Europe – EMA EudraVigilance Registration Manual

To set-up a new organisation in EudraVigilance, a series of steps need to be followed:

1. A person within the organisation needs to be chosen as being responsible for managing the organisation and its users in the EudraVigilance system. If the organisation is a marketing authorisation holder the primary responsible person will be a Qualified Person for
Pharmacovigilance (QPPV).
2. Register for an EMA user account in the EMA Account Management portal if you do not already have one (see 2. User registration with EMA Account Management portal (IAM)
3. Check Organisation Management System (OMS): if your organisation is not present in OMS it will need to be registered (see 4. Create a new Organisation
4. Submit request to be registered as the responsible person for the organisation (see 3.2. EU QPPV or Responsible Person access request
5. Complete organisation registration details in the EudraVigilance restricted area (see 4.1.
Finalise organisation information in EV Human Production
6. Set up the transmission mode (see 5.1. Annex EV restricted area and transmission mode for new organisation
7. Raise Service desk ticket to set up gateway connection or a webtrader connection if you need to send XEVMPD messages…