The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
All timeframes are subject to the cooperation of manufacturers and sponsors, and in some cases, international regulatory authorities.
Periods are measured from the time that application is 'effective' and can be progressed by the TGA. Licence(s) will be withheld until satisfactory resolution of any deficiencies identified.
Timeframes assume sites are ready for inspection at the time of application - applications may be rejected if sites are not ready for inspection.
| Application type outcomes | Measurement | Target timeframe |
|---|---|---|
| New Australian Licence Application | Application to Inspection Report | < 3 months |
| Variation to the scope, premises or conditions of licence (not requiring onsite assessment) | Application to Licence Issue | < 3 months |
| Re-inspection of Australian licensed premises | Inspection due date to Inspection report | 6 months |
| GMP certificate or notarised copy of Licence | Application to Issue | < 15 working days |
| New Certificate of GMP Compliance - Initial inspection | Application to Inspection report | < 6 months |
| Certificate of GMP Compliance - Re-Inspection | Inspection due date to Inspection Report | < 6 months |