News

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). […]

On August 3, 2024, the Technical Regulation on Cosmetic Products (hereinafter referred to as the Regulation), approved by the Resolution of the Cabinet of Ministers of Ukraine No. 65 dated January 20, 2021 (hereinafter referred to as CMU Resolution No. 65), came into force. This is a regulatory legal act whose requirements are mandatory for […]

On July 19 and 20, 2024, the Cabinet of Ministers of the Republic of Azerbaijan adopted Resolutions No. 345 (introduction of state registration of medical devices and in-vitro diagnostic devices, new rules for the registration of medicines) and No. 347 (amendments to the procedure for the examination of medicines, medical devices, and in-vitro diagnostic devices). […]

By Order of the Ministry of Health of Ukraine No. 1247 dated July 17, 2024, the methodological recommendations for the application of the Technical Regulation on cosmetic products concerning borderline groups of cosmetic products have been approved. The Technical Regulation defines a cosmetic product as “any substance or mixture intended for application to various external […]

Dear сolleagues, In this digest, you will find the most important news on the registration, pharmacovigilance and quality control of medicines in Armenia, Azerbaijan, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, Ukraine, Uzbekistan, and the Eurasian Economic Union (EAEU) which came into effect at the end of 2023 and the first half of 2024. In brief: […]