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Showing 2361–2370 of 59948 articles for “Art. R. 612-1”
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…
…pliance with the rules of good practice laid down under the conditions referred to in 3° of Article R. 5139-20 and designed to guarantee biological safety and security. The following definitions apply…
…s used by the manufacturer; 8° A summary of the product characteristics, in accordance with Article R. 5141-15, a mock-up of the immediate packaging and the outer packaging of the veterinary medicinal…
…sation shall be at least six months. This application includes the information indicated in article R. 5141-14, the summary of product characteristics provided for in article R. 5141-15 and the dossie…
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…
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…
…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 sufficient for the ev…
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.
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