1.

Welcome

2.

Apologies

3.

Confirmation of the Minutes of the 31^st Meeting

4.

Declaration of conflict of interests

5.

Matters Arising from the 31^st meeting

5.1

Phenylephrine

Consideration of the MCC proposal at the 31^st meeting. The matter was deferred pending comments from one of the stakeholder companies. These comments in support of the original submission have now been submitted.
Phenylephrine reclassification discussion paper (Adobe Acrobat document 497KB)

The original submission was from Wyeth Consumer Healthcare for the reclassification of phenylephrine to accommodate solid dose forms. The submission proposed a cut-off point of 10 milligrams or less per dose form for general sale and a pharmacy-only classification for solid dose forms containing more than 10 milligrams.
Original Wyeth submission (PDF document 442KB)

The MCC proposed at the 31^st meeting that all oral dose forms of phenylephrine should be classified as pharmacy-only medicines when in preparations containing 10 milligrams or less per recommended dose. Oral preparations containing doses greater than 10 milligrams should be prescription medicines. There should be no oral phenylephrine preparations sold as general sale medicines.

There are no oral general sale phenylephrine products currently on the market which would be affected by the proposed change. All those products containing general sales doses of phenylephrine are in combination products which also contain pharmacy-only medicines. However, there may be current pharmacy-only products which would require amended dosage instructions to retain their pharmacy-only classification.

5.2

Orlistat (Xenical, Roche)

Ongoing consideration of a company submission for reclassification from prescription medicine to restricted medicine for 120 milligram capsules for weight control. The matter will be considered in the light of the response from the Pharmaceutical Society to the Committee's wish for appropriate training in the sale of the medicine should it be reclassified as a restricted medicine and the assurance that a face-to-face consultation would be mandatory before an initial sale of the product.
Roche submission (PDF document 351KB)

6.

Submissions for Reclassification

6.1

Ketotifen eye drops 0.025% (Zaditen, Novartis)

A company submission for reclassification from prescription medicine to restricted medicine for ophthalmic use. The MCC had recently declined a submission for reclassification to pharmacy-only medicine but indicated its willingness to consider a further submission to restricted medicine.
Novartis submission (PDF document 342KB)

7.

New Medicines for classification

8.

Harmonisation of New Zealand and Australian Schedules

8.1

Harmonisation matters arising or outstanding

8.1.1

Fluorides

The NDPSC has proposed that the upper cut-off level for general sale for external use in oral hygiene products other than pastes, gels or powders for cleaning the teeth should be raised from 0.01% or less to 220 milligrams or less per litre or per kilogram. In addition a pack size limit of 120 milligrams of total fluoride ion should be imposed on general sale products.

This increase in the amount of fluoride permitted at general sale level should affect only mouthwashes. Classification levels for all other products containing fluoride should remain unchanged.

8.1.2

Antihistamines

The Committee had postponed consideration of the classification of antihistamines until the NDPSC had completed its review of the classification of these substances. This review is now complete. For details please see the document entitled Antihistamines, final proposal for harmonisation (PDF document 21KB).

8.1.3

NDPSC response to MCC recommendations

8.2

Recommendations made by the NDPSC to the MCC in February 2004

8.2.1

Pyridoxine

Classify as a prescription medicine in oral preparations containing more than 200 milligrams per recommended daily dose.

8.2.2

Mercury and methylmercury

Amend the cut-off point for exemption from scheduling from 10 milligrams per litre or per kilogram to:

Note that methylmercury is not currently scheduled in either New Zealand or Australia.

8.2.3

Nicotine in lozenges

Reclassify to general sale medicine.

Note that this would also apply to sublingual tablets in New Zealand.

8.3

Recommendations made by the NDPSC to the MCC in June 2004

8.3.1

Triamcinolone for buccal use

Amend the restricted medicine entry to: in medicines containing 0.1% or less and in packs of 5 grams or less.

The recommendation should not affect the products on the New Zealand market.

8.3.2

Porcine pancreatic enzymes

All porcine pancreatic enzymes should be prescription medicines. This means any porcine pancreatic enzymes which are currently general sale medicines would become prescription medicines. Any general sale pancreatic enzymes which are not porcine-derived would be unaffected by the proposed change.

The recommendation is based on the following:

• that contamination with porcine parvovirus and potential risk of human infection cannot be ruled out
• available data suggests that benefits associated with treatment of pancreatic exocrine insufficiency with porcine pancreatic enzymes outweighs the potential risk of porcine parvovirus contamination of these products
• the risk-benefit ratio for the use of porcine pancreatic enzymes for conditions unrelated to pancreatic insufficiency as OTC or complementary products is too high and those products should be withdrawn.

8.3.3

Treprostinil and ciclesonide

Add these two new chemical entities to the schedule as prescription medicines in the interest of harmonisation.

9.

For the Next Meeting

The next meeting is scheduled for April or May 2005. Comments are not required at this time. Opportunity for comment will occur if these items are placed on the agenda for the 33^rd meeting.

9.1

Zanamivir (Relenza) and oseltamivir (Tamiflu)

Proposed by a Committee member as possible candidates for future reclassification from prescription medicine to restricted medicine.

9.2

Trimethoprim

Proposed by a Committee member as a possible candidate for future reclassification from prescription medicine to restricted medicine or for sale by an accredited pharmacist.

9.3

Clobetasone

Proposed by a Committee member as a possible candidate for future reclassification from prescription medicine to restricted medicine for 0.05% topical preparations.

Alclometasone should be considered in conjunction with clobetasone. Both are due for 2-year review following an earlier MCC recommendation not to harmonise with Australia by making packs containing 0.05% available as restricted medicines.

9.4

Kava

Kava is scheduled in Australia but is classed as a dietary supplement in New Zealand.

10.

General Business