Updating medicine ingredient names - information for sponsors
Information for sponsors on the transition period for the move to sole medicine ingredient names for most affected ingredients.
We updated some medicine ingredient names used in Australia to align with names used in other countries. This was known as the international harmonisation of medicine ingredient names.
Not all medicine ingredient names were changed. A list of the old and updated medicine ingredient names is available on our list of affected ingredients.
Some of the ingredient name changes were significant, for example the change from benzhexol to trihexyphenidyl. For these name changes, medicine labels had to display the new and old ingredient name by 1 May 2020 for a specific dual labelling period. For example, 'trihexyphenidyl (benzhexol)'. This is dual labelling.
The Product Information (PI) and Consumer Medicines Information (CMI) must reference both the old and new name during the dual labelling period. You do not need to repeat the old name throughout the document.
Dual labelling after 30 April 2023
There are different dual labelling periods for different dual labelled ingredient names. At the end of the dual labelling period, medicine labels must be updated to show the sole new name within a 3-year transition period. Dual labelling ends for most ingredient names on 30 April 2023 and enters the transition period towards showing only new names on medicine labels. For more information see dual labelled medicine ingredient names start the transition to sole names on 30 April 2023.
The Therapeutic Goods Orders that outline labelling requirements for prescription and non-prescription medicines include specific text size requirements for medicines that contain these ingredients. See Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92).
Registered medicines that are not marketed
Medicines on the Australian Register of Therapeutic Goods (ARTG) that are not currently marketed can’t be released for supply until labels are updated with the new ingredient names if that ingredient name is in a transition period to the sole name. Relevant documentation should also be updated.
Consent to supply medicines that do not comply with a standard
Australian medicines that do not use approved ingredient names on labels cannot be released for supply without prior consent. In specific circumstances, the TGA may consider giving consent under section 14 of the Therapeutic Goods Act 1989 for individual products.
Transition period 2016 to 30 April 2020
Sponsors had 4 years to show the updated ingredient names on medicine labels. This first transition period for the harmonisation of medicine ingredient names ended on 30 April 2020. All affected medicines released for supply from 1 May 2020 are required to reflect the updated ingredient names on labels. Updated ingredient names must also be used in supporting documents like Product Information (PI) or Consumer Medicine Information (CMI) leaflets.
Leftover stock stored in warehouses using old ingredient names can only be supplied if it was released before 1 May 2020. This stock should be minimal. The 4-year transition period allowed time for sponsors to update labels, PIs and CMIs to use the new ingredient names and release existing stock.
For more information on the transition to sole names for most dual labelled ingredients see:
To check for ingredients that are dual labelled for longer see our List of Affected ingredients.