The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
From 22 March 2023, we can approve the temporary import or supply of an overseas-approved medicine as a substitute for one that is in short supply if it has been previously registered in Australia. These changes have been introduced to help alleviate the effects of medicine shortages on patients.
This includes medicines that have been discontinued, suspended or cancelled from the Australian Register of Therapeutic Goods (ARTG) but can still assist patients who don’t have other treatment options.
Previously, we could only grant temporary approval for import and supply of a substituted overseas medicine if the Australian medicine was currently included in the ARTG.
In addition, updates have been made to improve the accuracy of the information published on the TGA Medicine Shortage Reports Database. The changes clarify requirements around updating and resolving shortages.
These changes to the Therapeutic Goods Act 1989 will help reduce the impacts that medicine shortages have on Australian patients.
Read more on the recent amendments to the Therapeutic Goods Act 1989.
