Pharmacovigilance Requirements Brief Overview

Uzbekistan

Pharmacovigilance in Uzbekistan is regulated by the Center for Pharmaceutical Products Safety under the Ministry of Health. Since 15 April 2026, Ministerial Order No. 18, registered as No. 3752, requires manufacturers and registration-certificate holders to appoint a responsible pharmacovigilance person with higher medical or pharmaceutical education and an appropriate qualification certificate. The Order requires a responsible person for activities in Uzbekistan but does not expressly state that the person must reside in the country; changes must be notified within 30 days. Before implementation, the MAH should verify the current official text and product conditions for the pharmacovigilance system file, ICSR reporting route and timelines, periodic safety reports, RMPs, signal management, quality-system audits and inspections rather than importing EU requirements. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection; Effective Signal Management in Pharmacovigilance.

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