The Ministry of Environmental Protection and Natural Resources of Ukraine has published a standardized application form for the preliminary state registration (pre-registration) of a chemical substance, under paragraphs 140–146 of the Technical Regulation on the Safety of Chemical Products, approved by Resolution of the Cabinet of Ministers of Ukraine No. 847 dated July 23, 2024 […]

Please note that significant changes in the regulation of medicinal products in Ukraine have taken place in recent months, including: The establishment of the National Price Catalogue and the introduction of mandatory price declaration, The imposition of limits on wholesale and retail mark-ups on medicinal products, Restrictions on advertising and marketing agreements, and the requirement […]

As Ukraine transitions to MDR and IVDR, the government aims to use European electronic systems rather than developing its own. This approach seems reasonable, but is it feasible? One of the key innovations of MDR and IVDR is the Unique Device Identification (UDI) system and the EUDAMED electronic database. In Ukraine, the regulation of medical […]

Dear colleagues, Please pay attention that on January 18, 2025, Law of Ukraine No. 3910-IX, which prohibits advertising information on the labeling of medicinal products, will come into effect. The Law bans the inclusion of any advertising information on the packaging of medicinal products, as well as information about other legal or physical entities that […]

Previously, we informed you about the prohibition of advertising information on the labeling of medicinal products established by the Law of Ukraine No. 3910-IX “On amendments to the Law of Ukraine ‘On medicinal products’ regarding the labeling of medicinal products” (hereinafter referred to as “Law No. 3910”), which comes into force on January 18, 2025. […]

In recent months, several legislative acts have been adopted that significantly affect the regulation of medicinal products, specifically: A ban on advertising information on the labeling and information about persons other than the Manufacturer and MAH (marketing authorization holder), which comes into effect on January 18, 2025; Parallel import of medicines purchased by an authority […]

For more than four years, there were no market surveillance inspections concerning medical devices in Ukraine. Due to the COVID-19 pandemic, a ban on planned state market surveillance measures had been in place since March 2020, and in March 2022, a moratorium was introduced under Cabinet of Ministers Resolution No. 303 “On Suspension of State […]

By the Order of the Ministry of Health of Ukraine dated July 19, 2024, No. 1264, amendments to the Procedure for notification (submission) of information on cosmetic products (hereinafter referred to as the Procedure), approved by the Ministry of Health of Ukraine on December 18, 2023, No. 2147, were approved. The Procedure defines the mechanism […]

By the Resolution of the Cabinet of Ministers of Ukraine No. 847 dated July 23, 2024, the “Technical Regulation on the Safety of Chemical Products” was approved, which will come into effect on January 26, 2025. The regulation is based on Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH). […]