Classification of Medicines
Classification Process
Phases of the classification process
It takes approximately six months from the date a submission is lodged until the resulting classification change is notified in the New Zealand Gazette. A maximum of six further months is allowed in the legislation for companies to amend labelling to reflect classification changes.
There are nine phases in the classification process, as outlined below.
Phase 1: Submission
Closing dates for submissions to the Medicines Classification Committee
(MCC) are the end of January and the end of July each year.
While applications usually come from sponsor companies, anybody may make a submission to the MCC for the reclassification of a medicine using the format described in Submissions for reclassification. Submissions are received both in hard copy and electronically and are placed on the agenda for the next meeting. Because of the need for a full consultation period, late items cannot usually be accepted. Submissions are sometimes allocated to Medsafe evaluators for independent review. The resulting reports are peer reviewed to ensure that they reflect Medsafe's view rather than that of an individual evaluator. The reports may involve extensive literature searches as well as assessment of the material submitted.
Phase 2: Consultation
Soon after the closing date for submissions for each meeting, the
agenda for the next meeting is published on the
Medsafe website. Links to company submissions are provided. Any Medsafe
reports are also provided when these have been completed.
The consultation period provides an opportunity for interested parties to comment on the proposed agenda items. Comments should be supplied to the Secretary electronically (if more than five pages long, one hard copy should also be provided). Pharmaceutical companies and other interested bodies are expected to watch the Medsafe website to check whether any of their products are likely to be affected by a proposed change. Medsafe provides a weekly email service notifying updates to the Medsafe website.
Approximately six weeks is available for the preparation of comments. Closing dates are provided on the Medsafe website in Dates and deadlines.
During this period Medsafe may also seek independent advice from experts or specialist organisations.
Submissions, comments on agenda items and Medsafe reports are sent to MCC members three to four weeks before the date of a meeting. As MCC members need this time to prepare for meetings, late comments on agenda items cannot usually be accepted.
Phase 3: Recommendation
The MCC meets around April and October of each year to make recommendations to
the Minister of Health. Ministerial powers in relation to classification have
been delegated to the Chief Medical Officer, Clinical Leadership, Protection
and Regulation Business Unit, who acts as the Minister's Delegate. Minutes
containing the recommendations are drafted and sent to members for comment.
The final minutes are then forwarded to the Minister's Delegate together with
a report from Medsafe. If Medsafe does not agree with any recommendation made
by the MCC, Medsafe's view will be included in this report together with a
justification for that view.
Phase 4: Decision
The Minister's Delegate accepts or declines the recommendations made by the
MCC. The minutes are returned to Medsafe for further action.
Phase 5: Communication
During the period between a meeting and acceptance of the recommendations made
at that meeting it is not normal practice to make the MCC's recommendations
known.
As soon as the recommendations have been accepted or rejected by the Minister's delegate, the full minutes of the meeting are published on the Medsafe website in Minutes of Medicines Classification Committee meetings.
If the Minister's Delegate accepts the advice of Medsafe, rather than the MCC, the reasons for this will be published on the Medsafe website. Those who have made submissions to the MCC receive individual letters explaining the outcome. A period of four weeks' advance notice is provided before changes are put into effect by a notice in the New Zealand Gazette. This allows lead-in time for preparation of new labelling and for pharmacists to prepare for marketing under the new classification. Time is also allowed to lodge objections.
Phase 6: Objection
Notice of intention to object to a recommendation for reclassification, and
the grounds for that objection, should be lodged with the Secretary by the
date given on the Medsafe website. Approximately ten working days are allowed.
Supporting data for an objection need not be lodged at this time but should be
submitted electronically (if more than five pages long, one hard copy should
also be provided) by the closing date published on the Medsafe website. This
date usually coincides with the closing date for comments on agenda items for
the next meeting.
Phase 6 is an opportunity to object to the recommendation made by the MCC rather than to the initial proposal. If Medsafe considers that an objection has been made on valid grounds, the medicine in question will be removed from the New Zealand Gazette notice until the matter has been resolved.
Objections to recommendations on the classification of medicines should be made only on safety issues and should contain new safety data not available to the MCC at the time the recommendation was made. Financial or commercial reasons are not acceptable grounds for objection.
Medsafe will consider the evidence submitted in support of an objection and will decide whether or not the matter should be referred back to the MCC. Normally objections will be referred back to the MCC only when there is substantial new safety evidence to support the objection.
Medsafe will advise the objector of the outcome and give the original applicant a chance to comment to the MCC about the objection.
Phase 7: Confirmation
After the closing date for objections, the Minister's Delegate signs a notice
prepared by Medsafe for publication in the New Zealand Gazette in order to
implement those recommendations for a change of classification which have been
accepted earlier and which have not been the subject of a valid objection.
Phase 8: Notification
Approximately four weeks after the results of a meeting have been published on
the Medsafe website, classification changes are published in the New Zealand
Gazette. They take effect from the date of publication. The
classification list on the Medsafe website is
updated and a copy of the Gazette notice is published
on the Medsafe website. Changes are subsequently incorporated into an
amendment to the First Schedule to the Medicines Regulations 1984.
Phase 9: Implementation
When a classification change takes place a change of labelling will be
required. Other changes may also be necessary. Companies need to consult the
New Zealand Regulatory Guidelines for Medicines to see whether they are
required to submit a Self-assessable Change Notification, a Changed Medicine
Notification or a New Medicine Application.
Changes to labels / data sheets may be necessary or new labels / data sheets may be required.
Section 16(2) and (3) of the Medicines Regulations 1984 allows three months from the date of notification of a classification change for stock labelled with the old classification to be replaced at wholesale level and six months for replacement of stock at retail level. However, any existing stock must be sold at the new level of classification from the date on which the change comes into effect. Companies should contact Medsafe if they are unable to meet the timeframes specified.