Article R5121-107-11
When a herbal substance, a herbal preparation or a combination of substances is withdrawn from the list drawn up by the Commission of the European Communities, any registration of traditional herbal m…
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Showing 4421–4430 of 10201 articles for “Art. CE 29-9-1989 n° 68212”
When a herbal substance, a herbal preparation or a combination of substances is withdrawn from the list drawn up by the Commission of the European Communities, any registration of traditional herbal m…
…unity or in another State party to the European Economic Area, as attested by bibliographical evidence or expert reports; thirty-year medical use is established even if the product has not been market…
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…
…egistration application file includes the following information and documents, presented in accordance with the order referred to in Article R. 5121-11 : 1° The name and address of the applicant and,…
…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, de l'environnement et du travail or to the vet…
…t to his attention and to report it within 15 days at the latest to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail if the reacti…
…f 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, immediately…
…mmunicate to the public information on this veterinary medicinal product relating to pharmacovigilance without transmitting it, beforehand or simultaneously in the event of an emergency, to the Direct…
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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