This regulation is issued to implement the Food Medicine and Health Care Administration and Control Proclamation No 661/2009. and covers among other aspects of food safety and quality which includes manufacturing, storage and transportation among other aspects; sale of alcohol; medicine administration and control which includes manufacturing, registration, storage, transportation, importation ad clinical trials among others; traditional and complementary medicine administration and control; post-marketing surveillance; control of tobacco products and places prohibited for smoking among other aspects.
Medicines and Related Substances Act 101 of 1965
The Act provides for the registration and control of medicines and related substances for human and animal use, establishes the Medicines Control Council, and outlines its powers and responsibilities. It includes provisions for the licensing of manufacturers, distributors, and dispensers, as well as measures to ensure the availability of affordable medicines. The Act also addresses the regulation of medicine pricing, generic substitution, labeling, and procedures for appeals and re-evaluation of registered medicines.