To provide for the registration of medicines intended for human and for animal use; for the registration of medical devices; for the establishment of a Medicines Control Council; for the control of medicines, Scheduled substances and medical devices; for the control of manufacturers, wholesalers and distributors of medicines and medical devices; and for the control of persons who may compound and dispense medicines; and for matters incidental thereto.

Latest Developments:

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), has been updated with Exclusion of Medicines from the application of certain provisions of Regulation 12 of the General Regulations made in terms of the Act, as per Notice No. 5361 of GG51352 dated 4 October 2024.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), has been updated with the Amendment of Schedule 6 to the Principle Act, as per Notice No. 5181 of GG51171 dated 6 September 2024.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), has been updated with Exemption of Manufacturers, Wholesalers and Distributors of Class A Medical and In Vitro Diagnostics from the Operation of the provisions of Section 22C of the Act, as per Notice No. 4406 of GG50164 dated 28 February 2024.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), has been updated with Amendments to Regulation 12 of the Regulations relating to Transparent Pricing System for Medicines and Scheduled Substances under Notice No. R.1102 of 2005, as per Notice No. 3875 of GG49309 dated 15 September 2023.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), has been updated with Amendments to Regulation 10(1), (2) and (3) of the Regulations relating to a Transparent Pricing System for Medicines and Scheduled Substances under Notice R.1102 of November 2005, as per Notice No. 3816 of GG49189 dated 25 August 2023.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), has been updated with the Second Single Exit Price Increase [SEP] of Medicines and Scheduled Substances for the year 2023 [Top-up SEP], as per Notice No. 3801 of GG49140 dated 18 August 2023.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), has been updated with the Exclusion of Scheduled Zero (0) Medicines from the operations of Sections 22G and 18A of the Act, as per Notice No. 3800 of GG49140 dated 18 August 2023.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), has been updated with the Exclusion of certain alcohol-based hand-rubs from the operation of certain provisions of the Act, as per Notice No. 3382 of GG48542 dated 5 May 2023.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), has been updated with Amendments to the Regulations under Notice No. 859 of 2017, as per Notice No. R.3343 of GG48475 dated 28 April 2023.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), has been updated with the Annual Single Exist Price Adjustment [SEPA] of Medicines & Substances for the year 2023, as per Notice No. 2940 of GG47883 dated 20 January 2023.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), has been updated with Amendments to Regulation No. 859, GG41964 of 25 August 2017, as per Notice No. 2853 of GG47673 dated 8 December 2022.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), has been updated with Amendments to Schedules under Main Act, as per Notice No. 2685 of GG47373 dated 28 October 2022.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), has been updated with Amendments to Regulation 12 of the Regulations under Notice R1102 of 2005- Dispensing Fee to be charged by persons licensed in terms of Section 22C(1)(a) of the Act, as per Notice No. 2343 of GG47197 dated 5 August 2022.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), has been updated with Amendments to Notice R1102 of 2005-Regulations relating to Transparent Pricing System for medicines and scheduled substances: Dispensing Fee for Pharmacists, as per Notice No. 2266 of GG46688 dated 8 July 2022.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), has been updated with the Extension to the Exemption of Medical Devices and In-Vitro Diagnostics (IVDs) from the Provisions of Section 18A and Section 18B of the Act, as per Notice No. 1632 of GG45673 dated 17 December 2021.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), has been updated with the Exclusion of Schedule 0 Medicines from the Operations of Sections 22G and 18A of the Act, as per Notice No. 1581 of GG45614 dated 10 December 2021.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), has been updated with Exclusions of COVID-19 Vaccines from the Operation of Certain Provisions of the Act, as per Notice No. 1502 of GG45487 dated 15 November 2021.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) has been updated by the Exclusion of certain alcohol-based hand-rubs from the operation of specified provisions of the Act as per Notice No. R. 756 of GG45057 dated 27 August 2021.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) has been updated by an amendment to Regulations R1102 (26 March 2021): Regulation 12 Transparent Pricing System for Medicines and Schedule Substances (Dispensing fee to be charged by person licensed in terms of Sec 22C, as per Notice No. 139 of GG44333 dated 26 March 2021.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) has been updated by the publication of the Exclusion of Schedule 2, 3 and 4 substances from the Operation of Certain Provisions of the Act, as per Notice No. 252 of GG44322 dated 25 March 2021.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) has been updated by the Notification of Retention Fee Payment, as per Notice No. R. 164 of GG44215 dated 2 March 2021.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) has been updated by amending Regulations regarding fees payable in terms of provisions of the Act, as per Notice No. R. 1379 of GG44026 dated 22 December 2020.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) has been updated by amendments to Schedules in the Main Act, as per Notice No. R. 1375 of GG44019 dated 18 December 2020.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) has been updated by an Amendment of N514 of GG 43294 dated 7 May 2020, as per Notice No. R. 1233 of GG43913 dated 20 November 2020.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) has been updated by the exclusion of certain Alcohol-based hand-rubs from the operation of specified Provisions of the act, as per Notice No. R.721 of GG43484 dated 26 June 2020.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) has been updated by amendments to Notice R1102 of 2005, as per Notice No. R.679 of GG43447 dated 19 June 2020.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) has been updated by the changes to Schedules 4, 6 and 7 as per Notice No. R. 586 of GG43347 dated 22 May 2020.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) has been updated by a notice regarding the Exclusion of Medicines, Medical Devices and In Vitro Diagnostics (IVDs) donated to the State, as per Notice No. R. 585 of GG43346 dated 22 May 2020.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) has been updated by the Exclusion of Schedules 2, 3 and 4 substances from the operation of certain provisions of the Act as per Notice No. R. 481 of GG43260 dated 30 April 2020.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) has been updated by further Amendments to Schedules 1, 3 & 4 of the Act as per Notice No. R. 220 of GG43051 dated 28 February 2020.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) has been updated by Amendments to Schedules 1, 2, 3, 4 & 7 of the Act as per Notice No. R. 219 of GG43051 dated 28 February 2020.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) has been updated by Regulations, Regulations relating to a Transparent Pricing System for Medicines and Scheduled Substances as per Notice Numbers 27 and 28 of GG42183 dated 23 January 2019.

The Pharmacy Act, 1974 (Act No. 53 of 1974) has been amended by Guidance for the Issuing of Licenses for Pharmacy Premises, Notice No. 1476, Government Gazette 41354, dated 22 December 2017.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) has been updated by Notices, Registration of Oral Preparations containing Bacterial Strains as per Notice No. 1256 of GG41248 dated 14 November 2017.

The Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) has been amended by General Regulations, Notice No. 859, Government Gazette 41064, dated 25 August 2017.

The Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) has been amended by Commencement of Medicines and Related Substances Amendment Act, 2008 (Act No. 72 of 2008), Proclamation No. 20 of 2017, Government Gazette 40869, dated 26 May 2017.

The Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) has been amended by Medicines and Related Substances Amendment Act, 2015 (Act No. 14 of 2015), Notice No. 19, Government Gazette 39585, dated 8 January 2016.

The Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) has been amended by Medicines and Related Substances Amendment Act, 2008 (Act No. 72 of 2008), Notice No. 434, Government Gazette 32148, dated 21 April 2009.

The Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) has been updated by Regulations, Regulations relating to a Transparent Pricing System for Medicines and Scheduled Substances as per Notice No. 1479  of GG41362 dated 29 December 2005.

The Medicines and Related Substances Control Act, 1965 (Act No.101 of 1965) has been added to the site.