We would like to remind you that on 27 March 2025, a new law on dietary supplements was adopted (Law of Ukraine No. 4122-IX “On Amendments to Certain Laws of Ukraine Aimed at Improving the Regulation of the Manufacture and Circulation of Dietary Supplements and Addressing Other Issues in the Healthcare Sector”). The law entered […]

On 1 December, the Ministry of Health announced the launch of the notification portal for cosmetic products (the electronic system for notification of information on cosmetic products) and demonstrated its operation and functionality. The notification portal is required for submitting a notification prior to placing cosmetic products on the market, provided that they comply with […]

We are pleased to share that Cratia, in its role as regulatory-affairs partner and authorised representative, has contributed to a significant milestone in Ukraine’s medical-device market. A key international MedTech company has today announced regulatory approval for its AI-powered trauma-imaging solution in Ukraine — a major step forward in improving diagnostic care and strengthening our […]

We remind you that 31 December 2025 is the deadline for submitting applications for bringing national marketing authorisations into compliance with the requirements of the EAEU. On 22 May 2025, by Decision of the Council of the Eurasian Economic Commission No. 34, amendments were introduced to the Rules for Registration and Expert Examination of Medicinal […]

It is expected that in the near future amendments will be introduced to the Technical Regulations on the Classification, Labelling and Packaging of Chemical Products (UA CLP) and the Technical Regulation on the Safety of Chemical Products (UA REACH). The draft Resolution of the Cabinet of Ministers of Ukraine has been submitted to the central […]

We would like to draw your attention to important changes regarding price declaration for medicinal products and the transition to the eCTD format: 1. Price Declaration for Medicinal Products in the National Price Catalogue Please note that price declaration for medicinal products has been introduced by Law of Ukraine No. 4239 dated February 12, 2025, […]

In March 2025, Cratia, in collaboration with the “Apteka” Weekly, held an analytical webinar focused on the regulation of dietary supplements. The event aimed to highlight key trends in law enforcement, raise awareness among market operators, and promote compliance with legislative requirements. Cratia donated all proceeds from the event to UNITED24 as a charitable contribution […]

Despite the devastation of war, Ukraine is implementing sweeping pharmaceutical, medical device, and chemical safety reforms aimed at approximating its legislation and practices with EU standards.  When Russia launched its full-scale invasion in 2022, Ukraine’s healthcare infrastructure and supply chains came under immediate threat. Hospitals were destroyed, logistics disrupted, and critical shortages of medicines and […]

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 […]