Module 12 2019

Why does it matter?

• xEVMPD data records used in business processes of EMA

• For example: PSUSA delivery file.

• Without an entry in Eudravigilance / xEVMPD database, MAH can’t submit PSUSA

In addition, xEVMPD data is being used for: • annual PV fee calculation, • CTA application • IRIS (ODD) portal

The Organisation for Professionals in Regulatory Affairs