Annual Charge Exemption scheme: Forms

Declaration of $0 turnover

Making a 'declaration of $0 turnover' during the annual declaration period between 1 July and 22 July, confirms that an active or cancelled entry on the Australian Register of Therapeutic Goods (ARTG) (excluding export only) that met the legislated criteria for an exemption from annual charges, did not commence generating turnover in the previous financial year and is therefore exempt from incurring 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 may 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'.

A declaration of $0 turnover can only be made via the online portal between 1 July and 22 July. Declarations are not available in the portal at any other time.

Making an online declaration through the TBS portal allows sponsors to view and select only those active or cancelled ARTG entries (if any) which meet the legislated criteria for exemption from annual charges. Once an online declaration has been successfully submitted, sponsors will receive automatic confirmation.

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 and/or you wish to update the administrator, please complete and return an Updating Organisation Administrator form.

Late declaration

Sponsors who do not make a declaration of $0 turnover during the annual declaration period (between 1 July and 22 July), may submit a late declaration for an entry which meets the legislated criteria for exemption (e.g. has not commenced generating turnover), between 23 July and 15 September.

Late lodgement declaration of $0 turnover

The legislated criteria for exemption from annual charges under the ACE scheme requires an ARTG entry to be either a) or b) AND c) of the following:

1. a new (active or cancelled) entry in the ARTG during the last completed financial year; or
2. an existing (active or cancelled) entry in the ARTG for which a declaration was made in relation to the previous financial year; AND
3. the entry has not commenced generating turnover.

You can make your late declaration by completing and submitting the paper-based form via email to ace.scheme@health.gov.au accompanied by evidence of payment of the prescribed fee (instructions provided within the late declaration form), must both be received by the TGA no later than 15 September.

Late declarations cannot be accepted after 15 September, as this date is legislated and cannot be extended.

The late declaration form is only available between 23 July and 15 September each year.

Notification of turnover

Making a 'notification of turnover' during a financial year confirms that an entry that is exempt from annual charges, has commenced generating turnover during that year. Once an entry commences generating turnover, the exemption ceases and the relevant annual charge for the entry becomes due and payable (and then again each financial year thereafter, up to and including the financial year in which the entry is cancelled from the ARTG).

Sponsors who make a notification of turnover during a financial year are not required to make a declaration in respect of the entry during the next declaration period which occurs annually between 1 July and 22 July.

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

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

Note: ARTG entries that have commenced generating turnover cannot be declared $0 turnover between 1 July and 22 July. If a notification of turnover was not submitted as soon as an entry had commenced generating turnover, the sponsor simply takes no action during the next declaration period. The absence of a declaration will result in the issuance of (up to) two annual charge invoices for the entry, the first for the prior financial year which was not previously invoiced as the entry was recorded as ACE (until the declaration period passed), and the for new financial year, but only if the entry was still active in the ARTG on 1 July in the new financial year.

Annual charge invoices are due and payable in full by 15 September.

• Notification of turnover: Annual Charge Exemption (pdf,129kb)
• Notification of turnover: Annual Charge Exemption (docx,126kb)

You can make your notification of turnover by completing and submitting the paper-based form via email to ace.scheme@health.gov.au.

The notification of turnover form is only available between 16 September and 30 June.