You are here

Annual Charge Exemption scheme: Frequently asked questions

23 July 2019

About the Annual Charge Exemption (ACE) scheme

Open all | Close all
If you want to print all details, you need to Open all before you print.

The Annual Charge Exemption (ACE) scheme replaced the low value turnover (LVT) scheme on 1 July 2015. The LVT scheme provided an exemption from annual charges for goods in the Australian Register of Therapeutic Goods (ARTG) with low sales turnover, and had been in place in various forms since 1990.

The purpose of the ACE scheme is to recognise that TGA's post-market monitoring costs should only be incurred by goods that have been placed into the market. The ACE scheme allows sponsors to include their goods in the ARTG in advance of their marketing, without incurring annual charges until the good commences generating turnover.

Sponsors are required to make a declaration annually between 1 July and 22 July to confirm that an ARTG entry which meets the legislated criteria for exemption, did not commence generating turnover in the previous financial year.

  • All new goods that are registered, listed or included in the ARTG (excluding export only) during a financial year and did not commence generating turnover, meet the legislated criteria for exemption.
  • As the criteria for exemption from annual charges is legislated, sponsors cannot apply for, or request, an exemption.
  • Sponsors of an ARTG entry (excluding export only) that has met the legislated criteria for exemption during a financial year (being 1 July to 30 June) and has not commenced generating turnover during that financial year, must make a declaration of $0 turnover for that (active or cancelled) ARTG entry during the next declaration period which occurs annually between 1 July and 22 July.
  • If a sponsor does not make a declaration of $0 turnover for an exempt ARTG entry between 1 July and 22 July of a year, the exemption will cease and the relevant annual charge for that ARTG entry will become payable for the previous and current financial year. Annual charges will continue to be payable each financial year until the entry is cancelled from the ARTG.
  • Annual charge invoices will be issued to sponsors for only those ARTG entries (excluding export only) which do not meet the legislated criteria for exemption.
  • Once an ARTG entry commences generating turnover, the exemption ceases as the ARTG entry no longer meets the legislated criteria for exemption, even if the ARTG entry does not generate any turnover in a future financial year.
  • A notification of turnover can be made at any time during a financial year, except during the declaration period which occurs annually between 1 July and 22 July.
  • Annual charges become payable from the financial year in which the ARTG entry commenced generating turnover and will continue to be payable each financial year until the entry is cancelled from the ARTG.
  • Annual charges are payable annually by 15 September.
  • An application may be made for waiver of an annual charge on the grounds of public health risk / financial viability. Waivers are only granted under exceptional circumstances.

Legislated criteria for exemption:

  • the entry was new in the ARTG during a financial year; or
  • for an existing (active or cancelled) ARTG entry, a declaration was made in relation to the previous financial year; and
  • the ARTG entry has not commenced generating turnover

In all other cases, an ARTG entry has not met the legislated criteria for exemption and the annual charge in respect of that ARTG entry (excluding export only) is 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.

As the criteria for exemption from annual charges is legislated, sponsors cannot apply for an exemption.

'Turnover' for a therapeutic good means "gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year".

Under regulation 43AAA of the Therapeutic Goods Regulations 1990, "a person's turnover of therapeutic goods for a financial year is of low value if the turnover is $0".

Therefore, if an exempt ARTG entry commences generating turnover which is greater than $0, it no longer meets the legislated criteria for exemption.

An exemption from annual charges is valid for a single financial year (1 July to 30 June).

Sponsors of an ARTG entry that has met the legislated criteria for exemption, must make a declaration of $0 turnover annually between 1 July and 22 July until the ARTG entry commences generating turnover or until the next declaration period after the entry is cancelled from the ARTG.

Where an entry that has met the legislated criteria for exemption is cancelled from the ARTG during a financial year and the ARTG entry did not commence generating turnover prior to being cancelled, the sponsor must make a final declaration of $0 turnover during the next declaration period which occurs annually between 1 July and 22 July.

Making a final declaration will complete the annual charge exemption cycle. The ARTG entry will not incur annual charges and no further action will be required by the sponsor on an annual basis.

NOTE: To ensure declarations made in relation to previous financial years are true and accurate, the TGA may at any time, request that sponsors provide information in relation to their declaration(s) in order to verify that an exempt ARTG entry (active or cancelled) had not commenced generating turnover within the financial year for which the declaration was made.

The policy which applies to transfers of sponsorship is that the exemption follows the ARTG entry.

This is to ensure that any sponsor who receives an ARTG entry by a transfer of sponsorship is not affected (positively or negatively) upon receiving the entry. If an entry is exempt when transferred, the exemption continues for that entry (under the new sponsor) until:

  1. the sponsor notifies the TGA during the financial year that the exempt ARTG has commenced generating turnover; or
  2. the sponsor does not provide a declaration of $0 turnover during the next declaration period which occurs annually between 1 July and 22 July

Importantly, if an exempt ARTG entry is transferred to another sponsor during a financial year, the sponsor who 'acquired' the exempt entry is responsible for making a declaration of $0 turnover during the next declaration period which occurs annually between 1 July and 22 July.

Before the declaration of $0 turnover can be made, the sponsor who acquired the exempt ARTG entry must obtain evidence from the sponsor who relinquished or 'disposed' of the entry, to confirm whether (or not) the entry did not commence generating turnover during the financial year, prior to the date upon which the entry was transferred.

Example

Sponsor A transfers an exempt ARTG entry to Sponsor B on 1 January. As the exemption follows the ARTG entry, Sponsor B becomes responsible for making a declaration of $0 turnover for the entry (ONLY if the entry did not commence generating turnover in the financial year in which the transfer occurred) during the next declaration period which occurs annually between 1 July and 22 July.

As Sponsor B is responsible for making the next declaration of $0 turnover, Sponsor B must obtain evidence from Sponsor A to confirm the ARTG entry had not commenced generating turnover between 1 July and 31 December of that financial year (prior to the entry being transferred).

Importantly, Sponsor B should be always mindful that it is an offence under the Criminal Code to give a false or misleading declaration and should therefore seek reasonable evidence from Sponsor A (ideally, as part of the transfer of sponsorship process).

Certain details about ARTG entries which meet the legislated criteria for exemption are published on the TGA website under subsection 61(5C) of the Therapeutic Goods Act 1989 which authorises the publication of kinds of therapeutic goods information relating to exemptions under the Annual Charge Exemption Scheme.

Declaration of $0 turnover

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.

Sponsors can only make a declaration of $0 turnover annually between 1 July and 22 July.

NOTE: Declarations cannot be made prior to 1 July. However, sponsors are encouraged to review all of their ARTG entries in May or June to ensure any requests to cancel an ARTG entry can be actioned before 30 June. Sponsors do not need to wait until the declaration period commences in order to cancel an ARTG entry. A declaration can still be made for a cancelled entry that has met the legislated criteria for exemption.

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 homepage and make a declaration of $0 turnover by navigating 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).

NOTE: Only those ARTG entries (excluding export only) which meet the legislated criteria for exemption will appear in TBS. If you have any queries, please contact the ACE Scheme by email to ace.scheme@health.gov.au. Please ensure you quote your TGA Client ID number and/or the relevant ARTG number(s).

Sponsors who are unable to access the TBS portal, can download a paper-based declaration of $0 turnover form which will ONLY be available from the TGA website annually between 1 July and 22 July. Sponsors must complete the declaration of $0 turnover form and submit the signed document by 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

Declaration of $0 turnover forms must be received by the TGA no later than 22 July.

Annually, between 1 July and 22 July. Sponsors are required to make a declaration of $0 turnover on an annual basis to confirm that an ARTG entry (excluding export only) did not commence generating turnover during the previous financial year.

If an exempt entry was cancelled from the ARTG during a financial year and the entry had not commenced generating turnover during that financial year prior to be cancelled, the sponsor must make a final declaration of $0 turnover during the next declaration period which occurs annually between 1 July to 22 July. Once a final declaration has been made, no further declarations will be required for that entry in future financial years.

Once a declaration of $0 turnover has been made in respect of the previous financial year, the exemption for that ARTG entry will be confirmed (i.e. the entry did not commence generating turnover). Therefore, the ARTG entry will not incur annual charges for that financial year.

If a declaration of $0 turnover is not made in respect of an ARTG entry (excluding export only) which meets the legislated criteria for exemption, turnover is assumed to have commenced in the previous financial year. The exemption will therefore cease and the annual charge in respect of that ARTG entry will become payable. Annual charges will continue to 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.

The TGA will issue the sponsor with two annual charge invoices in August of a year for the previous financial year in which turnover is assumed to have commenced and the current financial year. Payment of both annual charge invoices are due by 15 September of the year in which they are issued.

Sponsors who inadvertently fail to make a declaration of $0 turnover during the declaration period in respect of an ARTG entry (excluding export only) which meets the legislated criteria for exemption, may submit a late declaration between 23 July and 15 September.

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'.

Sponsors can download a paper-based late declaration form which is only available between 23 July and 15 September. Sponsors must complete the late declaration form, remit payment of the prescribed fee and submit the signed document to the TGA no later than 15 September via email to accountsrec@health.gov.au and ace.scheme@health.gov.au or by regular mail to:

Therapeutic Goods Administration
Attention: Product Billing & Industry Assistance Section
PO Box 100
WODEN ACT 2606

Notifying that turnover has commenced

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 in Australia, the exemption ceases and the annual charge in respect of that entry will become payable from the financial year in which the turnover commenced. The notified ARTG entry will incur an annual charge each financial year thereafter, until 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 a notified ARTG entry during the next declaration period which occurs annually between 1 July and 22 July.

Making a notification of turnover is optional.

Sponsors can make a notification of turnover at any time during a financial year (except during the annual declaration period which occurs annually between 1 July and 22 July). If a sponsor chooses to make a notification of turnover during a financial year (e.g. at the time the ARTG entry (excluding export only) 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 after 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.

Sponsors can submit a notification of turnover at any time during the financial year (except during the declaration period which occurs annually between 1 July and 22 July) by downloading a paper-based form. The completed and signed notification of turnover form must be submitted to the TGA by email to ace.scheme@health.gov.au or by regular mail to:

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

NOTE: From 1 July 2019, sponsors will no longer be able to make a notification of turnover through the TGA Business Services (TBS) online portal.

Once a notification of turnover has been made for an ARTG entry (excluding export only), the exemption will cease. Annual charges in respect of that entry will become payable from the financial year in which the turnover commenced. The notified ARTG entry will incur an annual charge each financial year thereafter, until the entry is cancelled from the ARTG.

The annual charge invoice will be issued in the month the notification is made.

Sponsors who make a notification of turnover during a financial year are not required to make a declaration in respect of a notified ARTG entry during the next 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 (excluding export only) commences generating turnover, the sponsor must not make a declaration in respect of that 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 of a year for both the previous and current financial years.

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

Payment of both annual charge invoices are due by 15 September of the year in which they are issued.

Waivers

A waiver will effectively cancel or reverse the annual charge that would otherwise be payable for a financial year. Sponsors of certain high risk therapeutic goods can seek a waiver from (payment of) an annual charge for the relevant financial year if:

  • the good is not already exempt from paying an annual charge for the relevant financial year;
  • it is not financially viable for the good to remain on the ARTG if the annual charge was payable; AND
  • it is in the interest of public health for the good to remain on the ARTG.

The objective of the waiver provisions is to ensure the continued availability of essential therapeutic goods to the Australian public. The Secretary (decision maker) will only grant a waiver in exceptional circumstances.

Detailed information is available in the ACE scheme waiver guidance.

Sponsors of new goods included on the ARTG:

  • If an annual charge for a therapeutic good is payable for the financial year that it was first included on the ARTG, an application for a waiver must be made before 31 December in the next financial year.

NOTE: A waiver is only relevant if the sponsor is liable to pay the annual charge in relation to that financial year; that is, the sponsor of the therapeutic good has notified the TGA that turnover has commenced, therefore the good is no longer exempt from annual charges under the ACE scheme.

Sponsors of existing goods included on the ARTG:

  • Where the therapeutic good was already included on the ARTG on the first day of the financial year to which the annual charge relates, and the sponsor would otherwise be liable to pay the annual charge for that good, an application for a waiver must be made during that financial year.

A waiver only applies for a single financial year and only applies to the annual charge issued for the financial year in which the waiver was granted.

Any waiver that was granted in a previous financial year will no longer apply in the next financial year. The sponsor will be required to make a new application each financial year.

Sponsors must make an application for waiver in writing. The application must address both the financial viability and public health criteria referred to in the ACE scheme waiver guidance and also meet specific evidence requirements.

Sponsors can include more than one ARTG entry and entries for different types of therapeutic goods in the one application. However, the information required (i.e. evidence requirements) must be provided in relation to each entry.

When making an application, the sponsor must ensure that:

  • all the information you wish the Secretary (decision maker) to consider that is relevant to the criteria (i.e. evidence requirements), has been provided in support of the application;
  • the Chief Financial Officer or equivalent within your company, has signed the application;
  • all the relevant entries for which the application is being made, are listed in the application (per the evidence requirements, the list must include the ARTG number, the ARTG entry description, the annual charge invoice number and the type of therapeutic good); and
  • an email address is provided to ensure you are notified of the Secretary's decision

NOTE: An application for waiver will only be assessed if it addresses the requirements set out in the Regulations. That is, sub regulations 43AAH(7) and 43AAH(8) as described in the evidence requirements. If the application does not properly address the requirements, the application will not be considered.

Where the information provided in an application is assessed as being incomplete, insufficient or incorrect and therefore does not address the criteria and evidence requirements, the application will not be considered on the basis it is not an 'application'.

An application that does not contain sufficient information or sufficiently persuasive information to satisfy the Secretary (decision maker) that it is in the interests of public health for the entry to remain on the ARTG and that it would not be financially viable if the sponsor were required to pay the annual charge, may result in refusal of the waiver.

There is no fee associated with applying for a waiver.

The Secretary (decision maker) has 60 days from the date upon which the application for waiver is received, to consider the application and make a decision on whether or not to grant a waiver.

Written notice of the Secretary's decision, setting out the reasons for the decision, will be issued by email (to the email address provided in the application) as soon as practicable after the decision is made.

If the Secretary decides not to grant a waiver, the annual charge for the relevant financial year will become payable. The written notice of the Secretary's decision will specify the date upon which the annual charge becomes payable.

The written notice of the Secretary's decision will state that you can, within 90 days after the decision comes to your notice, make a request for a review of the Secretary's decision not to grant a waiver, under regulation 48 of the Therapeutic Goods Regulations 1990. Further information and guidance for requesting a reconsideration is available on the TGA website.

If the Secretary (decision maker) granted a waiver for an entry and the sponsor subsequently requests that entry be cancelled (i.e. revoked) from the ARTG in the same financial year, the annual charge for that financial year would become payable.

Certain information about waivers that have been refused or granted will be published on the TGA website. Information will also be published about sponsors who, having been granted a waiver, are required to pay the annual charge because of a request they subsequently made to cancel the entry.

Compliance monitoring

To ensure declarations made in relation to previous financial years are true and accurate, the TGA may at any time, request that sponsors provide information in relation to their declaration(s) in order to verify that an exempt ARTG entry had not commenced generating turnover within the financial year for which the declaration was made.

All ARTG entries for which a declaration of $0 turnover has been made will be published on the TGA website.

Sponsors are reminded that making a false or misleading declaration of $0 turnover is an offence under the Criminal Code.

Should the TGA become aware of the sponsor having made a false or misleading declaration of $0 turnover, the sponsor will be liable for the relevant financial years' annual charges, commencing from the year in which the false or misleading declaration of $0 turnover was made.

Contact us

If you were unable to resolve your query by reviewing information about the ACE Scheme on the TGA website, you can contact the ACE Scheme by email to ace.scheme@health.gov.au or by phone on 02 6232 8694.

Version history

Version history
Version Description of change Author Effective date
V1.0 Original publication TGA May 2015
V1.1 Minor updates TGA June 2015
V2.0 Two Q&A added to General information TGA August 2015
V2.1 Minor updates TGA July 2016
V2.2 Minor updates TGA November 2016
V3.0 Updated TGA June 2017
V4.0 Updated TGA June 2018
V4.1 Minor updates TGA June 2019
V4.2 Minor updates TGA July 2019