Pharmacovigilance in Ukraine in 2026: MAH Requirements

Updated 15 July 2026. Ukraine’s national pharmacovigilance system is based on the Pharmacovigilance Procedure approved by Ministry of Health Order No. 898 of 27 December 2006, as amended. The State Expert Center of the Ministry of Health of Ukraine (SEC) performs the principal expert and methodological functions.

For an applicant or marketing authorisation holder (MAH), compliance requires an operational pharmacovigilance system, a master file, responsible persons, case-processing procedures and continuous benefit-risk monitoring.

Authority and legal framework

• The Ministry of Health of Ukraine takes regulatory decisions.
• The State Expert Center collects and evaluates safety information, assesses regulatory materials and oversees the functioning of pharmacovigilance systems.
• Ministry of Health Order No. 898, in its current version, defines adverse-reaction and lack-of-efficacy reporting and the responsibilities of system participants.
• Ministry of Health Order No. 426 governs the assessment of marketing-authorisation dossiers and variations, including safety materials.

Ukraine uses European GVP structure and terminology in many areas, but EU rules should not be treated as automatically and directly applicable in Ukraine. MAHs should follow national legislation and official SEC guidance.

Core MAH obligations

Pharmacovigilance system and PSMF

The system is described in the Pharmacovigilance System Master File (PSMF). Under the SEC structure, it includes information on the qualified person, organisation, safety-data sources, computerised systems, pharmacovigilance processes, system performance and quality management. Delegating activities to a vendor does not remove the MAH’s ultimate responsibility.

Qualified and local contact persons

The system should identify a qualified person responsible for pharmacovigilance and, where applicable, a contact person in Ukraine. Authority, data access, current contact details, back-up arrangements and rapid safety escalation should be documented.

Individual safety reports

Processes should cover intake, validation, medical review, follow-up, duplicate detection and submission of reports on adverse reactions and/or lack of efficacy within applicable timelines. Case category, country of occurrence, seriousness, expectedness and medical confirmation affect the reporting route.

The SEC provides separate notification forms for patients or their representatives and for healthcare and pharmacy professionals. Patients can submit an electronic report through the Automated Pharmacovigilance Information System without registering an account.

Literature and regulatory monitoring

Monitoring frequency must support timely detection and reporting of new safety information. A universal weekly frequency should not be claimed for every product without a specific regulatory and procedural basis. Sources, languages, search strategy, screening criteria and quality control should be documented.

Periodic reports, RMPs and signals

MAHs should manage periodic safety-reporting schedules, maintain the Risk Management Plan, assess signals and evaluate risk-minimisation measures. New safety information should be reflected promptly in the marketing-authorisation dossier and product information when required.

Business continuity in emergency conditions

The quality system should provide alternative communication channels, remote access, staff back-up, database protection, deadline control and partner oversight during infrastructure disruption. Changing operating conditions do not remove the MAH’s responsibility for the safety of authorised medicines.

MAH readiness checklist

1. Confirm that the PSMF, SOPs and product list are current.
2. Verify responsible-person contacts and back-up coverage.
3. Reconcile cases with distributors and vendors.
4. Review ICSR and periodic-report deadlines.
5. Update RMPs, signals and risk-minimisation measures.
6. Review training, deviations, CAPA and audit trails.
7. Test business-continuity and data-backup arrangements.

Conclusion

Pharmacovigilance in Ukraine in 2026 requires an operational system rather than a formal document set: a current PSMF, accessible responsible persons, timely reports, signal and risk management, and resilient processes.

PharmExpert supports MAHs with local pharmacovigilance in Ukraine, including PSMF maintenance, local contacts, case processing, literature and regulatory monitoring, periodic reports, RMPs, signal management, audits and inspection preparation.

Official sources

1. SEC pharmacovigilance section.
2. Ukraine Pharmacovigilance Procedure.
3. SEC requirements for the pharmacovigilance system and PSMF.
4. SEC patient adverse-reaction reporting guidance.
5. SEC applicant reporting guidance.

This article provides general information only. Before taking regulatory action, verify the current legislation and product-specific requirements.