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LAWS OF THE REPUBLIC OF VANUATUConsolidated Edition 2006

SALE OF MEDICINES (Statutory Orders) [CAP. 48]

Commencement: 27 June 1988

SALE OF MEDICINES REGULATIONS

Order 25 of 1988Order 32 of 2005

To regulate the sale of medicines.

1. InterpretationIn these regulations unless the context otherwise requires:

“child-resistant closure” means –

(a) a closure which is resistant to opening by children;

(b) in the case of a can fitted with a press-on lid, a lid of the design known as "double tight" or "triple tight";

“dosage unit” means an individual dose of a medicine and includes a tablet, capsule, cachet, single dose powder or single dose sachet of powders or granules;

“essential drug list” means a list of medicines outlined by the Ministry of Health to meet the priority health care needs of the population;

“internal use” means administration –

(a) orally, except for topical effect in the mouth; or

(b) for absorption and the production of a systemic effect –

(i) by way of a body orifice other than the mouth; or

(ii) parenterally, other than by application to unbroken skin;

“medicine” means any substance or preparation which is included in the Schedules;

“primary pack” means the pack in which a medicine and its immediate container or immediate wrapper or measure pack are presented for sale or supply; and

(a) “immediate container” includes all forms of containers in which a medicine is directly packed but does not include any such container intended for consumption or any immediate wrapper;

(b) “immediate wrapper” means metal foil, plastic foil, waxed paper, or any such material not intended for consumption, when used as the first wrapper for a dosage unit which contains any medicine;

(c) “measure pack” means one of two or more sealed containers each of which contains a measured quantity of medicine for use on one occasion as a pesticide and which forms part of a single primary pack;

“sell” includes exposing or offering for sale or having in possession for sale, whether by wholesale or retail, and also includes delivery with or without consideration;

“therapeutic use” means use in or in connection with –

(a) the preventing, diagnosing, curing or alleviating of a disease, ailment, defect or injury in human beings or animals;

(b) the influencing, inhibiting or modifying of a physiological process in human beings or animals; or

(c) the testing of the susceptibility of human beings or animals to a disease or ailment;

“topical use” means application of a medicine for the purpose of producing a localised effect on the surface of the organ or within the tissue to which it is applied;

“wholesaler” means a person who imports, sells or otherwise supplies a medicine for resale.

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2. Sale of medicines(1) A person may sell any medicine listed in Schedule 1.

(2) A person referred to in subregulation (1) must not sell a medicine listed in schedule 1 unless the medicine is adequately labelled to ensure its appropriate and safe use.

(3) The medicines listed in Schedules 2 and 3 must not be sold by any person other than the following persons:

(a) a pharmacist;

(b) a druggist;

(c) a medical practitioner;

(d) a veterinary surgeon;

(e) a dental practitioner.

(4) A pharmacist or a druggist may sell any medicine listed under Schedule 3 only upon the prescription of:

(a) a medical practitioner; or

(b) a dental practitioner.

(5) A veterinary surgeon may only sell a medicine listed in schedule 2 or 3 if the medicine is for the treatment of animals.

(6) A dental practitioner may only sell a medicine listed in schedule 2 or 3 if the medicine relates to the practice of dentistry.

(7) A wholesaler approved by the Ministry of Health may only sell a medicine listed in schedule 2 or 3 to the persons mentioned in subregulation (3).

(8) Despite subregulation (3), a person approved by the Ministry of Health may supply a medicine listed on the Essential Drug List within the normal course of his or her duties.

2A. Urgent supply(1) Despite regulation 2(4), a pharmacist may sell a medicine listed under Schedule 3 to a person

who visits Vanuatu on a tourist visa if the pharmacist is satisfied that the person:

(a) is under a medical treatment which requires him or her to use the medicine continuously for the period of the treatment; and

(b) has not brought the medicine with him or her during the period of the visit.

(2) A pharmacist referred to in subregulation (1) may sell a sufficient supply of medicine for the duration of a maximum period of 32 days to a person who meets the criteria under paragraphs (a) and (b) of subregulation (1).

(3) A pharmacist may sell a 3 day supply of a medicine listed under Schedule 3 to a resident if the pharmacist is satisfied that the resident:

(a) is in urgent need for the medicine; and

(b) is under medical treatment that requires the use of the medicine; and

(c) requires continuous treatment for his wellbeing.

3. Notices(1) The Principal Pharmacist may issue such notices as he deems fit for the proper carrying out of

these regulations.

(2) Any notice issued under this regulation shall be published in the Gazette.1

1 Editor’s note: A Principal Pharmacist’s Notice was published in August 2005. This Notice follows the Schedules to these Regulations.

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SCHEDULE 1

AMMONIATED MERCURYALGINIC ACID and ALGINATEALMOND OILALUMINIUM CARBONATEALUMINIUM HYDROXIDE in preparations for oral use.ALUMINIUM OXIDEAMINACRINE for use in dental gels.AMINOACETIC ACIDAMINOBENZOIC ACID for external use.AMMONIUM CHLORIDE mixture.AMMONIUM ACETATE strong solution.AMYLMETOCRESOL for use in oral pastilles.ANISE OILANTACIDSARACHIS OILARNICA preparations for external use.ASCORBIC ACIDASPIRIN(a) except when included in Schedule 3;(b) when in individually wrapped powders or sachets of granules each containing 650 milligrams or less of

aspirin as the only therapeutically active constituent when – (i) the pack is labelled with the warning statement-

WARNING - THIS MEDICATION MAY BE DANGEROUS WHEN USED IN LARGE AMOUNTS OR FOR A LONG PERIOD; orCAUTION-THIS PREPARATION IS FOR THE RELIEF OF MINOR AND TEMPORARY AILMENTS AND SHOULD BE USED STRICTLY AS DIRECTED. PROLONGED USE WITHOUT MEDICAL SUPERVISION COULD BE HARMFUL; and

(ii) in a primary pack containing not more than 12 such powders or sachets of granules, or

(c) when in tablets or capsules each containing 325 milligrams or less of aspirin as the only therapeutically active constituent when –

(i) the pack is labelled with the warning statement –

WARNING-THIS MEDICATION MAY BE DANGEROUS WHEN USED IN LARGE. AMOUNTS OR FOR A LONG PERIOD; orCAUTION-THIS PREPARATION IS FOR THE RELIEF OF MINOR AND TEMPORARY AILMENTS AND SHOULD BE USED STRICTLY AS DIRECTED. PROLONGED USE WITHOUT MEDICAL SUPERVISION COULD BE HARMFUL

(ii) packed in blister or strip packaging or in containers with a child-resistant closure; and

(iii) in a primary pack containing not more than 25 such tablets or capsules, or

(d) when compounded with codeine as per schedule 1 entry for codeine.

AZADIRACHTA INDICA extracts (neem extracts), extracted from neem seed kernels using water, methanol or ethanol, in preparations containing 5 per cent or less of total limonoids, for agricultural use.BASIL OILBAY OILBEESWAX

BENZAMINE when included in – (a) lozenges, pastilles, tablets or capsules containing 30 mg or less of benzamine in each; or(b) suppositories or bougies containing 200 mg or less of benzamine in each; or(c) preparations for external use, other than eye drops, containing 10 per cent or less of benzamine.

BENZOCAINE when included in –(a) lozenges, pastilles, tablets or capsules containing 30 mg or less of benzocaine in each; or(b) suppositories or bougies containing 200 mg or less of benzocaine in each; or(c) preparations for external use, other than eye drops, containing 10 per cent or less of benzocaine.

BENZOIC ACID for external use.BENZALKONIUM CHLORIDE as lozenges or in preparations for external useBENZOYL PEROXIDE in preparations for external human therapeutic use containing 5 per cent or less of benzoyl peroxide. BENZYDAMINE in preparations for topical use containing 3 per cent or less of benzydamine.BENZYL ALCOHOL for external use.BENZYL BENZOATE application BP.

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BENZYL CINNAMATE for external use.BERGOMOT OILBISMUTH OXIDE for external use.BORIC ACID and BORAX

BUTYLAMINOBENZOATE when included in – (a) Lozenges, pastilles, tablets or capsules containing 30 mg or less of butylaminobenzoate in each; or(b) suppositories or bougies containing 200 mg or less of butylaminobenzoate in each; or(c) preparations for external use, other than eye drops, containing 10 per cent or less of

butylaminobenzoate.

CALAMINE preparations for topical use.CALCIUM CARBONATE BPCALCIUM CHLORIDE for oral use.CALCIUM GLUCONATE for oral use.CALCIUM LACTATE for oral use.CALCIUM PHOSPHATE for oral use.CARDAMOMCASSIA OILCASTOR OIL BPCARBETAPENTANE except in preparations containing 0.5 per cent or less of carbetapentane.CETALKONIUM CHLORIDECETOMACROGOL for use in external preparations.CETOSTEARYL ALCOHOLCETRIMIDE cream, ointment or liquid.CETYL ALCOHOLCETYLPYRIDINIUM CHLORIDE

CODEINE when compounded with aspirin, paracetamol or salicylamide or any one of their derivatives, in tablets or capsules each containing 10 mg or less of codeine, and no other analgesic substance, when –

(a) packed in blister or strip packaging or in containers with child-resistant closures;and(b) in a primary pack containing 25 or less dosage units; and

(c) one pack may only be supplied at a time to one person.

CHAMOMILE extract for external use.CHLORHEXIDINE solutions for external use (including mouthwash) and other topical products.CHLOROCRESOL for external use.CHOLINE SALICYLATE for external use or for teething gels containing 0.9 per cent or less of choline salicylate.CINEOLECINNAMIC ACID (maximum strength 500mcg) or external preparations.CINNAMON LEAF OILCLOVE OILCOD LIVER OIL preparations.COLLOIDAL OATMEALCREOSOTE, for therapeutic use, except in preparations containing 3 per cent or less of phenols included in Schedule 1.CROTAMITON for external use.CUPRIMYXIN for the treatment of animals.DEMBREXINE in oral preparations for the treatment of animals.TRANS-4-((3,5-DIBROMO-2-HYDROXYBENZYL) AMINO) CYCLOHEXANOL HYDROCHLORIDE MONOHYDRATE (Sputolysin) in oral preparations for the treatment of animals.DICHLOROBENZYL ALCOHOL for use in oral pastilles.DICHLOROPHEN for treatment of animals.DIMETHICONE for external use. DIMETHYL SULFOXIDE for the treatment of animals.DIPHEMANIL METHYLSULPHATE in preparations for topical use. DITHIAZANINE in preparations containing 2 per cent or less of dithiazanine for the treatment of animals.DORAMECTIN for external use for the treatment of animals in preparations containing 2 per cent or less of doramectin.DOCOSAHEXANOIC ACID.DOCUSATE preparations.EICOSAPENTAENOIC acidETHER except when included in schedule 2 or 3 or in preparations containing 10 per cent or less of ether.EUCALYPTUS OILFENBENDAZOLE for the treatment of animals.FLUBENDAZOLE for treatment of animals.FOLIC ACID in preparations for oral use.FRIARS BALSAMFULLERS EARTH Powders BPGLUTARALDEHYDE for human therapeutic use.

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GLYCERIN BPGLYCERIN THYMOL BPGLYCERYL MONOSTEARATEGENTIAN VIOLET GRIPE WATER (alcohol free)GUAIPHENESIN (a) when in liquid preparations containing 2 per cent (200 mg/10 mi) or less of guaiphenesin; or (b) when in divided preparations containing 120 mg or less of guaiphenesin in each dosage unit.

HALIBUT LIVER OILS preparations.HEPARIN for external use.HEXACHLOROPHANE in preparations for human skin cleansing purposes containing 3 per cent or less of hexachlorophane except in preparations for use on infants as specified in Schedule 3. HUMAN CHORIONIC GONADOTROPHIN OR ANTIBODY in pregnancy test kits. HYDROGEN PEROXIDE solutions in strengths not exceeding 30 vols.ICHTHAMMOL GLYCERININOSITOLIODINE except when included in Schedule 2.IRON COMPOUNDS for human internal use(a) except when included in Schedule 3; (b) when in divided preparations containing 5 mg or less of iron per dosage unit; or(c) when in liquid oral preparations containing 0.1 per cent or less of iron.

ISOPROPYL MYRISTATE for external useISPHAGULA HUSK LACTITOL preparationsLACTULOSE for therapeutic use.LECITHINLEMON OILLEVOMENTHOL for inhalation

LIGNOCAINE when included in – (a) lozenges, pastilles, tablets or capsules containing 30 mg or less of lignocaine in each; (b) suppositories or bougies containing 200 mg or less of lignocaine in each; or(c) preparations for external use, other than eye drops, containing 10 per cent or less of lignocaine.

LINDANE in preparations for external human therapeutic use containing 2 per cent or less of lindane. LIME OILLIQUID PARAFFINLIQUORICE extractLUTEINISING HORMONE ANTIBODIES in human ovulation test kits. MAGNESIUM ALGINATEMAGNESIUM CARBONATE BP MAGNESIUM HYDROXIDE BPMAGNESIUM STEARATEMAGNESIUM SULPHATE pasteMAGNESIUM TRISILICATE mixture and powder BPMALDISON in preparations for external human therapeutic use containing 2 per cent or less of maldison. MERCURY ORGANIC COMPOUNDS for topical therapeutic use in preparations containing 0.5 per cent or less of mercury. MENTHOLMETHYL SALICYLATE for external useMILBEMYCIN OXIME for the prophylaxis of heartworm in dogs and cats. MOXIDECTIN for the treatment of animals.MULTIVITAMIN preparations see vitaminsMYRRH tinctureNALIDIXIC ACID when packed and labelled for the treatment of ornamental fish.NETOBIMIN for the treatment of animalsNICOTINAMIDE tablets BPNICOTINE in preparations containing 3 per cent or less of nicotine when labelled and packed for the treatment of animals.NONOXYNOL preparationsNUTMEG OILOESTRADIOL in implant preparations for growth promotion in animalsOLBAS OILOLIVE OIL for therapeutic useORAL REHYDRATION sachetsORANGE OILOXANTEL EMBONATE in the treatment of animalsOXFENDAZOLE in the treatment of animals

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OXIBENDAZOLE in the treatment of animalsOXYTETRACYCLINE in the treatment of animalsPADIMATEPHENAZONE in the treatment of animalsPECTIN PARACETAMOL-

(a) except when included in Schedule 3;

(b) when in individually wrapped powders or sachets of granules each containing 1,000 milligrams or less of paracetamol as the only therapeutically active constituent when –


WARNING - THIS MEDICATION MAY BE DANGEROUS WHEN USED IN LARGE AMOUNTS OR FOR A LONG PERIOD; orCAUTION - THIS PREPARATION IS FOR THE RELIEF OF MINOR AND TEMPORARY AILMENTS AND SHOULD BE USED STRICTLY AS DIRECTED. PROLONGED USE WITHOUT MEDICAL SUPERVISION COULD BE HARMFUL; and

(ii) in a primary pack containing not more than 12 such powders or sachets of granules;

(c) when in tablets or capsules each containing 500 milligrams or less of paracetamol as the only therapeutically active constituent when –


WARNING - THIS MEDICATION MAY BE DANGEROUS WHEN USED IN LARGE AMOUNTS OR FOR A LONG PERIOD; orCAUTION - THIS PREPARATION IS FOR THE RELIEF OF MINOR AND TEMPORARY AILMENTS AND SHOULD BE USED STRICTLY AS DIRECTED. PROLONGED USE WITHOUT MEDICAL SUPERVISION COULD BE HARMFUL; and


(iii) in a primary pack containing not more than 25 such tablets or capsules.

(d) when compounded with codeine as per Schedule 1 entry for codeine.

PEPPERMINT OIL capsulesPEROXYLPETROLEUM JELLY BP white and yellowPHENOL and any homologue of phenol boiling between 220 C, for human therapeutic use, in preparations containing 3 per cent or less by weight of such substances.

PHENYLEPHRINE except when included in schedule 2 or 3 –(a) when in preparations containing 0.5 per cent or less of phenylephrine, or(b) when in preparations for external use containing 1 per cent or less of phenylephrine

PIPERAZINE for animal use. POLYSORBATES.POTASSIUM HYDROXIDE for external use.POTASSIUM THIOCYABATE for external use.POVIDONE IODINE for external use. PROFLAVINE HEMISULPHATE for external use.PROPYLENE GLYCOL for external use.PYRANTEL for human therapeutic use.PYRITHIONE ZINC for human therapeutic use, in preparations containing 2 per cent or less of pyrithione zinc, when –(a) in semisolid hair preparations; or(b) in shampoos.

SAGE OIL.SASSAFRAS OIL. SALICYLIC ACID preparations for topical use in concentrations less than 40%.

SALICYLAMIDE

(a) except when included in Schedule 3; or

(b) when in individually wrapped powders or sachets of granules each containing 1,000 milligrams or less of salicylamide as the only therapeutically active constituent when –

(i) the pack is labelled with the warning statement – WARNING – THIS MEDICATION MAY BE DANGEROUS WHEN USED IN LARGE AMOUNTS OR FOR A LONG PERIOD; or

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CAUTION – THIS PREPARATION IS FOR THE RELIEF OF MINOR AND TEMPORARY AILMENTS AND SHOULD BE USED STRICTLY AS DIRECTED. PROLONGED USE WITHOUT MEDICAL SUPERVISION COULD BE HARMFUL; and

(ii) in a primary pack containing not more than 12 such powders or sachets of granules; or

(c) when in tablets or capsules each containing 500 milligrams or less of salicylamide as the only therapeutically active constituent when –


WARNING – THIS MEDICATION MAY BE DANGEROUS WHEN USED IN LARGE AMOUNTS OR FOR A LONG PERIOD; orCAUTION – THIS PREPARATION IS FOR THE RELIEF OF MINOR AND TEMPORARY AILMENTS AND SHOULD BE USED STRICTLY AS DIRECTED. PROLONGED USE WITHOUT MEDICAL SUPERVISION COULD BE HARMFUL; and


(iii) in a primary pack containing not more than 25 such tablets or capsules.

(d) when compounded with codeine as per schedule 1 entry for codeine.

SARSAPARILLASENNA preparationsSHARK LIVER OIL for external useSODIUM BICARBONATE except when included in Schedule 3.SOYA OILSTERCULIASUNFLOWER OILSUNSCREEN preparationSULFACETAMIDE when packed and labelled for the treatment of ornamental caged birds or ornamental fish.SULFADIAZINE when packed and labelled for the treatment of ornamental caged birds or ornamental fish.SULFADIMIDINE when packed and labelled for the treatment of ornamental caged birds or ornamental fish.SULFAMERAZINE when packed and labelled for the treatment of ornamental caged birds or ornamental fish.

SULFAQUINOXALINE when (a) packed and labelled for use as a coccidiostat in poultry except in preparations containing 200mg/kg or less

of sulfaquinoxaline. sulfaquinoxaline when incorporated in:

(i) baits of destruction of vermin; or

(ii) animal feeds containing 200mg/kg or less of sulfaquinoxaline; or

(iii) when packed and labelled solely for use as a herbicide.

SULFATHIAZOLE when packed and labelled for the treatment of ornamental caged birds or ornamental fish.

TETRACYCLINE(a) in preparations for topical application to animals for ocular use; or(b) containing not more than 100,000 IU of tetracycline per dose, for intramammary infusion in animals; or(c) containing 40 per cent or less of tetracycline, when packed and labelled for the treatment of ornamental

caged birds or ornamental fish.

TESTOSTERONE in implant preparations for use in animals.TETRAMISOLE in preparations for the treatment of animals.TOLNAFTATE for tinea pedisTULLE dressingUNDECANOATES for external useVITAMINS and MINERAL preparations containing less than 7500 IU vitamin A (retinol) and/or less than 50mg vitamin B6 (pyridoxine) per dosage unit. WARFARIN in rodent baits containing 0.1 per cent or less of warfarin.WITCH HAZEL preparations for external use (excluding eye preparations)XYLOMETAZOLINE drops and spraysZINC CARBONATE for external use.ZINC OXIDE for external use containing 5 per cent or less of zinc.

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SCHEDULE 2

ACEPIFYLLINE in liquid oral preparations. ACETIC ACID (excluding its salts and derivatives) and preparations containing more than 80 per cent of acetic acid, for therapeutic use. ACETYLCYSTEINE as eye drops. ACICLOVIR in topical preparations containing 5 per cent or less of aciclovir.ACTIVATED CHARCOAL preparations ADRENALINE in preparations containing 1 per cent or less of adrenaline except in preparations containing 0.02 percent or less of adrenaline.ALBENDAZOLE in the treatment of animalsALCLOMETASONE in preparations for dermal use, as the only therapeutically active agent, containing 0.05 per cent or less of alclometasone.ALOXIPRIN ALLANTOIN for external useALOESALOINALUMINIUM CHLORIDE HEXAHYDRATE for external useAMETHOCAINE in preparations for topical use, other than eye drops, containing 10 per cent or less of total anaesthetic substances.AMINOPHYLLINE in liquid oral preparations containing 2 per cent or less of aminophylline. AMMONIATED MERCURYAMOROLFINE for topical use in preparations containing 0.25 per cent of less of amorolfine.ANTAZOLINE in eye drops. ASPERGUMASPIRIN except when included in Schedule 1 or 3.

ATROPINE, except atropine methonitrate included in Schedule 3 – (a) when in preparations containing 0.25 per cent or less of atropine; or(b) atropine sulphate, 0.6 mg tablets in packs of 6, when labelled for

treatment of organophosphorus poisoning.

AZATADINE in oral preparations.AZELAIC ACID in dermal preparations.AZELASTINE in nasal preparations.BANDAGES impregnated with anti-bacterial agents.BECLOMETHASONE in aqueous nasal sprays for the prophylaxis or treatment of allergic rhinitis, for up to 6 months use.BELLADONNA in preparations containing 0.25 per cent or less of the alkaloids of belladonna, calculated as hyoscyamine.BENZOYL PEROXIDE in preparations containing 10 per cent or less of benzoyl peroxide for external human therapeutic use, except when included in Schedule 1. BEPHENIUM SALTSBIFONAZOLE in preparations for dermal use except in preparations containing 1 per cent or less of bifonazole for the treatment of the scalp.BISACODYL preparationsBORAX (sodium borate) for therapeutic useBORIC ACID for external use

BORON for external human therapeutic use:(a) in glycerines or honeys of borax or boric acid; or(b) in dusting powders for paediatric use; or(c) as a therapeutically active ingredient in other preparations for dermal use except:

(i) in antifungal preparations; or (ii) in preparations containing 0. 1 per cent or less of boron.

BROMHEXINEBROMPHENIRAMINE in oral preparations BUCLIZINE in oral preparations.BUDESONIDE in aqueous nasal sprays for the prophylaxis or treatment of allergic rhinitis, for up to 6 months use.CADEXOMER-IODINE preparationsCAFFEINE oral preparations for human therapeutic use.CAMPHORCARBARYL in preparations for external human therapeutic use containing 2 per cent or less of carbaryl.CARBENOXOLONE for oral use.CARBOCISTEINE.CARBOMER eye drops/gels.CARBENOXOLONE for topical oral use

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CETIRIZINE in preparations for oral useCETRIMIDE shampooCHLORAL HYDRATE for human internal therapeutic use in preparations containing 5 per cent or less of chloral hydrate, when packed in containers of 100 ml or lessCHLORBUTOL for human use in topical preparations containing more than 0.5 per cent and less than 5 per cent of chlorbutol. CHLOROCRESOLCHLOROFLUOROCARBONS - See FLUOROCARBONS

CHLOROFORM in preparations for therapeutic use except – (a) when included in Schedule 3; or(b) in preparations containing 0.5 per cent or less of chloroform.

CHLOROQUINE tablet 150mg for uncomplicated malaria, maximum of 3 days treatment. CHLOROTHYMOL containing productsCHLOROXYLENOLCHLORPHENIRAMINE in oral preparations.CHOLINE SALICYLATE for external useCICLOPIROX in preparations for dermal use.CIMETIDINE for relief of symptoms of gastro-oesophageal reflux, in packs containing not more than 14 days supply.CINCHOCAINE for external use other than eye drops.CINNAMEDRINECINNARIZINECLEMASTINE in oral preparations. CLOBETASONE for dermal useCLOTRIMAZOLE for human use in preparations for dermal or vaginal use.COAL TAR preparations for external use

CODEINE when compounded with one or more other therapeutically active substances:(a) in divided preparations containing 15mg or less per dosage unit of codeine and with a recommended

dose not exceeding 30mg of codeine; or(b) in undivided preparations containing 0.25 per cent or less of codeine and with a recommended dose not

exceeding 30mg of codeine; or(c) where the quantity supplied in not more than a reasonable amount for personal use, except when

included in Schedule 1.

COTRIMOXAZOLE (trimethoprim with sulfamethoxazole) for minor infections where a maximum of 7 days treatment may be supplied.CRYSTAL VIOLETCYPROHEPTADINE in oral preparations.

DATURA spp. for oral use:(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids; or(b) in divided preparations containing 0.3mg or less of total solanaceous alkaloids per dosage unit, except if separately specified in these Schedules.

DATURA STRAMONIUM (Stramonium) for oral use;(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids; or(b) in divided preparations containing 0.3mg or less of total solanaceous alkaloids per dosage unit,except for smoking or burning.

DATURA TATULA (Stramonium) for oral use:(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids; or(b) in divided preparations containing 0.3mg or less of total solanaceous alkaloids per dosage unit;except for smoking or burning.

DELPHINIUM STAPHISAGRIA except in preparations containing 0.2 per cent or less of delphinium staphisagria.DESLORATADINE in preparations for oral useDEXCHLORPHENIRAMINE in oral preparations DEXTROMETHORPHAN when compounded with one or more other therapeutically active substances in such a way that the dextromethorphan contained therein cannot be readily extracted, when – (a) in divided preparations containing 30 mg or less per dosage unit and with a recommended dose

not exceeding 30 mg of dextromethorphan; or(b) in undivided preparations containing 0.3 per cent or less of dextromethorphan with a

recommended dose not exceeding 30 mg of dextromethorphan.

DICHLOROPHEN for internal human therapeutic use.

DICLOFENAC when –(a) oral preparations of 25mg or less per dosage unit in pack size up to 30 dosage units; and(b) as a preparation for external use.

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DICYCLOMINE in preparations containing 0.1 per cent or less dicyclomine.

DIHYDROCODEINE, when compounded with one or more other therapeutically active substances when – (a) in divided preparations containing 10 mg or less per dosage unit and with a recommended dose

not exceeding 15 mg of dihydrocodeine; or(b) in undivided preparations containing 0.25 per cent or less of dihydrocodeine with a

recommended dose not exceeding 15 mg of dihydrocodeine.

DI-IODOHYDROXYQUINOLONE for vaginal useDIMENHYDRINATE in oral preparations. DIMETHINDENE in oral preparations. DIPHENHYDRAMINE in oral preparations. DIPHENOXYLATE in packs of 8 or less dosage units, each dosage unit containing 2.5mg or less of diphenoxylate and a quantity of atropine sulphate equivalent to at least 1 per cent of the dose of diphenoxylate. DIPHENYLPYRALINE in oral preparations.DITHRANOL for human therapeutic use. DOXYLAMINE in oral preparations.

DUBOISIA LEICHARDTII for oral use.(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids; or(b) in divided preparations containing 0.3mg or less of total solanaceous alkaloids per dosage unit.

DUBOISIA MYOPOROIDES for oral use;(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids; or(b) in divided preparations containing 0.3mg or less of total solanaceous alkaloids per dosage unit.

ECONAZOLE for human use in preparations for dermal or vaginal useEPHEDRINE in nasal drops containing 0.5 per cent or less of ephedrine.ERYTHRITYL TETRANITRATE for therapeutic use.ERYTHROMYCIN for minor infections where a maximum of 7 days treatment may be supplied.ETHOHEPTAZINE in preparations containing 1 per cent or less of ethoheptazine.

ETHYLMORPHINE, when compounded with one or more other therapeutically active substances – (a) in divided preparations containing 10 mg or less per dosage unit and with a recommended dose

not exceeding 15 mg of ethylmorphine; or(b) in undivided preparations containing 0.25 per cent or less of ethylmorphine with a

recommended dose not exceeding 15 mg of ethylmorphine.

ETHER for therapeutic use except when included in Schedule 3.ETOFENAMATE for preparations for external use.FAMOTIDINE for relief of symptoms of gastro-oesophageal reflux, in packs containing not more than 14 days supply.FELBINAC in preparations for external useFENOTEROL in metered aerosols delivering 200 micrograms or less of fenoterol per metered dose. FEXOFENADINE for oral useFLAVOXATE

FLUORIDES for human therapeutic use:(a) Sodium fluoride, in preparations for ingestion containing 2.2 mg or less of sodium fluoride per dosage

unit, or in preparations for topical use except –(i) In dentifrices containing 1,000 mg/kg or less of fluoride ion; or (ii) In substances containing 15 mg/kg or less of fluoride ion.

FLUCONAZOLE for dermal or vaginal useFLUNISOLIDE in aqueous nasal sprays for the prophylaxis or treatment of allergic rhinitis, for up to 6 months use.FLURBIPROFEN in divided preparations for topical or oral use containing 10mg or less of flurbiprofen per dosage unit.FLUOROCARBONS and CHLOROFLUOROCARBONS alone or in combination with other propellants or refrigerants in liquefied gas form for therapeutic use. FLUORIDES dentrifices containing more than 1000mg/kg of fluoride ionFLUTICASONE in nasal spray for prophylaxis or allergic rhinitis for short term use.FORMALDEHYDE (excluding its derivatives) for human therapeutic use except in preparations containing 5 per cent or less of formaldehyde.GELSEMIUM SEMPERVIRENS.GLUTARALDEHYDE for human therapeutic use.GLUCAGONGLYCERYL TRINITRATE for therapeutic use except when included in Schedule 3 GLYCOPYRROLATE except when included in Schedule 3.HEXACHLOROPHANE in preparations for human skin cleansing purposes containing 3 per cent or less of hexachlorophane except in preparations for use on infants as specified in Schedule 3 HOMATROPINE in preparations containing 0.25 per cent or less of homatropine. HUMAN CHORIONIC GONADOTROPHIN or antibody in pregnancy test kits.

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HYDROCORTISONE and HYDROCORTISONE ACETATE Containing 1 per cent or less of hydrocortisone(a) for dermal use in packs containing 30g or less and containing no other therapeutically active agent except

for an antifungal;(b) for rectal use, in packs containing 35g or less or 12 suppositories or less but no other therapeutically active

substance except a local anaesthetic or astringent.

HYDROGEN PEROXIDE except when included in Schedule 1

HYOSCINE, except hyoscine butylbromide when included in Schedule 2 or 3 – (a) when in preparations containing 0.25 per cent or less of hyoscine; or (b) in transdermal applicators containing 2 mg or less of hyoscine.

HYOSCINE BUTYLBROMIDE as the only therapeutically active ingredient in a pack containing 200mg or less of hyoscine butylbromide.HYOSCYAMINE in preparations containing 0.25 per cent or less of hyoscyamine. HYOSCYAMUS NIGER in preparations containing 0.25 per cent or less of the alkaloids of hyoscyamus calculated as hyoscyamine. HYPROMELLOSE eye drops

IBUPROFEN when: (a) oral preparations of 200mg or less per dosage unit in pack size up to 30 dosage units; and(b) as a preparation for external use

IDOXURIDINE in preparations containing 0.5 per cent or less of idoxuridine for cutaneous use.INDANAZOLINE

INDOMETHACIN when –(a) oral preparations of 25mg or less per dosage unit in pack size up to 30 dosage units; or(b) as a preparation for external use

INOSITOL NICOTINATE.INSULINIODINE (excluding its salts, derivatives and iodophors), in preparations for human therapeutic use containing more than 2.5 per cent of available iodine.IPRATROPIUM as a nasal spray.IRON COMPOUNDS for human internal use with a recommended daily dose of 24mg of elemental iron or less.ISOCONAZOLE for human use in dermal or vaginal preparationsISOPROPAMIDE in preparations containing 2 per cent or less of isopropamide for cutaneous use. ISOSORBIDE DINITRATE for therapeutic use. IVERMECTIN for use in animals.KETOCONAZOLE for human use as a preparation for dermal or vaginal use

KETOPROFEN when –(a) oral preparations of 25mg or less per dosage unit in pack size up to 30 dosage units; and(b) as a preparation for external use containing 1% or less.

LACTULOSE in preparations for human therapeutic use.LEVOCABASTINE in topical eye or nasal preparations.LIQUID PARAFFIN preparations for internal use.LITHIUM preparations for therapeutic dermal use containing 1 per cent or less of lithium except in preparations containing 0.01 per cent or less of lithium.LOBELIA in preparations containing 0.5 per cent or less of lobeline, except in preparations for smoking or burning. LOBELINE except for preparations for smoking or burning.LODOXAMIDE in preparations for ophthalmic use.LOPERAMIDE in packs of 8 dosage units or less, each dosage unit containing 2 mg or less of loperamide.LORATADINE for oral use.MACROGOL 3350 for bowel cleansing prior to diagnostic medical or surgical procedures.MALDISON in preparations for external human therapeutic use except in preparations containing 2 per cent or less of maldison.MANNITYL HEXANITRATE for therapeutic use.MEBENDAZOLE in the treatment of animals.MEFENAMIC ACID in packs of 30 or less dosage units for treatment of spasmodic dysmenorrhoea. MERCURY ORGANIC COMPOUNDS for topical human therapeutic use, in preparations containing 0.5 per cent of less of mercury.MEPYRAMINE in oral preparations. METHDILAZINE in oral preparations.

METHOXAMINE except – (a) preparations containing 0.5 per cent or less of methoxamine; or(b) preparations for external use containing 1 per cent or less of methoxamine.

METHOXYPHENAMINEMETHYLEPHEDRINE

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METOCLOPRAMIDE packaged and labelled for the treatment of nausea in packs containing not more than 10 dosage units and supplied under medical advice.MICONAZOLE for human use in preparations for dermal or vaginal use.MINOXIDIL in preparations for dermal use containing 5 per cent or less of minoxidilMOMETSONE in aqueous nasal sprays for the prophylaxis or treatment of allergic rhinitis, for up to 6 months use.MUCOPOLYSACCHARIDE for external use.NAPHAZOLINE

NAPROXEN when –(a) oral preparations of 275mg or less per dosage unit in pack size up to 30 dosage units; and(b) as a preparation for external use containing 1% or less.

NICLOSAMIDE for human therapeutic use. NICOTINE in patches, gums, inhalers and other products for the purpose of smoking cessation with appropriate counselling from pharmacist or druggist.

NICOTINIC ACID for human therapeutic use except(a) in preparations containing 100mg or less of nicotinic acid per dosage unit; or(b) nicotinamide

NICOTINYL ALCOHOL except in preparations containing 100mg or less of nicotinyl alcohol per dosage unit.NIZATADINE for relief of symptoms of gastro-oesophageal reflux, in packs containing not more than 14 days supply.NITRIC ESTERS of polyhydric alcohols for therapeutic use except when separately specified in these Schedules.NITROFURAZONE in preparation for cutaneous use containing 0.2 per cent or less of nitrofurazone. NOSCAPINE NYSTATIN as oral drops, dermal and vaginal preparations.OXETHAZAINE (oxetacaine) in preparations for internal use only. OXYMETAZOLINE PANCREASE preparationsPARACETAMOL except when included in Schedule 1 or 3. PARADICHLOROBENZENE containing ear preparations.PAPAVERINE PARAFORMALDEHYDE for human therapeutic use except in preparations containing 5 per cent or less of paraformaldehyde.PENCICLOVIR for topical use containing 5% or less of penciclovir.PERMETHRIN in lice preparations.PHEDRAZINE PHENAMAZOLINE PHENAZONE for external use. PHENIRAMINE in oral preparations. PHENOTHRIN in lice preparations.PHENOXYMETHYLPENICILLIN for minor infections where a maximum of 7 days treatment may be supplied.

PHENYLEPHRINE except – (a) when included in Schedule 3; or(b) preparations containing 0.5 per cent or less of phenylephrine; or(c) preparations for external use containing 1 per cent or less of phenylephrine.

PHENYLPROPANOLAMINE in preparations for relief of coughs or colds, containing 25 mg or less per dose of phenylpropanolamine. PHENYLTOLOXAMINE in oral preparations.

PHOLCODINE, – (a) when compounded with one or more other therapeutically active substances in divided preparations

containing 10 mg or less of pholcodine per dosage unit and with a recommended dose not exceeding 25 mg of pholcodine; or

(b) in undivided preparations containing 0.5 per cent or less of pholcodine and with a recommended dose not exceeding 25 mg of pholcodine.

PHOSPHATE based enemas.PHOSPHATE tablets for internal use.PHYTOMENADIONE PIPERAZINE preparations for oral use.PODOPHYLLUM RESIN (Podophyllin) in preparations containing 20 per cent or less of podophyllin for external use on warts other than anogenital warts. PODOPHYLLOTOXIN in preparations containing 1 per cent or less of podophyllin for external use on warts other than anogenital warts.POLYETHYLENE GLYCOLSPOLYVINYL ALCOHOL eye preparation.POTASSIUM BICARBONATEPOTASSIUM CHLORIDE preparations.

12



POTASSIUM CHLORATE for therapeutic use except in preparations containing 10 per cent or less.POTASSIUM CITRATE mixturePOTASSIUM PERMANGANATE.PRAMOXINE when included in preparations for external use, other than eye drops, containing 1 per cent or less of pramoxine.PRILOCAINE in preparations for topical use other than eye drops, containing 10 per cent or less of total anaesthetic substances.PROCHLORPERAZINE packaged and labelled for the treatment of nausea in packs containing not more than 10 dosage units.PROCYCLIDINE in preparations containing 5 per cent or less of procyclidine for cutaneous use.PROMETHAZINE in oral preparations. PROPYL SALICYLATE for external use.PROPYLENE GLYCOL for internal use.PROPYLHEXEDRINE in appliances for inhalation in which the substance is absorbed upon an inert solid material.

PSEUDOEPHEDRINE, where the quantity supplied is not more than a reasonable amount for personal use and,(a) in divided preparations containing 60 mg or less of pseudoephedrine per recommended dosage unit

either as a single active agent or in combination with other therapeutically active agents; or(b) in liquid preparations containing 60 mg or less of pseudoephedrine per recommended adult dose

either as a single active agent or in combination with other therapeutically active agents

PULVERIZED MAIZEPYRANTEL for human therapeutic use.QUININE for human internal therapeutic use for the treatment of cramps except in liquids containing 40 mg/L or less of quinine. RANITIDINE for relief of symptoms of gastro-oesophageal reflux, in packs containing not more than 14 days supply.RESORCINOL containing preparations.SULFACETAMIDE for preparations for ophthalmic with 10% or less of sulfacetamide.

SALBUTAMOL (a) in metered aerosols delivering 100 micrograms or less of salbutamol per metered dose; or(b) in capsules of dry powder for inhalation delivering 200 micrograms or less of salbutamol per dose.

SALICYLIC ACID for dermal use containing more than 40% salicylic acid.SALICYLAMIDE except when included in Schedule 1 or 3.SANTONIN SELENIUM SULPHIDE for external use.SILVER for therapeutic use except in preparations containing 1 per cent or less of silver.SIMETHICONE in infant colic drops.SOAP SPIRITSODIUM CITRATE based enemas.SODIUM CROMOGLYCATE in nasal preparations or eye drops.SODIUM LACTATE for external use.SODIUM LAURYL SULPHATESODIUM NITRITE for therapeutic use ( excluding when included as an excipient)SODIUM PHOSPHATE in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures.SODIUM PICOSULFATE in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures.SORBIC ACIDSORBITOL in preparations for human therapeutic use.SQUILL except in preparations containing 1 per cent or less of squill.STRAMONIUM in preparations containing 0.25 per cent or less of the alkaloids calculated as hyoscyamine, except preparations for smoking or burning.SULCONAZOLE in preparations for dermal use. SULFACETAMIDE in preparations for ophthalmic use containing 10 per cent or less of sulfacetamide.SULFACONAZOLE in dermal use.SULFADOXINE with PYRIMETHAMINE 500mg/25mg (Fansidar™) tablet for treatment of malaria when required according to current standard practice.TERBINAFINE in preparations for dermal use.TERBUTALINE in metered aerosols delivering 250 micrograms or less of terbutaline per metered dose.TETRACHLOROETHYLENE for human therapeutic use.TETRACYCLINE eye ointment for use in infectious conjunctivitis. TETRAHYDROZOLINE THIABENDAZOLE in the treatment of animals.THENYLDIAMINE in oral preparations. THEOPHYLLINE in liquid oral preparations containing 2 per cent or less of theophyllineTHYMOL

13



TIOCONAZOLE for human in preparations for dermal or vaginal use.TRAMAZOLINE TRANEXAMIC ACID for treatment of menorrhagia.TRIAMCINOLONE ACETONIDE for treatment of mouth ulcers and nasal sprays only.TRICLOSAN

TRIMEPRAZINE (a) in solid oral preparations; or (b) in liquid oral preparations containing 10 mg or less of trimeprazine

per 5 ml.

TRIPROLIDINE in oral preparations.TUAMINOHEPTANE.TYMAZOLINE UREA HYDROGEN PEROXIDE or CARBAMIDE PEROXIDE ear dropsVITAMIN A for human therapeutic use except when included in Schedule 1or 3.XYLOMETAZOLINE ZINC CHLORIDE for human dermal use except in preparations containing 5 per cent or less of zinc chloride.ZINC SULPHATE eye drops.

ZINC COMPOUNDS for human internal use:(a) in preparations with a recommended daily dose of 25mg or less of zinc; or(b) in preparations with a recommended daily dose of more than 25mg but not more than 50mg of zinc when

labeled with a warning statement that it is dangerous to take a large amount of zinc for a long period of time.

SCHEDULE 3

(Substances marked # require special authorization from the Principal Pharmacist)

ABACAVIRABCIXIMABACAMPROSATE CALCIUMACARBOSEACEBUTOLOL ACEPIFYLLINE except when included in Schedule 2.ACEPROMAZINE ACETANILIDE and alkyl acetanilides, for human therapeutic use. ACETARSOLACETAZOLAMIDEACETOHEXAMIDE ACETYLCARBROMALACETYLCHOLINE and other choline esters except when separately specified in this Schedule. ACETYLCYSTEINE except when included in Schedule 2.ACETYLDIGITOXIN

ACETYL-DIHYDROCODEINE, when compounded with one or more other medicaments –(a) in divided preparations containing not more

than 100 mg of acetyldihydrocodeine per dosage unit; or

(b) in undivided preparations with a concentration of not more than 2.5 per cent of acetyldihydrocodeine.

ACETYLMETHYLDIMETHYLOXIMIDOPHENYLHYDRAZINE ACETYLSTROPHANTHIDINACICLOVIR expect when included in Schedule 2ACIPIMOX# ACITRETIN ACOKANTHERA OUABAIOACOKANTHERA SCHIMPERIACONITUMACTINOMYCIN D#ADAPALENEADENOSINE

ADIPHENINE ADONIS VERNALIS

ADRENALINE except – (a) when included in Schedule 2; or (b) in preparations containing 0.02 per cent or less of adrenaline.

ADRENOCORTICAL HORMONES except when separately specified in these Schedules.AGALSIDASE ALFAAGALSIDASE BETAAGLEPRISTONEALATROFLOXACIN MESYLATEALBENDAZOLE except when included in Schedule 2ALCLOFENACALCLOMETASONE except when included in Schedule 2ALCURONIUM SALTSALDESLEUKINALDOSTERONEALEFACEPTALENDRONATE SODIUMALENDRONIC ACIDALFACALCIDOLALFUZOSINALGLUCERASEALLERGENSALLOPURINOLALLYLOESTRENOLALOSETRONalpha-CHLORALOSE – See chloralose ALPHADOLONE ALPHAXALONE ALPRAZOLAM ALPRENOLOL ALPROSTADIL ALSEROXYLONALTEPLASEALTRENOGEST

14



ALTRETAMINE (hexamethylmelamine)AMANTADINE AMBENONIUM AMBUCETAMIDE AMBUTONIUM AMCINONIDEAMETHOCAINE except when included in Schedule 2AMIFOSTINEAMIKACIN AMILORIDE 3-AMINOBENZOIC ACID ETHYL ESTER METHANESULPHONATEAMINOCAPROIC ACID AMINOGLUTETHIMIDE AMINOMETRADINE AMINOPHENAZONE and derivatives therefrom for the treatment of animals. AMINOPHYLLINE except when included in Schedule 2. AMINOPTERIN 4-AMINOPYRIDINE for therapeutic use.AMINOREX AMINOSALICYCLIC ACIDAMIODARONE AMIPHENAZOLE AMISOMETRADINE AMISULPRIDEAMITRIPTYLINE and other compounds structurally derived therefrom by substitution in the side chain except when separately specified in this Schedule. AMLODIPINEAMMI VISNAGAAMMONIA BROMIDE for therapeutic use.AMODIAQUINE AMOROLFINE except when included in Schedule 2.AMOXAPINEAMOXYCILLINAMPHOMYCIN AMPHOTERICIN AMPICILLIN AMPRENAVIRAMRINONEAMSACRINE AMYL NITRITEAMYLOBARBITONE when packed and labelled for injection. AMYLOCAINE # ANABOLIC STEROIDAL AGENTS except when separately specified in this Schedule. ANAGRELIDEANAKINRAANASTROZOLEANCESTIMANCROD and its immunoglobulin antidote# ANDROGENIC STEROIDAL AGENTS.# ANDROISOXAZOLE# ANDROSTANOLONE# ANDROSTENEDIOL# ANDROSTENEDIONEANGIOTENSINAMIDE ANISTREPLASE ANTAZOLINE except when included in Schedule 2.

ANTIBIOTICS except (a) when separately specified in these Schedules; or(b) avoparcin when packed and labelled for use as an animal feed additive; or (c) nisin.

ANTIGENS for human therapeutic use except when separately specified in this Schedule.

ANTIHISTAMINES except(a) when included in Schedule 1 or 2; or (b) when separately specified in this Schedule.

ANTIMALARIAL SUBSTANCES except when separately specified in this Schedule. ANTIMONY, organic compounds of, for therapeutic use. ANTISERA (immunosera) for human use by injection except when separately specified in these Schedules.ANTITUBERCULAR SUBSTANCES including isoniazid and its derivatives, para-aminosalicyclic acid and thiacetazone except when separately specified in these Schedules.APOCYNUM spp.APOMORPHINE APRACLONIDINEAPRAMYCINAPREPITANTAPRONALAPROTININ APRECOLINEARSENIC - See THIACETARSAMIDE ARIPIPRAZOLEARTEMETHERASPIDOSPERMA QUEBRACHOASPIRIN when combined with caffeine, paracetamol or salicylamide or any derivative of these substances. ASTEMIZOLE# ATAMESTANE ATAZANAVIRATENOLOL ATIPAMEZOLEATOMOXETINEATORVASTATINATOVAQUONEATRACURIUM BESYLATEATROPA BELLADONNA (belladonna) except when included in Schedule 2.ATROPINE METHONITRATE ATROPINE except when included in schedule 2.AURANOFIN AUROTHIOMALATE SODIUM

AVILAMYCIN except(a) in animal feed premixes containing 15 per cent

or less of avilamycin activity ; or(b) in animal feeds containing 15 mg/kg or less of

avilamycin activity.

AVIPTADILAVOPARCIN AZACYCLONOLAZAPERONE AZAPETINE AZAPROPAZONEAZARIBINEAZATADINE except when included in Schedule 2.AZATHIOPRINEAZELAIC ACID except when included in Schedule 2.AZELASTINE except when included in Schedule 2.AZITHROMYCINAZLOCILLIN AZTREONAM BACAMPICILLIN

BACITRACIN except

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(a) in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances; or

(b) in milk replacers for calves and starter rations for pigs, containing 100 mg/kg or less of antibiotic substances.

BACLOFENBALSALAZIDEBAMBUTEROLBAMETHANBAMIPINE BARBITURIC ACID and its derivatives except when separately specified in this Schedule.BASILIXIMABBECAPLERMINBECLAMIDE BECLOMETHASONE except when included in Schedule 2.BEMEGRIDE BENACTYZINE and other substances structurally derived from diphenylmethane with ataractic properties when used for therapeutic purposes. BENAZEPRILBENDROFLUAZIDE BENETHAMINE PENICILLIN.BENORYLATE BENOXAPROFEN.BENPERIDOLBENSERAZIDE BENZAMINE, except when included in Schedule 1.BENZATHINE PENICILLINBENZHEXOL BENZILONIUM BENZOCAINE, except when included in Schedule 1.BENZODIAZEPINE derivatives except when separately specified in these Schedules. BENZOYL PEROXIDE in preparations for external human therapeutic use, except when included in Schedule 1 or 2. BENZPHETAMINE BENZTHIAZIDEBENZTROPINE BENZYDAMINE except when included in Schedule 1.BENZYLPENICILLIN (including procaine penicillin).BEPRIDILBERACTANTBETAHISTINE BETAMETHASONEBETAXOLOLBETHANECHOL CHLORIDEBETHANIDINE BEVANTOLOL# BEXAROTENEBEZAFIBRATEBICALUTAMIDEBIFONAZOLE except when included in Schedule 2.BIMATOPROSTBIPERIDEN

BISMUTH compounds of, for human therapeutic or cosmetic use, except – (a) bismuth citrate when incorporated in hair colourant preparations

in concentrations of 0.5 per cent or less; or(b) bismuth oxychloride in cosmetics; or (c) bismuth formic iodide or bismuth subiodide

in dusting powders containing 3 per cent or less of bismuth.

BISOPROLOLBIVALIRUDINBLEOMYCIN # BOLANDIN# BOLASTERONE# BOLAZINE# BOLDENONE (dehydrotestosterone)# BOLENOL# BOLMANTALATE

BORON for human therapeutic use – (a) for internal use; or(b) in glycerines or honeys of borax or boric acid; or(c) in dusting powders for paediatric use; or (d) as a therapeutically active ingredient in other

preparations for dermal use except -(i) in antifungal preparations; or (ii) in preparations containing 0. 1 per

cent or less of boron.

# BOSENTANBOTULINUM TOXINS for human use except when separately specified in the Schedules.BRETYLIUM TOSYLATEBRIMONIDINEBRINZOLAMIDEBROMAZEPAM BROMIDES, inorganic, for therapeutic use. BROMOCRIPTINE BROMOFORM for therapeutic use. BROMPHENIRAMINE except when included in Schedule 2. BROMVALETONE BRUGMANSIA sppBUCLIZINE except when included in Schedule 2. BUDESONIDE except when included in Schedule 2.BUFEXAMAC except in preparations containing 5 per cent or less of bufexamac for external human therapeutic use, including suppositories. BUMETANIDE BUPHENINEBUPIVACAINE BUPROPIONBUSERELINBUSPIRONE BUSULPHAN BUTACAINE BUTYLAMINOBENZOATE except when included in

Schedule 1.BUTYLCHLORAL HYDRATE BUTYL NITRATECABERGOLINECALCIPOTRIOLCALCITONIN CALCITRIOL CALCIUM CARBIMIDE for therapeutic use. CALCIUM POLYSTYRENE SULPHONATECALOTROPIS GIGANTEANCALOTROPIS PROCERA# CALUSTERONECAMPHORATED OIL excluding admixtures. CAMPHOTAMIDE CANDESARTEN CILEXETILCANDICIDIN CANINE TICK ANTI-SERUM CANTHARIDIN CAPECITABINECAPREOMYCIN

16



CAPTODIAME CAPTOPRIL CAPURIDE CARAMIPHEN CARBACHOL CARBAMAZEPINE CARBARYL for human therapeutic use except when included in Schedule 2. CARBAZOCHROME CARBENICILLIN CARBENOXOLONE except when included in Schedule 2. CARBIDOPA CARBIMAZOLE CARBOCROMEN CARBOPLATIN CARBOPROSTCARBROMAL CARDIAC GLYCOSIDES except when separately specified in these Schedules. CARBUTAMIDECARINDACILLIN CARISOPRODOLCARMUSTINE CARNIDAZOLE CARPROFENCARVEDILOLCASPOFUNGINCEFACLOR CEFEPIMECEFETAMETCEFIXIMECEFODIZIMECEFONICIDCEFOPERAZONE CEFOTAXIME CEFOTETAN CEFOTIAMCEFOXITIN CEFPIROMECEFPODOXIMECEFSULODINCEFTAZIDIME CEFTIBUTENCEFTIOFURCEFTRIAXONE CEFUROXIMECELECOXIBCELIPROLOLCEPHACETRILE CEPHADROXIL for the treatment of animals. CEPHAELIS ACUMINATA (ipecacuanha) except in preparations containing 0.2 per cent or less of emetine.CEPHALEXIN CEPHALONIUMCEPHALORIDINE CEPHALOTHIN CEPHAMANDOLE CEPHAPIRIN CEPHAZOLIN CEPHRADINE CERIVASTATINCERULETIDECETIRIZINE except when included in Schedule 2.CETRORELIX CHENODEOXYCHOLIC ACID CHLORAL FORMAMIDE

CHLORAL HYDRATE except –(a) when included in Schedule 2; or(b) in preparations for topical use containing 2 per cent or less of chloral hydrate.

CHLORALOSE CHLORAMBUCILCHLORAMPHENICOL # CHLORANDOSTENOLONE CHLORAZANIL CHLORBUTOL in preparations for human oral use, except when included in Schedule 2. CHLORCYCLIZINE CHLORDIAZEPOXIDE CHLORMERODRIN CHLORMETHIAZOLE CHLORMEZANONE CHLOROFORM for the use in anaesthesia. 4-CHLOROMETHANDIENONE2-(4-CHLOROPHENYL)-1,2,4-TRIAZOLE [5,1a]-ISOQUINOLINE for the treatment of animals. CHLOROQUINE except when included in Schedule 2.CHLOROTHIAZIDE CHLOROTRIANISENE# CHLOROXYDIENONECHLORPHENIRAMINE except when included in Schedule 2. CHLORPHENTERMINE CHLORPROMAZINE CHLORPROPAMIDE CHLORPROTHIXENECHLORQUINALDOL for human topical use.CHLORTETRACYCLINE CHLORTHALIDONE CHLORZOXAZONE CHOLERA VACCINECHOLESTYRAMINE for human therapeutic use. CHYMOPAPAIN, injection for human therapeutic use. CICLACILLIN CICLESONIDECICLOPIROX except when included in Schedule 2.CODOFOVIRCILASTATIN CILAZAPRILCIMETIDINE except when included in Schedule 2.CINCHOCAINE except when included in Schedule 2.CINOXACIN CIPROFLOXACINCISAPRIDECISATRACURIUM BESYLATECISPLATIN CITALOPRAMCLADRIBINECLANOBUTIN, in injections for the treatment of animals. CLARITHROMYCINCLAVULANIC ACID CLEMASTINE except when included in Schedule 2. CLEMIZOLE CLENBUTEROL CLIDINIUM CLINDAMYCIN CLIOQUINOL and other halogenated derivatives of 8-Hydroxyquinoline for external human use.CLOBAZAM CLOBETASOLCLOBETASONE-17-BUTYRATE except when included in Schedule 2.

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CLOCORTOLONECLODRONIC ACID (included sodium clodronate)CLOFAZIMINECLOFENAMIDE CLOFIBRATE # CLOMIPHENE CLOMIPRAMINE CLOMOCYCLINE CLONAZEPAM CLONIDINECLOPAMIDE CLOPIDOGRELCLOPROSTENOL CLORAZEPATE CLOREXOLONE CLORPRENALINE # CLOSTEBOL (4-chlorotestosterone).CLOTRIMAZOLE, except when included in Schedule 2.CLOXACILLIN # CLOZAPINE under regular monitoring by the doctor.

CODEINE when compounded with therapeutically active substances – (a) in divided preparations containing 30 mg or less of codeine per dosage unit;(b) in undivided preparations containing 1 per cent or less of codeine.except when included in Schedules 1or 2,

CO-DERGOCRINECOLASPASE COLCHICINE COLCHICUM AUTUMNALECOLESTIPOL for human therapeutic use. COLFOSCERIL PALMITATE for therapeutic use.COLISTIN COLLAGEN in injection or implantation for human useCONVALLARIA MAJALIS.COPPER COMPOUNDS for human use except when separately specified in these SchedulesCORONILLA spp.CORTISONE and steroid suprarenal cortical hormones, except hydrocortisone in Schedule 2. CORTICOTROPHINCOUMARINCRYSTAL VIOLET CUPRIMYXINCURARE, TUBOCURARINE , d-TUBOCURARINE, d-TUBOCURARINEDIMETHYLETHER and all synthetic quaternary ammonium compounds and other compounds having curarising properties except when separately specified in this Schedule. CYCLANDELATE CYCLIZINE CYCLOBENZAPRINE# CYCLOFENIL CYCLOHEXIMIDECYCLOPENTHIAZIDECYCLOPENTOLATE CYCLOPHOSPHAMIDECYCLOPROPANE for therapeutic use. CYCLOSERINE CYCLOSPORIN CYCLOTHIAZIDECYCRIMINE

CYMARINCYPROHEPTADINE except when included in Schedule 2. CYPROTERONECYSTEAMINECYTARABINEDACARBAZINE DACLIZUMABDALFOPRISTINDALTEPARINDANAPAROID# DANAZOL DANTHRON DANTROLENE DAPSONE and all derivatives of 4,4-diaminodiphenylsulphone. # DARBEPEOTIN ALFA.DATURA spp except when included in Schedule 2 or separately specified in this schedule.DATURA stramonium except when included in Schedule 2 or separately specified in this schedule.DATURA tatula except when included in Schedule 2 or separately specified in this schedule.DAUNORUBICINDEANOL DEBRISOQUINE DECAMETHONIUM SALTS.DEFERIPRONEDEFLAZACORT# DEHYDROCHLOROMETHYLTESTOSTERONEDIHYDROCORTICOSTERONEDELAVIRIDINEDEMBREXINE except when included in Schedule 1.DEMECARIUM BROMIDE DEMECLOCYCLINE DEOXYCORTONEDEOXYRIBONUCLEASE except for external use or when separately specified in these schedule.DESFERRIOXAMINEDESFLURANEDESIPRAMINE DESIRUDINDESLANOSIDEDESLORATADINE except when included in Schedule 2DESLORELINDESMOPRESSIN (D.D.A.V.P.) DESOGESTRELDESONIDEDEOXYMETHASONEDETOMIDINE DEXAMETHASONEDEXCHLORPHENIRAMINE except when included in Schedule 2. DEXFENFLURAMINE DEXMEDETOMIDINEDEXTROMETHORPHAN except when included in Schedule 2

DEXTROPROPOXYPHENE – (a) in divided preparations containing 135 mg of dextropropoxyphene or less per dosage unit, or(b) liquid preparations containing 2.5 per cent or less of dextropropoxyphene.

DEXTRORPHAN DIAMTHAZOLEDIAZEPAM

18



DIAZOXIDEDIBENZEPIN trans-4-((3,5-DIBROMO-2-HYDROXYBENZYL)-AMINO) CYCLOHEXANOL HYDROCHLORIDE MONOHYDRATE (Sputolysin) except when included in Schedule 1. DICHLORALPHENAZONE DICHLORPHENAMIDE DICLOFENAC except when included in Schedule 2.DICLOXACILLINDICYCLOMINE except when included in Schedule 2.DIDANOSINEDIENOESTROLDIENOGESTDIETHAZINE DIETHYLCARBAMAZINE for human therapeutic use. #DIETHYLPROPION DIFENOXIN in preparations containing, per dosage unit, 0.5 mg or less of difenoxin and a quantity of atropine sulphate equivalent to at least 5 per cent of the dose of difenoxin.DIFLORASONEDIFLOXACINDIFLUCORTOLONEDIFLUNISAL DIGITALIS and its glycosides.DIGITOXINDIGOXINDIGOXIN-SPECIFIC ANTIBODY FRAGMENT F (Ab).DIHYDRALAZINE

DIHYDROCODEINE when compounded with one or more other medicaments – (a) in divided preparations containing not more than 100 mg

of dihydrocodeine per dosage unit; or(b) in undivided preparations with a concentration of not more than 2.5

per cent of dihydrocodeine, except when included in Schedule 2

DIHYDROERGOTOXINE# DIHYROLONEDIHYDROSTREPTOMYCIN DI-IODOHYDROXYQUINOLINE except when included in Schedule 2.DIISOPROPYLAMINE DICHLOROACETATE DILTIAZEM DIMENHYDRINATE except when included in Schedule 2.DIMERCAPROL# DIMETHANDROSTANOLONE# DIMETHAZINEDIMETHINDENE except when included in Schedule 2.DIMETHOXANATE

DIMETHYL SULFOXIDE for therapeutic use except when – (a) included in Schedule 1; or(b) in in-vitro test kits.

DIMETRIDAZOLEDIMETHISOQUIN DINIETHOXANATE 2,4-DINITROCHLOROBENZENE for therapeutic useDINITROCRESOLS for therapeutic use. DINITRONAPHTHOLS for therapeutic use. DINITROPHENOLS for therapeutic use. DINITROTHYMOLS for therapeutic use.

# DINOPROST# DINOPROSTONEDIPERODON DIPHEMANIL METHYLSULPHATE except when included in Schedule 1. DIPHENHYDRAMINE except when included in Schedule 2. DIPHENIDOL DIPHENOXYLATE except when included in Schedule 2.DIPHENYLPYRALINE except when included in Schedule 2.DIPTHERIA TOXOIDDIPIVEFRIN DIPYRIDAMOLE DIRITHROMYCINDISOPHENOL DISPYRAMIDE DISTIGMINEDISULFIRAM for therapeutic use.DISULPHAMIDEDITHIAZANINE DITIOCARBDOBUTAMINE DOCETAXELDOFETILIDEDOLASETRONDOMPERIDONE DONEPEZILDOPAMINE DOPEXAMINEDORNASEDORZOLAMIDEDOTHIEPIN DOXANTRAZOLEDOXAPRAM DOXAZOSINDOXEPIN DOXORUBICIN DOXYCYCLINE DOXYLAMINE except when included in Schedule 2.DROSPIRENONEDROPERIDOL # DROSTANOLONE DROTRECOGIN ALFADUBOISIA LEICHHARDTII except when included in Schedule 2.DUBOISIA MYOPOROIDES except when included in Schedule 2.DUTASERIDEDYDROGESTERONEECONAZOLE except when included in Schedule 2.ECOTHIOPATEECTYLUREAEDETIC ACID for human therapeutic use in preparations for injection or infusion.EDOXUDINEEDROPHONIUM SALTS.EFAVIRENZEFLORNITHINEEFORMOTEROL (formoterol)ELETRIPTANELTENACEMEPRONIUM SALTS.EMETINE except in preparations containing 0.2 per cent or less of emetine.ENALAPRIL # ENESTEBOL.

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ENFLURANE for therapeutic use. ENOXACIN.ENOXAPARIN.ENOXIMONEENPROSTILENROFLOXACINENTACAPONEEPHEDRA spp except in preparations containing 0.001 per cent or less of ephedrine

EPHEDRINE when(a) in preparations for topical use containing 1

per cent or less of ephedrine; or(b) compounded with one or more other

therapeutically active substances in liquid preparations for internal use containing 10 mg or less of ephedrine per recommended dose, other than preparations for stimulant, appetite suppression or weight control purposes.

except when included in Schedule 2.

EPICILLIN EPIRUBICIN # EPITIOSTANOL# EPOETIN ALFA# EPOETIN BETAEPOPROSTENOLEPROSARTEN MESYLATEEPTIFIBATIDEERGOMETRINEERGOTERGOTAMINEERGOTOXINEERTAPENEMERYSIMUM spp

ERYTHROMYCIN except – (a) in animal feeds for growth promotion containing 50 mg/kg or less

of antibiotic substances; or(b) in milk replacers for calves or starter rations

for pigs, containing 100 mg/kg or less of antibiotic substances.

ERYTHROPOIETINERYTHROPOIETINS except when separately specified in these Schedules.ESMOLOLESOMEPRAZOLEESTRAMUSTINEESTROPIPATE (piperazine oestrone sulfate).ETANERCEPTETHACRYNIC ACID ETHAMBUTOL ETHAMIVAN ETHANOLAMINE in preparations for injection.ETHCHLORVYNOL ETHER for use in anaesthesia. ETHINAMATE ETHINYLOESTRADIOLETHISTERONEETHOGLUCID ETHOHEPTAZINE ETHOPROPAZINE ETHOSUXIMIDEETHOTOINETHOXZOLAMIDE ETHYL CHLORIDE for inhalation anaesthesia.# ETHYLDIENOLONE

ETHYLMORPHINE when compounded with one or more other medicaments – (a) in divided preparations containing not more

than 100 mg of ethylmorphine per dosage unit; or

(b) in undivided preparations with a concentration of not more than 2.5 per cent of ethylmorphine.

except when included in Schedule 2

# ETHYLOESTRENOL ETHYNODIOLETIDOCAINE ETIDRONATE except in toothpastes and gels containing 1 per cent or less of etidronate.ETILEFRIN HYDROCHLORIDE ETIPROSTONETODOLACETOFENAMATE except when included in Schedule 2.ETONOGESTRELETOPOSIDEETORICOXIB

# ETRETINATE –(The prescriber must, where the patient is a woman of child-bearing age:(a) ensure that the possibility of pregnancy has

been excluded prior to commencement of treatment; and

(b) advise the patient to avoid becoming pregnant during or for a period of one month after completion of treatment.)

EXEMESTANEEZETIMIBEFAMOTIDINE except when included in Schedule 2.FELBINAC except when included in Schedule 2.FELODIPINEFELYPRESSIN FENBUFENFENCAMFAMIN FENCLOFENACFENFLURAMINE FENOFIBRATEFENOLDOPAMFENOPROFENFENOTEROL except when included in Schedule 2. FENPIPRAMIDE FENPIPRANE FENPROPOREXFENPROSTALENE FEXOFENADINE except when included in Schedule 2.FIBRINOLYSINFILGRASTIMFINASTERIDEFIROCOXIBFLAVOPHOSPHOLIPOL (bambermycin) except - in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances.FLECAINIDE FLEROXACINFLOCTAFENINEFLORIFENICOLFLUANISONEFLUCLOROLONEFLUCLOXACILLIN FLUCONAZOLE FLUCYTOSINE FLUDARABINE

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FLUDROCORTISONEFLUFENAMIC ACID FLUMAZENILFLUMETHASONEFLUMETHIAZIDEFLUNISOLIDE except when included in Schedule 2.FLUNIXIN MEGLUMINE for the treatment of animals.FLUOCINONIDEFLUOCORTINFLUOCORTOLONEFLUORIDES in preparations for human ingestion except when included in Schedule 2.FLUORESCEIN FLUOROMETHOLONEFLUOROURACIL and other substances structurally derived from uracil with cytotoxic properties when used for therapeutic purposes.FLUOXETINE.# FLUOXYMESTERONE FLUPENTHIXOLFLUPHENAZINEFLUPROSTENOLFLURANDRENOLONEFLURAZEPAMFLURIBIPROFEN except when included in Schedule 2.FLUROXENE for inhalation anaesthesia.FLUSPIRILENE FLUTAMIDEFLUTICASONE except when included in Schedule 2.FLUVASTATINFLUVOXAMINEFOLIC ACID in preparations for injections.FOLINIC ACID in preparations for injections.# FOLLICLE STIMULATING HORMONE (See also gonadotrophins) # FOLLITROPIN ALPHA# FOLLITROPIN BETAFOMVIRSENFONDAPARINUX# FORMEBOLONEFORMESTANEFOSCARNETFOSFETROLFOSINOPRILFOSPHENYTOIN SODIUMFOTEMUSTINEFRAMYCETIN FRUSEMIDE FURALTADONE# FURAZABOLFURAZOLIDONEFUSIDIC ACID GABAPENTINGALANTHAMINE GALANTHUS spp.GALLAMINE.GANCICLOVIR.GANIRELIX.GATIFLOXACIN.GEFITINIB.GEMCITABINE.GEMEPROST. GEMFIBROZIL.GENTAMCIN.GESTODENE.GESTONORONE.GESTRINONE.

GITALIN.GLATIRAMER ACETATE.GLIBENCLAMIDE. GLIBORNURIDE.GLICLAZIDE. GLIMEPIRIDE.GLIPIZIDE.GLISOXEPRIDE.GLUTATHIONE for parenteral use.GLYCERYL TRINITRATE in preparations for injection or transdermal preparations for angina.GLYCOPYRROLATE in preparations for injection.GLYMIDINE GONADORELIN GONADOTROPHINS.GOSERELIN ACETATEGRAMICIDIN GRANISETRONGREPAFLOXACINGRISEOFULVIN GUAIPHENESIN except when included in Schedule 1.GUANABENZ GUANACLINE GUANETHIDINE GUANIDINEHACHIMYCINHAEMATINHAEMOPHILUS INFLUENZAE VACCINEHALCINONIDE HALOFANTRINEHALOFENATEHALOPERIDOL and other substances structurally derived from butyrophenone with ataractic properties when used for therapeutic purposes, except when separately specified in this Schedule.HALOTHANE for therapeutic use.HEMEROCALLISHEPARIN for internal therapeutic use. HEPATITIS A VACCINEHEPATITIS B VACCINEHETACILLIN

HEXACHLOROPHANE – (a) in preparations for use on infants; or(b) in other preparations except when included in schedule 1.

HEXAMETHONIUM BROMIDEHEXETIDINEHEXOBENDINEHEXOCYCLIUM HISTAMINE except for therapeutic use except in preparations containing 0.5 per cent or less of histamine.HOMATROPINE except when included in Schedule 2. HUMAN CHORIONIC GONADATROPHIN except when included in Schedule 2.HYALURONIDASEHYALURONIC ACID in preparations for injection.HYDRALAZINE HYDRARGAPHEN for internal use.HYDROCHLOROTHIAZIDEHYDROCORTISONE except when included in schedule 2.HYDROCYANIC ACID and CYANIDES in preparations for therapeutic use containing the

21



equivalent of 0.15 per cent or less of hydrocyanic acid.HYDROFLUMETHIAZIDE HYDROQUINONE for human therapeutic use except in preparations containing 2 per cent or less of hydroquinone. HYDROXYCHLOROQUINE HYDROXYCOBALAMIN as a preparation for injection.HYDROXYEPHEDRINEHYDROXYPHENAMATEHYDROXYPROGESTERONE# HYDROXYSTENOZOL1-HYDROXYPYRIDO (3,2,a)-5-PHENOXAZONE-3-CARBOXYLIC ACIDHYDROXYUREA HYDROXYZINE HYGROMYCIN except – in preparations in concentrations of 50 mg/kg or less of antibiotic substances.HYOSCINE BUTYLBROMIDE except when included in Schedule 2.HYOSCINE except when included in Schedule 2.HYPROMELLOSE in preparations for injection.HYOSCYAMINE except when included in Schedule 2.HYOSCYAMUS NIGER except when included in Schedule 2.HYPOTHALAMIC RELEASING FACTORS except when separately specified in this Schedule.IBANDRONIC ACIDIBUFENAC IBUPROFEN except when included in Schedule 2.IBUTEROLIBUTILIDEIDARUBICINIDOXURIDINE except when included in Schedule 2. IFOSFAMIDEILOPROSTIMATINIBIMIGLUCERASEIMIPENEM IMIPRAMINE IMIQUINODIMMUNOGLOBULINS for human parental use except when separately specified in these Schedules. INDAPAMIDE INDINAVIRINDOMETHACIN except when included in Schedule 2.INDOPROFENINDORAMININFLIXIMABINFLUENZA AND CORYZA VACCINES# INSULIN LIKE GROWTH FACTOR except when separately specified in these Schedules.INTERFERONSINTERLEUKINS except when separately specified in these Schedules.IODOTHIOURACILION-EXCHANGE RESINS, anionic and cationic, for internal use in humans except when separately specified in this Schedule.IOPAMIDOL IPRATROPIUM except when included in Schedule 2.IPRIFLAVINEIPRINDOLEIPRONIAZID

IRON compounds in injectable preparations for human therapeutic use. ISOAMINILE ISOAMYL NITRITEISOBUTYL NITRITEISOCARBOXAZIDISOCONAZOLE except when included in Schedule 2.ISOETARINE ISOFLURANE ISOMETHEPTENE ISONIAZIDISOPRENALINE ISOPRENALINEISOPRINOSINEISOPROPAMIDE except when included in Schedule 2ISOSORBIDE DINITRATE except when included in Schedule 2ISOSORBIDE MONONITRATE

# ISOTRETINOIN The prescriber must, where the patient is a woman of child-bearing age:(a) ensure that the possibility of pregnancy has been excluded prior to commencement of treatment; and(b) advise the patient to avoid becoming pregnant during or for a period of one month after completion of treatment.

ISOXICAMISOXSUPRINE ISRADIPINEIVERMECTIN for human therapeutic use or treatment of mange is dogs. KANAMYCIN KETAMINE KETANSERIN except in topical veterinary products containing 0.5 per cent or less of ketanserin.KETAZOLAMKETOCONAZOLE except when included in Schedule 2.KETOPROFEN except when included in Schedule 2.KETOROLACKETOTIFENKHELLIN KITASAMYCIN except –in animal feeds for growth promotion containing 100 mg/kg or less of antibiotic substances.LABETALOL LACIDIPINELAMIVUDINELAMOTRIGINELANATOCIDE CLANREOTIDELANSOPRAZOLELATAMOXEF LATANOPROSTLAUDEXIUM METHYLSULPHATE LAURETH-9 in preparations for injection.LAUROMACROGOLS in preparations for injections except when separately specified in these Schedules.LEAD COMPOUNDS for human therapeutic use. LEFETAMINELEFLUNOMIDELENOGRASTIMLEPIRUDINLEPTAZOL LERCANIDIPINELETROZOLE

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LEUPRORELIN LEVALLORPHAN

LEVAMISOLE – (a) for human therapeutic use; or(b) in preparations for the prevention or treatment of heartworm in dogs.

LEVETIRACETAMLEVOBUNOLOLLEVOBUPIVACAINELEVOCABASTINE except when included in Schedule 2.LEVODOPA LEVONORGESTRELLIDOFLAZINE LIGNOCAINE except when included in Schedule 1.LINCOMYCIN LINDANE for human therapeutic use except when included in Schedule 1. LIOTHYRONINE SODIUM (Triiodothyronine). LISINOPRILLISURIDELITHIUM salts for therapeutic use, except in preparations containing 0.01 per cent or less of lithium. LODOXAMIDE except when included in Schedule 2.LOFEXIDINELOMEFLOXACINLOMUSTINELOPERAMIDE except when included in Schedule 2. LOPINAVIRLOPRAZOLAMLORCARBEFLORATADINE except when included in Schedule 2.LORAZEPAM LORMETAZEPAMLOSARTANLOXAPINE LUMEFANTRINE# LUTEINISING HORMONE (See also gonadotrophins). LYMECYCLINE MAFENIDE MAGNESIUM SULPHATE as a preparation for injection.MANDRAGORA OFFICINARIUMMANNITOL injection.MALDISON for human therapeutic use except when

included in Schedule 1 or 2.MANNOMUSTINEMAPROTILINEMARBOFLOXACIN MAZINDOL MEASLES VACCINEMEBANAZINEMEBEVERINE MEBHYDROLIN # MEBOLAZINEMEBUTAMATEMECAMYLAMINE MESCASERMINMECILLINMECLOCYCLINEMECLOFENAMATEMECLOFENOXATE MECLOZINE MEDAZEPAM MEDETOMIDINE

MEDIGOXIN (methyldigoxin)MEDROXYPROGESTERONEMEDRYSONEMEFENAMIC ACID except when included in Schedule 2.MEFENOREXMEFLOQUINE MEFRUSIDE MEGESTROLMELATONINMELENGESTROL except when used as an animal feed additive.MELOXICAMMELPHALANMEMANTINEMENINGOCOCCAL VACCINEMENOTROPINMEPACRINE MEPENZOLATEMEPHENESIN and its derivatives except guaiphenesin where specified in Schedule 1 or 3.MEPHENTERMINE MEPINDOLOL# MEPITIOSTANEMEPIVACAINE MEPROBAMATE MEPYRAMINE except when included in Schedule 2.MERCEPTOMERINMERCAPTOPURINE and other substances structurally derived therefrom with cytotoxic properties when used for therapeutic purposes.MERCUROUS CHLORIDE for internal therapeutic use.MERCURY ORGANIC COMPOUNDS for cosmetic or

therapeutic use except when included in Schedule 1.

MEROPENEMMERSALYL# MESABOLONEMESALAZINEMESNA# MESTANOLONE (androstalone)# MESTEROLONEMESTRANOLMETARAMINOL # METENOLONEMETERGOLINEMETFORMIN METHACHOLINE SALTSMETHACYCLINE METHALLENOESTRIL# METHANDIENONE (metandienone)# METHANDRIOL METHANTHELINIUM METHAZOLAMIDE METHDILAZINE except when included in Schedule 2.# METHENOLONE METHICILLIN METHIMAZOLE METHISAZONEMETHIXENE METHOCARBAMOL METHOHEXITONEMETHOINMETHOTREXATE METHOTRIMEPRAZINEMETHOXAMINE preparations for injection.METHOXSALEN.

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METHOXYFLURANE for therapeutic use.METHSUXIMIDE.METHYCLOTHIAZIDE.METHYL AMINOLEVULINATE.METHYLANDROSTANOLONE. # METHYLCLOSTEBOL.METHYLENE BLUE in preparations for injection.METHYLDOPA. METHYLERGOMETRINEMETHYLPENTYNOL and other substituted alkynes for internal use.METHYLPHENOBARBITONEMETHYLPREDNISOLONE# METHYLTESTOSTERONEMETHYLTHIOURACIL# METHYLTRIENOLONEMETHYPRYLONE METHYSERGIDEMETOCLOPRAMIDE except when included in Schedule 2.METOLAZONE METOPROLOL # METRIBOLONEMETRIFONATE (trichlorfon)METRIZAMIDE METRONIDAZOLE including benzoylmetronidazole.METYRAPONE MEXILETINE MEZLOCILLIN MIANSERIN MIBEFRADIL# MIBOLERONE MICONAZOLE except when included in Schedule 2.MIDAZOLAM. MIDODRINE.MIGLITOLMILBEMYCIN OXIME except when included in

Schedule 1. MILRINONEMINOCYCLINE MINOXIDIL except when included in Schedule 2.MIRTAZEPINE.MISOPROSTOL. MITOBRONITOL. MITOMYCIN.MITOTANE.MITOZANTRONE. MIVACURIUM CHLORIDE.MOCLOBEMIDE.MODAFINIL.MOLGRAMOSTIM.MOLINDONE.MOMETASONE except when included in Schedule 2.MONENSIN except –in animal feeds containing 33 mg/kg or less of antibiotic substances.

MONOAMINE OXIDASE INHIBITORS, including iproniazid, isocarboxazid, nialamide, phenelzine, pheniprazine and other preparations for which monoamine oxidase inhibition is claimed, except triparanol.MONOBENZONE for human therapeutic use except in preparations containing 2 per cent or less of monobenzone.

MONOCLONAL ANTIBODIES for therapeutic use except

(a) in diagnostic kits; or(b) when separately mentioned in this Schedule.

MONTELUKAST.MOPERONE. MORAZONE.MORICIZINE.MOTRAZEPAM.MOTRETINIDE.MOXIDECTIN in preparations for injection containing 10 per cent or less of moxidectin. MOXIFLOXACINMUMPS VACCINEMUPIROCIN MUROMONABMUSTINE and other substances structurally derived therefrom with cytotoxic properties, when used for therapeutic purposes except when specified in this Schedule.MYCOPHENOLIC ACIDNABUMETRONENADOLOL NADROPARINNAFARELINNAFTIDROFURYLNALBUPHINE NALIDIXIC ACIDNALORPHINE NALOXONE NALTREXONE# NANDROLONE NAPROXEN except when included in Schedule 2.NARASIN except –in animal feeds containing 100 mg/kg or less of narasin.NARATRIPTAN NATAMYCIN NATEGLINIDENEBACUMABNEDOCROMILNEFAZODONENEFOPAMNELFINIVIR (included nelfinivir mesylate)NEOMYCIN NEOSTIGMINE NERIUM OLEANDERNETILMICIN NEVIRAPINENIALAMIDENICARDIPINENICERGOLINE

NICOCODINE when compounded with one or more other medicaments – (a) in divided preparations containing not more than 100 mg of nicocodine

per dosage unit; or(b) in undivided preparations with a

concentration of not more than 2.5 per cent of nicocodine.

NICODICODINE when compounded with one or more other medicaments – (a) in divided preparations containing not more

than 100 mg of nicodicodine per dosage unit; or

(b) in undivided preparations with a concentration of not more than 2.5 per cent of nicodicodine.

NICOFURANOSE

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NICORANDILNICOTINE for use as an aid in withdrawal from tobacco smoking except when included in Schedule 2.NICOTINIC ACID for human therapeutic use except when included in Schedule 2.NICOTINYL ALCOHOL for internal use.NICOUMALONE for internal therapeutic use. NIFEDIPINE NIFENAZONE NIFURSOLNIKETHAMIDENILUTAMIDENIMESULPRIDENIMODIPINENIMORAZOLENIRIDAZOLE NISOLDIPINENITRAZEPAM NITRENDIPINENITROFURAN and its derivatives for human therapeutic use except when included in Schedule 2. NITROFURANTOINNITROFURAZONENITROUS OXIDE for therapeutic use. NITROXOLINENIZATADINE except when included in schedule 2.NOMIFENSINE NORADRENALINE (excluding its derivatives).

NORCODEINE when compounded with one or more other medicaments – (a) in divided preparations containing not more

than 100 mg of norcodeine per dosage unit; or

(b) in undivided preparations with a concentration of not more than 2.5 per cent of norcodeine.

# 19-NORANDROSTENEDIOL.# 19-NORANDROSTENEDIONE.# NORANDROSTENOLONE.# NORBOLETHONE.# NORCLOSTEBOL.# NORETHANDROLONE NORETHISTERONE.NORFLOXACIN NORGESTEROL.# NORMETHANDRONE.NORTRIPTYLINE NOVOBIOCIN NOXIPTYLINENYSTATIN except when included in Schedule 2.OCTAMYLAMINE OCTATROPINE OCTREOTIDEOCTYL NITRITEOESTRADIOL except in implant preparations for growth production in animals.OESTRIOLOESTROGENS except when separately specified in these schedules.OESTRONEOFLOXACINOLANZAPINEOLEANDOMYCIN except – in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances.OLENDRIN

OLOPATADINEOLSALAZINEOMALIZUMABOMEPRAZOLEONDANSETRONOPIPRAMOL ORCIPRENALINE

ORGANOPHOSPHORUS COMPOUNDS with anticholinesterase activity for human therapeutic use except – (a) when included in Schedule 1; or (b) when separately specified in this Schedule.

ORLISTATORNIDAZOLE ORNIPRESSINORPHENADRINE ORTHOCAINE ORTHOPTERIN OSELTAMIVIROUABAIN# OVANDROTONE# OXABOLONEOXACILLIN OXALIPLATIN# OXANDROLONE OXAPROZINOXAZEPAM OXCARBAZEPINEOXEDRINE for human internal use except in preparations labelled with a recommended daily dose of 30mg or less of oxedrine.OXETACAINEOXICONAZOLEOXITROPIUM SALTSOXOLAMINEOXOLINIC ACIDOXPRENOLOL OXYBUPROCAINE OXYBUTYNIN# OXYMESTERONE# OXYMETHOLONE OXPENTIFYLLINE OXYPHENBUTAZONEOXYPHENCYCLIMINE OXYPHENONIUM OXYTETRACYCLINEOXYTOCIN PACLITAXELPALIVIZUMABPAMAQUINE PAMIDRONIC ACIDPANCREATIC ENZYMESPANCURONIUM PANTOPRAZOLEPARACETAMOL when combined with aspirin, caffeine or salicylamide or any derivative of these substances. PARALDEHYDE PARAMETHADIONEPARAMETHASONEPARECOXIBPAROMOMYCIN PAROXETINEPECAZINEPEGFILGRASTIMPEFLOXACINPEMOLINE

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PEMPIDINE PENBUTOLOLPENCICLOVIR except when included in Schedule 2.PENETHAMATEd-PENICILLAMINE PENTAGASTRINPENTAMETHONIUM PENTAMIDINEPENTHIENATE PENTOBARBITONE when packed and labelled for injection.PENTOLINIUM PENTOSAN POLYSULPHATE SODIUMPERGOLIDEPERHEXILENE PERICYAZINE PERINDOPRILPERPHENAZINE PERTUSSIS ANTIGENPHENACEMIDEPHENACETIN for therapeutic use.PHENACEMIDE PHENAGLYCODOLPHENAZONE except when included in Schedule 2.PHENAZOPYRIDINEPHENELZINEPHENETHICILLIN PHENFORMIN PHENGLUTARIMIDE PHENINDIONE for internal therapeutic use.PHENIRAMINE except when included in Schedule 2.PHENOBARBITONEPHENOL in preparations for injection.PHENOLPHTHALEIN for human therapeutic use.PHENOXYBENZAMINE PHENOXYMETHYLPENICILLIN except when included in Schedule 2.PHENSUXIMIDE and other substances structurally derived from succinamide with anticonvulsant properties when used for therapeutic purposes.# PHENTERMINEPHENTHIMENTONIUM PHENTOLAMINE PHENYLBUTAZONE PHENYLEPHRINE in preparations for human ophthalmic use containing 5 per cent or more of phenylephrine and except when included in Schedule 2.PHENYLPROPANOLAMINE except when included in Schedule 2.PHENYLTOLOXAMINE except when included in Schedule 2.PHENYTOIN and other substances structurally derived from hydantoin with anticonvulsant properties when used for therapeutic purposes.

PHOLCODINE when compounded with one or more other medicaments – (a) in divided preparations containing not more

than 100 mg of pholcodine per dosage unit; or

(b) in undivided preparations with a concentration of not more than 2.5 per cent of pholcodine;except when included in Schedule 2

PHTHALYLSULPHATHIAZOLEPHYSOSTIGMINE PICROTOXIN

PILOCARPINE except in preparations containing 0.025 per cent or less of pilocarpine.PIMECROLIMUSPIMOBENDANPIMOZIDE PINACIDILPINDOLOLPIOGLITAZONEPIPECURONIUM BROMIDEPIPEMIDIC ACIDPIPENZOLATE PIPERACILLIN PIPERIDINEPIPERIDOLATEPIPOBROMAN PIPOTHIAZINEPIPRADROL PIRBUTEROLPIRENZEPINEPIRETANIDEPIRFENOXONE SODIUM (catalin)PIROXICAMPIRPROFENPITUITARY, its extracts and active principles or their synthetic substitutes except when separately specified in this Schedule.PIVAMPICILLINPIZOTIFEN PLICAMYCINPNEUMOCOCCAL VACCINEPODOPHYLLOTOXIN for human use.PODOPHYLLUM EMODIPODOPHYLLUM PELTATUMPODOPHYLLUM RESIN (Podophyllin) for human therapeutic use except when included in Schedule 2.POLIDEXIDEPOLIOMYELITIS VACCINEPOLYACRYLAMIDEPOLYGELINEPOLYLACTIC ACID in preparations for injection or implantation for human use.POLYESTRADIOLPOLYMETHYLENE BISTRIMETHYL AMMONIUM COMPOUNDSPOLYMYXIN POLYSULPHATED GLYCOSAMINOGLYCANS in preparations for injection, except where otherwise specified in this Schedule.POLYTHIAZIDEPOTASSIUM BROMIDE for therapeutic use.POTASSIUM CHLORIDE injectionPOTASSIUM PERCHLORATE for therapeutic use.PRACTOLOLPRALIDOXIMEPRAMIPEXOLEPRAMPINE SALTSPRAMOXINE (pramocaine) except when included in Schedule 2. # PRASTERONE (dehydroepiandrosterone, dehydroisoandrosterone)PRAVASTATIN.PRAZEPAM. PRAZIQUANTEL for human therapeutic use.PRAZOSINPREDNISOLONEPREDNISONEPREGNENOLONE ACETATE except in preparations for topical use.

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PRENALTEROLPRENYLAMINE PRILOCAINE except when included in Schedule 2.PRIMAQUINE PRIMIDONEPROBENECID PROBUCOL PROCAINAMIDE PROCAINEPROCAINE PENICILLINPROCARBAZINEPROCHLORPERAZINE except when included in Schedule 2.PROCYCLIDINE except when included in Schedule 2.PROGESTERONE except for use in animals.PROGESTOGENS except when separately specified in these schedules.PROGLUMIDEPROGUANIL PROLINTANE PROMAZINEPROMETHAZINE except when included in Schedule 2.PROMOXOLONEPROPAFENONEPROPANIDID PROPANTHELINE PROPENTOFYLLINE# PROPETANDROLPROPIONIBACTERIUM ACNESPROPOFOLPROPOXUR for human therapeutic use.PROPRANOLOL#PROPYLHEXEDRINE except when included in Schedule 2.PROPYLTHIOURACILPROPYHENAZONE PROQUAZONE PROSCILLARIDINPROSTAGLANDINS except where separately specified in this Schedule.PROSTIANOL PROTAMINE SULPHATE except when included in insulins.PROTHIONAMIDE PROTHIONAMIDEPROTHIPENDYLPROTIRELIN (thyrotrophin releasing factor)PROTOVERATRINESPROTRIPTYLINEPROXYMETACAINEPSEUDOEPHEDRINE in preparations for stimulant, appetite suppression or weight control purposes except when included in Schedule 2.PYRAZINAMIDEPYRIDINOLCARBAMATEPYRIDOSTIGMINE

PYRIDOXINE HYDROCHLORIDE, PYRIDOXAL, or PYRIDOXAMINE in preparations for human use containing more than 50 mg of pyridoxine per recommended daily dose unless labelled with the warning statement "WARNING - THIS MEDICATION MAY BE DANGEROUS WHEN USED IN LARGE AMOUNTS OR FOR A LONG PERIOD”.

PYRIMETHAMINE except when included in Schedule 2 (see Sulfadoxine with Pyrimethamine entry)

PYROVALERONEQUAZEPAMQUETIAPINEQUINAGOLIDEQUINAPRIL# QUINBOLONEQUINETHAZONE QUINIDINE QUININE except when included in Schedule 2.QUINISOCAINE (dimethisoquin)QUINUPRISTINRABEPRAZOLERABIES VACCINERACTOPAMINE except in animal feed premixes containing 10 per cent or less of ractopamine.RALOXIFENERALTITREXEDRAMIPRILRANITIDINE except when included in Schedule 2.RAPACURONIUM BROMIDE.RASBURICASERAUWOLFIA SERPENTINA RAUWOLFIA VOMITORIARAZOXANEREBOXITINEREMOXIPRIDEREPAGLINIDERESERPINERETEPLASERIBAVIRINRIFABUTINRIFAMPICIN (rifamycin)RILUZOLERIMITEROL HYDROBROMIDERISEDRONIC ACIDRISPERIDONERITODRINE RITONAVIRRITUXIMABRIVASTIGMINERIZATRIPTANROCURONIUM BROMIDEROFECOXIBROLITETRACYCLINE ROMIFIDINERONIDAZOLEROPINIROLEROPIVACAINEROSIGLITAZONEROSOXACIN ROSUVASTATIN# ROXIBOLONEROXITHROMYCINRUBELLA VACCINESALBUTAMOL except when included in Schedule 2.SALCATONINSALICYLAMIDE when combined with aspirin, caffeine or paracetamol or any derivative of these substances.SALINOMYCIN except -in animal feeds containing 60 mg/kg or less of antibiotic substances.SALMETEROLSAQUINAVIRSCHOENOCAULON OFFICINALE (sabadilla)SCOPOLIA CARNIOLICASELEGILINE

SELENIUM except –

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(a) as selenium arsenide in photocopier drums; or(b) in animal feeds containing 0.1 g/tonne or less of selenium; or(c) in compressed pellets for control of selenium

responsive conditions in sheep or cattle; or

(d) in fertilizers containing 200 g/tonne or less of selenium; or(e) in preparations for human oral use with a

recommended daily dose of 100mcg or less of selenium except where the sum of the organic selenium expressed in mcg and half the inorganic selenium expressed in mcg, contained in the recommended daily dose of the preparation does not exceed 26 mcg.

SEMISODIUM VALPROATESERMORELINSERTINDOLESERTRALINESEVOFLURANESEX HORMONES and all substances having sex hormonal activity except when separately specified in these Schedules.SIBUTRAMINE# SILANDRONESILDENAFILSILICONES in injectable preparations for human use except when separately specified in these Schedules.SILVER SULPHADIAZINE SIMVASTATINSIROLIMUSSISOMYCIN SODIUM BICARBONATE as a preparation for injection.SODIUM BROMIDESODIUM CELLULOSE PHOSPHATE for human internal use. SODIUM CROMOGLYCATE except when included in Schedule 2. SODIUM MORRHUATE in preparations for injections.SODIUM NITROPRUSSIDE for human therapeutic use. SODIUM POLYSTYRENE SULPHONATESODIUM SALICYLATE in preparations for injections for treatment of animals.SODIUM PHOSPHATE in preparations for oral laxative use.SODIUM TETRADECYLSULFATE in preparations for injections.SODIUM VALPROATE SOLASODINESOMATOSTATIN.SOMATOTROPIN EQUINESOMATROPIN (human growth hormone).SONTOQUINE SOTALOL SPARFLOXACINSPARTEINE SPECTINOMYCIN except in animal feeds for growth production in pigs or poultry, containing 50mg/kg or less of antibiotic substances. SPIRAMYCIN except – in animal feeds for growth promotion in pigs or poultry containing 50 mg/kg or less of antibiotic substances.SPIRAPRILSPIRONOLACTONE

SPUTOLYSIN - trans-4-(3,5-bibroma-2-hydroxybenzyl)-amino cyclohexanol hydrochloride monohydrate.# STANOLONE # STANOZOLOL STAVUDINE# STENBOLONESTEROID HORMONES except when separately specified in these Schedules.STILBOESTROLSREPTODORNASESTREPTOKINASESTREPTOMYCINSTROPHANTHIN-KSTROPHANTHUS and its glycosides. STRYCHNINE in preparations containing 1.5 per cent or less of strychnine for the treatment of animals. STRYCHINOS spp.STYRAMATESULBACTAMSULCONAZOLE except when in Schedule 2SULFACETAMIDE except when included in Schedule 1 or 2.SULFADIAZINE except when included in Schedule 1.SULFADIMETHOXINESULFADIMIDINE except when included in Schedule 1.SULFADOXINE except when included in Schedule 2.SULFAFURAZOLESULFAGUANIDINESULFAMERAZINE except when included in Schedule 1.SULFAMETHIZOLESULFAMETHOXAZOLE except when included in Schedule 2 as Cotrimoxazole.SULFAMETHOXYDIAZINESULFAMETHOXYPYRIDAZINESULFAMETROLE SULFAMONOMETHOXINESULFAMOXOLESULFAPHENAZOLESULFAPYRIDINESULFAQUINOXALINESULFASALAZINESULFATHIAZOLE except when included in Schedule 1.SULPHONAMIDES except when separately specified in these Schedules.SULFONMETHANE (sulfonal) and alkyl sulfonals.SULINDAC

SULPHANILAMIDE and its derivatives except – sulphonamide (a) when separately specified in this Schedule; or(b) oryzalin; or(c) sulphaquinoxaline in animal feeds containing

200 mg/kg or less of sulphaquinoxaline; or(d) sulphaquinoxaline when incorporated in baits for the destruction of vermin.

SULPHATROXAZOLESULPHINPYRAZONESULPHOMYXIN SULPHONAL and alkyl sulphonals. SULTAMICILLINSULTHIAMESUMATRIPTANSUBROFEN

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SUTILAINSSUXAMETHONIUM SALTS SUXETHONIUM BROMIDETACRINETACROLIMUSTADALAFILTAMOXIFENTAMSULOSINTANACEUM VULGARE except in preparations containing 0.8 per cent or less of oil of tansyTASONERMINTAZAROTENETAZOBACTAMT-CELL RECEPTOR ANTIBODYTEGAFURTEGASERODTEICOPLANINTELITHROMYCINTELMISARTANTEMAZEPAM TEMOZOLOMIDETENECTEPLASETENIPOSIDE TENOFOVIRTENOXICAMTEPOXALINTERAZOSINTERBINAFINE except when included in Schedule 2.TERBUTALINE except when included in Schedule 2. TERFENADINE # TERIPARATIDETERODILINETEROPTERIN # TESTOLACTONE# TESTOSTERONE except when included in Schedule 1.TETANUS ANTITOXIN except when used for short-term protection or treatment of tetanus in animals.TETANUS TOXOID for human use.TETRABENAZINE TETRACOSACTRIN TETRACYCLINE except when included in Schedule 2.TETRAETHYLAMMONIUM SALTS.TETROXOPRIM

# THALIDOMIDE (The prescriber must, where the patient is a woman of child-bearing age:(a) ensure that the possibility of pregnancy has been excluded prior to commencement of treatment; and(b) advise the patient to avoid becoming pregnant during or for a period of one month after completion of treatment.)

THENYLDIAMINE except when included in Schedule 2. THEOPHYLLINE except when included in Schedule 2.THIEVETIA PERUVIANATHEVETINTHIACETARSAMIDE, in preparations for the prevention or treatment of heart worm in dogs. THIACETAZONE THIAMBUTOSINE THIAZOSULPHONE THIETHYLPERAZINE THIOCARLIDETHIOGUANINE

# THIOMESTERONE (tiomesterone)THIOPENTONETHIOPROPAZATE THIOPROPERAZINETHIORIDAZINETHIOSTREPTON THIOTEPA and other substances structurally derived therefrom with cytotoxic properties when used for therapeutic purposes. THIOTHIXENE THIOURACIL and substances structurally derived therefrom with antithyroid properties when used for therapeutic purposes. THIOUREA for therapeutic use. THYMOXAMINETHYROID and extracts, and its active principles except when separately specified in this Schedule. THYROTROPHIN (T.S.H.) THYROXINE SODIUM TIAGABINETIAMULIN except – in prepared animal feeds.TIAPROFENIC ACIDTIARAMIDETIBOLONETICARCILLIN TICLOPIDINETIEMONIUM TIENILIC ACIDTIGLOIDINE TILETAMINETILMICOSINTILUDRONIC ACIDTIMOLOL TINIDAZOLETINZAPARINTIOCONAZOLE except when in Schedule 2. TIOPROPIUMTIPEPIDINE TIRILAZADTIROFIBRAN HYDROCHLORIDETOBRAMYCIN TOCAINIDE TOLAZAMIDE TOLAZOLINE for internal use. TOLBUTAMIDE TOLCAPONETOLFENAMIC ACID.TOLMETIN.TOLONIUM CHLORIDE.TOLPROPAMINE. TOLRESTAT.TOLTERODINE TARTRATE.TOPIRAMATE.TOPOTECAN.TORASEMIDE.TOREMIFENE.TOXOIDS.TRAMADOL.TRANDOLAPRIL.TRANEXAMIC ACID except when included in Schedule 2.TRANYLCYPROMINETRASTUZUMABTRAVOPROSTTRAZADONE# TRENBOLONETREPROSTINILTREOSULPHAN

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# TRESTOLONETRETAMINE # TRETINOIN for external human therapeutic use. TRIACETYLOLEANDOMYCINTRIAMCINOLONE except when included in Schedule 2.TRIAMTERENE TRIAZIQUONE TRIAZOLAM TRICHLORMETHIAZIDETRICHLOROACETIC ACID for human dermal use except when in preparations containing 12.5 per cent of less of trichloroacetic acid for the treatment of warts other than anogenital warts.TRICHLOROETHYLENE for therapeutic use. TRICLOFOS TRICYCLAMOL TRIDIHEXETHYL TRIFLUOPERAZINE TRIFLUPERIDOL TRIFLUPROMAZINETRIMEPRAZINE except when included in Schedule 2. TRIMETAPHAN TRIMETHOPRIM except when included in Schedule 2 as Cotrimoxazole.TRIMIPRAMINE TRIMUSTINE TRIOXYSALEN TRIPELENNAMINE TRIPLE ANTIGEN VACCINETRIPROLIDINE except when included in Schedule 2. TRIPTORELINTROGLITAZONETROMETAMOL in preparations for injection.TROPICAMIDETROPISETRONTROVAFLOXACINTROXIDONE and other substances structurally derived from oxazolidinone with anticonvulsant properties when used for therapeutic purposes.TRYPTOPHANTUBOCURARINETULOBUTEROL

TYLOSIN except – (a) in animal feeds for growth promotion

containing 50 mg/kg or less of antibiotic substances; or

(b) in milk replacers for calves or starter rations for pigs, containing 100 mg/kg or less of antibiotic substances.

TYPHOID VACCINEUNOPROSTONEURACILURAPIDILURETHANE (excluding its derivatives) for therapeutic use.URETHANES AND UREIDES having or purporting to have soporific, hypnotic or narcotic properties except when separately specified in this Schedule. # UROFOLLITROPHIN.UROKINASE.URSODEOXYCHOLIC ACID.VACCINES, sera, toxoids, and antigens for human parenteral use.

VACCINES, veterinary live virus except – (a) poultry vaccines; or(b) pigeon pox vaccine; or (c) scabby mouth vaccine.

VALACICLOVIRVALDECOXIBVALGANCICLOVIRVALNOCTAMIDEVALSARTANVANCOMYCINVARDENAFILVARICELLA VACCINEVASOPRESSINVECURONIUMVEDAPROFENVENLAFAXINEVERAPAMIL VERATRUM for therapeutic use.VERTEPROFINVIDARABINE VIGABATRINVILOXAZINEVINBLASTINEVINCAMINEVINCRISTINEVINCA ALKALOIDS including semi-synthetic derivatives.VINDESINEVINORELBINEVINYL ETHER for anaesthesia.VIPRYNIUM VIRGINIAMYCIN except in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances.VISNADINE VITAMIN A for human therapeutic use, except in preparation containing 10,000 I.U. or less of vitamin A per recommended daily dosage.VITAMIN D for human therapeutic use, except in preparations containing 25 micrograms or less of vitamin D per recommended daily dosage.VORICONAZOLEWARFARIN for internal therapeutic use.XAMOTEROLXANTHINOL NICOTINATE XIPAMIDEXYLAZINE YOHIMBINE ZAFIRLUKASTZALCITABINEZALEPLONZANAMIVIRZERANOL ZIDOVUDINEZILPATEROLZIMELDINEZINC COMPOUNDS for human internal use except when included in Schedules 1 and 2.ZIPRASIDONEZOLAZEPAMZOLEDRONIC ACIDZOLMITRIPTAN#ZOLPIDEM#ZOPICLONEZOXAZOLAMINEZUCLOPENTHIXOL

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Table of Amendments 1 Amended by Order 32 of 20052 Substituted by Order 32 of 20052A Inserted by Order 32 of 2005Schedules 1,2,3 Substituted by Order 32 of 2005

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8 August 2005

PRINCIPAL PHARMACIST’S NOTICE

Published Gazette No. 25 of 2005(pursuant to the Sale of Medicines Regulations, Regulation 3)

All medicines which are not mentioned in the Schedules but are of a similar family type of medicine as a medicine which is listed in the Schedules will automatically be included in the Schedules until such time as they are separately listed.

All medicines which are not included in the Schedule will assume the corresponding status according to the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP)** in Australia unless otherwise stated in this Act.

All medicines labelled # require special authorisation from the Principal Pharmacist before importation or supply of these medicines is allowed.

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