Revised: 20 June 2013
Committees
AGENDA FOR THE 26TH MEETING
OF THE MEDICINES CLASSIFICATION COMMITTEE
TO BE HELD ON 11 DECEMBER 2011
Comments are invited from interested parties. These should be received
by the Secretary, Medicines Classification Committee, PO Box 5013 Wellington
by 5 October 2001
To download company submissions please click on the company name. Medsafe
reports will be available later.
MATTERS ARISING FROM THE 25TH MEETING
Objections to recommendations made at the 25th meeting
Belladonna A Weleda submission for modification to the
current cut-off points for restricted and pharmacy-only medicines and a
change to the exemption from scheduling. For details refer to the company
submission.
Weleda submission (PDF document 268KB)
Hyoscine, hyoscyamine, hyoscyamus A Weleda submission
for amendments to the schedule entries for hyoscine and hyoscyamine and
to their proposed exemption limit and for additional, consistent entries
for hyoscyamus. For details refer to the company submission.
Weleda submission (PDF document 272KB)
Sabadilla A Weleda submission for reclassification from
prescription medicine to allow pharmacy-only sale at some strengths and
for a change to the level for exemption from scheduling. For details refer
to the company submission
Weleda submission (PDF document 265KB)
SUBMISSIONS FOR RECLASSIFICATION
Omeprazole (Losec, AstraZeneca) A company submission
for the reclassification of 10mg tablets in packs of 14 from prescription
medicine to pharmacy-only medicine for the symptomatic relief and short-term
prevention of the recurrence of heartburn and indigestion.
Medsafe report (PDF document 287KB)
AstraZeneca submission (PDF document 545KB)
Fluocortolone (Ultraproct suppositories and ointment, Schering)
A company submission for the reclassification of fluocortolone in combination
with cinchocaine in packs of 12 suppositories or tubes of 30 grams.
Medsafe report (PDF document
240KB)
Schering submission (PDF document 150KB)
Paracetamol 665mg modified release tablets (GlaxoSmithKline)
A company submission for reclassification from prescription medicine to
pharmacy-only medicine. This submission had been withdrawn from the agenda
of the 25th meeting.
GlaxoSmithKline submission (PDF document
243KB)
NEW MEDICINES FOR CLASSIFCATION
Eflornithine hydrochloride A recommendation was postponed at the 25th meeting to seek further information about whether the medicine should become a prescription medicine or whether it is suitable for OTC sale.
HARMONISATION OF NZ AND AUSTRALIAN SCHEDULES
Proposed framework for herbal medicines and herbal medicines for which exemption from prescription medicine classification had been requested.
The following medicines have been recommended for inclusion as prescription medicines in order to harmonise with the Australian schedule. However, consideration is being given to ways of allowing continued access at general sale level in complementary medicines when in concentrations which can be demonstrated to be safe for use at that level of classification. The MCC is investigating applying a framework for the classification of herbal medicines based on a percentage of their lowest fatal dose. Interested parties are asked to submit data demonstrating fatal dose levels of these medicines as well as comments about the proposed framework. Medicines for which no data are received for the 26th meeting will be classified as prescription medicines. A closing date for responses will be published in Dates and Deadlines.
acorus calamus
amygdalin
borago officinalis
eupatorium cannabium
juniperus sabina
senecio
symphytum
tussilago farfara
petastes
pteridium
Proposed framework for herbal medicines
| Prescription medicine | Except when specified below |
| Pharmacy-only medicine | For oral or dermal use when:
|
| General sale medicine | For oral or dermal use when:
|
