Annual Charge Exemption (ACE) scheme forms

25 July 2017

Notification of turnover: Annual Charge Exemption (ACE) scheme

Sponsors are encouraged to notify commencement of turnover through the TGA Business Services (TBS) portal. If you do not have access to TBS, you should download and complete this form.

This form is for notifying the TGA that your product has started generating turnover. The Regulations enable you to notify us when you first start selling your product and generating turnover, as this is when the annual charge for the product will become payable. You can notify us using this form at any time during the year.

By completing this notification, you eliminate the annual requirement to provide a declaration to confirm that your exempt products have not yet had any turnover.

Completed forms should be forwarded to TGA via email to ace.scheme@health.gov.au or via regular mail to:

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

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.

Application for reinstatement of an annual charge exemption (ACE) on an ARTG entry

Sponsors of ACE entries on the ARTG were required to make a declaration in relation to those entries which had not yet started to generate turnover in order to maintain their exemption from annual charges.

The declarations could only be made between 1 and 22 July 2017. If no declaration was provided turnover was assumed to have commenced in 2016-17 and the annual charges for 2016-17 and 2017-18 became payable.

If however an ACE entry (or entries) had not started generating turnover (between 1 July 2016 and 30 June 2017), and you did not provide a declaration for those entries, you can still make an application under Regulation 43AAD of the Therapeutic Goods Regulations 1990.

Note: You cannot submit a late lodgement application for reinstatement of an ACE if your entry:

  1. was not eligible for the ACE scheme in 2016-17; or
  2. was eligible for the ACE scheme in 2016-17 but had turnover at any time between 1 July 2016 and 30 June 2017.

How to apply for late lodgement

To apply for late lodgement the following information must be provided by 15 September 2017:

  • Reason(s)
    • A notice in writing with the reason(s) why you were not able to provide a declaration under Regulation 43AAD, or 43AAGB (whichever is applicable) between 1 July and 22 July 2017, and
  • Declaration of no turnover
    • A declaration in writing stating that the entry (or entries) which is, or was, registered, listed or included on the ARTG did not commence generating turnover between 1 July 2016 and 30 June 2017.
  • Late lodgement application fee paid
    • A fee of $410 is payable for an ACE reinstatement (for up to 5 ARTG entries). An additional $50 per entry applies for each additional entry.

Information on how to make payment of a late lodgement application fee is set out in the form 'Application for reinstatement of an annual charge exemption (ACE) on an ARTG entry'.

Completed forms together with payment of the application fee should be forwarded via email to accountsrec@health.gov.au (cc to ace.scheme@health.gov.au) or via Registered Post® to:

Therapeutic Goods Administration
Attention: Accounts Receivable Team
Product Billing and Industry Assistance Section
PO Box 100 Woden ACT 2606

It is important that you obtain evidence of delivery of the form to the TGA by 15 September 2017. Forms and/or payments received after 15 September 2017 cannot be accepted:

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

Valid application - outcome

If your late lodgement application addresses the criteria outlined above the ACE on your entries will be restored.

If any of the above criteria are not met the application will be invalid.

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.