EMA EudraVigilance Registration Manual

On 14 January 2022 the EMA updated the EudraVigilance registration manual.

To set up a new organization in EudraVigilance Production or XCOMP (Test system), a series of steps need to be followed:

1. A person within the organization needs to be chosen as being responsible for managing the organization and its users in the EudraVigilance Production system. If the organization is a marketing authorization holder the primary responsible person will be a Qualified Person for Pharmacovigilance (QPPV); if the organization is a sponsor/non-commercial sponsor it will be a Responsible Person (RP).

2. Register for an EMA user account in the EMA Account Management portal, if you do not already have one – see section 2.

3. Search for your organization in SPOR Organization Management System (OMS). If your organization is not present, it will need to be created – see section 3.3.

4. Submit a request to be registered as the QPPV/RP for the organization – see section 4.1.

5. Complete organization registration details in the EudraVigilance restricted area – see section 4.2.

6. Wait for EMA confirmation that WebTrader or Gateway transmission mode has been set up for your organization – see section 6.1.1.

Once the QPPV or RP is registered for the Production EudraVigilance system they will automatically also be registered for an XCOMP test account for the same organization.

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