Updates to the Permissible Ingredients Determination for listed medicines

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in June 2018. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2018. A total of 88 changes have been made in the updated Determination. These changes include the addition of 9 new ingredients. Changes to 75 existing ingredient entries, including:

  • making requirements for ingredients less restrictive, such as broadening the use to allow oral use when previously only for topical use;
  • making requirements for ingredients more restrictive, such as requiring warning statements with transitional provisions for existing listed medicines;
  • reflecting existing requirements from the Poisons Standard (SUSMP); and
  • making minor changes to make a number of entries clearer.
  • the removal of 4 ingredients that have been determined not to be suitable for inclusion in listed medicines or were synonymous with other existing ingredients to avoid duplication.

The Determination provides transitional arrangements for medicines that are currently listed in the Register to comply with new requirements for ingredients included in the previous Determination, such as new concentration limits or safety information required on product labels. The transitional provisions do not apply to new products that are entered into the Register after the introduction of the new requirements. A complete list of changes to ingredient availability is below:

New ingredients

  • 2,3-dihydro-1,1-dimethyl-1H-indene-ar-propanal
  • Bis-butyldimeticone polyglyceryl-3
  • C12-22 alkyl acrylate/hydroxyethylacrylate copolymer
  • PEG-10 dimeticone
  • PEG-9 polydimethylsiloxyethyl dimeticone
  • Piperine
  • Sodium metaphosphate
  • Sucrose tristearate
  • Tinospora cordifolia

Removed ingredients

The following ingredients are not currently used in any products and there is either a more appropriate Australian Approved Name available or the ingredient name was insufficiently characterised.

  • Lovage extract
  • Meadowsweet herb powder
  • Mentha x piperita nothosubsp. citrata
  • Raisin

Changed ingredients

Details of the changed ingredients are available on the TGA website:

https://www.tga.gov.au/updates-permissible-ingredients-determination-listed-medicines.

TGA, 18 June 2018 ; http://www.tga.gov.au/

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