Ukrainian Scientific Institute of Certification

New legislative acts to prevent COVID-19

23/03/2020

The Cabinet of Ministers of Ukraine adopted legislative acts in order to establish a legal framework for the prevention and treatment of coronavirus disease (COVID-19):

Resolution of the Cabinet of Ministers of Ukraine No.224 “On Approval of the List of Medicinal Products, Medical Devices and/or Medical Equipment Required for Implementation of Measures aimed at Prevention and Distribution, Localization and Elimination of Outbreaks, Epidemics and Pandemics of Coronavirus Disease (COVID-19), which are Exempt from Import Duty and the Operation on Import of which into the Customs Territory of Ukraine are Exempt from Value Added Tax“.

Resolution of the Cabinet of Ministers of Ukraine No.226 “On Amendments to Certain Resolutions of the Cabinet of Ministers of Ukraine”: placing on the market (market authorization) of personal protective equipment, medical devices, medical devices for in-vitro diagnostics and active implantable medical devices according to the list approved by the Cabinet of Ministers of Ukraine has been substantially simplified.

For placing such products on the market it is required to submit an Application to the competent authority specifying the purpose of import, information about the manufacturer, name of the device(s), lot(s) or serial number(s), volume, as well as data on the purpose of the device and intended use. The competent authority shall process the submitted documents and issue a notification on the placing on the market of products for which the requirements of technical regulations are not met, but the use of which is required in the interests of public health.

The competent authority for personal protective equipment is the State Labour Service. The competent authority for medical devices, medical devices for in-vitro diagnostics and active implantable medical devices is the Ministry of Health.