Medicines And Related Substances Act, 1965 (Act no. 101 Of 1965) as amended

The Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), which was amended by Amendment Act, 2008 (Act No. 72 of 2008) and Amendment Act, 2015 (Act No. 14 of 2015) and enacted in May 2017, enabled, amongst others, the establishment of SAHPRA, the licensing of manufacturers and importers of active pharmaceutical ingredients, and the regulation of medical devices.

In terms of the Medicines Act, the objectives of the Authority are to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, medical devices, radiation control, clinical trials and related matters in the public interest. It also provides for registration and control of veterinary medicines in such a way as to ensure that they are produced, distributed and used without compromising human and animal health. Antimicrobials intended for use in animals and registered under the Medicines Act may only be administered or prescribed by a veterinarian.

As per section 2B (1) of the Medicines Act, the Authority must, in order to achieve its objects:

• Ensure the efficient, effective and ethical evaluation or assessment and regulation of medicines, medical devices, radiation emitting devices and radioactive nuclides that meet the defined standards of quality, safety, efficacy and performance, where applicable;
• Ensure that the process of evaluating or assessing and registering of medicines, medical devices, radiation-emitting devices and radioactive nuclides is transparent, fair, objective and concluded timeously;
• Ensure the periodic re-evaluation or re-assessment and ongoing monitoring of medicines, medical devices, radiation emitting devices and radioactive nuclides;

General Regulations

The General Regulations of the above Act include the arrangement of regulations for supply of medicines, registration of medicines, permits, licencing and authorisation, management of medicines, the Authority, appeals, investigations, offences, and penalties.