Public Consultation - Annual Charge Exemption (ACE) Scheme Compliance Program Updates

Overview

Annual Charge Exemption Scheme

The Annual Charge Exemption (ACE) scheme commenced on 1 July 2015. It provides an exemption from paying Therapeutic Goods Administration (TGA) annual charges until a therapeutic good covered by an entry on the Australian Register of Therapeutic Goods (ARTG) begins generating turnover. The scheme allows sponsors to enter their goods in the ARTG in advance of marketing without incurring an annual charge, until the goods are taken to the market.

Further information about the ACE scheme is available on the TGA website. The link to the relevant pages on the website is recorded below under 'Related Content'.

ACE Scheme Compliance Program

Sponsors confirm and renew exemptions under the ACE scheme through annual self-declarations. The Compliance Program which monitors those self-declarations, aims to uphold the integrity of the scheme by instituting regular reviews of sponsor records to verify the accuracy of self-declarations concerning exempt entries.

The Compliance Program ensures that sponsors who are eligible for exemptions receive the full benefit, while ineligible entries are identified and addressed accordingly. This helps to minimise any misuse of the ACE scheme and mitigates revenue loss arising from incorrectly claimed exemptions.

Why your views matter

ACE Scheme Compliance Progam Issues

The Compliance Program is increasingly encountering ARTG entries whose turnover status cannot be verified due to incomplete information.

Changes to the regulations which prescribe the ACE scheme are proposed. The changes will give greater authority to require information about exempt goods, and will also enable the cancellation of exemptions where a sponsor will not or cannot demonstrate that an ARTG entry was $0 turnover in a financial year that the sponsor declared the entry was $0 turnover.