While the consultation is open, you can make a submission at our TGA consultation hub.
We review the submissions carefully. After that, the submissions and our decision will be available on the same page at the TGA consultation hub.
We're conducting a public consultation and seeking feedback from interested parties on proposed changes to the requirements of ingredients used in listed (low-risk) medicines. The proposals address the following issues:
- Myristica fragrans use during pregnancy and lactation
- Requirements relating to amygdalin and hydrocyanic acid
These ingredients are included in the Therapeutic Goods (Permissible Ingredients) Determination ('the Determination'). This is a legislative instrument made under section 26BB of the Therapeutic Goods Act 1989. This instrument specifies all of the ingredients that are available for use in listed medicines and the requirements for their use. We continually review The Determination to ensure that all ingredients are safe for use in low-risk medicines.
Timetable
The consultation opens on Monday 2 November 2026. Interested parties must respond by close of business Monday 14 December 2026.
Please see the Schedule for annual low-negligible risk changes.
Enquiries
For enquiries relating to the consultation document or your submission, please email nonprescriptionmedicines@health.gov.au.