Annual charge exemption scheme

4 April 2017

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 ARTG in advance of their marketing with no annual charge.

The Scheme

All new entries are eligible for an ACE

Products automatically qualify for ACE once they are entered on to the ARTG. Sponsors will not be invoiced for an annual charge for that product until it generates turnover.

Only products which have $0 turnover are eligible for an ACE

Products will retain their ACE status so long as they continue to have $0 turnover and the sponsor declares this between 1 July and 22 July each year. As soon as a product generates turnover greater than $0 it will no longer be eligible for an ACE, even if it generates $0 turnover in the future.

The ACE scheme is a self-declaration scheme

No third party certification is required for the ACE scheme. To maintain an ACE, sponsors are able to self-declare that their product had no turnover. Self-declarations must be submitted to the TGA between 1 July and 22 July each year (starting July 2016), or it will be assumed that the product generated greater than $0 turnover.

An audit program will be in place to monitor compliance

To ensure compliance with the scheme an audit program will be in place to ensure that self-declarations are true and accurate.

Have more questions?

See the Annual Charge Exemption scheme: Questions and answers page.

Key dates

  • 1 July 2015 - ACE scheme commences
  • Between 1 July and 22 July each year (from July 2016) - sponsor must self-declare that entry had $0 turnover in the previous financial year in order to maintain the exemption for each entry
  • 15 September (annually) - payment of annual charges

Transition from the low value turnover (LVT) scheme

The ACE scheme will replace the LVT scheme on 1 July 2015.

Certain entries that received LVT exemptions in the 2013–14 and/or 2015–14 financial years may pre-quality for the ACE scheme. See the Questions and answers for more details.

Important information

Question mark iconQuestions and answers

Frequently asked questions about the ACE scheme

Calculator mark iconPayment dates for ACE entries that have generated turnover

Use this tool to work out when annual charges are due after a declaration of turnover

Process map iconACE process map

Find out more information about the ACE scheme

Entries declaring no turnover in 2015-16

In order to ensure transparency of the availability of therapeutic goods in Australia, all entries in the Australian Register of Therapeutic Goods that are yet to commence turnover and were exempt from annual charges in 2015-16 under the TGA's ACE scheme have been published on the TGA website under subsection 61 (5C) of the Act.

Annual Charge Exemption Scheme - entries declaring no turnover in 2015-16.

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 his delegate becomes aware that there was turnover for an entry for the financial year, the ACE on the entry will be cancelled under regulation 43AAG and the relevant annual charge(s) will become payable.