The Zambia Medicines Regulatory Authority is a Statutory Body established under an Act of Parliament; the Medicines and Allied Substances Act No. 3 of 2013 to Regulate and Control the Manufacture, Importation, Storage Distribution, Supply, Sale and Use of Medicines and Allied Substances.
The main objective of the Authority is to ensure that all Medicines and Allied Substances being made available to the Zambian people consistently meet the set standards of Quality, Safety and Efficacy.
Medicines regulation is a combination of Legal, Administrative, and Technical Measures taken to ensure the Quality, Safety and Efficacy of Medicines, as well as the relevance and accuracy of product information. The Legal requirements for Medicines Control provide for effective implementation of various regulatory processes and framework for compliance.
ZAMRA incorporates several mutually reinforcing activities all aimed at promoting and protecting Public and Animal Health. This is accomplished through a range of regulatory activities throughout the supply chain, including: Marketing Authorisation, Inspection of facilities, Advertising and Promotion, and Post Marketing Surveillance.
To support implementation of the MASA, the following regulations have been developed and in use;
