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Update to listed medicine ingredients in June 2020
Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2020
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.
|Ingredient||Change type||Change reason|
|BIS-STEARYL DIMETICONE||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|