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Showing 9911–9920 of 24814 articles for “Art. 4 Mar 2013”
…onnement et du travail. Registration decisions include the information provided for in Article R. 5141-63.
…endments concerning the data mentioned in the application and dossier provided for in articles R. 5141-63 and R. 5141-64 are submitted for approval to the Director General of the Agence nationale de s…
…or human use administered to an animal under the conditions provided for in a of 3° of article L. 5143-4, shall immediately report it to the Agence nationale de sécurité sanitaire de l'alimentation, d…
…on of the decentralised procedure or the mutual recognition procedure provided for in articles R. 5141-47-1 et seq., any company exploiting a veterinary medicinal product authorised under one of these…
The holder of an authorisation referred to in Article L. 5141-12 must report to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail,…
The company exploiting a veterinary medicinal product may not communicate to the public information on this veterinary medicinal product relating to pharmacovigilance without transmitting it, beforeha…
…erinary medicinal products authorised by the European Medicines Agency in Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures fo…
…rm for the declarations and the periodic pharmacovigilance update report mentioned in articles R. 5141-103 to R. 5141-105-1 are laid down by decision of the Director General of the Agence nationale de…
Without prejudice to the conditions laid down when the marketing authorisation is granted pursuant to the provisions of the fourth paragraph of Article L. 5141-5, the company operating the veterinary…
…devices and shall apply the necessary corrective measures.For Class I medical devices placed on the market in a sterile state or having a measuring function, the manufacturer must also follow, at his…
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