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Zambia Zambia

Official Name: Republic of Zambia
Capital: Lusaka
Independence Day: 24 October 1964
Currency: Kwacha (ZMW)

  • Indicators

Indicators

Medicine Regulation

Medicine regulatory in Zambia is overseen by the Zambia Medicines Regulatory Authority (ZAMRA). The authority has a website that provides stakeholders with comprehensive information on their undertaken processes. The regulatory authority ensures that the medicines and allied substances made available to the Zambian population adhere to the set standards to safeguard public health.
The authority regulates and controls the manufacture, importation, exportation, distribution and sale of medicines and allied substances in Zambia. The authority also inspects the premises used for manufacturing, distribution, importation and the exportation of these medicines and allied substances. They grant pharmaceutical licenses and marketing authorization, among other functions.

Information Management System

The website of the Zambia Medicine Regulatory Authority has various application documents, guidelines and forms available to its stakeholders and the public on varied topics such as the guidelines for the establishment of a pharmaceutical retail business in Zambia, application for the importation of medicine for personal use, the invitation for expression of interest to register medicines via the Zazibona collective process and the application form for a pharmaceutical license. There are also CTD forms, a fee schedule available to pharmaceutical companies and the public.
ZAMRA has also made available various approved registers to the public. These registers include Certificate of registration for hospital and retail pharmacies, Pharmaceutical licenses, Certificate of registration for agro-veterinary shops, Pharmaceutical licenses – manufacturers, Human Medicines (2019) and Veterinary medicines (2019). Other sections on the website include News, FAQs, consultancy tender, among others.

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