Module 12 2019

TOM in theory

Create or update and submit an application dataset (MAA, Variation, Renewal)

Agree on “Implementation phase data group” Create “Approval Data Group” • Process is similar but if needed an updated dataset has to be submitted • Approval of “Implementation phase data group” by the relevant regulator • Create approval data by regulator • Lock data group for further usage

Additional data feed after approval by MAH or Agency

Agree on ”Common data group”

Re-use application data for publishing data - PMS

• Process is similar but if needed an updated dataset has to be submitted

• Utilizes OMS, SMS, RMS and PMS

- Art 57 - Union

• Approval of data group by the RMS (tbc)

Product Database

• Lock data group for further usage

The Organisation for Professionals in Regulatory Affairs