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Showing 3911–3920 of 28899 articles for “Art. Loi 2023-171 du 9 mars 2023”
If, after a traditional herbal medicinal product has been registered, the proprietor considers, on the basis of new data available to him, that, given its characteristics, the medicinal product is now…
…by the Commission of the European Communities, any registration of traditional herbal medicinal products containing this substance is cancelled by the Director General of the Agency, unless the holde…
…y bibliographical evidence or expert reports; thirty-year medical use is established even if the product has not been marketed with a specific authorisation or if the number of components of the produ…
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…
…5121-11 : 1° The name and address of the applicant and, where applicable, those of the company exploiting the medicinal product as well as those of the manufacturer when neither the applicant nor th…
…ious 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 human use administered to an a…
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…
…ctor General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail, immediately after becoming aware of any suspected serious adverse reaction in animals an…
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…
…ns laid down in this section apply without prejudice to those laid down for veterinary medicinal products authorised by the European Medicines Agency in Regulation (EC) No 726/2004 of the European Par…
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