TGA’s 67 changes to permissible ingredients

medicine label

For listed medicines, there are now four new ingredients, while eight have been removed due to safety issues

The TGA has updated its permitted ingredients list for complementary medicines.

This latest iteration of the Therapeutic Goods (Permissible Ingredients) Determination revokes and replaces the last determination, which commenced in April 2017.

A total of 67 changes have been made in the updated list. These changes include the addition of four new ingredients, changes to 55 existing medicines, and the removal of eight ingredients that have been determined not to be suitable for inclusion in listed medicines.

New ingredients

  • Active Ingredients
    • Eggshell Membrane Hydrolysate
    • Eggshell Membrane Powder
    • Guar Galactomannan
  • Excipient Ingredients
    • Tocopheryl Glucoside

Removed ingredients

  • Removal of ingredients due to safety related issues:
    • Absidia Ramosa
    • Alternaria Alternata
    • Botrytis Cinerea
    • Chaetomium Indicum
    • Claviceps Purpurea
    • Cochliobolus Heterostrophus
    • Drechslera Sorakiniana
    • Microsporum Gypseum

The TGA’s update also includes changes to 55 existing ingredient entries, such as:

  • 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 the inclusion of additional warning messages; and
  • making minor changes to make a number of entries clearer.

See the full list of these changes and the related medicines here.

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