Ukraine

Ukraine regulates pharmaceutical products through a two-tier structure: the Ministry of Health of Ukraine (MOZ) is the lead authority and issues marketing authorisations (registratsiyni svidotstva), with scientific assessment performed by the State Expert Center of MOZ (Derzhavnyi Ekspertnyi Tsentr — SEC, in English known as 'State Expert Center of the Ministry of Health'); and the State Service of Ukraine on Medicines and Drugs Control (Derzhavna sluzhba z likarskykh zasobiv ta kontrolyu za narkotykamy — Derzhlikslyzhba, SSUMD), responsible for licensing of pharmaceutical activity, GMP/GDP inspection, post-market quality control, controlled substances and pharmacovigilance support. The framework is set by the Law of Ukraine 'On Medicinal Products' (Law No. 2469-IX, adopted 2022, in force from 2024 alongside the EU-aligned implementation period) replacing the prior 1996 Law, and supporting MOZ orders. Ukraine is a candidate EU Member State (status granted June 2022) and has comprehensively aligned its pharmaceutical legislation with the EU acquis (Directives 2001/83/EC, 2001/20/EC, Regulation 726/2004 and the EU Clinical Trials Regulation). Ukraine has been a PIC/S member since 2011 and the SSUMD GMP Inspectorate is internationally recognised; SEC is an active observer to ICH and EMA committees. Marketing authorisation procedures include the National Procedure, an Abridged Procedure based on SRA (US FDA, EMA, MHRA, Health Canada, TGA, PMDA, Swissmedic) or WHO Prequalification approval, and dedicated Wartime / Emergency Procedures introduced in 2022. Public-sector access runs through (i) the National Health Service of Ukraine (NSZU) which administers the Programme of Medical Guarantees (PMG, since 2018) and the Affordable Medicines (Dostupni Liky) reimbursement programme covering selected outpatient medicines for cardiovascular disease, type 2 diabetes, asthma and other priorities; (ii) MOZ centralised procurement (since 2015 via international procurement agencies — UNICEF, UNDP, Crown Agents — for HIV, TB, oncology, vaccines and rare diseases); and (iii) regional and local budgets. The pharmaceutical market and supply chain have shown remarkable resilience during the full-scale Russian invasion since February 2022, with continued imports, domestic manufacturing and humanitarian supply support from EU, US and global donors.