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Medicine
Pharmacovigilance obligations of drug manufacturers in Vietnam — what changes under Luật 44/2024 and Circular 12/2025
From 1 July 2025, the amended Pharmacy Law (Luật 44/2024/QH15) and the new drug-registration circular (Thông tư 12/2025/TT-BYT) took effect together, reshaping the operational duties of marketing-authorisation holders, manufacturers, importers and distributors. The 2021 National Pharmacovigilance Guideline (Quyết định 122/QĐ-BYT) survives as the technical backbone. A synthesis of the consolidated Pharmacy Law (VBHN 39/VBHN-VPQH / 76/VBHN-VPQH), DAV guidance, and industry analysis from LuatVietnam, ThuVienPhapLuat, the canhgiacduoc.org.vn DI&ADR portal, Lexology and Dione.