Recall Code of Practice in New Zealand

1. Introduction and Scope

The Recall Code of Practice outlines the procedures sponsors should follow when recalling therapeutic products (medicines and medical devices) in New Zealand. https://www.medsafe.govt.nz/safety/RecallCode.pdf It applies to voluntary recalls initiated by sponsors due to quality, safety, or efficacy concerns, and aims to ensure consistent, timely, and effective recall actions to protect public health. https://www.medsafe.govt.nz/safety/RecallCode.pdf

2. Recall Classification System

Recalls are classified into three classes based on health risk:

• Class I — Situations where there is a reasonable probability of serious adverse health consequences or death (e.g., contaminated products, wrong active ingredient). Requires immediate action. https://www.medsafe.govt.nz/safety/RecallCode.pdf
• Class II — Use may cause temporary or medically reversible adverse effects, or serious consequences are remote (e.g., sub-potent product, minor labelling error). https://www.medsafe.govt.nz/safety/RecallCode.pdf
• Class III — Unlikely to cause adverse health consequences but violates regulatory requirements (e.g., GMP non-compliance, minor defects). https://www.medsafe.govt.nz/safety/RecallCode.pdf

Classification determines urgency, depth of recall, and communication requirements. https://www.medsafe.govt.nz/safety/RecallCode.pdf

3. Recall Levels (Depth)

The level specifies how far back in the distribution chain the recall extends:

• Consumer Level — To end-users/patients (used for Class I or high patient risk). https://www.medsafe.govt.nz/safety/RecallCode.pdf
• Retail Level — To pharmacies, hospitals, clinics (common for Class II). https://www.medsafe.govt.nz/safety/RecallCode.pdf
• Trade/Wholesale Level — To distributors/wholesalers only (for Class III or low risk). https://www.medsafe.govt.nz/safety/RecallCode.pdf

The appropriate level is determined by the risk assessment and product distribution. https://www.medsafe.govt.nz/safety/RecallCode.pdf

4. Notification and Communication Requirements

Sponsors must:

• Notify Medsafe immediately upon deciding to recall.
• Submit a recall strategy including classification, level, reason, communication plan, and effectiveness checks.
• Issue recall notices using approved templates (e.g., direct letters for consumer level, trade notices).
• For devices, field safety notices (FSNs) may be used for corrective actions not requiring full return. https://www.medsafe.govt.nz/safety/RecallCode.pdf

Communications should be clear, concise, and include product details, reason, actions required, and contact information. https://www.medsafe.govt.nz/safety/RecallCode.pdf

5. Effectiveness Checks and Completion

Sponsors are required to:

• Conduct effectiveness checks (e.g., follow-up calls, response rates) to confirm receipt and action by recipients.
• Maintain detailed records of all recall activities.
• Report completion to Medsafe, including reconciliation of returned stock and final effectiveness results. https://www.medsafe.govt.nz/safety/RecallCode.pdf

Medsafe may monitor the process and request additional information. https://www.medsafe.govt.nz/safety/RecallCode.pdf

6. Special Considerations

• Urgency — Class I recalls require action within hours/days; timelines decrease with lower classes.
• International Coordination — For globally affected products, align with actions in other jurisdictions.
• Voluntary Basis — Recalls remain voluntary, but sponsors must act responsibly under the Code. https://www.medsafe.govt.nz/safety/RecallCode.pdf

7. Supporting Resources

The Code includes templates for recall notices, strategy forms, and effectiveness check reports to assist compliance. https://www.medsafe.govt.nz/safety/RecallCode.pdf

Adherence to this Code ensures recalls are conducted efficiently and transparently, minimizing risks to patients in New Zealand. https://www.medsafe.govt.nz/safety/RecallCode.pdf