1.

Welcome

2.

Apologies

3.

Confirmation of Minutes of the 38th Meeting

4.

Declaration of Conflicts of Interest

5.

Matters Arising

5.1

Objections to recommendations made at the 38th meeting

5.2

Matters arising from the 38th meeting

5.2.1

Cough and cold medicines in children under 2 years of age

Following the recommendation to reclassify non-sedating antihistamines as prescription medicines when for children under the age of two and recent moves in the United States of America, the Committee will consider whether or not all cough and cold preparations should be reclassified as prescription medicines when for use in children under the age of two years.

5.2.2

Chloramphenicol to restricted medicine in eye preparations

Ongoing consideration of whether chloramphenicol eye preparations should be reclassified from prescription medicines to restricted medicines with particular interest in matters relating to the possible development of antibiotic resistance and to proposals for pharmacist training in the sale of such products.

5.2.3

Codeine in over-the-counter combination products

Further consideration of the Medsafe request that the MCC consider whether or not the current "Controlled Drug CVI" status for codeine as a pharmacy-only medicine was still appropriate for combination products containing increasingly larger doses of codeine.

As a Class C Controlled Drug listed in Schedule 3 Part 6, codeine may be sold as a pharmacy-only medicine when in dose units containing not more than 100 milligrams each and when compounded with one or more pharmacologically active ingredients in such a way that the substance may not be recovered by readily acceptable means or in a yield which could constitute a risk to health.

The proposal is that codeine should be classified as follows:

• pharmacy-only combination medicines containing codeine should be limited to products containing 12 milligrams or less of codeine per dose unit and in packs containing not more than 50 dose units.
• Packs containing more than 12 milligrams of codeine but not more than 30 milligrams per dose unit and in pack sizes of not more than 12 dose units should be restricted medicines.
• Any codeine combination products qualifying as Class C Controlled Drugs listed in Schedule 3 Part 6 other than those fulfilling the above criteria for pharmacy-only or restricted medicines, should be classified as prescription medicines.

These limits should retain the pharmacy-only status of most of the codeine phosphate products currently on the market.

5.2.4

Potassium in glucosamine sulfate complexed dietary supplements

The Committee is seeking a more feasible way of implementing its earlier recommendation for glucosamine sulfate complexed dietary supplements to carry a statement of the amount of potassium per dose and a warning against use with kidney problems.

6.

Submissions for Reclassification

6.1.

Oseltamivir (Tamiflu, 75 mg capsules Roche)

A company submission for the reclassification of oseltamivir capsules from prescription medicine to restricted medicine.

Oseltamivir capsules are currently prescription medicines but are exempt from prescription medicine status when sold by a registered pharmacist between May and September each year to a person over the age of 12 years presenting in a pharmacy with early symptoms of influenza.

7.

New Medicines for Classification

8.

Harmonisation of the New Zealand and Australian Schedules

8.1

Update on harmonisation matters

8.2

Recommendations made by the NDPSC to the MCC in October 2007

8.2.1

New medicines which are prescription medicines in Australia but which are not scheduled in New Zealand.

8.2.2

Fractionated and recombinant blood products

These are exempt from scheduling under Appendix A of the Australian schedule. The Committee will decide whether or not to harmonise as closely as possible by making fractionated and recombinant blood products general sale medicines in New Zealand. Apart from Factor VIII which is a general sale medicine, they are currently classified as prescription medicines.

9.

For the Next Meeting

10

General business