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…
After evaluating the information reported to him/her, the Director General of the Agence de la biomédecine analyses the appropriateness of the corrective measures put in place. If the latter appear to be insufficient or inappropriate, he/she immediately informs the local correspondent of the vigilance system for medically assisted procreation who reported the event to him/her, and if necessary, proposes recommendations. Where appropriate, it will draw up recommendations to limit the…
The establishments and organisations mentioned in 2° of article R. 2142-42 organise the implementation of the local system of vigilance in medically assisted procreation, in particular by making available to professionals the tools necessary to implement their missions of monitoring, reporting or declaring incidents and adverse effects. The Agence de la biomédecine offers methodological tools for this purpose. The local monitoring system for medically assisted procreation sets out the procedures…
I.-The establishments and organisations mentioned in 2° of Article R. 2142-42 shall appoint a local correspondent and his/her alternate. As soon as they are appointed, the identity, status, experience and contact details of the local correspondent and his/her alternate are communicated to the Agence de la biomédecine by the head of the structure in which the correspondent and his/her alternate perform their duties. The provisions of this decree also apply…
The local correspondent for the vigilance system relating to medically assisted procreation is responsible for : 1° Ensuring that the health professionals involved in the activities mentioned in 2° of I of Article R. 2142-39; 2° Gathering, keeping and making accessible the information communicated to it relating to incidents and undesirable effects; 3° Identifying and declaring serious incidents and unexpected undesirable effects to the Agence de la biomédecine without delay;…
Each establishment or body mentioned in 2° of Article R. 2142-42 shall ensure that a procedure is put in place to prevent the use of gametes, germinal tissue or embryos mentioned in 1° of I of Article R. 2142-39 that are likely to present a quality or safety defect.
Without prejudice to the obligation mentioned in Article L. 1413-14: 1° Any healthcare professional practising in a facility with a local correspondent for the vigilance system relating to medically assisted procreation and who is aware of the occurrence of any serious incident or unexpected adverse reaction must report it to this correspondent without delay. If the local correspondent or his/her deputy is unable to act, the healthcare professional must report…
For the application of this chapter: 1° Where the embryo or embryos referred to in the first paragraph of Article L. 2143-1 have been conceived as a result of a sperm donation, an oocyte donation or a sperm donation and an oocyte donation, the notion of third party donor refers to the person or persons having consented to these gamete donations as well as the couple, the surviving member or…
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75001, Paris France
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is a Registered Trademark of
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75001, Paris France
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