Australia – Updated GMP licence application e-forms

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: