This message was posted by a user wishing to remain anonymous
Hello Anon
Since you haven't received a definitive reply on this, I'll take a guess...
PAC often stands for Post Approval Change. So if you didn't already have a mockup (prototype) of the package, then after approval you can do the mockup? And if no distributor was identified pre-approval, then it's a PAC report when one is added?
Original Message:
Sent: 23-Nov-2022 05:27
From: Anonymous Member
Subject: National phase labeling queries
This message was posted by a user wishing to remain anonymous
Hello everyone
I have received the below queries after EOP, during national phase review of my product registration submission, from Belgium HA. Does anyone know what is 'PAC mockup' and what is to be submitted in the below queries? FYI, we do not have a distributor at the moment.
- Mock-up package or a PAC Mockup (in case no Mockup available) even if the product will not be marketed
- Delegation of power (if needed)
- PAC Distributor ( in case no distributor available)