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Showing 3371–3380 of 21284 articles for “Art. BOFiP-BIC-CHAMP-40-10-§§ 115 et 165”
In accordance with article L. 5151-2 of the French Labour Code, a personal activity account is opened for any person subject to the contribution provided for in articles L. 6331-48, L. 6331-53 and L.…
…on of Article 16f of Directive 2001/83/EC, a herbal medicinal product which is the subject of a marketing authorisation now falls wholly or partly under the registration system, the holder sends the N…
…1, R. 5121-97, R. 5121-107-4 and R. 5121-107-5, or if at least one of the following conditions is met: 1° The qualitative or quantitative composition of the medicinal product does not correspond to t…
Following the establishment of a new Community herbal monograph or the revision of an existing monograph, the registration holder shall submit a request for amendment of the registration dossier to th…
…EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products, in accor…
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…
…ition procedure or the decentralised procedure under the same conditions as those laid down for marketing authorisation in articles R. 5121-51 to R. 5121-51-7.
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When a herbal substance, a herbal preparation or a combination of substances is withdrawn from the list drawn up by the Commission of the European Communities, any registration of traditional herbal m…
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