MEDICINES AND RELATED SUBSTANCES AMENDMENT ACTS COME INTO FORCE

By Julie Oppenheim Friday, June 09, 2017
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On 1 June 2017, the Medicines and Related Substances Act, 101 of 1965 was formally amended by the coming into force of the provisions of the Medicines and Related Substances Amendment Act, 72 of 2008 (2008 Amendment Act) and the Medicines and Related Substances Amendment Act, 14 of 2015 (2015 Amendment Act).

The 2008 Amendment Act read together with the 2015 Amendment Act provides for the establishment of a new body to replace the MCC, called the South African Health Products Regulatory Authority (SAHPRA).

SAHPRA is established as an organ of state within the public administration but outside the public service. The objects of SAHPRA are to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, in vitro diagnostic medical devices and related matters in the public interest. These amendments also provide for the regulation of medical devices and IVDs in much the same way as that which currently applies to medicines.