Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)SchedulesSchedule 2 |
Schedule 2
| (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 their 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 2 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);
Annexure 1C: Basic Ambulance Assistant
Annexure 1D: Ambulance Emergency Assistant
Annexure 1E: Emergency Care Technician
Annexure 1F: Emergency Care Assistant
| (ii) | Annexure 2: Dental Therapist. |
| (iii) | Annexure 3: Optometrist |
| (iv) | Annexure 4: Podiatrist |
Aconite alkaloids; preparations containing 0,02 percent or more. (S0)
Acrivastine.
Adrenaline (epinephrine), except—
| (a) | ophthalmic preparations when intended for glaucoma, and |
| (b) | preparations for injection. (S3, S4) |
Alcaftadine.
Alkaloids and glycosides, all poisonous alkaloids and glycosides, and the salts of such poisonous alkaloids and glycosides, when not specifically named in any other Schedule.
Alverin.
Amethocaine - see Tetracaine.
Aminopentamide.
Amyl nitrite.
Antazoline.
Antihistamines, except—
| (a) | astemizole and terfenadine; (S4) |
| (b) | when listed separately in these Schedules; (S5) |
Antimicrobial substances, namely—
| (a) | griseofulvin, mupirocin, natamycin when intended for application to the skin, nares and external ear; (S4) |
| (b) | nystatin preparations intended for application to the oral cavity, nares and external ear. (S1, S4) |
Apomorphine; except when indicated for the treatment of erectile dysfunction. (S4)
Aptocaine.
Arecoline.
Arsenic;
| (a) | except in oral dosage forms containing the equivalent of 0,01 percent or more of arsenic trioxide. (S1) |
(b) except when intended for injection. (S4)
Aspirin (acetyl salicylic acid), when intended for:
(a) the treatment of children or adolescents; and
(b) the prophylaxis of cardiovascular disease in adults. (S0)
Atropine; except
(a) when intended for use in ophthalmic preparations; (S3)
(b) when intended for use in injections. (S4)
Azatadine.
Azelastine.
Bambuterol.
Bamipine.
BCG vaccine - see Mycobacterium bovis.
Beclomethasone dipropionate, 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. (S3, S4) |
Belladonna alkaloids, except when intended for topical application. (S1)
Benproperine.
Benzydamine,
| (a) | when intended for use human vacinal use; (S3) |
| (b) | except preparations and mixtures containing 3 percent or less of benzydamine, when intended for application to the skin (S0); |
| (c) | except preparations and mixtures 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 milligrams of benzydarnine per day: (S1) |
| (d) | except preparations and mixtures 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) |
Bevonium methylsulphate.
Bismuth, when intended for oral use.
Bromhexine.
Bromides, preparations containing less than 80 milligrams of bromine per recommended daily dose. (S5)
Brompheniramine.
Buclizine.
Budesonide,
| (a) | when intended for the prophylaxis and treatment of seasonal and perennial allergic rhinitis in adults and children aged 12 years and older; (S3) |
| (b) | except when intended for inhalation and nasal administration, unless listed in another Schedule. (S4) |
Butinoline.
Calabar bean alkaloids.
Camphorated Opium Tincture.
Camylofin.
Cantharidin.
Canthaxanthin.
Carbinoxamine.
Carbocisteine.
Carbuterol, except—
| (a) | when contained in respirator solutions; (S3) and |
| (b) | when intended for injection. (S4) |
Carisoprodol.
Cetirizine.
Chlormezanone; preparations containing not more than 100 milligrams per recommended dose. (S5)
Chlorodyne (as described by Chloroform and Morphine Tincture BP 1980); preparations containing 5,0 percent or less of chlorodyne in combination with other active medicinal ingredients. (S6)
Chloroquine, when used in combination with proguanil and when intended specifically for malaria prophylaxis. (S4)
Chlorpheniramine.
Chlorprenaline.
Cholestyramine.
Chlorzoxazone.
Clonidine when intended for the prevention of migraine. (S3)
Cimetidine, when intended for the short-term symptomatic relief of heartburn, dyspepsia and hyperacidity, subject to a maximum unit dose of 200 milligrams, a maximum unit dose of 200 milligrams, a maximum daily dose of 800 milligrams and a maximum treatment period of 2 weeks. (S3)
Cinnarizine.
Clemastine.
Clemizole.
Clidinium bromide.
Codeine (methylmorphine),
| (a) | 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; |
| (b) | 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, 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 more than 10 milligrams of codeine f calculated as base) per dosage unit: (S3) |
| (d) | except 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; (S3) |
| (e) | except single component codeine preparations. (S6) |
Colchicine, when intended for the emergency treatment of acute gout, subject to a maximum total treatment course of 6 milligrams. (S3)
Cyclandelate.
Cyclizine.
Cyclopentolate, except when intended for ophthalmic administration. (S3)
Cyproheptadine, when indicated for allergic rhinitis or antipruritic use. (S5)
Dequalinium
(a) when intended for human vaginal use;
(b) except when intended for oral topical use, as oral solutions or lozenges. (S1)
Desloratidine.
Dexchlorpheniramine.
Dextromethorphan.
Diclofenac,
| (a) | 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; (S3) |
| (b) | 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; |
| (c) | 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) |
| (d) | when intended for application to the skin and containing more than 1% m/m of diclofenac. (S1) |
(e) except when intended for veterinary use. (S3)
Dicyclomine.
Difenoxin (or diphenoxylic acid), mixtures containing, per dosage unit, 0,5 milligrams or less of difenoxin, calculated as the base, and a quantity of atropine sulphate equal to at least 5 per cent of such quantity of difenoxin, calculated as the base, as is present in the mixture. (S6)
Dihydrocodeine;
| (a) | 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, 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 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, 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 more than 10 milligrams of dihydrocodeine (calculated as base) per dosage unit; (S3) |
| (d) | except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing more than 10 milligrams of dihydrocodeine (calculated as base) per 5 millilitre dosage unit; (S3) |
| (e) | except single component dihydrocodeine preparations. (S6) |
Dimethindene.
Dimethothiazine.
Dimetindene.
Diphenhydramine.
Diphenoxylate preparations containing not more than 2,5 milligrams of diphenoxylate, calculated as the base, and not less than 25 micrograms of atropine sulphate per dosage unit. (S6)
Diphenylpyraline.
Diphtheria toxoid vaccine.
{D-norpseudoephedrine - see cathine (S6)}
Doxycycline,
| (a) | when intended and labelled for the chemoprophylaxis of malaria in those aged 8 years and older. (S4) |
Doxylamine.
Ebastine.
Emedastine.
Emepronium.
Emetine, substances, preparations and mixtures containing less than 0,2 percent of alkaloids, calculated as emetine. (S4)
Ephedra alkaloids (natural or synthetic), contained in products registered in terms of the Act, and not intended for export, unless listed separately in the Schedules:
| (a) | oral preparations and mixtures, in combination with another pharmacologically active substance and intended for the symptomatic relief of colds and flu, containing not more than 30 milligrams of ephedra alkaloids per dose, with a maximum daily dose not exceeding 120 milligrams, subject to a maximum pack size of 360 milligrams and limited to one pack per customer; (S6) |
| (b) | except when intended for application to skin, eyes, ears and nares and containing 1 percent or less of ephedra alkaloids. (S1) |
Ephedrine, contained in products registered in terms of the Act, and not intended for export,
| (a) | oral preparations and mixtures, in combination with another pharmacologically active substance and intended for the syptomatic relief of colds and flu, containing not more than 30 milligrams of ephedrine per dose, with a maximum daily dose not exceeding 120 milligrams, subject to a maximum 360 milligrams and limited to one pack per customer; (S6) |
| (b) | except preparations and mixtures intended for application to the skin, eyes, ears and nares and containing 1 percent or less of ephedrine. (S1) |
Epinastine.
Ergot alkaloids (natural or synthetic), when intended for the treatment of migraine. (S4)
Ergotamine.
Estradiol,
(a) when intended for human vaginal use;
(b) except when intended for oral contraception; (S3)
(c) except when intended for hormone replacement therapy. (S4)
Estriol
(a) when intended for human vaginal use
(b) except when intended for oral contraception; (S3)
(c) except when intended for hormone replacement therapy; (S4)
(d) except when intended for veterinary use. (S4)
Ethylmorphine:
| (a) | oral solid preparations, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of ethylmorphine (calculated as base) per dosage unit; (S6) and |
| (b) | liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of ethylmorphine (calculated as base) per 5 millilitre dosage unit. (S6) |
Etilefrine.
Etodroxizine, preparations and mixtures when used solely as an antihistamine. (S5)
Exalamide.
Famotidine, when intended for the short-term symptomatic relief of heartburn caused by excess acid, subject to—
| (a) | a maximum dose of 10 milligrams; |
| (b) | a maximum daily dose (per 24 hours) of 20 milligrams; |
| (c) | a maximum treatment period of 2 weeks. (S4) |
Fedrilate.
Fenoprofen,
| (a) | when intended for the emergency treatment of acute gout attacks, and |
| (b) | when intended for the treatment of post traumatic conditions, for a maximum period of 5 days. (S3) |
Fenoterol, except—
| (a) | when contained in respirator solutions; (S3) and |
| (b) | when intended for injection or for the prevention or delay of labour. (S4) |
Flavoxate.
Flunarizine.
Flunisolide, when intended for nasal administration as an aqueous spray, other than by pressurised aerosol, in a strength not exceeding 0,025 per cent (m/v), and indicated for 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 per nostril in the case of adults and children over the age of 16 years of age; |
| (b) | a maximum dose of 25 micrograms per nostril and a maximum daily dose of 75 micrograms per nostril in the case of children 12 to 16 years of age; and |
| (c) | a maximum pack size of 240 doses. (S3, S4) |
Flurbiprofen,
| (a) | when intended for the treatment of post-traumatic conditions, for a maximum period of 5 days; (S3) |
| (b) | except 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)
| (c) | 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 maximum of 4 weeks. (S0)
(d) except when intended for ophthalmic use; (S4)
Fluticasone furoate,
| (a) | 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. (S3) |
| (b) | except when intended for administration other than by inhalation or nasal administration. (S4) |
Fluticasone propionate,
| (a) | when intended for nasal administration as an aqueous spray, in the short-term (less than 6 months) prophylaxis and treatment of 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; |
| (ii) | a maximum pack size limit of 120 doses. (S3) |
| (b) | except when intended for administration other than by inhalation or nasal administration. (S4) |
Fusafungine.
Fusidic acid, when intended for topical application. (S4)
Gadopentetic acid.
Gamma benzene hexachloride when intended to be used for the second line treatment of lice in a pack size not exceeding 60ml. (S4)
Gelsemium alkaloids.
Griseofulvin, when intended for application to the skin, nares and external ear. (S4)
Haemophilus influenzae vaccine (Hib.)
Halogenated hydroxyquinolines, when intended for application to the skin. (S4)
Hepatitis B vaccine.
Hexametazine.
Hexoprenaline—
| (a) | except when contained in respirator solutions; (S3) and |
| (b) | except when intended for injection or for the prevention or delay of labour. (S4) |
Homatropine; preparations and mixtures thereof, except ophthalmic preparations. (S3)
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 human vaginal use, and |
| (b) | when specifically intended for emergency postcoital contraception. (S3, S4, S5) |
Human pappillomavirus vaccine.
Hyaluronic acid and its salts,
| (a) | when intended for ophthalmic use in preparations (except injectables) containing 0,1 percent; |
| (b) | except when intended for use with contact lens solutions or as an ophthalmic lubricant in concentrations of not more than 0,1 percent; (S0) |
| (c) | except when intended for topical application to the skin; (S1) |
| (d) | except when intended for parenteral use; (S4) |
| (e) | except in preparations containing less than 2.5 percent when intended for topical use in terms of the provisions of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972). |
Hydrocortisone and hydrocortisone acetate, when used in
| (a) | a maximum concentration of 1 percent in preparations intended for application to the skin, and |
| (b) | a maximum concentration of 1 percent used in combination with miconazole for topical application in the treatment of athlete's foot. (S4) |
Hydroquinone; preparations and mixtures containing 2 percent or less thereof, when intended for application to the skin. (S3)
Hyoscine butylbromide; substances, preparations and mixtures thereof—
| (a) | when intended for oral administration in pack sizes exceeding 20 tablets or 100 ml, or strengths exceeding 10mg per oral solid dosage form or 0.1% mass/volume; (S1); and |
| (b) | transdermal preparations when intended for the prevention of the symptoms of motion sickness. (S3) |
| (c) | except when intended for parenteral administration. (S3) |
Ibuprofen,
| (a) | 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 where 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; |
| (b) | 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 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; (S1, S3) |
| (c) | for the emergency treatment of acute gout attacks for a maximum treatment period of 5 days; (S3) |
| (d) | except when contained in preparations intended for application to the skin; (S1) |
| (e) | except 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) |
| (f) | except when intended for the treatment of haemodynamically significant patent ductus arteriosus in infants less than 34 weeks of gestational age; (S4) |
| (g) | except when intended for veterinary use. (S3) |
Indometacin,
| (a) | when intended for the emergency treatment of acute gout attacks; (S3) |
(b) except when intended for application to the skin; (S1)
(c) except when intended for veterinary use. (S3)
Influenza virus vaccine.
Insulin glargine.
lpratropium, except when contained in respirator solutions. (S3)
Isoaminile.
Isoprenaline (isoproterenol), except
| (a) | when contained in respirator solutions; (S3) and |
| (b) | when intended for injection. (S4) |
Isopropamide.
Isothipendyl.
Ketoprofen,
| (a) | when intended for the short term management of headache, toothache, muscular ache, backache, minor pain associated with arthritis, pain 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; |
| (b) | when intended for the emergency treatment of acute gout attacks or for the treatment of post-traumatic conditions, subject to a maximum dose of 100 milligrams of ketoprofen per day, for a maximum treatment period of 5 days; |
| (c) | 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. (S3) |
| (d) | except when intended for application to the skin. (S1) |
Ketotifen.
Lansoprazole, when intended for the temporary short-term relief of heartburn and hyperacidity, subject to—
| (a) | a maximum daily dose of 15mg; |
| (b) | a maximum treatment period of 14 days. (S4) |
Levocabastine.
Levocetirizine.
Levodropropizine.
Levonorgestrel,
| (a) | when intended for emergency post coital contraception; |
| (b) | except when intended for oral contraception; (S3) |
| (c) | except when administered via an Infra Uterine System. (S4) |
Lithium salts, when intended for application to the skin. (S5)
Local anaesthetics,
| (a) | except when intended for ophthalmic and parental use; (S4) |
| (b) | oxybuprocaine, proxymetacaine and tetracaine, when contained in eye drops intended for emergency treatment of "arc eyes". |
Lobelia alkaloids.
Lodoxamide.
Loperamide.
Measles vaccine.
Mebeverine.
Mebhydrolin.
Meclozine.
Mefenamic acid,
| (a) | when intended for the treatment of post traumatic conditions, for a maximum treatment period of 5 days; and |
| (b) | preparations containing mefenamic acid as the only therapeutically active substance, when intended for human use only in the treatment of primary dysmenorrhoea, subject to a maximum daily dose of 500 milligrams 3 times a day and a maximum treatment period of 3 days; (S3) |
| (c) | except when intended for veterinary use. (S3) |
Melatonin, when used for the amelioration of desyncronosis (jet-lag) in doses not exceeding 6mg daily. (S4)
Mepenzolate bromide.
Mephenesin.
Mepyramine.
Mequitazine.
Mercuric ammonium chloride.
Mercuric chloride.
Mercuric iodide.
Mercuric oxides; substances, preparations and mixtures thereof, except those containing less than 3 per cent of mercury. (S4)
Mercury organic compounds
| (a) | substances, preparations and mixtures in the form of aerosols, intended for application to the skin and mucous membranes and substances, |
| (b) | preparations and mixtures containing the equivalent of 0,6 per cent or more of elemental mercury, intended for application to the skin and mucous membranes, |
| (c) | except phenylmercuric nitrate when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947). |
Mesna, except preparations intended for injection. (S4)
Metaproterenol (orciprenaline) except
| (a) | when contained in respirator solutions; (S3) |
| (b) | when intended for injection; (S4) and |
| (c) | when intended for the prevention or delay of labour. (S4) |
Methixene.
Methocarbamol.
Metholilazine.
Methoxyphenamine.
Metronidazole, when intended for human vaginal use, specifically for the treatment of recurrent bacterial vaginosis and except when intended and registered for use in pigeons in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947). (S4)
Miconazole, when intended for human use in preparations containing 2 percent or less of miconazole, for the topical treatment of fungal infections of the mouth (oral candidiasis). (S1, S4)
Minoxidil, when intended for application to the scalp in preparations containing not more than 2 percent (m/v) and which are registered in terms of the Act. (SS4)
Mizolastine.
Mometasone furoate, when intended for nasal administration as an aqueous spray, other than by pressurized 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. (S3, S4) |
Monoethanolamine.
Morphine; mixtures containing 0,2 percent or less of morphine, calculated as anhydrous morphine. (S6)
Mumps vaccine.
Mupirocin, when intended for application to the skin, nares and external ear. (S4)
Mycobacterium bovis vaccine (BCG).
Nabumetone, when intended for the treatment of post-traumatic conditions for a maximum treatment period of 5 days. (S3)
Naphazoline, except when intended for nasal use. (S1)
Naproxen,
| (a) | when intended for the treatment of acute gout attacks, for a maximum treatment period of 5 days in patients over 16 years of age; (S3) |
| (b) | except when contained in preparations intended for application to the skin; (S1) and |
| (c) | except 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, S3) |
| (d) | except when intended for veterinary use. (S3) |
Natamycin, when intended for application to the skin, nares and external ear. (S4)
Nedocromil.
Nicergoline.
Nicotine,
| (a) | when registered for human medicinal use as an aid to smoking cessation and presented as nicotine gum or lozenges containing more than 4mg nicotine per piece; |
| (b) | when registered as metered sprays containing 1mg per dose or less; |
| (c) | when registered as oral solid dosage forms containing 2 mg or less; |
| (d) | when registered as inhalers containing 10mg or less per cartridge; |
| (e) | 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; |
| (f) | except when registered for human medicinal use as an aid to smoking cessation and presented as nicotine gum or lozenges containing not more than 4mg nicotine per piece; (S0) |
| (g) | 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) |
| (h) | except 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). (S3) |
Nizatidine, when administered orally for short-term symptomatic relief of heartburn and hyperacidity, subject to—
| (a) | a maximum dose of 150 milligrams; |
| (b) | a daily dose of 300 milligrams; |
| (c) | a maximum treatment period of two weeks. (S4) |
{(+)-norpseudoephedrine - see cathine (S6)}.
Noscapine.
Nux vomica; substances, preparations and mixtures thereof, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Nystatin,
| (a) | when presented as oral drops containing not more than 100 000 I.U. per ml; and |
| (b) | except when intended for application to the skin; (S1) and |
| (c) | except when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis; (S1) |
| (d) | except when intended for sytemic use or the initial treatment of vaginal candidiasis; (S1) and |
| (e) | except when intended and registered as a stock remedy for pigeons in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947). |
Octatropine.
Oleoresin of aspidium (Filix Mas).
Olopatidine.
Omeprazole, when intended for the temporary, short-term relief of heartburn and hyperacidity, subject to:
| (a) | a maximum daily dose of 20 mg |
| (b) | a maximum treatment period of 14 days. (S4) |
Opium; mixtures containing not more than 0,2 percent of morphine, calculated as anhydrous morphine. (S6)
Orlistat, when used in a dose not exceeding 60mg per main meal and not exceeding a maximum dose of 180mg per 24 hour period. (S3)
Orphenadrine.
Otilonium bromide.
Oxatomide.
Oxybuprocaine, when contained in eye drops intended for emergency treatment of arc eyes. (S4)
Oxymetazoline, except when intended for nasal use. (S1)
Oxyphencyclimine.
Oxyphenonium.
Pantoprazole, when intended for the temporary short-term relief of heartburn and hyperacidity, subject to:
| (a) | maximum daily dose of 20 milligrams |
| (b) | maximum treatment period of 14 days. (S4) |
Papaverine; substances, preparations and mixtures thereof.
Paracetamol,
| (a) | when contained in rectal suppositories, or |
| (b) | when contained in modified release formulations. (S0, S1, S3) |
Pentoxyfylline
Perfluorcoctane, except when intended for intraocular use. (S4)
Pertussis toxoid vaccine.
Phenazone (antipyrone).
Phenazopyridine.
Phenindamine.
Pheniramine.
Phenylpropanolamine (norephedrine), contained in products registered in terms of the Act, and not intended for export, unless listed separately in the Schedules,
| (a) | oral preparations and mixtures where the recommended daily dose for adults does not exceed 100 milligrams and for children 6 to 12 years does not exceed 50 milligrams, when in combination with another pharmacologically active substance and intended for the symptomatic relief of nasal and sinus congestion, subject to a maximum pack size of 300 milligrams for adults and 150 milligrams for children, limited to one pack per customer. (S6) |
Phenyltoloxamine.
Pholcodine, when prepared, mixed or compounded,
| (a) | containing 20 milligrams or less of pholcodeine (calculated as base) per dosage unit; or |
| (b) | containing 20 milligrams or less of pholcodine (calculated as base) per 5 millilitre dosage unit in the case of liquid oral preparations and mixtures. (S6) |
Pholedrine.
Pimethixene, preparations and mixtures thereof when used solely as an antihistaminic. (S5)
Pinaverium.
Pipenzolate.
Pipoxolan.
Pirbuterol, except when contained in respirator solutions. (S3)
Piroxicam,
| (a) | when intended for the emergency treatment of acute gout attacks, and |
| (b) | when intended for the treatment of post-traumatic conditions, for a maximum treatment period of 5 days. (S3) |
Pizotifen; preparations and mixtures, when intended for prophylaxis of migraine. (S5)
Pneumococcal vaccine, conjugated.
Podophyllum resin; preparations and mixtures containing 20 percent or less thereof. (S4)
Poldine methylsulphate.
Polio vaccine.
Potassium,
| (a) | in oral preparations or mixtures containing more than 20 millimoles (1 500mg) of potassium per 24 hours; |
| (b) | except when intended for intravenous infusion or for injection; (S3) |
| (c) | except when contained in oral rehydration preparations. (S0) |
Povidone iodine when intended for application to the vagina. (S0)
Prifinium bromide.
Procaterol, except when contained in respirator solutions. (S3)
Procyclidine.
Proglumide.
Promethazine,
| (a) | when intended for use as an antihistamine, and |
| (b) | when intended for application to the skin, and |
| (c) | when intended specifically for the treatment of travel sickness. (S5) |
Propantheline bromide.
Propyphenazone.
Proxymetacaine, when contained in eye drops intended for emergency treatment of arc eyes. (S4)
Pseudoephedrine, contained in products registered in terms of the Act, and not intended for export,
| (a) | Immediate-release oral preparations and mixtures containing not more than 60 milligrams of pseudoephedrine per dose or controlled-release oral preparations and mixtures containing not more than 120 milligrams of pseudoephedrine per dose, and not more than 240 milligrams per day, when in combination with another pharmacologically active substance and intended for the symptomatic relief of colds and flu, subject to a maximum pack size of 720 milligrams and limited to one pack per customer. (S6) |
Pyrobutamine.
Quinine; preparations and mixtures containing not more than 1 percent thereof. (S4)
Rabeprazole, when intended for the temporary short term relief of heartburn and hyperacidity, subject to—
| (a) | maximum daily dose of 10 milligrams; |
| (b) | maximum treatment period of 14 days. (S4) |
Ranitidine, when administered orally for short-term symptomatic relief of heartburn and hyperacidity, subject to—
| (a) | a maximum dose of 75 milligrams; |
| (b) | a maximum daily dose of 300 milligrams |
| (c) | a maximum treatment period of two weeks. (S3) |
Reproterol, except when contained in respirator solutions. (S3)
Rimiterol, except
| (a) | when contained in respirator solutions (S3) and |
| (b) | when intended for injection. (S4) |
Rizatriptan
when in oral solid dosage forms providing 5 mg or less and presented as packs of no more than 2 oral solid dosage forms, indicated for the acute relief of migraine attacks, with or without aura, in patients previously diagnosed by a medical practitioner and initiated on treatment with rizatriptan (S4)
Rotavirus, live attenuated.
Rubella vaccine.
Rupatidine.
Sabadilla alkaloids; substances, preparations and mixtures containing 1 per cent or more thereof.
Salbutamol, except
| (a) | when contained in respirator solutions; (S3) and |
| (b) | when intended for injection. (S4) |
Salmefamol, except
| (a) | when contained in respirator solutions; (S3) and |
| (b) | when intended for injection. (S4) |
Siccanin, when intended for application to the skin.
Sodium cromoglycate, except when intended for veterinary use. (S4)
Strychnine, preparations and mixtures containing 0,2 percent or less thereof. (S4)
Sulfadiazine silver when intended for application to the skin in the short-term treatment of minor burns, provided that the pack size is limited to a maximum of 50 grams. (S4)
Sulphonamides, when intended for application to the eyes, nares and vagina, (S4)
p-Synephrine,
| (a) | oral preparations and mixtures registered in terms of the Act and intended for the symptomatic relief of nasal and sinus congestion, where the recommended daily dose for adults is more than 50 milligrams and for children 6 to 12 years is more than 25 milligrams; (S6) |
| (b) | except preparations and mixtures registered in terms of the Act and intended for application to the skin, ears and nares containing 1 percent or less of p-synephrine and containing 0,2 percent or less for application to the eyes; (S0) |
| (c) | except oral preparations and mixtures registered in terms of the Act and intended for the symptomatic relief of nasal and sinus congestion, where the recommended daily dose for adults is 50 milligrams or less and for children 6 to 12 years is 25 milligrams or less, with a maximum pack size of 5 days. (S1) |
Terbutaline, except when contained in respirator solutions. (S3)
Tetanus vaccine.
Tetracaine
| (a) | when contained in eye drops intended for emergency treatment of "arc eyes"; |
| (b) | except when intended for topical use; (S1) |
| (c) | except in oral preparations containing 2% or less of tetracaine per dosage unit; (S1) |
| (d) | except when intended for ophthalmic or parenteral use.(S4) |
Tetrahydrozoline, except when intended for nasal use. (S1)
Thenalidine.
Thenyldiamine.
Theophylline and its derivatives, unless listed in mother Schedule, except preparations for injection. (S4)
Thiethylperazine.
Tiaprofenic acid, when intended for the treatment of post-traumatic conditions such as pain, swelling and inflammation, for a maximum period of 5 days. (S3)
Timepidium.
Tiamcinolone, when intended for application to oral lesions. (S4)
Trimebutine.
Trimeprazine (Alimemazine).
Tripelennamine.
Triprolidine.
Trospium.
Tulobuterol, except when contained in respirator solutions (S.3)
Typhoid vaccine.
Ulipristal.
Vitamin A and derivatives thereof and including retinol, retinal, retinoic acids and beta-carotene (but excluding isotretinoin) and not listed elsewhere in the Schedules, contained in preparations or mixtures containing more than 5 000 I.0 (or 1 500 mg of the retinol equivalent or 3 000 mg of the beta-carotene equivalent) but not more than 10 000 I.0 (or 3 000 mg of the retinol eauivalent or 6 000 mg of the beta-carotene equivalent) of Vitamin A per recommended daily dose alone or in combination with other active pharmaceutical ingredients, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agriculture Remedies and Stock Remedies Act, 1947 (Act 36 of 1947. (S0, S3)
Vitamin E and derivatives thereof, including dl-alpha-tocopherol and not listed elsewhere in the Schedules, contained in preparations or mixtures containing more than 400 I.U. of Vitamin E per recommended daily dose.(S0)
Xylometazoline, except when intended for nasal use. (S1)
ANNEXURE 1A: EMERGENCY CARE PROVIDER (PARAMEDIC)
PARAMEDIC (National Diploma in Emergency Medical Care graduates only) registered with Health Professions Council of South Africa
PARAMEDIC (National Diploma in Emergency Medical Care graduates only) |
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SELECTIVE ß2 AGONISTS |
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NON-STEROIDAL ANTI-INFLAMMATORY |
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ANALGESIC |
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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
EMERGENCY CARE PRACTITIONER (B Tech: Emergency Medical Care) |
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ANTI-CHOLINERGIC |
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SELECTIVE ß2 AGONISTS |
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ANTI-SPASMODIC |
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ANTI-PROPULSIVE |
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NON-STEROIDAL ANTI-INFLAMMATORY |
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ANALESIC |
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ANNEXURE 1C: BASIC AMBULANCE ASSISTANT
BASIC AMBULANCE ASSISTANT registered with Health Professions Council of South Africa
BASIC AMBULANCE ASSISTANT registered with Health Professions Council of South Africa |
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*ANTI-CHOLINERGIC |
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*SELECTIVE ß2 AGONISTS |
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ANNEXURE 1D: AMBULANCE EMERGENCY ASSISTANT
AMBULANCE EMERGENCY ASSISTANT registered with Health Professions Council of South Africa
AMBULANCE EMERGENCY ASSISTANT registered with Health Professions Council of South Africa |
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ANTI-CHOLINERGIC |
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SELECTIVE ß2 AGONISTS |
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ANNEXURE 1E: EMERGENCY CARE TECHNICIAN
EMERGENCY CARE TECHNICIAN registered with Health Professions Council of South Africa
EMERGENCY CARE TECHNICIAN registered with Health Professions Council of South Africa |
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SELECTIVE ß2 AGONISTS |
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ANNEXURE 1F: EMERGENCY CARE ASSISTANT
EMERGENCY CARE ASSISTANT registered with Health Professions Council of South Africa
EMERGENCY CARE ASSISTANT registered with Health Professions Council of South Africa |
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ANTI-CHOLINERGIC |
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SELECTIVE ß2 AGONISTS |
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ANNEXURE 2: DENTAL THERAPIST
DENTAL THERAPIST (Bachelors degree in Dental Therapy) registered with Health Professions Council of South Africa
DENTAL THERAPIST (Bachelors degree in Dental Therapy) |
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ANALGESIC, ANTIPYRETIC, ANTI INFLAMMATORY |
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ANALGESIC, ANTIPYRETIC, ANTI INFLAMMATORY |
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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 in possession of a Section 22A(15) permit as provided for by the Medicines and Related Substances Act, 1965 (Act 101 of 1965)
OPTOMETRIST |
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ANTIHISTAMINE/VASOCONSTRICTOR/MAST CELL STABILISER |
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ANTIHISTAMINE/VASOCONSTRICTOR/MAST CELL STABILISER |
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ANTIHISTAMINE/VASOCONSTRICTOR/MAST CELL STABILISER |
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ANTIHISTAMINE/ VASOCONSTRICTOR/ MAST CELL STABILISER |
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ANTIHISTAMINE/VASOCONSTRICTOR/MAST CELL STABILISER |
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STEROIDAL ANTI INFLAMMATORY |
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ANNEXURE 4: PODIATRIST
PODIATRIST registered with the Health Professions Council of South Africa in terms of the Health Professions Act, 1974 (Act 56 of 1974)
PODIATRIST |
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[Schedule 2 substituted by Notice No. 2685, GG47373, dated 28 October 2022]