We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
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 |