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Annual charge exemption scheme
The Annual Charge Exemption (ACE) scheme allows for the exemption of annual charges until a product first generates turnover.
The purpose of the scheme is to recognise that TGA's post-market monitoring costs should only be incurred by products that have been placed into the market. The scheme allows sponsors to enter their products on the Australian Register of Therapeutic Goods (ARTG) in advance of their marketing with no annual charge.
New entries are eligible for an ACE
All new entries that are registered, listed or included on the ARTG during a financial year automatically qualify for an ACE in their first year. Sponsors do not need to apply for an ACE and will not be invoiced an annual charge for an ACE entry until it commences generating turnover.
Only products which have $0 turnover are eligible for an ACE
Existing entries which are active on the ARTG as at 1 July in a financial year, will retain their ACE if the sponsor makes a declaration stating the entry did not commence turnover (i.e. had $0 turnover) in the previous financial year.
Sponsors are required to make their declaration of $0 turnover between 1 July and 22 July each year, but only if their entry or entries was $0 turnover in the previous financial year.
As soon as an entry commences generating turnover greater than $0, the entry will no longer be eligible for ACE, even if the entry does not generate turnover in later financial years.
The ACE scheme is a self-declaration scheme
No third party certification is required for the ACE scheme. To retain ACE on an entry, a sponsor is able to self-declare that their entry had $0 turnover.
Self-declarations can only be submitted to the TGA between 1 July and 22 July each year.
If no declaration is received, the Regulations which stipulate the ACE scheme are designed to assume that an entry commenced generating turnover in the previous financial year and result in the ACE ceasing on the entry. Once ACE ceases, the relevant financial year annual charges are incurred and the sponsor is issued invoices for those relevant financial years. The annual charge will continue to be incurred each (next) 1 July until the entry is cancelled from the ARTG.
ACE scheme compliance monitoring
To ensure that self-declarations are true and accurate, the TGA may at any time, request sponsors to provide further information in relation to an ACE entry in order to verify that the entry did not commence turnover in the period(s) so declared as $0 turnover by the sponsor.
Sponsors are reminded that making a false or misleading declaration is an offence under the Criminal Code.
Have more questions?
See the Annual Charge Exemption scheme: Questions and answers page.
- Between 1 July and 22 July (each year) - sponsors must self-declare that an ACE entry had $0 turnover in the previous financial year in order to retain the exemption on the entry.
- 15 September (annually) - due date for payment of annual charges
Frequently asked questions about the ACE scheme
Use this tool to work out when annual charges are due after a declaration of turnover
Annual Charge Exemption Scheme - Entries declaring $0 turnover
In order to ensure transparency of the availability of therapeutic goods in Australia, all entries in the Australian Register of Therapeutic Goods that had not commenced turnover and were exempt from annual charges under the ACE scheme in the previous financial year(s), are published annually on the TGA website under subsection 61 (5C) of the Therapeutic Goods Act 1989.
Sponsors are reminded that the entries which were declared as $0 turnover may be subject to further review and verification by the TGA and, if the Secretary or their delegate becomes aware that there was turnover for an entry for the financial year, the exemption on the entry will be cancelled under regulation 43AAG or 43AAGF of the Therapeutic Goods Regulations 1990 and the relevant annual charge(s) will become payable.
Information published is accurate as at 15 October 2018.