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Guidance 2: Fees and charges for prescription medicines
2.9 Annual charges for prescription medicines
An annual charge is payable for maintaining registration in the ARTG unless the ARTG entry qualifies for the Annual Charge Exemption (ACE) scheme. There are three levels of annual charges, one for medicines of biological origin, and two for medicines of nonbiological origin. A list of charges can be found in the Therapeutic Goods (Charges) Regulations 1990.
A sponsor can seek a waiver from the annual charge for an entry in the ARTG if the therapeutic good qualifies for a waiver from annual charges for essential therapeutic goods.
The low value turnover (LVT) scheme has been replaced by the Annual Charge Exemption (ACE) scheme commencing 1 July 2015. For information on the new ACE scheme, including the transitional arrangements in place for entries previously granted LVT exemptions, see: ACE Scheme.
Where a number of prescription medicines are 'grouped' under a grouping order in accordance with ss. 16(2) of the Act, only one relevant annual charge is payable by a sponsor for the purposes of maintaining all that sponsor's medicines registered in the ARTG that are included in the same grouping order - ss. 4(1A) of the Therapeutic Goods (Charges) Act 1989.