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Recall procedure

Uniform recall procedure for therapeutic goods, V2.2

12 December 2019

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Step 7. Submitting recall information

For recalls and non-recall actions, undertake one of the following:

Preferred method:

  • Submit an online recall or non-recall notification through the TGA Business Services portal. Sponsors, agents and manufacturers should provide all information previously collected within the relevant tabs of the online form.
    • Upon saving the web form, you will receive a new TGA reference number.
    • The TGA Recalls Section will not be able to see the notification until it has been 'validated' and 'submitted'.
    • Documents such as Draft Customer Letters, Distribution Lists, Consumer Level Communication Strategies and Health Hazard Evaluation reports can be uploaded under the 'Supporting Information' tab.
  • Alternatively, we will still accept email notification from you until 30 June 2020, sent to recalls@health.gov.au with information you currently have including:
    • distribution details and stock status from Step 2
    • risk analysis from Step 3
    • type, class and level of recall from Step 4
    • recall strategy from Step 5
      • not needed for non-recall actions
    • communication strategy from Step 6
    • media release from Step 6 (if needed).
  • You may need to submit your recall information via a non-government notification service. For therapeutic goods supplied in at least one Australian state, sponsors, agents and manufacturers are required (by that state) to use GS1 Australia's Recall Health online portal. This is not a TGA requirement.
  • In these cases, once you have submitted your recall notification via this portal, you do NOT need to also submit it online via the TGA Business Services portal. We will receive your notification automatically and will contact you soon thereafter as we still need to assess the information you have provided.
  • It is therefore very important that you do NOT proceed to notify customers until you have received an 'Agreement Letter' from the TGA Recalls Section.
  • Complete the Human blood and tissues recall report form for biologicals, human blood and blood components. The Blood Service:
    • requests a TGA recall reference number before completing this form. If using the TGA online form, this number can be obtained during the draft submission phase.
    • submits this form, along with the end user recall notification forms (e.g. hospital notification forms) to the TGA after the end-user has been contacted about quarantining the recalled components.

Contact us if you need help about what to submit.

TGA recall reference number

We will issue a TGA recall reference number.

Use this reference number in all correspondence about this recall, including follow-up actions.

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