Pursuant to section 106 (1) of the Medicines Act 1981,
I, Don Matheson, Deputy Director?General, 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 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 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
Adalimumab
Adefovir
Adenosine; for injection
Alefacept
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
Amygdalin; at all strengths
Amylocaine
Aprepitant
Aripiprazole
Aristolochic acid; at all strengths
Articaine
Atazanavir
Atomoxetine
Atropa belladonna; except when specified elsewhere in the Shedule; 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
Atropine methonitrate
Benorylate
Benzocaine; for internal use; for external use in medicines containing more than 10%
Benzydamine; for internal use
Bevacizumab
Bexarotene
Bortezomib
Bosentan
Butacaine
Butyl aminobenzoate; except in medicines for dermal use containing 2% or less
Carbetocin
Ciclesonide
Cinacalcet
Cinchocaine; for ophthalmic use; for external use in medicines containing more than 0.5%
Clindamycin
Colestyramine
Collagen; in injections or implantations for tissue augmentation or cosmetic use
Darbepoetin
Datura spp; except for oral use when specified elsewhere in the Schedule; except in datura stramonium or datura tatula for smoking or burning
Deferiprone
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
Duloxetine
Efalizumab
Emtricitabine
Enfuvirtide
Eplerenone
Epinastine
Epoetins
Etidocaine
Everolimus
Ezetimibe
Felypressin; except when combined with a local anaesthetic and when used in practice by a registered dental therapist
Fenofibrate
Fluorides; except when specified elsewhere in the Schedule; except in parenteral nutrition replacement preparations; for external use in medicines other than pastes, gels or powders for cleaning the teeth containing more than 2.5% except when used in practice by a registered dental therapist; except in medicines containing 15 milligrams or less per litre or per kilogram
Folic acid; for injection
Folinic acid; for injection
Fulvestrant
Gefitinib
Glatiramer acetate
Glyceryl trinitrate; for injection; for transdermal use; except in medicines containing 100 micrograms or less per litre or per kilogram
Guaiphenesin; except for oral use in medicines containing 2% or less or 200 milligrams or less
Haemophilus influenzae vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds
Homatropine
Human protein C
Hyaluronic acid; in injections or implantations for tissue augmentation or cosmetic use
Hydroquinone; except in medicines for external use containing 2% or less
Hylan polymer; in injections or implantations for tissue augmentation or cosmetic use
Hyoscine; except when specified elsewhere in the Schedule; except in medicines containing 300 micrograms or less per litre or per kilogram
Hyoscine butylbromide; except when specified elsewhere in the Schedule
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
Insulins
Isosorbide dinitrate
Ketotifen; except for ophthalmic use in medicines containing 0.025% or less
Laronidase?rch
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 in practice as a local anaesthetic by a nurse whose scope of practice permits the performance of general nursing functions or by a registered podiatrist or dental therapist; for external use in medicines containing more than 10%
Lumiracoxib
Melagatran
Memantine
Methyl mercury; except in medicines containing 300 micrograms of methyl mercury per litre or per kilogram
Mitragyna speciosa
Mitragynine
Nicoumalone
Nitrofurazone
Norelgestromin
Nux vomica
Orlistat; except in medicines containing 120 milligrams or less per dose form
Oxedrine; in medicines containing more than 30 milligrams per recommended daily dose
Palonosetron
Pegfilgrastim
Pemetrexed
Piridoxine; in medicines containing more than 200 milligrams per recommended daily dose
Pneumococcal vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds
Podophyllotoxin; for internal use; for external use for the treatment of anogenital warts; for other external use in medicines containing more than 1%
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
Polyacrilamide; in injections or implantations for tissue augmentation or cosmetic use
Polylactic acid; in injections or implantations for tissue augmentation or cosmetic use
Poractant alfa
Pramocaine
Pregabalin
Pregnenolone
Prilocaine; for injection except when used as a local anaesthetic by a registered dental therapist; except when specified elsewhere in the Schedule
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
Propantheline
Protamine sulfate
Quinisocaine
Sabadilla; except when specified elsewhere in the Schedule
Sevelamer
Strontium ranelate
Strychnos spp
Tenofovir
Terlipressin
Thiomesterone
Thiourea; except in medicines containing 0.1% or less
Treprostinil
Trichloroacetic acid; except for external use in medicines containing 12.5% or less for the treatment of warts other than anogenital warts
Vardenafil
Ximelagatran
Schedule 2
Restricted Medicines
Ciclopirox; for dermal use in medicines containing more than 2%
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
Erythryl tetranitrate
*Fluconazole; for oral use in medicines which have received the consent of the Minister or the Director?General to their distribution as restricted medicines and are sold
in the manufacturer’s original pack containing 150 milligrams or less as a single dose for the treatment of vaginal candidiasis
Fluorides; in pastes, gels or powders for cleaning the teeth containing more than 0.1%
Glyceryl trinitrate; for oral or sublingual use
Haemophilus influenzae vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds
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
Ketotifen; for ophthalmic use in medicines containing 0.025% or less
Mannityl hexanitrate
Orlistat; in medicines containing 120 milligrams or less
per dose form
Pneumococcal vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds
Podophyllotoxin; for external use for the treatment of warts other than anogenital warts in medicines containing 1% or less and more than 0.5%
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
Prochlorperazine; in packs containing not more than
10 tablets for the treatment of nausea associated
with migraine
Salicylic acid; in medicines containing more than 40%
Silver sulfadiazine; except for external use in packs containing 50 grams or less
Sodium picosulfate; in preparations for bowel cleansing prior to diagnostic, medical or surgical procedures
Triamcinolone; for buccal use in medicines containing 0.1% or less of triamcinolone acetonide and in pack sizes no greater than 5 grams
Schedule 3
Pharmacy?only Medicines
Acetylcysteine; for oral use in medicines containing more than 1 gram per recommended daily dose
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 organophosphorous 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
*Beclomethasone; in aqueous nasal sprays delivering up
to 50 micrograms per actuation when the maximum recommended daily dose is not greater than 400 micrograms and the medicine has received the consent
of the Minister or the Director?General to its distribution as a pharmacy?only medicine
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
*Budesonide; in aqueous nasal sprays delivering up to
50 micrograms per actuation when the maximum recommended daily dose is not greater than 400 micrograms and the medicine has received the consent
of the Minister or the Director?General to its distribution as a pharmacy?only medicine
Ciclopirox; for dermal use in medicines containing 2% or less except in medicines for tinea pedis only
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
Dextromethorphan; in liquid form containing more
than 0.25% or in solid dose form containing more than 15 milligrams per dose form when in packs containing not more than 600 milligrams and with a recommended daily dose of not more than 120 milligrams
Diclofenac; in solid dose form containing 12.5 milligrams or less per dose form in packs of not more than 20 tablets
or capsules
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
Fluorides; for internal use in medicines containing
2.2 milligrams or less per dose form of sodium fluoride; for external use in medicines other than pastes, gels or powders for cleaning the teeth containing 2.5% or less; except in dental hygiene products other than pastes,
gels or powders for cleaning the teeth containing 220 milligrams or less per litre or per kilogram and in packs containing not more than 120 milligrams of total fluoride
Flurbiprofen; in throat lozenges containing 10 milligrams
or less per lozenge
*Fluticasone; in aqueous nasal sprays delivering up to
50 micrograms per actuation when the maximum recommended daily dose is not greater than 200 micrograms and the medicine has received the consent
of the Minister or the Director?General to its distribution as a pharmacy?only medicine
Folic acid; for oral use in medicines containing more than 500 micrograms per recommended daily dose
Folinic acid; for oral use in medicines containing more than 500 micrograms per recommended daily dose
Glyceryl trinitrate; for external use; except in medicines containing 100 micrograms or less per litre or per kilogram
Hydroquinone; for external use in medicines containing
2% or less except in hair preparations containing 1% or less
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 except in packs containing
30 micrograms or less of total solanaceous alkaloids
*Ibuprofen; for oral use in liquid form in packs containing not more than 4 grams 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; for oral use in solid dose form containing not more than 200 milligrams per dose form 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; except in packs containing 200 milligrams or less per oral solid dose form and not more than 25 dose units per pack when in medicines which have received the consent of the Minister or the Director?General to their sale as general sale 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
*Mometasone; in aqueous nasal sprays delivering up
to 50 micrograms per actuation when the maximum recommended daily dose is not greater than 200 micrograms and the medicine has received the consent
of the Minister or the Director?General to its distribution as a pharmacy?only medicine
Nicotine; for inhalation except when sold from a smoking cessation clinic run under the auspices of a registered medical practitioner, nurse, pharmacist or psychologist
*Nizatidine; 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 containing not more than 14 days’ supply
Nystatin; for dermal use
Phenylephrine; for nasal use in medicines containing more than 1%; for ophthalmic use in medicines containing 5% or less and more than 1%; for oral use in medicines containing more than 50 milligrams per recommended daily dose and in packs containing more than 250 milligrams of phenylephrine per pack
Podophyllotoxin; for external use for the treatment of warts other than anogenital warts in medicines containing 0.5% or less
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
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
Sodium picosulfate; for laxative use
*Triamcinolone; in aqueous nasal sprays delivering up to
55 micrograms per actuation when the maximum 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 pharmacy?only medicine
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; for oral use in medicines containing 1 gram or less per recommended daily dose
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
Collagen; except in injections or implantations for tissue augmentation or cosmetic use
Dextromethorphan; in liquid form containing 0.25% or
less or in solid dose form containing 15 milligrams
or less per dose form when in packs containing not
more than 600 milligrams and with a recommended daily dose of not more than 120 milligrams
Dichlofenthion
Diprophylline
Ephedra navadensis
Fluorides; in pastes, gels or powders for cleaning the
teeth containing 0.1% or less; in parenteral nutrition replacement preparations; in oral hygiene products
other than pastes, gels or powders for cleaning the
teeth containing 220 milligrams or less per litre or per kilogram and in packs containing not more than
120 milligrams of total fluoride; in other medicines containing 15 milligrams or less per litre or per kilogram
Folic acid; for oral use in medicines containing 500 micrograms or less per recommended daily dose
Folinic acid; for oral use in medicines containing 500 micrograms or less per recommended daily dose
Gadobenic acid
Gadobutrol
Guaiphenesin; for oral use in medicines containing 2% or less or 200 milligrams or less
Hyaluronic acid; except in injections or implantations for tissue augmentation or cosmetic use
Hydroquinone; for external use in hair preparations containing 1% or less
Hylan polymer; except injections or implantations for tissue augmentation or cosmetic use
Hyoscyamus niger; in packs containing 30 micrograms or less of total solanaceous alkaloids
*Ibuprofen; for external use; for oral use in solid dose form containing 200 milligrams or less per dose form when in packs containing not more than 25 dose units and when in medicines which have received the consent of the Minister or the Director?General to their sale as general sale medicines and which are sold in the manufacturer’s original pack
Injectable medicines; except when specified in the First Schedule to the Medicines Regulations
Ketoprofen; for external use
Mandelic acid
Monosulfiram
Nicotine; for transdermal use or in chewing gum, lozenges or sublingual tablets
Oxedrine; in medicines containing 30 milligrams or less per recommended daily dose
Phenylephrine; for nasal or ophthalmic use in medicines containing 1% or less; for oral use in medicines containing 50 milligrams or less per recommended daily dose and in packs containing 250 milligrams or less of phenylephrine per pack
Piridoxine; in medicines containing 200 milligrams or less per recommended daily dose
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
Trichloroacetic acid; for external use in medicines containing 12.5% or less for the treatment of warts other than anogenital warts
*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.
Dated this 21st day of July 2005.
DON MATHESON, Deputy Director?General, Public Health Directorate.