Revised: 4 September 2019

Safety Information

New Zealand Medicines and Medical Devices Recall Code

The current Recall Code came into effect on 1 December 2015 and replaces the Uniform Recall Procedure for Medicines and Medical Devices issued as Part 5 of the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods.

The purpose of the code is to clearly define a process which deals with product issues that might require some action to be taken in the distribution chain and to provide assistance in expediting matters efficiently. It is a technical document and is not intended to cover commercial relationships and obligations.

The current version includes procedures and processes as well as providing information on how the system for deciding on and executing recalls and similar market actions operates. It is particularly designed to be informative for those who have a part to play in the recalls process and to describe the processes and information flows required in order to decide on, and communicate, an action. Other parties, including those receiving communications in the distribution chain, will recognise that the processes described have been in place for some time, but have not been formally described in a code previously.

Sponsors should ensure their processes and procedures for conducting recall and non-recall actions are in accordance with this edition of the Recall Code.

New Zealand Medicines and Medical Devices Recall Code (PDF 468 KB, 49 pages)

Recall Code Appendix 6: Guidance on Legal Issues (PDF 57 KB, 4 pages)