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

12 August 2020
Download User guide: Evaluation of substances for use in listed medicines and assessed listed medicines

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 history
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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