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Uniform recall procedure for therapeutic goods (URPTG)

V2.4, March 2024

Guidance on procedure to undertake recalls and non-recall actions on therapeutic goods.

Last updated

We have released a preview of the new Procedure for Recalls, Product Alerts and Product Corrections (PRAC) which will take effect in early March 2025. Please familiarise yourself with this new resource now.

Sponsors should continue to follow the Uniform Recall Procedure for Therapeutic Goods (URPTG) until we advise the precise date for when the URPTG will be replaced by the PRAC.

The URPTG is for Australian sponsors who need to undertake actions (recall and non-recall actions) for therapeutic goods in Australia. 

It outlines the processes to respond efficiently and effectively to problems with therapeutic goods that could pose a risk to public health and safety. 

It also explains the roles and responsibilities of all stakeholders who are involved in therapeutic good recalls.

Summary of updates

A new version of the Uniform Recall Procedure for Therapeutic Goods (URPTG) (V2.4, March 2024) has been implemented, with effect from 25 March 2024.

This version includes the following updates:

  1. additional clarity on the requirements for immediate recalls
  2. removal of the requirement for monthly compiled lists of Single Donor Notifications from the Australian Red Cross Lifeblood
  3. new information on the ‘Early Advice’ process
  4. clarification on the timing for release of recall information by us
  5. refined recall reporting requirements, including more flexible timeframes and removal of the 2-week report
  6. additional clarity around the definition of Class III recall actions, including a guide for estimating the classification
  7. additional clarity on the requirements for customer acknowledgement forms (now called customer response forms)
  8. removal of the recall action document templates. All templates will now be available directly from our website (see below)
  9. clarification concerning the TGA and ACCC ‘lead regulator’ roles for recalls of therapeutic goods that are also consumer goods and
  10. removal of outdated guidance, such as information concerning addressing letters, labelling envelopes and submitting notifications via email.

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

Templates

You can use our Recall action templates to help you with your communications:

  • example sponsor customer’s letter 
  • example customer response form
  • example customer/distribution list
  • example consumer recall notice for consumer level recall.

Contact details

TGA Recalls Section:

Phone: +61 2 6289 4613

Recall coordinators for therapeutic goods

Australian recall coordinator recall notification list

After hours emergency contact:

0412 205 568

Please note: this number is for genuine recall emergencies only – Please see Contact us for all other enquiries.

Related links

System for Australian Recall Actions (SARA) database
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Page history

Show all page updates (1)
VersionDescription of changeAuthorEffective date
V1.0Publication for consultationTherapeutic Goods Administration27 October 2015
V2.0

This version of the URPTG consists of:

  • V2.0 Overview
  • V2.0 Recall procedure
  • V2.0 Recalls and non-recall actions. 
  • V2.0 Sponsor's customer letter for recalls
  • V2.0 Advertisements: consumer level recalls
  • V2.0 Roles in recalling therapeutic goods
  • V2.0 Mandatory recalls

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

V2.1This 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 SectionFebruary 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 SectionDecember 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 SectionJuly 2022
VersionDescription of changeAuthorEffective date
V1.0Publication for consultationTherapeutic Goods Administration27 October 2015
V2.0

This version of the URPTG consists of:

  • V2.0 Overview
  • V2.0 Recall procedure
  • V2.0 Recalls and non-recall actions. 
  • V2.0 Sponsor's customer letter for recalls
  • V2.0 Advertisements: consumer level recalls
  • V2.0 Roles in recalling therapeutic goods
  • V2.0 Mandatory recalls

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

V2.1This 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 SectionFebruary 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 SectionDecember 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 SectionJuly 2022

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