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The Zambia Medicines Regulatory Authority formally the Pharmaceutical Regulatory Authority is a Statutory National Medicines Regulatory Body in Zambia established under an Act of Parliament, the Medicines and Allied Substances Act No. 3 of 2013 of the Laws of Zambia 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.

The history of medicines regulation in Zambia dates back to 1941 when the Pharmacy and Poisons Act, Chapter 299 of the Laws of Zambia was first enacted. This Act was to provide for the control of the profession of pharmacy and trade in drugs and poisons.

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