[Blog] Ukraine’s Potential Path to a National Medicines Verification System by 2028
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Ukraine’s Potential Path to a National Medicines Verification System by 2028
Ukraine has taken a decisive step toward aligning its pharmaceutical supply chain with European Union standards. On 26 September 2024, the Cabinet of Ministers of Ukraine approved the creation of a national medicines verification system with 2D coding.
The move is designed to ensure patient safety, prevent counterfeit medicines, and prepare Ukraine for closer integration with the EU market.
Why It Matters
Counterfeit medicines remain a serious risk for patients and healthcare systems. With the adoption of serialization and 2D coding, Ukraine is following the same model as the EU Falsified Medicines Directive (FMD) and Delegated Regulation (DR).
Deputy Minister of Health of Ukraine for Digital Development, Maria Karchevych, noted that 2D coding is the global standard for detecting falsified medicines and preventing their future distribution.
How the System Will Work
- Serialization: Manufacturers must mark each medicine pack with a 2D DataMatrix code containing a unique identifier and an anti-tampering device.
- Verification at every stage: Distributors and pharmacies will scan codes throughout the supply chain.
- Deactivation at dispensing: When the medicine is given to a patient, the code will be scanned and deactivated in the national system.
- Alerts in case of fraud: If the scanned code does not match the national database, the medicine will be flagged and withheld from distribution.
This mirrors the end-to-end verification model used in the EU and ensures interoperability with the European Medicines Verification System (EMVS).
Implementation Timeline
- 2024: Government approves Decree No. 1121 (pending enforcement).
- January 1, 2026: System available on a voluntary basis.
- January 1, 2028: Compliance becomes mandatory for all stakeholders.
This phased approach allows manufacturers, CMOs, distributors, and pharmacies to adapt IT systems, upgrade packaging lines, and train staff.
Key Challenges Ahead
- NMVO creation: Establishment of a Ukrainian National Medicines Verification Organization.
- Secure IT infrastructure: Ensuring data protection and interoperability with the EU Hub.
- Industry readiness: Adoption of GS1 DataMatrix coding and compliance with ISO 21976:2020 standards.
What This Means for Pharma Companies
For pharmaceutical manufacturers, CMOs, wholesalers, and distributors, Ukraine’s transition means:
- Implementation/Upgrading packaging lines with serialization hardware & software (Serialization Services).
- Preparing IT systems for integration with the Ukrainian NMVO (Cloud Services).
- Aligning operations with EU FMD standards to ensure compliance and market access.
Companies already compliant with EU FMD will adapt more quickly and cost-effectively to the Ukrainian system.
SoftGroup’s Perspective
At SoftGroup, we view Ukraine’s adoption of a medicines verification system as a milestone for regional pharma compliance.
With more than 22 years of expertise in serialization, aggregation, and regulatory integration, we support:
- Manufacturers and CMOs preparing packaging lines for 2D coding.
- Distributors and wholesalers connecting to national verification systems.
- Global pharma companies ensuring interoperability with both Ukrainian and EU systems.
Our SATT PLATFORM, built on Microsoft Azure, is validated for multiple global markets and designed to manage complex compliance challenges while providing real-time visibility and security across the supply chain.
Frequently Asked Questions (FAQ)
When will Ukraine’s medicines verification system become mandatory?
The system launches on a voluntary basis on January 1, 2026 and becomes mandatory on January 1, 2028.
What is the role of the Ukrainian NMVO?
The National Medicines Verification Organization (NMVO) will operate the centralized database, manage verification, and ensure interoperability with the EMVS.
How will medicines be verified?
Every pack will have a 2D DataMatrix code. Pharmacies and distributors will scan it, and the code will be deactivated upon dispensing. If there is a mismatch, the medicine will be flagged and not released.
What does this mean for pharmaceutical companies?
- Serialization upgrades to packaging lines.
- Compliance with GS1 and ISO standards.
- IT system integration with the NMVO.
- Early testing and piloting before 2026.
Conclusion
Ukraine’s journey toward a medicines verification system marks a decisive step in strengthening pharmaceutical safety and aligning with EU standards.
With the voluntary phase beginning in 2026 and full compliance in 2028, now is the time for pharmaceutical companies to plan, invest, and adapt.
Contact SoftGroup to learn how we can help your organization get ready for Ukraine’s medicines verification system.