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:
- additional clarity on the requirements for immediate recalls
- removal of the requirement for monthly compiled lists of Single Donor Notifications from the Australian Red Cross Lifeblood
- new information on the ‘Early Advice’ process
- clarification on the timing for release of recall information by us
- refined recall reporting requirements, including more flexible timeframes and removal of the 2-week report
- additional clarity around the definition of Class III recall actions, including a guide for estimating the classification
- additional clarity on the requirements for customer acknowledgement forms (now called customer response forms)
- removal of the recall action document templates. All templates will now be available directly from our website (see below)
- clarification concerning the TGA and ACCC ‘lead regulator’ roles for recalls of therapeutic goods that are also consumer goods and
- removal of outdated guidance, such as information concerning addressing letters, labelling envelopes and submitting notifications via email.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
After hours emergency contact:
Please note: this number is for genuine recall emergencies only – Please see Contact us for all other enquiries.
Related links
Page 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:
This version also includes a number of other minor editorial amendments. | Recalls Section | December 2019 |
| V2.3 |
This version also includes a number of other minor editorial amendments. | Recalls Section | July 2022 |
| 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:
This version also includes a number of other minor editorial amendments. | Recalls Section | December 2019 |
| V2.3 |
This version also includes a number of other minor editorial amendments. | Recalls Section | July 2022 |