Based on the policy adopted at the level of the ICH MedDRA Management Board, the MSSO supports the use of MedDRA by providing special MedDRA licences to regulatory authorities. These special licences are intended to help government and other governmental agencies worldwide to give access to MedDRA coding for non-commercial users and small commercial organisations with low revenue and often limited IT resources.
Special licences allow MedDRA’s use without charge in a non-downloadable format within agency electronic (software) tools designed to allow a company to meet their regulatory (adverse reaction) reporting requirements. Reilly
European Web Portal – The EMA (European Medicines Agency) provides to interested organisations with reporting obligations in pharmacovigilance the possibility to use EVWEB, a web-based application, which is an integrated part of the European pharmacovigilance system called EudraVigilance. EVWEB incorporates the latest version of MedDRA and allows for electronic reporting to the EMA and the various national regulatory agencies in the EEA in compliance with the applicable ICH standards. It allows small and micro-sized companies (with an annual revenue threshold of 10 million Euros) to transmit ADR reports to regulators, with a fee waiver MedDRA subscription.
Regulatory authorities interested in a MedDRA special licence should contact the MSSO Help Desk