New resources on market actions and minor PRAC updates

The final package of TGA recall reforms was implemented in March 2025, with the release of the Procedure for Recalls, Product Alerts and Product Corrections (PRAC), officially replacing the Uniform Recall Procedure for Therapeutic Goods (URPTG).

The TGA is now releasing two new resources to compliment the PRAC. These are:

• A new webpage featuring frequently asked questions (FAQs) on the PRAC, and
• A new guidance page on the use of legislative powers related to recalls and other market actions.

The new FAQ resource includes over 20 questions which the TGA receives frequently on the PRAC and market action requirements. This list of questions and answers will be updated as new enquiries emerge.

While the PRAC itself is not a legislative instrument, the new legislation guidance page is designed to help sponsors and suppliers of therapeutic goods understand the powers which the TGA can impose relating to market actions in Australia. This follows the legislative review which occurred as part of the final phase of the Recall Reforms Program, with the aim of ensuring our existing legislative provisions continue to support effective market actions under the new PRAC.

Additionally, the PRAC has also been updated with minor changes, including:

• amendment of the ‘Purpose’
• updates to, and renaming the section titled ‘Situations requiring additional documents’ to ‘High profile actions or actions involving product which isn’t traceable’
• minor wording changes to the definitions of ‘Recall’ and ‘Product Correction’
• other minor editorial or small improvements.

All updates are listed under the heading ‘Page History’ located at the bottom of the PRAC’s webpage. The PRAC, and our processes, will continue to be updated following consideration of stakeholder feedback as required.