This Decree regulates the production, import, marketing and dispensing of medicines and one of its objectives is to ensure that medicines in the Republic of Mozambique are safe, effective, of good quality and meet the needs of the population.
This proclamation provides rules to control drugs, medical supplies and sanitary items.
The Medical Stores Department Act
This Act establishes the Medical Stores Department for the procurement, storage and distribution of medical supplies and provides for other matters connected or incidental to the establishment and management of the department.
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.