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Updating medicine ingredient names - information for sponsors

1 May 2020

The 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 and in supporting documentation such as Product Information (PI) or Consumer Medicine Information (CMI) leaflets.

Leftover stock stored in warehouses using old ingredient names can still be supplied as long as it was released before 1 May 2020. This stock should be minimal as the four year transition period has allowed time for sponsors to update labels, PIs and CMIs to use the new ingredient names and release existing stock.

Dual labelling until April 2023

Some of the ingredient name changes were more significant, for example the change from benzhexol to trihexyphenidyl. For these types of changes, the labels must display the old and new ingredient name until 30 April 2023, e.g. 'trihexyphenidyl (benzhexol)'. The PI and CMI must make reference to both the old and new name but you do not need to repeat the old name throughout the document.

The Therapeutic Goods Orders that outline labelling requirements for prescription and non-prescription medicines (TGO 91 and 92, respectively) include specific text size requirements for medicines that contain these ingredients.

Registered medicines that are not marketed

Medicines on the ARTG that are not currently marketed will need to update their labels and relevant documentation with the new ingredient names before they can be released for supply. For registered medicines, these will need to be processed as a variation request, subject to the usual fees.

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.

Sponsors can apply for this consent using the relevant application form. Where consent is given, the TGA publishes a record of these decisions on the TGA website.