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Article R1131-13 of the French Public Health Code

November 6, 2023

The analyses mentioned in 1° and 2° of Article R. 1131-2 may only be performed in the medical biology laboratories of public health establishments, the laboratories of cancer centres, the medical biology analysis laboratories mentioned in Article L. 6211-2 and the medical biology analysis laboratories of the Etablissement Français du Sang (French Blood Establishment) authorised under the conditions defined in Articles R. 1131-14 et seq. These analyses may also be…

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Article R1131-14 of the French Public Health Code

November 6, 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 R. 1131-13, to perform the analyses mentioned in 1° and 2° of Article R. 1131-2 is subject to compliance with the rules laid down in this paragraph. These rules constitute the establishment conditions and the technical operating conditions provided for in 3° of article L. 6122-2….

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Article R1131-15 of the French Public Health Code

November 6, 2023

The authorisation provided for in Article R. 1131-13 is issued for a period of five 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 Conference on Health and Autonomy 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…

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Article R1131-16 of the French Public Health Code

November 6, 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 this application to the Director General of the Agence de la biomédecine.

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Article R1131-17 of the French Public Health Code

November 6, 2023

In the event of failure to comply with the legislative and regulatory provisions of this Title and Books I and II of Part Six of this Code, or breach of the conditions laid down in the authorisation, the authorisation may be suspended or withdrawn under the conditions set out in Article L. 6122-13. When the provisions of the last paragraph of this article relating to the continued suspension or withdrawal…

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Article R1131-18 of the French Public Health Code

November 6, 2023

The holder of the authorisation referred to in Article R. 1131-13 is required to declare to the competent regional health agency and to the Agence de la biomédecine, the names of the approved practitioners prior to implementation of the authorisation, as well as the name of any new approved practitioner prior to taking up their post. It is also required to inform the Regional Health Agency and the Agence de…

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Article R1131-19 of the French Public Health Code

November 6, 2023

The report on the analyses mentioned in 1° and 2° of article R. 1131-2 is commented on and signed by the practitioner approved in accordance with article R. 1131-6 and that on the medical biology analyses mentioned in 3° of article R. 1131-2 by the practitioner responsible for these analyses. The prescribing doctor communicates the results of the examination of genetic characteristics to the person concerned or, where applicable, to…

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Article R1131-20 of the French Public Health Code

November 6, 2023

The written consent and the duplicates of the prescription for the examination of genetic characteristics and the commented and signed medical biology analysis reports are kept by the prescribing doctor in the medical file of the person concerned, in compliance with professional secrecy. The medical biology analysis reports and their explanatory comments are kept by the medical biology analysis laboratories mentioned in article R. 1131-13 for a period of thirty…

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Article R1131-20-1 of the French Public Health Code

November 6, 2023

I. – Prior to the prescription, under the conditions laid down in Article R. 1131-5, of an examination of genetic characteristics likely to identify a genetic anomaly which may be responsible for a serious condition justifying preventive measures, including genetic counselling, or care, the prescribing doctor shall inform the person that, if the diagnosis of this anomaly is confirmed, he or she is obliged to inform the members of his…

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Article R1131-20-2 of the French Public Health Code

November 6, 2023

In the event of the diagnosis of a genetic anomaly which may be responsible for a serious condition justifying preventive measures or care, the doctor, except in cases where the person has asked to be kept in ignorance of the diagnosis, shall communicate the result of the examination to the person and then give him/her the document summarising this information mentioned in the second paragraph of article L. 1131-1-2 under…

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75001, Paris France
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