EudraVigilance

To address the electronic data collection process in the frame of the pharmacovigilance activities in the EEA, the EMA 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 EMA provides to interested organizations 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 EMA 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. Two types of organizations qualify for the EudraVigilance MedDRA License fee waiver:

• Organizations (MAH or sponsors) that are Small and Micro Size Enterprises
• Sponsors of non-commercial Clinical Trials conducted in the EEA

For more information, see the Special License tab on the MedDRA Subscription Types page.

Any current, valid MedDRA subscriber can also utilize the EudraVigilance system as well.

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