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Showing 4771–4780 of 56695 articles for “Art. comité juridique of 9 January 2019”
I.-The period of traditional medical use provided for in 4° of Article L. 5121-14-1 is thirty years, including at least fifteen years in a Member State of the European Community or in another State pa…
Where the application for registration concerns a product which has been the subject of a Community herbal monograph established by the Committee for Herbal Medicinal Products of the European Medicine…
…presented in accordance with the order referred to in Article R. 5121-11 : 1° The name and address of the applicant and, where applicable, those of the company exploiting the medicinal product as wel…
…whom has been reported, a serious or unexpected adverse reaction which may be attributed to the use of a veterinary medicinal product, whether or not he has prescribed it, or a medicinal product for h…
A company operating a veterinary medicinal product must: 1° Keep detailed records of all suspected adverse reactions which have occurred inside or outside the European Union; 2° To record any suspecte…
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,…
…ct relating to pharmacovigilance without transmitting it, beforehand or simultaneously in the event of an emergency, to the Director General of the Agence nationale de sécurité sanitaire de l'alimenta…
…inary 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 for…
…igilance 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 sécurité sanitaire de l'alimentation, de l'enviro…
…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 medicinal product…
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