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Showing 6681–6690 of 49805 articles for “Art. 25-8 II”
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…
…L. 1123-8 and accepted by the Agence nationale de sécurité du médicament et des produits de santé. II.-The importing establishment or organisation ensures that the investigational advanced therapy me…
…are carried out;4° the creation of new premises in which the authorised activities are carried out.II - The application for authorisation to modify is sent to the Director General of the Agence natio…
…pdate the authorisation, within three months of the declaration referred to in the first paragraph. II - Updating the authorisation does not extend the duration of the authorisation initially granted.…
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…
…uirements mentioned in the authorisation granted in application of Section 17 of Chapter I of Title II of Book I of Part Five of the Public Health Code.
An authorised establishment or organisation may transfer to another authorised establishment or organisation advanced therapy medicinal products prepared on an ad hoc basis with a view to their storag…
Changes other than those mentioned in articles R. 4211-43 and R. 4211-44 are declared in the annual activity report provided for in article R. 4211-47.
In the event of non-compliance with the legislative and regulatory provisions or the conditions of the authorisation, the suspension, which may not exceed one year, and the withdrawal of the authorisa…
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