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Showing 9871–9880 of 24499 articles for “Art. 4 Dec 2013”
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registration of a homeopathic veterinary medicinal product mentioned in Article L. 5141-9 may be refused, suspended or withdrawn by the Director General of the Agency.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…
…e, 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 clear indication "homeopathic vete…
…omeopathic 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 l'alimentation, de l'environnement et…
…ntrol file for each pharmaceutical form and a description of the dilution and dynamisation methods; 4° The reference of the authorisation to manufacture the medicinal products in question or a documen…
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…
…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…
…t the latest. When France is designated as the reference Member State for the implementation of the decentralised procedure or the mutual recognition procedure provided for in articles R. 5141-47-1 et…
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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