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Showing 3561–3570 of 18199 articles for “Art. CE 10-7-2012 n° 336492”
…n article L. 5132-6-1 on an open-ended contract is declared by electronic means, using the teleservice mentioned in article R. 5132-1-19. Where applicable, the termination of this employment contract…
The request for an opinion from the Agence nationale de sécurité du médicament et des produits de santé by the ministers responsible for health and social security, on the order mentioned in the last…
…relating to this change. On expiry of a period of sixty days from the date of the application, silence on the part of the Director of the Agency will be deemed to constitute acceptance of the applicat…
…s that the pharmacological effects or efficacy are not plausible despite the age of use and experience; 4° The pharmaceutical quality is not satisfactorily demonstrated. Where the application for regi…
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…
…s laid down in Chapters I and IIa of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing authorisation for medicinal produc…
…e application for registration and the expert reports are drawn up and signed by persons with the necessary qualifications and experience as mentioned in Article R. 5121-33.
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…
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When a herbal substance, a herbal preparation or a combination of substances is withdrawn from the list drawn up by the Commission of the European Communities, any registration of traditional herbal m…
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