Module 12 Presentations

When do you have to do a xEVMPD submission?

• When changes are introduced to the MA on the level of:

• Active substance(s), strength, pharmaceutical form, route of administration

Change to the SmPC in..

•

Section 1 – product name

•

• Section 2 – qualitative and quantitative composition

Section 3 – pharmaceutical form

•

Section 4.1 – Indications

•

• Section 4.2 – Posology and method of administration

• Section 5.1 – Pharmacodynamic properties (e.g., change in ATC)

• Section 6.1 – list of excipients (e.g., change of excipients)

Section 7 – MAH

•

• Changes to QPPV, PV Contact Details, PSMF • MA-Transfer • Renewal • Significant change to section 4.1-4.9

The Organisation for Professionals in Regulatory Affairs