Registration

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):

• EudraVigilance: how to register