Guidelines and Codes
Interim guidance for industry on preparing and submitting data sheets and CMI for publication on the Medsafe website
11 December 2009
From 1 January 2010, new requirements and processes will apply when data sheets and Consumer Medicine Information (CMI) are submitted for publication on the Medsafe website.
From that date, only data sheets and CMI that are in Portable Document Format (PDF) and are submitted electronically to the new mailbox datasheet.cmi@moh.govt.nz will be accepted for publication.
In addition, data sheets and CMI currently published on the Medsafe website will need to be re-submitted in PDF for re-publication on the Medsafe website by 31 August 2010.
The roles of Data Sheet Co-ordinator and CMI Co-ordinator at Medsafe have been disestablished, therefore, please do not send any data sheets or CMI or any questions regarding the publication of these documents to Marie Prescott or Abby Cutfield. All queries should be sent to datasheet.cmi@moh.govt.nz where they will be passed on to the appropriate person for a response.
The New Zealand Regulatory Guidelines for Medicines (Volume 1, Part D, section 3 for data sheets and Volume 4 for CMI) are being updated to incorporate these new requirements and processes. It is expected that the revised guidelines will be published in February 2010.
In the meantime, this guidance document replaces the relevant sections of the guidelines. This information is also available in step-chart form through the following links:
Step chart 1:
Re-submitting data sheets and CMI
to Medsafe in PDF format with NO changes to content
(Microsoft Word 36KB)
Step chart 2:
Submitting data sheets and CMI to
Medsafe in PDF format WITH changes to content
(Microsoft Word 37KB)
Preparation of data sheets and CMI in PDF
Sponsors (or their authorised agents) should prepare data sheets and CMI in Microsoft Word, as is current practice. Medsafe encourages sponsors to take the time to ensure that these documents are of a suitable layout and style to ensure readability.
All data sheets and CMI must be New Zealand-specific. This means that the information they contain must be consistent with the terms of the New Zealand approval (e.g. only list indications approved in New Zealand), and New Zealand contact details must be provided for the sponsor, the National Poisons Centre (“0800 POISON or 0800 764 766”) and any relevant consumer groups.
A data sheet must be approved before it is submitted for publication. Consideration and approval of the data sheet is part of the evaluation and approval process for New Medicine Applications and Changed Medicine Notifications. Sponsors must ensure they hold the required approvals and must make a declaration to this effect when submitting a data sheet for approval.
Approval is not required for a CMI, but sponsors will be required to declare that the CMI has been written in compliance with the requirements set out in guidelines published by Medsafe.
Once the content of the data sheet or CMI document is finalised, the sponsor (or their authorised agent) must convert the document to PDF, ensuring that
- A password is NOT required to open the document
- The document can be printed (printing allowed)
- Copying of text, images and other contents is enabled
- The document is searchable (NOTE - scanned documents can not be accepted).
Submission of data sheets and CMI in PDF
Each data sheet and CMI submitted for publication must be in PDF, accompanied by a completed and signed declaration, and sent to datasheet.cmi@moh.govt.nz. The following new declaration forms have been created and must be used when submitting data sheets and CMI for publication on the Medsafe website from now on:
Declaration
to accompany a data sheet submitted for publication
(Microsoft Word 40KB)
Declaration to accompany a Consumer
Medicine Information (CMI) submitted for publication
(Microsoft Word 45KB)
Medsafe will not check the content of, or make any changes to any data sheets or CMI that have been submitted for publication. The data sheet submitted must be identical in content and wording to that approved in the NMA or CMN process. Sponsors are responsible for ensuring the content of the document is correct and the formatting is appropriate. If a document is incorrectly formatted or any change is required, Medsafe will return it to the sponsor (or their authorised agent) for correction and re-submission. An administrative fee may be incurred.
Notification of publication of data sheets and CMI
Medsafe will use the weekly 'Additions to Medsafe's website' e-mail to notify sponsors and users that a new or revised data sheet or CMI has been published. Individual letters and e-mails confirming publication will not be issued. Those involved in the submission of data sheets and CMI should therefore ensure that they subscribe to the weekly e-mail alert through the following link (http://www.medsafe.govt.nz/regulatory/subscribe.asp)