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Guidance materials for permitted indications for listed medicines

9 March 2021

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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).

The list of permitted indications can be accessed via the Permissible Indications Determination(Determination) or via the TGA Business Services website.

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:

Learning modules

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.

The transition period for permitted indications ended 5 March 2021 and the information provided on transitioning to permitted indications in Modules 1 and 2 is no longer relevant. However, these modules still provide useful information in relation to selecting permitted indications for your listed medicine.

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