Published: 11 December 2009
Outcome of Consultation on Submission and Publication Processes for Data Sheets and Consumer Medicine
Information on the Medsafe Website
11 December 2009
To: Product sponsors , Regulatory affairs consultants
The purpose of this letter is to:
In October 2009, Medsafe published proposed changes to the submission and publication processes for data
sheets and CMI) on the Medsafe website, and sought feedback on the proposals by 20 November 2009.
Medsafe received 22 submissions on the proposed changes (one from an industry association, one from a
professional body and 20 from pharmaceutical companies and regulatory consultants).
From 1 January 2010, sponsors (and their authorised agents) will be required to submit all new and
updated data sheets and CMI for publication on the Medsafe website in Portable Document Format (PDF)
to the new mailbox:
email@example.com. From 1 January 2010,
any documents received in Microsoft Word or Rich Text Format will be returned to the sponsor for re-formatting.
Medsafe is aware of the recent addition of Product Information and CMI on the Australian Therapeutic
Goods Administration (TGA) website. Medsafe notes that the proposed changes are in line with the new TGA
processes whereby product information and CMI are published on the website in PDF.
A summary of the feedback received, and Medsafe's decisions following consideration of the feedback, is
Submitters supported the proposal to change the submission and publication processes for data sheets and
CMI on the Medsafe website. Ninety-five percent of responses from pharmaceutical companies and regulatory
consultants identified PDF as the preferred format for submitting these documents. The remaining 5%
preferred Hyper Text Markup Language (HTML) format due to the cost of Adobe software.
Submitters also supported the proposed timeline for submitting data sheets and CMI in the new format.
Ninety percent of responses from pharmaceutical companies and regulatory consultants considered the timeline
for completing submission of data sheets and CMI in the new format (31 August 2010) to be appropriate. The
remainder considered 31 December 2010 to be preferable.
Issues raised in the consultation
The submissions raised the following issues for consideration by Medsafe:
- Searchability and security settings for data sheets and CMI
One submitter requested that data sheets and CMI remain electronically searchable and that the security
settings used should enable readers to copy, paste and re-format text into separate documents. These
requests are supported by Medsafe.
- Ensuring healthcare professionals and consumers refer to the most recent versions of data sheets
One submitter expressed concern that healthcare professionals and consumers may download the PDF files
and store them electronically for future use. This creates a potential risk that out-of-date versions will
be referred to by the individual.
The submitter proposed that all data sheets and CMI contain a header stating 'Please refer to the Medsafe
website (www.medsafe.govt.nz) for the most recent [data sheet / CMI]'.
Medsafe agrees that this would be useful and encourages sponsors submitting new or revised data sheets
and CMI to consider including this advice in the document. However, the inclusion of such a header will not
be a requirement at this stage.
- Utilisation of text formatting as outlined in the NZRGM and the need for templates.
A number of submitters queried the utilisation of the text formatting as outlined in the New Zealand
Regulatory Guidelines for Medicines.
Medsafe encourages sponsors to maintain the readability of data sheets and CMI through continued use of
the standard styles identified in the current New Zealand Regulatory Guidelines for Medicines (Volume 1,
Part D, section 3.4 for data sheets and Volume 4 for CMI).
Medsafe acknowledges that it is not possible to maintain a consistent look for data sheets and CMI across
the Medsafe website without the utilisation of a template. However, requiring use of a template would delay
completion of the resubmission process well beyond 31 August 2010, which would not be desirable.
In its review of the New Zealand Regulatory Guidelines for Medicines, Medsafe may provide further advice
on style and formatting of data sheets and CMI to assist sponsors in the production of quality medicine
- Book-marking each section of the data sheet and CMI at the top of each document.
One submitter noted the potential benefits of book-marking within data sheets and CMI.
Medsafe agrees that this would be a beneficial approach and encourages sponsors submitting new or revised
data sheets and CMI to consider book-marking the relevant headings within the document. However,
book-marking will not be a requirement at this stage.
- Sponsor-specific information contained in data sheets and CMI.
One submitter queried whether it would be appropriate to include sponsor-specific information in the
footer of data sheets and CMI in PDF format.
Under current legislation, no promotional material is permitted in data sheets and CMI (with the
exception of company logos).
- Fees for submitting re-formatted data sheets.
A number of submitters requested clarification regarding fees applicable when re-submitting a data sheet
or CMI for publication for publication on the Medsafe website in PDF.
No fee will apply when a currently published data sheet is submitted in PDF without any
changes to wording or content.
Normal CMN fees will apply for changes to the content and wording of data sheets. No further fee will
apply when the approved data sheet is submitted for publication.< br />
As is current practice, a CMI which has been re-submitted to Medsafe in PDF will incur no fee whether or
not there are changes to the content.
- Publication of data sheets and CMI for non-marketed medicines.
One submitter queried whether PDF versions of data sheets and CMI are required to be submitted for a
medicine that has been approved but is not marketed in New Zealand.
Medsafe will not require electronic copies of data sheets and CMI for medicines not currently marketed.
However an electronic copy of the data sheet for any prescription or restricted medicine must be provided to
Medsafe in PDF for publication on the Medsafe website prior to launch or re-introduction of the medicine to
the New Zealand market.
- Recognition of errors in published data sheets and CMI.
One submitter queried whether a data sheet or CMI will be returned to the sponsor if Medsafe notices any
errors following the submission of a PDF file.
Medsafe will not check the content of, or make any changes to, data sheets or CMI that have been
submitted for publication. All data sheets submitted for publication on the Medsafe website must have been
approved as part of the NMA or CMN (including SACN) processes. The sponsor will be required to complete and
sign a declaration form stating that the data sheet is identical to that approved by Medsafe during the CMN
or NMA process.
As Medsafe will not be amending data sheets and CMI on behalf of sponsors, the responsibility lies with
sponsors to ensure they are correct with regard to both content and style. Medsafe will perform random
audits of published data sheets and CMI to ensure this responsibility is being met. If any issues are
identified, the sponsor will be required to take appropriate corrective action and resubmit the corrected
document for publication, with the applicable fee.
Should the sponsor, a healthcare professional, a consumer or Medsafe notice an error in a data sheet, the
sponsor will be required to amend the error, obtain approval for the revised data sheet (through the CMN
process) and submit the revised document for publication with the applicable fee.
If a data sheet or CMI is submitted to Medsafe in a format other than PDF or without an accompanying
declaration form, the e-mail will be returned to the sender, who will be asked to ensure that the required
documentation is submitted.
From 1 January 2010, all electronic copies of data sheets and CMI must be submitted to Medsafe in PDF
format. These documents must be submitted to the following address:
Some data sheets and CMI currently published on the Medsafe website are likely to be updated during the
first six months of 2010 and can be submitted and published in the new format following relevant approval of
the changes. Remaining data sheets and CMI will need to be resubmitted in the new format without any changes
to the content or wording.
Sponsors have until 31 August 2010 to re-submit all currently published data sheets and CMI in
PDF. An administrative fee may be charged for the re-submission of data sheets and CMI in PDF, with no
changes in content, which are received by Medsafe after this date.
The number of data sheets and CMI requiring re-publication is large. They will be re-published as quickly
as possible. However, should a publication backlog develop, priority will be given to publishing those that
include new information.
It is anticipated that following completion of the re-publication exercise in 2010, all new and updated
data sheets and CMI will be published on the Medsafe website within one week of receipt.
Please see the following link for guidance on how to proceed with submitting data sheets and CMI in PDF
for publication on the Medsafe website:
Interim guidance for industry on
preparing and submitting data sheets and CMI for publication on the Medsafe website (superseded).
Please refer to Guideline on the Regulation of Therapeutic Products
in New Zealand, Part 10).
Advisor Science, Pharmacovigilance
Clinical Risk Management