PRAC Replaces URPTG: New Timelines for Recalls, Product Alerts and Product Corrections

1. Key takeaways

The TGA’s Procedure for recalls, product alerts and product corrections (PRAC) was published on 24 February 2026 and replaces the former Uniform Recall Procedure for Therapeutic Goods (URPTG). It defines four classes of market action — Recall, Product Alert, Product Correction and Quarantine. PRAC’s 48-hour rule is the deadline for contacting the TGA after notifying customers and taking mitigation measures; it is not a rule that a recall must be launched within 48 hours of becoming aware of a problem. The procedure is strictly sequenced, and the order of its steps is as important as any of its individual deadlines; mapping the four action classes to the right workflow at the outset avoids rework later. The four action classes are defined in the Questions and answers companion, so both documents belong in the plan annex.

2. Legal basis

The recall framework combines the new PRAC procedure, its question-and-answer companion, and the statutory provisions on corrective action and tampering. The timeframes below are the ones a sponsor must be able to evidence in a recall project, and several of them start at different points — after customer notification, after the action begins, or after the TGA issues its letter of consent — which is why the project plan must record the trigger point for each clock.

1. Current procedure: TGA, Procedure for recalls, product alerts and product corrections (PRAC), published 24 February 2026; the page carries a dedicated section titled “What’s changed from the URPTG to the PRAC”, confirming that the PRAC replaces the URPTG.
2. Four classes of market action (PRAC – Questions and answers, 14 July 2026): Recall, Product Alert, Product Correction and Quarantine; Recall is the higher-level action.
3. Timeframes: contact the TGA within 48 hours after notifying customers and taking mitigation measures such as quarantine; 24 hours for actual or suspected tampering (section 42T of the Therapeutic Goods Act 1989); where the product is also a consumer goods product, notify the ACCC within 2 days of starting the action; the TGA publishes within 2 working days of issuing the letter of consent; an interim report within 6 weeks and a closeout report within 3 months; beyond 6 months a written justification is required for the action remaining open.
4. Procedural requirement: the PRAC sets no fixed deadline for how soon after becoming aware of an issue a market action must be submitted — the governing principle is as soon as practicable; and TGA consent must be obtained before contacting customers (Step 3).
5. Obligation provisions: section 41KA (corrective action and market action) and section 42T (24-hour notification for tampering).
6. [Practical estimate] Neither the current PRAC nor the PRAC Questions and answers page uses the recall classification terminology Type I/II/III or Class I/II/III; no current official source has been found for the classification terms of the old URPTG.

3. Expert insights

Insight 1: obtain TGA consent before notifying customers — this order cannot be reversed. Step 3 of the PRAC requires TGA consent to be obtained before customers are contacted. Teams accustomed to sending the customer letter first and notifying the regulator afterwards will create a procedural inversion if they apply that habit in Australia. In practice this means the customer notification letter is drafted and approved, but held back until the TGA’s consent has been granted. The consent request should describe the action, its scope and its timing in the same terms that the interim report will later use.

Insight 2: the 48-hour clock starts after the customers have been notified. This differs from the awareness-based start of the adverse event reporting clock. The two 48-hour rules carry different meanings, and mixing them up produces sequencing errors in the recall record. A recall project plan should therefore show both clocks on its timeline, with the customer notification step marked as the trigger point for the 48-hour contact with the TGA. Both clocks should be visible to the project owner at all times.

Insight 3: the reporting loop has a fixed rhythm. An interim report at 6 weeks, a closeout report at 3 months, and a written justification for anything beyond 6 months. These three nodes determine the staffing cycle of a recall project; a recall cannot be scheduled as “send the notice and finish”. The interim and closeout reports are separate deliverables with their own content expectations, and they should be resourced as such rather than treated as extensions of the initial notification. Because the closeout report is the document on which the TGA closes the action, under-resourcing it tends to stretch projects past the 6-month mark, where a justification then becomes necessary.

4. Practical recommendations

• Embed the PRAC three-step sequence in the recall plan: assess → obtain TGA consent (Step 3) → notify customers → contact the TGA within 48 hours. The arrows are one-directional; no step in the sequence may be swapped with its neighbour.
• Set up a separate 24-hour channel for tampering cases (section 42T), kept apart from routine market actions, with its own escalation path and evidence file.
• Resource the reporting workload around the 6-week and 3-month nodes, and prepare a written justification for any project extending beyond 6 months, drafted while the evidence is still fresh rather than reconstructed later.
• Where the product also falls within consumer goods, configure a parallel action to notify the ACCC within 2 days, and record that notification in the same project file as the TGA correspondence.

5. Verification checklist

• □ The recall plan has been updated to the PRAC (24 February 2026 version)
• □ Confirmed that TGA consent must be obtained before customers are notified
• □ The 48-hour clock is configured to start after customers have been notified, in the workflow system as well as in the plan
• □ A separate 24-hour channel for tampering cases is in place
• □ Resources have been assigned to the 6-week and 3-month reporting nodes
• □ A 2-day ACCC notification action is configured for consumer goods cases

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Australian market. Our team manages adverse event reporting and recall coordination with the TGA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com