Pursuant to section 106 (1) of the Medicines Act 1981,
I, G. R. Boyd, Chief Advisor, Public Health Directorate, 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 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 also applies:
(i) in the case of medicines which are injections or eye preparations, to any concentration of that medicine.
(ii) in the case of medicines which are not injections or eye preparations, when 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
Acamprosate
Acetylcysteine; for injection or inhalation
Aconite; except when specified elsewhere in the Schedule
Adiphenine
Agalsidase alfa
Alcohol; for injection in medicines containing more than 20%
Ambucetamide
Ambutonium
Anakinra
Benzilonium
Caspofungin
Clidinium
Cyclizine; for injection
Dienogest
Drospirenone
Ertapenem
Fluorescein; for injection
Glyceryl trinitrate; for injection; for transdermal use; except in medicines containing 100 micrograms or less per litre or per kilogram
Hexocyclium
Hyaluronic acid; for injection
Hydrocyanic acid; except when specified elsewhere in the Schedule; except in medicines containing 1 microgram or less per litre or per kilogram
Isoetarine
Isoprenaline
Isosorbide dinitrate; except for oral use in medicines containing 10 milligrams or less per dose form
Isosorbide mononitrate
Lanreotide
Levonorgestrel; except when used for emergency contraception and when sold by registered nurses or pharmacists recognised by their respective professional bodies as having competency in the field of sexual and reproductive health
Loperamide; in packs containing more than 20 tablets or capsules
Mepenzolate
Methanthelinium
Modafinil
Octatropine
Oxybutynin
Oxyphencyclimine
Oxyphenonium
Penthienate
Phenthimentonium
Pipenzolate
Piperidolate
Piracetam
Promethazine; for injection
Rimiterol
Rifapentine
Salbutamol; for oral use
Salcatonin
Tasonermin
Terbutaline; for oral use
Tiemonium
Tigloidine
Tiotropium
Tricyclamol
Tridihexethyl
Trometamol; for injection in medicines containing more than 3%
Verteporfin
Voriconazole
Zoledronic acid
Schedule 2
Restricted Medicines
*Triamcinolone; in aqueous nasal sprays delivering up
to 55 micrograms per actuation when the maximum recommended daily dose is no greater than 220 micrograms and the medicine has received the consent of the Minister or the Director-General to its distribution as a restricted medicine.
Schedule 3
Pharmacy-only Medicines
Acetylcysteine; for oral use
Aconite; for oral use in packs containing 0.2 milligrams or less and more than 0.02 milligrams of total alkaloids; for dermal use in concentrations of 0.02% or less and in packs containing not more than 0.2 milligrams of total alkaloids.
Cyclizine; except for injection
Glyceryl trinitrate; for oral or rectal use; except in medicines containing 100 micrograms or less per litre or per kilogram
Hydrocyanic acid; for oral use in packs containing
5 milligrams or less and more than 0.5 milligrams; except in medicines containing 1 microgram or less per litre or per kilogram
Injectable medicines; except when specified elsewhere in this Schedule; except Factor VIII; except for contrast media, parenteral nutrition replacement preparations or plasma volume expanders
Isosorbide dinitrate; for oral use in medicines containing
10 milligrams or less per dose form
Lithium; for dermal use in medicines containing 1% or less and more than 0.01%
Loperamide; in packs containing not more than 20 tablets or capsules
Pseudoephedrine; in cough or decongestant medicines containing not more than 240 milligrams per recommended daily dose either: in slow release preparations; or in liquid preparations containing not more than 60 milligrams per recommended dose; or when compounded with other active ingredients; or in solid dose form with no other active ingredients and containing not more than 60 milligrams per recommended dose and in packs containing not more than 30 dose units.
Medicines for General Sale
Please note that the following medicines are no longer classified as prescription medicines, restricted medicines or pharmacy-only medicines. As such, they are now available for general sale.
Acetylcysteine; for external use
Aconite; for oral use in packs containing 0.02 milligrams or less of total alkaloids; for dermal use in concentrations of 0.02% or less and in packs containing not more than 0.02 milligrams of total alkaloids
Alcohol; except for injection in medicines containing more than 20%
Factor VIII
Fluorescein; except for injection
Hyaluronic acid; except for injection
Hydrocyanic acid; for oral use in packs containing
0.5 milligrams or less; in medicines containing
1 microgram or less per litre or per kilogram
Injectable medicines which contain Factor VIII or which are parenteral nutrition replacement preparations, plasma volume expanders or contrast media
Lithium; for dermal use in medicines containing 0.01% or less
Trichloroacetic acid
Trometamol; except for injection in medicines containing more than 3%
Dated this 29th day of September 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).
*Regulation 20 of the Medicines Regulations 1984 requires that all medicines sold without a practitioner's prescription must include a consumer information panel on the label. Further, all material changes to a medicine (including changes to labelling), must be notified to the
Director-General of Health in accordance with section 24 of the Medicines Act 1981.