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EU legislation

This article was originally published in The Tan Sheet

Executive Summary

New EU medicines legislation comes into effect Oct. 30, requiring all drugs authorized after that date to carry the name of the medicine in Braille and provide additional aid to patients suffering from sight loss, such as leaflets in large print and audio versions of Patient Information Leaflets made available in CD and tape format. The legislation also deems it a criminal offense if companies fail to submit new information that may affect the risk/benefit ratio of a product. The EU directive on Herbal Medicines also comes into effect Oct. 30, requiring herbal manufacturers to register their products prior to sale, rather than selling them as unlicensed herbal remedies. The UK's Medicines & Healthcare products Regulatory Agency sought comments on the directive's implementation in June (1"The Tan Sheet" July 4, 2005, p. 14)...





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