Who can access the EudraVigilance Database Management System (DBMS)?

• About the EudraVigilance Database Management System (DBMS)
• Who can access the DBMS?

The EVDBMS is based on a three-tier, light client based architecture. Offering remote access to administrative and scientific users in the European Commission, the EMA, Competent Authorities in the EEA, marketing authorisation holders (MAHs), applicants and sponsors of clinical trials via secure connection over the Internet.

Only registered partners and their registered individual users are granted access to the EVDBMS. Individual users of Competent Authorities have access to all ICSRs and SUSARs stored in the European pharmacovigilance database.

MAHs, applicants and sponsors have currently only restricted access to the EVDBMS, whereby individual users of a MAH, applicants and sponsors can only view the ICSRs that have been submitted to the EMA. MAHs, applicants and sponsors may also define specific user rights for their affiliates and their individual users during the registration process.

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Last update: Monday, 19 June 2006.