Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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)...

You may also be interested in...



Nearly One Year Post-Celgene: BMS CMO On Pipeline Progress, Clinical Trial Diversity

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.

Lilly’s 340B Restrictions: Jury Is Still Out On Appropriateness, But Optics Are Bad, HHS Says

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.’

Health And Wellness Trademark Review 22 September, 2020

Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.

Topics

UsernamePublicRestriction

Register

PS122308

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel