Evaluation of substances for use in listed medicines and assessed listed medicines: user guide

This user guide is for applicants using the TGA Business services (TBS) portal to:

• complete an online application form for a new substance to be evaluated for use as an ingredient in a listed or assessed listed medicine, or 
• to change the purpose and/or requirements associated with an ingredient already permitted for use in a listed or assessed listed medicine.

Contents

• Introduction
• Accessing the TGA Business Services (TBS)
• How to login
• Open/Create a Substance Evaluation application
• Step 1 - Organisation details
• Step 2 - Application details
• Step 3 - Proposed use
• Step 4 - Substance details
• Step 5 - Supporting documentation
• Step 6 - Declaration
• Fees
• Troubleshooting