Pursuant to section 106 (1) of the Medicines Act 1981,
I, Barry Borman, Acting 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 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
Acrivastine
Adalimumab
Adefovir
Adenosine; for injection
Alclometasone; except when specified elsewhere in the Schedule
Alefacept
Alemtuzumab
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
Anecortave
Antazoline; except for ophthalmic use
Aprepitant
Aripiprazole
Aristolochic acid; at all strengths
Articaine
Atazanavir
Atomoxetine
Atropa belladonna; except when specified elsewhere in the Schedule; 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
Azatadine; except for oral use
Bamipine
Benorylate
Benzocaine; for internal use; for external use in medicines containing more than 10%
Benzydamine; for internal use
Bethanechol
Bevacizumab
Bexarotene
Bortezomib
Bosentan
Brompheniramine; except when specified elsewhere in the Schedule
Buclizine; except for oral use
Butacaine
Butoconazole
Butyl aminobenzoate; except in medicines for dermal use containing 2% or less
Carbetocin
Carbuterol
Chlorcyclizine
Chlorpheniramine; except when specified elsewhere in
the Schedule
Ciclesonide
Cinacalcet
Cinchocaine; for ophthalmic use; for external use in medicines containing more than 0.5%
Clemastine; except for oral use
Clemizole
Clindamycin
Clobetasone; except when specified elsewhere in the Schedule
Colestyramine
Collagen; in injections or implantations for tissue augmentation or cosmetic use
Cyclizine; except for oral use
Cyproheptadine; except for oral 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
Dexchlorpheniramine; when specified elsewhere in the Schedule
Dextrorphan
Dibromopropamidine; except for ophthalmic use
Dichlorophen
Dicyclomine
Digoxin-specific antibody fragment
Dimenhydrinate; except when specified elsewhere in the Schedule
Dimethindene; except for oral use
Dimethothiazine
Diperodon
Diphenhydramine; except when specified elsewhere in the Schedule
Diphenylpyraline; except when specified elsewhere in the Schedule
Doxylamine; except when specified elsewhere in the Schedule
Drotrecogin
Duboisia leichhardtii; except when specified elsewhere in the Schedule
Duboisia myoporides; except when specified elsewhere in the Schedule
Duloxetine
Efalizumab
Emtricitabine
Enfuvirtide
Entecavir
Eplerenone
Epinastine
Ephedra spp; except ephedra navadensis
Epoetins
Erlotinib
Ethyl chloride; for inhalation
Etidocaine
Everolimus
Ezetimibe
Felypressin; except when combined with a local anaesthetic and when used in practice by a registered dental therapist
Fenofibrate
Flunisolide
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
Fosamprenavir
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
Hexoprenaline
Homatropine
Human protein C
Hyaluronic acid; in injections or implantations for tissue augmentation or cosmetic use
Hydrargaphen
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
Juniperus sabina; at all strengths
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 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%
Lumiracoxib
Mebhydrolin
Meclozine; except when specified elsewhere in the Schedule
Melagatran
Melia azedarach; at all strengths
Memantine
Mepyramine; except for dermal use
Mequitazine
Mercury; except when specified elsewhere in the Schedule; except in medicines containing 1 milligram or less per litre or per kilogram
Methdilazine; except for oral use
Methyl mercury; except in medicines containing 300 micrograms of methyl mercury per litre or per kilogram
Mitragyna speciosa
Mitragynine
Muraglitazar
Nesiritide
Nicoumalone
Nitrofurazone
Norelgestromin
Nux vomica; except in medicines containing 1 milligram or less per litre or per kilogram of strychnine
Orlistat; except when specified elsewhere in the Schedule
Oxedrine; in medicines containing more than 30 milligrams per recommended daily dose
Palonosetron
Pegaptanib
Pegfilgrastim
Pemetrexed
Pentaerithrityl tetranitrate
Phenazopyridine
Pheniramine; except when specified elsewhere in the Schedule
Phenyltoloxamine; except for oral use
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
Posaconazole
Pramocaine
Pregabalin
Pregnenolone
Prilocaine; for injection except when used as a local anaesthetic by a 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
Promethazine; except when specified elsewhere in the Schedule
Propamidine; except for ophthalmic use
Propantheline
Protamine sulfate
Quinisocaine
Sabadilla; except when specified elsewhere in the Schedule
Sevelamer
Solifenacin
Strontium ranelate
Strychnos spp
Tenofovir
Terlipressin
Thenyldiamine; except when specified elsewhere in the Schedule
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
Trimeprazine; except when specified elsewhere in the Schedule
Triprolidine; except when specified elsewhere in the Schedule
Vardenafil
Ximelagatran
Schedule 2
Restricted Medicines
*Alclometasone; for dermal use in medicines containing 0.05% or less and in packs containing not more than
30 grams 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
Azatadine; for oral use
Brompheniramine; for oral use except when specified elsewhere in the Schedule
Buclizine; for oral use
Chlorpheniramine; for oral use except when specified elsewhere in the Schedule
Ciclopirox; for dermal use in medicines containing more than 2%
Clemastine; for oral use
*Clobetasone; for dermal use in medicines containing 0.05% or less and in packs containing not more than
30 grams 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
Cyclizine; for oral use
Cyproheptadine; for oral use
Dexchlorpheniramine; for oral use except when specified elsewhere in the Schedule
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
Dimenhydrinate; for oral use except when specified elsewhere in the Schedule
Dimethindene; for oral use
Diphenhydramine; for oral use except when specified elsewhere in the Schedule
Diphenylpyraline; for oral use except when specified elsewhere in the Schedule
Doxylamine; for oral use except when specified elsewhere in the Schedule
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
Methdilazine; for oral use
Orlistat; in medicines containing 120 milligrams or less per dose form for the purpose of weight control
Pheniramine; for oral use except when specified elsewhere in the Schedule
Phenyltoloxamine; for oral use
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
Promethazine; for oral use except when specified elsewhere in the Schedule
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
Stramonium; for oral use in liquid form; in solid dose form in medicines containing more than 0.3 milligrams per dose or more than 1.2 milligrams per recommended daily dose
Thenyldiamine; for oral use in solid dose form or in liquid form containing 10 milligrams or less of thenyldiamine per 5 millilitres except when specified elsewhere in the Schedule
Triamcinolone; for buccal use in medicines containing
0.1% or less of triamcinolone acetonide and in pack sizes no greater than 5 grams
Trimeprazine; for oral use in solid dose form or in liquid form containing 10 milligrams or less per 5 millilitres; except when specified elsewhere in the Schedule
Triprolidine; for oral use except when specified elsewhere in the Schedule
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 10 grams or less
Amethocaine; for external use in medicines containing
10% or less and more than 2%
Antazoline; for ophthalmic use
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; in mouthwashes containing 10% or less; for external use in medicines other than mouthwashes containing 10% or less and more than 2% except in throat lozenges containing 30 milligrams or less per dose form
Benzydamine; for external use
Bifonazole; for external use except in medicines for tinea pedis only or in shampoos containing 1% or less
Brompheniramine; for oral use when combined with one or more other therapeutically active substances for the treatment of coughs, colds or influenza when at least
one of the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing brompheniramine in the bedtime dose and in preparations for adults or children two years of age or more
*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
Chlorpheniramine; for oral use when combined with one or more other therapeutically active substances for the treatment of coughs, colds or influenza when at least
one of the other therapeutically active substances is
a sympathomimetic decongestant or in a day/night pack containing chlorpheniramine in the bedtime dose and in preparations for adults or children two years of age or more
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
Dexchlorpheniramine; for oral use when combined with one or more other therapeutically active substances for the treatment of coughs, colds or influenza when at least
one of the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing dexchlorpheniramine in the bedtime dose and in preparations for adults or children two years of age or more
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
Dibrompropamidine; for ophthalmic use
Diclofenac; in solid dose form containing 12.5 milligrams or less per dose form in packs of not more than 20 tablets
or capsules
Dimenhydrinate; for oral use in a sealed container of not more than 10 tablets or capsules for the prevention or treatment of motion sickness except when sold at a transport terminal or aboard a ship or plane
Diphenhydramine; for oral use when combined with one or more other therapeutically active substances for the treatment of coughs, colds or influenza when at least
one of the other therapeutically active substances is
a sympathomimetic decongestant or in a day/night
pack containing diphenhydramine in the bedtime dose and in preparations for adults or children two years of age or more; in a sealed container of not more than
10 tablets or capsules of diphenhydramine theoclate for the prevention or treatment of motion sickness except when sold at a transport terminal or aboard a ship or plane
Diphenylpyraline; for oral use when combined with one or more other therapeutically active substances for the treatment of coughs, colds or influenza when at least
one of the other therapeutically active substances is
a sympathomimetic decongestant or in a day/night pack containing diphenylpyraline in the bedtime dose and in preparations for adults or children two years of age or more
Doxylamine; for oral use when combined with one or
more other therapeutically active substances for the treatment of coughs, colds or influenza when at least
one of the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing doxylamine in the bedtime dose and in preparations for adults or children two years of age or more
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
Meclozine; in a sealed container of not more than 12 tablets or capsules for the prevention of travel sickness except when sold at a transport terminal or aboard a ship or plane
Mepyramine; for dermal 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
Naphazoline
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
Pheniramine; for ophthalmic use; for oral use when combined with one or more other therapeutically active substances for the treatment of coughs, colds or influenza when at least one of the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing pheniramine in the bedtime dose and in preparations for adults or children two years of age or more
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
Promethazine; for oral use when combined with one or more other therapeutically active substances for the treatment of coughs, colds or influenza when at least one of
the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing promethazine in the bedtime dose and in preparations for adults or children two years of age or more; in a sealed container of not more than 10 tablets
or capsules for the prevention or treatment of motion sickness except when sold at a transport terminal or aboard a ship or plane
Propamidine; for ophthalmic use
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
Stramonium; in solid dose form in medicines containing
0.3 milligrams or less per dose and 1.2 milligrams or less per recommended daily dose
Thenyldiamine; for nasal use; for oral use when combined with one or more other therapeutically active substances for the treatment of coughs, colds or influenza when at least one of the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing thenyldiamine in the bedtime dose and in preparations for adults or children two years of age or more
*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
Trimeprazine; for oral use when combined with one or
more other therapeutically active substances for the treatment of coughs, colds or influenza when at least one of the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing trimeprazine in the bedtime dose and in preparations for adults or children two years of age or more
Triprolidine; for oral use when combined with one or
more other therapeutically active substances for the treatment of coughs, colds or influenza when at least one of the other therapeutically active substances is a sympathomimetic decongestant or in a day/night pack containing triprolidine in the bedtime dose and in preparations for adults or children two years of age or more
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 in tubes containing 10 grams or less
Acriflavin
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
Pomegranate
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 26th day of January 2006.
BARRY BORMAN, Acting Deputy Director-General, Public Health Directorate.