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Sale of Medicines (Control) Act [Cap 48]

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

3. Limitation on the wholesale sale of medicines
4. Sale of narcotics
5. Control of price
6. Inspection of premises
7. Regulations
8. Penalties

9. Application

-----------------------------------------

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

4. No person other than a pharmacist shall have in his possession, import, sell or otherwise deal in any of the substances subject to the Regulations of the Permanent Opium Committee:

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

5. The Minister may by Order take such measures as he may deem necessary to control the sale price of medicines.


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

9. Notwithstanding the provisions of this Act the Minister may, by Order, authorise the health service, hospitals and clinics (public or private), to sell medicines under the same conditions as a pharmacist or a druggist, and the conditions governing distance provided for in section 2(2) shall not apply to them.

_____________________

[Subsidiary]

SUBSIDIARY LEGISLATION

SALE OF MEDICINES REGULATIONS

Order 25 of 1988

ARRANGEMENT OF REGULATIONS


REGULATION

1. Interpretation
2. Sale of medicines
3. Notices

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