Article R5141-16
…efficacy of the veterinary medicinal product, in particular test or trial reports relating to pharmaceutical, non-clinical, clinical or efficacy trials, including the results obtained during these var…
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Showing 5251–5260 of 52948 articles for “Art. CE 27-1-2017 n° 391817”
…efficacy of the veterinary medicinal product, in particular test or trial reports relating to pharmaceutical, non-clinical, clinical or efficacy trials, including the results obtained during these var…
…g 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 et du travail, by any means…
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…
…summary of product characteristics, the presentation and content of which are laid down in accordance with Article 14 of Directive 2004 / 28 / EC of 31 March 2004 by order of the Ministers for Agricu…
…lication is compiled under the following conditions: 1° Where the applicant demonstrates, by reference to appropriate bibliographical documentation, that the application relates to a veterinary medici…
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…
…l products mentioned in articles R. 5141-16 and R. 5141-18 are considered to include all the data necessary and sufficient for the evaluation of these medicinal products within the meaning of 8° of ar…
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.
…iate care to a patient who presents himself during the opening hours of his consultations and, if necessary, refers him or has him transferred, after regulation by the SAMU, to a health establishment…
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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