Pharmacovigilance in Belarus in 2026: MAH Requirements

Pharmacovigilance in Belarus in 2026: Requirements for Marketing Authorisation Holders

Updated 15 July 2026. Belarus is a member of the Eurasian Economic Union (EAEU). Marketing authorisation holders (MAHs) must therefore operate their pharmacovigilance systems in line with the EAEU Good Pharmacovigilance Practice Rules, together with applicable national procedures of the Ministry of Health of the Republic of Belarus and authorised bodies.

Regulatory framework

• EEC Council Decision No. 87 of 3 November 2016 approved the EAEU Good Pharmacovigilance Practice Rules.
• EEC Council Decision No. 81 of 19 May 2022 amended the EAEU GVP Rules.
• The common pharmaceutical inspection rules were supplemented in 2024 by EEC Council Decision No. 83 with provisions for pharmacovigilance system inspections.
• Belarusian national procedures apply to interaction with competent authorities, circulation of medicinal products and communication of safety information.

Core MAH obligations

• maintain an effective pharmacovigilance system and quality system;
• appoint a qualified person responsible for pharmacovigilance and ensure continuous availability;
• maintain an accurate pharmacovigilance system master file (PSMF);
• collect, validate, follow up and submit individual case safety reports (ICSRs);
• perform medical literature monitoring, signal management and benefit–risk evaluation;
• prepare periodic safety reports (PSUR/PBRER) and risk management plans (RMPs) where required;
• document safety-data exchange responsibilities in partner agreements;
• provide staff training, internal audits and continuous inspection readiness.

Practical compliance checklist

1. Confirm that global and local processes reflect the current EAEU GVP requirements.
2. Verify responsible-person contacts, escalation routes and business-continuity arrangements.
3. Reconcile the PSMF and standard operating procedures with actual practice.
4. Review safety-data exchange timelines with distributors, medical representatives and other partners.
5. Document signal assessments, corrective actions and the effectiveness of risk-minimisation measures.
6. Maintain evidence of training, quality control and closure of identified deficiencies.

Pharmacovigilance inspections

Inspectors may assess both documentation and the real performance of the system, including case-database completeness, decision traceability, partner agreements, consistency between the PSMF and operational practice, and implementation of corrective and preventive actions. MAHs should maintain inspection readiness continuously.

Official sources

• EEC: acts governing medicinal products
• EEC: common rules for pharmacovigilance system inspections

How PharmExpert can help

PharmExpert supports MAHs operating in Belarus and the EAEU with pharmacovigilance system audits, PSMF and SOP preparation, local safety-data collection, training and inspection readiness.

This article is for general information. Regulatory decisions should be based on the current EAEU legislation and official guidance from the competent authorities of the Republic of Belarus.