1

Welcome

2

Apologies

3

Confirmation of the minutes of the 53rd meeting held on Tuesday 5 May 2015

4

Declaration of conflicts of interest

5

Matters arising

5.1

Objections to recommendations made at the 53rd meeting

The deadline for intentions to object to a recommendation made at the 53rd meeting, together with a statement of the grounds on which the objection will be made, was 21 July 2015. The Committee will consider any objections raised.

5.1.1

Oral contraceptives – proposed reclassification from prescription medicine to restricted medicine (Green Cross Health Limited)

Valid objections have been received regarding the Committee’s recommendation that the selected oral contraceptives (ethinylestradiol with norethisterone, ethinylestradiol with levonorgestrel, norethisterone, levonorgestrel and desogestrel) should not be reclassified from prescription medicine to restricted medicine when supplied for oral contraception by a registered pharmacist who has successfully completed a training course for the supply of oral contraceptives in accordance with the approved protocol for supply.

Valid objections were received from Green Cross Health and the Pharmacy Guild of New Zealand. The objectors feel the Committee was working outside of its guidelines and the application for reclassification met the criteria for a medicine to be suitable for non-prescription sale. This recommendation will be reconsidered by the Committee.

5.2

Matters arising for information

5.2.1

Update to the First Schedule to the Medicines Regulations 1984

The Medicines Amendment Regulations (No 2) updated the First Schedule to the Medicines Regulations 1984. The update incorporated all Gazette notices published after 1 August 2011.

6

Submissions for reclassification

6.1

Influenza vaccine – extension of influenza vaccination by pharmacists (Green Cross Healthcare)

This is a company submission to extend the classification of influenza vaccine from prescription medicine except when administered to a person 18 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health to prescription medicine except when administered to a person 13 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health.

Extension of influenza vaccination by pharmacists submission (PDF 653 KB, 17 pages)

7

New medicines for classification

7.1

1,3-dimethylamylamine (DMAA) - proposed classification as a prescription medicine (Medsafe)

This is a Medsafe submission for the classification of 1,3-dimethylamylamine (DMAA) as a prescription medicine except; when specified as an unmodified, naturally occurring substance.

DMAA proposed classification as a prescription medicine submission (PDF 466 KB, 8 pages)

8

Harmonisation of the New Zealand and Australian schedules

8.1

New chemical entities which are not yet classified in New Zealand

8.2

Decisions by the Secretary to the Department of Health and Aging in Australia (or the Secretary's Delegate)

8.2.1

Decisions by the Delegate -  November 2014

Decisions also included under agenda item 8.1.

1. Performance and image enhancing drugs
   New Schedule 4 (prescription medicine) entries should be created for AOD-9604 (CAS No. 221231-10-3), CJC-1295 (CAS No. 863288-34-0), pralmorelin ((growth hormone releasing peptide-2) (GHRP-2)), growth hormone releasing peptide-6 (GHRP-6), growth hormone releasing hormones (GHRHs), growth hormone releasing peptides (GHRPs), growth hormone secretagogues (GHSs), hexarelin and ipamorelin.
2. Benzydamine
   The Schedule 2 (pharmacy-only medicine) entry should be amended to benzydamine; in preparations for topical use except in preparations for dermal use; in divided topical oral preparations containing 3 mg or less of benzydamine; in undivided topical oral preparations containing 0.3% or less of benzydamine in a primary pack containing not more than 50 mL.
   

   The Schedule 4 (prescription medicine) entry should be amended to benzydamine except when included in Schedule 2; in preparations for dermal use; in divided topical oral preparations containing 3 mg or less of benzydamine; in undivided topical oral preparations containing 0.3% or less of benzydamine in a primary pack containing not more than 50 mL.

3. Pantoprazole
   A new Schedule 2 (pharmacy-only medicine) entry should be created for pantoprazole; in oral preparations containing 20 mg or less of pantoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease in packs not containing more than 7 days’ supply.
   
   The Schedule 3 (restricted medicine) entry should be amended to pantoprazole; in oral preparations containing 20 mg or less of pantoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days’ supply except when included in Schedule 2. The Schedule 4 (prescription medicine) entry should be amended to pantoprazole; except when included in Schedule 2 or 3.
4. Cyclizine
   The Schedule 3 (restricted medicine) entry should be amended to cyclizine; in divided preparations for oral use in primary packs containing 6 dosage units or less.
5. Cannabidiol
   A new Schedule 4 (prescription medicine) entry should be created for cannabidiol in preparations for therapeutic use containing 2% or less of other cannabinoids found in cannabis.

8.2.2

Decisions by the Delegate -  March 2014

Decisions also included under agenda item 8.1.

1. Hydrocortisone
   The Schedule 3 (restricted medicine) entry should be amended to hydrocortisone and hydrocortisone acetate, but excluding other salts and derivatives, in preparations for human therapeutic use containing 1% or less of hydrocortisone for dermal use, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; for dermal use, in packs containing 2 g or less of such preparations, containing no other therapeutically active constituent other than aciclovir (5% w/w or less) in adults and adolescents (12 years of age and older); for rectal use when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents in undivided preparations, in packs of 35 g or less or in packs containing 12 or less suppositories.
2. Ranitidine
   The Schedule 2 (pharmacy only) entry should be amended to ranitidine; in preparations supplied in the manufacturer’s original pack containing not more than 14 days’ supply except in divided preparations for oral use containing 150 mg or less of ranitidine per dosage unit in the manufacturer’s original pack containing not more than 14 dosage units; in divided preparations for oral use containing 300 mg or less of ranitidine per dosage unit in the manufacturer’s original pack containing not more than 7 dosage units.
   
   The Schedule 4 (prescription medicine) entry should be amended to ranitidine; except when included in Schedule 2; in divided preparations for oral use containing 150 mg or less of ranitidine per dosage unit in the manufacturer’s original pack containing not more than 14 dosage units; in divided preparations for oral use containing 300 mg or less of ranitidine per dosage unit in the manufacturer’s original pack containing not more than 7 dosage units.

8.2.3

Decisions by the Delegate - May 2014

Decisions also included under agenda item 8.1.

1. Allergens
   The Schedule 4 (prescription medicine) entry should be amended to allergens; for therapeutic use.

9

Agenda items for the next meeting

10

General business

11

Date of next meeting