In preparation for the commencement of the new financial year, it is important to be aware of information and key deadlines regarding your TGA account and your annual obligations as the sponsor of a good in the Australian Register of Therapeutic Goods (ARTG) or as the holder of a manufacturing licence.
Sponsors are reminded that if your good is no longer supplied, you can cancel your entry from the ARTG. Goods that are active in the ARTG on 1 July will incur the new financial year’s annual charge (unless exempt).
Read information on how to request to cancel an ARTG entry.
Similarly, manufacturers are reminded that if your licence is no longer required, you can revoke your licence. Manufacturing licences that are active on 1 July will incur the new financial year’s annual charge.
Read information on how to revoke a manufacturing licence.
Important dates
| Dates | Details | Enquiries |
|---|---|---|
| May-June | Review and update organisation account details including billing email addresses, authorised users and user roles | Email: ebs@health.gov.au Phone: 1800 010 624 |
| 15 June | Requests for voluntary revocation of a manufacturing licence must be received by the TGA to avoid incurring the new financial year's annual charge. For more information, please see: Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence | Email: gmp@health.gov.au Phone: 1800 020 653 |
| 30 June | Requests for voluntary cancellation of ARTG entries must be received by the TGA to avoid incurring the new financial year's annual charge. For more information, please see: Request to cancel an ARTG entry | Email: ebs@health.gov.au Phone: 1800 010 624 |
Requests for transfer of sponsorship of ARTG entries must be received by the TGA. The sponsor of any entries that are active in the ARTG on 1 July, will be issued with the new financial year’s annual charge invoice (unless exempt). For more information, please see: Changing the sponsor of therapeutic goods | ||
1 July
| The TGA’s annual Summary of Fees and Charges is published prior to the commencement of the new financial year. | Email: TGAFeesAndCharges@health.gov.au Phone: 1800 020 653 |
| Fees and charges take effect annually from 1 July and are automatically applied to all active ARTG entries and manufacturing licences for the purposes of invoicing the new financial year’s annual charge. | Email: accountsrec@health.gov.au Phone: 1800 020 653 (option 5) | |
| Annual charge invoices are issued for active manufacturing licences. | Email: accountsrec@health.gov.au Phone: 1800 020 653 (option 5) | |
| 1-22 July | Submit online ‘Declaration of $0 Turnover’ for only those ARTG entries which meet the legislated criteria for exemption from annual charges under the Annual Charge Exemption (ACE) Scheme. For more information, please see: Annual Charge Exemptions scheme (ACE) | Email: ace.scheme@health.gov.au |
| Processing of requests for transfer of sponsorship will pause during this period to allow for End of Financial Year system transitioning to occur. | Email: ebs@health.gov.au Phone: 1800 010 624 | |
| 23 July-15 September | Submit manual ‘Late Declaration’ (of $0 Turnover) form for only those ARTG entries which meet the legislated criteria for exemption from annual charges under the Annual Charge Exemption (ACE) Scheme but were not declared exempt between 1-22 July. NOTE: A fee is payable for making a late declaration. For more information, please see: Annual Charge Exemptions scheme (ACE) | Email: ace.scheme@health.gov.au Phone: 1800 020 653 |
| 1-15 August | Annual charge invoices are issued for active ARTG entries. For more information, please see Annual Charges | Email: accountsrec@health.gov.au Phone: 1800 020 653 (option 5) |
| 15 September | Legislated due date for payment IN FULL of annual charge invoices issued in relation to active ARTG entries. | Email: accountsrec@health.gov.au Phone: 1800 020 653 (option 5) |
| 1 October | Legislated due date for payment IN FULL for annual charge invoices issued in relation to manufacturing licences. | Email: accountsrec@health.gov.au Phone: 1800 020 653 (option 5) |
| December | Commence cancellation of ARTG entries and revocation of manufacturing licences for non-payment of annual charge invoices. | Email: accountsrec@health.gov.au Phone: 1800 020 653 (option 5) |
Update your organisation details
It is the responsibility of the Administrator to update the organisation details to ensure correspondence from the TGA is sent to the correct recipient. The Administrator can follow the instructions available on the TGA Website.
Revoking a manufacturing licence
If a manufacturer no longer requires a manufacturing licence for the new financial year, an application to revoke the licence must be submitted via the TGA Business Services (TBS) portal. Licences will remain active until such time as the manufacturer voluntarily revokes the licence or the licence is revoked by the Secretary. To avoid incurring further financial year annual charges, the request must be received by the TGA on or before COB 15 June. For more information, please refer to the Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence on the TGA website.
Cancelling ARTG entries
If a good (ARTG entry) is no longer being supplied, it is the sponsor’s responsibility to request voluntary cancellation of the ARTG entry via the TGA Business Services (TBS) portal. Goods which are registered, listed or included in the ARTG will remain active in the ARTG until such time as the sponsor voluntarily cancels the good or the good is cancelled by the Secretary. To avoid incurring further financial year annual charges, a request to voluntarily cancel an ARTG entry must be received by the TGA on or before COB 30 June. For more information, please refer to the request to cancel an ARTG entry on the TGA website.
Summary of TGA fees and charges
The TGA is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities.
- A fee is charged for a service, such as a product evaluation.
- A charge is a form of tax on regulated industry and is applied annually based on a 1 July to 30 June financial year.
Each year the TGA consults with industry representative bodies in relation to proposed changes to fees and charges and publishes a Cost Recovery Implementation Statement (CRIS) on the TGA website.
The TGA’s annual Summary of fees and charges is published on the TGA website prior to the commencement of the new financial year. The new fees and charges take effect from 1 July of the new financial year.
Annual Charge Exemption (ACE) Scheme
Between 1 July and 22 July annually, sponsors are required to make an online declaration of $0 turnover via the TBS Portal to confirm (retrospectively) that an ACE entry has not commenced generating turnover during the previous financial year. If the TGA does not receive a $0 turnover declaration, it is assumed that the entry has commenced generating turnover in the previous financial year and result in the ACE ceasing on the entry. If the sponsor fails to make a declaration between 1 July and 22 July and the ACE entry did not commence generating turnover in the previous financial year, the sponsor can apply to have the exemption reinstated between 23 July and 15 September each year. For more information, please refer to the Annual Charge Exemptions scheme (ACE) on the TGA website.
Note. The TGA will also issue weekly, targeted, information bulletins to ACE sponsors from 1 July. As sponsors give their declarations (between 1 July and 22 July), the sponsors will be removed from weekly distribution lists, as no further reminders (to submit a declaration) will be required.
TGA annual charges
Under the TGA legislation, annual charges are automatically incurred for the relevant financial year for any good that is actively registered, listed or included in the ARTG (excluding exempt or export only), or for any manufacturing licence that is active, at any time during that financial year, regardless of whether or not the good or licence is subsequently cancelled or revoked within the same financial year.
Sponsors and manufacturers remain liable for annual charges incurred regardless of whether or not the good is subsequently cancelled or a licence is subsequently revoked within the same financial year. Cancellation or revocation does NOT extinguish the annual charge incurred for that financial year and remains payable as a debt to the Commonwealth.
IMPORTANT: In addition to current financial year annual charge invoices, annual charge invoices will be issued in relation to the previous financial year for only those ARTG entries which met the legislated criterion for exemption but were not declared exempt under the Annual Charge Exemption (ACE) Scheme between 1-22 July.
It is a legislated requirement that payment of TGA annual charge invoices be settled IN FULL on or before the respective legislated payment due date of 15 September for ARTG entries and 1 October for manufacturing licences. Failure to remit payment in full by the legislated due date may result in the TGA exercising its legislated authority to cancel an ARTG entry or revoke a manufacturing licence for non-payment. If you are experiencing financial hardship, you must notify the TGA of your inability to fully settle annual charge invoices, prior to the invoice due date.
Annual charge invoices will be issued to the organisation’s registered billing email address only. However, only authorised users with the ‘financial’ role can view and pay TGA invoices at any time via the TBS portal. For more information, please refer to the TBS portal ‘how to’ guide on the TGA website.
Remitting payments to the TGA
The TGA’s preferred method of payment for invoices issued by the TGA is via the TGA Business Services (TBS) portal (restricted to authorised users with the ‘financial’ role. Invoices can be accessed from the TBS portal dashboard by clicking on the menu bar option titled 'Financials' then 'View Invoices>Action>Pay Invoice').
Alternatively, payment of a TGA fee or charge may be remitted via the unrestricted TGA website Online Payment Portal (select Biller Code "1 - Payment of Invoice" and enter the organisation’s Identification Number prefixed by 'TGA00' (e.g. TGA00xxxxx)).
Remitting payment via either of these two options will ensure the TGA invoice is settled on the next business day.
The TGA cannot guarantee that payments remitted directly to the TGA’s bank account via Electronic Funds Transfer (EFT) will be matched to an account or invoice on the next business day unless the following requirements have been met:
- payment ‘Reference’ field contains the respective organisation’s Identification Number (e.g. TGA00xxxxx)
- a corresponding remittance advice is issued by email to TGARemittanceAdvices@health.gov.au within 24 hours. Please ensure your systems are updated to reflect this email address.
- remittance advice emails must quote the respective organisation’s Identification Number (e.g. TGA00xxxxx) in the email subject field.
- remittance advices must individually itemise all invoice numbers for which the payment is intended.
- Bank transfer fees are the responsibility of the payer. TGA does not accept liability for fees incurred. The payer must not instruct financial institutions to deduct fees from the amount remitted to the TGA.
For more information about payments to the TGA, please refer to Payment Options on the TGA website.
Need assistance?
Please be advised that the TGA does not have any legislated authority to consider unique or extenuating circumstances in relation to annual charges, exemptions or due dates. Once a legislated timeframe has lapsed, it is no longer possible for the TGA to accept requests or submissions. If you are in any doubt, please ensure you make your request or submission within the relevant legislated timeframe first and then immediately request assistance in writing, from the relevant area.