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 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 or the concentration of the total active principles 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
Acepromazine
Adenosine; for injection
Amethocaine; for internal use; for external use in medicines containing more than 10%; for ophthalmic use except when used in practice by a registered optometrist
Amylocaine
Aristolochic acid; at all strengths
Atomoxetine
Atropa belladonna; except when specified elsewhere in the Schedule
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 100 micrograms or less per litre or per kilogram
Atropine methonitrate
Benorylate
Benzocaine; for internal use; for external use in medicines containing more than 10%
Benzydamine; for internal use
Bexarotene
Butacaine
Butyl aminobenzoate; except in medicines for dermal use containing 2% or less
Cinchocaine; for ophthalmic use; for external use in medicines containing more than 0.5%
Clindamycin
Colestyramine
Darbepoetin
Datura spp; except for oral use when specified elsewhere in the Schedule; except in datura stramonium or datura tatula for smoking or burning
Dextrorphan
Dicyclomine
Digoxin-specific antibody fragment
Diperodon
Drotrecogin
Duboisia leichhardtii; except when specified elsewhere in the Schedule
Duboisia myoporides; except when specified elsewhere in the Schedule
Etidocaine
Ezetimibe
Folic acid; for injection
Folinic acid; for injection
Glatiramer acetate
Guaiphenesin; except for oral use in medicines containing 2% or less or 200 milligrams or less
Homatropine
Hyoscine; except when specified elsewhere in the Schedule
Hyoscine butylbromide; except when specified elsewhere in the Schedule
Hyoscyamine; except when specified elsewhere in the Schedule
Hyoscyamus niger; except when specified elsewhere in the Schedule
Hypromellose; for injection
Insulins
Levetiracetam
Levosimendan
Lignocaine; for oral use except in throat lozenges containing 30 milligrams or less per dose form; for ophthalmic use except when used in practice by a registered optometrist; for injection except when used as a local anaesthetic in practice by a registered nurse or podiatrist or by a dental therapist; for external use in medicines containing more than 10%
Nicoumalone
Nitrofurazone
Nux vomica
Podophyllum emodi; for internal use; for external use for the treatment of anogenital warts; for other external use in medicines containing more than 20% of podophyllin
Podophyllum peltatum; for internal use; for external use for the treatment of anogenital warts; for other external use in medicines containing more than 20% of podophyllin
Podophyllotoxin; for internal use; for external use for the treatment of anogenital warts; for other external use in medicines containing more than 1%
Pramocaine
Pregnenolone
Prilocaine; for injection except when used as a local anaesthetic by a dental therapist; except when specified elsewhere in the Schedule
Propantheline
Protamine sulfate
Quinisocaine
Sabadilla; except when specified elsewhere in the Schedule
Strychnos spp
Thiomesterone
Vardenafil
Schedule 2
Restricted Medicines
Erythryl tetranitrate
Hyoscine butylbromide; for oral use in medicines containing not more than 10 milligrams per dose form and in packs containing not more than 20 tablets or capsules
Mannityl hexanitrate
Podophyllum emodi; for external use for the treatment of warts other than anogenital warts in medicines containing 20% or less and more than 10% of podophyllin
Podophyllum peltatum; for external use for the treatment of warts other than anogenital warts in medicines containing 20% or less and more than 10% of podophyllin
Podophyllotoxin; for external use for the treatment of warts other than anogenital warts in medicines containing 1% or less and more than 0.5%
Prochlorperazine; in packs containing not more than
10 tablets for the treatment of nausea associated with migraine or, when sold by pharmacists or nurses accredited to sell levonorgestrel for emergency contraception, for the treatment of nausea associated with emergency contraception
Salicylic acid; in medicines containing more than 40%
Silver sulfadiazine; except for external use in packs containing 50 grams or less
Schedule 3
Pharmacy-only Medicines
Aciclovir; for external use for the treatment of herpes labialis except in medicines containing 5% or less and in tubes containing 3 grams or less
Amethocaine; for external use in medicines containing
10% or less and more than 2%
Atropa belladonna; for external use in medicines containing 0.03% of the alkaloids of belladonna; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than
1.2 milligrams per recommended daily dose of the alkaloids of belladonna or in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of the alkaloids of belladonna
Atropine; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and
not more than 1.2 milligrams per recommended daily dose or in solid dose form in medicines containing
0.3 milligrams or less per dose form and not more
than 1.2 milligrams per recommended daily dose; in medicines containing atropine sulfate for the treatment of organophosphorus poisoning either in packs of up
to 20 tablets containing 0.6 milligrams or less per
tablet or in injections in packs of 5 or less containing
0.6 milligrams per millilitre or less; except when used as an antidote in a device designed for self-injection; except when sold by licencees under the Toxic Substances Regulations
Benzocaine; for external use in medicines containing 10% or less and more than 2%
Benzydamine; for external use
Bifonazole; for external use except in medicines for tinea pedis only or in shampoos containing 1% or less
Cinchocaine; for external use in medicines containing 0.5% or less
Datura spp; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids or in solid
dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids
Duboisia leichhardtii; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids or in solid
dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids
Duboisia myoporides; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids or in solid dose form in medicines containing 0.3 milligrams or less
per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids
Folic acid; in medicines containing more than 500 micrograms per recommended daily dose
Folinic acid; in medicines containing more than 500 micrograms per recommended daily dose
Hyoscine; for transdermal use in medicines containing
2 milligrams or less of total solanaceous alkaloids per dose unit; for oral use in liquid form in medicines containing 0.03% and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose or in solid dose form in medicines containing 0.3 milligrams or less per dose unit and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids
Hyoscyamine; for external use in medicines containing
0.03% or less of total solanaceous alkaloids; for oral
use in liquid form in medicines containing 0.03% and 0.3 milligrams or less per dose and not more than
1.2 milligrams per recommended daily dose or in solid dose form in medicines containing 0.3 milligrams or less per dose unit and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids
Hyoscyamus niger; for oral use in liquid form in medicines containing 0.03% and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids or in solid
dose form in medicines containing 0.3 milligrams or less per dose unit and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids
*Ibuprofen; for external use; for oral use in either liquid form in packs containing not more than 4 grams or in solid dose form containing not more than 200 milligrams per dose form and when in medicines which have received the consent of the Minister or the Director-General to their sale as pharmacy-only medicines and which are sold in the manufacturer's original pack
Lignocaine; for external use in medicines containing 10% or less and more than 2%; for urethral use
Minoxidil; for external use in medicines containing 5% or less
Nystatin: for dermal use
Podophyllum emodi; for external use for the treatment
of warts other than anogenital warts in medicines containing 10% or less of podophyllin
Podophyllum peltatum; for external use for the treatment
of warts other than anogenital warts in medicines containing 10% or less of podophyllin
Podophyllotoxin; for external use for the treatment of warts other than anogenital warts in medicines containing 0.5% or less
Potassium chlorate; except in medicines containing 10% or less
Prilocaine; for dermal use in medicines containing 10% or less
Pyrithione zinc; for external use in medicines containing more than 2%
Sabadilla; in packs containing 18 milligrams or less of
total alkaloids except in packs containing 1.8 milligrams or less and a recommended daily dose of not more than 0.6 milligrams of total alkaloids
Silver; except in oral solutions containing 0.3% or less or other medicines containing 1% or less
Silver sulfadiazine; for external use in packs containing
50 grams or less
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.
Aciclovir; for external use for the treatment of herpes labialis in medicines containing 5% or less and tubes containing 3 grams or less
Bamyphylline
Benzamine
Benzyl benzoate
Bifonazole; for external use in medicines for tinea pedis only or in shampoos containing 1% or less
Butyl aminobenzoate; in medicines for dermal use containing 2% or less
Dichlofenthion
Diprophylline
Folic acid; in medicines containing 500 micrograms or less per recommended daily dose
Folinic acid; in medicines containing 500 micrograms or less per recommended daily dose
Gadobutrol
Guaiphenesin; for oral use in medicines containing 2% or less or 200 milligrams or less
Mandelic acid
Monosulfiram
Reproterol
Sabadilla; in packs containing 1.8 milligrams or less with a recommended daily dose of not more than 0.6 milligrams of total alkaloids
Salicylic acid; in medicines containing 40% or less
Silver; in oral solutions containing 0.3% or less or other medicines containing 1% or less
Terebene
Tetrastarch
Dated this 21st day of January 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).
*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.