Medicines

Draft Resolution of the Cabinet of Ministers of Ukraine "Certain Issues Related to the Importation and Quality Control of Medicines"; (60 page(s), in Ukrainian)

The draft Resolution has been developed to regulate the procedures for imports of medicines (except active pharmaceutical ingredients) into the territory of Ukraine, the state quality control of medicines imported into Ukraine, quality control testing of medicines in a state laboratory or a laboratory authorised by a state control authority and the official batch release of certain biological medicines (immunological medicinal products and medicinal products derived from human blood or plasma).

The draft Resolution proposes to amend the Resolution of the Cabinet of Ministers of Ukraine No. 287 of 14 March 2025 "On Approval of the Procedure for Importation of Medicines into the Territory of Ukraine" in order to establish a unified procedure for the importation of medicines and the state quality control of medicines imported into the territory of Ukraine. The draft Resolution also provides for the approval of the Procedure for State Quality Control of Medicines Conducted in a State Laboratory or a Laboratory Authorized by the State Control Authority; the Procedure for Official Batch Release of Certain Biological Medicines (Immunological Medicinal Products and Medicinal Products Derived from Human Blood or Human Plasma); the Criteria for Establishing the Annual Programme (Plan) for Sampling of Medicines and repeal certain resolutions of the Cabinet of Ministers of Ukraine, including Resolution No. 902 of 14 September 2005 "On Approval of the Procedure for State Quality Control of Medicinal Products Imported into Ukraine" and Resolution No. 260 of 3 February 2010 "Certain Issues of State Quality Control of Medicinal Products".