Ukraine

The primary regulatory authority for health products in Ukraine is the State Expert Centre (SEC) of the Ministry of Health of Ukraine, which operates under the framework established by the Law of Ukraine 'On Medicinal Products' (No. 123/96-VR) and subsequent amendments, as well as Cabinet of Ministers resolutions governing registration and market authorization procedures. The SEC is responsible for scientific evaluation, registration, and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and increasingly digital health solutions. Medical devices are additionally subject to technical regulation under Resolution No. 753 (2013), which aligns with EU directives on active implantable medical devices, general medical devices, and in-vitro diagnostics. The general approval process requires submission of a registration dossier to the SEC, scientific review, laboratory testing where applicable, and issuance of a registration certificate valid for five years.

Ukraine has progressively aligned its regulatory framework with European Union standards, particularly following the EU-Ukraine Association Agreement (2014) and ongoing Euro-integration commitments. Dossier submissions generally follow the Common Technical Document (CTD) format for pharmaceuticals, and EU-aligned technical files for medical devices. Applicants are required to appoint a local representative or registration holder with a legal presence in Ukraine. A simplified or accelerated registration pathway exists for products already approved by stringent regulatory authorities such as the EMA, US FDA, Health Canada, or TGA Australia, significantly reducing timelines for qualifying products. Since 2022, wartime legislation has introduced emergency authorization mechanisms allowing expedited access to critical health products, and Ukraine has intensified cooperation with the European Medicines Agency as part of its EU candidacy process, signaling further harmonization reforms in the near term.

Public procurement of health products in Ukraine is primarily coordinated through the Ministry of Health of Ukraine (MOZ), which sets national health policy, defines essential medicines and device lists, and allocates state budget funds for centralized procurement programs. The central procurement function is executed through ProZorro, Ukraine's transparent electronic public procurement platform, which is mandatory for all public tenders and has been recognized internationally for its anti-corruption design. The MOZ publishes annual procurement plans covering pharmaceuticals, vaccines, medical devices, and diagnostics, with contracts awarded through open competitive tenders on ProZorro. Regional and municipal health authorities (oblasts and hromadas) may conduct decentralized procurement for locally funded needs, creating a two-tier system of central and regional purchasing. The State Enterprise 'Medical Procurement of Ukraine' (Derzhavne Pidpryiemstvo 'Medychni Zakupivli Ukrainy') was established specifically to professionalize and centralize high-value procurement, particularly for medicines and supplies funded through the National Health Service of Ukraine (NHSU), which manages the capitation-based reimbursement system introduced under the 2017-2018 healthcare reform.

Ukraine has a well-established network of international donor-funded procurement channels that play a significant role in the health market, particularly for essential medicines, vaccines, diagnostics, and emergency medical supplies. Key partners include UNICEF, which manages procurement of vaccines and maternal and child health commodities; the Global Fund to Fight AIDS, Tuberculosis and Malaria, which funds antiretroviral, anti-tuberculosis, and HIV diagnostic procurement; USAID and its implementing partners, who support health system strengthening and supply chain interventions; and WHO, which provides technical and logistical support. Since the full-scale Russian invasion in February 2022, international donor contributions have expanded substantially, with the EU, UK, and G7 nations channeling emergency health commodity support through these mechanisms. Ukraine does not currently enforce formal local manufacturing preference policies in public tenders; however, domestic manufacturers may benefit from pricing advantages and strategic partnerships encouraged under national industrial policy. Ongoing Euro-integration efforts are expected to further open the procurement landscape to EU-compliant suppliers while raising quality and regulatory standards across the board.