Dual labelling introduced some new ingredient names to Australia
Dual labelling ended for most ingredient names on 30 April 2023 and entered a transition period towards showing only new names on medicine labels. For some ingredient names, dual labelling continued for longer and ends on 30 April 2025. A small set of ingredient names will continue with dual labelling.
The new medicine ingredient names are more common in other countries and were chosen for this reason. Using both old and new names on medicine labels gave consumers and health professionals time to adjust to the new names. Both names had to be shown together on labels of medicines released for supply since May 2020. This is known as dual labelling.
Most dual labelling ended 30 April 2023 and moves towards new names only
Dual labelled ingredient names must show both the old and new ingredient name on medicine labels until the end of 30 April 2023. After this date, for most names, labels can show the new ingredient name only or continue with both names while work is done to change the label.
Medicine sponsors have 3 years to update labels to show only the new name. For example, labels of medicines containing ‘lidocaine (lignocaine)’ will need to be updated to show ‘lidocaine’.
The transition period for most dual labelled ingredients started on 1 May 2023 and ends 30 April 2026. Medicines released for supply from 1 May 2026 must show the sole name.
Ingredient names that are changing to show new names only are found in our list of affected ingredient names marked as ‘Dual labelling - until 30 April 2023’.
Medicine sponsors should also update Product Information (PI) and Consumer Medicine Information (CMI) documents to reflect sole names as labels are updated during the transition period.
A small set of ingredient names will continue with dual labelling.
Dual labelling continues for longer for some ingredient names
We consulted about moving to only new names on 30 April 2023 for the dual labelled ingredients. Feedback showed that a longer dual labelling period will help for some ingredient names. For those names the labels must continue to show the old and new names either:
- until 30 April 2025 for some ingredients
- ongoing with no plans to move to sole names for some ingredients.
Read more about our consultation International harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine ingredient names.
List of ingredient names for dual labelling until 30 April 2025
The dual labelling period for these ingredient names continues until 2025 to allow more time for health professionals to get used to the new names. Medicine labels must continue to show the new and old name for these ingredients until 30 April 2025:
- dosulepin (dothiepin) hydrochloride
- hydroxycarbamide (hydroxyurea)
- tetracaine (amethocaine)
- tetracaine (amethocaine) hydrochloride
- trihexyphenidyl (benzhexol) hydrochloride.
The transition period for these ingredients subject to an extended dual labelling period starts on 1 May 2025 and ends 30 April 2028. Medicines released for supply from 1 May 2028 must show sole names for this list of ingredient names.
These ingredient names are in our list of affected ingredient names marked as ‘Dual labelling - extended until 30 April 2025’.
After 30 April 2023 medicine labels will start to show sole names
Changes to medicine labels take time. New labels will appear gradually as new stock is distributed, and existing stock is sold.
Medicines with labels using only the sole ingredient name will start to appear on shelves over time. For example, medicines containing ‘lidocaine (lignocaine)’ will begin to appear as containing ‘lidocaine’ sometime after 30 April 2023.
For more information see Understand ingredient names on medicine labels as they transition to show new names only.
List of ingredient names for ongoing dual labelling
These names continue in the dual labelling format in the Australian Approved Names List with no planned transition to sole names:
- alimemazine (trimeprazine) tartrate
- mercaptamine (cysteamine)
- mercaptamine (cysteamine) bitartrate
- mercaptamine (cysteamine) hydrochloride
- Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain).
For medicines included in the Australian Register of Therapeutic Goods (ARTG) labels must continue to use both the old and new ingredient name.
Background to dual labelling
In 2016, we updated some medicine ingredient names to align with names used internationally.
Some changes were more significant, for example, the change from benzhexol to trihexyphenidyl.
For these types of changes medicine labels needed to display the old and new ingredient name by 1 May 2020 and until the end of the dual labelling period. This is to help consumers and health professionals become familiar with the new name. For example, medicines containing trihexyphenidyl need to be dual labelled as ‘trihexyphenidyl (benzhexol)’ during the dual labelling period.