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Vanuatu Consolidated Legislation - 1988 |
Commencement: 27 August 1966
LAWS OF THE REPUBLIC OF VANUATU
REVISED EDITION 1988
CHAPTER 48
SALE OF MEDICINES (CONTROL)
JR 32 of 1966
Act 9 of 1988
ARRANGEMENT OF SECTIONS
SECTION
1. Interpretation
2. Limitation on the retail sale of medicines
9. Application
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SALE OF MEDICINES (CONTROL)
To control the sale of medicines.
INTERPRETATION
1. In this Act, unless the context otherwise requires -
"medicine" means any substance which is referred to in the article itself, or in advertisements or documents of any kind in terms calculated to lead to the use of the substance for the prevention or treatment of any ailment, infirmity or injury afflicting the human body;
"pharmacist" means a person holding a licence issued by the Pharmacists Practitioners Commission as provided for by the Control of Pharmacists Act, Cap. 23;
"medical or dental practitioner" means a medical or dental practitioner registered in accordance with the provisions of the Health Practitioners Act, Cap. 164;
"Minister" means the Minister responsible for health;
"veterinary surgeon" means a person authorised by the Minister, by reason of his qualifications, to act as such;
"druggist" means a person who shall have obtained from the Pharmacists Practitioners Commission a licence authorising him to sell medicines under the conditions prescribed in this Act and outside the zone protecting a pharmacist.
LIMITATION ON THE RETAIL SALE OF MEDICINES
2. (1) When a pharmacist has his principal place of business in any place within Vanuatu,
no person other than a pharmacist shall operate a drug-store within 5 miles of that place of business.
(2) Outside this zone and subject to their observing international legislation, in particular legislation prohibiting anyone other than a pharmacist from selling narcotics, druggists may sell the same medicines as a pharmacist.
LIMITATION ON THE WHOLESALE SALE OF MEDICINES
3. (1) No person shall sell wholesale any medicine other than those as may be prescribed
under section 7(l) to any person other than a pharmacist or druggist.
(2) Any importation of medicines shall be recorded by the Director of Customs who shall send a list thereof to the Director of Health.
SALE OF NARCOTICS
Provided that a person shall be lawfully in possession of the substances aforesaid if he is in such possession by virtue of a medical prescription.
CONTROL OF PRICE
INSPECTION OF PREMISES
6. (1) Every member of the Department of Health or any other person authorised in that
behalf by the Director of Health shall, for the purpose of ensuring that the provisions of this Act have been complied with, have the right of access to any premises on which he reasonably suspects that such provisions are not being so complied with.
(2) Any person who obstructs any member of the Department of Health or any person authorised under the provisions of subsection (1) in or upon the occasion of the execution of his duty under this Act shall be guilty of an offence and on conviction thereof shall be liable to a fine not exceeding VT20,000.
REGULATIONS
7 (1) The Minister may by Order make regulations not inconsistent with the provisions
of this Act -
(a) regulating the sale of medicines; or
(b) prohibiting the sale of any medicines except upon the prescription of a medical practitioner or dental practitioner or veterinary surgeon.
(2) Any regulation made under subsection (1) may authorize the Principal Pharmacist to make and issue notices or directives with respect to such matters prescribed by that regulation.
PENALTIES
8. (1) Any person who acts in contravention of sections 2 and 3 shall be guilty of an
offence and on conviction thereof shall be liable to a fine not exceeding VT50,000 or to a term of imprisonment not exceeding 1 year or to both such fine and imprisonment.
(2) Any person who acts in contravention of section 4 shall be guilty of an offence and on conviction thereof shall be liable to a fine not exceeding VT100,000 or to a term of imprisonment not exceeding 2 years or to both such fine and imprisonment.
APPLICATION
_____________________
[Subsidiary]
SUBSIDIARY LEGISLATION
SALE OF MEDICINES REGULATIONS
Order 25 of 1988
ARRANGEMENT OF REGULATIONS
REGULATION
SCHEDULE 1
SCHEDULE 2
SCHEDULE 3
----------------------------------------
SUBSIDIARY LEGISLATION
SALE OF MEDICINES REGULATIONS
To regulate the sale of medicines.
INTERPRETATION
1. In 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;
"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;
"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 issue to which it is applied.
SALE OF MEDICINES
2. (1) Any person may sell any of the medicines specified in Schedule 1.
(2) No person, other than a pharmacist or a druggist, shall sell any of the medicines specified in Schedule 2.
(3) No person shall sell the medicines specified in Schedule 3, except upon the prescription of is a medical practitioner, dental practitioner or a veterinary surgeon.
NOTICES
3. (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.
___________________
SCHEDULE 1
ACETIC ACID (excluding its salts and derivatives) and preparations containing more than 80 per cent of acetic acid, for therapeutic use.
ALOXIPRIN
AMMONIATED MERCURY
ANTAZOLINE in eye drops.
ASPIRIN except -
(a) when included in Schedule 3;
(b) 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; or
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) 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; or
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) 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.
ATROPINE, except atropine methonitrate included in Schedule 3 -
(a) 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.
BELLADONNA in preparations containing 0.25 per cent less or less of the alkaloids of belladonna, calculated as hyoseyamine.
BENZAMINE when included in -
(a) lozenges, pastilles, tablets or capsules containing 30 mg or less of benzamine in each;
(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;
(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.
BENZOYL PEROXIDE in preparations for external human thereapeutic use containing 5 per cent or less benzoyl peroxide.
BENZYDAMINE in preparations for tropical use containing 3 per cent or less of benzydamine.
BROMHEXINE
BROMPHENIRAMINE when compounded with one or more of the following medicaments -
(a) an antitussive except codeine or dihydrocodeine;
(b) an expectorant; or
(c) a sympathomimetic amine;
except in preparations for the treatment of children under 2 years of age.
BUCLIZINE in primary packs of 10 doses or less, for the prevention or treatment of motion sickness.
BUTYLAMINOBENZOATE when included in -
(a) lozenges, pastilles, tablets or capsules containing 30 mg or less of butylaminobenzoate in each;
(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 butyla- minobenzoate.
CARBARYL in preparations for external human therapeutic use containing 2 per cent or less of carbaryl.
CARBENOXOLONE for topical oral use.
CAR.BETAPENTANE except in preparations containing 0.5 per cent or less of carbetapentane. 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.
CHLORPHENIRAMINE when compounded with one or more of the following medicaments -
(a) an antitussive except codeine or dihydrocodeine;
(b) an expectorant; or
(c) a sympathomimetic amine;
except in preparations for the treatment of children under 2 years of age.
CINNAMEDRINE
CLIOQUINOL and other halogenated derivatives of 8-Hydroxyquinoline for external human use. CODEINE -
(a) 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 -
(i) packed in blister or strip packaging or in containers with child-resistant closures; and
(ii) in a primary pack containing 25 or less dosage units; or
(b) when compounded with one or more other therapeutically active substances -
(i) in divided preparations containing 10 mg or less per dosage unit of codeine and with a recommended dose not exceeding 15 mg of codeine; or
(ii) in undivided preparations containing 0.25 per cent or less of codeine and with a recommended dose not exceeding 15 mg of codeine.
CREOSOTE, for therapeutic use, except in preparations containing 3 per cent or less of phenois included in Schedule 1.
CYANIDES-see hydrocyanic acid.
DDT-see dicophane.
DEXCHLORPHENIRAMINE when compounded with one or more of the following medicaments-
(a) an antitussive except codeine or dihydrocodeine;
(b) an expectorant; or
(c) a sympathomimetic amine;
except in preparations for the treatment of children under 2 years of age.
DEXTROMETHORPHAN when compounded with one or more other therapeutically active sub- stances 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.
TRANS-4-((3,5-DIBROMO-2-HYDROXYBENZYL) AMINO) CYCLOHEXANOL HYDROCHLORIDE MONOHYDRATE (Sputolysin) in oral preparations for the treatment of animals.
DICOPHANE (DDT) in preparations for human therapeutic use.
DICYCLOMINE in preparations containing 0. I per cent or less of dicyclomine.
DIMENHYDRINATE in primary packs of 10 doses or less, for the prevention or treatment of motion sickness.
DIMETHISOQUIN in preparations for topical use.
DIPHEMANIL METHYLSULPHATE in preparations for topical use.
DIPHENHYDRAMINE -
(a) in primary packs of 10 doses or less, for the prevention or treatment of motion sickness; or
(b) when compounded with one or more of the following medicaments -
- (i) an antitussive except codeine or dihydrocodeine;
- (ii) an expectorant; or
(iii) a sympathomimetic aniine;
except in preparations for the treatment of children under 2 years of age.
DIPHENYLPYRA,LINE when compounded with one or more of the following medicaments -
(a) an antitussive except codeine or dihydrocodeine;
(b) an expectorant; or
(c) a sympathomimetic aniine;
except in preparations for the treatment of children under 2 years of age.
DOXYLAMINE when compounded with one or more of the following medicaments -
(a) an antitussive except codeine or dihydrocodeine;
(b) an expectorant; or
(c) a sympathomimetic amine;
except in preparations for the treatment of children under 2 years of age.
EPHEDRINE for internal use, when compounded with one or more other therapeutically active substances in preparations containing 30 mg or less of ephedrine per recommended dose, other than preparations for stimulant, appetite suppression or weight control purposes, except in liquid preparations containing 10 mg or less of ephedrine per recommended dose.
ERYTHRITYL TETRANITRATE for therapeutic use.
ETAFEDRINE
ETHER for therapeutic use except -
(a) when included in Schedule 3; or
(b) in preparations containing 10 per cent or less of ether.
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.
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
(b) 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.
GELSEMIUM
GLUTARALDEHYDE for human therapeutic use.
GLYCERYL TRINITRATE for therapeutic use except when included in Schedule 3.
GUAIPHENESIN -
(a) in liquid preparations containing 2 per cent (200 mg/10 ml) or less of guaiphenesin; or
(b) in divided preparations containing 120 mg or less of guaiphenesin in each dosage unit.
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.
HYDROCYANIC ACID and CYANIDES in preparations for therapeutic use containing the equivalent of 0. 15 per cent or less of hydrocyanic acid.
8-HYDROX'YQUINOLINE and its non-halogenated derivatives for human therapeutic use, except in preparations for external use containing 1 per cent or less of such substances.
HYOSCINE, except hyoseine butylbromide included in Schedule 3 -
(a) in preparations containing 0.25 per cent or less of hyoscine; or
(b) in transdermal applicators containing 2 mg or less of hyoscine.
HYOSCYAMINE in preparations containing 0.25 per cent or less of hyoseyamine.
HYOSCYAMUS in preparations containing 0.25 per cent or less of the alkaloids of hyoscyamus calculated as hyoseyamine.
IODINE (excluding its salts, derivatives and iodophors), in preparations for human therapeutic use containing more than 2.5 per cent of available iodine.
IRON COMPOUNDS for human internal use except -
(a) when included in Schedule 3;
(b) in divided preparations containing 5 mg or less of iron per dosage unit; or
(c) in liquid oral preparations containing 0.1 per cent or less of iron.
ISOPROPAMIDE in preparations containing 2 per cent or less of isopropamide for cutaneous use.
ISOSORBIDE DINITRATE for therapeutic use.
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 lignocame.
LINDANE in preparations for external human therapeutic use containing 2 per cent or less of lindane.
LOBELIA in preparations containing 0.5 per cent or less of lobeline, except in preparations for smoking or burning.
LUTEINISING HORMONE ANTIBODIES in human ovulation test kits.
MALDISON in preparations for external human therapeutic use containing 2 per cent or less of maldison.
MEBENDAZOLE for human therapeutic use.
MERCURIC CHLORIDE in preparations containing 0.5 per cent or less of mercuric chloride, except when included in a notice.
MERCURIC IODIDE in preparations for therapeutic use containing 2 per cent or less of mercuric iodide.
MERCURIC NITRATE in preparations for therapeutic use containing 5 per cent or less of mercuric nitrate.
MERCURIC OXIDE and all oxides of mercury.
MERCURIC-POTASSIUM IODIDE in preparations containing the equivalent of 2 per cent or less of mercuric iodide, in such form.
MERCURY (metallic) for therapeutic use.
MERCURY ORGANIC COMPOUNDS for topical therapeutic use in preparations containing 0.5 per cent or less of mercury.
METHOXAMINE except -
(a) preparations containing 0.5 per cent or less of methoxamine; or
(c) preparations for external use containing 1 per cent or less of methoxamine.
METHOXYPHENAMINE
METHYLEPHEDRINE
NAPHAZOLINE
NICLOSADINE for human therapeutic use.
NITRIC ESTERS of polyhydric alcohols for therapeutic use except when separately specified in these Schedules.
NOSCAPINE
OXETHAZAINE in preparations for internal use only.
OXOLAMINE
OXYMETAZOLINE
PAPAVERINE
PARACETAMOL except -
(a) when included in Schedule 3;
(b) in individually wrapped powders or sachets of granules each containing 1,000 milligrams or less of paracetamol 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
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) tablets or capsules each containing 500 milligrams or less of paracetamol 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
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) 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.
PHEDRAZINE
PHENAMAZOLINE
PHENAZONE for external use.
PHENIRAMINE -
(a) in primary packs of 10 doses or less, for the prevention or treatment of motion sickness; or
(b) when compounded with one or more of the following medicaments -
- (i) an antitussive except codeine or dihydrocodeine;
- (ii) an expectorant; or
(iii) a sympathomimetic amine;
except in preparations for the treatment of children under 2 years of age.
PHENOL and any homologue of phenol boiling between 220 C, for human therapeutic use, except in preparations containing 3 per cent or less by weight of such substances.
PHENYLENEDIAMINES and alkylated phenylenediamines for therapeutic use.
PHENYLEPHRINE except -
(a) when included in Schedule 3;
(b) preparations containing 0.5 per cent less of phenylephrine; or
(c) preparations for external use containing 1 per cent or less of phenylephrine.
PHOLCODINE, when compounded with one or more other therapeutically active substances -
(a) in divided preparations containing 10 mg or less of pholeodine 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 recom- mended dose not exceeding 25 mg of pholcodine.
PODOPHYLLUM RESIN (podophyllin) for external human use in preparations containing 10 per cent or less of Oodophyllin.
POTASSIUM CHLORATE for therapeutic use except in preparations containing 10 per cent or less of potassium chlorate.
PRAMOXINE when included in preparations for external use, other than eye drops, containing 1 per cent or less of pramoxine.
PROCYCLIDINE in preparations containing 5 per cent or less of procyclidine for cutaneous use. PROMETHAZINE -
(a) in primary packs of 10 doses or less, for the prevention or treatment of motion sickness; or
(b) when compounded with one or more of the following medicaments -
(i) an antitussive except codeine or dihydrocodeine;
(ii) an expectorant; or
(iii) a sympathomimetic amine,
except in preparations for the treatment of children under 2 years of age.
PROPANTHELINE in preparations for topical use.
PROPYLHEXEDRINE in appliances for inhalation in which the substance is absorbed upon an inert solid material.
PSEUDOEPHEDRINE except when included in Schedule 3 -
(a) in divided preparations containing 60 mg or less of pseudoephedrine per recommended dosage unit; or
(b) in liquid preparations containing 60 mg or less of pseudoephedrine per recommended adult dose.
PYRANTEL for human therapeutic use.
PYRITHIONE ZINC for human therapeutic use, except in preparations containing 2 per cent or less of pyrithione zinc, when -
(a) in semisolid hair preparations; or
(b) in shampoos.
SALICYLAMIDE except -
(a) when included in Schedule 3;
(b) 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
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) tablets or capsules each containing 500 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
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) 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.
SILVER SALTS for therapeutic use, except -
(a) chewing tablets containing 5 mg or less of silver per tablet; or
(b) solutions containing 0.3 per cent or less of silver.
SODIUM NITRITE for therapeutic use.
SPUTOLYSIN-See trans -4-((3,5-dibromo-2-hydroxybenzyl)-amino) cyclohexanol hydrochloride monohydrate.
STAPHISAGRIA except in preparations containing 0.2 per cent, or less of staphisagria.
STRAMONIUM in preparations containing 0.25 per cent or less of the alkaloids calculated as hyoscyamine, except preparations for smoking or burning.
TETRAHYDROZOLINE
THENYLDIAMINE
(a) in nasal preparations for topical use; or
(b) when compounded with one or more of the following medicaments -
(i) an antitussive except codeine or dihydrocodeine;
(ii) an expectorant; or
(iii) a sympathomimetic amine,
except in preparations for the treatment of children under 2 years of age.
TRAMAZOLINE
TRIMEPRAZINE when compounded with one or more of the following medicaments -
(a) an antitussive except codeine or dihydrocodeine;
(b) an expectorant; or
(c) a sympathomimetic amine,
except in preparations for the treatment of children under 2 years of age.
TRIPROLIDINE when compounded with one or more of the following medicaments -
(a) an antitussive except codeine or dihydrocodeine;
(b) an expectorant; or
(c) a sympathomimetic amine,
except in preparations for the treatment of children under 2 years of age.
TYMAZOLINE
XYLOMETAZOLINE
______________________
SCHEDULE 2
ACEPIFYLLINE in liquid oral preparations.
ADRENALINE in preparations containing 1 per cent or less of adrenaline except in preparations containing 0.02 per cent or less of adrenaline.
AMINOPHYLLINE in liquid oral preparations.
AMYL NITRITE
BENZOYL PEROXIDE in preparations containing 10 per cent or less of benzoyl peroxide for external human therapeutic use, except when included in Schedule 1.
BROMPHENIRAMINE in oral preparations except when included in Schedule 1.
BUCLIZINE in oral preparations except when included in Schedule 1.
BUTYL NITRITE
CHLORAL 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 less.
CHLOROFLUOROCARBONS-See FLUOROCARBONS
CHLORPHENIRAMINE in oral preparations except when included in Schedule 1.
CLEMASTINE in oral preparations.
CLOTRIMAZOLE for human use in preparations containing 1 per cent or less of clotrimazole, for treatment of fungal infections of the skin.
CODEINE in tablets or capsules each containing 10 mg or less of codeine when compounded with aspirin, paracetamol or salicylamide or any one of their derivatives and no other analgesic substance, except when included in Schedule 1.
CYPROHEPTADINE in oral preparations.
DEXCHLORPHENIRAMINE in oral preparations except when included in Schedule 1.
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.
DIMENHYDRINATE in oral preparations except when included in Schedule 1.
DIMETHINDENE in oral preparations.
DIPHENHYDRAMINE in oral preparations except when included in Schedule 1.
DIPHENYLPYRAILINE in oral preparations except when included in Schedule 1.
DITHRANOL for human therapeutic use.
DOXYLAMINE in oral preparations except when included in Schedule 1.
ECONAZOLE for human use in preparations containing 1 per cent or less of econazole for treatment of fungal infections of the skin.
EPHEDRINE for internal use when compounded with one or more other therapeutically active substances, other than preparations for stimulant, appetite supression or weight control purposes, except -
(a) when included in Schedule 1; or
(b) in liquid preparations containing 10 mg or less of ephedrine per recommended dose.
FENOTEROL in metered aerosols delivering 200 micrograms or less of fenoterol per metered dose.
FELAVOXATE
FLUOROCARBONS and CHLOROFLUOROCARBONS alone or in combination with other propellants or refrigerants in liquefied gas form for therapeutic use.
FOLIC ACID for human therapeutic use except in preparations containing 500 micrograms or less of folic acid per recommended daily dose.
FOLINIC ACID for human therapeutic use except in preparations containing 500 micrograms or less of folinic acid per recommended daily dose.
HYDROCORTISONE and HYDROCORTISONE ACETATE as the only therapeutically active substances in preparations for dermal use containing 0.5 per cent or less of hydrocortisone in packs containing 30 grams or less where the labelling warns against contact with the eyes and against use for acne and on children below 2 years of age, use beyond 7 days, and use under occlusive dressings, except on medical advice.
IDOXURIDINE in preparations containing 0.5 per cent or less of idoxuridine for cutaneous use.
INSULIN
ISOCONAZOLE for human use in preparations containing 1 per cent or less of isoconazole, for
treatment of fungal infections of the skin.
LOPERAMIDE in packs of 8 dosage units or less, each dosage unit containing 2 mg or less of loperamide.
MEFENAMIC ACID in packs of 30 or less capsules for treatment of spasmodic dysmenorrhoea.
MEPYRAMINE in oral preparations.
METHDILAZINE in oral preparations.
MICONAZOLE for human use in preparations containing 2 per cent or less of miconazole for treatment of fungal infections of the skin.
NAPROXEN in packs of 12 or less tablets for capsules, for treatment of spasmodic dysmenorrhoea.
NITROPFURAZONE in preparation for cutaneous use containing 0.2 per cent or less of nitrofurazone.
OCTYL NITRITE
PHENIRAMINE in oral preparations except when included in Schedule 1.
PHENYLPROPANOLAMINE in preparations for relief of coughs or colds, containing 25 mg or less per dose of phenylpropanolamine.
PHENYLTOLOXAMINE in oral preparations.
PODOPHYLLUM RESIN (Podophyllin) for external human use in preparations containing 20 per cent or less of podophyllin except when included in Schedule 1.
PROMETHAZINE in oral preparations except when included in Schedule 1. PSEUDOEPHEDRINE except when included in Schedule 1 or 3.
QUININE for human internal therapeutic use except in liquids containing 40 mg/L or less of is quinine.
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.
SANTONIN
SODIUM CROMOGLYCATE in nasal preparations for topical use.
TERBLTTALINE.in metered aerosols delivering 250 micrograms or less of terbutaline per metered dose.
THENYLDIAMINE in oral preparations except when included in Schedule 1.
THEOPHYLLINE in liquid oral preparations.
TIOCONAZOLE for human use in preparations containing 1 per cent or less of tioconazole, for treatment of fungal infections of the skin.
TRETINOIN for external human therapeutic use.
TRIMEPRAZINE
(a) in solid oral preparations; or
(b) in liquid oral preparations containing 10 mg or less of trimeprazine per 5 mi. except when included in Schedule 1.
TRIPROLIDINE in oral preparations except when included in Schedule 1.
_________________________
SCHEDULE 3
(Substances marked + are listed in the Notice)
ACEBUTOLOL
ACEPIFYLLINE except when included in Schedule 2.
ACEPROMAZINE
ACETANILIDE and alkyl acetanilides, for human therapeutic use.
ACETAZOLAMIDE ACETOHEXAMIDE
ACETYLCHOLINE and other choline esters except when separately specified in this Schedule.
ACETYLCYSTEINE
ACETYLDIHYDROCODEINE, 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 acetyldihy drocodeine.
ACETYLMETHYLDIMETRYLOXIMIDOPHENYLHYDRAZINE
ACYCLOVIR
ADIPHENINE
ADRENALINE except -
(a) when included in Schedule 2; or
(b) in preparations containing 0.02 per cent or less of adrenaline.
ALCURONIUM
alpha-CHLORALOSE-See chloralose.
ALPHADOLONE
ALPHAXALONE
ALPRAZOLAM
ALPRENOLOL
ALPROSTADIL
AMANTADINE
AMBENONIUM
AMBUCETAMIDE
AMBUTONIUM
AMETHOCAINE
AMIKACIN
AMILORIDE
AMINOCAPROIC ACID
AMINOGLUTEMMIDE
AMINOMETRADINE
AMINOPHENAZONE and derivatives therefrom for the treatments of animals.
AMINOPHYLLINE except when included in Schedule 2.
AMINOPTERIN
AMINOREX
AMIODARONE
AMIPHFNAZOLE
AMISOMETRADINE
AMITRIPTYLINE and other compounds structurally derived therefrom by substitution in the side chain except when separately specified in this Schedule.
AMODIAQUINE
AMOXYCILLIN
AMPHOMYCIN
AMPHOTERICIN
AMPICILLIN
AMSACRINE
AMYLOBARBITONE when packed and labelled for injection.
AMYLOCAINE
ANABOLIC STEROIDAL AGENTS except when separately specified in this Schedule.
ANGIOTENSINAMIDE
ANTAZOLINE except when included in Schedule 1.
ANTIBIOTICS except -
(a) when separately specified in these Schedules;
(b) avoparcin when packed and labelled for use as an animal feed additive; or
(c) nisin.
ANTIHISTAMINES
(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.
ANTITUBERCULAR SUBSTANCES including isoniazid and its derivatives, para-aminosalicyclic acid and thiacetazone except when separately specified in these Schedules.
APOMORPHINE
APROTININ
ARSENIC-See THIACETARSAMIDE
ASPIRIN when combined with caffeine paracetamol or salicylamide or any derivative of these substances.
ATENOLOL
ATROPINE METHONITRATE
AURANOFIN
AZAPERONE
AZAPETINE
AZATADINE AZLOCILLIN
AZTREONAM
BACAMPICILLIN
BACITRACIN except -
(a) when specified in the Notice;
(b) in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances; or
(c) in milk replacers for calves and starter rations for pigs, containing 100 mg/kg or less of
antibiotic substances.
BACLOFEN BAMIPINE
BARBITURIC ACID and its derivatives except -
(a) when included or separately specified in the Notice; or
(b) when separately specified in this Schedule.
BECLAMIDE
BEMEGRIDE
BENACTYZINE and other substances structurally derived from diphenylmethane with ataractic properties when used for therapeutic purposes.
BENDROFLUAZIDE
BENORYLATE
BENSERAZIDE
BENZAMINE, except when included in Schedule 1.
BENZHEXOL
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 and other substances structurally derived from beta-aminopropylbenzene or beta-aminoisopropylbenzene by substitution in the side-chain or by ring-closure therein (or by both such substitution and such closure) except -
(a) when separately spe6fied in this or any other Schedule; or
(b) ephedrine and pseudoephedrine in preparations exempted from Schedule 1.
BENZTROPINE
BENZYDAMINE except when included in Schedule 1.
BENZYLPENICILLIN (including procaine penicillin) except when specified in the Notice.
BETAHISTINE
BETHANIDINE
BIFONAZOLE
BIPERIDEN
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;
(b) bismuth oxychloride in cosmetics; or
(c) bismuth formic iodide or bismuth subiodide in dusting powders containing 3 per cent or less of bismuth.
BLEOMYCIN
BORON for human therapeutic use -
(a) for internal use;
(b) in glycerines or honeys of borax or boric acid;
(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.
BRETYLIUM
BROMAZEPAM
BROMIDES, inorganic, for therapeutic use.
BROMOCRIPTINE
BROMOFORM for therapeutic use.
BROMPHENIRAMINE except when included in Schedule 1 or 2.
BROMVALETONE
BUCLIZINE except when included in Schedule 1 or 2.
BUFEXAMAC except in preparations containing 5 per cent or less of bufexamac for external
human therapeutic use, including suppositories.
BUMETANIDE BUPIVACAINE
BUPRENORPHINE
BUSPIRONE
BUSULPHAN
BUTACAINE
BUTYLAMINOBENZOATE except when included in Schedule 1.
BUTYLCHLORAL HYDRATE
CALCITONIN
CALCITRIOL
CALCIUM CAR.BIMIDE for therapeutic use.
CAMPHORATED OIL excluding admixtures.
CAMPHOTAMIDE
CANDICIDIN
CANINE TICK ANTI-SERUM
CANTRARIDIN
CAPREOMYCIN
CAPTODIAME
CAFITOPRIL
CAPURIDE
CARAMIPHEN
CARBACHOL
CARBAMAZEPINE
CARBARYL for human therapeutic use except when included in Schedule 1.
CARBAZOCHROME
CARBENICILLIN
CARBENOXOLONE except when included in Schedule 1.
CARBIDOPA
CARBIMAZOLE
CARBOCROMEN
CARBOPLATIN
CARBROMAL
CARDIAC GLYCOSIDES except when separately specified in these Schedules.
CARINDACILLIN
CARMUSTINE
CARNIDAZOLE
CEFACLOR
CEFOPERAZONE
CEFOTAXIME
CEFOTETAN
CEFOXITIN
CEFFAZIDIME
CEFFRIAXONE
CEPHACETRILE
CEPHADROXIL, for the treatment of animals.
CEPHALEXIN
CEPHALORIDINE
CEPHALOTHIN
CEPHAMANDOLE
CEPHAPIRIN
CEPHAZOLIN
CEPHRADINE
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 except when specified in the Notice.
CHLORAMPHENICOL
CHLORAZANIL
CHLORBLTTOL in preparations for human oral use, except in preparations containing 0.5 per cent or less of chlorbutol as a preservative.
CHLORCYCLIZINE
CHLORDIAZEPOXIDE
CHLORMERODRIN
CHLORMEMAZOLE
CHLORMEZANONE
CHLOROFORM for the use in anaesthesia.
2-(4-CHLOROPHENYL)-1,2,4-TRIAZOLE [5,la]-ISOQUINOLINE for the treatment of animals.
CHLOROQUINE
CHLOROTHIAZIDE
CHLORPHENIRAMINE except when included in Schedule 1 or 2.
CHLORPHENTERMINE
CHLORPROMAZINE
CHLORPROPAMIDE
CHLORTETRACYCLINE except when specified in the Notice.
CHLORTHALIDONE CHLORZOXAZONE
CHOLESTYRAMINE for human therapeutic use.
CHYMOPAPAIN, injection for human therapeutic use.
CICLACILLIN
CILASTATIN
CIMETIDINE
CINCHOCAINE
CINOXACIN
CISPLATIN
CLANOBUTIN, in injections for the treatment of animals.
CLAVULANIC ACID
CLEMASTINE except when included in Schedule 2.
CLEMIZOLE
CLENBUTEROL
CLIDINIUM
CLINDAMYCIN
CLOBAZAM
CLOBETASONE-17-BUTYRATE
CLOFENAMIDE
CLOFIBRATE
CLOMIPHENE
CLOMIPRAMINE
CLOMOCYCLINE
CLONAZEPAM
CLONIDINE
CLOPAMIDE
CLOPROSTENOL
CLORAZEPATE
CLOREXOLONE
CLORPRENALINE
CLOTRIMAZOLE, except when included in Schedule 2 or in the Notice.
CLOXACILLIN
CLOZAPINE
CODEINE, except when included in Schedule 1 or 2, when compounded with one or more other therapeutically active substances -
(a) in divided preparations containing 30 mg or less of codeine per dosage unit; or
(b) in undivided preparations containing 1 per cent or less of codeine.
COLASPASE
COLCHICINE
COLESTIPOL for human therapeutic use.
COLISTIN
CORTISONE and steroid suprarenal cortical hormones, except hydrocortisone in Schedule 2.
CURARE, TUBOCURARINE, d-TUBOCURARINE, d-TUBOCURARINEDI- METHYLETHER and all synthetic quaternary ammonium compounds and other compounds having curarising properties except when separately specified in this Schedule.
CYCLANDELATE
CYCLIZINE
CYCLOFENIL
CYCLOPENTOLATE
CYCLOPROPANE for therapeutic use.
CYCLOSERINE
CYCLOSPORIN
CYCRIMINE
CYPROHEPTADINE except when included in Schedule 2.
DACARBAZINE
DANAZOL
DANTROLENE
DAPSONE and all derivatives of 4,4-diaminodiphenylsulphone.
DEANOL
DEBRISOQUINE
DEMECARIUM BROMIDE
DEMECLOCYCLINE
DESIPRAMINE
DESMOPRESSIN (D.D.A.V.P.)
DETOMIDINE
DEXCULORPHENIRAMINE except when included in Schedule 1 or 2.
DEXTROMETHORPHAN except when included in Schedule 1.
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
DIAZEPAM
DIBENZEPIN
TRANS-4-((3,5-DIBROMO-2-HYDROXYBENZYL)-AMINO) CYCLOHEXANOL HYDRO-
CHLORIDE MONOHYDRATE (Sputolysin) except when in Schedule 1.
DICHLORALPHENAZONE
DICHLORPHENAMIDE
DICLOFENAC
DICYCLOMINE except when included in Schedule 1.
DIETHAZINE
DIETHYLCARBAMAZINE for human therapeutic use.
DIETHYLPROPION
DIFFNOXIN 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.
DIFLUNISAL
DIGITALIS and its glycosides.
DIRYDRALAZINE
DIRYDROCODEINE 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 dihydro- codeine,
except when included in Schedule 1.
DIHYDROSTREPTOMYCIN except when specified in the Notice.
DIISOPROPYLAMINE DICHLOROACETATE
DILTIAZEM
DIMENHYDRINATE except when included in Schedule 1 or 2.
DIMETHINDENE except when included in Schedule 2.
DIMETHISOQUIN except when included in Schedule 1.
DIMETHOXANATE
DIMETHYL SULPHOXIDE for therapeutic use except when specified in the Notice.
DINITROCRESOLS for therapeutic use.
DINITRONAPHTHOLS for therapeutic use.
DINITROPHENOLS for therapeutic use.
DINITROTHYMOLS for therapeutic use.
DINOPROST
DIPERODON
DIPHEMANIL
METHYLSULPHATF except when included in Schedule 1.
DIPHENHYDRAMINE except when included in Schedule 1 or. 2.
DIPHENIDOL
DIPHENOXYLATE in preparations containing per dosage unit, 2.5 mg or less of (liphenoxylate and a quantity of atropine sulphate equivalent to at least 1 per cent of the dose of diphenoxylate.
DIPHENYLPYRALINE except when included in Schedule 1 or 2.
DIPIVEFRIN
DIPYRIDAMOLE
DISOPHENOL
DISPYRAMIDE
DISULFIRAM for therapeutic use.
DITHIAZANINE except when specified in the Notice.
DOBUTAMINE
DOMPERIDONE
DOPAMINE
DOTHIEPIN
DOXAPRAM
DOXEPIN
DOXORUBICIN
DOXYCYCLINE
DOXYLAMINE except when included in Schedule 1 or 2.
DROPERIDOL
DROSTANOLONE
ECONAZOLE except when included in Schedule 2 or in the Notice.
EDETIC ACID for human therapeutic use in preparations for injection or infusion.
EMETINE except in preparations containing 0.2 per cent or less of emetine.
ENALAPRIL
EPHEDRINE except -
(a) when included in Schedule 1 or 2;
(b) in preparations for topical use containing 1 per cent or less of ephedrine; or
(c) when 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.
ENFLURANE for therapeutic use.
EPICILLIN
EPIRUBICIN
ERGOT
ERYTHROMYCIN except -
(a) when specified in the Notice;
(b) in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances; or
(c) in milk replacers for calves or starter rations for pigs, containing 100 mg/kg or less of antibiotic substances.
ETHACRYNIC ACID
ETHAMBUTOL
ETHAMIVAN
ETHCHLORVYNOL
ETHER for use in anaesthesia.
ETHINAMATE
ETHOGLUCID
ETIiOHEPTAZINE except when included in Schedule 1.
ETHOPROPAZINE
ETHOXZOLAMIDE
ETHYL CHLORIDE for inhalation anaesthesia.
ETHYLMORPHINE when compounded with one or more other medicatments -
(a) in divided preparations containing not more than 100 mg of ethylmorphine per dosage unit; or
(b) in undivided preparations with a concentration of more than 2.5 per cent of ethylmorphine.
except when included in Schedule 1.
ETHYLOESTRENOL
ETIDOCAINE
ETIDRONATE except in toothpastes and gel containing 1 per cent or less of etidronate.
ETILEFRIN HYDROCHLORIDE
ETOPOSIDE
ETRE'NNATE
FELYPRESSIN
FENCAMFAMIN
FENFLURAMINE
FENOPROFEN
FENOTFROL except when included in Schedule 2.
FENPIPRAMIDE
FENPIPRANE
FENPROSTALENE
FLAVOPHOSPEOLIPOL except -
(a) when specified in the Notice; or
(b) in animals feeds for growth promotion containing 50 mg/kg or less of antibiotic substances.
FLECAINIDE
FLUCLOXACILLIN
FLUCYTOSINE
FLUFENAMIC ACID
FLUNISOLIDE
FLUNITRAZEPAM
FLUNIXIN MEGLUMINE for the treatment of animals.
FLUORIDES in preparations for human ingestion except when included in Schedule 1.
FLUOROURACIL and other substances structurally derived from uracil with cytotoxic properties when used for therapeutic purposes.
FLUOXYMESTERONE
FLUPHENAZINE
FLUPROSTENOL
FLURAZEPAM
FLUROXENE for inhalation anaesthesia
FLUSPIRILENE
FOLLICLE STIMULATING HORMONE (See also gonadotrophins)
FRAMYCETIN
FRUSEMIDE
FUSIDIC ACID
GALANTHAMINE
GALLAMINE
GEMEPROST
GENTAMCIN
GLIBENCLAMIDE
GLIBORNURIDE
GLICLAZIDE
GLUCAGON
GLUTETHIMIDE
GLYCERYL TRINITRATE in preparations for injection.
GLYCOPYRROLATE
GLYMIDINE
GONADORELIN
GONADOTROPHINS except when included in Schedule 1.
GRAMICIDIN
GRISEOFULVIN
GROWTH HORMONE
GUAIPHENESIN except when included in Schedule 1.
GUANABENZ
GUANACLINE
GUANETHIDINE
HALCINONIDE
HALOPERIDOL 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.
HEPARIN for internal therapeutic use.
HETACILLIN
HEXACHLOROPHANE -
(a) in preparations for use on infants; or
(b) in other preparations except when included in Schedule 1 or specified in the Notice.
HEXAMETHONIUM
HEXOCYCLIUM
HYALURONIC ACID in preparations for injection.
HYDRALAZINE
HYDROFLUMETHIAZIDE
HYDROQUINONE for human therapeutic use except in preparations containing 2 per cent or less of hydroquinone.
HYDROXYCHLOROQUINE
1-HYDROXYPYRIDO (3,2,a)-S-PHENOXAZONE-3-CARBOXYLIC ACID
HYDROXYUREA
HYDROXYZINE
HYGROMYCIN except -
(a) when specified in the Notice; or
(b) in preparations in concentrations of 50 mg/kg or less of antibiotic substances.
HYOSCINE BUTYLBROMIDE
HYPOTHALAMIC RELEASING FACTORS except when separately specified in this Schedule.
IBUFENAC
IBUPROFEN
IDOXURIDINE except when included in Schedule 2.
IMIPENEM
IMIPRAMINE
INDAPAMIDE
INDOMETHACIN
INOSITOL NICOTINATE, for internal use.
ION-EXCHANGE RESINS, anionic and cationic, for internal use in humans except when separately specified in this Schedule.
IOPAMIDOL
IPRATROPIUM
IRON compounds in injectable preparations for human therapeutic use.
ISOAMINILE
ISOCONAZOLE except when included in Schedule 2 or specified in the Notice.
ISOETHARINE
ISOFLURANE
ISOMETHEPTENE
ISOPRENALINE
ISOPROPAMIDE except when included in Schedule 1.
ISOTRETINOIN
ISOXUPRINE
KANAMYCIN
KETAMINE
KETOCONAZOLE
KETOPROFEN
KHELLIN
KITASAMYCIN except -
(a) when specified in the Notice; or
(b) in animal feeds for growth promotion containing 100 mg/kg or less of antibiotic, substances.
LABETALOL
LATAMOXEF
LAUDEXIUM METHYLSULPHATE
LEAD COMPOUNDS for human therapeutic use.
LEFETAMINE
LEPTAZOL
LEUPRORELIN
LEVALLORPHAN
LEVAMISOLE -
(a) for human therapeutic use; or
(b) in preparations for the prevention or treatment of heartworm in dogs.
LEVODOPA
LIDOFLAZINE
LIGNOCAINE except when included in Schedule 1.
LINCOMYCIN
LINDANF for human therapeutic use except when included in Schedule 1.
LIOTHYRONINE SODIUM (Triiodothyronine).
LITHIUM salts for therapeutic use, except in preparations containing 0.01 per cent or less of lithium.
LOPERAMIDE except when included in Schedule 2.
LORAZEPAM
LOXAPINE
LUTEINISING HORMONE (See also gonadotrophins).
LYMECYCLINE
MAFENIDE
MALDISON for human therapeutic use except when included in Schedule 1.
MAPROTILINE
MAZINDOL
MEBEVERINE
MEBHYDROLIN
MECAMYLAMINE
MECLOFENOXATE
MECLOZINE
MEDAZEPAM
MEFENAMIC ACID except when included in Schedule 2.
MEFLOQUINE
MEFRUSIDE
MEPACRINE
MEPENZOLATE
MEPHENESIN and its derivatives except guaiphenesin where specified in Schedule 1 or 3.
MEPHENTERMINE
MEPIVACAINE
MEPROBAMATE
MEPYRAMINE except when included in Schedule 2.
MERCAPTOPURINE and other substances structurally derived therefrom with cytotoxic properties when used for therapeutic purposes.
MERCUROUS CHLORIDE for internal therapeutic use.
MERCURY ORGANIC COMPOUNDS for therapeutic use, except when included in Schedule 1.
METARAMINOL
METFORMIN
METHACYCLINE
METHANDIENONE
METHANDRIOL
METHANTHELINIUM
METHAZOLAMIDE
METHDILAZINE except when included in Schedule 2.
METHENOLONE
METHICILLIN
METHIMAZOLE
METHIXENE
METHOCARBAMOL
METHOTREXATE
METHOXSALEN
METHOXYFLURANE for therapeutic use.
METRYLANDROSTANOLONE
METHYCLOTHIAZIDE
MET'HYLDOPA
METHYLPENTYNOL and other substituted alkynes for internal use.
METFIYPRYLONE
METOCLOPRAMIDE
METOLAZONE
METOPROLOL
METRIZAMIDE
METRONIDAZOLE including benzoylmetronidazole
METYRAPONE
MEXILETINE
MEZLOCILLIN
MIANSERIN
MIBOLERONE
MICONAZOLE except when included in Schedule 2 or in the Notice.
MIDAZOLAM
MINOCYCLINE
MINOXIDIL
MISOPROSTOL
MITHRAMYCIN
MITOBRONITOL
MITOMYCIN
MITOZANTRONE
MONENSIN except -
(a) when specified in the Notice; or
(b) 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 i.-ent or less of monobenzone.
MOPERONE
MUPIROCIN
MUSTINE and other substances structurally derived therefrom with cytotoxic properties, when
used for therapeutic purposes except when specified in this Schedule.
NADOLOL
NALBUPHINE
NALIDIXIC ACID except when specified in the Notice.
NALORPHINE
NALOXONE
NANDROLONE
NAPROXEN except when included in Schedule 2.
NARASIN except -
(a) when specified in the Notice; or
(b) in animal feeds containing 100 mg/kg or less of narasin.
NATAMYCIN
NEOMYCIN except when specified in the Notice.
NEOSTIGMINE
NETILMICIN
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 nicocodille.
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 nicodiodine.
NICOTINE in chewing tablets containing 4 mg or less of nicotine per tablet for use as an aid in withdrawal from tobacco smoking.
NICOTINIC ACID for human therapeutic use except in preparations containing 250 mg or less of nicotinic acid per recommended daily dose.
NICOTINYL ALCOHOL for internal use.
NICOUMALONE for internal therapeutic use.
NIFEDIPINE
NIFENAZONE
NIKETHAMIDE
NIRIDAZOLE
NITRAZEPAM
NITROFURAN and its derivatives for human therapeutic use except when included in Schedule 2.
NITROUS OXIDE for therapeutic use.
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. except when included in Schedule 1.
NORETHANDROLONE
NORFLOXACIN
NORTRIPTYLINE
NOVOBIOCIN except when specified in the Notice.
NYSTATIN
OCTAMYLAMINE
OCTATROPINE
OLEANDOMYCIN except -
(a) when specified in the Notice; or
(b) in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances.
OPIPRAMOL
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.
ORNIDAZOLE
ORNIPRESSIN
ORPRENADRINE
ORTHOCAINE
ORTHOPTERIN
OXACILLIN
OXANDROLONE
OXAZEPAM
OXPRENOLOL
OXYBUPROCAINE
OXYMESTERONE
OXYMETHOLONE
OXPENTIFYLLINE
OXYPHENBUTAZONE
OXYPHENCYCLIMINE
OXYPHENONIUM
OXYTF-TRACYCLINE except when specified in the Notice.
OXYTOCIN
PAMAQUINE
PANCURONIUM
PARACETAMOL when combined with aspirin, caffeine or salicylamide or any derivative of these substances.
PARALBEHYDE
PAROMOMYCIN
PEMOLINE
PEMPIDINE
d-PENICILLAMINE
PENTAMETHONIUM
PENTHIENATE
PENTOBARBITONE when packed and labelled for injection.
PENTOLINIUM
PERHEXILENE
PERICYAZINE
PERPHENAZINE
PHENACETIN for therapeutic use.
PHENACEMIDE
PHENAZONE except when included in Schedule 1.
PHENAZOPYRIDINE
PHENETHICILLIN except when specified in the Notice.
PHENFORMIN
PHENGLUTARIMIDE
PHENINDIONE for internal therapeutic use.
PHENIRAMINE except when included in Schedule 1 or 2.
PHENOXYBENZAMINE
PHENOXYMETHYLPENICILLIN except when specified in the Notice.
PHENSUXIMIDE and other substances structurally derived from succinamide with anticonvulsiint properties when used for therapeutic purposes.
PHENTERMINE
PHENTHIMENTONIUM
PHENTOLAMINE
PHENYAPIN
PHENYLBUTAZONE
PHENYLEPHRINE in preparations for human ophthalmic use containing 5 per cent or more of phenylephrine.
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 1.
PHYSOSTIGMINE
PICROTOXIN
PILOCARPINE except in preparations containing 0.025 per cent or less of pilocarpine.
PIMOZIDE
PINDOLOL
PIPENZOLATE
PIPERACILLIN
LAWS OF THE REPUBLIC OF VANUATU
SALE OF MEDICINES (CONTROL) [CAP. 48.
________________________________________________________________________________
[Subsidiary]
PIPERIDOLATE
PIPOBROMAN
PIPRADROL
PIRENZEPINE
PIROXICAM
PITUITARY, its extracts and active principles or their synthetic substitutes except when separately specified in this Schedule.
PIZOTIFEN
PODOPHYLLUM RESIN (Podophyllin) for human therapeutic use except when included in Schedule 1 or 2.
POLYMETHYLENE BISTRIMETHYL AMMONIUM COMPOUNDS
POLYMYXIN
POLYSULPHATED GLYCOSAMINOGLYCANS in preparations for injection, except where otherwise specified in this Schedule.
POTASSIUM PERCHLORATE for therapeutic use.
PRACFOLOL
PRAMOXINE except when included in Schedule 1.
PRAZEPAM
PRAZOSIN
PREGNENOLONE ACETATE except in preparations for topical use.
PRENYLAMINE
PRILOCAINE
PRIMAQUINE
PRIMIDONE
PROBENECID
PROBUCOL
PROCAINAMIDE
PROCAINE
PROCARBAZINE
PROCHLORPERAZINE
PROCYCLIDINE except when included in Schedule 1.
PROGUANIL
PROLINTANE
PROMAZINE
PROMETHAZINE except when included in Schedule 1 or 2.
PROPANIDID
PROPATHFLINE except when included in Schedule 1.
PROPRANOLOL
PROPOFOL
PROPOXUR for human therapeutic use.
PROPYLHEXEDRINE except when included in Schedule 1.
PROPYHENAZONE
PROQUAZONE
PROSTAGLANDINS except where separately specified in this Schedule.
PROSTIANOL
PROTHIONAMIDE
PROTIRELIN (thyrotrophin releasing factor).
PROTRIPTYLINE
PROXYMETACAINE
PSEUDOEPHEDRINE in preparations for stimulant, appetite suppression or weight control purposes.
PYRIDOSTIGMINE
PYRIDOXINE HYDROCHLORIDE in preparations for human use containing more than 50 mg of pyridoxine per recommended daily dose unless labelled with the warning statement "WARN- ING-THIS MEDICATION MAY BE DANGEROUS WHEN USED IN LARGE AMOUNTS OR FOR A LONG PERIOD".
PYRIMETHAMINE
QUINETHAZONE
QUINIDINE
RANITIDINE
RAUWOLFIA SERPENTINA
RIFAMPICIN
RITODRINE
ROLITETRACYCLINE
ROSOXACIN
SALBUTAMOL except when included in Schedule 2.
SALICYLAMIDE when combined with aspirin, caffeine or paracetamol or any derivative of these substances.
SALINOMYCIN except -
(a) when specified in the Notice; or
(b) in animal feeds containing 60 mg/kg or less of antibiotic substances.
SELENIUM except -
(a) when specified in the Notice;
(b) as selenium arsenide in photocopier drums;
(c) in animal feeds containing 0.1 g/tonne or less of selenium;
(d) in compressed pellets for control of selenium responsive conditions in sheep or cattle; or
(e) in fertilizers containing 200 g/tonne or less of selenium.
SEX HORMONES and all substances having sex hormonal activity except when separately specified in these Schedules.
SILVER SULPHADIAZINE
SISOMYCIN
SODIUM CELLULOSE PHOSPHATE for human internal use.
SODIUM CROMOGLYCATE except when included in Schedule 2.
SODIUM NITROPRUSSIDE for human therapeutic use.
SODIUM VALPROATE
SONTOQUINE
SOTALOL
SPARTEINE
SPECTINOMYCIN
SPIRAMYCIN except -
(a) when specified in the Notice; or
(b) in animal feeds for growth promotion in pigs or poultry containing 50 mg/kg or less of antibiotic substances.
SPIRONOLACTONE
SPUTOLYSIN-See trans-4-(3,5-bibroma-2-hydroxybenzyl)-amino cyclohexanol hydrochloride monohydrate.
STANOLONE
STANOZOLOL
STREPTOMYCIN except when specified in the Notice.
STROPHANTHUS and its glycosides.
STRYCHNINE in preparations containin 1.5 per cent or less of strychnine for the treatment of 9 animals.
SULFAMETROLE
SULINDAC
SULPHANILAMIDE and its derivatives except -
(a) when specified in the Notice;
(b) when separately specified in this Schedule;
(c) oryzalin;
(d) sulphaquinoxaline in animal feeds containing 200 mg/kg or less of sulphaquinc,xaline; or
(e) sulphaquinoxaline when incorporated in baits for the destruction of vermin.
SULPHATROXAZOLE
SULPHINPYRAZONE
SULPHOMYXIN
SULPHONAL and alkyl sulphonals.
SULTHIAME
SUXAMETHONIUM
TACRINE
TAMOXIFEN
TEMAZEPAM
TENIPOSIDE
TERBUTALINE except when included in Schedule 2.
TERFENADINE
TEROPTERIN
TETRABENAZINE
TETRACOSACTRIN
TETRACYCLINE except when specified in the Notice.
THALIDOMIDE
THENYLDIAMINE except when included in Schedule 1 or 2.
THEOPHYLLINE except when included in Schedule 2.
MACETARSAMIDE, in preparations for the prevention or treatment of heart worm in dogs.
MACETAZONE
THIAMBUTOSINE
THIAZOSULPHONE
METHYLPERAZINE
THIOPROPAZATE
TRIORIDAZINE
THIOTEPA and other substances structurally derived therefrom with cytotoxic properties when used for therapeutic purposes.
THIOTHIXENE
THIOURACIL and substances structurally derived therefrom with antihyroid properties when used for therapeutic purposes.
THIOUREA for therapeutic use.
THYROID and extracts, and its active principles except when separately specified in this Schedule.
THYROTROPHIN (T.S.H.)
THYROXINE SODIUM
TIAMULIN except -
(a) when specified in the Notice;
(b) in prepared animal feeds.
TICARCILLIN
TIEMONIUM
TIGLOIDINE
TIMOLOL
TINIDAZOLE
TIOCONAZOLE except when in Schedule 2.
TIPEPIDINE
TOBRAMYCIN
TOCAINIDE
TOLAZAMIDE
TOLAZOLINE for internal use.
TOLBUTAMIDE
TOLPROPAMINE
TRANEXAMIC ACID
TRETAMINE
TRIAMTERENE
TRIAZIQUONE
TRIAZOLAM
TRICHLOROETHYLENE for therapeutic use.
TRICLOFOS
TRICYCLAMOL
TRIDIHEXETHYL
TRIFLUOPERAZINE
TRIFLUPERIDOL
TRIMEPRAZINE except when included in Schedule 1 or 2.
TRIMETAPHAN
TRIMETHOPRIM
TRIMIPRAMINE
TRIMUSTINE
TRIOXYSALEN
TRIPELENNAMINE
TRIPROLIDINE except when included in Schedule 1 or 2.
TROXIDONE and other substances structurally derived from oxazolidinone with ainiticonvulsant properties when used for therapeutic purposes.
TYLOSIN except -
(a) when included in the Notice;
(b) in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances; or
(c) in milk replacers for calves or starter rations for pigs, containing 100 mg/kg or less of
antibiotic substances.
URETHANE (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.
VACCINES, sera, toxoids, and antigens for human parenteral use.
VACCINES, veterinary live virus except -
(a) poultry vaccines;
(b) pigeon pox vaccine; or
(c) scabby mouth vaccine.
VALNOCTAMIDE
VASOPRESSIN
VERAPAMIL
V'ERATRUM for therapeutic use.
VECURONIUM
VIDARABINE
VINCA ALKALOIDS including semi-synthetic derivatives.
VIPRYNIUM
VIRGINIAMYCIN except -
(a) when specified in the Notice; or
(c) 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 l.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.
WARFARIN for internal therapeutic use.
XANTHINE OXIDASE INHIBITORS including allopurinol.
XANTHINOL NICOTINATE XYLAZINE
YOHIMBINE
ZERANOL except when specified in the Notice.
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URL: http://www.paclii.org/vu/legis/consol_act1988/soma235