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08:21 Oct 15, 2010 |
English to French translations [PRO] Law/Patents - Law: Patents, Trademarks, Copyright / Pharma. | |||||||
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| Selected response from: FX Fraipont (X) Belgium Local time: 02:10 | ||||||
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Summary of answers provided | ||||
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4 +3 | monographies des médicaments en ventre libre |
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4 | systèmes de monographies pour les médicaments en vente libre |
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Discussion entries: 1 | |
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otc monograph systems systèmes de monographies pour les médicaments en vente libre Explanation: "Pour vous donner une idée de l'efficacité de ce système de monographie, permettez-moi de vous dire que lorsque la loi sur les médicaments est entrée en vigueur en 1978, nous avions plus de 40 000 tisanes anciennes sur le marché allemand. Aujourd'hui, il en reste environ 20 000, qui sont couvertes par des autorisations standards de commercialisation. Ces 20 000 produits ne nécessitent aucune ressource à l'Institut, sauf une exception: nous devons mettre à jour les exigences d'étiquetage et d'autorisation standard. " http://www2.parl.gc.ca/HousePublications/Publication.aspx?Do... "In the United States, the manufacture and sale of OTC substances is regulated by the FDA. The Federal Food, Drug, and Cosmetic Act requires that all "new drugs" obtain a New Drug Application ("NDA") prior to entering interstate commerce, but the act exempts any drugs generally recognized as safe and effective ("GRAS/E") from this requirement. In order to deal with the vast number of OTC drugs that were already on the market prior to the requirement that all drugs obtain an NDA, the FDA created the OTC monograph system to review classes of drugs and categorize them as GRAS/E after review by expert panels. This meant that certain classes of OTC drugs were not required to obtain an NDA and could remain on the market if they conformed to the monograph guidelines for doses, labeling, and warnings." http://en.wikipedia.org/wiki/Over-the-counter_drug |
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otc monograph systems monographies des médicaments en ventre libre Explanation: Propre aux États Unis ((over the counter). -------------------------------------------------- Note added at 1 heure (2010-10-15 10:00:27 GMT) -------------------------------------------------- VENTE, évidemment !!! Reference: http://www.senat.fr/rap/r96-196/r96-19682.html |
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Notes to answerer
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