EU Module 15 Safety Communications

By Bart Cobert

On January 24, 2013 the EMA’s latest Good PV Practices Module 15 on Safety Communications came into force.  Although this module may be a little less critical compared to the other already-released modules which have changed the way PV is done, this module still is worth reviewing.

The goal is to provide Marketing Authorisation Holders (MAHs) and Competent Authorities (CAs) guidance on communication & coordination of safety information. It covers product information, namely: the Summary of Product Characteristics (SmPC or SPC), the Package Leaflet (PL), other labeling, public assessment reports and various other drug related documents.  Its focus is on new or emerging safety information about a previously known or unknown risk which has or may have an impact on the benefit-risk balance and conditions of use.