Request to cancel an ARTG entry
Guidance and form for cancelling an Australian Register of Therapeutic Goods entry
To request cancellation of a therapeutic good on the Australian Register of Therapeutic Goods (ARTG), you can use either our online form (encouraged), or submit a paper based form.
Do not request cancellation if your product is still being supplied in (or exported from or imported to) Australia.
Annual charges and cancellations
Deadline for requests
To avoid incurring an annual charge for the next financial year, we must receive cancellation requests by 5:00 pm, 30 June.
If we don't receive your request by this time, the entry(ies) will incur an annual charge for the following financial year.
Note: An annual charge for the current financial year remains payable after an entry has been cancelled.
Annual charge exemption
An entry that has pre-qualified for an annual charge exemption in a given financial year will not pay an annual charge for that financial year unless it generates greater than $0 turnover.
How to cancel
Online form
After logging into the TGA Business Services (TBS) portal, you can submit cancellation requests if you are the sponsor and have the submitter system role. Agents cannot request cancellations on behalf of a sponsor.
Select the ARTG entry Cancellation link in the Applications menu.
Before you can select the ARTG entry(ies) you wish to cancel, you must read and Accept the Conditions of Use.
If you accept, a list of ARTG entries for your organisation will be displayed. Select each entry you wish to cancel and press Submit.
A dialogue box will appear with your selections. Select Yes to proceed with the cancellation.
Timeframe
Cancellations lodged in TBS are processed within 5 business days.
Help
If you don’t have access to TBS, you can:
- register for access by following the instructions at TGA Business Services: getting started with the TGA.
- use our paper-based form to request a cancellation.
If you are experiencing any difficulties cancelling your ARTG entries in TBS, please contact the TGA Business Services helpdesk.
Paper form
You can request a cancellation with our paper-based form:
Cancellation requests on the paper form that are accurate and complete are processed within 10 business days.
Send completed forms to TGA Business Services. Please note that if you send your form by post, you will need to send it in sufficient time for us to receive it by 30 June.
Help
If you need any help filling out the form, please contact the TGA Business Services helpdesk.
Publication of cancellations
We publish ARTG cancellations (including those initiated by the sponsor) on the TGA website or in an Australian Government gazette. This is a requirement of the Therapeutic Goods Act 1989.