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Showing 6351–6360 of 12694 articles for “Art. CAA Lyon 19-8-2021 n° 19LY01666”
I. - Are applicable in the Wallis and Futuna Islands, subject to the adaptations provided for in II, the provisions of the articles mentioned in the left-hand column of the table below, in the wording…
For the purposes of this section, the following definitions shall apply1° Incident: an accident or error related to activities involving gametes, germinal tissue or embryos mentioned in 1° of the I of…
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 f…
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 th…
I.-Establishments or organisations that prepare or import investigational advanced therapy medicinal products prepared on an ad hoc basis ensure that all preparation operations are carried out in acco…
I. - Substantial changes to the activities authorised in application of this section which relate to: - the preparation of a new pharmaceutical form of an advanced therapy medicinal product prepared o…
I. - Any changes relating to: 1° The name or administrative address of the registered office of the establishment or authorised body; 2° The appointment of a new director of the establishment or autho…
Establishments and authorised organisations shall implement a procedure for the withdrawal of advanced therapy medicinal products prepared on an ad hoc basis in accordance with the rules of good pract…
Establishments or authorised organisations shall draw up and keep up-to-date a full list of the agreements they have entered into with third parties whose involvement has an influence on the quality a…
Advanced therapy medicinal products prepared on an ad hoc basis are distributed, under the responsibility of the person in charge referred to in article R. 4211-37 or, where applicable, the person in…
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