1.

Welcome

2.

Apologies

3.

Confirmation of the minutes of the 32^nd meeting

4.

Declaration of conflict of interests

5.

Matters Arising from the 32^nd Meeting

5.1

Zanamivir (Relenza)

Medsafe is seeking comment about whether the sponsor company wishes to make a submission for reclassification to restricted medicine.

5.2

Orlistat

Confirmation of the Committee's request for a change to the product indication and the requirement for face-to-face consultation preceding initial sale.

5.3

Porcine pancreatic enzymes

The change to prescription medicine for lower strength products did not proceed in Australia. Therefore the change will not be accepted in New Zealand and the reclassification to prescription medicine will not occur.

5.4

Mercury

The change to the exemption from prescription status for mercury has been removed from the Gazette notice at the request of Weleda who would like its submission reconsidered in the light of the NDPSC discussion. While the maximum weekly dose of the Weleda product is only 84 micrograms, the concentration of the tablets exceeds the proposed cut-off point of 1 milligram per litre or per kilogram. Weleda is requesting a statement be added to the exemption to permit the general exemption of l0 milligrams per litre or per kilogram to remain valid when a maximum weekly dose limit is applied to the pack size permitted for general sale.

6.

Submissions for Reclassification

6.1

Domperidone (Motilium, 10mg tablets, Janssen-Cilag)

A company submission for reclassification from prescription medicine to restricted medicine for the symptomatic relief of nausea and vomiting and for the treatment of symptoms of dysmotility-like dyspepsia.
Janssen-Cilag submission (PDF document 374KB)

6.2

Oseltamivir (Tamiflu 75mg caspules, Roche)

A company submission for reclassification from prescription medicine to restricted medicine for the treatment and prophylaxis of influenza in adults and adolescents.
Roche submission (PDF document 167KB)

6.3

Simvastatin (10 milligram tablets, GlaxoSmithKline)

A company submission for the reclassification of 10 milligram tablets from prescription medicine to restricted medicine.
GlaxoSmithKline sibmission (PDF document 257KB)

7.

New Medicines for classification

8.

Harmonisation of New Zealand and Australian schedules

8.1

Harmonisation matters arising or outstanding

8.1.1

Alclometasone and clobetasone

Reconsideration of the current prescription medicine status of 0.05% dermal preparations. These have now been available in Australia as restricted medicines for some years.

8.1.2

Antihistamines

Finalisation of the review of antihistamines. For details please see the document entitled Antihistamines, final proposal for harmonisation (PDF document 33KB). This document confirms the earlier accepted principles for the classification of antihistamines and includes a list of the proposed classification of all antihistamines, both sedating and non-sedating. Companies should check all antihistamine products against this document. Please note that the earlier policy relating to sedating antihistamines for anxiety or insomnia is no longer necessary as these products will now be captured under the restricted medicine classification for sedating antihistamines.

8.1.3

Kava

At the previous meeting the Committee agreed that kava should be considered with a view to harmonising with Australia.

The Australian prescription medicine classification for kava is as follows:
Piper methysticum (kava) except:

1. in preparations for oral use containing dried whole or peeled rhizome or containing aqueous dispersions or aqueous extracts of whole or peeled rhizome when labelled with a recommended daily dose of 250 milligrams or less of kavalactones:
   1. containing more than 25 milligrams of kavalactones per dose, labelled with the
      statement:
      WARNING: Not for prolonged use. Not recommended for use by pregnant or
      lactating women. May harm the liver;
   2. in tablet or capsule form containing 125 milligrams or less of kavalactones per
      tablet or capsule or:
   3. in the form of a teabag when the amount of dried whole or peeled rhizome does
      not exceed 3 grams
2. in topical preparations for use on the rectum, vagina or throat containing dried whole or peeled rhizome or containing aqueous dispersions or aqueous extracts of whole or peeled rhizome; or
3. in dermal preparations.

8.1.4

NDPSC response to MCC recommendations

8.2

Recommendations made by the NDPSC to the MCC in October 2004

8.2.1

Salbutamol and terbutaline

Reconsideration of the earlier NDPSC recommendation to harmonise on the restricted medicine classification of salbutamol and terbutaline in dry powder and metered dose aerosol formulations. The MCC had earlier declined a recommendation to harmonise on these medicines. However, the matter is now due for two-year review.

8.2.2

Melia Azedarach

The NDPSC has announced its intention to list this plant in Appendix C of the SUSDP. Appendix C lists substances of such danger to health as to warrant prohibition of sale, supply and use. In order to harmonise at the highest possible level of classification in New Zealand Melia azedarach would need to be classified as a prescription medicine at all strengths.

8.2.3

Fosamprenavir

Add to the schedule as a prescription medicine. Fosamprenavir is used with other antiretrovirals for combination therapy of HIV infection.

8.3

Recommendations made by the Trans-Tasman Harmonisation Working Party to the MCC in October 2004

8.3.1

Aciclovir

Increase the pack size of 5% dermal aciclovir products for general sale from 3 grams to 10 grams to harmonise with Australia. The recommendation is based on a history of safe use in Australia.

8.3.2

Hyoscine butylbromide

Reclassify from:

• restricted medicine in medicines containing 10 milligrams or less and in packs containing not more than 20 tablets or capsules,
• to:
• pharmacy-only medicine in medicines containing 20 milligrams or less and in packs containing not more than 200 milligrams of hyoscine butylbromide.

The recommendation is based on an established safety record in Australia.

8.3.3

Savin oil

On the grounds of harmonisation and with regard to the toxicity of the juniperus sabina plant, the prescription medicine entry for savin oil should be replaced by an entry for juniperus sabina.

8.3.4

Alclometasone and clobetasone

Reclassify 0.05% dermal preparations from prescription medicine to restricted medicine. (See item 8.1.1 above)

9.

For the Next Meeting

10.

General Business