Spring Intro 2023

Definition of a Variation? • A change to the previously approved content of the Marketing Authorisation • Filing variations ensures continued compliance

New indication, New population i i ti , l ti

New warnings, Side effects r i , i ff t

Safety

Indication

Quality

Admin

Name changes, Pack removal ges, r o al

New process, New site process, New site

The Organisation for Professionals in Regulatory Affairs

5

Some Variations Can be Avoided

 Post-approval changes to a product often require the submission of a variation, but not always  Amount of detail put into Module 3 at time of MAA submission will determine the number of variations  Need to maintain a balance between: 1. The amount of data required for assessor review to ensure a product of consistent and appropriate quality is manufactured vs. 2. What is required to be maintained in the Company’s Quality Systems (e.g. GMP info)  It is in the interest of both the MAH & CA to avoid unnecessary variations

The Organisation for Professionals in Regulatory Affairs

6