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Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025

Published

Listed medicines indications and requirements for their use have been updated in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, which commenced on 3 April 2025. This determination replaces the previous instrument, the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021.

Ensure you are accessing the current version of the instrument through the Therapeutic Goods Determination page.

A list of changes is provided below and detailed information can be found in the accompanying Explanatory Statement.

Updates to indications:

Previous textUpdated text
Rubefaciant/simulate blood flow to skinRubefacient/stimulate blood flow to skin
nourish/tonify/replenish strenthen liver-bloodnourish/tonify/replenish/strengthen liver-blood
warm and nourish/strenghten/tonify/enrich kidneys/kidney-yangwarm and nourish/strengthen/tonify/enrich kidneys/kidney-yang
Decrease/reduce symptoms of medically diagnosed cystitis by reducing urinary PH.Decrease/reduce symptoms of medically diagnosed cystitis by increasing urinary pH.

Updates to Requirements:

Relates to Items in Part 2, Schedule 1 (formerly Table 2).

Previous textUpdated text
Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis. Note: this requirement is not intended to apply where the indications referring to osteoporosis specified in column 2 of Table 2 of this instrument are also used.Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis. Note: this requirement is not intended to apply where the indications referring to osteoporosis specified in column 2 of the table in Part 2 of Schedule 1 to this instrument are also used.

Impact to existing medicines and listed medicine applications

The updates to indications and requirements will shortly be reflected in the Indications for Listed Medicines Table in the TGA eBusiness Services Code Tables. This will allow selection of the updated indications in new and change applications for listed medicines.

These updates will also be reflected in ARTG entries for existing listed medicines to ensure alignment with the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025. Affected sponsors will be contacted individually where a medicine is affected by an update, other than a spelling correction or the update to the permitted indication requirement relating to bone disease and disorders.

Other updates:

  • Updates to the definition of:
    • code tables
    • evidence guidelines
    • health professional
    • scientific
    • traditional
  • “Tables” now referred to as “Parts”
  • title in Column 4 changed to “Requirements”
  • new subsections added to section 5 and 6
  • Table 10 - Indications relating to the reproductive system that included 16 pregnancy indications are now included in Part 17. Note there have been no changes to any of these indications or requirements. 
  • Table 12 - Indications relating to skin that included 16 sunscreen indications are now included in Part 16. Note there have been no changes to any of these indications or requirements.

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