Labelling requirements for the International Harmonisation of Ingredient Names project

• Dual labelled medicine ingredient names transition to sole names

  28 April 2025

  Page

  Read about dual labelled medicine ingredient names transitioning to show only the new name.

• Understand ingredient names on medicine labels as they transition to show new names only

  5 April 2023

  Page

  Take care when prescribing, dispensing, and administering medicines as labels will start to show sole names.

• Updating medicine ingredient names - list of affected ingredients

  5 April 2023

  Page

  The list shows the medicine ingredient names that are changing. The list is split into active ingredients and excipient ingredients.

• Updating medicine ingredient names - the overview

  28 April 2023

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  Over time we've updated some medicine ingredient names used in Australia to align with names used internationally.

• Updating medicine ingredient names - information for sponsors

  28 April 2023

  Page

  Information for sponsors on the transition period for the move to sole medicine ingredient names for most affected ingredients.

Guidance and resources

• Understanding rules for labelling biologicals

  8 October 2024

  Guidance

  Guidance on TGO 107: Mandatory labelling requirements for biologicals and human cell and tissue materials.

• Ingredient basics

  22 March 2024

  Page

  Information about types of ingredients, restrictions on use and why they are scheduled.