EMA Updated EudraVigilance Registration Manual

On 21 July 2020 the EMA announced the availability of the updated EudraVigilance registration manual.

Update Note: The EudraVigilance XCOMP (Test system) has been aligned with Production.

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 section 2: User registration with EMA Account Management portal (IAM).

3. Check the Organisation Management System (OMS). If your organisation is not present in the OMS it will need to be registered – see section 4: Create a new Organisation.

4. Submit request to be registered as the responsible person for the organisation – see section 3.2: EU QPPV or Responsible Person access request.

5. Complete organisation registration details in the EudraVigilance restricted area – see section 4.1: Finalise organisation information in EV Human Production and XCOMP.

6. The EMA confirms separately to the organisation that their Webtrader or Gateway transmission mode has been set up – see section 6: Webtrader and Gateway transmission.

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

Read the pdf 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /