Revised: 10 May 2011
Safety related actions taken by manufacturers and suppliers to address issues affected products in the market are called recalls and corrective actions. These should be conducted in consultation with Medsafe according to the Medsafe Uniform Recall Procedure for Medicines and Medical Devices (Adobe PDF document 416 KB).
Understand the language of recalls and corrective actions. The glossary provides definitions for the key words used when describing or conducting corrective actions.
Sponsors should have a plan or procedure describing how to respond to a corrective action should the need arise. This planning should include where to obtain additional information, who is responsible for the action, and when to communicate with Medsafe.
Recalls and corrective actions should be conducted in consultation with Medsafe. To assist with this process the sponsor should be able to provide Medsafe with information about the nature of the problem, the product(s) involved, details of the distribution of the affected product(s), and the action planned.
Corrective actions are communicated to the affected customers via corrective action notices. These notices should be reviewed by Medsafe prior to being distributed to customers/users for appropriateness and to ensure compliance with the Uniform Recall Procedure. Draft templates for key types of corrective actions are available for download.
Once Medsafe and the sponsor are agreed on the action to be taken the sponsor will be required to advise the affected customers and conduct the corrective action. Medsafe may offer guidance on how customers should be advised and the action be conducted.
While the corrective action is in progress Medsafe requests that sponsors provide regular progress reports. These reports should detail how the action is progressing and provide information about the manufacturer's investigation and response to the issue leading to the action.
When the agreed action has been completed the sponsor should submit a final report on the action to close the investigation. The final report will also include details of the disposal or export of any affected product.
