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Annual Charge Exemption scheme: Forms

23 July 2021

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 of $0 turnover can only be made between 1 July and 22 July. A declaration cannot be made prior to 1 July.

The 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'.

Making an online declaration through the TBS portal allows sponsors to view and select only those 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.

Alternately, you can make your declaration by completing and submitting the paper-based form via email to ace.scheme@health.gov.au. The declaration form must be received by the TGA no later than 22 July.

Declarations cannot be accepted after this date, as the date is legislated and cannot be extended.

Late declaration

Sponsors who do not make a declaration of $0 turnover for an entry which was eligible for ACE during the annual declaration period (between 1 July and 22 July), may submit a late declaration in respect of the entry between 23 July and 15 September, but only if the entry did not commence generating turnover before or by the period covered by the declaration, Vis the previous financial year, 1 July to 30 June.

A late declaration of $0 turnover can only be made between 23 July and 15 September.

To be qualified to be exemption from annual charges under the ACE scheme in the financial year 2020-21, an ARTG entry was required to be:

  1. A new entry in the ARTG in financial year 2020-21; or
  2. An existing entry in the ARTG on 1 July 2020 which was ACE in the previous FY 2019-20, and the sponsor of the entry subsequently gave a declaration of $0 turnover for the entry between 1 July 2020 and 15 September 2020 (so the entry was ACE again in 2020-21); and
  3. The entry, whether a new entry or an existing entry, did not commence generating turnover before or by 30 June 2021.

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

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 15 September 2021, as the date is legislated and cannot be extended.

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

Late declaration of $0 turnover

To ensure a record of your late declaration 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.

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.

A notification of turnover can only be made between 16 September and 30 June.

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.