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, the Australian TGA charges fees for all its services. Such services include, for instance, product evaluations.
The charges, meaning tax imposed on the regulated industry, are updated annually based on a 1 July to 30 June financial year. The guidance summarizes the fees and charges set by the Australian therapeutic goods legislation and refers to:
- application fees to include a medical device in the Australian Register of Therapeutic Goods (ARTG)
- annual charges for Medical Devices in the ARTG (maintain them in the database);
- application for Medical Devices (priority applicant) determination;
- application audit assessment fee (payable in addition to the application fee for the inclusion of some Medical Devices in the ARTG).
The GMP clearance fees of overseas manufacturers (per manufacturer, per site, per sponsor) have also been revised, as follows:
- Application processing fee, increased from $400 to $650;
- Compliance Verification (CV) fee, increased from $2070 to $2480.
These changes will come into effect for GMP clearance applications submitted on or after July 1st, 2019.