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North Macedonia's medicines regulator, set up in 2014. It authorises medicines and medical devices, keeps their registers, controls quality and oversees clinical trials.
The Agency for Medicines and Medical Devices of the Republic of North Macedonia (MALMED) was established on 16 September 2014 under the Law on Medicines and Medical Devices as an independent state administration body founded by the Government. It took over the assets of the Bureau of Medicines, a body within the Ministry of Health, which ceased to exist. Its site covers registers of medicines, placing medicines on the market, quality control, advertising of human medicines, medicines traffic and consumption, clinical trials, parallel imports and the register of medical devices; its mission statement refers to aligning with EU standards. The coordinates are an approximate Skopje city point.
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