Variation Classification

Decide how to classify a post-approval change in the EU

Role: Regulatory Affairs Associate

Context: Your company has approved a new packaging supplier for the 30-tablet pack in the EU. The primary packaging material (blister) and artwork remain the same; only the secondary carton supplier is new.

Task: Determine the correct variation type and what the company must do before implementing the change.

Step 1 of 1

Classify the change

info

The change is: new secondary packaging supplier, same design and materials (carton only). No change to blister, leaflet, or SmPC. The new supplier is already qualified and has been audited.

How should this change be classified in the EU?