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Australian manufacturing licences and overseas GMP certification

A step-by-step guide

19 March 2019

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8: Determining whether your application is effective

We will determine whether your application is effective when we have received:

Please note that it may take two to three days to process your payment and release the application for processing.

Our target timeframes for inspections commence from when we deem the application effective (i.e.: the relevant fees have been paid and that all of the required evidence to support your application has been supplied).

Screening your application

We will review your application after we have received your fees and contact you if we require any clarification or additional information.

If we determine that no inspection is required, we will notify you. This could be because:

  • you could obtain GMP clearance using the MRA or CV pathway
  • you selected the wrong type of application
  • the goods or the manufacturer are exempt from the manufacturing principles
  • the application was made by an overseas manufacturer or representative acting on behalf of the overseas manufacturer instead of an Australian sponsor or agent acting on behalf of the Australian sponsor

If an inspection is warranted, we will schedule one. This could take up to six months depending on the completeness of the application and inspector availability. It is your responsibility that you submit your application with this timeframe in mind.

Advising us of changes

Once you have submitted your application you cannot change it via TGA Business Services.

If your anticipated timeline changes or you would like to vary the scope of your application, email the Manufacturing Quality Branch. We will review your request and accommodate the changes where possible. However, we may not be able to change the scope or duration of the inspection if you do not give us enough notice.

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