22 JULY 2010 NEW ZEALAND GAZETTE, No. 88 2381

Classification of Medicines

Pursuant to section 106(1) of the Medicines Act 1981, I, Janice Wilson, Deputy Director-General, Population Health Directorate, Ministry of Health, acting under delegated authority, hereby declare the following:

1. The medicines listed in Schedule 1 to this notice are classified as prescription medicines.

2. The medicines listed in Schedule 2 to this notice are classified as restricted medicines.

3. The medicines listed in Schedule 3 to this notice are classified as pharmacy-only medicines.

Every reference to a medicine in this notice applies whether the medicine is synthetic in origin or is from biological or mineral sources.

Unless specific reference is made otherwise, every reference applies also to medicines that are:

(a) preparations and admixtures containing any proportion of any substance listed in the notice.

(b) salts and esters of any substance listed in the notice.

(c) preparations or extracts of biological materials listed in the notice.

(d) salts or oxides of elements listed in the notice.

Unless specific reference is made otherwise, every reference to a medicine applies:

(i) if the medicine is in an injection or eye preparation, to any concentration of that medicine; and

(ii) if the medicine is not in an injection or eye preparation, only if the concentration of the medicine is greater than 10 milligrams per litre or per kilogram.

Where any reference is modified by a statement of the strength of the medicine, the strength is calculated using the free acid, base, alcohol or element unless specifically stated otherwise.

Schedule 1

Prescription Medicines

Amyl nitrite; except when sold to a person who holds a valid Controlled Substances Licence authorising them to possess cyanide

Calcipotriol; except in medicines containing not more than 50 micrograms per gram or per millilitre and when sold in a pack of not more than 30 grams or 30 millilitres by a pharmacist to an adult with mild to moderate psoriasis previously diagnosed by a doctor

Fluorides; for internal use in medicines containing more than 0.5 milligrams per dose unit except in medicines containing 15 milligrams or less per litre or per kilogram; except in parenteral nutrition replacement preparations; for external use in medicines containing more than 5500 milligrams per litre or per kilogram except when supplied to a dental professional recognised by the Dental Council of New Zealand

Loperamide; except when specified elsewhere in this notice

Nebivolol

Rizatriptan; except when specified elsewhere in this notice

Roflumilast

Saxagliptin

Staphylococcus aureus vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds

Streptococcus beta-haemolyticus vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds

Succimer

Tapentadol

Ustekinumab

Vaccines; except when specified elsewhere in this notice

Vaccinia virus vaccine

Vernakalant

Vinflunine

Schedule 2

Restricted Medicines

Fluorides; for external use in liquid form in medicines containing 5500 milligrams or less and more than 1000 milligrams per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as restricted medicines; for external use in non-liquid form in medicines containing 5500 milligrams or less and more than 1000 milligrams per litre or per kilogram, except in medicines containing 1500 milligrams or less and more than 1000 milligrams per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as general sale medicines; except when supplied to a dental professional recognised by the Dental Council of New Zealand

Rizatriptan; for oral use in medicines for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms, when in wafers containing 5 milligrams or less per wafer and when sold in a pack containing not more than 2 wafers approved by the Minister or the Director-General for distribution as a restricted medicine

Staphylococcus aureus vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds

Streptococcus beta-haemolyticus vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds

Schedule 3

Pharmacy-only Medicines

Diclofenac; in solid dose form in medicines containing 12.5 milligrams or less per dose form in packs containing not more than 30 tablets or capsules and with a recommended daily dose of not more than 75 milligrams

Fluorides; for internal use in medicines containing 0.5 milligrams or less per dose unit; except in parenteral nutrition replacement preparations; for external use in liquid form in medicines containing 1000 milligrams or less per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as pharmacy-only medicines, except in medicines containing 220 milligrams or less per litre or per kilogram and in packs containing not more than 120 milligrams of total fluoride which have been approved by the Minister or the Director-General for distribution as general sale medicines; except when supplied to a dental professional recognised by the Dental Council of New Zealand; except in medicines containing 15 milligrams or less per litre or per kilogram

Loperamide; in packs containing not more than 20 tablets or capsules; except in divided solid dosage forms for oral use containing 2 milligrams or less of loperamide per dosage form when sold in a pack containing not more than eight dosage forms approved by the Minister or the Director-General for distribution as a general sale medicine for the symptomatic treatment of acute non specific diarrhoea

Sodium nitrite; except when present as an excipient