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
Abrus precatorius; at all strengths
Acamprosate
Acetylcholine; except in medicines containing 1 milligram or less per litre or per kilogram
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%
Aldosterone; except in medicines containing 10 micrograms or less per litre or per kilogram
Allylisopropylacetylurea; at all strengths
Ambucetamide
Ambutonium
Aminophenazone; at all strengths
Aminophylline; except in liquid form for oral use in medicines containing 2% or less
Anakinra
Anchusa officinalis; at all strengths
Antimony; except in medicines containing 1 milligram or less per litre or per kilogram
Apomorphine; except in medicines containing 1 milligram or less per litre or per kilogram
Aristolochia spp; at all strengths
Arsenic; except in medicines containing 1 milligram or less per litre or per kilogram
Atropine; for ophthalmic use; for injection except when used as an antidote in a device designed for self-injection; except in medicines containing 100 micrograms or less per litre or per kilogram
Benzilonium
Bithionol; at all strengths
Buclosamide; at all strengths
Buniodyl sodium; at all strengths
Cacalia spp; at all strengths
Caspofungin
Clidinium
Clioquinol; at all strengths
Colecalciferol; in medicines for internal use containing more than 25 micrograms per recommended daily dose except in parenteral nutrition replacement preparations
Coniine; at all strengths
Cotarnine; at all strengths
Crotalaria spp; at all strengths
Croton tiglium; except in medicines containing 1 milligram or less per litre or per kilogram
Cyclizine; for injection
Cynoglossum spp; at all strengths
Desloratadine; except for oral use
Dienogest
Drospirenone
Dulcin; at all strengths
Ertapenem
Erysimum; except in medicines containing 1 milligram or less per litre or per kilogram
Ethylhexanediol; at all strengths
Etofenamate; except for external use
Farfugium japonicum; at all strengths
Fluorescein; for injection
Fluorides; for internal use in medicines containing more than 2.2 milligrams per dose form except in parenteral nutrition replacement preparations; for external use
in medicines containing more than 2.5% of elemental fluorine
Follicle stimulating hormone; except in medicines containing 100 micrograms or less per litre or per kilogram
Gemifloxacin
Glyceryl trinitrate; for injection; for transdermal use; except in medicines containing 100 micrograms or less per litre or per kilogram
Haloperidol; except in medicines containing 1 milligram or less per litre or per kilogram
Heliotropium spp; at all strengths
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
Indomethacin; except for external use in medicines containing 1% or less; except in medicines containing
1 milligram or less per litre or per kilogram
Iron; for injection except in parenteral nutrition replacement preparations
Isoetarine
Isoprenaline
Isopropamide; except for dermal use in preparations containing 2% or less
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
Ligularia dentata; at all strengths
Loperamide; in packs containing more than 20 tablets or capsules
Lopinavir
Mepenzolate
Methanthelinium
Methylene blue; for injection
Mifepristone
Modafinil
Octatropine
Oestradiol; except in medicines containing 10 micrograms or less per litre or per kilogram
Oestrone; except in medicines containing 1 milligram or less per litre or per kilogram
Omalizumab
Oxybutynin
Oxyphencyclimine
Oxyphenisatin; at all strengths
Oxyphenonium
Oxytocin; except in medicines containing 1 microgram or less per litre or per kilogram
Phenolphthalein
Penthienate
Phenthimentonium
Pipenzolate
Piperidolate
Piracetam
Podophyllum; in medicines containing more than 20%; except in medicines containing 1 milligram or less per litre or per kilogram
Progesterone; except in medicines containing 1 milligram or less per litre or per kilogram
Promethazine; for injection
Propranolol; except in medicines containing 1 milligram or less per litre or per kilogram
Pulmonaria spp; at all strengths
Rimiterol
Rifapentine
Safrole; for internal use except in preparations containing 0.1% or less
Salbutamol; for oral use
Salcatonin
Sibutramine
Silicones; for injection at all strengths
Tasonermin
Telithromycin
Terbutaline; for oral use
Testosterone; except in medicines containing 1 milligram or less per litre or per kilogram
Theophylline; except in liquid form for oral use in medicines containing 2% or less
Thyroxine; except in medicines containing 10 micrograms or less per litre or per kilogram
Tiemonium
Tigloidine
Tiotropium
Trichodesma africana; at all strengths
Tricyclamol
Tridihexethyl
Triparanol; at all strengths
Trometamol; for injection in medicines containing more than 3%
Tryptophan; in medicines containing more than 100 milligrams per recommended daily dose except in parenteral nutrition replacement preparations
Verteporfin
Vitamin A; in preparations containing more than 3000 micrograms of retinol equivalents per recommended daily dose except in parenteral nutrition replacement preparations
Vitamin D; in medicines for internal use containing more than 25 mcg per recommended daily dose except in parenteral nutrition replacement preparations
Voriconazole
Zinc: for internal use in medicines containing more than
25 milligrams per recommended daily dose except in parenteral nutrition preparations
Zoledronic acid.
Schedule 2
Restricted Medicines
Aminophylline; in liquid form for oral use in medicines containing 2% or less
Atropine; in liquid form for oral use; in solid dose form containing more than 0.3 milligrams per dose or more than 1 milligram per recommended daily dose; except in medicines containing 100 micrograms or less per litre or per kilogram
Glucagon; except in medicines containing 100 micrograms or less per litre or per kilogram
Hydrocortisone and hydrocortisone acetate but no other esters of hydrocortisone; for dermal use in medicines containing 1% or less but more than 0.5% by weight of hydrocortisone base with no other active ingredient except an antifungal and in a quantity of 30 grams or less or 30 millilitres or less per container
Macrogols; in oral preparations for bowel cleansing prior to diagnostic, medical or surgical procedures
Nicotine; in lozenges except when sold from a smoking cessation clinic run under the auspices of a registered medical practitioner, nurse, pharmacist or psychologist
Oxiconazole; for vaginal use
Podophyllum; in medicines containing 20% or less; except in medicines containing 1 milligram or less per litre or per kilogram
Strychnine; except in medicines containing 1 milligram or less per litre or per kilogram
Theophylline; in liquid form for oral use in medicines containing 2% or less
Triamcinolone*; in aqueous nasal sprays delivering up
to 55 micrograms peractuation 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
Atropine; in solid dose form containing 0.3 milligrams or less per dose and 1 milligram or less per recommended daily dose; except in medicines containing 100 micrograms or less per litre or per kilogram; except when used as an antidote in a device designed for self-injection; except when sold by licensees under the Toxic Substances Regulations
Cyclizine; except for injection
Desloratadine; for oral use
Dibromopropamidine; for ophthalmic use
Etofenamate; for external use
Fluorides; for internal use in medicines containing 2.2 milligrams or less per dose form except in parenteral nutrition replacement preparations; for external use in medicines containing 2.5% or less but more than
0.1% of elemental fluorine
Folic acid; in medicines containing more than 500 micrograms per recommended daily dose except in parenteral nutrition replacement preparations
Formaldehyde; in medicines containing more than 5%
Gelsemium; except in medicines containing 1 milligram or less per litre or per kilogram
Glyceryl trinitrate; for oral or rectal use; except in medicines containing 100 micrograms or less per litre or per kilogram
Hydrocortisone and hydrocortisone acetate but no other esters of hydrocortisone; for dermal use in medicines containing 0.5% or less by weight of hydrocortisone base with no other active ingredient except an antifungal and in a quantity of 30 grams or less or 30 milliltres or less per container
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
Indomethacin; for external use in medicines containing
1% or less; except in medicines containing 1 milligram 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
Isopropamide; for dermal use in preparations containing
2% or less
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
Paraformaldehyde; in medicines containing more than 5%
Potassium; except when specified elsewhere in the schedule; for internal use in slow release or enteric coated forms; in medicines containing more than 100 milligrams
per recommended dose except in medicines for oral rehydration therapy , parenteral nutrition replacement or dialysis
Propamidine; for ophthalmic use
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
Staphisagria; except in medicines containing 0.2% or less
Zinc chloride; for dermal use in medicines containing more than 5%.
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.
Acetomenaphthone
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%
Bentiromide
Bromelains
Broxaldine
Broxyquinoline
Calcium hypochlorite
Calcium salicylate
Camphor, ammoniated
Capsicum oleo-resin
Chromium oxide
Colecalciferol; in medicines for internal use containing
25 micrograms or lessper recommended daily dose; in parenteral nutrition replacement preparations
Copper
Cyanocobalamin
Deoxyribonuclease; for external use
Dextranomer
Dextrans
Diamthazole
Dibromopropamidine; except for ophthalmic use
Factor VIII
Fluorescein; except for injection
Fluorides; in parenteral nutrition replacement preparations; for external use in medicines containing 0.1% of elemental fluorine
Folic acid; in medicines containing 500 micrograms or less per recommended daily dose; in parenteral nutrition replacement preparations
Formic acid
Hetastarch
Hexamidine
Hippuric acid
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
Hydrogen peroxide
Hydroiodic acid
Hydroxocobalamin
Ichthammol
Injectable medicines which contain Factor VIII or which are parenteralnutrition replacement preparations, plasma volume expanders or contrast media
Iodic acid
Iron; in medicines containing 24 milligrams or less
per recommended daily dose; in parenteral nutrition replacement preparations
Irrigation medicines
Isopropyl alcohol
Jaborandi
Krameria,
Lithium; for dermal use in medicines containing 0.01% or less
Magenta
Menadiol
Methylene blue; except for injection.
Monoacetin
Nitrous ether spirit
Oxerutins
Pentastarch
Phenoxyethanol
Phytomenadione
Picric acid
Piroctone
Polygeline
Potassium; for external use; for internal use except
when specified in the First Schedule to the Medicines Regulations 1984 or amendments; for oral rehydration therapy, parenteral nutrition replacement or dialysis
Propamidine; except for ophthalmic use
Ribonuclease
Salsalate
Scillarins
Sodium hydroxide
Sodium iodide
Sodium salicylate
Solcoseryl
Stannous chloride
Stannous oxide
Staphisagria; in medicines containing 0.2% or less
Sucralfate
Tannic acid
Theobromine
Thiomersal
Thioxolone
Trichloroacetic acid
Trometamol; except for injection in medicines containing more than 3%
Tryptophan; in medicines containing 100 milligrams or
less per recommended daily dose; in parenteral nutrition replacement preparations
Vitamin A; in preparations containing 3000 micrograms or less of retinol equivalents per recommended daily dose; in parenteral nutrition replacement preparations
Vitamin D; in medicines for internal use containing more than 25 micrograms per recommended daily dose except in parenteral nutrition replacement preparations
Zinc: for external use except zinc chloride in medicines containing more than 5%; for internal use in
medicines containing 25 milligrams or less per recommended daily dose or in parenteral nutrition preparations.
Dated this 4th day of March 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on 20 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.