GENERAL REGULATIONS TO THE MEDICINES AND RELATED SUBSTANCES ACT, 1965
The publication of the general regulations to the Medicines and Related Substances Act, 1965 (General Regulations) on 25 August 2017 follows the promulgation 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) on 1 June 2017.
As you may also be aware, the Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices were published on 9 June 2016.
As is the case with the amendments arising from the 2008 Amendment Act and the 2015 Amendment Act, the General Regulations do not contain any transitional provisions and are accordingly effective with effect from 25 August 2017.
The purpose of the General Regulations is, among other things, to align with the new provisions introduced by the 2008 Amendment Act and the 2015 Amendment Act. A brief highlight of some of its key features is set out here.