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Uniform recall procedure for therapeutic goods (URPTG)

V2.3, June 2022

30 June 2022

Important notice to all stakeholders

A new version of the Uniform Recall Procedure for Therapeutic Goods (URPTG) (V2.3, June 2022) has been implemented, with effect from 30 June 2022.

This version includes the following updates:

  1. Removal of the references to the Crisis Management Guidelines
  2. Clarification on the submission of customer/distribution lists, including an example list in the appropriate format
  3. Additional guidance related to the online notification of actions through the TGA Business Services (TBS) website. For further user information about the online notification form, open the tab below
  4. Clarification on the submission of final reports, including additional guidance regarding root cause, CAPA information, customer follow-up attempts, and TGA close out letters
  5. Minor changes to the information on consumer recall notices, including targeted SMS alerts and clarification on website publication timeframes

This version also includes a number of other minor editorial amendments.

To make an immediate recall...

  • Go to Step 1 of the recall procedure.
  • Immediate recalls apply to:
    • Immediate and significant threats
    • Actual (or potential) product tampering
    • Human blood or blood component
    • Biologicals
    • Radiopharmaceuticals

For all other recalls and non-recall actions, go to Step 2 of the recall procedure.

This guidance on the Uniform Recall Procedure for Therapeutic Goods (URPTG) provides a consistent approach for undertaking recall and non-recall actions of therapeutic goods supplied, imported into or exported from Australia.

The purpose of the URPTG is to assist the sponsors of therapeutic goods to conduct recalls and non-recall actions using a standardised systematic procedure.

It enables sponsors to respond efficiently and effectively to issues with a therapeutic good that has or may pose a risk to public health and safety.

Requirements of this procedure can also be applicable when the TGA orders an appropriate responsible entity to conduct a mandatory recall. Civil and criminal penalties apply if you do not comply with a mandatory recall.

Version history
Version Description of change Author Effective date
V1.0 Publication for consultation Therapeutic Goods Administration 27 October 2015
V2.0

This version of the URPTG consists of:

Recalls and Case Management Section

Regulatory Guidance Team

Publication date: 3 October 2017

From publication date, a familiarisation period applies until 15 January 2018

Implementation date: 15 January 2018

V2.1 This version of the URPTG includes clarifying amendments in relation to the new (January 2018) requirements for 'quarantine' actions and introduces a more flexible approach for 'consumer recall notices' required as part of conducting consumer level recalls. (These 'notices' were formerly referred to as 'recall advertisements'). Recalls Section February 2019
V2.2

This version of the URPTG includes:

  1. additional clarity on the provision of surgeon contact details for implanted therapeutic goods
  2. amendments related to the online notification of recall and non-recall actions
  3. removal of the placeholder referring to the National Patient Contact Principles for Patients with Implanted Medical Devices subject to Hazard Alerts
  4. a second example template for the sponsor's customer letter.

This version also includes a number of other minor editorial amendments.

Recalls Section December 2019
V2.3
  1. Removal of the references to the Crisis Management Guidelines
  2. Clarification on the submission of customer/distribution lists, including an example list in the appropriate format
  3. Additional guidance related to the online notification of actions through the TGA Business Services (TBS) website. For further user information about the online notification form, open the tab below
  4. Clarification on the submission of final reports, including additional guidance regarding root cause, CAPA information, customer follow-up attempts, and TGA close out letters
  5. 5. Minor changes to the information on consumer recall notices, including targeted SMS alerts and clarification on website publication timeframes

This version also includes a number of other minor editorial amendments.

Recalls Section July 2022

Templates to help you with your communications:

  • example sponsor customer's letter
  • example customer acknowledgement form
  • example consumer recall notice
  • envelopes for safety-related recalls

Submit an online recall or non-recall notification through the TGA Business Services portal. This applies to organisations that already have a TGA client identification number (Client ID), as well as new organisations submitting their first recall. Sponsors, agents and manufacturers should provide all information previously collected within the relevant tabs of the online form.

To access the online web form, please log into your TBS Portal, and go to Applications > Recalls > Recall / Non-Recall Submission. Information can then be entered into the tabs provided.

Documents such as Draft Customer Letters, Distribution Lists and Health Hazard Evaluation reports can be uploaded under the 'Supporting Information' tab. Upon saving the web form, you will receive a new TGA reference number (RC-2022-RN-XXXXX-X).

NB. The TGA will not be able to see the notification until it has been 'validated' and it has been 'submitted' by you. Any further updates required for the notification can still be sent via email to recalls@health.gov.au, quoting the TGA reference number in the subject line.

Before submitting recall or non-recall notifications to the TGA, please refer to the Uniform recall procedure for therapeutic goods (URPTG) which outlines a consistent approach for undertaking both recall and non-recall actions for therapeutic goods supplied, imported into or exported from Australia.

When using the form, please avoid the use of symbols such as ™, ©, ® and be sure to fill in all fields as completely as possible. A working example of the online web form (pdf,651kb)* is also available for your further reference with our recommendations on how best to complete the various sections required.

Once you log into the TBS Portal, you will note that 'hover help' has also been incorporated into various sections of the form itself.

Incomplete or unclear entries may lead to your submissions being delayed in terms of processing, combined with the need for our staff to make further enquiries of you, as to the matters at hand.

If you have any further questions regarding recall notifications, please do not hesitate to contact us via recalls@health.gov.au.

We will still accept email notification under exceptional circumstances, or if you cannot access the TGA Business Services portal. If you do not yet have access to the TGA Business Services (TBS) website, additional information can be found here - Getting started with the TGA. In the event of a system issue with the online form, please contact the TBS Helpdesk on 1800 010 624 or by email at ebs@health.gov.au.