Pursuant to section 106(1) of the Medicines Act 1981,
I, Mark Jacobs, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, 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
Benzocaine; except when specified elsewhere in this
notice; except in dermal preparations containing 2% or less of total anaesthetic substances; except in lozenges containing 30 milligrams or less of total anaesthetic substances per dosage unit
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
Canakinumab
Certolizumab pegol
Chloramphenicol; except when sold in practice by a registered optometrist; except when specified elsewhere in this notice
Clofarabine
Codeine; except when specified elsewhere in this notice
Corifollitropin alfa
Eltrombopag olamine
Famciclovir; except when specified elsewhere in this notice
Fampridine
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
Flurbiprofen; except in locally acting oromucosal preparations containing 10 milligrams or less per preparation
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
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
Benzocaine; in preparations for topical use, other than
eye drops, containing 10% or less of total anaesthetic substances except in dermal preparations containing
2% or less of total anaesthetic substances; in divided preparations containing 200 milligrams or less of
total anaesthetic substances per dosage unit except
in lozenges containing 30 milligrams or less of total anaesthetic substances per dosage unit
Brompheniramine; for oral use in medicines for adults
and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose
of a day/night pack containing brompheniramine or when at least one of the other active ingredients is a sympathomimetic decongestant
Chlorpheniramine; for oral use in medicines for adults
and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose
of a day/night pack containing chlorpheniramine or when at least one of the other active ingredients is
a sympathomimetic decongestant
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
Dexchlorpheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose
of a day/night pack containing dexchlorpheniramine or when at least one of the other active ingredients is a sympathomimetic decongestant
Dextromethorphan; in liquid form containing more than 0.25% or in solid dose form containing more than 15 milligrams per dose form when in packs containing not more than 600 milligrams and with a recommended daily dose
of not more than 120 milligrams; in medicines for the treatment of the symptoms of cough and cold in children aged 6-12 years
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
Diphenhydramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing diphenhydramine or when
at least one of the other active ingredients is a sympathomimetic decongestant; for oral use in a sealed container of not more than 10 tablets or capsules
of diphenhydramine theoclate for the prevention or treatment of motion sickness in adults and children
over 2 years of age except when sold at a transport terminal or aboard a ship or plane
Doxylamine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing doxylamine or when at least one of the other active ingredients is a sympathomimetic decongestant
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
Flurbiprofen; in locally acting oromucosal preparations containing 10 milligrams or less per preparation
Ipecacuanha; in medicines containing 0.2% or less of emetine and 40 micrograms or more of ipecacuanha alkaloids per recommended dose for the treatment of the symptoms of cough and cold in children aged 6-12 years
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
Omeprazole; in divided solid dosage forms for oral use containing 20 milligrams or less, with a maximum daily dose of 20 milligrams in a pack size of up to 14 dosage units, for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over, when sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine
Pheniramine; for ophthalmic use except when sold in practice by a registered optometrist; for oral use
in medicines for adults and children over 6 years of
age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing pheniramine or when at least one of the other active ingredients is a sympathomimetic decongestant
Phenylephrine; for nasal use in medicines containing
more than 1%; for ophthalmic use in medicines containing 5% or less and more than 1%; for oral use in medicines containing more than 50 milligrams per recommended daily dose or in packs containing more than 250 milligrams of phenylephrine per pack; in medicines for the treatment of the symptoms of cough and cold in children aged 6-12 years
Promethazine; for oral use in medicines for adults and children over 6 years of age when combined in the
same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing promethazine or when at least one of the other active ingredients is a sympathomimetic decongestant; for oral use in a sealed container of not more than 10 tablets or capsules for the prevention or treatment of motion sickness in adults and children over 2 years of age except when sold at a transport terminal or aboard a ship or plane
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
Trimeprazine; for oral use in medicines for adults and children over 6 years of age when combined in the
same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing trimeprazine or when at least one of the other active ingredients is a sympathomimetic decongestant
Triprolidine; for oral use in medicines for adults and children over 6 years of age when combined in the
same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing triprolidine or when at least one of the other active ingredients is a sympathomimetic decongestant
Medicines for General Sale
Please note that the following medicines are now available for general sale.
Benzocaine; in dermal preparations containing 2% or less
of total anaesthetic substances; in lozenges containing
30 milligrams or less of total anaesthetic substances per dosage unit
Dextromethorphan; in liquid form containing 0.25% or
less or in solid dose form containing 15 milligrams
or less per dose form when in packs containing not
more than 600 milligrams and with a recommended
daily dose of not more than 120 milligrams; except in medicines for the treatment of the symptoms of cough and cold in children aged 6-12 years
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
Ipecacuanha; in medicines containing less than 40 micrograms of ipecacuanha alkaloids per recommended dose for the treatment of the symptoms of cough and cold in children aged 6-12 years
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
Nicotine; in preparations for oromucosal or transdermal absorption
Phenylephrine; for nasal or ophthalmic use in medicines containing 1% or less; for oral use in medicines containing 50 milligrams or less per recommended daily dose and in packs containing 250 milligrams or less of phenylephrine per pack; except in medicines for the treatment of the symptoms of cough and cold in children aged 6-12 years
Dated this 22nd day of June 2011.
MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health.