New on FRL: Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2024

This Instrument, available here, repeals and replaces the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2024. The new Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2024 commenced Friday 14 June 2024.

Important changes in this Determination include:

NEW ingredients for use in listed and assessed listed medicines and specific requirements that apply to those ingredients:

  • Addition of the new active ingredient Bacillus subtilis with exclusive use provisions for 2 years;
  • Addition of the new excipient ingredients behentrimonium metilsulfate; Dglucose, polymer with xylitol; polyglyceryl-2 isostearat;
  • Addition of the new excipient ingredient 1,8,12- bisabolatriene for use in flavour proprietary excipient formulations;

CHANGED ingredients including:

  • amendments to introduce specific requirements for the ingredient Litchi chinensis, in relation to its use in flavour proprietary excipient formulations;
  • amendments to the specific requirements for the ingredient nonivamide, in relation to its use in fragrance proprietary excipient formulations, and minor formatting changes for the purposes of improving the internal consistency of the Determination; and
  • the removal of requirements for the following ingredients to reflect the expiry of periods of exclusive uses for the relevant sponsors, and minor formatting changes and correction of minor grammatical errors for the purpose of improving the internal consistency of the Determination:
  • Euglena gracilis whole cell dry;
  • beeswax alcohols.

Please read CMA’s 14 June tech alert for more details, including a summary of changes as well as a comparison table of all changes to the Determination.

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