Updating medicine ingredient names
Some medicine ingredient names are changing
Gradual 4 year transition period for existing products
In different countries, different names are used to describe the same medicinal ingredient.
Over the years, some medicine ingredient names in Australia have become out of date. This can be confusing for Australian consumers and healthcare professionals who travel internationally, as well as other people like doctors who have trained overseas or people trying to access medicine information online.
We are updating some medicine ingredient names used in Australia to align with names used internationally. This has been done by a number of other countries over the years, including the United Kingdom in 2003 and New Zealand in 2008.
Not all medicine ingredient names are changing. A list of medicine ingredient names that will be changing is available at: List of affected ingredients.
What is happening
- The four year transition period for these changes has started and will end in April 2020.
- Medicines with labels using the new ingredient names will gradually start to appear on shelves.
- Although the name of the ingredient may have changed, the medicine is the same.
- Take care when prescribing, dispensing and administering medicines to make sure that the right product is selected.
What types of changes?
Some changes are minor, for example changing a 'y' to an 'i', and will not affect how the ingredient name is pronounced.
Some changes are more significant. For these products, medicine labels will need to use both the old and new ingredient name for an additional three years after the end of the transition period (until 2023) to help consumers and healthcare professionals become familiar with the new name.
For example, medicines containing lignocaine will need to be dual labelled as 'lidocaine (lignocaine)'.
- The transition period began on 6 April 2016.
- The Australian Approved Names list has been updated with new ingredient names.
- Formulation details of all affected Australia Register of Therapeutic Goods (ARTG) entries have been updated with the new ingredient names.
- Further information for sponsors is available at: Information for sponsors
We are also working on updating the labelling Order, where changes may also be required to medicine labels. To reduce the impact on sponsors, we aim to coordinate the two transition periods as much as possible.
Contact the Project Manager at IHIN@tga.gov.au.