EMA RELEASES GUIDANCE ON PREPARING PRODUCT CHARACTERISTIC SUMMARIES
February 1st, 2013
THE EUROPEAN Medicines Agency (EMA) has published guidance helping pharmaceutical companies prepare and review summaries of product characteristics (SmPCs) for human medicines. It details information required for each SmPC section, plus background information, for instance on therapeutic indication, pharmacodynamic properties and undesirable effects sections. The guidance “is intended to enable companies to make sure that the information in SmPCs is of high quality when they submit them to the agency” during marketing authorisation applications, said an EMA ...
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.