This article was originally published in The Tan Sheet
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)...
You may also be interested in...
Chief medical officer Samit Hirawat outlines R&D successes – though there have been some setbacks since it bought Celgene for $74bn last year – and the company’s commitment to clinical trial diversity.
Letter from department’s general counsel responds to request from the company for a pre-enforcement advisory opinion. Despite the letter, Lilly maintains its ‘limited distribution program is fully consistent with applicable laws and regulations.’
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.