Module 12 Presentations

EMA is migrating xEVMPD data into PMS

As part of the target operating model (TOM), the MAH will need to submit their SPOR data together with the dossier, as part of the regulatory submission.* If the data in PMS is not of high quality, the submission will not be accepted. To start off with high quality data in PMS, the data in xEVMPD needs to be of high quality .

On the short term, only the variation submission is relevant (i.e. PLM eAF) . On the long term, IDMP data will be reused across regulatory procedures .

xEVMPD

PMS

Variation submission

EU IDMP-IG chapter 7

Pediatric use application

…

Variation submission

Eventually xEVMPD will be fully replaced (2025+)

Pediatric use application

“Garbage in = Garbage out”

xEVMPD

PMS

…

* NB: target operating model (TOM) is currently under discussion (July 2022). PLM eAF implementation is not yet in line with the TOM.

The Organisation for Professionals in Regulatory Affairs