Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)SchedulesSchedule 1 |
Schedule 1
| (a) | All substances referred to in this Schedule are excluded when specifically packed, labeled, 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(4)(a)(v) 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 1 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 |
| (v) | Annexure 5: Oral hygienists |
Acetanilide and alkyl acetanilides.
Acetarsol, when intended for human vaginal use.
Acetylcysteine,
| (a) | when used as a mucolytic in acute respiratory conditions for a maximum treatment period of 14 days; |
(b) except when intended for injection or for the management of paracetamol overdosage. (S3)
Acyclovir, when intended for application to the lips in the early treatment of recurrent herpes simplex virus infections. (S4)
Ambroxol.
Amethocaine - see Tetracaine.
Amorolfine.
Anethole trithione.
Anticoagulants, when intended for application to the skin. (S4)
Antimony potassium tartrate and antimony sodium tartrate; in concentrations of 1 percent or more. (S0)
Any compound structurally derived from either beta-aminopropylbenzene or beta-aminoisopropylbenzene by substitution in the side chain or by ring closure therein (or by both such substitution and such ring closure); and presented as:
| (a) | preparations and mixtures when used as vasoconstrictors and decongestants in antihistamine-containing nose and eye preparations; and |
| (b) | appliances for inhalation in which the substance is adsorbed onto sold material but excluding cathine ((+)-norpseudoephedrine), ephedrine, etafedrine, N-methylephedrine, N-diethylaminoethylephedrine, phenylpropanolamine, prenylamine. (S2, S6, S7) |
Arsenic;
| (a) | in oral dosage forms in concentrations equivalent to 0,01 percent or less of arsenic trioxide; (S2) |
| (b) | except when intended for injection. (S4) |
Ascorbic Acid - see Vitamin C.
Azelaic acid.
Bacitracin, when intended for topical application to the epidermis, nares and external ear. (S4)
Bee venom, preparations intended for application to the skin. (S4)
Belladonna alkaloids, when specifically intended for application to the skin. (S2).
Benzethonium chloride, when intended for human vaginal use.
Benzocaine,
| (a) | when intended for topical use; |
| (b) | in oral preparations containing 2% or less of benzocaine; |
| (c) | in lozenges containing 30 mg or less of benzocaine, per dosage unit; |
| (d) | except when intended for ophthalmic or parenteral use. (S4) |
Benzydamine,
| (a) | 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 benzydamine per day. (S3) |
| (b) | except preparations and mixtures containing 3 percent or less of benzydamine, when intended for application to the skin (S0); or |
| (c) | 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) |
| (d) | except when indicated for human vaginal use. (S2) |
Bifidobacterium adolescentis,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s), |
| (b) | except in pharmaceutical preparations and mixtures for one or more strain containing ≥1 x 109 cfu per dosage unit with the general health claim; |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut ". (S0)
Bifidobacterium animalis subsp. Animalis,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0).
Bifidobacterium animalis subsp. Lactis,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0).
Bifidobacterium bifidum,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0).
Bifidobacterium breve,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0)
Bifidobacterium lactis,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0)
Bifidobacterium longum subsp. lnfantis,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0)
Bifidobacterium longum subsp. Longum,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0)
Bifonazole, when intended for application to the skin. (S4)
Bioallethrin.
Bitolterol.
Boron, in oral preparations or mixtures containing more than 3 mg of Boron per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S0)
Bufexamac, when intended for application to the skin. (S3)
Bunamidine.
Butoconazole,
| (a) | when intended for human vaginal use specifically for the treatment of recurrent vaginal candidiasis; (S4) or |
| (b) | when intended for application to the skin. (S4) |
Calcium
| (a) | in oral preparations or mixtures containing more than 1300 mg of calcium per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S0) |
| (b) | except in preparations thereof for injection; (S3) |
| (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). |
Carbamoyl benzamide phenyl isoxazoline, except when intended and registered as a stock remedy in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Chlorhexidine, when intended for human vaginal use. (S0)
Chloroform, preparations and mixtures containing more than 0,5 percent and less than 20 percent of chloroform. (S0, S5)
Chromium, in oral preparations or mixtures containing more than 200 µg of Chromium per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S0)
Ciclopirox.
Clotrimazole,
| (a) | when intended for human vaginal use specifically for the treatment of recurrent vaginal candidiasis; (S4) and |
| (b) | when intended for application to the skin. (S4) |
Collagenase clotridiopeptidase, when intended for application to the skin.
Copper,
| (a) | 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; (S0) |
| (b) | except in preparations thereof for injection. (S3) |
Cyanocobalamin - see Vitamin B12.
Deanol and its derivatives, unless listed in another Schedule, when specifically packaged, labelled and used for industrial purposes including the manufacture or compounding of consumer items or products which have no pharmacological action or 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 54 of 1972) and for analytical laboratory purposes. (S5)
Dequalinum
(a) when intended for oral topical use, as oral solutions or lozengers;
(b) except when intended for human vaginal use. (S2)
Diclofenac,
| (a) | when intended for application to the skin and containing more than 1% m/m of diclofenac; (S3) |
| (b) | 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) |
| (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) |
| (e) | except when intended for veterinary use. (S3) |
Diosmine.
Dithiazanine.
Econazole,
| (a) | when intended for human vaginal use specifically for the treatment of recurrent vaginal candidiasis; (S4) or |
| (b) | when intended for application to the skin. (S4) |
Enilconazole, when intended for application to the skin. (S4)
Ephedra alkaloids (natural or synthetic),
| (a) | when intended for application to skin, eyes, ears and nares containing 1 percent or less of ephedra alkaloids, and not intended for export; (S6) |
| (b) | except 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 ephedrine 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. (S2) |
Ephedrine,
| (a) | preparations and mixtures intended for application to the skin, eyes, ears and nares and containing 1 per cent or less of ephedrine, and not intended for export; (S6) |
| (b) | except products registered in terms of the Act, not intended for export, and being 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 ephedrine 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. (S2) |
Escin (aescin); medicinal preparations and mixtures thereof intended for application to the skin and containing 1 per cent or less of escin. (S3)
Ether (diethyl ether); in concentrations of less than 20 per cent. (S5)
Ethyl chloride.
Ethylphenylephrine.
Etofenamate, when intended for application to the skin. (S3)
Felbinac, when intended for application to the skin. (S3)
Fenbendazole, except when registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Fenticonazole, when intended for application to the skin. (S3)
Fexofenadine.
Flubendazole, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Flufenamic acid, when intended for application to the skin. (S3)
Fluorescein, when intended for ophthalmic use by the topical route only. (S3)
Fluorides,
| (a) | in oral medicinal preparations or mixtures intend for ingestion containing not more than 0,25 milligrams of fluorine per dosage unit; |
| (b) | except in toothpaste containing not more than 0,15 percent flouride; (S0) and |
| (c) | except in mouth rinses containing not more than 0,15 percent flouride; (S0) |
| (d) | except in oral medicinal preparations or mixtures intended for ingestion containing more than 0.25 milligrams of fluorine per dosage unit. (S4) |
Flurbiprofen,
| (a) | 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. (S3) |
| (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 maximum of 4 weeks (S0). |
| (c) | except when intended for the treatment of post-traumatic conditions, for a maximum period of 5 days; (S2) |
| (d) | except when intended for ophthalmic use. (S4) |
Folic Acid, in oral preparations or mixtures containing more than 500 µg of Folic Acid per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S0)
Glycosaminoglycan polysulphate (previously mucopolysaccharide poly-sulphuric acid ester) when intended for application to the skin. (S4)
Gramicidin, when intended for topical application to the epidermis, nares and external ear. (S4)
0-(β-hydroxyethyl) rutosides.
Hyaluronic acid and its salts,
| (a) | when intended for topical application to the skin; |
| (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 ophthalmic use in preparations (except injectables) containing more than 0,1 percent; (S2) |
| (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). |
5-Hydroxy Tryptophan,
| (a) | in oral preparations with a maximum daily dose not exceeding 220 mg of 5-Hydroxy tryptophan, alone or in combination with other active pharmaceutical ingredients; (S5) |
| (b) | except in oral preparation with a maximum daily dose not exceeding 220 mg of 5-Hydroxy alone or in combination with other active pharmaceutical ingredients, with general health claims as a health supplement. (S0) |
Hyoscine butylbromide; substances, preparations and mixtures thereof—
| (a) | when intended for oral administration in pack sizes not exceeding 20 tablets of 10 mg strength or less, or 100 ml of oral liquid dosage of 0.1% mass/ volume or less; (S2) |
| (b) | except transdermal preparations when intended for the prevention of the symptoms of motion sickness; (S2) |
| (c) | except when intended for parenteral administration. (S3) |
Ibuprofen,
| (a) | when contained in preparations intended for application to the skin, containing 5% m/m or less of ibuprofen, and presented in a pack size exceeding 50 grams; (S0) |
| (b) | when contained in oral medicinal preparations, intended for human use only, 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. (S2, S3) |
| (c) | except when intended for veterinary use. (S3) |
Icodextrin.
Idoxuridine, when intended for application to the skin. (S4)
Indanazoline.
Indometacin,
| (a) | when intended for application to the skin; (S3) |
| (b) | except when intended for the emergency treatment of acute gout attacks; (S2) |
(c) except when intended for veterinary use. (S3)
Iodine,
| (a) | in oral preparations or mixtures containing more than 150 µg of Iodine per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S0) |
Iron,
| (a) | 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; (S0) |
| (b) | except in preparations thereof for injection; (S3) |
| (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). |
Irrigation fluids, being sterile fluids intended for irrigation of wounds or hollow visci.
Isoconazole, when intended for
| (a) | human vaginal use specifically for the treatment of recurrent vaginal candidiasis (S4); and |
| (b) | application to the skin. (S4) |
Ketoconazole, when intended for
| (a) | application to the skin, |
| (b) | except preparations and mixtures containing not more than 1,0 percent of ketaconazole, when intended for the prevention and treatment of dandruff. (S0, S4) |
Ketoprofen,
(a) when intended for application to the skin; (S3)
| (b) | except 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; (S2) |
| (c) | except when intended for the emergency treatment of acute gout attacks; (S2) |
| (d) | except when intended 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; (S2) |
| (e) | 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) |
Lactobacillus acidophilus,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0)
Lactobacillus brevis,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0)
Lactobacillus caucasicus,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0)
Lactobacillus casei,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0)
Lactobacillus fermentum,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0)
Lactobacillus gasseri,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0)
Lactobacillus helveticus,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0)
Lactobacillus johnsonii,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0)
Lactobacillus paracasei,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0)
Lactobacillus plantarum,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut".S0)
Lactobacillus reuteri,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s);. |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0)
Lactobacillus rhamnosus,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0)
Lactobacillus salivarius,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0)
Lactococcus lactis,
| (a) | in pharmaceutical preparations and mixtures with medicinal claim(s); |
| (b) | except in pharmaceutical preparations and mixtures for one or more strains containing ≥1 x 109 cfu per dosage unit with the general health claim: |
"When ingested on a regular basis, probiotics should improve or normalise the microbial balance in the human intestines and thereby improve the functioning of the digestive tract/gut". (S0)
Lidocaine,
| (a) | when intended for topical use; |
| (b) | in oral preparations containing 2% or less of lidocaine, per dosage unit; |
| (c) | except when intended for ophthalmic or parenteral use; (S4) |
| (d) | except when intended for the treatment of neuropathic pain associated with previous herpes zoster infection. (S4) |
Lignocaine - see Lidocaine.
Local anaesthetics, except
| (a) | when intended for ophthalmic and for parenteral use; (S4) |
| (b) | oxybuprocaine, proxymetacaine and tetracaine, when contained in eye drops intended for emergency treatment of "arc eyes"; (S2) and |
| (c) | ophthalmic preparations registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947). |
Loratidine.
Lufenuron, except when intended and registered as a systemic preparation against fleas in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Luxabendazole, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Lysozyme, when intended for application to the skin. (S4)
Magnesium, in oral preparations or mixtures containing more than 250 mg of Magnesium per recommended
daily dose alone or in combination with other active pharmaceutical ingredients. (S0)
Malathion, except when intended and registered as an ectoparasiticide in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Manganese,
| (a) | in oral preparations or mixtures containing more than 4 mg of Manganese per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S0) |
| (b) | in preparations thereof for injection when intended for veterinary use. |
Mebendazole, except intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Methenamine (hexamine), when intended for application to the skin. (S4)
Methionine,
| (a) | in oral preparations containing more than the maximum daily dose of 210 mg of methionine alone or in combination with other active pharmaceutical ingredients. (S0) |
Miconazole,
| (a) | when intended for human vaginal use specifically for the treatment of recurrent vaginal candidiasis; (S4) and |
| (b) | when intended for application to the skin; (S4) |
| (c) | except for topical treatment of fungal infections of the mouth. (S2) |
Microfibrillar collagen hydrochloride.
Molybdenum and derivatives thereof in oral preparations or mixtures containing more than 230 µg of Molybdenum per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S0)
Morantel except when registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
N-acetyl-aspartyl-glutamic acid.
Naphazoline, when intended for nasal use. (S2)
Naproxen
| (a) | when contained in preparations intended for application to the skin; (S2, S3) |
| (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; (S2, S3) |
| (c) | except when intended for veterinary use. (S3) |
Niacin (Nicotinic Acid, Vitamin B3) and derivatives thereof,
| (a) | in oral preparations or mixtures containing more than 35 mg of Niacin per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S0) |
| (b) | except when intended for hypercholesterolaemia and for the management of dyslipidaemias. (S4) |
Nicotinamide and derivatives thereof, in oral preparations or mixtures containing more than 500 mg of Nicotinamide per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S0)
Nicotine,
| (a) | 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 and including 21 mg/24 hours or 25 mg/16 hours; |
| (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 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) |
| (d) | except when intended for human medicinal use as an aid too smoking cessation, when registered and presented as nicotine transdermal patches for continuous application to the skin in strengths containing more than 21 mg/24 hours or 25 mg/16 hours; (S2) |
| (e) | except when registered as metered sprays containing not more than 1 mg per dose; (S2) |
| (f) | except when registered as oral solid dosage forms containing not more than 2 mg; (S2) |
| (g) | except when registered as inhalers containing not more than 10 mg per cartridge; (S2) |
| (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) |
Nitrofurantoin, when intended for application to the skin. (S4)
Nitrofurazone, when intended for application to the skin. (S4)
Normal Saline (Sodium chloride 0,9% m/v) when intended for injection, in a dosage form not exceeding 20 milliliters in volume. (S0, S3)
Nystatin,
| (a) | when intended for application to the skin, and |
| (b) | when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis, and |
| (c) | except when presented as oral drops containing not more than 100 000 I.U. per ml. (S2) |
| (d) | except when intended for systemic use or the initial treatment of vaginal candidiasis, (S4) |
| (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). |
Ornidazole, when intended for application to the skin. (S4)
Orthodichlorobenzene, when intended for topical human medicinal use.
Oxetacaine (Oxethazaine),
| (a) | in oral preparations containing an antacid; |
| (b) | except when intended for ophthalmic or parenteral use. (S4) |
Oxibendazole, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Oxymetazoline, when intended for nasal use. (S2)
Pancreatin.
Pantothenic Acid - see Vitamin B5.
Paracetamol, except—
| (a) | immediate release tablets or capsules each containing 500 milligrams or less of paracetamol, or in individually wrapped powders or in sachets containing 1 000 milligrams or less of paracetamol, subject to— |
| (i) | a maximum of 12,5 grams of paracetamol per primary pack, and |
| (ii) | in the case of tablets or capsules, presented in blister strip packaging or in containers with child-resistant closures; and |
| (iii) | labeled with the following boxed warning, placed prominently on at least the main panel of the immediate container label and outer label (carton): |
"CONTAINS PARACETAMOL - READ THE PACKAGE INSERT"; (S0)
| (b) | in liquid or syrup dosage form containing 120 milligrams or less of paracetamol per millilitres or in paediatric drops containing 120 milligrams or less of paracetamol per 1,2 millilitres, subject to— |
| (i) | a maximum of 100 millilitres per primary pack in the case of the liquid or syrup dosage form containing 120 milligrams or less of paracetamol per 5 millilitres; |
| (ii) | a maximum of 20 millilitres per primary pack in the case of paediatric drops; |
| (iii) | labelled with the following boxed warning, placed prominently on at least the main panel of the immediate container label and outer label (carton); |
"CONTAINS PARACETAMOL - READ THE PACKAGE INSERT"; (S0)
| (c) | when contained in rectal suppositories. (S2) |
| (d) | when contained in modified release formulations. (S2) |
| (e) | when intended for injection. (S3) |
Paradichlorobenzene, when intended for topical human medicinal use.
Penciclovir, when intended for application to the lips in the early treatment of recurrent herpes simplex virus infections. (S4)
Pentosan polysulfate sodium, except when intended for the treatment of interstitial cystitis. (S3)
Phenylephrine
(a) when intended for oral dosage forms, nasal dosage forms, or ophthalmic dosage forms containing more than 0,2 percent. (S1)
(b) except ophthalmic preparations containing 0,2 percent or less. (S0)
(c) except when intended for injection. (S4)
Phospholipids, when applied for therapeutic purposes.
Phosphorus, in oral preparations or mixtures containing more than 250 mg of Phosphorus per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S0)
Polymixin B, when intended for topical application to the epidermis, nares or external ear. (S4)
Pramoxine.
Prilocaine,
| (a) | in topical preparations containing 10% or less of prilocaine; |
| (b) | except when intended for ophthalmic or parenteral use. (S4) |
Procaine, when intended for oral administration.
Propentofylline, when intended for veterinary use. (S4)
Propylhexedrine, when used as a vasoconstrictor and decongestant in nose preparations and inhalants. (S4)
Proteolytic (fibrinolytic) enzymes,
| (a) | for oral use and |
| (b) | when intended for application to the skin, and |
| (c) | except when intended for soft contact lens cleaners; (S0) and |
| (d) | except when intended for injection. (S4) |
Pyrantel pamoate, including veterinary use, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947). Correct
Pyridoxilate.
Pyridoxine -see Vitamin B6.
Racecadotril.
Riboflavin - see Vitamin B2.
Selenium,
| (a) | in oral preparations or mixtures containing more than 200µg of Selenium per recommended daily dose alone or in combination with other active pharmaceutical ingredients: (S0) |
(b) except in preparations thereof for injection when intended for veterinary use. (S4)
Sertaconazole, when intended for application to the skin. (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 50 milligrams or less and for children 6 to 12 years is 25 milligrams or less, with a maximum pack size of 5 days; (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 eves; (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 more than 50 milligrams and for children 6 to 12 years is more than 25 milligrams. (S2) |
Terbinafine, when intended for application to the skin. (S4)
Tetracaine,
| (a) | when contained in eye drops intended for the 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, when intended for nasal use. (S2)
Thiabendazole, when intended for application to the skin. (S4)
Thiamine - see Vitamin B1.
Thiomersal.
Thiram, except when intended and registered as a fungicide in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Ticlatone, when intended for application to the skin.
Tioconazole,
| (a) | when intended for human vaginal use specifically for the treatment of recurrent vaginal candidiasis; and |
| (b) | when intended for application to the skin. (S4) |
Tolmetin, when intended for application to the skin. (S3)
L-tryptophan,
| (a) | in oral preparations with a maximum daily dose not exceeding 220 mg of L-tryptophan, alone or in combination with other active pharmaceutical ingredients; (S5) |
| (b) | except in oral preparation with a maximum daily dose not exceeding 220 mg of L-tryptophan alone or in combination with other active pharmaceutical ingredients, with general health claims as a health supplement. (S0) |
Tyrothricin when intended for topical application to the epidermis, nares and external ear. (S4)
Vanadium,
| (a) | in oral preparations or mixtures containing more than 182 µg of Vanadium per recommended daily dose atone or in combination with other active pharmaceutical ingredients. (S0) |
Vitamin B1 (Thiamine) and derivatives thereof,
| (a) | 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; (S0) |
| (b) | except in preparations thereof for injection. (S3) |
Vitamin B2 (Riboflavin) and derivatives thereof,
| (a) | 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; (S0) |
| (b) | except in preparations thereof for injection. (S3) |
Vitamin B5 (Pantothenic Acid) and derivatives thereof,
| (a) | 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; (S0) |
| (b) | except in preparations thereof for injection. (S3) |
Vitamin B6 (Pyridoxine) and derivatives thereof,
| (a) | 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; (S0) |
| (b) | except in preparations thereof for injection. (S3) |
Vitamin B12 (Cyanocobalamin) and derivatives thereof,
| (a) | in oral preparations or mixtures containing more than 100 µg of Vitamin B12 per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S0) |
| (b) | except in preparations thereof for injection. (S3) |
Vitamin C (Ascorbic Acid),
| (a) | 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; (S0) |
| (b) | except in preparations thereof for injection. (S3) |
Vitamin H (Biotin) and derivatives thereof, in oral preparations or mixtures containing more than 500 µg of Vitamin H per recommended daily dose alone or in combination with other active pharmaceutical ingredients.
(S0)
Vitamin K and derivatives thereof,
| (a) | 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; (S0) |
| (b) | except in injection preparations; (S3) |
| (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 in a dosage form not exceeding 20 milliliters in volume. (S3)
Xylometazoline, when intended for nasal use. (S2)
Zinc and derivatives thereof,
| (a) | in injection preparations when intended for veterinary use; (S3) |
| (b) | except in oral preparations or mixtures containing not more than 25 mg of Zinc per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S0) |
| (c) | except when intended for topical use; (S0) |
| (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). |
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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LOCAL ANAESTHETIC |
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WATER |
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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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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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WATER |
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WATER |
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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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WATER |
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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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WATER |
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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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WATER |
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WATER |
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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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SURFACE ANAESTHETIC |
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ANTI-VIRAL |
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VITAMINS AND MINERALS |
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MOUTH AND THROAT PREPARATIONS |
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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 recognised by the Health Professions Council of South Africa as an authorised prescriber.
OPTOMETRISTS (Bachelors degree in Optometry) |
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OPHTHALMIC PREPARATIONS: OTHER |
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ANALGESIC |
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ANALGESIC/ANTI INFLAMMATORY |
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SYMPATHOMIMETIC |
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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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LOCAL ANAESTHETIC |
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LOCAL ANAESTHETIC |
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ANNEXURE 5: ORAL HYGIENISTS
ORAL HYGIENISTS registered with the Health Professions Council of South Africa (HPCSA) in terms of the Health Professions Act, 1974 (Act 56 of 1974)
PODIATRIST |
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TOPICAL FLOURIDES |
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[Schedule 1 substituted by Notice No. 2685, GG47373, dated 28 October 2022]