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Showing 271–280 of 59300 articles for “Art. 9° and 10°”
…e same professionals may, under the same conditions, inform the veterinary pharmacovigilance centre and the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail o…
…nside or outside the European Union; 2° To record any suspected serious adverse reaction in animals and any suspected adverse reaction in humans resulting from the use of veterinary medicinal products…
The declaration and reporting obligations laid down in this section apply without prejudice to those laid down for veterinary medicinal products authorised by the European Medicines Agency in Regulati…
The procedures and standard form 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 Gene…
…s reported or which have been reported to it, together with a scientific evaluation of the benefits and risks of the veterinary medicinal product: 1° Immediately on request ; 2° Half-yearly: a) During…
The principles of good veterinary pharmacovigilance practice to which veterinarians, pharmacists and members of the other health professions mentioned in 4° of article R. 5141-93 are subject are defin…
…r : 1° Receiving reports sent, in application of article R. 5141-103, by veterinarians, pharmacists and any member of a health profession or any person who has observed an adverse reaction in an anima…
…an, responsible for veterinary pharmacovigilance residing in the European Union. The name, position and contact details of this person are communicated to the Director General of the Agence nationale…
The creation, organisation and funding of veterinary pharmacovigilance centres, as well as the conditions under which they carry out the tasks entrusted to them by the Agence nationale de sécurité san…
…igid devices. Removal of the devices used may only be carried out on the orders of the site manager and under his personal supervision.
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