Published: 9 July 2014
Consultations
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.
Submissions received
Medsafe received five submissions on the proposed changes (one from an industry association and four from sponsors of medicines).
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)
Consultation feedback
All submissions were supportive of the proposed changes. The submissions raised the following issues for consideration by Medsafe:
- Medsafe needs to have an internal check process to ensure that
all PDFs issued have both letterhead and signature.
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 website. - 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 security measures.
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.
Implementation
The revisions to the processes will be implemented from 14 July 2014.
Enquiries
Any questions relating to this consultation should be directed via email to: medsafeapplications@health.govt.nz
