Published: 9 July 2014
Outcome of consultation on Medsafe’s proposed changes to
evaluation administrative processes
About the consultation
In May 2014, Medsafe published proposed changes to the format
of correspondence issued by Medsafe in relation to New Medicine
Applications (NMAs), Changed Medicine Notifications (CMNs), Self
Assessable Changed Notifications (SACNs) and Drug Master Files
(DMFs). Medsafe proposed that all correspondence will be emailed
as PDF attachments with Medsafe letterhead and an electronic
signature inserted into the letter. Medsafe also proposed
reduced requirements for electronic submissions.
Medsafe received five submissions on the proposed changes
(one from an industry association and four from sponsors of
Four of the submissions received in response to the
consultation are published below. One has been withheld at the
request of the company.
Submission one: Bayer Australia Ltd (pdf 33 KB, 2 pages)
Submission two: Bristol-Myers Squibb (NZ) Limited (pdf 94
KB, 2 pages)
Submission three: GlaxoSmithKline Australia Pty Ltd (pdf 32
KB, 2 pages)
Submission four: New Zealand Self Medication Industry (pdf
31 KB, 3 pages)
All submissions were supportive of the proposed changes. The
submissions raised the following issues for consideration by
- Medsafe needs to have an internal check process to
ensure that all PDFs issued have both letterhead and
Medsafe has developed internal procedures to ensure that
correspondence will be issued with letterhead and signature.
- Clarification is sought on the proposal that
electronic copies of SACNs and small CMNs would not be
mandatory. Specifically clarify that this does not
relate specifically to Over the Counter (OTC) applications
and define what constitutes a small CMN
Medsafe proposed to forgo the requirement that OTC CMNs
include two electronic copies of the data. This option was
proposed because it was considered to be inconvenient for
sponsors. However, most of the submissions call for Medsafe to
reduce its reliance on paper copies of the dossier.
Medsafe plans to consider these suggestions in greater detail
and has therefore decided to continue to mandate two electronic
copies for all OTC medicine applications and notifications until
the review is concluded.
- To avoid confusion, Medsafe should consider placing
a statement on the website stating that only electronic
versions of communications will henceforth be issued and
these constitute official Medsafe documents.
Medsafe will include the recommended statement on its
- There are potential security implications if
confidential information is routinely sent unsecured via
email. Would Medsafe consider using a secure email, or
perhaps establish a secure portal that sponsors and Medsafe
could each log into?
Medsafe currently has internal security processes to ensure
that confidential information is emailed to the intended
recipient. The Ministry of Health is currently reviewing how it
transmits and receives electronic information and Medsafe will
await the results of this review before considering further
A number of comments were received in relation to Medsafe's
policy on electronic submissions that were outside the scope of
this consultation. Submitters requested that Medsafe consider
extending the current policy on electronic submissions.
Medsafe's current IT infrastructure does not support extending
capacity for electronic submissions. This feedback will be taken
into consideration when Medsafe is able to further review the
electronic submission process.
The revisions to the processes will be implemented from 14 July 2014.
Any questions relating to this consultation should be
directed via email to: firstname.lastname@example.org