Mandatory call up for holders of certificates of registration to submit post marketing adverse event reports for human medicines (serious and non-serious) through Industry e- Reporting VigiFlow module

This document is intended to provide communication to all Holders of Certificates of Registration (HCRs)/ Applicants about the mandatory submission of Post-marketing Adverse Event (AE) reports for human medicines through Industry eReporting VigiFlow module. The submission of post-marketing AE reports for human medicines is applicable to all new serious and non-serious cases while all follow up reports submitted via XML or Council for International Organizations of Medical Sciences (CIOMS) Forms, must be submitted using the same format as the initial reports.

Guideline for Industry e-reporting