You are here
The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.
Guidance on licensing/certification inspections
Version 1.0, April 2013
Appendix 1: Performance measures and targets
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|