Notice Type
Departmental
A Classification of Medicines Pursuant to section 106 (1) of the Medicines Act 1981, I, Maurice Donald Williamson, Associate Minister of Health, 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. Schedule 1 Prescription Medicines 4-hydroxyandrostenedione 5-Amino salicylate Abciximab Acetrizoate sodium Adapalene Adenosine Acitretin Alendronate sodium Alglucerase Altretamine Amethocaine; and its salts; in medicines for internal use and in medicines for ophthalmological use except when used in practice by a registered optometrist Amidotrizoic acid; and its salts Amifostine Aminophylline; except in liquid form for oral use Amorolfine hydrochloride Anabolic steroids; either natural or synthetic Anaesthetics: local: in medicines for ophthalmological use Anastrazole Anistreplase Antigens; in a multipuncture device for cutaneous application Antimony; and its compounds Apomorphine; and its salts Apraclonidine hydrochloride Atovaquone Atropine; and its salts; in medicines containing 0.15% or more of atropine; except when used in an auto injection device for use as an antidote Azelastine hydrochloride Azithromycin Belladonna; alkaloids of; and their salts; in medicines containing 0.15% or more of the alkaloids of belladonna calculated as hyoscyamine Benazepril Beractant Beta carotene; in medicines containing more than 18 mg per recommended daily dose Bisoprolol Botulinium toxin Cabergoline Calcipotriol Carbachol Carbuterol; and its salts; in medicines for inhalation or for parenteral use Carvedilol Cefazolin; and its salts Cefepime Cefetamet Cefixime Cefodizime Cefpirome; and its salts Cefpodoxime proxetil Ceftibuten Cefuroxime; and its salts and esters Celiprolol; and its salts Cholecalciferol: in medicines containing more than 25 micrograms per recommended daily dose Cilazapril Cinchocaine; for parenteral use Cisapride Cisatracurim besylate Cladribine Clarithromycin Clodronic acid disodium salt Clozapine Co-dergocrine Colchicine; and its salts Colfosceril palmitate Crystal violet Cyclopentolate; and its salts Dalteparin sodium Danthron Deflazacort Desflurane Dexfenfluramine Diatrizoic acid; and its salts Dicloxacillin sodium Didanosine (DDI) Diphtheria toxoid Dirithromycin Docetaxel Dorzolamide Edetic acid; in medicines containing more than 0.25% of edetic acid Edoxudine Enoximone Epoprostenol Erythropoietin Esmolol; and its salts Etidronate disodium Famciclovir Famotidine; except when specified elsewhere in this notice Fenoldopam Fibrinolysin; except in medicines for external use Filgrastim Finasteride Fleroxacin Fluconazole Fludarabine; and its salts Fluoxetine hydrochloride Fluticasone; and its esters Fluvastatin Follicle stimulating hormone Follitropin Formoterol Foscarnet sodium Fosinopril Fotemustine Gabapentin Gadodiamide Gadopentetate demeglumine Ganciclovir Gestrinone Glutathione; for parenteral use Glycopyrronium; and its salts; in medicines for parenteral use Granisetron; and its salts Haematin Halofantrine Haloperidol decanoate Hexoprenaline; and its salts; in medicines for inhalation or for parenteral use Homatropine; and its salts; except homatropine methylbromide; Human somatotropin Hydrocortisone 17 butyrate Hydrocortisone; and hydrocortisone acetate; except when specified elsewhere in this notice Hydrocortisone sodium succinate Hyoscine; and its salts; except in medicines for transdermal use and oral use Hyoscyamine; and its salts; in medicines for parenteral use and in medicines containing more than 0.15% of hyoscyamine Idarubicin Ilomedin Iloprost Indinavir sulphate Interferons Iodamide; and its salts Iodised oil; for injection Iodixanol Iodoxamic acid Iohexol Iopamidol Iopromide Iopronic acid Iothalamic acid Iotroxic acid Ioversol Ioxaglic acid Ipodate, sodium Isoetharine; and its salts; in medicines for inhalation or parenteral use Isradipine Itraconazole Ketanserin Ketorolac; and its salts L-asparaginase Lacidipine Lamivudine Lamotrigine Lansoprazole Lenograstim Leucovorin; and its salts Levamisole; and its salts Lignocaine; and its salts; for ophthalmological use except when used in practice by a registered optometrist; for parenteral use except when used as a local anaesthetic by a registered nurse, dental nurse or podiatrist in their practice; for internal use by ingestion other than throat lozenges Liquorice deglycyrrhizinised Lithium succinate; for external use Lofexidine; and its salts Lomefloxacin; and its salts Loracarbef Losartan potassium Measles vaccine Mecasermin Meningococcal vaccine Mepivacaine Mercaptoethane sulphonate sodium (mesna) Meropenem Mesalazine Metrizamide Metrizoic acid; and its salts Midodrine Milrinone Mivacurium chloride Moclobemide Molgramostim Mono-octanoin Mometasone; and its esters Morecizine; and its salts Mumps vaccine Mycophenelate mofetil Nadroparin calcium Nafarelin; and its salts Naproxen; and its salts; except where specified elsewhere in this notice Nebacumab Nefazodone Nicardipine Nicergoline Nicorandil Nicotine; for inhalation; for nasal administration Nilutamide Nimodipine Nisoldipine Nizatidine Octreotide Olsalazine sodium Ondansetron; and its salts Oxandrolone Oxitropium Oxybuprocaine: except when used in practice by a registered optometrist Paclitaxel Pamidronate disodium Pancreatic enzymes; in medicines containing more than 20,000 BP unitsof lipase activity Pantoprazole Paroxetine Pefloxacin Pentagastrin Pergolide Perindopril Permethrin; in medicines containing more more than 1% of permethrin Phenylephrine; and its salts; in eye preparations containing more than 0.12% of phenylephrine Physostigmine; and its salts; Pilocarpine; and its salts; Pinacidil Pipecuronium bromide Podophyllotoxin; except when specified elsewhere Podophyllum extracts; tinctures of podophyllum; podophyllum; in medicines containing more than 20% of podophyllum Pravastatin; and its salts Prilocaine; for parenteral use except when used by a dental therapist Procaine; for parenteral use; for internal use Propafenone hydrochloride Propyliodone Proxymetacaine; and its salts; except when used in practice by a registered optometrist Radiographic contrast media; unless specified elsewhere in this notice Quinagolide Quinapril Quinine; and its salts; in medicines containing more than 50 mg per recommended daily dose Ramipril Recombinant human DNase Remoxipride Ribavirin Rifabutin Risperidone Rocuronuim bromide Ropivacaine hydrochloride monohydrate Roxithromycin Rubella vaccine Salmeterol Saquinavir mesylate Sermorelin Sertraline hydrochloride Sevoflurane Simvastatin Sodium ditiocarb Sodium ipodate Solanaceous alkaloids; and their salts; in medicines containing more than 0.15% of solanaceous alkaloids calculated as hyoscyamine Somatropin Sparfloxacin Spirapril Steroid hormones; either natural or synthetic, which exhibit anabolic activity Stramonium; alkaloids of; and their salts; in medicines containing 0.15% or more of alkaloids calculated as hyoscyamine Sultamicillin; and its salts Sumatriptan; and its salts Tamsulosin hydrochloride Tazobactam T cell receptor antibody Teicoplanin Terazosin; and its salts Terbinafine; except for external use Thymoxamine; Tibolone Ticlopidine; and its salts Tinzaparin Tirilazad mesylate Tolrestat Torasemide Trandolapril Trazodone Tretinoin Triptorelin Tropicamide; except when used in practice by a registered optometrist Tropisetron Ursodeoxycholic acid Valaciclovir Venlafaxine Vigabatrin Xamoterol Zalcitabine Zinc; and its salts; in medicines for internal use containing more than 25 mg of elemental zinc per recommended daily dose Zuclopenthixol; and its salts and esters Schedule 2 Restricted Medicines Alcohol, absolute; in medicines for internal and external use, except when compounded in a medicine Aminacrine; and its salts; in medicines for external use Amphotericin; for buccal use Aspirin; in slow-release forms; in enteric-coated forms containing more than 300 mg per dose form Astemizole *Beclomethasone dipropionate; in aqueous nasal sprays delivering 50 micrograms per actuation when the maximum recommended daily dose is no greater than 400 micrograms *Budesonide; in aqueous nasal sprays delivering 50 micrograms per actuation when the maximum recommended daily dose is no greater than 400 micrograms Bismuth; and its salts; in medicines for internal use Beta 2-adrenoceptor agonists; except in medicines for inhalation or for parenteral use Carbuterol; and its salts; except when contained in medicines for inhalation or for parenteral use Ciclopirox; for dermatological use in medicines containing more than 1% of ciclopirox *Cimetidine; in medicines which are sold in the manufacturer's original pack containing not more than 14 days' supply Clindamycin; and its salts; in medicines for dermatological use Clotrimazole; in medicines for vaginal use when in pack sizes equivalent to one course of treatment Cholestyramine resin Diclofenac; and its salts; in tablets or capsules containing 25 mg or less and in pack sizes of not more than 30 tablets or capsules Dithranol; and its esters Econazole; and its salts; in medicines for vaginal use when in pack sizes equivalent to one course of treatment Ether; except when used as a vehicle for a topical dose form Ethyl chloride *Famotidine; in medicines which are sold in the manufacturer's original pack containing not more than 14 days' supply Fenoterol; and its salts; except in medicines for inhalation or for parenteral use *Flunisolide; in aqueous nasal sprays delivering 50 micrograms per actuation when the maximum recommended daily dose is no greater than 200 micrograms Glycopyrronium; and its salts; except in medicines for parenteral use Hexoprenaline; and its salts; except in medicines for inhalation or for parenteral use Hydrocortisone; and hydrocortisone acetate; in dermatological medicines containing 1% or less and more than 0.5% by weight of hydrocortisone base with no other active ingredient except an antifungal and in a quantity of not more than 15 grams or 15 millilitres per container Hydrocortisone; and hydrocortisone acetate; in rectal medicines in cream or ointment form containing 1% or less by weight of hydrocortisone base and in combination with a local anaesthetic and in a quantity of not more than 35 grams per container Hyoscine; and its salts; in medicines for transdermal use and oral use Hyoscine-N butyl bromide; in medicines for oral use Hyoscyamine; and its salts; in medicines containing 0.15% and less of hyoscyamine; except in forms for parenteral use *Ibuprofen; in liquid form for oral use in medicines which are sold in the manufacturer's original pack containing 200 millilitres or less in volume and in strengths of 100 milligrams or less per 5 millilitres Insulins Isoconazole; and its salts; in medicines for vaginal use when in pack sizes equivalent to one course of treatment Isoetharine; and its salts; except when contained in medicines for inhalation or for parenteral use Ketoprofen; and its salts; in tablets or capsules containing 25 mg or less of ketoprofen and in pack sizes of not more than 30 tablets or capsules Levocabastine Mercury oxides Mercury, ammoniated Mercury; and its salts; and its compounds Metoclopramide; when compounded with paracetamol and in a pack size of not more than ten tablets or capsules Miconazole; in medicines for buccal use; and for vaginal use when in pack sizes equivalent to one course of treatment Minoxidil; in medicines for external use Mupirocin; and its salts Naproxen; and its salts; in tablets or capsules containing 250 mg or less of naproxen and in pack sizes of not more than 30 tablets or capsules Nicotinamide; in medicines containing more than 100 mg per dose form Nicotinic acid; in medicines containing more than 100 mg per dose form Nicotinyl alcohol; in medicines containing more than 100 mg per dose form Nitrite, butyl Nitrite, isobutyl Nitrite, octyl Nystatin; in medicines for buccal use; and for vaginal use when in pack sizes equivalent to one course of treatment Orciprenaline; and its salts; in medicines for oral use Papaverine; and its salts Podophyllum extracts; tinctures of podophyllum; podophyllum; in medicines containing 20% or less of podophyllum Pralidoxime; and its salts *Prochlorperazine; for buccal use in medicines which are sold in the manufacturer's original pack containing not more than 10 tablets for the treatment of nausea associated with migraine Quinine; and its salts; in medicines containing 200 mg or less per dose form and in packs containing not more than 5 days' supply for the treatment of cramp Reproterol; and its salts; except in medicines for inhalation or for parenteral use Rimiterol hydrobromide; except in medicines for inhalation or for parenteral use Salbutamol; and its salts; except in medicines for inhalation or for parenteral use Solanaceous alkaloids; and their salts; in medicines not specified elsewhere in this notice; and in medicines containing 0.15% and less of solanaceous alkaloids calculated as hyoscyamine; except in forms for parenteral use Sulphacetamide; and its salts; in ophthalmological medicines Terbutaline; and its salts; except in medicines for inhalation, or for parenteral use Terfenadine Tioconazole; and its salts; in medicines for vaginal use when in pack sizes equivalent to one course of treatment Triamcinolone acetonide; in medicines for buccal use and when in a pack containing 5 mg or less of triamcinolone acetonide Tulobuterol; and its salts; except in medicines for inhalation or for parenteral use *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. Schedule 3 Pharmacy-Only Medicines Aciclovir; for the treatment of herpes labialis Acrivastine Amethocaine; and its salts; in medicines for external use except in medicines for ophthalmological use Aminophylline; in liquid form for oral use Amyl nitrite; except when sold from outlets licensed under the Toxic Substances Regulations 1983 to sell sodium cyanide paste for the purpose of vertebrate pest control Azelaic acid Benzocaine; for external use in medicines containing more than 2% Benzoyl peroxide; in medicines for external use containing more than 5% of benzoyl peroxide Benzydamine; and its salts Benzyl benzoate; in medicines containing more than 2.5% of benzyl benzoate Biphenylacetic acid Bisacodyl Bithionol Bufexamac Calcium glucono-galacto-gluconate; for parenteral use Camphorated oil Carbetapentane; in medicines containing more than 0.5% Carboxymethylcysteine Cetirizine; and its salts Chlophedianol hydrochloride Ciclopirox; for dermatological use in medicines containing 1% or less of ciclopirox Cinchocaine; for external use in medicines containing more that 2% Clidinium; and its salts Desoxyribonuclease; for external use Dextranomer Dextromethorphan; and its salts; in medicines containing more than 0.25% of dextromethorphan Diclofenac; and its salts; in medicines for external use but not ophthalmological use Dicyclomine; and its salts Dimenhydrinate; and its salts; except in a sealed container of not more than 12 tablets or capsules, labelled for the prevention of travel sickness and sold at a transport terminal or aboard a ship or plane Emetine; and its salts; in medicines containing more than 0.05% Ether; when used as a vehicle for a topical dose form Fluorescein Fluorides; in medicines for internal use containing 2.2 milligrams or less of fluoride per dosage unit; in medicines for external use containing fluoride in proportion equivalent to more than 0.1% of elemental fluorine Folic acid; in medicines containing more than 500 mcg of folic acid per recommended daily dose Glucagon Guaiphenesin; in medicines containing more than 2% of guaiphenesin Hetastarch Hydrocortisone; and hydrocortisone acetate; in medicines for dermatalogical use containing 0.5% or less by weight of hydrocortisone base with no other active ingredient except an antifungal and in a quantity of not more than 15 grams or 15 millilitres per container. Hydroquinone; in medicines containing more than 2% of hydroquinone Ibuprofen: for external use Idoxuridine; in medicines containing 0.5% or less of idoxuridine for dermatological use Indomethacin; in medicines for external use containing 1% or less of indomethacin Ipecacuanha; in medicines containing more than 0.05% of emetine Jaborandi; alkaloids of; and its salts; in medicines containing 0.5% or more of the alkaloids of jaborandi Ketoconazole; for dermatological use Ketoprofen; and its salts; in medicines for external use Lignocaine; and its salts; in medicines for external use containing more than 2% of lignocaine Lobelia; alkaloids of; and their salts Lodoxamide trometamol; for ophthalmological use Loratidine Meclozine; and its salts; except in a sealed container of not more than 12 tablets or capsules, labelled for the prevention of travel sickness and sold at a transport terminal or aboard a ship or plane Mefenamic acid; and its salts; in solid dose forms of 250 mg or less and in a pack containing not more than 20 tablets or capsules for the treatment of dysmenorrhoea Mequitazine Naproxen; and its salts; in solid dose forms containing the equivalent of 250 mg or less of naproxen per dose form, when in a pack containing not more than 20 tablets or capsules and sold for the treatment of dysmenorrhoea Nicotine; in medicines for transdermal use Noradrenaline; and its salts Nystatin; in medicines for dermatological use Oxerutins Oxiconazole nitrate Oxymetazoline; and its salts; for nasal use except when sold at an airport Paracetamol; except where specified elsewhere in this notice Pentastarch Phenazone Phenoxyethanol; in medicines containing more than 2% Phenylephrine; for nasal use except when sold at an airport Piroxicam; in medicines for external use containing 1% or less of piroxicam Polygeline Potassium chloride; except in medicines for oral rehydration therapy; except for use in haemodialysis concentrates and peritoneal dialysis solutions; except for ophthalmological use Potassium citrate: except in medicines for oral rehydration therapy Potassium perchlorate Pramocaine; for external use in medicines containing more than 2% Pregnancy test kits Prilocaine; for external use in medicines containing more than 2% Promethazine; and its salts; except promethazine theoclate in a sealed container of not more than 12 tablets or capsules, labelled for the prevention of travel sickness and sold at a transport terminal or aboard a ship or plane Salicylic acid; and its salts; in medicines for external use containing more than 12.5% Selenium; and compounds of selenium; in medicines for external use containing more than 2.5% of selenium; and in medicines for internal use where the recommended daily dose exceeds 150 micrograms of selenium Sennosides Sodium cromoglycate; for nasal and ophthalmological use Sodium picosulphate Sulphadiazine; and its salts; in medicines for external use when in pack sizes containing 50 g or less Terbinafine; for external use Thiomersal Xylometazoline; and its salts. except for nasal use when sold at an airport Yohimbe; alkaloids of; and their salts B 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. Aconite; alkaloids of; and their salts; in medicines for external use containing less than 0.02% of the alkaloids of aconite Adrenal extract; in dermatological medicines containing 0.02% or less of ketosteroids Aescin; in medicines for external use Aloes; in medicines for external use Aluminium; and its salts; in medicines for external use Aspirin; in enteric coated forms containing 300 mg or less per dose form Barium Sulphate Benzocaine; for external use in medicines containing 2% or less; in throat lozenges containing 30 milligrams or less per dose form Benzoyl peroxide; in medicines for external use containing 5% or less of benzoyl peroxide Benzoic acid Benzyl benzoate; in medicines containing 2.5% or less of benzyl benzoate Beta carotene; in medicines containing 18 mg or less per recommended daily dose Berberine Bioallethrin; in medicines for external use Butoxyethyl nicotinate Cade oil; in medicines for external use Calcium glucono-galacto-gluconate; except for parenteral use Carbaryl; in medicines for external use, containing 2% or less or carbaryl Carbenoxolone; and its salts; compounds of carbenoxolone; in medicines for external use Carbetapentane; in medicines containing 0.5% or less Cardamom; compound tincture; aromatic tincture Catechu Cholecalciferol: in medicines containing 25 micrograms or less per recommended daily dose Choline salicylate Chorhexidine Chlorphenesin Chymotrypsin Cinchocaine; for external use in medicines containing 2% or less Clioquinol; in medicines for external use Contact lens solutions Crocus sativus; extracts of Crotamiton 2,4-Dichlorobenzyl alcohol Dequalinium; and its salts Dibromopropamidine isethionate; except for ophthalmological use Diethylamine salicylate Di-iodohydroxyquinoline; in medicines for external use Dimenhydrinate; and its salts; in a sealed container of not more than 12 tablets or capsules, labelled for the prevention of travel sickness and sold at a transport terminal or aboard a ship or plane Dioctyl sodium sulphosuccinate Diphemanil; and its salts Edetic acid; in medicines containing 0.25% or less Emetine; in medicines containing 0.05% or less Ethyl nicotinate Ethyl salicylate Fenticlor; in medicines for external use Fibrinolysin; in medicines for external use Folic acid; in medicines containing 500 mcg or less per recommended daily dose Galactose Gentian compound concentrated infusion Glycol salicylate Guaiphenesin; in medicines containing 2% or less of guaiphenesin 8-Hydroxyquinoline; and its halogenated and alkyl derivatives and their salts; in medicines for external but not vaginal use Haloprogin Halquinol; in medicines for external use Heparins; in medicines for external use Hexetidine; in medicines for external but not vaginal use Hexyl nicotinate Histamine acid phosphate; in medicines containing 0.5% or less of histamine acid phosphate Hyaluronidase; for external use Hydroxocobalamin; in medicines containing 50 mcg or less of hydroxocobalamin per daily dose Intrinsic factor Iodine; in medicines for external use Iodoform Ipececuanha; in medicines containing 0.05% or less of emetine Isopropyl myristate Lignocaine; and its salts; in medicines for external use containing 2% or less of lignocaine and in throat lozenges containing 30 milligrams or less per dose form Malathion; in medicines for external use containing 2% or less of malathion Meclozine; and its salts; in a sealed container of not more than 12 tablets or capsules, labelled for the prevention of travel sickness and sold at a transport terminal or aboard a ship or plane Menthyl valerate Methyl nicotinate Nicotinamide; in medicines containing 100 mg or less per dose form Nicotinic acid; in medicines containing 100 mg or less per dose form Nicotinyl alcohol; in medicines containing 100 mg or less per dose form Nonylic acid; and its derivatives Oxymetazoline; and its salts; for nasal use when sold at an airport Pancreatic enzymes; in medicines containing 20,000 BP units or less of lipase activity Paracetamol; in solid dose form for oral use, containing 500 mg or less of paracetamol and in packs containing not more than 10 g of paracetamol per pack Pepsin Permethrin; in medicines containing 1% or less of permethrin Phenothrin Phenoxyethanol; in medicines containing 2% or less Phenylephrine; and its salts; in eye preparations containing 0.12% or less of phenylephrine; and in nasal preparations when sold at an airport Piperonyl butoxide Polynoxylin Potassium chloride; in medicines for oral rehydration therapy; for use in haemodialysis concentrates and peritoneal dialysis solutions; for ophthalmological use Potassium citrate; in medicines for oral rehydration therapy Potassium guaiacolsulphonate Pramocaine; for external use in medicines containing 2% or less Prilocaine; for external use in medicines containing 2% or less Promethazine theoclate; in a sealed container of not more than 12 tablets or capsules, labelled for the prevention of travel sickness and sold at a transport terminal or aboard a ship or plane Pronase Propylene glycol Propyl undecylenate Pumilio pine oil Pyrethrins I and II Quaternary ammonium antiseptic compounds Quinine; and its salts; in medicines containing 50 mg or less of quinine per recommended daily dose Salicylic acid; and its salts; in medicines for external use containing 12.5% or less of salicylic acid Senega Sodium bitartrate Sodium dichloroisocyanurate Sodium lauryl sulphoacetate Sodium sulphide Strontium chloride Subtilisin A Sulphurated potash Tars; coal or wood Terpin hydrate Thurfyl salicylate Tolciclate Tolnaftate Triclosan Trypsin Tyloxapol Undecenoic acid; and its salts and esters Xylometazoline; and its salts; for nasal use when sold at an airport Zinc; and its salts; in medicines for internal use containing 25 mg or less of elemental zinc per recommended daily dose Dated this 2nd day of September 1996. MAURICE WILLIAMSON, Associate Minister of Health.
Publication Date
5 Sep 1996

Notice Number

1996-go5742

Page Number

2742