Vaccine / biological registration
Vaccine and Biological Product Registration Dossier
- EN
- Vaccine and Biological Product Registration Dossier
- VI
- Hồ sơ đăng ký vaccine và sinh phẩm
- JA
- ワクチン・生物製剤登録ドシエ
Medicine
https://dichvucong.dav.gov.vn
Description
The vaccine-and-biological registration dossier under Circular 12/2025/TT-BYT. Includes the modular CMC quality data, nonclinical and clinical data, plus a mandatory Risk Management Plan (RMP). For vaccines, SRA / WHO PQ reliance is available within 5 years of the first SRA approval, but the in-Vietnam NICVB lot release remains mandatory. From 1 October 2026, Circular 32/2026/TT-BYT replaces Circular 12/2025; vaccines and biologicals remain in scope of the successor framework.
Legal basis
Circular 12/2025/TT-BYT. To be replaced by Circular 32/2026/TT-BYT from 1 October 2026 (vaccines and biologicals remain in scope) — see /regulations/#tt-32-2026 and /news/thong-tu-32-2026-tt-byt-dang-ky-luu-hanh-thuoc/ Pharmacy Law 105/2016/QH13 + Law 44/2024/QH15.
- Issuing authority
- DAV (registration); NICVB (lot release)
- Format
- PDF + Word
- Last reviewed:
- 2026-06-28
- Page updated:
- 2026-08-16