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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 Register) or upon registration/listing/inclusion of the goods on the Register 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 Register at any time during a financial year, regardless of whether the product is subsequently cancelled within the same financial year.
Sponsors who wish to cancel a product from the Register should submit their request ASAP (by 30 June) to avoid incurring annual charges for the new (subsequent) financial years (the TGA annual charges financial year is from 1 July to 30 June).
Any new product entering the Register on or after 1 July 2015 will qualify for an annual charge exemption (ACE) until such time as the product generates turnover.
Fees, charges and ACE
- Important annual charge deadlines
Information for sponsors on key annual charge due dates
- Annual charges for therapeutic goods
Annual charges apply to all product entries on the Register
- Annual Charge Exemption (ACE) Scheme
The scheme allows for the exemption of annual charges until a product first generates turnover