We are 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). 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 • 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. 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. Read more: https://lnkd.in/g6J8gYa2
