Use this guide to determine if your change meets any of the following categories:
· corrects an ARTG entry
· creates a separate and distinct good
· is a safety-related variation
· has the potential to impact quality, safety, or efficacy
This article describes the following steps;
For a sponsor to determine if a change is a variation to an ARTG entry and how to apply for
approval, the following processes are involved:
1. Determine if the change would have been relevant to the inclusion decision
2. Determine if the change is a correction to your ARTG entry
3. Determine the variation category
4. Determine the supporting document requirements
5. Submit your application
6. Prepare and submit your cover letter and supporting documents
7. Pay your application fee
8. TGA screening of your application
9. Pay your evaluation fee
10. TGA evaluation of your supporting documents
11. Making a decision on your application
12. Implement the change(s) if approved