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TGA uses a combination of fees and charges to recover the costs of regulation of therapeutic goods.
A fee is charged for a service, such as a product evaluation and the level is based on the cost of providing that service using an activity based costing methodology. A list of fees is included in Schedule 9 of the Therapeutic Goods Regulations 1990.
A charge is a form of tax imposed on the regulated industry and is applied on an annual basis (in July of each year for existing entries on the Australian Register of Therapeutic Goods (the ARTG) or upon registration/listing/inclusion of the goods on the ARTG during a financial year). A list of charges can be found in the Therapeutic Goods (Charges) Regulations 1990. Annual charges are applied to recover the cost of monitoring and compliance activities.
Annual charges apply to all product entries (except export only products) on the ARTG at any time during a financial year, regardless of whether the product is subsequently cancelled within the same financial year.
There are also annual charges for manufacturer licences. Please see the information below for more details on our fees, charges and payment.