Annual Charge Exemption (ACE) scheme forms

1 July 2018

Declaration of low value ($0) turnover: Annual Charge Exemption (ACE) scheme

Sponsors with qualified ACE entries on the ARTG in 2017-18 are required to make a declaration, in respect of those entries which had not yet commenced generating turnover in order to:

  1. confirm the 2017-18 ACE on the entry or entries; and
  2. maintain their exemption from annual charges in 2018-19.

The declarations of $0 turnover can only be made between 1 July and 22 July 2018. If no declaration is provided by 22 July 2018, turnover is assumed to have commenced on the entry or entries in 2017-18 and the relevant annual charges for 2017-18 and 2018-19 will become due and payable by 15 September 2018.

By completing the declaration of $0 turnover, the ACE on your entry or entries will continue until:

  1. an entry commences turnover and you notify us of that turnover; or
  2. you do not provide a further declaration of $0 turnover between 1 July and 22 July in the next financial year (i.e. between 1 July and 22 July 2019).

Completed declaration forms should be forwarded to TGA via email to ace.scheme@health.gov.au or via Registered Post® to:

Therapeutic Goods Administration
Attention: ACE Scheme Coordinator
Regulatory Pricing and Decision Review Section
PO Box 100
Woden ACT 2606

It is important that you obtain evidence of delivery of the form to the TGA by the declaration due date of 22 July 2018. Any forms received prior to 1 July 2018 or after 22 July 2018 cannot be accepted as these are legislated dates.

  • If submitting by email, you should ensure 'tracking' settings on your email account require a 'delivery receipt' or 'read receipt'.
  • If submitting by post, it is recommended that you send by Registered Post® to ensure proof of receipt (with a signature required on delivery).

Further instructions about how to complete the declaration are set out in the declaration form.

How to access a pdf or Word document

This form is available in pdf and Microsoft Word formats. The pdf form can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.