Ukraine

Pharmacovigilance in Ukraine is regulated by the Ministry of Health and administered by the State Expert Center (SEC) under national pharmacovigilance legislation. The MAH must establish a PV system, appoint a qualified person responsible for pharmacovigilance, maintain the required pharmacovigilance system master documentation, report ICSRs and comply with PSUR/PBRER, RMP, signal-management and inspection obligations. If the QPPV does not reside in Ukraine, a single Ukrainian contact person responsible for pharmacovigilance is required under the national procedure. The SEC expressly publishes Annex 11: Structure of the applicant's pharmacovigilance system master file, and its official guidance states that the applicant's pharmacovigilance-system description must be included in the master file. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.