To begin data submission on authorised medicines, marketing-authorisation holders need to register with EudraVigilance. This is to ensure that proper privacy and security measures are in place and that the principles of integrity, accountability and availability of data are adhered to.
Registration is based on the existing EudraVigilance registration process. This has been in operation since the implementation of the electronic transmission of individual case safety reports (ICSRs) and the establishment of the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD):
Organisations previously registered in the EVMPD need to upgrade their registration profile and to be added to the XEVMPD community by contacting the EudraVigilance registration team at firstname.lastname@example.org stating the name of their organisation and their EudraVigilance organisation identification. This request needs to be made before starting the electronic submission of information on medicines using the new XEVPRM format.
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For support with EMA information technology (IT) systems:
EMA Service Desk