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Showing 3991–4000 of 48677 articles for “Art. II-9°”
Veterinary pharmacovigilance centres are responsible for : 1° Receiving reports sent, in application of article R. 5141-103, by veterinarians, pharmacists and any member of a health profession or any…
The poison control centres referred to in article L. 6141-4 and the regional pharmacovigilance centres referred to in article R. 5121-167 shall transmit, without delay, to the Agence nationale de sécu…
A company operating veterinary medicinal products has at its disposal, on a permanent basis, the services of a person, pharmacist or veterinarian, responsible for veterinary pharmacovigilance residing…
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…
A veterinarian who has observed, or to 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 pres…
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,…
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…
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…
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