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Showing 9821–9830 of 24245 articles for “Art. 1843-4”
The registration of a homeopathic veterinary medicinal product mentioned in Article L. 5141-9 may be refused, suspended or withdrawn by the Director General of the Agency. Decisions to refuse, suspend…
The labelling and, where appropriate, the package leaflet of the homeopathic veterinary medicinal products referred to in article L. 5141-9 must bear the following information exclusively: 1° The very…
The application for registration of a homeopathic veterinary medicinal product or a series of medicinal products mentioned in article L. 5141-9 is sent to the Agence nationale de sécurité sanitaire de…
The application for registration must be accompanied by a dossier containing : 1° The scientific name, or other name appearing in a pharmacopoeia, of the homeopathic stock or stocks, mentioning the va…
Decisions to register homeopathic veterinary medicinal products or to suspend or cancel these registrations are made public in an extract on the website of the Agence nationale de sécurité sanitaire d…
Amendments 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…
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…
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