Permitted indications for listed medicines

On 6 March 2018, the TGA implemented a list of permitted indications for medicines listed under section 26A of the Therapeutic Goods Act 1989 (the Act). All new listed medicines included in the Australian Register of Therapeutic Goods (ARTG) since this time have only been able to use permitted indications.

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).

FAQs on using permitted indications

Since the implementation of permitted indications, sponsors have raised a number of questions in relation to using the indications. To address these issues we have published a list of frequently asked questions and answers on our website - see FAQs on issues raised by industry in relation to permitted indications.

Background

'Indications' are statements that describe the specific therapeutic use for a medicine. They describe a medicine's claimed purpose or health benefit, for example: 'relieves coughs'. Indications can be specific (e.g. refer to a named non-serious condition); or non-specific (e.g. refer to general health maintenance).

Indications available for use for listed medicines are contained in a 'list of permitted indications' which is contained in the Therapeutic Goods (Permissible Indications) Determination. The list of permitted indications is maintained by the TGA and provides a comprehensive list of indications currently accepted for listed medicines, provided appropriate evidence is held by the medicine sponsor.

The list of permitted indications provides transparency on what indications are suitable for listed medicines to help prevent sponsor non-compliance and provides greater protection for consumers from misleading and inappropriate claims.

What medicines does it apply to?

The permitted indications requirements apply to all medicines listed under section 26A of the Therapeutic Goods Act 1989 (the Act). This includes complementary medicines and sunscreens.

The requirement to use permitted indications does not apply to medicines that are listed for export only and medicine kits.

How do I select permitted indications to list a medicine?

• All permitted indications and the requirements for their use by listed medicines are contained in the Permissible Indications Determination.
• Sponsors can access and search the list of permitted indications within the Listed Medicine Application form (please see the Listed medicine application and submission user guide) and on the TGA Business Services website.
• Regular updates will be made to the Determination when new indications are added or changes made to any indication requirements. This will occur quarterly unless no changes are required.
• Sponsors can apply to have new indications considered for inclusion in the Permissible Indication Determination. The application form is available after logging in to your sponsor portal via the TGA Business Services website. An application fee applies.

'Variation' and 'Correction of ARTG Record' in the Guidance on product changes in ELF3.

Further information

If you have any issues accessing or using the Permissible Indication Determination or the search functions within with Listed Medicine Application form or TGA Business Services website, please contact Complementary Medicines via phone on 1800 020 653 or via email at nonprescriptionmedicines@health.gov.au.