Annual charge exemption scheme

5 February 2016

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.

Notifications and declarations can be completed online

Sponsors can complete notifications of turnover and declarations of $0 turnover quickly and easily through TGA Business Services portal.

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

Interim impact assessment of the Therapeutic Goods Administration Annual Charge Exemption (ACE) scheme

The Interim Impact Assessment of the Therapeutic Goods Administration Annual Charge Exemption (ACE) Scheme presents the findings of an analysis by the TGA to identify the early impacts of the ACE scheme across and between industry sectors.

It is important to note that at the time of undertaking the assessment, the scheme had only been in operation for five months and that we do not expect to know the full impact of the scheme until it has been in operation for a minimum of 2 years. The TGA will continue to monitor the impact of the ACE scheme.

Important information

Question mark iconQuestions and answers

Frequently asked questions about the ACE scheme

Process map iconACE interactive tool and process map

Find out more information about the ACE scheme

Calculator on a blue circlePayment dates for ACE entries that have generated turnover

This calculator will show you when annual charges will be payable, based on the date you intend to notify the TGA of turnover

Clipboard on a blue circleACE scheme waiver guidance

Sponsors of certain therapeutic goods can seek a waiver from the annual charge