The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Applications for extension of indications to align with a reference product can be submitted via the Variation e-form. This electronic form is available through the TBS portal - external site.
For further information see:
- Extension of indications to align with a reference product in Variations to prescription medicines: excluding variations requiring evaluation of clinical or bioequivalence data (for chemical entities).
- Extension of indications to align with a reference product in Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data: process guidance.