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Annual Charge Exemption scheme: Forms

21 September 2020

Declaration of $0 turnover

Making a 'declaration of $0 turnover' confirms an (active or cancelled) entry on the Australian Register of Therapeutic Goods (ARTG) (excluding export only) that has met the legislated criteria for exemption, has not commenced generating turnover in the previous financial year and is therefore exempt from paying annual charges for that financial year.

Making a declaration of $0 turnover during the declaration period which occurs annually between 1 July and 22 July, does not incur a fee.

A declaration of $0 turnover can be made online via the TGA Business Services (TBS) portal by navigating through 'Applications > Annual Charge Exemption > Manage My Entries' - and then click on the blue coloured link titled > 'Submit Declaration of $0 Turnover'.

Notes:

  1. Access to make a declaration of $0 turnover is only available between 1 July and 22 July.
  2. Making an online declaration through the TBS portal allows sponsors to efficiently view and select eligible entries (if any) for exemption. TBS provides automatic electronic confirmation when a declaration has been submitted successfully.
  3. Sponsors who require access to TBS are encouraged to contact the administrator of your organisation’s account. If the administrator is no longer associated with the organisation or you wish to update the administrator, please complete and return an Updating Organisation Administrator form.

Late declaration

Sponsors who inadvertently fail to make a declaration of $0 turnover during the annual declaration period (between 1 July and 22 July), may submit a late declaration in respect of an entry on the Australian Register of Therapeutic Goods (ARTG) (excluding export only) that has met the legislated criteria for exemption, between 23 July and 15 September.

In order to be exempt, an ARTG entry must first meet the following legislated criteria:

  1. the entry was new in the ARTG during a financial year; or
  2. for an existing entry, a declaration was made in relation to the previous financial year; and
  3. the entry has not commenced generating turnover

The late declaration form accompanied by evidence of payment of the prescribed fee, must be received by the TGA no later than 15 September. Late declarations cannot be accepted after this date as the date is legislated and cannot be extended.

Notes:

  1. Access to make a late declaration is only available via this page between 23 July and 15 September.
  2. To make a late declaration, sponsors must complete a paper-based late declaration form, remit payment of the prescribed fee (per instructions provided in the late declaration form) and submit evidence of payment (i.e. remittance advice) together with the completed and signed late declaration form by email to accountsrec@health.gov.au by no later than 15 September.

Notification of turnover

Making a 'notification of turnover' confirms an entry on the Australian Register of Therapeutic Goods (ARTG) (excluding export only) that is currently exempt from annual charges, has commenced generating turnover. Once an entry commences generating turnover in Australia, the exemption ceases. The annual charge in respect of the notified ARTG entry becomes payable for the financial year in which turnover commenced and each new financial year thereafter, up to and including the financial year in which the entry is cancelled from the ARTG.

A notification of turnover should be made as soon as the ARTG entry commences generating turnover. In the month after the notification is made, the sponsor will be issued with an annual charge invoice in respect of the notified entry for the financial year in which the turnover commenced.

Annual charges will be issued in August of each new financial year thereafter.

Failure to submit a notification of turnover as soon as an ARTG entry has commenced generating turnover, will result in the sponsor being issued with two annual charge invoices (at the same time) in August for the financial year in which the notified entry commenced generating turnover and the current financial year.

Payment of both annual charge invoices are due by 15 September.

Annual charges in respect of the notified ARTG entry will then be payable each financial year up to and including the financial year in which the entry is cancelled from the ARTG, even if the entry has not generated turnover in a future financial year.

Notes:

  1. Access to make a notification of turnover is only available via this page between 16 September and 30 June.
  2. 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.

To ensure a record of your notification of turnover is saved, please download the form to your computer before completing it. See How to save a document to your own computer if you are not sure how to do this.

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