Vietnam

Pharmacovigilance in Viet Nam is overseen by the Drug Administration of Vietnam (DAV) with the National Drug Information and Adverse Drug Reactions Monitoring Centre. The National Pharmacovigilance Guideline issued under Decision No. 122/QĐ-BYT requires pharmaceutical businesses and marketing authorisation holders to organise pharmacovigilance activities, assign trained personnel, maintain procedures and records, collect safety information and cooperate with national and regional centres. The public guideline does not describe the responsible person as an EU-style QPPV or establish a separate EU-format PSMF. The MAH should verify current DAV and national-centre directions for ICSR routes and timelines, periodic safety reporting, product-specific RMPs, signal management, risk-minimisation actions, audits and inspections. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection; Effective Signal Management in Pharmacovigilance.