Notice Type
Departmental
Notice Title

Classification of Medicines

Pursuant to section 106 (1) of the Medicines Act 1981,
I, G. R. Boyd, Chief Advisor, Safety and Regulation, 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 an injection or eye preparation, to any concentration of that medicine; and
(ii) if the medicine is not 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
Adalimumab
Alefacept
Atropa belladonna; except when specified elsewhere in
the Schedule; except in medicines containing 300 micrograms or less of total solanaceous alkaloids per litre or per kilogram
Atropine; except when specified elsewhere in the Schedule; except when used as an antidote in a device designed
for self-injection; except in medicines containing 300 micrograms or less per litre or per kilogram
Ephedra
Epoetins
Gefitinib
Glyceryl trinitrate; for injection; for transdermal use; except in medicines containing 100 micrograms or less per litre or per kilogram
Hyaluronic acid; for injection except in intraocular viscoelastic products
Hyoscine; except when specified elsewhere in the Schedule; except in medicines containing 300 micrograms or less per litre or per kilogram
Hyoscyamine; except when specified elsewhere in the Schedule; except in medicines containing 300 micrograms or less per litre or per kilogram
Hyoscyamus niger; except when specified elsewhere in the Schedule; except in medicines containing 300 micrograms or less of total solanaceous alkaloids per litre or per kilogram
Hypromellose; for injection except in intraocular viscoelastic products
Ibritumomab tiuxetan
Memantine
Poractant alfa
Prochlorperazine; except when specified elsewhere in the Schedule; except when sold for the treatment of nausea associated with emergency contraception by pharmacists or nurses accredited to sell levonorgestrel for emergency contraception
Sodium picosulfate; in oral laxative preparations
Thiourea; except in medicines containing 0.1% or less
Schedule 2
Restricted Medicines
Diclofenac; in solid dose form containing 25 milligrams or less and more than 12.5 milligrams per dose form in packs of not more than 30 tablets or capsules
Glyceryl trinitrate; for oral or sublingual use
Isosorbide dinitrate; for oral use in medicines containing
10 milligrams or less per dose form
Prochlorperazine; in packs containing not more than
10 tablets for the treatment of nausea associated with migraine
Sodium picosulfate; in preparations for bowel cleansing prior to diagnostic, medical or surgical procedures
Schedule 3
Pharmacy-only Medicines
Diclofenac; in solid dose form containing 12.5 milligrams or less per dose form in packs of not more than 20 tablets or capsules
Flurbiprofen; in throat lozenges containing 10 milligrams or less per lozenge
Glyceryl trinitrate; for external use; except in medicines containing 100 micrograms or less per litre or per kilogram
Injectable medicines; except when specified elsewhere in the Schedule; except for Factor VIII; except for contrast media, parenteral nutrition replacement preparations, plasma volume expanders or intraocular viscoelastic preparations
Nicotine; for inhalation except when sold from a smoking cessation clinic run under the auspices of a registered medical practitioner, nurse, pharmacist or psychologist
Medicines for General Sale
Please note that the following medicine is no longer classified as a prescription medicine, restricted medicine or
pharmacy-only medicine. As such, it is now available for general sale.
Gadobenic acid
Dated this 10th day of February 2003.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health of the 20th day of February 1997).