In a comprehensive new article,Maksym Bagrieiev, CEO of the regulatory consultancy Cratia, examines how Russia's full-scale war against Ukraine inadvertently triggered one of the most significant healthcare and regulatory overhauls in Eastern Europe. Titled “How War Accelerated Ukraine's Integration Into the European Health and Regulatory Space”, the article outlines how Ukraine used the wartime crisis as a strategic opportunity to align its legislation with European Union norms-across pharmaceuticals, medical devices, cosmetics, and chemical safety.
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The full article is available at: https://cratia.ua/en/how-war-accelerated-ukraines-integration-into-the-european-health-and-regulatory-space
“The war didn't delay Ukraine's convergence with the EU-it accelerated it,” says Bagrieiev. “Even under missile strikes, our institutions prepared for full harmonization with the European regulatory model.”
WAR AS A CATALYST FOR STRUCTURAL REFORM
Following the February 2022 invasion, Ukraine's healthcare system was pushed to the brink. More than 1,900 medical facilities were damaged or destroyed. Traditional supply chains collapsed, triggering immediate shortages of medicines, devices, and supplies.
In response, Ukraine introduced temporary regulatory relief:
— Emergency importation of unregistered medicines and devices,
— Waivers for GMP documentation and import rules,
— Suspension of compliance deadlines,
— Authorization for non-standard pharmaceutical transport,
— Relaxation of quality control checks and registration formalities.
Meanwhile, the Ministry of Health coordinated delivery of over 12,800 tons of humanitarian medical aid-valued at more than 350 million USD from 35 countries and partners.
STRATEGIC ROLLBACK & STRUCTURAL ALIGNMENT
As stability returned, Ukraine began reversing wartime exemptions and building a permanent, EU-compatible regulatory system:
— Emergency import waivers were discontinued,
— GMP and GxP compliance reinstated,
— Expedited registration routes phased out,
— Full adoption of EU regulatory formats initiated.
This transition was not a return to old norms-but a leap forward. With Ukraine's EU candidate status (2022) and accession track (2024), the government fast-tracked legal approximation across several critical sectors.
PHARMACEUTICAL REFORM: A LANDMARK EU-BASED LAW
The centerpiece of this transformation is the new Law “On Medicinal Products”, which came into force in 2023 and is based on EU Directive 2001/83/EC. The law regulates:
— Marketing authorization,
— Manufacturing and importation,
— Pharmacovigilance and post-market surveillance,
— Advertising and market control.
Key reforms include:
— Establishment of a centralized regulatory authority (mirroring EU agencies),
— Mandatory use of eCTD format by August 2025 for new applications,
— Introduction of GS1 DataMatrix serialization and anti-tampering by 2028,
— Residency requirements for MA holders (EU, EFTA, or Ukraine),
— Streamlined recognition of EU origin medicines (no re-testing upon import).
In addition, Ukraine introduced reference pricing mechanisms to control medicine costs:
— Distributors limited to 8% markup,
— Pharmacies subject to a 10-35% regressive scale,
— Generics capped at 75% of originator prices,
— All products linked to average pricing in three EU reference countries.
MEDICAL DEVICES: TOWARD MDR AND IVDR COMPLIANCE
Although Ukraine currently applies directives 93/42/EEC, 98/79/EC, and 90/385/EEC (adopted in 2013), the government is preparing to adopt full alignment with EU Regulation 2017/745 (MDR) and 2017/746 (IVDR) by 2025.
Key features of the transition include:
— 10-year transitional period for manufacturers and authorities,
— Simplified recognition of EU-issued certificates, including legacy directives and MDR/IVDR,
— Continued legal validity of existing Ukrainian conformity until full MDR/IVDR implementation.
Ukraine also prioritized rehabilitation and prosthetics, allocating 6.7 billion UAH (~160 million USD) in 2024. Notable facilities include:
— Superhumans Center, supported by Howard G. Buffett, Mastercard, and Virgin,
— Unbroken, backed by Germany, Japan, South Korea, and UNDP.
These centers offer world-class prosthetics, trauma care, and psychological rehabilitation.
COSMETICS AND CHEMICALS: MODERN EU-BASED FRAMEWORKS
Ukraine adopted a new Technical Regulation on Cosmetic Products in August 2024, based on EU Regulation 1223/2009. The law enforces:
— Mandatory safety reports (CPSR) and local safety assessors,
— Designation of a Responsible Person (RP) based in Ukraine,
— Compilation of Product Information Files (PIF),
— Electronic notification via the Health Ministry's portal,
— A 2-year transition period ending August 2026.
In January 2025, Ukraine also implemented a Chemical Safety Regulation modeled on EU REACH (1907/2006). It requires:
— Pre-registration of all chemical substances by January 2026,
— 5-year transitional periods (shorter for CMRs and high-volume substances),
— Application to both standalone substances and embedded chemicals,
— Industry accountability for traceability and toxicological safety.
Business groups have raised concerns about the short timelines, and regulatory bodies are developing detailed guidance.
CRATIA: LEADING THROUGH CHANGE
As one of the region's foremost regulatory consulting firms, Cratia plays a pivotal role in helping manufacturers navigate these changes. Founded in Ukraine, Cratia operates in 11 countries, with offices in Ukraine, Kazakhstan, and Uzbekistan. It serves over 1,000 clients across medicines, medical devices, cosmetics, chemicals, and biocidal products, offering:
— Product market authorization,
— GMP compliance,
— Local representation services,
— Pharmacovigilance and post-marketing compliance,
— Graphic and legal documentation support.
“Our role is to be a partner in transformation,” says Bagrieiev. “We help international companies meet new standards and ensure their products stay on the Ukrainian market-today and in the future European framework.”
ABOUT MAKSYM BAGRIEIEV
Maksym Bagrieiev is CEO of Cratia, a regulatory consulting firm specializing in registration of medicinal products, medical devices, cosmetics, chemicals, and biocidal products across the CIS region. He is Chair of the Medical Devices Working Group at the American Chamber of Commerce in Ukraine.
For more information, interviews, or full article access:
Website:www.cratia.ua/en
LinkedIn: https://www.linkedin.com/in/maksym-bagrieiev-659062121/
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