The embryo register that must be kept by any health establishment, body, health cooperation group or laboratory authorised to store embryos must mention : 1° The identity of the couple or unmarried woman who is at the origin of the embryo and, where applicable, the unique European donation code or the anonymisation code of the gamete donor in the case of an embryo conceived with recourse to a third party…
Practitioners meeting the criteria mentioned in article R. 2142-11 for the conservation of gametes, germinal tissue or embryos are responsible for keeping the registers mentioned in articles R. 2142-33 and R. 2142-34 and for ensuring the accuracy of the information they record therein.
These registers must be kept in premises close to those where gametes, germ tissue or embryos are stored, under conditions that ensure confidentiality.
The responsible person referred to in Article L. 2142-3-1 must meet one of the requirements set out in Article R. 2142-11 and have at least two years’ practical experience in reproductive medicine and biology. It is responsible for : 1° Ensuring that gametes, germ tissue and embryos used for the purposes of medically assisted procreation or for restoring hormonal function are collected, retrieved, prepared, preserved, made available and transported, in…
To facilitate the performance of the responsible person’s duties, agreements are concluded between the structures authorised to carry out one or more clinical activities in medically assisted procreation and those authorised to carry out one or more biological activities in medically assisted procreation.
I. – The vigilance system for medically assisted procreation concerns : 1° Gametes, germinal tissue and embryos used for the purposes of medically assisted procreation and the restoration of hormonal function ; 2° Activities relating to these gametes, germ tissue and embryos as implemented by the persons mentioned in Article L. 2142-1 ; 3° Persons who have recourse to medically assisted procreation or are the result of such assistance, gamete…
The purpose of vigilance in medically assisted procreation is to : 1° Systematically monitor all incidents and undesirable effects; 2° Report serious incidents and unexpected undesirable effects to the local correspondent without delay; 3° Report serious incidents and unexpected undesirable effects to the Agence de la biomédecine without delay after they have been reported; 4° Analyse, evaluate and use this information in order to limit the probability of occurrence of…
For the purposes of this section, the following definitions shall apply 1° Incident: an accident or error related to activities involving gametes, germinal tissue or embryos mentioned in 1° of the I of article R. 2142-39, resulting in or likely to result in: a) An adverse reaction in the persons mentioned in 3° of the I of article R. 2142-39 ; b) A loss of these gametes, germinal tissues or…
The players involved in the monitoring system relating to medically assisted procreation are: 1° The Agence de la biomédecine; 2° Health establishments, medical biology laboratories and organisations authorised to carry out the activities mentioned in Article L. 2142-1; 3° The following professionals: a) Practitioners working in the health establishments, medical biology laboratories or organisations mentioned in 2°; b) Any other health professional who is aware of an adverse reaction which,…
The Director General of the Agence de la biomédecine is responsible for implementing the monitoring system relating to medically assisted procreation. Within this framework, the Agency: 1° Leads and coordinates the actions of the various parties involved; 2° Ensures compliance with the procedures organised by this section; 3° Evaluates the information reported to it, including the results of investigations carried out by the local correspondent and the corrective measures put…
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call us at +33 (0) 1 84 88 31 00 or send us an email.
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
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
Resources
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
Useful links
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call +33 (0) 1 84 88 31 00 or send us an email.
All information exchanged through this website will be communicated to lawyers registered with a French Bar and will remain confidential.
