Updates to the Permissible Ingredients Determination for listed medicines

Therapeutic Goods (Permissible Ingredients) Determination No. 3 of 2018

26 September 2018

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in September 2018. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 3 of 2018. A total of 10 changes have been made in the updated Determination. These changes include:

  • The addition of 5 new ingredients.
  • Changes to 5 existing ingredient entries, including:
    • making requirements for ingredients less restrictive, such as expanding permitted concentration limit; and
    • correcting the approved ingredient name.

A complete list of changes to ingredient is below:

New ingredients

  • Capryloyl Glycerin/Sebacic Acid Copolymer
  • Khaya senegalensis
  • Saxifraga stolonifera
  • Sodium polyacrylate starch
  • Syzygium jambos

Changed ingredients

Ingredient Reason for update
4-ISOPROPYL-3-METHYLPHENOL Update to ingredient name
ASTRAGALUS MEMBRANACEUS Update to ingredient name
METHYL METHACRYLATE CROSSPOLYMER Less restrictive requirements
POLYGLYCERYL-2 TRIISOSTEARATE Less restrictive requirements
SODIUM METAPHOSPHATE Less restrictive requirements