Request to cancel an ARTG entry

19 June 2016

Request to cancel an ARTG 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 still 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 Sponsor Cancellation link in the Applications menu.

Screenshot of TGA Business Services portal: Sponsor Cancellation link

Before you can select the ARTG entry(ies) you wish to cancel, you have to read and agree to the conditions of use.

Screenshot of TGA Business Services portal: I agree to the Conditions of Use button

If you agree, you will then see a list of all ARTG entries for your company. Select each entry you wish to cancel by selecting the check box for each. The entry will also appear in a shaded box on the left of screen.

Screenshot of TGA Business Services portal: ARTG entry with checkbox ticked and entry information appearing in shaded box on left of screen

Once you have made your selection(s), select the Submit button on the bottom right of the TBS window. You will then be prompted to confirm your request.

Screenshot of TGA Business Services portal: Message and button to confirm cancellation of ARTG record

Timeframe

Cancellations lodged in TBS are processed within 5 business days.

Help

If you don’t have access to TBS, you can:

If you are experiencing any difficulties cancelling your ARTG entries in TBS, please contact the TGA Business Services helpdesk.

Paper form

How to access a pdf or word document

Alternatively, 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.