Each health establishment, organisation, health cooperation group or medical biology laboratory authorised to carry out medically assisted procreation activities shall set up and keep up to date a quality assurance system. Documentation of the quality assurance system includes, in particular, validated procedures and operating methods.
The traceability of gametes for donation and embryos intended for reception is ensured by the use of the unique European donation code, the structure and allocation procedures for which are defined in the order mentioned in articles R. 2142-24 and R. 2142-27. This code is affixed to the traceability sheet accompanying the gametes and embryos concerned.
Health establishments and organisations authorised to carry out one or more biological activities in medically assisted procreation are responsible for : 1° Assigning the unique European donation code at the latest before gametes for donation and embryos intended for reception are made available; 2° affixing the unique European donation code on the traceability sheet and, where applicable, on the label of the gametes and embryos concerned; 3° Informing the Agence…
As part of the system relating to the single European donation code, the Agence de la biomédecine is responsible for : 1° allocating a unique establishment number to all health establishments and organisations authorised to carry out one or more biological activities for medically assisted procreation on national territory; 2° choosing the system or systems for allocating unique donation numbers used on national territory; 3° monitoring and implementing the system…
Traceability data is kept for forty years after gamete insemination, germ tissue transplant or embryo transfer.
The health care organisation in which the activities defined in 1° of Article R. 2142-1 are performed must have a doctor experienced in ultrasound and an anaesthetist-resuscitator. In addition, the establishment must enlist the help of a psychologist or a doctor qualified in psychiatry. When oocyte retrieval is carried out by a practitioner meeting the criteria mentioned in article R. 2142-10 who does not have a surgical qualification, a practitioner…
The activities defined in a, c, d, e and f of 1° of article R. 2142-1 must be carried out within an establishment authorised to carry out surgical or gynaecology-obstetrics activities, in a centre comprising at least : -a room for interviews between couples and unmarried women and the medical team, as provided for in article L. 2141-10 ; -a room for embryo transfer; -a retrieval room equipped in accordance…
The healthcare establishment or organisation must comply with the rules of good practice defined by order of the Minister for Health, issued on a proposal from the Director General of the Agence de la biomédecine after receiving the opinion of the Agence nationale de sécurité du médicament et des produits de santé. These rules take into account the recommendations of the French National Authority for Health in accordance with the…
The health care organisation must keep, with due regard for confidentiality : 1° A copy of the documents attesting to compliance with the conditions laid down in Article L. 2141-2 ; 2° The written consent of the couple or of the unmarried woman benefiting from medically assisted procreation, given before the procedure is carried out and before the embryo is transferred or before insemination, as well as, in cases where…
The collection, preparation, storage and provision of gametes or germ tissue and the preparation, storage and provision of embryos are carried out, in accordance with the rules of good practice for medically assisted procreation mentioned in articles R. 2142-24 and R. 2142-27, in each health establishment, organisation, health cooperation group or medical biology laboratory in which the activities defined in 2° of article R. 2142-1 are carried out.
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75001, Paris France
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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