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Guidance materials for permitted indications for listed medicines
In March 2018 the TGA implemented a list of permitted indications for medicines listed under Section 26A of the Therapeutic Goods Act 1989 (the Act).
Introduction of the permitted indications reform implements one of the Government's reforms to the regulatory framework for complementary medicines arising from the Medicines and Medical Devices Regulation Review (MMDR).
For more information see Permitted indications for listed medicines.
Permitted indications for listed medicines guidance
Guidance for listed medicine sponsors on what permitted indications are, how they should be used and how to apply for new indications.
FAQs on using permitted indications
Since the implementation of permitted indications, sponsors have raised a number of frequently asked questions about using permitted indications. To address these issues we have published a list of frequently asked questions and answers:
This set of e-learning modules provide information on the transition arrangements for permitted indications and instructions on how to create an application on the TGA Business Services portal to include permitted indications for listed medicines.
- Module 1: Overview of permitted indications and transition arrangements
Provides an overview of permitted indications and the transition arrangements for medicines listed before 6 March 2018
- Module 2: How to remove indications and add permitted indications for your existing medicine
Demonstrates how to change a listed medicine through the TGA Business Services (TBS) portal to remove indications, add permitted indications and add indication qualifiers
- Module 3: Selecting parent indications and linking indications
Demonstrates how to link indications in your application using 'parent' indications