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Fees and charges: summary from 1 December 2021

23 November 2021

The TGA is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities.

  • A fee is charged for a service, such as a product evaluation.
  • A charge is a form of tax on regulated industry and is applied annually based on a 1 July to 30 June financial year.

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This guidance is a summary of fees and charges, which are in the Australian therapeutic goods legislation. This is not an exhaustive list.

For a complete list of all fees and charges and the exact legislative wording, please refer directly to the legislation.

Fees and charges: summary from 1 December 2021

We aim to provide documents in an accessible format. If you're having problems using this document, please contact TGAFeesAndCharges@health.gov.au.

Contents

  • Introduction
  • Prescription medicines
  • Non-prescription medicines
  • Manufacturing medicines and OTGs
  • Export of therapeutic goods
  • Biologicals
  • Blood, blood components and HPCs
  • Medical devices
  • IVD medical devices
  • Other listed and registered therapeutic goods (OTGs)
  • Clinical trials
  • General fees