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18 December 2020 – to Date) (18 December 2020 – to date) MEDICINES AND RELATED SUBSTANCES ACT 101 OF 1965 (Gazette No. 1171, Notice No. 1002 dated 7 July 1965. Commencement date: 1 April 1966 [Proc. No. 94, Gazette No. 1413] SCHEDULES Government Notice 935 in Government Gazette 31387 dated 5 September 2008. Commencement date: 5 September 2008. As amended by: Government Notice R1230 in Government Gazette 32838 dated 31 December 2009. Commencement date: 31 December 2009. Government Notice R227 in Government Gazette 35149 dated 15 March 2012. Commencement date: 15 March 2012. Government Notice R674 in Government Gazette 36827 dated 13 September 2013. Commencement date: 13 September 2013. Government Notice R690 in Government Gazette 36850 dated 20 September 2013. Commencement date: 20 September 2013. Government Notice R104 in Government Gazette 37318 dated 11 February 2014. Commencement date: 11 February 2014. Government Notice R352 in Government Gazette 37622 dated 8 May 2014. Commencement date: 8 May 2014. Government Notice R234 in Government Gazette 38586 dated 20 March 2015. Commencement date: 20 March 2015. Government Notice 254 in Government Gazette 39815 dated 15 March 2016. Commencement date: 15 March 2016. Government Notice 620 in Government Gazette 40041 dated 3 June 2016. Commencement date: 3 June 2016. Prepared by: Page 2 of 199 Government Notice 748 in Government Gazette 41009 dated 28 July 2017. Commencement date: 28 July 2017. Government Notice 1261 in Government Gazette 41256 dated 17 November 2017. Commencement date: 17 November 2017. Government Notice R1098 in Government Gazette 41971 dated 12 October 2018. Commencement date: 12 October 2018. Government Notice R1262 in Government Gazette 42052 dated 23 November 2018. Commencement date: 23 November 2018. Government Notice R755 in Government Gazette 42477 dated 23 May 2019. Commencement date: 23 May 2019. Government Notice R219 and Government Notice R220 in Government Gazette 43051 dated 28 February 2020. Commencement date: 28 February 2020. Government Notice R586 in Government Gazette 43347 dated 22 May 2020. Commencement date: 22 May 2020. Government Notice R1375 in Government Gazette 44019 dated 18 December 2020. Commencement date: 18 December 2020. The Minister of Health has, in terms of section 22A(2) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965), on the recommendation of the Medicines Control Council, made and updated the Schedules in the Schedule SCHEDULE In these Schedules, "the Act" means the Medicines and Related Substances Act, 1965 (Act 101 of 1965) Note: Where an alternative schedule(s) is included in natural parentheses at any point of an inscription, this is provided to indicate one or more alternative scheduling designation/s. This is for information only and shall not be used in the interpretation of such inscription. SCHEDULE 0 (a) All substances referred to in this Schedule are excluded when specifically packed, labelled, sold and used for - Prepared by: Page 3 of 199 (i) industrial purposes including the manufacture or compounding of consumer items or products which have no pharmacological action or medicinal purpose, and which are intended to be ingested by man or animals as a 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) or that are registered in terms of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947); and (ii) analytical laboratory purposes. (b) This Schedule shall include all substances or mixtures of such substances containing or purporting to contain substances referred to, including the salts and esters of such substances, where the existence of such salts and esters is possible, except where such substances or mixtures of substances are expressly excluded. This Schedule includes all substances or mixtures of substances subject to registration in terms of the Act and which are not listed in any of the other Schedules. SCHEDULE 1 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(4)(a)(v) of the Act, a practitioner, nurse or a person registered under the Health Professions Act, 1974 (Act No. 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 Authority, 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. Prepared by: Page 4 of 199 (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 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) Prepared by: Page 5 of 199 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 eve preparations; and (b) appliances for inhalation in which the substance is adsorbed onto solid 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 topical application. (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, Prepared by: Page 6 of 199 a. preparations and mixtures containing [sic] 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 benzydarrine 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 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) c. except for use in ready-to-drink single serving infant formula sold in liquid form, in terms of the provisions of the Foodstuffs, Cosmetic and Disinfectant Act, 1972 (Act 54 of 1972) containing no less than 1 x 108 cfu probiotics per daily serving, provided no medicinal or general health claim is made. 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
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