Ukraine

The primary regulatory authority for health products in Ukraine is the State Expert Centre (SEC) of the Ministry of Health of Ukraine, operating under the framework established by the Law of Ukraine 'On Medicinal Products' (No. 123/96-VR) and subsequent amendments, as well as separate legislation governing medical devices and diagnostics. The SEC is responsible for scientific evaluation, registration, and post-market surveillance of pharmaceuticals, medical devices, in vitro diagnostics, and increasingly digital health solutions. Marketing authorisation is required prior to placing any health product on the Ukrainian market, and applications are processed through the SEC's centralised review mechanism, with the Ministry of Health issuing the final registration certificate.

Ukraine has progressively aligned its regulatory framework with European Union standards, particularly following the implementation of the Association Agreement with the EU. Submissions for pharmaceuticals are accepted in Common Technical Document (CTD) format, and Ukraine recognises registration decisions from stringent regulatory authorities including the European Medicines Agency (EMA), the US FDA, and other ICH member agencies, enabling an abbreviated or expedited registration pathway for already-approved products. Local representation is mandatory: applicants must designate a Ukrainian-based regulatory representative or marketing authorisation holder. For medical devices, Ukraine has been transitioning toward EU MDR and IVDR-aligned requirements. Wartime conditions since 2022 have prompted emergency legislative measures, including simplified import and registration procedures for critical health products, temporary authorisations, and expanded use of WHO prequalification as a basis for accelerated approval.

Public procurement of health products in Ukraine is coordinated primarily by the Ministry of Health of Ukraine, which plans and funds the national medicine and medical device procurement programmes through the State Budget. The centralised procurement function was significantly reformed following the establishment of the State Enterprise 'Medical Procurement of Ukraine' (MPU, or Derzhavne Pidpryiemstvo 'Medychni Zakupivli Ukrainy'), which conducts centralised tenders for essential medicines, vaccines, medical devices, and diagnostics on behalf of the state. All public procurement transactions are governed by the Law of Ukraine 'On Public Procurement' (No. 922-VIII) and conducted through the electronic procurement system ProZorro, which mandates transparency and open competition. Regional and municipal health authorities may conduct decentralised procurement for locally funded needs, but national priority programmes are managed centrally through the MPU.

Ukraine has a substantial donor-funded procurement channel, particularly for essential medicines and health commodities addressing HIV/AIDS, tuberculosis, malaria, and reproductive health. Key partners include the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNICEF Supply Division, USAID and its implementing partners, as well as WHO and various bilateral donors. These agencies frequently procure directly using their own procurement rules, often bypassing domestic registration requirements under emergency or humanitarian provisions. Since 2022, international humanitarian and defence-related health procurement has expanded considerably, with NATO member states, the European Commission, and multilateral organisations supplying health products under expedited frameworks. Ukraine does not currently impose extensive formal local manufacturing preference policies in public tenders, though national strategies promote domestic pharmaceutical industry development, and locally manufactured products may benefit from certain pricing advantages in specific tender categories.