The TGA is providing sponsors with advance notice of the final package of the recall reforms which will be implemented in early March 2025. This includes providing a preview of Australia's new recall procedure which will be known as the Procedure for Recalls, Product Alerts and Product Corrections (PRAC).
Sponsors will continue to follow the Uniform Recall Procedure for Therapeutic Goods (URPTG) until early March 2025, at which time the URPTG will be replaced by the PRAC. We will advise the precise implementation date closer to this time.
The PRAC addresses stakeholder feedback from our 2023 discussion paper, as part of the broader consultation on potential changes and improvements to the management of product recalls in Australia.
The PRAC will:
- enhance the transparency, communication and timeliness of recalls, alerts and corrections
- introduce new market action terminology, reducing the categories from 8 to 4, as illustrated below
- halve the number of steps in the process from 10 to 5 but will not require any major changes to how sponsors approach the process
- feature fewer pages with less repetition, clearer information and instructions.
One of the most requested changes was to update the recall terminology, removing the sometimes confusing categories of 'recall' and 'non-recall' actions, and replacing them with one category called 'market actions'.
