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
Medicines for General Sale
Please note that the following medicine is now available for general sale.
Loperamide; 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
Dated this 13th day of July 2010.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health.