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Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2020, which commenced on 8 June 2020. This determination replaces the previous instrument, the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2020.
This instrument is updated frequently and there may be a more recent version of the instrument. Ensure you are accessing the current version of the instrument through the Therapeutic Goods Determination page.
A total of 17 changes have been made in the updated Determination. These changes include:
- 8 new and 2 variations of ingredients, following evaluation;
- removal of expired transition period provisions for Andrographis paniculata; and
- clarification of requirements for 4 ingredients for consistency with other legislative instruments.
- a minor change to the ingredient 'hydrolysed wheat protein' for consistency with other gluten-containing ingredients and applicable standards relating to medicine labelling.
- removal of 1 ingredient as a synonym of an existing ingredient.
A complete list of changed ingredients is below.
Changed ingredients
| Ingredient | Change type | Change reason |
|---|---|---|
| 1,2,3,4,4a,5,8,8a-OCTAHYDRO-2,2,6,8-TETRAMETHYL-1-NAPHTHALENOL | Addition | Substance evaluation |
| 2-METHYLDECANAL | Addition | Substance evaluation |
| ACETOXYDIHYDRODICYCLOPENTADIENE | Addition | Substance evaluation |
| BIS-STEARYL DIMETICONE | Addition | Substance evaluation |
| BITTERN | Addition | Substance evaluation |
| CALLITRUS COLUMELLARIS SUBSP. INTRATROPICA | Addition | Substance evaluation |
| PARTIALLY DEHYDRATED LIQUID SORBITOL | Addition | Substance evaluation |
| STEARYL BEHENATE | Addition | Substance evaluation |
| TAGETES ERECTA | Change | Substance evaluation |
| BENZYL CINNAMATE | Change | Substance evaluation |
| ANDROGRAPHIS PANICULATA | Change | Remove expired transition |
| THYMUS ZYGIS | Change | Consistency with Poisons Standard |
| ILLICIUM VERUM | Change | Consistency with Poisons Standard |
| THYMUS VULGARIS | Change | Consistency with Poisons Standard |
| THYMUS VULGARIS MIS | Change | Consistency with Poisons Standard |
| HYDROLYSED WHEAT PROTEIN | Change | Consistency with gluten labelling requirements |
| VIOLET LEAVES | Removal | Synonym of violet leaf absolute |