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Updated GMP licence application e-forms

13 March 2019

The revised fees and charges model for domestic medicine manufacturers commenced on 1 July 2018. To fully support these changes the TGA needed to update our TBS (TGA Business Services) submission e-forms used by Australian manufacturers when applying for a GMP Licence. Updated Licence e-forms will be available on the TBS portal from 15 March 2019 and support the revised fees and charges model by:

  • Automatically generate the application fee invoice according to the current Schedule of Fees and Charges when submitting a New or Variation Licence Application.
  • Allowing the applicant to identify the activities intended to be undertaken at the licenced site(s) and the Licence variation type when submitting a Licence application.
  • Enable the applicant to request a new manufacturer be added in the Client Database in the e-form prior to commencing the Licence application.

To further support these changes the TGA will also publish the following updated guidance:

What you need to do with your draft Licence applications

If you have 'draft' New and Variation Licence applications created prior to 15 March 2019 in your portal, please discard them by clicking the 'Delete' button in your draft applications and resubmit a new application.

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