You are here

Comparable Overseas Bodies (COB) checklists

4 December 2019

You must complete and submit the relevant checklist as part of your dossier submission. This checklist will enable the TGA to assess whether the application meets the requirements of the selected application category. If certain criteria are not met, the application must include appropriate justification.

Assessed listed medicines checklist

This checklist must be submitted as part of Module 1.2 of your dossier submission.

How to access a pdf or Word document

*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open it from there.

Registered complementary medicines checklist

This checklist must be submitted as part of Module 1.2 of your dossier submission.

Substance evaluation checklist

If you are providing multiple COB evaluation reports (i.e. separate for Quality and Safety), you will need to complete this checklist for each COB report.