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Update to listed medicine ingredients in November 2019

Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2019
Published

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation in November 2019. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2019. A total of 40 changes have been made in the updated Determination. These changes include:

  • Addition of 6 new ingredient entries.
  • Changes to 34 existing ingredient entries to make requirements clearer and less restrictive.

A complete list of changes to ingredients is below.

Alignment of gluten requirements with labelling orders

The requirements relating to the declaration of gluten on medicine labels were removed from the Permissible Ingredients Determination as the requirement exist in the labelling orders: Therapeutic Goods Order No. 69 - General requirements for labels of medicines (TGO 69) and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92).

This does not change the need to declare gluten on medicine labels in some circumstances. Sponsors must continue to comply with the gluten requirements specified in the relevant labelling order. Labels must fully comply with all provisions in either the old or the new Order. A label cannot selectively comply with parts of multiple Orders. See Labelling changes: information for sponsors about the transition period for labelling orders.

New ingredients

  • 2,5-dimethyl-4-ethoxy-3(2h)-furanone
  • 2-ethyl-N-methyl-N-(3-methylphenyl) butanamide
  • Hexylresorcinol
  • Nicotinamide riboside chloride
  • Palmidrol
  • Styrallyl propionate

Changed ingredients

IngredientReason for update
AVENA FATUAAlignment of gluten requirement with labelling orders
AVENA SATIVAAlignment of gluten requirement with labelling orders
BARLEYAlignment of gluten requirement with labelling orders
BARLEY BRANAlignment of gluten requirement with labelling orders
BARLEY GERMAlignment of gluten requirement with labelling orders
BENZYL ALCOHOLExtension of purpose
BOVINE SODIUM CHONDROITIN SULFATEExtension of purpose
CANDIDA UTILISExtension of purpose
CETYLPYRIDINIUMExtension of purpose
CINNAMOMUM CAMPHORAAligned with the Poisons Standard (SUSMP)
HORDEUM DISTICHONAlignment of gluten requirement with labelling orders
HORDEUM VULGAREAlignment of gluten requirement with labelling orders
MALTODEXTRINAlignment of gluten requirement with labelling orders
METHYLISOTHIAZOLINONEAligned with the Poisons Standard (SUSMP)
OATAlignment of gluten requirement with labelling orders
OAT BRANAlignment of gluten requirement with labelling orders
OATMEAL COLLOIDALAlignment of gluten requirement with labelling orders
PREGELATINISED WHEAT STARCHAlignment of gluten requirement with labelling orders
RYEAlignment of gluten requirement with labelling orders
SACCHARINLess restrictive requirements
SECALE CEREALEAlignment of gluten requirement with labelling orders
SHARK CHONDROITIN SULFATEExtension of purpose
SHARK SODIUM CHONDROITIN SULFATEExtension of purpose
SODIUM CHLORIDELess restrictive requirements
SODIUM CHONDROITIN SULFATEExtension of purpose
TRITICUM AESTIVUMAlignment of gluten requirement with labelling orders
TRITICUM DURUMAlignment of gluten requirement with labelling orders
WHEATAlignment of gluten requirement with labelling orders
WHEAT BRANAlignment of gluten requirement with labelling orders
WHEAT DEXTRINAlignment of gluten requirement with labelling orders
WHEAT GERMAlignment of gluten requirement with labelling orders
WHEAT GERM GLYCERIDESAlignment of gluten requirement with labelling orders
WHEAT SPROUTAlignment of gluten requirement with labelling orders
WHEAR STARCHAlignment of gluten requirement with labelling orders
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