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Withdraw your ARTG application

How to withdraw your ARTG application, for medical device sponsors (includes importers and exporters).

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You can withdraw your application at any time before we’ve made a decision. Below is a step-by-step guide for sponsors (official suppliers) to withdraw a device Australian Register of Therapeutic Goods (ARTG) application.

Application fees are non-refundable. See refunds for more information.

Civil and criminal penalties can apply if you supply a device:

  • without an associated ARTG entry
  • via an appropriate exemption without meeting the conditions of that exemption.

Steps to withdraw an application

If you have not paid the application fee, you can withdraw your application in your Business Services portal.

If you have paid the fee

You can’t withdraw in the portal once you have paid the fee.

If you have paid the fee, email devices@tga.gov.au with your application ID and ask to withdraw your application. 

If you haven’t paid the fee

Step 1: Access the TGA Business Services page, and click ‘Open TGA Business Services’

Screenshot showing TGA Business Services page - click on Open TGA Business Services button.
Figure 1 - TGA Business Services page

Step 2: Login using your username/ID and password

Screenshot of TGA Business Services login page showing 'Username or login ID' and 'Password' fields.

Figure 2 - TGA Business Services - Login page

Step 3: Navigate to and click on ‘View submissions’

 

Cropped screenshot of TGA Business Services window showing the section 'What would you like to do today?'. 'View submissions' is highlighted in the 'My work' menu.

Figure 3 - TGA Business Services - Home page
 

Step 4: Find the submission you want to withdraw

Cropped screenshot of the list of example submissions. An example submission is highlighted. The submission states ‘Under Review’ in the ‘Workflow Status’ column.

Figure 4 - TGA Business Services screen – List of submissions

Step 5: Click the down arrow icon

Cropped screenshot of the list of example submissions zoomed in. The down arrow menu icon is highlighted and sub-menu items 'Print Preview' and 'Withdraw' are showing.

Figure 5 - TGA Business Services screen – List of submissions – Down-arrow menu
 

Step 6: Click ‘Withdraw’

Screenshot of down arrow button menu with the 'Withdraw' menu item highlighted.

Figure 6 - TGA Business Services screen – Down-arrow menu - Withdraw

Step 7: A pop-up window should appear asking you to confirm, then click 'OK'
 

The pop-up window shows the text 'Are you sure you want to withdraw this Submission?' with the buttons 'OK' and 'Cancel'. The 'OK' button is highlighted.

Figure 7 - TGA Business Services screen – Withdraw submission confirmation box – OK button highlighted

A withdrawal request will be raised and should change status or disappear once the request has been done.

Screenshot showing figure 8 to withdraw an ARTG application

Figure 8 - TGA Business Services screen – List of example submissions with Withdrawal Requested highlighted

Next steps

You will receive an email confirming that your application has been withdrawn.

You cannot supply your device, as it has not been included in the ARTG.

You can resubmit a new application and restart the process at any time.

Civil and criminal penalties can apply if you supply a device:

  • without an associated ARTG entry 
  • via an appropriate exemption without meeting the conditions of that exemption.

You may also wish to inform your manufacturer and customers that you have withdrawn your application.

Get help

If you are having issues with this process, email the relevant area with your application ID and ask to withdraw your application as follows:

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