EMA has issue clarifications on what consitutes “significant non-compliance” when it comes to notifying EMA and relevant NCAs these situations including what types of ICSR notification delays are considered significant

OC Vigilance
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.