EMA EudraVigilance Registration Manual

On 26 March 2020 the EMA updated the EudraVigilance XCOMP (Test system) registration process.

The EudraVigilance XCOMP (Test system) has been aligned with Production. For more detailed information on the EV XCOMP registration process, please refer to Section 7 of this manual.

To set-up a new organisation in EudraVigilance Production or XCOMP (Test system), 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 Production 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 and XCOMP

6. Set up the transmission mode - see 5.1. 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

8. Once the QPPV or responsible person is registered for the Production EudraVigilance system they will automatically also be registered for an XCOMP test account for the same organisation.

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