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.
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
4-aminopyridine
Aconite
Adrenocortical hormones; except adrenal extract for dermal use containing 0.02% or less of ketosteroids
Alosetron
Amisulpride
Amprenavir
Androstanolone
Androstenediol
Androstenedione
Angiotensinamide
Antibiotic substances; except when specified elsewhere in the Schedule
Antihistamines; except when specified elsewhere in the Schedule
Artemether
Atamestane
Balsalazide
Benzodiazepines; except when specified in the Third Schedule to the Misuse of Drugs Act 1975
Benzoyl peroxide; except for external use in medicines containing 10% or less
Bismuth; except for external use in medicines containing 3% or less
Brinzolamide
Bromoform
Caramiphen
Carbazochrome
Catalin
Colchicum
Coumarin
Croton oil
Dehydrochlormethyltestosterone
Dexmedetomidine
Diethazine
Dinitrophenols
Emetine; in medicines containing more than 0.2%
Ephedrine
Esomeprazole
Etanercept
Exemestane
Ganirelix
Gatifloxacin
Hydrocyanic acid
Ipecacuanha; in medicines containing more than 0.2% of emetine
Lercanidipine
Levobupivacaine
Linezolid
Lumefantrine
Melengestrol
Metandienone
Methazolamide
Methoxamine; except for external use
Minoxidil; except for external use in medicines containing 5% or less
Moxifloxacin
19-norandrostenediol
19-norandrostenedione
Nateglinide
Nimesulide
Nitrous oxide
Oxaliplatin
Oxcarbazepine
Papaverine; for injection
Paraldehyde
Permethrin; in medicines containing more than 5%
Pioglitazone
Pirfenoxone
Pralidoxime
Prampine
Pregnenolone; except for external use
Propionbacterium acnes
Propyphenazone
Quebracho
Rapacuronium
Risendronic acid
Sabadilla
Savin oil
Sertindole
Sialoepoetin
Sirolimus
Sulfacetamide; except for ophthalmic use in medicines containing 10% or less
Tegafur
Tegaserod
Tenecteplase
Thiourea
Trastuzumab
Trenbolone
Trestolone
Tryptophan; in medicines containing more than 100 milligrams per recommended daily dose
Unoprostone
Uracil
Zaleplon
Schedule 2
Restricted Medicines
Inositol nicotinate
Metoclopramide; when compounded with paracetamol in packs of not more than 10 tablets or capsules for the treatment of nausea associated with migraine
Minoxidil; for external use in medicines containing 5% or less
Santonin
Sulfacetamide; for ophthalmic use in medicines containing 10% or less
Schedule 3
Pharmacy-only Medicines
Acetic acid (excluding its salts and derivatives) and preparations containing more than 80 per cent of acetic acid (CH3COOH)
Benzoyl peroxide; for external use in medicines containing more than 5% and not more than 10%
Etafedrine
8-hydroxyquinoline and its non-halogenated derivatives; except in medicines containing 1% or less of such substances
*Famotidine; in medicines which are sold in the manufacturer's original pack containing not more than 14 days' supply
Icodextrin
Injectable medicines; except when specified elsewhere in the Schedule; except for contrast media
Mercuric oxide; for ophthalmic use
Methoxamine; for external use in medicines containing more than 1%
Papaverine; except for injection
Phedrazine
*Ranitidine; in medicines which are sold in the manufacturer's original pack containing not more than 14 days' supply
Tymazoline
Zinc chloride; for external use in medicines containing more than 5%
Medicines for General Sale
The following medicines are no longer classified as prescription medicines, restricted medicines or pharmacy-only medicines. They are, therefore, now available for general sale.
Acetrizoate sodium
Alcohol, absolute
Amidotrizoic acid
Aminacrine
Bismuth; for external use in medicines containing 3% or less
Diatrizoic acid
Emetine; in medicines containing 0.2% or less
Gadodiomide
Gadopentetic acid
Gadoteric acid
Injectable medicines which are contrast media
Iodamide
Iodised oil
Iodixanol
Iodoxamic acid
Iohexol
Iomeprol
Iopamidol
Iopodic acid
Iopromide
Iopronic acid
Iothalamic acid
Iotrolan
Iotroxic acid
Ioversol
Ioxalgic acid
Ipecacuanha; in medicines containing 0.2% or less of emetine
Mangafodipir
Methoxamine; for external use in medicines containing 1% or less
Metrizamide
Metrizoic acid
Nicotine; in chewing gum or transdermal patches for smoking cessation
Permethrin; in medicines containing 5% or less
Piroxicam; for external use
Propyliodine
Tryptophan; in medicines containing 100 milligrams or less per recommended daily dose
Zinc chloride; for external use in medicines containing 5% or less
Dated this 14th day of August 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation.
*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.