Health Legislation

The Constitution of South Africa was adopted in 1996 and approved by the Constitutional Court. It consists of 241 articles grouped into 14 chapters that are supplemented by 7 schedules. The Constitution is the prime law of the country and sets out the founding provisions of the organization of the state, regulates the civil, political, cultural and economic rights of the people, divides the powers within the state and establishes the key state institutions and organs, etc.

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.