How do you find using the New Zealand Gazette? Please give your feedback by completing this survey.

Notice Type
Departmental
Notice Title

Classification of Medicines

Pursuant to section 106(1) of the Medicines Act 1981,
I, Dr Stewart Jessamine, 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
5-aminolevulinic acid
Afamelanotide
Aflibercept
Amorolfine; except when specified elsewhere in this notice; except in preparations for the treatment of tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Apixaban
Asenapine
Azelastine; except when specified elsewhere in this notice
Belatacept
Belimumab
Boceprevir
Cabazitaxel
Catumaxomab
Ceftaroline fosamil
Cholera vaccine; except in the form of an oral liquid containing Vibrio cholerae when sold in a pharmacy by a registered pharmacist
Cyclizine; except when specified elsewhere in this notice
Clotrimazole; except in medicines for vaginal or external use
Dapagliflozin propanediol
Degarelix
Denosumab
Diclofenac; in preparations for the treatment of solar keratosis; except when specified elsewhere in this notice; except in preparations for external use other than for the treatment of solar keratosis
Dronedarone
Econazole; except in medicines for vaginal or dermal use
Eculizumab
Eribulin mesylate
Ferric carboxymaltose
Fingolimod
Follistatin
Guaiphenesin; for oral use in medicines containing more than 2% or 200 milligrams per dose form except when specified elsewhere in this notice; except for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 grams when sold in the manufacturer’s original pack containing not more than 10 days’ supply
Icatibant
Indacaterol
Influenza vaccine; except when administered to an adult
in a pharmacy by a registered pharmacist who has successfully completed the New Zealand Qualifications Authority approved vaccinator training course and who is complying with the immunisation standards of the Ministry of Health
Ingenol mebutate
Ipilimumab
Isoconazole; except in medicines for vaginal or dermal use
Linagliptin
Lixisenatide
Lovastatin; except when present as an unmodified, naturally occurring substance in a food that has not been subject to a manufacturing process other than heating, freezing, drying, preserving, bottling, canning, or packaging in retort pouches
Mercurochrome; except when specified elsewhere in this notice
Miconazole; except when specified elsewhere in this notice; except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Nitisinone
Nomegestrol
Nystatin; except when specified elsewhere in this notice; except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Ofatumumab
Omeprazole; except when specified elsewhere in this notice
Pantoprazole; except when specified elsewhere in this notice
Pitavastatin
Plerixafor
Prucalopride
Pseudoephedrine
Ranitidine; except when specified elsewhere in this notice; except in medicines containing 150 milligrams or less per dose unit when sold in the manufacturer’s original pack containing not more than 7 days’ supply
Remestemcel-L
Rifaximin
Rilpivirine
Rupatadine
Sapropterin
Tafluprost
Taliglucerase alfa
Telaprevir
Terbinafine; except in medicines for dermal use
Ticagrelor
Tioconazole; except in medicines for vaginal or dermal use
Tolvaptan
Trimethoprim; except in medicines for oral use containing 300 milligrams or less per dose unit when sold in a pack of 3 solid dosage units to a woman aged 16-65 years for the treatment of an uncomplicated urinary tract infection by a registered pharmacist who has successfully completed the New Zealand College of Pharmacists’ training in the treatment of urinary tract infections
Tuberculin
Velaglucerase alfa
Vemurafenib
Vorinostat
Schedule 2
Restricted Medicines
Brompheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of anxiety or insomnia; for oral use for the treatment of anxiety or insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
Chlorpheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of anxiety or insomnia; for oral use for the treatment of anxiety or insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
Cimetidine; in medicines for the symptomatic relief of heartburn, dyspepsia and hyperacidity or to be used on the recommendation of a registered medical practitioner that are sold in the manufacturer’s original pack containing not more than 14 days’ supply
Cyclizine; for oral use other than in medicines used for the treatment of anxiety or insomnia; for oral use for
the treatment of anxiety or insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
Dexchlorpheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of anxiety or insomnia; for oral use for the treatment of anxiety or insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
Diclofenac; in solid dose form in medicines containing
25 milligrams or less and more than 12.5 milligrams per dose form in packs containing not more than 30 tablets or capsules
Diphenhydramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of anxiety or insomnia; for oral use for the treatment of anxiety or insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
Doxylamine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of anxiety or insomnia; for oral use for
the treatment of anxiety or insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
Famciclovir; in divided solid dosage forms for oral use containing 500 milligrams or less for the treatment of recurrent herpes labialis when sold in the manufacturer’s original pack containing up to 3 dosage units
Guaiphenesin; for oral use in modified release form with
a maximum recommended daily dose of not more than 2.4 grams when sold in the manufacturer’s original pack containing more than 10 days’ supply but not more than 30 days’ supply
Lansoprazole; in divided solid dosage forms for oral use containing 15 milligrams or less with a maximum daily dose of 15 milligrams for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over or the relief of heartburn when sold in the manufacturer’s original pack containing not more than 14 dosage units
Meclozine; in a pack size of up to 10 dosage units for the treatment of anxiety or insomnia
Mepyramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of anxiety or insomnia; for oral use for
the treatment of anxiety or insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
Miconazole; for the treatment of oral candidiasis; for vaginal use
Nystatin; for the treatment of oral candidiasis; for vaginal use
Pheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of anxiety or insomnia; for oral use for
the treatment of anxiety or insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
Promethazine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of anxiety or insomnia; for oral use for the treatment of anxiety or insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
Trimeprazine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for the treatment of anxiety or insomnia; for oral use for the treatment of anxiety or insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units
Schedule 3
Pharmacy-only Medicines
Amorolfine; in preparations for topical use except in preparations for the treatment of tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Azelastine; for nasal use; in topical eye preparations containing 0.05% or less
Beclomethasone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age in aqueous nasal sprays delivering up to 50 micrograms per actuation when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril) in a pack containing 200 actuations or less
Budesonide; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age in aqueous nasal sprays delivering up to 50 micrograms per actuation and when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril) in a pack containing 200 actuations or less
Cetirizine; for oral use except in divided solid dosage forms for oral use containing 10 milligrams or less of cetirizine hydrochloride per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer’s original pack containing not more than 5 days’ supply
Ciclopirox; for external use in medicines containing 2% or less except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Clotrimazole; for external use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
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
Econazole; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Famotidine; for the symptomatic relief of heartburn, dyspepsia and hyperacidity or to be used on the recommendation of a registered medical practitioner when sold in the manufacturer’s original pack containing not more than 14 days’ supply
Fexofenadine; for oral use except for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in capsules containing
60 milligrams or less of fexofenadine hydrochloride or
in tablets containing 120 milligrams or less of fexofenadine hydrochloride with a maximum daily dose of 120 milligrams when sold in the manufacturer’s original pack containing 10 dosage units or less and not more than 5 days’ supply
Fluticasone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age when in aqueous nasal sprays delivering up to 50 micrograms per actuation with a maximum recommended daily
dose of 200 micrograms (as a single dose) in a pack containing 200 actuations or less
Ibuprofen; for oral use in liquid form with a recommended daily dose of not more than 1.2 grams for the relief of pain and reduction of fever or inflammation when sold in the manufacturer’s original pack containing not more than 8 grams; for oral use in solid dose form containing not more than 200 milligrams per dose form and with a recommended daily dose of not more than 1.2 grams when sold in the manufacturer’s original pack containing not more than 100 dose units; except in divided solid dosage forms for oral use containing 200 milligrams or less per dose form with a recommended daily dose of
not more than 1.2 grams and when sold in the manufacturer’s original pack containing not more than 25 dose units
Isoconazole; for dermal use except when sold in practice by a podiatrist registered with the Podiatrists Board
Ketoconazole; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board; except in medicines for treatment of the scalp containing 1% or less
Loratadine; for oral use except in divided solid dosage forms for oral use containing 10 milligrams or less per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer’s original pack containing not more than 5 days’ supply
Mercurochrome; in preparations for external use containing 2% or less
Miconazole; for external use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Mometasone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age in aqueous nasal sprays delivering up to 50 micrograms per actuation when the maximum recommended daily dose is no greater than 200 micrograms (as a single dose) in a pack containing 200 actuations or less
Nizatidine; in medicines for the symptomatic relief of heartburn, dyspepsia and hyperacidity or to be used on the recommendation of a registered medical practitioner when sold in the manufacturer’s original pack containing not more than 14 days’ supply
Nystatin; for dermal use except when sold in practice by a podiatrist registered with the Podiatrists Board
Omeprazole; in divided solid dosage forms for oral use containing 20 milligrams or less with a maximum daily dose of 20 milligrams for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over when sold in the manufacturer’s original pack containing not more than 28 dosage units
Pantoprazole; in divided solid dosage forms for oral use containing 20 milligrams or less with a maximum daily dose of 20 milligrams for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over when sold in the manufacturer’s original pack containing not more than 28 dosage units
Ranitidine; in medicines for the symptomatic relief of heartburn, dyspepsia and hyperacidity or to be used on the recommendation of a registered medical practitioner when sold in the manufacturer’s original pack containing not more than 14 days’ supply; except in medicines containing 150 milligrams or less per dose unit when sold in the manufacturer’s original pack containing not more than 7 days’ supply
Terbinafine; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Tioconazole; for dermal use except in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Medicines for General Sale
Please note that the following medicines are now available for general sale.
Amorolfine; in preparations for the treatment of tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
C1 esterase inhibitors
Cetirizine; in divided solid dosage forms for oral use containing 10 milligrams or less of cetirizine hydrochloride per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer’s original pack containing not more than 5 days’ supply
Ciclopirox; for external use in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Clotrimazole; for external use in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Diclofenac; in preparations for external use other than for the treatment of solar keratosis
Econazole; for dermal use in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Factor VIII inhibitor bypassing fraction
Fexofenadine; for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over
when in capsules containing 60 milligrams or less of fexofenadine hydrochloride or in tablets containing 120 milligrams or less of fexofenadine hydrochloride with a maximum daily dose of 120 milligrams when sold in the manufacturer’s original pack containing 10 dosage units or less and not more than 5 days’ supply
Guaiphenesin; for oral use in medicines containing 2% or less or 200 milligrams or less per dose form; for oral use in modified release form with a maximum recommended daily dose of not more than 2.4 grams when sold in the manufacturer’s original pack containing not more than 10 days’ supply
Human protein C
Ibuprofen; for external use; in divided solid dosage forms for oral use containing 200 milligrams or less per dose form with a recommended daily dose of not more than 1.2 grams and when sold in the manufacturer’s original pack containing not more than 25 dose units per pack
Isoconazole; for dermal use when sold in practice by a podiatrist registered with the Podiatrists Board
Ketoconazole; for dermal use in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board; in medicines for treatment of the scalp containing 1% or less
Loratadine; in divided solid dosage forms for oral use containing 10 milligrams or less per dose form for the treatment of seasonal allergic rhinitis when sold in
the manufacturer’s original pack containing not more than 5 days’ supply
Miconazole; for external use in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Nystatin; for dermal use when sold in practice by a podiatrist registered with the Podiatrists Board
Ranitidine; in medicines containing 150 milligrams or less per dose unit when sold in the manufacturer’s original pack containing not more than 7 days’ supply
Terbinafine; for dermal use in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Tioconazole; for dermal use in medicines for tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Dated this 13th day of December 2012.
DR STEWART JESSAMINE, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health.