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Showing 8161–8170 of 53704 articles for “Art. CA Paris 1-12-2021 n° 20/04742”
…offer, transfer, acquisition or use of the micro-organisms and toxins on the list drawn up in application of article L. 5139-1 and products containing them is subject to an authorisation issued by th…
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…
The application for marketing authorisation for a veterinary medicinal product shall be sent to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement…
The expert reports provided for in article R. 5141-16 consist of a critical evaluation of the various trials carried out, taking into account the state of scientific knowledge at the time of submissio…
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…
…icinal products mentioned in this Article, the dossier attached to the marketing authorisation application is compiled under the following conditions: 1° Where the applicant demonstrates, by reference…
The application for marketing authorisation for a veterinary medicinal product contains the following information: 1° The name or corporate name and address of the future holder of the marketing autho…
The dossiers provided in support of the authorisation of the veterinary medicinal products mentioned in articles R. 5141-16 and R. 5141-18 are considered to include all the data necessary and sufficie…
The Agency is subject to the provisions of Titles I and III of Decree 2012-1246 of 7 November 2012 on public budgetary and accounting management.
Without prejudice to the provisions of article R. 6123-32-9, the provisions of this section do not apply to the health establishments mentioned in the first paragraph of article L. 3211-1 and article…
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