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Showing 4861–4870 of 56936 articles for “Art. I-3°”
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 applicant for marketing authorisation is responsible for the accuracy and sincerity of the information and data provided to the Agence nationale de sécurité sanitaire de l'alimentation, de l'envir…
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…
By way of derogation from the first paragraph of Article R. 5141-16, for the veterinary medicinal products mentioned in this Article, the dossier attached to the marketing authorisation application is…
Where a veterinary medicinal product, which has already been authorised or is the subject of an application for marketing authorisation under examination in another Member State of the European Union,…
When an application for authorisation concerns a generic veterinary medicinal product of a reference veterinary medicinal product which has not been authorised in France but which has been authorised…
When informed by the holder of a marketing authorisation granted under 1°, 2° or 3° of Article R. 5141-20, before the marketing of the veterinary medicinal product concerned, of the fact that for all…
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…
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