Compliance Tools — Medibase

Tender Simulator

Determine the technical group (1–5) for a medicine in public-hospital tenders under Circular 15/2019/TT-BYT (and subsequent amendments).

1
Is the drug a brand-name (biệt dược gốc) or reference bioequivalent?

Yes No
2
Where is the drug manufactured?
(only if Q1 = No)

SRA US, EU member states, Japan, Canada, Switzerland, UK, Australia, … Vietnam Local production Other India, China, Pakistan, …
3
Factory GMP standard?

EU-GMP / PIC/S-GMP EU inspectorate or PIC/S authority WHO-GMP Certified by Vietnam Ministry of Health
4
Bioequivalence proven in Vietnam?
(if WHO-GMP)

Yes No

Reset

Group quick-reference

1 Brand-name or SRA + EU/PIC/S-GMP
2 Vietnam + EU/PIC/S-GMP
3 Imported WHO-GMP + BE proven
4 Vietnam WHO-GMP + BE proven
5 WHO-GMP, no BE

Circular 15/2019/TT-BYT (Article 6) — foundational 5-group framework. Currently in force: Circular 40/2025/TT-BYT (effective 25 October 2025), which preserves the same group criteria with refined wording and mid-contract drug-substitution rules.
See the tendering guide for the full framework.

SRA reference list (40)

Countries commonly recognised by Vietnam MOH as "SRA" (reference country) for the Group-1 origin criterion in drug bidding. Combines the WHO-defined SRA list (ICH members and observers before 23 October 2015) with EU-GMP / PIC/S-GMP equivalents cited in MOH announcements.

EU European Union EMA
JP Japan PMDA
US United States US-FDA
AT Austria BASG
BE Belgium FAMHP
BG Bulgaria BDA
HR Croatia HALMED
CY Cyprus CyPHA
CZ Czech Republic SUKL
DK Denmark DKMA
EE Estonia SAM
FI Finland Fimea
FR France ANSM
DE Germany BfArM
GR Greece EOF
HU Hungary OGYÉI
IE Ireland HPRA
IT Italy AIFA
LV Latvia ZVA
LT Lithuania VVKT
LU Luxembourg MS-LU
MT Malta MAH
NL Netherlands MEB/CBG
PL Poland URPL
PT Portugal INFARMED
RO Romania ANMDMR
SK Slovakia ŠÚKL
SI Slovenia JAZMP
ES Spain AEMPS
SE Sweden MPA
CA Canada Health Canada
CH Switzerland Swissmedic
IS Iceland IMA
LI Liechtenstein AGES
NO Norway NoMA
AU Australia TGA
NZ New Zealand Medsafe
GB United Kingdom MHRA
KR Republic of Korea MFDS
SG Singapore HSA

Expiry & Renewal Calculator

Compute when a Vietnamese registration / notification expires, the latest legal renewal-submission date, and when to start preparing the dossier.

1
Type of registration?

Drug — marketing authorisation Cosmetic — notification number Supplement (TPCN) — self-declaration Supplement (TPCN) — conformity declaration Food — self-declaration Food — conformity declaration Medical device — Class A (declared standard) Medical device — Class B / C / D (số lưu hành)
2
Issue date (or last renewal date)

Enter the issue date printed on the marketing authorisation / notification number / số lưu hành.

Reset

Validity quick-reference

5y Drug — new: before expiry (≥3mo = auto-extension) / old: 12mo before expiry
5y Cosmetic — renewal is a new filing
5y MedDev B/C/D — NĐ 07/2023 auto-extension
No fixed TPCN & Food — NĐ 15/2018 in force (NĐ 46/2026 indefinitely suspended by NQ 15/2026)
A MedDev A — declared standard, no fixed period

See the per-product-kind registration-process pages for the full procedure and citations.

Regulatory pivots

2025-07-01: Law 44/2024/QH15 effective: drug renewal window 12mo → 3mo, automatic extension added.
2026-04-06: NQ 15/2026 extends suspension of NĐ 46/2026 indefinitely — NĐ 15/2018 continues to apply until the revised Food Safety Law and its implementing decree take effect.
TBD: Revised Food Safety Law (expected September 2026 UBTVQH session, NQ 119/2026) — once in force may re-activate NĐ 46 (or successor) transition milestones and the HACCP deadline.

Check compliance with Vietnamese regulation

Ingredient Screener

Tender Simulator

Is the drug a brand-name (biệt dược gốc) or reference bioequivalent?

Where is the drug manufactured?

Factory GMP standard?

Bioequivalence proven in Vietnam?

Expiry & Renewal Calculator

Type of registration?

Issue date (or last renewal date)