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Showing 6641–6650 of 53863 articles for “Art. Rép. Cherki: AN 24-1-2017 n° 94515”
For the purposes of this chapter, "establishment" means any place or site where one or more operations involving micro-organisms and toxins or products containing them are carried out.
Any production, manufacture, transport, import, export, possession, offer, transfer, acquisition or use of the micro-organisms and toxins on the list drawn up in application of article L. 5139-1 and p…
The authorisation holder keeps the list provided for in 1° of Article R. 5139-3 up to date and sends it to the Agence nationale de sécurité du médicament et des produits de santé by 15 February each y…
The establishment in which the operations for which authorisation has been granted are carried out operates in compliance with the rules of good practice laid down under the conditions referred to in…
The application for marketing authorisation is accompanied by a dossier containing : 1° The administrative information required to examine the application ; 2° Scientific documentation demonstrating t…
…rinary medicinal product shall be sent to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail, by any means capable of producing a da…
…e state of scientific knowledge at the time of submission of the dossier, presented in summary form and concluding with an analysis of the relationship between the benefits and the risks associated wi…
The application for marketing authorisation is accompanied by a draft summary of product characteristics, the presentation and content of which are laid down in accordance with Article 14 of Directive…
…marketing authorisation application is compiled under the following conditions: 1° Where the applicant demonstrates, by reference to appropriate bibliographical documentation, that the application re…
…or a veterinary medicinal product contains the following information: 1° The name or corporate name and address of the future holder of the marketing authorisation and, where appropriate, those of the…
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