Revised: 16 December 2014
Consultations
New Zealand Medicines and Medical Devices Recall Code
December 2014
Medsafe is seeking submissions, by 27 February 2015, on an update to the draft Uniform Recall Procedure for Medicines and Medical Devices (Recall Code).
The purpose of this consultation is to provide a final review and to advise Medsafe's intent to adopt the Recall Code. The content of the draft Recall Code has been consulted on previously by interested parties.
Consultation on update of the New Zealand Medicines and Medical Devices Recall Code (PDF 244 KB, 46 pages)
Invitation to comment
Medsafe is seeking comments on the following questions:
Timetable
Document released for consultation on 16 December 2014.
Interested parties should respond by close of business day on 27 February 2015.
Background
In 2010 a small cluster of consumer-level recalls triggered a review of the recalls process. A working party, that included various stakeholders, prepared a draft Recall Code that went out for consultation in August 2010.
This draft Recall Code was not formally adopted at that time as work on it was superseded by Trans-Tasman harmonisation work carried out with the Therapeutic Goods Administration (TGA) in Australia in anticipation of ANZTPA. As a consequence of this harmonisation work, agreed terminology was developed, which was consulted on prior to the introduction of the Medsafe Online Recalls Database (MORD) in July 2012.
About this consultation
This draft update is based on the Recall Code prepared following the 2010 consultation and includes terminology and processes agreed with the TGA in anticipation of ANZTPA.
It provides clarification around the roles and responsibilities of parties responsible for the recalls process and describes ways to improve communication between the different points of contact during the conduct of a recall action.
Feedback is sought on support for the adoption of the draft Recall Code and preference as to where the additional legal information supplied in Appendix 6 of the document should be published.
Content of submissions
Your submission should include full personal or organisation contact details.
Confidentiality
If you wish any information contained in your submission to be treated as confidential, please clearly identify that information and outline the reasons why you consider it to be confidential.
Submissions may be placed on the Medsafe website with the outcome of consultation unless marked confidential.
How to respond
Please complete the submission form. Submissions must include full personal or organisation contact details.
Recall Code Submission Form (Word document, 52 KB, 2 pages)
Electronic submissions are preferred and should be emailed to recalls@health.govt.nz including 'New Zealand Medicines and Medical Devices Recall Code' in the subject line of the email.
Alternatively hard copy (not required if an emailed submission has been received) submissions may be mailed to:
Recall Code Update
Medsafe Product Safety Team
Medsafe
Ministry of Health
PO Box 5013
Wellington 6145
Enquiries
Any questions relating to this consultation should be directed via email to: recalls@health.govt.nz.
Next steps
The final version of the updated Recalls Code is expected to be published on the Medsafe website (www.medsafe.govt.nz) on 30 March 2015. Submitters will receive an email to advise when the updated Recall Code is available.
