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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.
Each year we consult with industry representative bodies in relation to proposed changes to fees and charges and publish a Cost Recovery Implementation Statement (CRIS). The CRIS provides information on how the TGA implements cost recovery activities associated with the registration and listing of medicines and inclusion of medical devices, including IVD devices, and biologicals onto the ARTG and the ongoing monitoring and surveillance of them.
Below you can find 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.