Permitted Indications For Complementary Medicines - DTS Regulatory Consultants
‘Indications’ are statements that describe the specific therapeutic use for a complementary medicine. They describe a complementary 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).

The TGA implemented a new regulatory framework for complementary medicines in 2018, to take full effect in 2021. The new framework applies to all medicines listed under section 26A of the Therapeutic Goods Act 1989 (the Act). This includes complementary medicines and sunscreens.

What has Changed

• There will no longer be a ‘free-text field’ for sponsors to enter their medicine indications when applying to list the medicine on the ARTG.
• Sponsors applying to list a new medicine will be required to select from a list of permitted indications.
• Sponsors can apply to have a new indication considered for inclusion in the Permissible Indications Determination. An application fee will apply.

Key Transition Dates

• The fee-free period for sponsors to transition existing products ends on 6 March 2021. After this, an application fee of $840 will apply to transitioning products.
• The transition period for existing listed medicines ends 6 March 2021. All Listed Medicines must only contain Permitted Indicated from this date.

If you require assistance to implement these please contact our team at DTS Regulatory Consulting (