TGA Procedure for Recalls, Product Alerts and Product Corrections

Overview

The TGA oversees post-market actions when therapeutic goods (medicines, biologicals, medical devices, IVDs) pose actual or potential safety risks. Sponsors must initiate and coordinate recalls, alerts or corrections, with TGA oversight to ensure appropriate risk mitigation.

Risk Classification

Actions are classified by potential patient harm:

• Class I: Reasonable probability of serious adverse health consequences or death.
• Class II: Temporary or medically reversible adverse health consequences; remote probability of serious harm/death.
• Class III: Unlikely to cause adverse health consequences, but product does not conform to standards.

Classification guides urgency, communication scope, and reporting requirements.

Types of Actions

• Recall: Removal of goods from supply chain and user level due to safety risk.
• Product Alert: Notification to users/healthcare professionals about risks without full removal (e.g., usage restrictions).
• Product Correction: Repair, modification, adjustment, relabelling, or advisory notice to address non-conformance or risk.

Key Steps in the Process

• Sponsor identification: Detect issue via complaints, testing, vigilance reports, or international alerts.
• Risk assessment: Evaluate hazard severity, probability, and affected population.
• Consult TGA: Discuss proposed action, classification, and strategy before public communication.
• Strategy development: Define scope (batch/lot/serial), depth (wholesale, retail, user), communication plan, and effectiveness checks.
• TGA agreement: Obtain TGA concurrence on classification and strategy.
• Implementation:
  • Notify consignees/users (urgent for Class I).
  • Publish TGA recall/alert notice on website.
  • Recover/repair/replace goods as required.
• Effectiveness verification: Confirm action completion and risk resolution.
• Closure: TGA confirms satisfactory completion; sponsor provides final report.

Sponsor Responsibilities

• Initiate action promptly upon identifying risk.
• Maintain records of distribution to facilitate traceability.
• Provide regular progress updates to TGA.
• Cover costs of recall/correction.
• Report outcomes and any further incidents.

TGA Role

• Provide guidance and technical input.
• Assess and agree on classification/strategy.
• Publish public notices for transparency.
• Monitor compliance and effectiveness.
• Enforce if sponsor fails to act adequately.

Detailed classification criteria, communication templates, reporting timelines, effectiveness check methods, and examples of past actions are provided in the TGA procedure for recalls, product alerts and product corrections. Source: Procedure for recalls, product alerts and product corrections - TGA

This risk-based system ensures rapid, proportionate response to safety issues while protecting Australian patients and maintaining supply chain integrity.