MHRA Outlines Reporting Procedure During EudraVigilance System Changeover

The UK’s Medicine and Healthcare Products Regulatory Agency added methods for reporting electronic suspected unexpected serious adverse reaction (eSUSAR) reports during the changeover blackout period for the European Medicines Agency’s new EudraVigilance system.

During the planned outage, from Nov. 8-21, sponsors may continue to report to MHRA through the agency’s eSUSAR website, where reports will be held, queued and then submitted to the new system after it goes live Nov. 22. Forms may also be submitted by email or post.

In addition, two cumulative line listings of all serious adverse event reports should be provided — with one listing submitted Nov. 14 covering Nov. 8-13, and the other submitted Nov. 21, covering Nov. 14-20.