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Uniform recall procedure for therapeutic goods (URPTG)
V2.2, December 2019
14 January 2020
Important notice to all stakeholders
A new version of the Uniform Recall Procedure for Therapeutic Goods (URPTG) (V2.2, December 2019) has been implemented, with effect from 12 December 2019.
This version updates V2.1 to include:
- additional clarity on the provision of surgeon contact details for implanted therapeutic goods
- amendments related to the online notification of recall and non-recall actions. For further user information about the new online web form, open the tab below
- removal of the placeholder referring to the National Patient Contact Principles for Patients with Implanted Medical Devices subject to Hazard Alerts
- a second example template for the sponsor's customer letter.
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 | 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 |
Templates to help you with your communications:
- envelopes for safety-related recalls
- example consumer recall notice
- example sponsor customer's letter
- example customer acknowledgement form
In October 2019, the TGA announced the release of a new online web form for submitting recall and non-recall actions for the TGA's assessment.
This initiative will streamline the process and provide greater service to sponsors, replacing our current practice of sponsors having to submit new actions for assessment via email to recalls@health.gov.au.
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-2020-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.
*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open it from there.
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.
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.