EMA Updates EudraVigilance Registration Manual

On 18 May 2020 the EMA updated the EudraVigilance registration manual.

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 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 Organisation Management System (OMS). If your organisation is not present in 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 organization. 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. 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.

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