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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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