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Showing 3691–3700 of 8145 articles for “Art. 1352-9”
The detailed summaries of the tests accompanying the application for registration and the expert reports are drawn up and signed by persons with the necessary qualifications and experience as mentione…
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…
Where a Community herbal 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 C…
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When a herbal substance, a herbal preparation or a combination of substances is withdrawn from the list drawn up by the Commission of the European Communities, any registration of traditional herbal m…
I.-The period of traditional medical use provided for in 4° of Article L. 5121-14-1 is thirty years, including at least fifteen years in a Member State of the European Community or in another State pa…
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…
The registration 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…
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…
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