You are here

Annual Charge Exemption scheme: Forms

16 September 2019

Declaration of $0 turnover (1 July to 22 July)

A 'declaration of $0 turnover' enables sponsors to confirm that an ARTG entry (excluding export only) which meets the legislated criteria for exemption, did not commence generating turnover in the previous financial year and is therefore exempt from paying annual charges for that financial year.

NOTE: The declaration period occurs annually between 1 July and 22 July. Access to a declaration of $0 turnover is only available during this time.

A declaration of $0 turnover can be made, as follows:

  • Online declaration: Sponsors who have a login with the 'submitter' system role assigned to them for their organisation, can log into the TGA Business Services (TBS) portal via the TGA website (www.tga.gov.au) and then navigate to 'Applications > Annual Charge Exemption > Manage My Entries > Submit Declaration of $0 Turnover'. Sponsors who wish to create an account, are having trouble accessing an existing account or who do not have a login with the appropriate system role, are encouraged to contact their organisation's TBS administrator or the TBS Helpdesk for assistance (email ebs@health.gov.au or phone 1800 010 624).
  • Paper-based declaration: Sponsors who are unable to access the TBS portal, can download a paper-based declaration of $0 turnover form (between 1 July and 22 July only). Sponsors must complete the declaration of $0 turnover form and submit the signed document to the TGA no later than 22 July 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

Late declaration of $0 turnover (23 July to 15 September)

Sponsors who inadvertently fail to make a declaration of $0 turnover during the declaration period which occurs annually between 1 July and 22 July in respect of an ARTG entry (excluding export only) which meets the legislated criteria for exemption, may submit a late declaration.

NOTE: The late declaration period occurs annually between 23 July and 15 September. Access to a late declaration of $0 turnover form is only available during this time.

A late declaration accompanied by payment of the prescribed fee, must be received by the TGA no later than 15 September.

Late declarations and/or payment of the prescribed fee received by the TGA after 15 September cannot be accepted as the date is legislated and cannot be extended.

The prescribed fee for making a late declaration under regulation 43AAE or 43AAGD of the Therapeutic Goods Regulations 1990 is set out in the TGA Schedule of Fees and Charges, under 'General Fees'.

NOTE: A late declaration is only available for download from the TGA website between 23 July and 15 September.

Notification of turnover

A 'notification of turnover' enables sponsors to notify the TGA that an ARTG entry (excluding export only) which had met the legislated criteria for exemption has commenced generating turnover. Once an ARTG entry commences generating turnover, the exemption ceases and the annual charge in respect of that ARTG entry will become payable each financial year until it is cancelled from the ARTG.

NOTE: A notification of turnover cannot be made during the declaration period which occurs annually between 1 July and 22 July. Access to a notification of turnover form is available at all other times.

Making a notification of turnover is optional.

If a sponsor chooses to make a notification of turnover during a financial year (at the time the ARTG entry commences generating turnover), the TGA will issue the sponsor with an annual charge invoice in respect of the notified ARTG entry for the current financial year, in the month in which the notification is made. For example, if the sponsor notifies the TGA in April that turnover commenced in March, the sponsor will receive an annual charge invoice in April, for the current financial year.

NOTE: Sponsors who make a notification of turnover during a financial year cannot make a declaration in respect of the notified ARTG entry during a future declaration period which occurs annually between 1 July and 22 July.

If a sponsor chooses NOT to make a notification of turnover at the time an ARTG entry commences generating turnover, the sponsor must not make a declaration in respect of that ARTG entry during the next declaration period which occurs annually between 1 July and 22 July. It will be assumed that turnover has commenced in the previous financial year and the TGA will issue the sponsor with two annual charge invoices in August for both the previous and current financial years.

Annual charges in respect of the ARTG entry will then be payable each financial year until the entry is cancelled from the ARTG, even if the entry has not generated turnover during a future financial year.

NOTE: Sponsors are no longer be able to make a notification of turnover through the TGA Business Services (TBS) online portal. To make a notification of turnover, sponsors must complete a paper-based notification of turnover form and submit the signed document to the 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

Notification of turnover 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.