Statistics Act, 1999
R 385
Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)SchedulesSchedule 3 |
Schedule 3
| (a) | All substances referred to in this Schedule are excluded when specifically packed, labelled, sold and used for— |
| (i) | industrial purposes including the manufacture or compounding of consumer items or products, which have no pharmacological action or medicinal purpose; and |
| (ii) | analytical laboratory purposes. |
| (b) | All preparations of substances or mixtures of such substances containing or purporting to contain any substance referred to in this Schedule and includes the following: |
| (i) | The salts and esters of such substances, where the existence of such salts and esters is possible; and |
| (ii) | all preparations and mixtures of such substances where such preparations and mixtures are not expressly excluded. |
| (c) | In terms of section 22A(5)(f) of the Act, a practitioner, nurse or a person registered under the Health Professions Act, 1974 (Act 56 of 1974) other than a medical practitioner or dentist may prescribe and supply, only within his/her scope of practice and subject to the indication for use of such substances and medicines and to the conditions determined by the Medicines Control Council, to patients under his/her care, the Schedule 3 substances and medicines provided for in the Annexures to this Schedule published in the Gazette in terms of the Act. |
| (i) | Annexure 1A: Emergency Care Provider (Paramedic); |
Annexure 1B: Emergency Care Provider (Emergency Care Practitioner);
| (ii) | Annexure 2: Dental Therapist; |
| (iii) | Annexure 3: Optometrist. |
| (iv) | Annexure 4: Podiatrist. |
Acamprosate.
Acebutolol.
Aceclofenac.
Acetazolamide.
Acetohexamide.
Acetylcholine, when intended for ophthalmic use.
Acetylcysteine,
| (a) | when intended for injection or for the management of paracetamol overdosage; |
| (b) | except when used as mucolytic in acute respiratory conditions for a maximum treatment period of 14 days. (S2) |
Acipimox.
Aclidinium
Adapalene.
Adrenaline (epinephrine); ophthalmic preparations thereof, when intended for glaucoma. (S2, S4)
Alclofenac.
Alendronic acid.
Alogliptin.
Aliskiren.
Allopurinol.
Alogliptin.
Alprenolol.
Amiloride.
Amlodipine.
Ancrod.
Anthiolimine, when intended for injection.
Arsanilic acid.
Ascorbic Acid - see Vitamin C.
Atenolol.
Atropine,
(a) when intended for use in ophthalmic preparations; (S2)
(b) except when intended for use in injections. (S4)
Azapropazone.
Balsalazide.
Barnidipine.
Beclamide.
Beclomethasone dipropionate, when intended for inhalation or nasal administration, except when intended for nasal administration as an aqueous spray, other than by pressurised aerosol, and indicated for the treatment of the symptoms of seasonal allergic rhinitis (hay fever) in adults and children over 12 years of age, subject to
| (a) | a maximum dose of 100 micrograms per nostril and a maximum daily dose of 200 micrograms per nostril and |
| (b) | a maximum pack size of 200 doses. (S2, S4) |
Benazepril.
Bendazac.
Benfluorex.
Benoxaprofen.
Benzbromarone.
Benzydamine, except preparations and mixtures containing—
| (a) | 3 per cent or less of benzydamine when intended for application to the skin; (S0) |
| (b) | intended for use as a mouth rinse or for topical application in the mouth and throat: provided that the total dose swallowed does not exceed 36 mg of benzydamine per day; (S1) |
| (c) | containing 3 milligrams or less of benzydamine per throat lozenge: Provided that the total dose swallowed does not exceed 36 milligrams of benzydamine per day and the pack size does not exceed 16 lozenges. (S0) |
| (d) | intended for human vaginal use. (S2) |
Bepridil.
Beta-benzalbutyramide.
Beta-galactosidase, when intended for therapeutic purposes.
Betahistine.
Betaxolol.
Bethanidine.
Bevantolol.
Bezafibrate.
Bisoprolol.
Bopindolol.
Bowel cleansers, preparations intended for the management of faecal impaction, or for the purpose of bowel cleansing prior to surgical or diagnostic procedures, unless listed elsewhere in the Schedules. (S0)
Brimonidine.
Brinzolamide.
Budesonide,
| (a) | when intended for inhalation or nasal administration, unless listed in another Schedule; (S4) |
| (b) | except when intended for the prophylaxis and treatment of seasonal and perennial allergic rhinitis in adults and children aged 12 years and older. (S2) |
Bufexamac, except when intended for application to the skin. (S1)
Buflomedil.
Buformin.
Bumetanide.
Butecosone, when intended for inhalation or nasal administration.
Cadralazine.
Caffeine, when intended for injection.
Calcipotriol.
Calcium carbimide.
Calcium,
| (a) | in preparations thereof for injection; (S0) |
| (b) | except in oral preparations or mixtures containing more than 1 300 mg of calcium per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S1) |
| (c) | except when indicated for the treatment of hyperphosphataemia; (S4) |
| (d) | except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947). |
Calcium disodium edetate, when intended for injection.
Calcium dobesilate.
Candesartan.
Captopril.
Carazolol.
Carbachol, ophthalmic preparations thereof when intended for glaucoma. (S4)
Carbamazepine.
Carbenoxolone, except when intended for application to the oral mucosa. (S0)
Carbuterol, when contained in respirator solutions. (S2, S4)
Carprofen.
Carteolol.
Carvedilol.
Celecoxib.
Celiprolol.
Chenodeoxycholic acid.
Chlorazanil.
Chlorexolone.
Chlorothiazide and other derivatives of benzo-1,2,4-thiadiazine-7-sulphonamide-1 ,1-dioxide, whether hydrogenated or not, including hydrochlorothiazide, bendrofluazide, benzthiazide, cyclopenthiazide, hydroflumethiazide, metchlorothiazide and polythiazide.
Chlorpropamide.
Chlorthalidone.
Cholecalciferol,- see Vitamin D.
Chromonar.
Ciclesonide
Cilazapril.
Cilomilast.
Cimetidine, except when intended for the short-term symptomatic relief of heartburn, dyspepsia and hyperacidity, subject to a maximum unit dose of 200 milligrams, a maximum daily dose (per 24 hours) of 800 milligrams and a maximum treatment period of 2 weeks. (S2)
Clofibrate.
Clonidine, except when intended for the prevention of migraine. (S2)
Clopidogrel.
Codeine (methylmorphine),
| (a) | oral solid preparations, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per dosage unit, when contained in products registered in terms of the Act, and not intended for export; |
| (b) | liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit, when contained in products registered in terms of the Act, and not intended for export; |
| (c) | except oral solid preparations, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per dosage unit, with a maximum daily dose not exceeding 80 milligrams, and in packs containing sufficient dosage units for a maximum treatment period of 5 days and limited to one pack per customer, when contained in products registered in terms of the Act, and not intended for export; (S2) |
| (d) | except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit, with a maximum daily dose not exceeding 80 milligrams, and with a pack size not exceeding 100 millilitres and limited to one pack per customer, when contained in products registered in terms of the Act, and not intended for export; (S2) |
| (e) | except single component codeine preparations. (S6) |
Colchicine, except when intended for the emergency treatment of acute gout, subject to a maximum total treatment course of 6 milligrams. (S2)
Colestipol.
Copper,
| (a) | in preparations thereof for injection; (S0) |
| (b) | except in oral preparations or mixtures containing more than 4 mg of Copper per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S1). |
Corticosteroids (natural or synthetic), except when listed separately in the Schedules, when contained in preparations intended for inhalation or nasal administration. (S4)
Cyanocobalamin - see Vitamin B12.
Cyclandalate.
Cyclopentolate; ophthalmic preparations thereof. (S2)
Cyphenothrin (Pyrethroid), except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Darifenacin.
Debrisoquine.
Delapril.
Dexketoprofen trometamol
(-)-6 epigallocatechin gallate
Dialysate preparations.
Dichlorphenamide.
Diclofenac,
| (a) | except when intended for application to the skin and containing 1% m/m or less of diclofenac subject to a maximum pack size of 50 grams; (S0) |
| (b) | except when intended for application to the skin and containing more than 1% m/m of diclofenac; (S1) |
| (c) | except when intended for the emergency treatment of acute gout attacks, subject to a maximum daily dose of 150 mg for a maximum treatment period of 3 days; (S2) |
| (d) | except when intended for human use only in the treatment of fever or mild to moderate pain of inflammatory origin, subject to a maximum daily dose of 75 mg for a maximum treatment period of 5 days. (S2) |
Dienogest.
Diflunisal.
Diftalone.
Digitalis, its glycosides and other active principles thereof, unless diluted below one unit (BP) in each 2,0 grams. (S0)
Dihydrocodeine
| (a) | oral solid preparations, in combination with one or more therapeutically active substances, containing more than 10 milligrams of dihydrocodeine (calculated as base) per dosage unit, when contained in products registered in terms of the Act, and not intended for export; |
| (b) | liquid oral preparations and mixtures, ìn combination with one or more therapeutically active substances,containing more than 10 milligrams of dihydrocodeine (calculated as base) per 5 millilitre dosage unit, when contained in products registered in terms of the Act, and not intended for export; |
| (c) | except oral solid preparations, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of dihydrocodeine (calculated as base) per dosage unit, with a maximum daily dose not exceeding 80 milligrams, and in packs containing sufficient dosage units for a maximum treatment period of 5 days; (S2) |
| (d) | except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of dihydrocodeine (calculated as base) per 5 millilitre dosage unit, with a maximum daily dose not exceeding 80 milligrams, and with a pack size not exceeding 100 millilitres; (S2) |
| (e) | except single component dihydrocodeìne preparations. (S6) |
Dihydroergocristine.
Dilevalol.
Diltiazem.
Dimercaprol, when intended for injection.
Dipivefrin.
Dipyridamole.
Dipyrocetyl.
Disulfiram.
Dithranol.
Domase alfa (rh DNase).
Dorzolamide.
Doxazosin.
Drospirenone,
| (a) | when intended for oral contraception; |
| (b) | except when intended for hormone replacement therapy. (S4) |
Eltenac.
Enalapril.
Endralazine.
Eprosartan.
Ergocalciferol - see Vitamin D.
Escin (aescin), except preparations and mixtures thereof intended for application to the skin and containing 1 percent or less of escin. (S1)
Esculin, when intended for oral use.
Esmolol.
Estriol,
| (a) | when intended for oral contraception; |
| (b) | except when intended for human vaginal use; (S2) |
| (c) | except when intended for hormone replacement therapy. (S4) |
| (d) | except when intended for veterinary use. (S4) |
Ethacrynic acid.
Ethosuximide.
Etisazol.
Etodolac.
Etodolic acid.
Etofenamate, except when intended for application to the skin. (S1)
Etofenprox (Pyrethroid), except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Etoricoxib.
Exenatide.
Felbamate.
Felbinac, except when intended for application to the skin. (S1)
Felodipine.
Fenbufen.
Fenclofenac.
Fendiline.
Fenofibrate.
Fenoprofen,
| (a) | except when intended for the emergency treatment of acute gout attacks, (S2) and |
| (b) | when intended for the treatment of post traumatic conditions, for a maximum period of 5 days. (S2) |
Fenoterol, when contained in respirator solutions. (S2, S4)
Fentiazac.
Fenticonazole, except when intended for application to the skin. (S1)
Firocoxib.
Floctafenine.
Flufenamic acid, except preparations and mixtures intended for application to the skin. (S1)
Flunisolide, when intended for inhalation or nasal administration, except when intended for nasal administration as an aqueous spray, other than by pressurised aerosol, in a strength not exceeding 0,025 percent (m/v), and indicated for the treatment of the symptoms of seasonal allergic rhinitis (hay fever) in adults and children over 12 years of age, subject to
| (a) | a maximum dose of 50 micrograms per nostril and a maximum daily dose of 100 micrograms of per nostril in the case of adults and children over 16 years of age; |
| (b) | a maximum dose of 25 micrograms per nostril and a maximum dose of 75 micrograms in children 12 to 16 years of age; |
| (c) | a maximum pack size of 2 400 doses. (S2, S4) |
Flunixin.
Fluorescein, except when intended for ophthalmic use by the topical route only. (S1)
Flurbiprofen, except
| (a) | when intended for the treatment of post-traumatic conditions, for a maximum period of 5 days; (S3) |
| (b) | when in the form of lozenges, indicated for the relief of pain associated with sore throats, subject to: |
| (i) | a maximum of 8,75 milligrams per lozenge; |
| (ii) | a maximum treatment period of 3 days; and |
| (iii) | a maximum pack size of 15 lozenges. (S1) |
| (b) | except when intended for application to the skin and indicated for the symptomatic relief of localised pain and inflammation, provided that in the case of application by transdermal patch; |
| (i) | use is restricted to adults and children 12 years and older; and |
| (ii) | the treatment period is limited to a maximim of 4 weeks. (S0) |
| (c) | when intended for the treatment of post-traumatic conditions, for a maximum period of 5 days; (S2) |
| (d) | when intended for ophthalmic use; (S4) |
Fluticasone furoate,
| (a) | when intended for inhalation or nasal administration; |
| (b) | except when intended for nasal administration, as an aqueous spray, in the short-term (less than 6 months) prophylaxis and treatment of the symptoms of seasonal allergic rhinitis (hay fever) in adults and children over 12 years of age, subject to— |
| (i) | a maximum daily dose of 55 micrograms per nostril; and |
| (ii) | a maximum pack size limit of 120 doses. (S2) |
(c) except when intended for administration other than by inhalation or nasal administration. (S4)
Fluticasone propionate,
| (a) | when intended for inhalation or nasal administration; |
| (b) | except when intended for nasal administration as an aqueous spray, in the short-term (less than 6 months prophylaxis and treatment of the symptoms of seasonal allergic rhinitis (hay fever) in adults and children over 12 years of age, subject to— |
| (i) | a maximum daily dose of 100 micrograms per nostril; and |
| (ii | a maximum pack size of 120 doses. (S2) |
| (c) | except when intended for administration other than by inhalation or nasal administration. (S4) |
Folinic acid (leucovorin)
Frusemide.
Gabapentin.
Gadozetic acid.
Gellatine succinylated.
Gemfibrozil.
Gestodene.
Glafenine.
Glibenclamide.
Glibonuride.
Gliclazide.
Glimepiride.
Glimidine.
Glipizide.
Gliquidone.
Glucosamine, substances, preparations and mixtures when intended for the treatment of primary and secondary osteoarthritis, osteochondrosis and spondylosis, except when registered as a feed supplement in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Glutathione, when intended for intravenous infusion or for injection. (S0)
Glycopyrronium.
Guanabenz.
Guanethidine.
Guanfacine.
Guanoxan.
Hexoprenaline, when contained in respirator solutions. (S2, S4)
Homatropine; ophthalmic preparations thereof. (S2)
Hormones (natural or synthetic, including recombinant forms), with either hormonal, prohormonal or anti-hormonal action, unless listed elsewhere in the schedules,
| (a) | when intended for oral contraception; |
| (b) | except when intended for human vaginal use (S2), and |
| (c) | except hormones when specifically intended for emergency postcoital contraception. (S2, S4, S5) |
Hydralazine.
Hydrochlorothiazide.
Hydroquinone; preparations and mixtures thereof containing more than 2,0 percent hydroquinone. (S2)
Hydroxypropyl methylcellulose when intended for opthalmIc use. (S0)
Hyoscine butylbromide; substances, preparations and mixtures thereof—
| (a) | except when intended for oral administration; (S1, S2) and |
| (b) | except transdermal preparations when intended for the prevention of the symptoms of motion sickness. (S2) |
Ibuprofen, except
| (a) | when contained in preparations intended for application to the skin; (S1) |
| (b) | when contained in oral medicinal preparations supplied in a solid dose form as divided doses contained in packs not exceeding 24 dosage units or divided doses and containing ibuprofen as the only active therapeutic substance, intended for the treatment of mild to moderate pain or fever of inflammatory origin or for the treatment of post-traumatic conditions in adults and children over 12 years of age where the recommended daily dose of ibuprofen in the case of adults does not exceed 1,2 grams and in children 12 years and older does not exceed 20 milligrams per kilogram of body weight; (S1) |
| (c) | when contained in oral medicinal preparations intended for human use only, in combination with one or more other active therapeutic substances and intended for the treatment of mild to moderate pain or fever of inflammatory origin for a maximum treatment period of 10 days when the recommended daily dose of ibuprofen in the case of adults does not exceed 1,2 grams and in children over the age of 1 year and up to and including the age of 12 years does not exceed 20 milligrams per kilogram of body weight; (S2) |
| (d) | when contained in oral medicinal preparations, intended for human use only, as the only active therapeutic substance in oral liquid preparations in packs not exceeding 100 millilitres in volume or in oral solid preparations in packs exceeding 24 dosage units or divided doses, when intended for adults and children over the age of 1 year; for the treatment of mild to moderate pain of inflammatory origin for a maximum treatment period of 10 days, or for the treatment of fever of inflammatory origin or for the treatment of post-traumatic conditions where the recommended daily dose of ibuprofen for adults does not exceed 1,2 grams and for children over the age of 1 year and up to and including the age of 12 years does not exceed 20 milligrams per kilogram of body weight; (S2) |
| (e) | for the emergency treatment of acute gout attacks for a maximum treatment period of 5 days; (S2) |
| (f) | when intended for the treatment of haemodynamically significant patent ductus arteriosus in infants less than 34 weeks of gestational age. (S4) |
Imepitoin, when intended for veterinary use.
Imidapril.
Indacaterol.
Indapamide.
Indomethacin, except
| (a) | for application to the skin (S1), and |
| (b) | for the emergency treatment of acute gout attacks. (S2) |
Indoprofen.
Indoramin.
Injections, unless listed in another Schedule.
Insulin.
Insulin Aspart.
Insulin Degludec.
Insulin Glargine.
Ipratropium, when contained in respirator solutions. (S2)
Irbesartan.
Iron,
| (a) | in preparations thereof for injection; (S0) |
| (b) | except in oral preparations or mixtures containing more than 24 mg of Iron per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S1) |
| (c) | except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947). |
Isoniazid and its derivatives, unless listed in another Schedule.
Isoprenaline (isoproterenol), when contained in respirator solutions. (S2, S4)
Isosorbide.
Isoxicam.
Isradipine.
Ivabradine.
Ivermectin, except when intended and registered as an anthelmintic and/or ectoparasiticide in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Ketanserin.
Ketoprofen,
(a) except when intended for application to the skin; (S1)
| (b) | except when intended for the short term management of headache, toothache, muscular ache, backache, minor pain associated with arthritis, pains associated with menstrual cramps (dysmenorrhoea), minor aches and pains associated with the common cold and fever, at a maximum dose of 75 milligrams of ketoprofen in 24 hours; (S2) |
| (c) | except when intended for the emergency treatment of acute gout attacks or for the treatment of post-traumatic conditions, subject to a maximum dose of 75 milligrams of ketoprofen per day and a maximum treatment period of 5 days. (S2) |
| (d) | except in the form of lozenges indicated and intended for the relief of pain associated with sore throats in patients 18 years and older subject to— |
| (i) | a maximum of 12,5 milligrams per lozenge; |
| (ii) | a maximum of 5 lozenges in any 24 hour period; |
| (iii) | a maximum treatment period of 3 days; and |
| (iv) | a maximum pack size of 15 lozenges. (S2) |
Ketorolac, when intended for ophthalmic use. (S4)
Labetalol.
Lacosamide.
Lacidipine.
Lamotrigine.
Lercanidipine.
Levalbuterol.
Lumiracoxib.
Levonorgestrel,
| (a) | when intended for oral contraception |
| (b) | except when intended for emergency post coital contraception; (S2) |
| (c) | except when administered via an Inta-Uterine System. (S4) |
Levothyroxine.
Levetiracetam.
Levobunolol.
Levosemindan.
Lidoflazine.
Linagliptin.
Liothyronine sodium.
Lisinopril.
Lonazolac.
Lornoxicam.
Losartan.
Lumiracoxib.
Macrogol (polyethylene glycol), when used for faecal impaction, or for the purposes of bowel cleansing prior to surgery or diagnostic procedures, except when intended for the treatment of constipation. (S0)
Meclofenamic acid.
Mefenamic acid, except—
| (a) | when intended for the treatment of post-traumatic conditions, for a maximum period of 5 days; and |
| (b) | preparations containing mefenamic acid as the only therapeutic active substance, when intended for human use only in the treatment of primary dysmenorrhoea subject to a maximum daily dose of 500 milligrams mefanamic acid 3 times a day and a maximum treatment period of 3 days. (S2) |
Meloxicam. (S4)
Mepindolol.
Mesalazine (5-aminosalicylic acid).
Mesulphene.
Metaproterenol (orciprenaline), when contained in respirator solutions. (S2, S4)
Metformin.
Methazolamide.
Methimazole.
Methsuximide.
Methyldopa.
Metipranolol.
Metolazone.
Metoprolol.
Mibefradil.
Mirabegron.
Moexipril.
Mometasone furoate, when intended for inhalation or nasal administration, except when intended for nasal administration as an aqueous spray, other than by pressurised aerosol, and indicated for the treatment of the symptoms of seasonal or perennial allergic rhinitis (hay fever) in adults and children between the age of 2 and 11 years of age, subject to
| (a) | a maximum dose of 200 micrograms per nostril in adults and 50 micrograms per nostril in children; and |
| (b) | a maximum pack size of 200 doses. (S2, S4) |
Montelukast.
Moxonidine.
Nabumetone, except when intended for the treatment of post-traumatic conditions, for a maximum treatment period of 5 days. (S2)
Nadolol.
Naftidrofuryl.
Naproxen, except—
| (a) | when contained in preparation intended for application to the skin; (S1, S2) |
| (b) | when contained in oral medicinal preparations, intended for human use only containing naproxen as the only active therapeutic substance intended for patients over 16 years of age, for the treatment of mild to moderate pain or fever of inflammatory origin at a maximum dose of 600 milligrams naproxen base (660 milligrams naproxen sodium) in a 24 hour period for a maximum treatment period of 5 days and supplied in a solid dose form as divided doses contained in packs not exceeding the stated maximum treatment period. (S1, S2) |
| (c) | when intended for the treatment of acute gout attacks, for a maximum treatment period of 5 days in patients over 16 years of age. (S1, S2) |
Nateglinide.
Nebivolol.
Nepafenac.
Nicardipine.
Nicotine,
| (a) | when intended for human medicinal use as an aid to smoking cessation or as a substitute for a tobacco product (as defined in the Tobacco Products Control Act, 1993, as amended); |
| (b) | except when registered for human medicinal use as an aid to smoking cessation and presented as nicotine gum or lozenges containing not more than 4 mg nicotine per piece; (S0) |
| (c) | except when intended for human medicinal use as an aid to smoking cessation, when registered and presented as nicotine transdermal patches for continuous application to the skin in strengths up to an including 21mg/ 24 hours or 25mg/16 hours; (S1) |
| (d) | except when intended for human medicinal use as an aid to smoking cessation, when registered and presented as nicotine transdermal patches for continuous application to the skin in strengths containing more than 21mg/ 24 hours or 25 mg/ 16 hours; (82) |
| (e) | except when registered for human medicinal use as an aid to smoking cessation and presented as nicotine gum or lozenges containing more than 4 mg nicotine per piece; (S2) |
| (f) | except when registered as metered sprays containing not more than 1 mg per dose; (S2) |
| (g) | except when registered as oral solid dosage forms containing not more than 2 mg; (S2) |
| (h) | except when registered as inhalers containing not more than 10 mg per cartridge. (S2) |
Nifedipine.
Niflumic acid.
Nimodipine.
Nisoldipine.
Nitrendipine.
Nitroglycerine, when intended for medicinal use.
Noradrenaline theophylline - see Theodrenaline.
Norelqestromin.
Norethisterone,
| (a) | when intended for oral contraception. |
| (b) | except when intended for parenteral use as a contraceptive; (S4) |
| (c) | except when intended for hormone replacement therapy. (S4) |
Norgestrel,
| (a) | when intended for oral contraception; |
| (b) | except when intended for hormone replacement therapy. (S4) |
Normal Saline (Sodium chloride 0,9% m/v) when intended for injection, except when intended for injection in a dosage form not exceeding 20 millilitres in volume. (S0, S1)
Olsalazine.
Omesartan.
Orlistat, except when used in a dose not exceeding 60mg per main meal and not exceeding a maximum dose of 180mg per 24-hour period. (S2)
Oxaprozin.
Oxcarbazepine.
Oxitracetam.
Oxovinca.
Oxyprenolol.
Oxybutynin.
Pantothenic Acid - see Vitamin B5.
Parecoxib.
Para-aminosalicylic acid and its esters.
Paracetamol, when intended for injection. (S0, S1, S2)
Parenteral Nutrition formulations.
Penbutolol.
Penicillinase, when intended for injection.
Pentaerythritol tetranitrate.
Pentolinium.
Pentosan polysulfate sodium, when intended for the treatment of interstitial cystitis. (S1)
Perindopril.
Phenformin.
Phenobarbital, preparations and mixtures containing not more than 90 milligrams of phenobarbital per minimum recommended or prescribed dose when intended for continued use in epilepsy. (S5)
Phenoxymethylpenicillin, when intended for the prophylaxis of rheumatic fever. (S4)
Phentolamine.
Phenytoin.
Physostigmine; ophthalmic preparations thereof, when intended for glaucoma. (S4)
Pilocarpine; ophthalmic preparations thereof intended for glaucoma. (S4)
Pindolol.
Pioglitazone.
Piracetam.
Pirbuterol, when contained in respirator solutions. (S2)
Piretanide.
Piroxicam,
| (a) | except when intended for the emergency treatment of acute gout attacks, (S2) or |
| (b) | when intended for the treatment of post-traumatic conditions, for a maximum treatment period of 5 days. (S2) |
Pirprofen.
Potassium canrenoate.
Potassium,
| (a) | when intended for intravenous infusion or for injection; |
| (b) | except when contained in oral rehydration preparations; (S0) |
| (c) | except in oral preparation or mixtures containing more than 20 millimoles (1500mg) of potassium per 24 hours. (S2) |
Practolol.
Prazosin.
Primidone.
Probenecid.
Probucol.
Procaterol, when contained in respirator solutions. (S2)
Proctofene.
Propacetamol.
Propiverine.
Propranolol.
Proquazone.
Proscillaridine.
Protamine.
Prothionamide, when intended for oral use.
Pygeum africanum (lipido-sterolic complex extract thereof).
Pyrazinamide, when intended for oral use.
Pyridoxine -see Vitamin B6.
Pyrimethamine.
Pyrithioxin.
Quinapril.
Racecadotril.
Raloxifene.
Ramipril.
Ranitidine, except where administered orally for short-term symptomatic relief of heartburn and hyperacidity, subject to a maxim dose of 75 milligrams, a maximum daily dose of 300 milligrams and a maximum treatment period of two weeks. (S2)
Raubasine.
Rauwolfia alkaloids.
Repaglinide.
Reproterol, when contained in respirator solutions. (S2)
Reserpine (natural or synthetic).
Riboflavin - see Vitamin B2.
Rimiterol, when contained in respirator solutions. (S2, S4)
Risedronate.
Rofecoxib.
Rosiglitazone.
Roxarzone (3-nitro-4-hydroxyphenylarsonic acid), when intended for veterinary use.
Sacubitril.
Salbutamol, when contained in respirator solutions. (S2, S4)
Salmefamol, when contained in respirator solutions. (S2, S4)
Saxagliptin.
Silymarin, except when present in a complementary medicine with an accepted low risk claim or health claim, providing note more than 600 mg of Silymarin per day (calculated as silibinin/silybin). (S0)
Sitagliptin phosphate.
Sodium phosphate, in preparations intended for the management of faecal impaction or for bowel cleansing prior to surgical and diagnostic procedures. (S0)
Sodium picosulphate, in preparations intended for the management of faecal impaction or for bowel cleansing prior to surgical and diagnostic procedures. (S0)
Solcoseryl; ophthalmic preparations thereof. (S0, S4)
Solifenacin.
Sotalol.
Spirapril.
Spironolactone.
Strontium, except when contained in toothpaste. (S0)
Strophanthus; its glycosides and their hydrolysis products, and their derivatives, unless listed in another Schedule.
Sulindac.
Suloctidil.
Sulphinpyrazone.
Sulthiame.
Suprofen.
Tasosartan.
Tazarotene.
Telmisartan.
Tenidap.
Tenoxicam.
Tepoxalin.
Terazosin.
Terbutaline, when contained in respirator solutions. (S2)
Terizidone.
Terodiline.
Theodrenaline - see Noradrenaline theophylline.
Thiacetazone.
Thiamine - see Vitamin B1.
Thiocolchicoside
Thyroid gland and its active principles and derivatives, unless listed another Schedule.
Tiagabine.
Tiaprofenic acid, except when intended for the treatment of post-traumatic conditions, for a maximum treatment period of 5 days. (S2)
Ticagrelor.
Ticlopidine.
Timolol.
Tiotropium.
Tolamolol.
Tolazamide.
Tolbutamide.
Tolfenamic acid.
Tolmetin, except when intended for application to the skin. (S1)
Tolterodine.
Topiramate.
Torasemide.
Trandolapril.
Tretinoin, when intended for application to the skin. (S5)
Triamterene.
Tricaine.
Trimethadione.
Tropicamide.
Tulobuterol, when contained in respirator solutions. (S2)
Umeclidinium.
Ursodeoxycholic acid.
V. cholera
Valdecoxib.
Valproic acid and its derivatives, unless listed in another Schedule.
Valsartan.
Vedaprofen.
Verapamil (iproveratril).
Veratrum alkaloids.
Vigabatrin.
Vildagliptin.
Vincamine.
Vinpocetine.
Vitamin B1 (Thiamine) and derivatives thereof,
| (a) | in preparations thereof for injection; (S0) |
| (b) | except in oral preparations or mixtures containing more than 100 mg of Vitamin B1 per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S1) |
Vitamin B2 (Riboflavin) and derivatives thereof,
| (a) | in preparations thereof for injection; (S0) |
| (b) | except in oral preparations or mixtures containing more than 100 mg of Vitamin B2 per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S1) |
Vitamin B3 - see Niacin.
Vitamin B5 (Pantothenic Acid) and derivatives thereof,
| (a) | in preparations thereof for injection; (S0) |
| (b) | in oral preparations or mixtures containing more than 200 mg of Vitamin B5 per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S1) |
Vitamin B6 (Pyridoxine) and derivatives thereof,
| (a) | in preparations thereof for injection; (S0) |
| (b) | except in oral preparations or mixtures containing more than 100 mg of Vitamin B6 per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S1) |
Vitamin B12 (Cyanocobalamin) and derivatives thereof,
| (a) | in preparations thereof for injection; (S0) |
| (b) | except in oral preparations or mixtures containing more than 100 ug of Vitamin B12 per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S1) |
Vitamin C (Ascorbic Acid),
| (a) | in preparations thereof for injection; (S0) |
| (b) | except in oral preparations or mixtures containing more than 1000 mg of Vitamin C per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S1) |
Vitamin D (cholecalciferol), preparations thereof for injection and oral preparations and mixtures thereof containing more than 1 000 I.U. per recommended daily dose, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947). (S0)
Vitamin K and derivatives thereof,
| (a) | in injection preparations; (S0) |
| (b) | except in oral preparations or mixtures containing more than 120 µg of Vitamin K per recommended daily dose alone or in combination with other active pharmaceutical ingredients, (S1) |
| (c) | except when used in infant milk feeds or formulae in terms of the provisions of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972). |
Water for injection except in a dosage form not exceeding 20 milliliters in volume. (S1)
Xamoterol.
Xipamide.
Zafirlukast.
Zinc salts,
| (a) | for oral ingestion, where the daily dose is more than 50 milligrams of elemental zinc; (S0), |
| (b) | except preparations thereof for injection, when intended for veterinary use; (S1) and |
| (c) | except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947). |
Zomepirac.
ANNEXURE 1A: EMERGENCY CARE PROVIDER (PARAMEDIC)
PARAMEDIC (National Diploma in Emergency Medical Care graduates only) registered with Health Professions Council of South Africa
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PARAMEDIC (National Diploma in Emergency Medical Care graduates only) |
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ANALGESIC |
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PLATELET AGGREGATION INHIBITOR |
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PLASMA SUBSTITUTES AND COLLOID SOLUTIONS |
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PLASMA SUBSTITUTES AND COLLOID SOLUTIONS |
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Substance |
Polygeline |
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PLASMA SUBSTITUTES AND COLLOID SOLUTIONS |
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Balanced Salt Solution |
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PLASMA SUBSTITUTES AND COLLOID SOLUTIONS |
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PLASMA SUBSTITUTES AND COLLOID SOLUTIONS |
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PLASMA SUBSTITUTES AND COLLOID SOLUTIONS |
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PLASMA SUBSTITUTES AND COLLOID SOLUTIONS |
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SELECTIVE β2 AGONISTS |
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SELECTIVE β2 AGONISTS |
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MINERAL SUPPLEMENT/ELECTROLYTE |
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OTHER MINERAL SUPPLEMENT |
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CARBOHYDRATES |
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HIGH CEILING LOOP DIURETIC |
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ORGANIC NITRATES |
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ANTI-EMETIC |
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CO-ENZYME |
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Indication |
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Route of Administration |
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ANNEXURE 1B: EMERGENCY CARE PROVIDER (EMERGENCY CARE PRACTITIONER)
EMERGENCY CARE PRACTITIONER (Bachelor of Technology Degree in Emergency Medical Care) registered with Health Professions Council of South Africa
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EMERGENCY CARE PRACTITIONER (B Tech: Emergency Medical Care) |
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PLATELET AGGREGATION INHIBITOR |
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Indication |
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PLASMA SUBSTITUTES AND COLLOID SOLUTIONS |
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PLASMA SUBSTITUTES AND COLLOID SOLUTIONS |
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PLASMA SUBSTITUTES AND COLLOID SOLUTIONS |
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Indication |
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Schedule |
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Route of Administration |
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SELECTIVE β2 AGONISTS |
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Indication |
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Route of Administration |
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SELECTIVE β2 AGONISTS |
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Indication |
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Route of Administration |
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MINERAL SUPPLEMENT/ ELECTROLYTE |
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OTHER MINERAL SUPPLEMENTS |
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Indication |
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HIGH CEILING LOOP DIURETIC |
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Indication |
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ORGANIC NITRATES |
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ANTI-EMETIC |
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CO-ENZYME |
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Indication |
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ANNEXURE 3: OPTOMETRIST
OPTOMETRIST (Bachelors degree in Optometry – B OPTOM) registered with the Health Professions Council of South Africa in terms of the Health Professions Act, 1974 (Act 56 of 1974) and and recognised by the Health Professions Council of South Africa as an authorised prescriber.
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OPTOMETRISTS |
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BETA-BLOCKER |
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Indication |
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Route of Administration |
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SYMPATHOMIMETIC |
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Indication |
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Route of Administration |
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BETA-BLOCKER |
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Substance |
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Indication |
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Route of Administration |
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CYCLOPLEGICS |
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Indication |
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Route of Administration |
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MYDRIATICS/CYCLOPLEGICS |
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Indication |
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Route of Administration |
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MYDRIATICS/CYCLOPLEGICS |
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Indication |
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MYDRIATICS/CYCLOPLEGICS |
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Indication |
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Route of Administration |
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ANTI GLAUCOMA |
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Substance |
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Indication |
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Route of Administration |
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ANTI GLAUCOMA |
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Substance |
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Indication |
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Route of Administration |
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ANNEXURE 4: PODIATRIST
PODIATRIST (B. Tech degree in Podiatry) registered with the Health Professions Council of South Africa in terms of the Health Professions Act, 1974 (Act 56 of 1974)
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PODIATRIST |
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SYMPATHOMIMETIC |
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Substance |
: Adrenaline/Epinephrine |
|
Indication |
: Sympathomimetic catecholamine for the management of shock |
|
Route of Administration |
: Parenteral |
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LOCAL ANAESTHETIC |
|
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Substance |
: Bupivacaine Hydrochloride 2 % |
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Indication |
: Local Anaesthesia |
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Route of Administration |
: Parenteral |
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LOCAL ANAESTHETIC |
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Substance |
: Bupivacaine Hydrochloride 2 % with Adrenaline |
|
Indication |
: Local Anaesthesia |
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Route of Administration |
: Parenteral |
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LOCAL ANAESTHETIC |
|
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Substance |
: Levobupivacaine Hydrochloride with Adrenaline |
|
Indication |
: Local Anaesthesia |
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Route of Administration |
: Parenteral |
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LOCAL ANAESTHETIC |
|
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Substance |
: Lidocaine (Lignocaine) Hydrochloride |
|
Indication |
: Local Anaesthesia |
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Route of Administration |
: Parenteral |
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LOCAL ANAESTHETIC |
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Substance |
: Lidocaine (Lignocaine) Hydrochloride with Adrenaline |
|
Indication |
: Local Anaesthesia |
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Route of Administration |
: Parenteral |
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SYMPATHOMIMETIC |
|
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Substance |
: Mepivacaine Hydrochloride |
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Indication |
: Local Anaesthesia |
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Route of Administration |
: Parenteral |
[Schedule 3 substituted by Notice No. 2685, GG47373, dated 28 October 2022]
