These are the guidelines for the registration, renewal, change in characteristics and extension in range of both imported and locally manufactured registered pharmaceutical products.
South Africa
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.