EudraVigilance (EV)




About the EudraVigilance Gateway

The EMA has implemented an electronic regulatory submission environment, the EudraVigilance Gateway, which follows the ICH M2 Gateway Recommendation for the Electronic Transfer of Regulatory Information (ESTRI-Gateway).

The purpose of the EudraVigilance Gateway is to operate a single, common, European Economic Area (EEA)-wide Gateway for receiving regulatory submissions in a fully automated and secure way including all aspects of privacy, authentication, integrity and non-repudiation of all transactions in pharmacovigilance.

The EudraVigilance Gateway allows marketing authorisation holders (MAHs), applicants and sponsors of clinical trials (sponsors) to report to a common reporting point within the EEA from where the transactions are re-routed to the addressed Competent Authorities and the EMA. It provides the Competent Authorities with a secure reporting mechanism to the MAHs, applicants, and sponsors and to the EMA. The MAHs, applicants and sponsors are responsible for implementing at least one of the multiple ESTRI standards in order to ensure electronic communication with any Regulatory Authority.

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Last update: Monday, 29 May 2006.




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