Pursuant to section 106(1) of the Medicines Act 1981,
I, Anthony Hill, Deputy Director-General, Sector Accountability and Funding 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
Abatacept
Alglucosidase alfa
Aliskiren
Amphotericin
Amyl nitrite; except when sold from outlets licensed to sell cyanide paste for the purpose of vertebrate pest control
Anagrelide
Aspirin; for injection; when combined with caffeine, paracetamol or salicylamide
Azacitidine
Azatadine; except when specified elsewhere in this Schedule
Azelastine; except in medicines for ophthalmic use containing 0.05% or less
Boron including borax and boric acid; except for internal use in medicines containing 6 milligrams or less per recommended daily dose; except in dermal medicines for use other than paediatric use containing 0.35% or less; except when present as an excipient
Brompheniramine; except when specified elsewhere in this Schedule
Brugmansia spp
Butoconazole; except for vaginal use
Chlorpheniramine; except when specified elsewhere in this Schedule
Chlorquinaldol
Choline salicylate; except in medicines containing 10% or less and in pack sizes of 15 grams or less
Dabigatran
Daptomycin
Darunavir
Dasatinib
Deslorelin
Dexchlorpheniramine; except when specified elsewhere in this Schedule
Di-isopropylamine dichloroacetate
Dimenhydrinate; except when specified elsewhere in this Schedule
Dimethoxinate
Diphenhydramine; except when specified elsewhere in this Schedule
Diphenylpyraline
Doxylamine; except when specified elsewhere in this Schedule
Etidronic acid; except in medicines for external use containing 1% or less
Exenatide
Felbinac; except for external use
Fomivirsen
Fosaprepitant
Furosemide
Galsulfase
Guanidine
Ipriflavone
Ivabradine
Ixabepilone
Ketoprofen; except when specified elsewhere in this Schedule; except for dermal use
Lanthanum
Lapatinib
Laropiprant
Lefetamine
Levonorgestrel; except when specified elsewhere in this Schedule; except in medicines for use as emergency post-coital contraception when sold by nurses recognised by their professional body as having competency in the field of sexual and reproductive health
Lithium; except when specified elsewhere in this Schedule; except when present as an excipient in dermal medicines containing 0.25% or less
Lodoxamide; except in medicines for ophthalmic use
Mepyramine; except when specified elsewhere in this Schedule
Methyl salicylate; for internal use except when present as an excipient in medicines containing 1.04% or less per dose form
Methotrimeprazine
Natalizumab
Nepafenac
Nicotinic acid except nicotinamide; in medicines containing more than 250 milligrams per dose form
Nilotinib
Olmesartan
Oseltamivir; except when sold by a registered pharmacist between the months of May to September inclusive
for the treatment of seasonal influenza to a consumer
12 years of age or more presenting in a pharmacy with early symptoms of influenza
Oxiconazole; except when specified elsewhere in this Schedule
Palifermin
Paliperidone
Paracetamol; except when specified elsewhere in this Schedule
Paricalcitol
Pegvisomant
Pheniramine; except when specified elsewhere in this Schedule
Phenyltoloxamine
Picric acid
Polysulfated glycosaminoglycans; for injection except in intraocular viscoelastic products
Promethazine; except when specified elsewhere in this Schedule
Pyridoxal; in medicines containing more than 200 milligrams per recommended daily dose
Pyridoxamine; in medicines containing more than 200 milligrams per recommended daily dose
Pyrvinium
Raltegravir
Ranibizumab
*Ranitidine; except when specified elsewhere in this Schedule; except in medicines containing 150 milligrams or less per dose unit which have received the consent of the Minister or the Director-General to their distribution as general sale medicines and which are sold in the manufacturer’s original pack containing not more than
7 days’ supply
Rasagilin
Rifampicin
Riluzole
Rimexolone
Rimonabant
Ruboxistaurin
Sabadilla
Schoenocoulon officinale
Scopolia carniolica
Selenium; except when specified elsewhere in this
Schedule; except for oral use in medicines containing 150 micrograms or less per recommended daily dose; except for external use in medicines containing 3.5% or less of selenium sulfide
Sitagliptin
Sitaxentan
Sorafenib
Sumatriptan; except when specified elsewhere in this Schedule
Sunitinib
Telbivudine
Thenyldiamine
Tipepidine
Tiprinavir
Tolpropamine
Trimeprazine; except when specified elsewhere in this Schedule
Trinitrophenol
Triprolidine; except when specified elsewhere in this Schedule
Varenicline
Vildagliptin
Vitamin A; for internal use in medicines containing
more than 3000 micrograms of retinol equivalents per recommended daily dose except in parenteral nutrition replacement preparations; for external use in medicines containing more than 1%
Vitamin D; for internal use in medicines containing more than 25 micrograms per recommended daily dose except in parenteral nutrition replacement preparations
*Zinc; for internal use in medicines containing more than
25 milligrams per recommended daily dose; except for internal use in medicines containing 50 milligrams or less and more than 25 milligrams per recommended daily dose in packs which have received the consent of the Minister or the Director-General to their distribution as general sale medicines and which are sold in the manufacturer’s original pack and when labelled with a statement that the product may be dangerous if taken in large amounts or for long periods; except in parenteral nutrition replacement preparations
Schedule 2
Restricted Medicines
Aspirin; in slow release forms; in enteric coated forms containing more than 300 milligrams per dose
form; except when specified elsewhere in this Schedule
Azatadine; for oral use in adults and children over 2 years
of age
Azelastine; in medicines for ophthalmic use containing 0.05% or less
Brompheniramine; for oral use medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Butoconazole; for vaginal use
Chlorpheniramine; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Dexchlorpheniramine; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Dimenhydrinate; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Diphenhydramine; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Diphenylpyraline; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Doxylamine; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
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 ingredient except
an antifungal and in a quantity of 30 grams or less or
30 millilitres or less per container; in rectal medicines containing 1% or less but more than 0.5% by weight of hydrocortisone base and in combination with a local anaesthetic and in a quantity of 35 grams or less per container or up to 12 suppositories per pack
*Ibuprofen; for oral use in tablets or capsules containing up to 400 milligrams per dose form and in packs containing not more than 50 dose units and 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 labelled for use by adults and children over 12 years of age
Levonorgestrel; in medicines for use as emergency
post-coital contraception when in packs containing
not more than 1.5 milligrams except when sold by
nurses recognised by their professional body as having competency in the field of sexual and reproductive health
Mepyramine; for oral use in medicines for adults and children over 2 years of age
Nicotinic acid except nicotinamide; in medicines containing 250 milligrams or less but more than 100 milligrams
per dose form
Oxiconazole; for vaginal use
Pheniramine; for oral use in medicines for adults and children over 2 years of age
Prochlorperazine; in packs containing not more than
10 tablets or capsules for the treatment of nausea associated with migraine
Promethazine; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Salicylic acid; except in medicines for dermal use containing 40% or less
*Sumatriptan; for oral use in medicines for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms when in tablets containing 50 milligrams or less per tablet and when sold in a pack containing not more than 2 tablets which has received the consent of the Minister or the Director-General to its sale as a restricted medicine
Trimeprazine; for oral use in medicines for adults and children over 2 years of age
Triprolidine; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Schedule 3
Pharmacy-only Medicines
Antazoline; for ophthalmic use except when sold in practice by a registered optometrist
*Beclomethasone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years
of age when in aqueous nasal sprays delivering up
to 50 micrograms per actuation and when the maximum recommended daily dose is no 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
Benzydamine; for external use except for dermal use
Brompheniramine; for oral use in medicines for adults or children over two years of age when combined in the same container with one or more other therapeutically active ingredient either when in the bedtime dose of a day-night pack containing brompheniramine or when at least one of the other therapeutically active ingredients is a sympathomimetic decongestant
*Budesonide; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age
when in aqueous nasal sprays delivering up to
50 micrograms per actuation and when the maximum recommended daily dose is no 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
Chlorpeniramine; for oral use in medicines for adults and children over 2 years of age when combined in the
same container with one or more other therapeutically active ingredient either when in the bedtime dose of a day-night pack containing chlorpheniramine or, when at least one of the other therapeutically active ingredients is a sympathomimetic decongestant
Clotrimazole; for external use except in medicines for tinea pedis only
Dexchlorpheniramine; for oral use in medicines for adults and children over 2 years of age when combined in the same container with one or more other therapeutically active ingredient either when in the bedtime dose of a day-night pack containing dexchlorpheniramine or when at least one of the other therapeutically active ingredients is a sympathomimetic decongestant
Dibromopropamidine; for ophthalmic use except when sold in practice by a registered optometrist
Diclofenac; in solid dose form in medicines containing
12.5 milligrams or less per dose form in packs containing not more than 20 tablets or capsules and
with a recommended daily dose of not more than
75 milligrams
Dimenhydrinate; for oral use in a sealed container of not more than 10 tablets or capsules for the prevention or treatment of motion sickness in adults and children over 2 years of age except when sold at a transport terminal or aboard a ship or plane
Diphenhydramine; for oral use in medicines for adults
and children over 2 years of age when combined in the same container with one or more other therapeutically active ingredient either when in the bedtime dose of a
day-night pack containing diphenhydramine or when at least one of the other therapeutically active ingredients
is a sympathomimetic decongestant; for oral use in a sealed container of not more than 10 tablets or capsules of diphenhydramine theoclate for the prevention or treatment of motion sickness in adults and children
over 2 years of age except when sold at a transport terminal or aboard a ship or plane
Diphenylpyraline; for oral use in medicines for adults
and children over 2 years of age when combined in the same container with one or more other therapeutically active ingredient either when in the bedtime dose of
a day-night pack containing diphenylpyraline or when at least one of the other therapeutically active ingredients is a sympathomimetic decongestant
Doxylamine; for oral use in medicines for adults and children over 2 years of age when combined in the
same container with one or more other therapeutically active ingredient either when in the bedtime dose of a day-night pack containing doxylamine or when at least one of the other therapeutically active ingredients is a sympathomimetic decongestant
*Fluticasone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age when in aqueous nasal sprays delivering up to 50 micrograms per actuation and when the maximum recommended daily dose is no 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
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 ingredient except an antifungal and in a quantity of 30 grams or less or 30 millilitres or less per container; in rectal medicines containing 0.5% or less by weight of hydrocortisone base and in combination with a local anaesthetic and in a quantity of 35 grams or less per container or 12 suppositories or less per pack
*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 and with a recommended daily dose of not more than 1200 milligrams and in packs containing
not more than 100 tablets or capsules 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; 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
Levocabastine; for nasal use; for ophthalmic use except when sold in practice by a registered optometrist
Lithium; for dermal use in medicines containing 1% or less but more than 0.01%; except when present as an excipient in dermal medicines containing 0.25% or less
Lobeline; except when in medicines for smoking or burning
Lodoxamide; for ophthalmic use except when sold in practice by a registered optometrist
Mepyramine; for dermal use
*Mometasone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age
when in aqueous nasal sprays delivering up to
50 micrograms per actuation and when the maximum recommended daily dose is no greater than 200 micrograms and the medicine has received the consent
of the Ministeror the Director-General to its distribution as a pharmacy-only medicine
Naphazoline; except for ophthalmic use when sold in practice by a registered optometrist
Oxiconazole; for dermal use except in medicines for tinea pedis only
Oxymetazoline; except for nasal use when sold at an airport; except for ophthalmic use when sold in practice by a registered optometrist
Paracetamol; in liquid form; in suppositories; in tablets or capsules containing 500 milligrams or less and in packs containing more than 10 grams; in slow release forms containing 665 milligrams or less and more than 500 milligrams; in powder form containing not more than 1000 milligrams per sachet and more than 10 grams per pack
Pheniramine; for ophthalmic use except when sold in practice by a registered optometrist; for oral use
in medicines for adults and children over 2 years of
age when combined in the same container with one or more other therapeutically active ingredient either when in the bedtime dose of a day-night pack containing pheniramine or when at least one of the other therapeutically active ingredients is a sympathomimetic decongestant
Promethazine; for oral use in medicines for adults and children over 2 years of age when combined in the
same container with one or more other active
ingredient either when in the bedtime dose of a
day-night pack containing promethazine or when at
least one of the other therapeutically active ingredients is a sympathomimetic decongestant; for oral use in a sealed container of not more than 10 tablets or capsules for the prevention or treatment of motion sickness in adults
and children over 2 years of age except when sold at a transport terminal or aboard a ship or plane
Propamidine; for ophthalmic use except when sold in practice by a registered optometrist
Pyrethrins; in medicines containing more than 10%
Pyrithione zinc; except in medicines for treatment of the scalp containing 2% or less
*Ranitidine; in medicines which have received the consent of the Minister or the Director-General to their distribution as pharmacy-only medicines and which are sold in the manufacturer’s original pack containing
not more than 14 days’ supply; except in medicines containing not more than 150 milligrams per dose unit which have received the consent of the Minister or
the Director-General to their distribution as general sale medicines and which are sold in the manufacturer’s original pack containing not more than 7 days’ supply
Selenium; for oral use in medicines containing 300 micrograms or less and more than 150 micrograms
per recommended daily dose; for external use except in medicines containing 3.5% or less of selenium sulfide
Sodium cromoglycate; for nasal use; for ophthalmic use except when sold in practice by a registered optometrist
Tetrahydrazoline; except for ophthalmic use when sold in practice by a registered optometrist
*Triamcinolone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age
when in aqueous nasal sprays delivering up to
55 micrograms per actuation and 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 pharmacy-only medicine
Trimeprazine; for oral use in medicines for adults and children over 2 years of age when combined in the
same container with one or more other therapeutically active ingredients either when in the bedtime dose of a day-night pack containing trimeprazine or when at least one of the other therapeutically active ingredients is a sympathomimetic decongestant
Triprolidine; for oral use in medicines for adults and children over 2 years of age when combined in the
same container with one or more other therapeutically active ingredient either when in the bedtime dose of a day-night pack containing triprolidine or when at least one of the other therapeutically active ingredients is a sympathomimetic decongestant
Xylometazoline; for nasal use except when sold at an airport; for ophthalmic use except when sold in practice by a registered optometrist
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.
Aspirin; except when specified in the First Schedule to the Medicines Regulations 1984
Benzydamine; for dermal use
Choline salicylate; in medicines containing 10% or less and in pack sizes of 15 grams or less
Boron including borax and boric acid; in medicines for internal use containing 6 milligrams or less per recommended daily dose; for dermal use other than paediatric use in medicines containing 0.35% or less; when present as an excipient
Etidronic acid; in medicines for external use containing
1% or less
Liquorice; deglycyrrhizinised
Lithium; for dermal use in medicines containing 0.01% or less; when present as an excipient in medicines for dermal use containing 0.25% or less
Lobeline; in medicines for smoking or burning
Methyl salicylate; for external use; for internal use when present as an excipient in medicines containing 1.04% or less per dose form
Nicotinamide
Nicotinic acid; in medicines containing 100 milligrams or less per dose form
Octocog alfa
Oxiconazole; for dermal use in medicines for tinea pedis only
Perflutren
Polysulfated glycosaminoglycans; except in injections other than intraocular viscoelastic products
Pyrethrins; in medicines containing 10% or less
Pyridoxal; in medicines containing 200 milligrams or less per recommended daily dose
Pyridoxamine; in medicines containing 200 milligrams or less per recommended daily dose
Pyrithione zinc; for treatment of the scalp in medicines containing 2% or less
*Ranitidine; in medicines containing not more than 150 milligrams per dose unit which have received the consent of the Minister or the Director-General to their distribution as general sale medicines and which are sold in the manufacturer’s original pack containing not more than 7 day’s supply
Salicylic acid; in medicines containing 40% or less
Selenium; for oral use in medicines containing 150 micrograms or less per recommended daily dose; for external use in medicines containing 3.5% or less of selenium sulfide
Vitamin A; for internal use in medicines containing 3000 micrograms or less of retinol equivalents per recommended daily dose; in parenteral nutrition replacement preparations; for external use in medicines containing 1% or less
Vitamin D; for external use; for internal use in medicines containing 25 micrograms or less per recommended daily dose; in parenteral nutrition replacement preparations
*Zinc; for external use except in medicines containing
more than 5% of zinc chloride; for internal use in medicines containing 25 milligrams or less per recommended daily dose; for internal use in medicines containing 50 milligrams or less and more than
25 milligrams per recommended daily dose in packs which have received the consent of the Minister or the Director-General to their distribution as general sale medicines and which are sold in the manufacturer’s original pack and when labelled with a statement that the product may be dangerous if taken in large amounts or for long periods; in parenteral nutrition replacement preparations
*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 7th day of August 2008.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate.