The orders mentioned in 2° of article R. 1211-25 specify the conditions under which the practitioner mentioned in article R. 1211-25 is required to repeat the test for all or some of the biological markers of the infections mentioned in the same 2°: 1° In the case of sperm donation, at the time of donation or at the time of the last collection if donations are made on several dates;…
Gametes may only be made available if they are accompanied by a document drawn up by the practitioner mentioned in article R. 1211-25 specifying : 1° The name and address of the authorised establishment that collected the gametes and, where applicable, the name and address of the authorised establishment that carried out the in vitro fertilisation of the oocytes made available; 2° The results of the medical biology examinations provided…
The practitioner carrying out medically assisted procreation, whether this involves artificial insemination or in vitro fertilisation with gametes from a donation, is required to have prior access to the document mentioned in article R. 1211-27, to be aware of the results of the examinations mentioned in 2° of article R. 1211-25 and article R. 1211-26 and to ensure that they do not reveal a risk of transmission of an infection.
Research into risk factors for the transmission of a genetic anomaly may only be carried out with the consent of the donor and in compliance with articles R. 1131-4 and R. 1131-5 and the rules of good practice defined by the decree provided for in article L. 1131-2. Gamete donors who refuse to undergo this research cannot be retained.
I. – The biovigilance system covers : 1° Elements and products of the human body and their derivatives used for therapeutic purposes as well as medical devices incorporating them; 2° Activities relating to these elements, products or derivatives as implemented by the persons mentioned in article R. 1211-32; 3° Donors of elements or products of the human body, patients and recipients who have recourse to grafting or the administration of…
The purpose of biovigilance is to : 1° Systematically monitor all incidents and adverse reactions; 2° Immediately report serious incidents and unexpected adverse reactions to the local biovigilance correspondent; 3° Immediately report serious incidents and unexpected adverse reactions to the Agence de la biomédecine; 4° Analyse, evaluate and use this information to limit the probability of occurrence of any new serious incident or unexpected adverse reaction or to reduce their…
For the purposes of this section, the following definitions apply 1° Incident: an accident or error related to activities involving the elements, products or derivatives mentioned in 1° of the I of article R. 1211-29, resulting or likely to result in: a) an adverse reaction in the persons mentioned in 3° of the I of article R. 1211-29; b) A loss of the element, product or derivative; c) A quality…
The players involved in the biovigilance system are: 1° The Agence de la biomédecine; 2° The Agence nationale de sécurité du médicament et des produits de santé; 3° The following establishments or organisations: a) Establishments and organisations authorised to carry out sampling and collection activities pursuant to Articles L. 1233-1, L. 1242-1 and L. 2323-1; b) Establishments and organisations authorised to carry out the activities of preparation, treatment, conservation, distribution,…
The Agence de la biomédecine is responsible for implementing the biovigilance system. 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 biovigilance correspondent and the corrective measures put in place; 4° After evaluating this information, implements…
After evaluating the information reported to him/her, the Director General of the Agence de la biomédecine analyses the relevance of the corrective measures implemented. If these seem insufficient or inappropriate, he informs the local biovigilance correspondent who reported the event without delay and, if necessary, proposes recommendations. Where appropriate, it draws up recommendations to limit the probability of serious incidents or unexpected adverse reactions occurring, and to reduce their seriousness….
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is a Registered Trademark of
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182, rue de Rivoli
75001, Paris France
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