EMA EudraVigilance Registration Documents and Manual

7 December 2022 – the EMA published the updated EudraVigilance registration related documents and manual.

To set-up a new organization in EudraVigilance (EV) Production or XCOMP (test) system, the following series of steps need to be followed:

1. EMA EudraVigilance Registration Documents

2. New Organization First User QPPV/RP or Change of EU QPPV/RP

3. Vendor registration in the EudraVigilance external compliance testing environment (XCOMP)

4. EMA EudraVigilance Registration Manual

EMA Registration Documents New Organization First User Vendor Registration EMA Registration Manual 
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