About SMDC

The State Service of Ukraine on Medicines and Drugs Control (SMDC) is the central executive body whose activities are directed and coordinated by the Cabinet of Ministers of Ukraine through the Minister of Health who implements state policy in the spheres of quality control and safety of medicinal products, including immunobiological medicines (hereinafter referred to as medicinal products), medical equipment and medical devices and the circulation of narcotic drugs, psychotropic substances and precursors, counteracting their illegal circulation, blood and blood component donation and the functioning of the blood system.

According to the Regulation on the State Service of Ukraine on Medicines and Drugs Control, approved by Resolution No. 647 of the Cabinet of Ministers of Ukraine dated 12 August 2015, the main tasks of the State Service are:

implementation of state policy in the spheres of quality control and safety of medicines, medical devices and circulation of narcotic drugs, psychotropic substances and precursors, combating their illegal circulation, as well as submitting proposals to the Minister of Health on the formation of state policy in these spheres;

licensing of economic activities related to the manufacture of medicinal products, import of medicinal products (except for active pharmaceutical ingredients), wholesale and retail trade in medicinal products, circulation of narcotic drugs, psychotropic substances and precursors;

technical regulation in specific spheres;

exercising state regulation and control in the spheres of narcotic drugs circulation, psychotropic substances and precursors and combating their illegal trafficking;

licensing of economic activities related to the collection and testing of donated blood and blood components, regardless of their final destination and the processing, storage, distribution and sale of donated blood and blood components intended for transfusion;

{Paragraph 3 supplemented by a clause in accordance with Resolution of the Cabinet of Ministers No. 1378 dated 23.12.2021}

implementation of state policy in the field of blood and blood component donation, functioning of the blood system, verification of compliance with the requirements of good manufacturing practice by entities in the blood system that collect, process, test, store, distribute and sell donated blood and blood components.

{Paragraph 3 supplemented by a clause in accordance with Resolution of the Cabinet of Ministers No. 1378 dated 23.12.2021}