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Annual Charge Exemption scheme
The Annual Charge Exemption (ACE) scheme provides an exemption from paying the annual charge for a good that is registered, listed or included in the Australia Register of Therapeutic Goods (ARTG) until the ARTG entry first commences generating turnover.
The purpose of the scheme is to recognise that TGA's post-market monitoring costs should only be incurred by goods that have been placed into the market. The scheme allows sponsors to enter their goods in the ARTG in advance of their marketing with no annual charge.
Once an ARTG entry commences generating turnover in Australia, the exemption ceases and the annual charge in respect of that ARTG entry is payable each financial year until it is cancelled from the ARTG.
Sponsors of an ARTG entry which meets the legislated criteria for exemption during a financial year (being 1 July to 30 June), must make a declaration of $0 turnover for that ARTG entry during the next declaration period which occurs annually between 1 July and 22 July.
Legislated criteria for exemption:
- the entry was new in the ARTG during a financial year; or
- for an existing (active or cancelled) ARTG entry, a declaration was made in relation to the previous financial year; and
- the ARTG entry has not commenced generating turnover.
In all other cases, an ARTG entry has not met the legislated criteria for exemption and the annual charge in respect of that ARTG entry is payable each financial year until the entry is cancelled from the ARTG, even if the entry has not generated turnover during a future financial year.
As the criteria for exemption from annual charges is legislated, sponsors cannot apply for an exemption.
Cancelled ARTG entries
Where an entry that has met the legislated criteria for exemption, is cancelled from the ARTG during a financial year and the ARTG entry did not commence generating turnover prior to being cancelled, the sponsor must make a final declaration of $0 turnover during the next declaration period which occurs annually between 1 July and 22 July.
Making a final declaration will complete the annual charge exemption cycle. The ARTG entry will not incur annual charges and no further action will be required by the sponsor on an annual in respect of that entry.
Annual declaration period between 1 July and 22 July
Sponsors can make a declaration annually between 1 July and 22 July as follows:
- Online declaration: Sponsors who have a login with the 'submitter' system role assigned to them for their organisation, can log into the TGA Business Services (TBS) portal via the TGA website (www.tga.gov.au) and make a declaration of $0 turnover.
- Paper-based declaration: Sponsors who are unable to access the TBS portal, can download a paper-based declaration of $0 turnover by navigating to 'Applications > Annual Charge Exemption > Manage My Entries > Submit Declaration of $0 Turnover'.
NOTE: Access to a declaration of $0 turnover is only available between 1 July and 22 July each year.
If a declaration of $0 turnover is not made in respect of an ARTG entry (excluding export only) which meets the legislated criteria for exemption, turnover is assumed to have commenced in the previous financial year. The exemption will therefore cease and the annual charge in respect of that ARTG entry will become payable for the previous and current financial years. Annual charges will continue to be payable each financial year until the entry is cancelled from the ARTG, even if the entry has not generated turnover during a future financial year.
Sponsors who inadvertently fail to make a declaration of $0 turnover during the declaration period which occurs annually between 1 July and 22 July in respect of an ARTG entry (excluding export only) which meets the legislated criteria for exemption, may submit a late declaration between 23 July and 15 September of a year. A late declaration must be accompanied by the prescribed fee and must be received by the TGA no later than 15 September of a year. Late declarations cannot be accepted after this date as the date is legislated and cannot be extended.
A late declaration is only available for download from the TGA website between 23 July and 15 September.
ACE scheme compliance monitoring
To ensure declarations made in relation to previous financial years are true and accurate, the TGA may at any time, request that sponsors provide information in relation to their declaration(s) in order to verify that an ARTG entry had not commenced generating turnover within the financial year for which the declaration was made.
Should the TGA become aware that an ARTG entry commenced generating turnover during a financial year for which a declaration was made, 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.
Making a false or misleading declaration is an offence under the Criminal Code.
Frequently asked questions (FAQ)
Publishing of exemptions
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 generating turnover and were exempt from annual charges under the ACE scheme in previous financial years, are published annually on the TGA website under subsection 61 (5C) of the Therapeutic Goods Act 1989.
Information published is accurate as at 23 July 2019.