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Showing 4541–4550 of 9197 articles for “Art. 1352-8”
The provisions of the articles mentioned in the left-hand column of the following table shall apply in the Wallis and Futuna Islands, in the wording indicated in the right-hand column of the same tabl…
Article D*. 351-4 is applicable in the Wallis and Futuna Islands, in the version resulting from decree no. 2005-1006 of 2 August 2005.
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…
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