Changes to Legislation: Medicines and Related Substances Act

The Medicines and Related Substances Act was amended on the 22nd of May 2017 by the promulgation of the Act 72 of 2008 and Act 14 of 2015 – the Medicines and Related Substances Amendment Acts.

  • These changes to the legislation gave rise to the South African Health Products Regulatory Authority (SAHPRA), replacing the Medicines Control Council at the time of the first meeting of the SAHPRA Board.
  • The SAHPRA Board was appointed by the Minister of Health for a 3-year term ending 30 September 2020 (GG. 41171 | 09.10.2017 | Notice No. 1091).
  • SAHPRA was also delegated the responsibility of managing Radiation Control in South Africa – previously managed by Department of Health: Radiation Control.

The General Regulations to the Medicines Act were amended on the 25th of August 2017, with significant changes to the layout of the regulations, the labelling expectations and the categorisation of Health Products. Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs) were published on 9 December 2016. This is a separate set of regulations to the General Regulations to the Medicines and Related Substances Act and these regulations were effective on the date of publication. Various communications were published by SAHPRA as to the implementation process for the regulations, including the need to license facilities involved with the importation, sale and logistics of MDs & IVDs.

The Labeling Regulations for Health Products have been amended to allow for the use of the EU SmPC format/headings, as well as enabling SAHPRA to manage changes without requiring updates to legislation.

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