You are here

Annual charge exemption (ACE) scheme

11 June 2019

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 will become payable each financial year until it is cancelled from the ARTG.

The Scheme

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.

As the criteria for exemption from annual charges is legislated, sponsors cannot apply for an exemption.

New entries in the ARTG

All new goods that are registered, listed or included in the ARTG during a financial year and did not commence generating turnover, meet the legislated criteria for exemption.

Existing entries in the ARTG

Only those existing entries for which a declaration of $0 turnover was made in relation to the previous financial year and did not commence generating turnover during the current financial year, meet the legislated criteria for exemption.

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 cancelled from the ARTG, even if the entry has not generated turnover during a future financial year.

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 from the TGA website.

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 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 annual declaration period between 1 July and 22 July in respect of an ARTG entry 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 2019.

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.

If the Secretary or their delegate becomes 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.

Key dates

  • Between 1 July and 22 July (each year) - sponsors must make a declaration of $0 turnover for those entries which meet the legislated criteria for exemption and did not commence generating turnover in the previous financial year
  • 15 September (each year) - due date for payment of annual charges

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 5 June 2019.