The KMA was established in 1999, initially under the name “Kosovo Medicines Regulatory Authority” (KMRA), and based on Administrative Instruction 7/2000 of 23 March 2000, its legal existence as an Executive Agency of the Ministry of Health of Kosovo was established. Later, the legal basis of the KMA was regulated by Law No. 2003/26, amended in 2010 by Law 03/L 188 on Medical Products and Devices, which entered into force on 15 November 2010.
The rules, duties and responsibilities of the KMA regarding the production, import, export, supervision, etc. of medical products and devices are precisely defined based on the Law on Medical Products and Devices, approved by the Assembly of the Republic of Kosovo on 7 April 2014.
The mission of the KMA is to protect public health by ensuring the quality, safety and efficacy of medicinal products placed in Kosovo.