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Guidance on licensing/certification inspections

Version 1.0, April 2013

29 April 2013

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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

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