Uniform recall procedure for therapeutic goods (URPTG)

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 removal of outdated guidance, such as information concerning addressing letters, labelling envelopes and submitting notifications via email.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.