In March 2017, the Ministry of Economic Development and Trade of Ukraine and the State Regulatory Service of Ukraine provided official clarifications on the scope of Law of Ukraine No. 1728-VIII "On Temporary Special Aspects of Conducting State Surveillance (Control) Measures in the Area of Business Activity" dated 3 November 2017 (the "Law"). The Law established (i) a moratorium on scheduled inspections of business entities until 31 December 2017; and (ii) a limited list of grounds on the basis of which an unscheduled inspection can be conducted by a state supervision authority. More details regarding the Law can be found in the November issue of our Newsletter.
Based on the provided clarifications, the Law does not extend to state market surveillance. State market surveillance activities include collecting samples of products, product testing, product recall or withdrawal, and warning the consumers about the revealed dangers of products.
Given these clarifications, the State Agency of Ukraine on Pharmaceuticals and Control of Narcotics stated that it will perform state market surveillance activities in relation to medical devices in accordance with its plans published on the official websites of its regional offices.