Module 12 2019

EMA changes data after submission

First validation: 2ndACK

EMA makes changes to our data

Submit via gateway

Hi, this is EMA, we changed the name of your product! Frommessage not clear what was old and what is new name. Need to check record in Register, vs record in EVweb, vs SmPC.

Notification of the changes: 3rdACK

Now what?

Time consuming!

The Organisation for Professionals in Regulatory Affairs