POTENCY LABELLING ADVICE RELEASED BY EMA
April 12th, 2014
THE EUROPEAN Medicines Agency (EMA) has released guidance on declaring quantitative composition and potency labelling regarding biological medicinal products with modified proteins as an active substance. The advice says manufacturers should take into account the product class, mass unit and assay methods. For product labelling, chosen unit systems must avoid prompting confusion in clinical practice, it said. *http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/03/WC500140709.pdf
Full access to this article can be arranged with permission from the client that first ordered it. Please contact us to request access. Entries are uploaded to our archive at least one year after being published by a client – free access is restricted to International News Services journalists for background research only. The article date indicates when copy was filed to a client, not when posted to this archive. Upon client requests, International News Services will remove such articles from the archive or not upload them in the first place. They are included to demonstrate the breadth of topics undertaken by the agency and also to help promote clients’ coverage.