Article R5121-107-6
Where the application for registration concerns a herbal substance, a herbal preparation or a combination thereof included in the list drawn up for use in traditional herbal medicinal products by the…
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Showing 4481–4490 of 10563 articles for “Art. CE 27-9-2006 n° 285279”
Where the application for registration concerns a herbal substance, a herbal preparation or a combination thereof included in the list drawn up for use in traditional herbal medicinal products by the…
…rbal monograph has been established or where the herbal medicinal product consists of herbal substances, preparations or combinations thereof included in the list drawn up by the Commission of the Eur…
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…
When a herbal substance, a herbal preparation or a combination of substances is withdrawn from the list drawn up by the Commission of the European Communities, any registration of traditional herbal m…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…
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