Ukraine

The primary regulatory authority for health products in Ukraine is the State Expert Center (SEC) of the Ministry of Health of Ukraine, which operates under the framework of the Law of Ukraine on Medicinal Products (No. 123/96-VR) and related bylaws governing medical devices and diagnostics. The SEC is responsible for the scientific evaluation and registration of pharmaceuticals, medical devices, and in vitro diagnostics, while the Ministry of Health issues final marketing authorizations. The general approval process involves submission of a registration dossier, scientific review by the SEC, and issuance of a registration certificate, which is typically valid for five years and subject to renewal. Medical devices are additionally subject to conformity assessment procedures aligned with European frameworks, and digital health solutions are increasingly scrutinized under evolving national health IT regulations.

Key submission requirements include the appointment of a local legal representative or authorized representative established in Ukraine, who bears regulatory responsibility for the product on the Ukrainian market. Ukraine formally adopted the Common Technical Document (CTD) format for pharmaceutical submissions, aligning progressively with ICH guidelines and European standards as part of its EU Association Agreement obligations. Notable recent reforms include Ukraine's accelerated regulatory harmonization efforts with the European Union under the EU-Ukraine Association Agreement, the introduction of simplified registration pathways for products already approved by stringent regulatory authorities such as the EMA, FDA, or comparable bodies, and ongoing digitalization of the submission and review process through the SEC's electronic registry platforms. Wartime conditions since 2022 have prompted additional emergency authorization procedures to expedite access to critical health products.

Public procurement of health products in Ukraine is centrally coordinated through the Ministry of Health of Ukraine, which allocates national budget funds for essential medicines, vaccines, medical devices, and diagnostics. The central procurement function is primarily executed through the State Enterprise Medical Procurement of Ukraine (MPU), established to professionalize and streamline public health purchasing and reduce corruption risks. Tenders are conducted in accordance with the Law of Ukraine on Public Procurement (No. 922-VIII) and are published on the national electronic procurement platform ProZorro, which mandates open competitive bidding and full transparency of procurement records. In wartime conditions, emergency and simplified procurement procedures have been authorized to ensure continuity of supply for critical medical commodities, with increased central coordination between the Ministry of Health, regional health authorities, and civil-military administrations.

Ukraine has a substantial donor-funded procurement channel that plays a significant role in the health market, particularly since the onset of the full-scale conflict in 2022. International organizations including UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through its implementing partners, the World Health Organization, and the European Commission have provided substantial volumes of health commodities and technical assistance, effectively supplementing and in some cases substituting state procurement. Ukraine is also a recipient of support through the COVAX facility and various bilateral donor arrangements for vaccines and critical medicines. Local manufacturing preference policies exist in principle, with Ukrainian-manufactured products sometimes receiving preferential scoring in public tenders, and there are ongoing government initiatives to strengthen domestic pharmaceutical and medical device production capacity. However, the country remains heavily import-dependent for many advanced diagnostics, medical devices, and specialty pharmaceuticals, and donor agencies frequently procure internationally through established UN or third-party procurement mechanisms.