised studies in gynaecology-obstetrics or an equivalent diploma ; b) A practitioner practising on this site, with training and experience in foetal ultrasound ; c) A doctor practising on this site who holds a diploma in paediatrics or…

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Article R2131-5-5 of the French Public Health Code

Article R2131-6 of the French Public Health Code

Article R2131-7 of the French Public Health Code

Article R2131-8 of the French Public Health Code

Article R2131-9 of the French Public Health Code

Article R2131-9-1 of the French Public Health Code

Article R2131-10 of the French Public Health Code

Article R2131-10-1 of the French Public Health Code

Article R2131-11 of the French Public Health Code

Article R2131-12 of the French Public Health Code

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