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Introduction

Safety related actions taken by manufacturers and suppliers to address issues affecting products in the market are called recall and non-recall actions. These should be conducted in consultation with Medsafe according to the New Zealand Medicines and Medical Devices Recall Code (Adobe PDF document 468 KB). The latest edition of the Recall Code came into effect on 1 December 2015. The Recall Code provides guidance and information about the key parts of conducting recall and non-recall actions, including: Responsibilities of sponsors Recall preparation and planning Advising Medsafe Drafting a recall action notice Conducting the recall action Reporting to Medsafe Closure of a recall action

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Responsibilities of Sponsors

Sponsors are responsible for identifying potential issues with their products, assessing the risks of any identified hazards and mitigating those risks. In addition, sponsor and local manufacturers are responsible for maintaining records and establishing procedures which will assist in facilitating a recall action should such action become necessary. Sponsors should have access to staff with the required knowledge and expertise of the products and the regulatory process to effect a recall action.

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Recall Preparation and Planning

Every sponsor should have in place a written recall procedure that describes how a recall action will be initiated and carried out, and should ensure that relevant staff members are appropriately trained in the procedure. Detailed requirements are to be listed in the procedure and must include requirements which correspond to the agreed recall action strategy and reporting requirements.

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Advising Medsafe

Sponsors should discuss the issue with Medsafe prior to initiating any recall or non-recall action. Medsafe should be informed as soon as possible and advised of the proposed actions for New Zealand.

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Drafting a recall action notice

As the legal representative of the manufacturer in New Zealand, the sponsor must issue a recall action notice to their customers about the issue. The notice must be clear and concise, and comply with the Recall Code. The draft recall notice must be reviewed and agreed to by Medsafe before it is distributed to the affected parties.

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Conducting the recall action

Conducting a recall action involves; informing the respective persons / organisations (health care professionals, patients, hospitals, retailers, wholesalers or distributors as appropriate), monitoring the effectiveness of the recall action and implementing the communication strategy.

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Reporting to Medsafe

The sponsor should provide Medsafe with progress reports on the implementation of the recall action, the response rates, the investigation into the issue and any corrective and preventive actions planned or implemented.

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Closure of a recall action

At the conclusion of the recall action the sponsor is to provide a final report summarising the action taken, its causes, manufacturer’s actions to prevent a recurrence, status of the recalled product, or confirmation the product correction has been applied to all affected units.