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Update to listed medicine ingredients in June 2020

Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2020

10 June 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.

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