Notice Type
Departmental
Notice Title

Classification of Medicines

Pursuant to section 106(1) of the Medicines Act 1981,
I, Barbara Phillips, Acting 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
Chloramphenicol; except when sold in practice by a registered optometrist; except when specified elsewhere in this notice
Codeine; except when specified elsewhere in this notice
Corifollitropin alfa
Famciclovir; except when specified elsewhere in this notice
Fexofenadine; except for oral use
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
Heparins; for internal use; except when present as an excipient
Human papillomavirus vaccine
Ibogaine
Japanese encephalitis vaccine
Lansoprazole; except when specified elsewhere in this notice
Loperamide; except when specified elsewhere in this notice
Nebivolol
Noribogaine
Omeprazole; except when specified elsewhere in this notice
Pazopanib
Phosphodiesterase type 5 inhibitors; except when present
as an unmodified, naturally occurring substance; except when specified elsewhere in this notice
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
Stramonium; except for oral use when specified elsewhere in this notice; except datura stramonium or datura tatula for smoking or burning
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
Zolmitriptan; except when specified elsewhere in this notice
Schedule 2
Restricted Medicines
Chloramphenicol; for ophthalmic use; except when sold in practice by a registered optometrist
Codeine; in medicines for oral use, containing not more
than 15 milligrams of codeine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 milligrams of codeine, when combined with 1 or more active ingredients, in such a way that the substance cannot be recovered by readily applicable means or in a yield which would constitute a risk to health, for use as an analgesic and when sold in a pack of not more than 5 days’ supply, approved by the Minister or the Director-General for distribution as a restricted medicine
Famciclovir; in tablets containing 500 milligrams or less when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine
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
Lansoprazole; in tablets or capsules containing 15 milligrams or less when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine
Omeprazole; in tablets or capsules containing 20 milligrams or less when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine
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
Zolmitriptan; in a prefilled nasal spray device containing not more than 5 milligrams for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms when sold in a pack of not more than 2 devices approved by the Minister or the Director-General for distribution as a restricted medicine
Schedule 3
Pharmacy-only Medicines
Codeine; in medicines for oral use, containing not more than 15 milligrams of codeine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 milligrams of codeine, when combined with 1 or more active ingredients, in such a way that the substance cannot be recovered by readily applicable means or in a yield which would constitute a risk to health, for the treatment of the symptoms of cough and cold and when sold in a pack of not more than 6 days’ supply approved by the Minister or the Director-General for distribution as a pharmacy-only medicine
Controlled drugs; that are medicines specified in Part 6 of Schedule 3 of the Misuse of Drugs Act 1975; except codeine as specified elsewhere in this notice
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
Fexofenadine; for oral use; except when in capsules containing 60 milligrams or less of fexofenadine hydrochloride or in tablets containing 120 milligrams
or less of fexofenadine hydrochloride when sold in a pack approved by the Minister or the Director-General for distribution as a general sale medicine
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 8 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
Stramonium; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less
per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids
Medicines for General Sale
Please note that the following medicines are now available for general sale.
Fexofenadine; in capsules containing 60 milligrams or
less of fexofenadine hydrochloride or in tablets containing 120 milligrams or less of fexofenadine hydrochloride when sold in a pack approved by the Minister or the Director-General for distribution as
a general sale medicine
Heparins; for external use; when present as an excipient
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 8 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 14th day of January 2011.
BARBARA PHILLIPS, Acting Deputy Director-General, Population Health Directorate, Ministry of Health.