Welcome to the EudraVigilance Regulatory Status portion of our web site. Here you will find information on the electronic data collection process. On the sub menu to the left, you will find regulatory mandate status updates, as well as EVWEB and EudraVigilance Fee Waiver MedDRA subscription information. We hope you find this area helpful.

To address the electronic data collection process in the frame of the pharmacovigilance activities in the EEA, the EMEA and the European Commission set up the following two EudraVigilance modules:

•  EudraVigilance Clinical Trial Module (EVCTM)

To collect SUSAR reports as described in chapter 1 in accordance with the provisions of Directive 2001/20/EC

•  EudraVigilance Post-Authorisation Module (EVPM)

To collect ICSRs as described in chapter 1 in accordance with the provisions of Council Regulation ( EEC ) No. 2309/93 as amended and Regulation (EC) No. 726/2004

Further, the EMEA provides to interested organisations with reporting obligations in pharmacovigilance (pre- and post-authorisation phase) the possibility to use EVWEB , a web-based application, which is an integrated part of the European pharmacovigilance system called EudraVigilance. EVWEB also incorporates MedDRA in the latest version and allows for electronic reporting to the EMEA and the NCAs in the EEA in compliance with the applicable ICH standards.

MedDRA is a component of both of the EudraVigilance modules. The MSSO has a special license in place to support both EudraVigilance modules that allows qualifying organizations to utilize MedDRA at no charge (Fee Waiver MedDRA Subscription) within EudraVigilance. Any current, valid MedDRA subscriber can also utilize the EudraVigilance system as well.

Please email any questions to: mssohelp@ngc.com or call at 877.258.8280 (ATT Worldwide).