Revised: 11 April 2013

Committees

AGENDA FOR THE 49th MEETING
OF THE MEDICINES CLASSIFICATION COMMITTEE
TO BE HELD IN THE MEDSAFE BOARDROOM,
LEVEL 6, DELOITTE HOUSE, 10 BRANDON STREET, WELLINGTON
on TUESDAY 30 APRIL 2013 AT 9:30AM

1 Welcome
2 Apologies
3 Confirmation of the minutes of the 48th meeting held on Tuesday 30 October 2012
4 Declaration of conflicts of interest
5 Matters arising
5.1 Objections to recommendations made at the 48th meeting
No objections have been received.
5.2 Review of the classification criteria
The Committee will discuss the factors when considering a medicine for reclassification for non-prescription sale using the paper put together by Medsafe.
The classification criteria currently used by the Committee can be found on the Medsafe website at www.medsafe.govt.nz/downloads/How_to_change_medicine_classification.pdf.
Any changes to the classification criteria recommended by the Committee will be subject to public consultation before implementation.
5.3 Further data to support the reclassification of diphtheria, tetanus and pertussis (acellular, component) vaccine
(Pharmacybrands Limited)
The Committee will reconsider the submission to reclassify diphtheria, tetanus and pertussis (acellular, component) vaccine (Tdap), in a single dose from prescription medicine to prescription medicine except when administered to a person aged 18 years or over by a pharmacist who has successfully completed the Immunisation Advisory Centre vaccinator course and is complying with the immunisation standards of the Ministry of Health, now that further data has been submitted.
5.4 Classification of febuxostat as a prescription medicine
(Adenuric, Te Arai Biofarma Limited)
As out-of-session consultation took place in December 2012 regarding the classification of febuxostat.
The Committee recommended that febuxostat should be classified as a prescription medicine. This classification was gazetted on 7 February 2013 alongside the recommendations from the 48th meeting.
5.5 Classification of cholera vaccine as a prescription medicine
(Dukoral, Pharmacybrands Limited)
At the 46th meeting on 15 November 2011, the Committee recommended that vibrio cholera and enterotoxigenic Escherichia coli vaccine should be reclassified from prescription medicine to restricted medicine.
The manufacturer of the vaccine requested that the reclassification to restricted medicine be deferred until a decision had been made in Australia.
In October 2012, the Delegate in Australia decided not to harmonise and that the current scheduling of cholera vaccine (as a prescription medicine) remained appropriate.
To ensure that there was no requirement to produce an entirely New Zealand specific product, cholera vaccine has been reclassified in New Zealand as a prescription medicine; except in the form of an oral liquid containing Vibrio cholerae when sold in a pharmacy by a registered pharmacist. This reclassification allows pharmacists to gain access to the vaccine as if it was classified as a restricted medicine.
6 Submissions for reclassification
6.1 Meningococcal vaccine - proposed reclassification from prescription medicine to prescription medicine except when
(Pharmacybrands Limited)
This is a submission (Adobe PDF document 1468 KB) from Pharmacybrands Limited (the parent company for Life, Unichem, Amcal, Radius and Care Chemist pharmacies in New Zealand) for the reclassification of meningococcal vaccine from prescription medicine to prescription medicine except when administered to a person aged 16 years or over by a pharmacist who has successfully completed the Immunisation Advisory Centre vaccinator course and is complying with the immunisation standards of the Ministry of Health.
6.2 Naproxen - proposed reclassification from pharmacy-only medicine to general sale medicine
(Naprogesic, Bayer New Zealand Limited)
This is a company submission (Adobe PDF document 1158 KB) from Bayer New Zealand Limited for the reclassification of naproxen, in solid dose form for oral use containing 250 mg or less per dose form with a recommended daily dose of not more than 1.25 g and in a pack containing not more than 25 tablets or capsules, from pharmacy-only medicine to general sale medicine.
The indications proposed for naproxen as a general sale medicine are the temporary relief of pain and / or inflammation associated with headache, migraine headache, tension headache, muscular pain, period pain, dental pain, back pain, arthritic pain, pain associated with sprains and strains, aches and pains associated with cold and flu, joint pain, tendonitis, and the reduction of fever.
7 New medicines for classification
8 Harmonisation of the New Zealand and Australian schedules
8.1 New chemical entities which are not yet classified in New Zealand
8.2 Decisions by the Secretary to the Department of Health and Aging in Australia (or the Secretary's Delegate)
8.2.1 Decisions by the Delegate - September 2012
No harmonisation decisions relevant to the Committee we made by the Delegate.
8.2.2 Decisions by the Delegate - October 2012
  1. Tranexamic acid
    The Schedule 4 (prescription medicine) entry for tranexamic acid should be amended to include the wording 'except in preparations containing 3% or less of cetyl tranexamate hydrochloride for dermal cosmetic use'.
8.2.3 Decisions by the Delegate - November 2012
  1. Ibuprofen in combination with phenylephrine
    Ibuprofen should be rescheduled from Schedule 2 (pharmacy-only medicine) to unscheduled when in divided preparations containing 200 mg or less of ibuprofen in fixed dose combinations with phenylephrine in packs containing not more than 25 tablets. This includes restricting the entry for the treatment of adults and children aged 12 years of age and over.
8.2.4 Decisions by the Delegate - February 2013
  1. Diclofenac
    The Schedule 2 (pharmacy-only medicine) entry for diclofenac should be amended to include transdermal preparations for topical use containing 140 mg or less of diclofenac.
  2. Enobosarm and Selective Androgen Receptor Modulators
    A new entry should be created for enobosarm and a new class entry should be created for selective androgen receptor modulators in Schedule 4 (prescription medicine).
  3. Vitamin D
    A new Schedule 3 (restricted medicine) entry should be created to allow a weekly dose of vitamin D up to 175 mcg per recommended dose.
9 Agenda items for the next meeting
10 General business
10.1 Review of the pilot for having observers during reclassification submissions
This meeting is the fourth and last meeting that will pilot having observers during reclassification submissions.
The Committee will review this pilot using the feedback (Adobe PDF document 2390KB) from the companies involved alongside any comments received from interested parties during the consultation period.
10.2 Reclassification of medicines in Denmark
The Committee will be presented with an email that describes a new automatic process in Denmark which transforms products from over-the-counter to general sale after two years on the market.
To date, very few products have been transformed into general sale products using this automatic procedure.
11 Date of next meeting
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