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Government Gazettes and Regulations

The Government Gazette is used by the government as an official way of communicating to the general public. The Gazette includes proclamations by the President as well as both general and government notices made by its various departments.

 

The gazettes on the SAHPRA website relate to Acts and Regulations specific to SAHPRA business.

GOVERNMENT GAZETTES

Document NumberTitleCategoriesDate UpdatedVersionUnitsLinkdoc_categories_hfilterdoc_tags_hfilter
No. 42052Amended_Schedules_R1262_No42052, 23/11/2018Downloadamended-schedules government-gazettecorporate
No. 43051Government_Gazette 43051_R219, 29/02/2020Downloadamended-schedules government-gazettecorporate
No. 44019Amended_Schedules_R1375_No44019, 19/12/2020Downloadamended-schedules government-gazettecorporate
No. 415176Amended_schedules_883_No45176, 17/09/2021Downloadamended-schedules government-gazettecorporate
No. 46789Government_gazette46789_R2412, 26/08/2022Downloadamended-schedules government-gazettecorporate
No. 47373Amended_schedules_2685_No47373, 28/10/2022Downloadamended-schedules government-gazettecorporate
No. 51171Amendment to Schedules_R5181_GG51171, 06/09/2024Downloadamended-schedules government-gazettecorporate
No. 53099Amendment to Schedules_R6466_GG53099, , 19/08/2025Downloadamended-schedules corporate-documents government-gazettecorporate
No. 51821An Extension to the Exemption of medical Devices and In-Vitro Diagnostics (IVDs) from the provisions of Section 18A and Section 18B of the Medicines and Related substance , 1965(ACT No 101 of 1965 )25/02/20255732Downloadgovernment-gazettecorporate
No. 52105Exemptions of manufacturer, wholesalers and distributors of Class A Medical Device and in vitro diagnostics from the operation of the provisions of Section 22C(1) of the medicines and related substances Act 101 of 196525/02/2025716Downloadgovernment-gazettecorporate
No. 48358Medicines and Related Substance Act_1965_Schedules, 24/03/20233261Downloadamended-schedules government-gazettecorporate
No. 40869Medicines and Related Substances Act Schedules26/05/2017Downloadgovernment-gazettecorporate
No. 52106Regulations Regarding Fees Payable In Terms Of The Provisions Of The Medicines And Related Substances Act, 1965 (Act No. 101 Of 1965)12/02/2025716Downloadgovernment-gazettecorporate
No. 43346Exclusion Of Medicines, Medical Devices And (IVDs) Donated To The State22/05/2020659Downloadgovernment-gazettecorporate
No. 41064General Regulations – Medicines And Related Substances Act, 1965 (25 August 2017), 25/08/2017859Downloadgovernment-gazette regulationcorporate
No. 43347Amendment To Schedules – CBD-containing Products 2020, 15/05/2020659Downloadamended-schedules government-gazettecorporate
No. 43484Published Gazette – Alcohol based hand sanitiser 202025/06/2020721Downloadgovernment-gazettecorporate
No. 45673Published Gazette – Extension Notice (SECTION 18 OF ACT 101)16/12/2021678Downloadgovernment-gazettecorporate

REGULATIONS

Revised Guideline -Donation of Medicines, Medical Devices and IVDs

Regulations Relating to Medical Devices and In-Vitro Diagnostic Medical Devices (IVDs)