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Classification of Medicines

Agenda Items for the 29th Medicines Classification Committee Meeting

AGENDA FOR THE 29TH MEETING OF THE MEDICINES CLASSIFICATION COMMITTEE TO BE HELD IN MAY 2003 IN THE MEDSAFE MEETING ROOM, 18th FLOOR, GRAND PLIMMER TOWER, WELLINGTON COMMENCING AT 9.30AM

1.

WELCOME

2.

APOLOGIES

3.

CONFIRMATION OF THE MINUTES OF THE 28TH MEETING

4.

DECLARATION OF CONFLICT OF INTERESTS

5.

MATTERS ARISING FROM THE 28TH MEETING

5.1 Buccaline Berna
A submission from Pharmabroker Sales for the reclassification of pneumococcus I,II and III vaccine and haemophilus influenzae vaccine from prescription medicine to pharmacy-only medicine when contained in oral vaccines.
Pharmabroker Sales submission (Microsoft Word document 94KB)
5.2 Moderately potent topical corticosteroids
Progress to date regarding information sought relevant to safety for OTC sale with particular reference to clobetasone and alcometasone 0.05% topical preparations.

6.

SUBMISSIONS FOR RECLASSIFICATION

6.1 Hyoscyamus niger
A submission from Weleda for reclassification of hyoscyamus niger from pharmacy-only medicine to general sale medicine when in packs containing 30 micrograms or less of total solanaceous alkaloids.
Weleda submission (Microsoft Word document 71KB)
6.2 Ibuprofen ( Nurofen gel)
A submission from Boots Healthcare for reclassification of topical ibuprofen from pharmacy-only medicine to general sale medicine.
Boots submission (Microsoft Word document 197KB)
6.3 Ketoprofen (Oruvail gel)
A submission from Aventis Pharma for reclassification of 2.5% topical ketoprofen gel from pharmacy-only medicine to general sale medicine.
Aventis Pharma submission (Microsoft Word document 53KB)

7.

NEW MEDICINES FOR CLASSIFICATION

8.

HARMONISATION OF NZ AND AUSTRALIAN SCHEDULES

8.1 Harmonisation matters arising or outstanding
8.1.1 Paracetamol 665 milligram tablets
NDPSC response to MCC recommendation.
8.1.2 Fluorides
These are harmonised for internal use. However, there are still differences in the scheduling of products for external use. Comment is invited on possible ways of harmonising the two schedules.
8.2 Recommendations made by the NDPSC to the MCC in June 2002
8.2.1 Pseudoephedrine
Due to increasing illicit use, the NDPSC has recently reclassified pseudoephedrine from pharmacy-only to restricted medicine when in single-ingredient tablets or capsules of not more that 60 milligrams each and in packs containing not more than 30. The change does not apply to slow-release or combination products which remain pharmacy-only as before. The NDPSC recognised that the change has resulted in an unharmonised position with NZ and has recommended that the MCC be advised of the outcome for consideration.
8.2.2 Hyoscine butylbromide
Increase the amount permitted for sale as a pharmacy-only medicine from 10 milligrams per tablet to 20 milligrams per tablet. The maximum pack size remains the same at 200 milligrams.

To date the MCC has recommended that 10 milligram tablets in packs of 20 should remain restricted medicine.

8.2.3 Polyacrilamide and polylactic acid
Schedule as prescription medicines when in injections for tissue augmentation or cosmetic use.

9.

FOR THE NEXT MEETING

10.

GENERAL BUSINESS