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Guidance 2: Fees and charges for prescription medicines
2.1 Background to fees and charges
The TGA operates on a cost-recovery basis by charging fees for services and collecting annual charges. Schedule 9 of the Regulations outlines the range of fees for services that the TGA provides. Each fee in Schedule 9 reflects the cost of providing that service to an applicant.
The Regulations allow the TGA to waive or reduce the fees payable for certain services in limited circumstances. These involve applications for registration of orphan drugs, and for the registration and variation of prescription medicines in response to a public health emergency.
Annual charges are a tax imposed on users of the regulatory scheme.
The Therapeutic Goods (Charges) Regulations 1990 list the charges that apply to prescription medicines, payable every year by a sponsor to maintain that entry in the ARTG.