1.

Welcome

2.

Apologies

3.

Confirmation of the minutes of the 30th meeting

4.

Declaration of conflict of interests

5.

Matters arising from the 30th meeting

5.1

Fluconazole 150 milligram single dose tablet

The recommendation from the NDPSC to reclassify from prescription medicine to restricted medicine was deferred from the 30^th meeting pending further information.

5.2

Hydroquinone

Hydroquinone should be classified as a general sale medicine in hair preparations containing 1% or less and a pharmacy-only medicine for external use in medicines containing 2% or less. All other preparations should be prescription medicines.

5.3

Isosorbide dinitrate

Isosorbide dinitrate was recently reclassified as part of the harmonisation process. Lower dose oral preparations were classified as restricted medicines in order to be consistent with glyceryl trinitrate for acute treatment.

However, the product currently marketed is not indicated for acute treatment. This has caused the MCC to query whether the restricted medicine classification is appropriate.

Medsafe is seeking advice about whether or not isosorbide dinitrate is used for acute treatment in Australia.

5.4

Phenylephrine

The MCC has proposed 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.

6.

Submissions for Reclassification

6.1

Orlistat (Xenical, Roche)

A company submission for reclassification from prescription medicine to restricted medicine for 120mg capsules for weight control.
Roche submission (PDF document 351KB)

6.2

Simvastatin (HeartCare Plus Ltd)

A submission for the reclassification of 10mg simvastatin tablets from prescription medicine to pharmacy-only medicine.
HeartCare Plus submission (PDF document 308KB)

6.3

Triamcinolone acetonide aqueous nasal spray (Nasacort, Aventis Pharma)

A company submission for reclassification from restricted medicine to pharmacy-only medicine for aqueous nasal sprays containing 55mcg per actuation and in packs containing 120 actuations. The submission also seeks a change to the OTC indication to 'allergic rhinitis' in line with recent changes to other OTC corticosteroid nasal sprays.
Aventis Pharma submission (PDF document 271KB)

7.

New Medicines for classification

8.

Harmonisation of New Zealand and Australian Schedules

8.1

NDPSC response to MCC recommendations

8.2

Recommendations made by the NDPSC to the MCC in October 2003

8.2.1

Trichloroacetic acid

Classify as a prescription medicine except when in preparations containing 12.5% or less for the treatment of warts other than anogenital warts.

8.2.2

Orlistat

Classify as a restricted medicine when in preparations for weight-control purposes containing 120 mg or less or orlistat. (See agenda item 6.1)

8.2.3

New prescription medicines

Add aripiprazole and fenofibrate to the schedule as a prescription medicines.

9.

For the Next Meeting

10.

General business