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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.
Assessed listed medicines checklist
This checklist must be submitted as part of Module 1.2 of your dossier submission.
- COB report-based process - Assessed listed medicines checklist (pdf,131kb)
- COB report-based process - Assessed listed medicines checklist (docx,91kb)
Registered complementary medicines checklist
This checklist must be submitted as part of Module 1.2 of your dossier submission.
- COB report-based process - Registered complementary medicines checklist (pdf,133kb)
- COB report-based process - Registered complementary medicines checklist (docx,104kb)
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.