Updated GMP Clearance application forms

26 September 2017

The TGA have published redesigned e-forms to be used by Australian sponsors when applying for GMP Clearances. These application forms are now available on the TGA Business Services portal.

The redesigned e-forms aim to:

  • Improve the user experience by:
    • Displaying a list of evidence required based on the application type selected
    • Pre-populating some data using client details already registered with TGA
    • Reducing duplication in data entry for applicants
    • Providing an improved 'Help' function within the e-form
  • Allow upfront payment of all relevant GMP Clearance fees
  • Allow extension requests to be submitted via the TGA Business Services GMP clearance application e-form

We have also published updated guidance on GMP Clearance and a Clearance Application Assistance Tool (CAAT) which assist Australian sponsors to prepare GMP clearance applications that provide us with all required information.

Please contact the Manufacturing Quality Branch if you have any questions.