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Government Gazette REPUBLIC OF SOUTH AFRICA Regulation Gazette No. 7636 Vol. 454 Pretoria 10 April 2003 No. 24727 AIDS HELPLINE: 0800-0123-22 Prevention is the cure I STAATSKOERANT, 10 APRIL 2003 No. 24727 3 GOVERNMENT NOTICES GOEWERMENTSKENNISGEWINGS DEPARTMENT OF HEALTH DEPARTEMENT VAN GESONDHEID NO. R. 509 10 April 2003 SCHEDULES The Minister of Health has, in terms of section 22A(2) of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), on the recommendation of the Medicines Control Council, made the Schedulesin the Schedule SCHEDULE I In these Schedules, "the Act" meansthe Medicines and Related SubstancesAct, 1965 (Act No. 101 of 1965) SCHEDULE 0 (a) All substancesreferred to in thisSchedule are excluded when specifically packed, labelled and usedfor - (i) industrialpurposes including the manufacture or compounding of consumer items or products which have no pharmacological oraction medicinal purpose, which are intended to be ingested by man or animals as food, or applied to the body as a cosmetic, and which are approved for such use in terms of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972) or registeredin terms of theFertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36 of 1947); and (ii)analytical laboratory purposes. (b) All substances referred to in this Schedule include the following: 4 No. 24727 GOVERNMENT GAZETTE, 10 APRIL 2003 (i) The saltsand esters of suchsub2ances,+vhere the existence of such salts and esters is possible; and (ii) All preparationsand mixtures of suchsubstances where such preparations and mixtures arenot expressly excluded. This Schedule includesall substances subject to registration in termsof the Act and which are not listed in anyof the other Schedules. ~~ STAATSKOERANT, 10 APRIL 2003 No. 24727 5 SCHEDULE 1 (a) All substances referred to in this Schedule are excluded when specifically packed, labeled and used for- (i) industrial(i) purposes including the manufacturecompoundingor of consumer items or products which have no pharmacological action or medicinal purpose; and (ii)analytical laboratory purposes. All substances referred to in this Schedule include the following: (i) The salts and esters of such substances, where the existence of such salts and esters is possible; and (i) all preparationsand mixtures of suchsubstances where such preparations and mixtures are not expressly excluded. In terms of section 22A(4)(a)(v) of the Act, a practitioner, nurse ora person registered under the Health Professions Act, 1974 (ActNo. 56 of 1974) other than a medical practitioner or dentist, may prescribe and supply to patients under their care, the Schedule 1 substances and medicines providedfor in theAnnexures, only within their scope of practiceand subject to the conditions determined by the Medicines Control Council. The conditions and the Annexures will be publishedin the Gazetfe. Acetanilide and alkyl acetanilides, Acetarsol, when intended for human vaginal use. Acyclovir, when intended for application to thelips in the early treatment of recurrent herpes simplex virus infections.(S4) Anethole trithione. Anticoagulants, when intendedfor application to the skin. (S4) Antimalarials; chloroquine in combination with proguanil when intended specificallyfor malaria prophylaxis. (S4) Antimicrobial substances, namely bacitracin, gramicidin, polymyxinB and tyrothricin, 6 No. 24727 GOVERNMENT GAZETTE, 10 APRIL 2003 when intended for application to the skb, nares-and external ear, as excluded from the conditionsof Schedule 4. (S2,S4) Antimony potassium tartrate and antimony sodium tartrate; substances, preparations and mixtures containing1 ,O percent or more thereof. Arsenic; SUbSfanCeS, preparations and mixtures containing the equivalent of less than 0,Ol percent of arsenic trioxide. (S2) Azelaic acid. Belladonnaalkaloids; when specifically intended for topicalapplication (~2). Benzethonium chloride, when intendedfor human vaginal use. Benzydamine; preparations and mixtures containing- (a) 3 per cent or lessof benzydamine when intendedfor application to the skin; (b) 0,15per cent or less of benzydamine when intended for use as a mouth rinse or for topical application in the mouth and throat: Provided that the total daily dose does not exceed36 mg of benzydamine. (S3) Beta-aminopropylbenzeneand beta-aminoisopropylbenzene asexcluded from the conditions of Schedule 5. (S5) Bifonazole, when intended for application tothe skin. Bioallethrin. Bitolterol. Bufexamac, when intended for applicationto the skin. Bunamidine. Calcium salts; preparations thereof, when intendedfor injection, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947. Chlohexidine,when intended humanfor vaginal use. .* Chloroform, preparations and mixtures containing less than 20 percent Of chloroforn. (S5) Clotrimazole, when intended for application to the skin and when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis.(S4) Dialysate preparations. Diclofenac, when intended for applicationto the skin. (s2, s3) Diosmine. Dithiazanine. STAATSKOERANT, 10 APRIL 2003 No. 24727 7 Econazole, when intended for application to the skin and when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis. (S4) Enilconazole, when intended for application to the skin.(s4) Ephedra alkaloids (natural or synthetic) except ephedrine preparations and mixtures intended for application to skin, eyes, ears and nares containing1 ,O per cent or less of ephedra alkaloids, and other preparations and mixtures containing not more than 30 milligrams of ephedrine or ephedra alkaloids per dose.(S2, S5) Ephedrine contained in products registered in terms of the Act, preparations and mixtures intended for application to the skin, eyes, ears and nares containing 1,O per cent or less of ephedrine, and other oral preparations and mixtures containing not more than30 milligrams of ephedrine per dose.(S2, S5) Escin (aescin); medicinal preparations and mixtures thereof intended for application to the skin'and containing1 ,O per cent or less of escin.(S3) Ether (diethyl ether); all substances, preparations and mixtures containingless than 20 per cent of ether. (S5) Ethylphenylephrine. Etofenamate, when intended for application to the skin. Felbinac, when intendedfor application to the skin. Fenbendazole, except when registered in termsof the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock RemediesAct, 1947. Fenticonazole, when intended for application to the skin. Flubendazole, except when intended and registered as an anthelmintic in terms of the provisions of theFertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947. Flufenamic acid, when intended for application to the skin.(S3) Flurbiprofen, when intended for application to the skin, including by tmnsdermal patch, provided that in the case of application by transdermal patch indications are for use by adults and children12 years and older and the treatment period is limited to 4 weeks. (S2, S3,S4) Fluorescein, when intended for ophthalmic use. Fluorides; oral medicinal preparations and mixtures thereof containing0,25 milligrams Or more of fluorine as fluoride per recommended daily dose, unless listed in another Schedule. (S4) 8 No. 24727 GOVERNMENT GAZETTE, 10 APRIL 2003 Gamma benzene hexachloride human medicinalprepqtions and mixtures when intended for applicationto the skin. GlYcosaminoglYcan PobsulPhate (Previously mucopolysaccharide poly-sulphuric acid ester) when intended for application to the skin.(S4) 0- (6-hydroxyethyi)rutosides. Ibuprofen, when containedin preparations intendedfor application to the skin (S2,S3) Idoxuridine, when intendedfor application to the skin. (S4) Indanazoline. indomethacin, when intendedfor application to the skin.(S2, S3) Injections, unless listed in another Schedule, except whenregisteied in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947. Irrigation fluids. Isoconazole, when intendedfor application to the skin and when intended for human vaginal use specificallyfor the treatment of recurrent vaginal candidiasis.(S4) Ketoconazoie, when intended for applicationto the skin, except preparations and mixtures containing not more than1 ,O percent of ketaconazole, when intendedfor the prevention and treatment of dandruff.(SO, S4) Ketoprofen, when intended for applicationto the skin. (S2, S3) Lactobacillus acidophilus and Lactobacillus bifidus, when intendedfor therapeutic purposes, except when registeredin terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock RemediesAct, 1947. Local anaesthetics, except when intendedfor ophthalmic andfor parenteral use. (52, S4) Lufenuron, except when intended and registereda systemicas prepamtion againstfleas in terms of the provisionsof the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947. Luxabendazole, except when intended and registered as an anthelminticin terms Of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947. Lysozyme, when intendedfor application to the skin. (S4) Malathion, except when intended and registered as an ectoparasiticidein terms of the provisions ofthe Fertilizers, Farm Feeds, Agricultural Remedies and Stockhnedies Act, 1947. STAATSKOERANT, 10 APRIL 2003 No. 24727 9 Manganese salts, preparations
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