The Department with the authorization of the Macedonian Agency for medicines and medical devices (MALMED) based on the Law on Medicines and Medical Devices/Agents (Official Gazette of the Republic of Macedonia no. 106/07, 88/10, 36/11, 53/11, 136/11, 11/12, 147/13 , 164/13, 27/14, 43/14, 88/15, 154/15, 228/15, 7/16, 53/16, 83/18, 113/18, 245/18 and Official Gazette of RNM” No. 28/21) as well as by-laws, conducts independent testing, that is, analytical testing and quality control of drugs in order to confirm their compliance with previously approved quality specifications.

Analytical testing is done in line with the guidelines of the valid editions of the European Pharmacopoeia, British Pharmacopoeia and American Pharmacopoeia, the principles and guidelines of Good Laboratory Practice and WHO recommendations.

Department for testing and drug quality control explicitly defines the mission, vision and goals for establishing a robust system for quality control of drugs/medicines. Within the frameworks of joint actions with the Macedonian Agency for medicines and medical devices (MALMED), this Department also defines and coordinates the national priorities in the health system. The activities conducted by this Department are at the request of Macedonian Agency for medicines and medical devices (MALMED) and the State Sanitary and Health Inspectorate at the Ministry of Health.

Department for testing and drug quality control has the responsibility to confirm that cosmetic products and hygiene cleaning products in the household and industry are safe and do not harm human health by applying the Law on Safety of Cosmetic Products (Official Gazette no. 55/07) and the by-laws: Rulebook on data about the composition of detergents that should be indicated on the packaging, as well as the general and special regulations for labeling the detergent packaging - Official Gazette no. 84/2011, Rulebook on data about the composition of detergents - Official Gazette no. 84/2011 and Regulation/Directive banning production, trade and use of detergents for machine washing of textile products with phosphorus content in organic or inorganic form of more than 0.5%, as well as European Regulation.

The goal of the Department is to provide the market with medicines, herbal preparations, preparations of biological origin, cosmetic products, hygiene cleaning products and other products with solid and reliable quality. The activities are realized according to the quality system, i.e., the standard MKS ISO/IEC 17025:2018 (accredited techniques in the Division for Physico- Chemical Testing, Division for Pharmaco-Technological Testing, Division for Cosmetology and Bacterial endotoxin testing laboratory, which is done in the Department of microbiological control of food and drug quality).