The gamete, germinal tissue and embryo registers provided for in articles R. 2142-33 and R. 2142-34, as well as, where applicable, the information mentioned in article R. 1244-5 concerning the gamete donor, must be sent to the health establishment, body, health cooperation group or laboratory receiving the gametes, germinal tissue or embryos under conditions that guarantee their confidentiality.
The registers of gametes or germinal tissue to be kept by any health establishment, body, health cooperation group or laboratory authorised to store such gametes or tissue must include : 1° The identity of the person whose gametes have been collected or retrieved in the case of medically assisted procreation without recourse to a third-party donor, or the identity of the person whose gametes or germ tissue are stored in…
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…
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75001, Paris France
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is a Registered Trademark of
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182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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