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User guide: Evaluation of substances for use in listed medicines and assessed listed medicines
12 August 2020
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Description
This guidance is intended 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
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | Complementary and OTC Medicines | September 2019 |
| V2.0 | Changes made to include assessed listed medicines, changes to sections 26BD and 26BE of the Act and to the guidelines documentation | Complementary and OTC Medicines Branch | August 2020 |
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