According to regulation EG/726/2004 the marketing authorisation holder (MAH) shall send, as from 20 November 2005, spontaneous reports electronically to the EudraVigilance Human Post-Authorisation Module (EVPM) and to concerned regulatory agencies. Concerned agencies shall also forward spontaneous reports electronically to the EVPM.
If your company wants to start electronic reporting of adverse reactions, please fill in the application form.
All reporting should be directed to the MPA (SEMPA) via the ESTRI Gateway of EMEA.
In case of error the ’Electronic Failure’ procedure should be used and the reports may then be sent via e-mail or fax, followed by a backlog reporting when the problems have been solved.