Health Legislation

The Resolution approved the Treaty Establishing the African Medicines Agency, adopted in February 2019 by the 32nd Ordinary Session of the Assembly of Heads of State and Government of the African Union, held in Addis Ababa – Ethiopia. 

This decree regulates the exercise of hospital pharmaceutical activity in the health structures of the National Health Service. It covers all health structures of the National Health Service that carry out this activity, namely central hospitals and regional hospitals. Its purpose is to organize, improve, optimize and standardize hospital pharmaceutical services in the National Health Service.

The decree provides the National List of Essential Medicines.

This decree regulates the marketing authorization, registration, manufacture, import, export, marketing, donations and advertising of medicines for human use.

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.