Article R754-24
…ted in the right-hand column of the same table:Applicable articlesIn the wording resulting from the decreeR. 351-3no. 2014-551 of 27 May 2014R. 351-5No. 2005-1738 of 30 December 2005II. - For the appl…
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Showing 4581–4590 of 9305 articles for “Art. 8 Dec 1999”
…ted in the right-hand column of the same table:Applicable articlesIn the wording resulting from the decreeR. 351-3no. 2014-551 of 27 May 2014R. 351-5No. 2005-1738 of 30 December 2005II. - For the appl…
…or evolution of which is not expected with regard to the criteria defined by the Agence de la biomédecine under the conditions provided for in 7° of Article R. 2142-43 or taking into account the stat…
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…
…hout 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…
…rmation provided by the sponsor in the application for authorisation referred to in article L. 1123-8 and accepted by the Agence nationale de sécurité du médicament et des produits de santé. II.-The i…
…ompanied by a technical file adapted to the type of change requested, the model for which is set by decision of the Director General of the Agence nationale de sécurité du médicament et des produits d…
…ded for in 5° of Article R. 4211-34. 4211-34. Within one month of their implementation, changes are declared to the Agence nationale de sécurité du médicament et des produits de santé by the legal ent…
…measure. It shall send a copy of this notification to the Director General of the Agence de la biomédecine.
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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