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Updates to the Permissible Ingredients Determination for listed medicines

Therapeutic Goods (Permissible Ingredients) Determination No. 4 2018

10 December 2018

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in December 2018. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 4 2018. A total of 6 changes have been made in the updated Determination. These changes include:

  • Changes to 5 existing ingredient entries, including making requirements clearer and less restrictive;
  • Removal of 1 ingredient that was a proprietary formulation and incorrectly classified as being appropriate for use in listed medicines during the drafting of the original Determination. The removed ingredient is not currently used in any listed medicines in Australia.

A complete list of changes to ingredient is below.

Removed ingredients

  • Natural cherry flavour

Changed ingredients

Ingredient Reason for update
AMYL ACETATE Less restrictive requirements
ARTHROSPIRA MAXIMA Less restrictive requirements
ARTHROSPIRA PLATENSIS Less restrictive requirements
EUTERPE OLERACEA Clarification of requirements; Less restrictive requirements
LARIX ARABINOGALACTAN Less restrictive requirements