October 14, 2026, from 11:00 AM to 2:00 PM, Online. Duration: approx. 2.5 hours, plus Q&A session. Effective January 1, 2027, the main provisions of Ukraine’s new Law “On Medicines” come into force, making the transition to digital mandatory for all regulatory procedures: new registration, re-registration, indefinite registration renewal, and variations. This not only alters […]
News
eCTD Training in Ukraine, Online. Theoretical and Practical Parts, Q&A Session
Ukraine has approved new Technical Regulations on medical devices and in vitro diagnostic medical devices based on the MDR and IVDR
On 10 June 2026, the Cabinet of Ministers of Ukraine approved: the Technical regulation on medical devices (Resolution of the Cabinet of Ministers of Ukraine No. 759), developed based on Regulation (EU) 2017/745 (MDR); the Technical regulation on in vitro diagnostic medical devices (Resolution of the Cabinet of Ministers of Ukraine No. 758), developed based […]
Transitional Period Under the Technical Regulation on Cosmetic Products Extended
Resolution No. 976 of the Cabinet of Ministers of Ukraine, dated 29 July 2026, has extended the transitional period under the Technical Regulation on Cosmetic Products from 3 August 2026 until 31 July 2027. This means that the making available on the market of cosmetic products placed on the market by 31 July 2027 may […]
Ukraine Pharma Reform 2027: The New Law on Medicinal Products
On 2 July 2026, Cratia and CMS Ukraine held a joint webinar, “Ukraine Pharma Reform 2027: What International Pharma Companies Must Do Now”. Maksym Bagrieiev, Managing Partner of Cratia, and Borys Danevych, Partner, Global Co-Head and CEE Head of Life Sciences & Healthcare at CMS, reviewed the legal and practical changes affecting pharmaceutical companies supplying […]
Amendments to the Technical Regulation on Cosmetic Products
Resolution of the Cabinet of Ministers of Ukraine No. 737 dated 4 June 2026 introduced amendments to the Technical Regulation on Cosmetic Products, in particular: a final deadline has been set for making available on the market cosmetic products that were placed on the market before 3 August 2026 and do not comply with the […]
Cancellation of automatic renewals and change in validity periods of marketing authorisations for certain medicinal products
On 1 June, Resolution of the Cabinet of Ministers of Ukraine No. 377 entered into force. The Resolution abolishes the automatic extension of the validity period of marketing authorisations during martial law and provides for the extension of the validity period of marketing authorisations issued under the emergency registration and authenticity procedures for procurement by […]
Maksym Bagrieiev Spoke at a Medical Procurements of Ukraine Webinar on Medical Device Safety and Incident Reporting
On 6 May, Medical Procurement of Ukraine held a webinar dedicated to ensuring the quality and safety of medical devices after their procurement and transfer to healthcare institutions. The event was supported by the USAID project “Safe, Affordable and Effective Medicines for Ukrainians”, SAFEMed, and brought together representatives of Medical Procurement of Ukraine, the State […]
Regulatory Workshop on Cosmetic Products: practical review of the new Regulation following the launch of the notification portal
On March 13, 2026, Cratia will hold a Regulatory Workshop on Cosmetic Products as part of the international exhibition Pro Beauty Expo in Kyiv. The transitional period for the Technical Regulation on cosmetic products is approaching its end – starting from August 3, 2026, all cosmetic products placed on the Ukrainian market must fully comply […]
Dietary supplements: notification and other requirements of the new Law
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 […]