Regulatory calendar

Effective dates & transitional milestones

A chronological view of recent and upcoming Vietnamese regulatory milestones across pharma, cosmetic, food and medical practice. Each milestone shows the governing document, affected product kinds and a link to a Medibase deep-dive article when one exists.

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All Drug Cosmetic Supplement Food Medical device Practice Tender Treaty

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All Upcoming Past

2024

2 milestones

2024-01-01

915 days ago

Pivot

Law Luật 15/2023/QH15

Law on Medical Examination & Treatment in force

Replaces the 2009 law; introduces a 5-year CCHN KCB validity, a CME mandate, and establishes the Hội đồng Y khoa Quốc gia (National Medical Council) as the body that will run the future licensing exam.

Practice

2024-11-21

590 days ago

Law Luật 44/2024/QH15

Pharmacy Law amendment passed

National Assembly passes the Pharmacy Law amendment (amends Luật Dược 105/2016); takes effect 1 July 2025.

Drug

2025

8 milestones

2025-01-01

549 days ago

Mechanism Nghị định 96/2023/NĐ-CP

Three-tier medical facility system in force

Cấp ban đầu / cấp cơ bản / cấp chuyên sâu replaces the legacy four-tier scheme; reshapes referral pathways and BHYT entitlement.

Practice

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2025-07-01

368 days ago

Pivot

Law Luật 44/2024/QH15

Pharmacy Law amendment effective

Automatic-extension safety net for in-flight renewals, explicit reference-dossier pathway for SRA-approved products, 3-month renewal window (down from 12), dedicated innovative-drug pathway.

Drug

2025-07-01

368 days ago

Decree NĐ 163/2025/NĐ-CP

Decree implementing the amended Pharmacy Law in force

Implements Law 44/2024: special-control drug classification, storage / production / distribution rules, FIE notification regime (Art. 91 §12).

Drug

2025-07-01

368 days ago

Circular TT 31/2025/TT-BYT

Drug-registration procedure circular

Operational circular for Luật Dược Chapter IV — dossier modules, timelines, expert-council process.

Drug

2025-07-01

368 days ago

Circular TT 28/2025/TT-BYT

GMP for drug manufacturing — refreshed

Replaces Circular 35/2018/TT-BYT with an updated GMP framework aligned to PIC/S developments.

Drug

2025-07-01

368 days ago

Circular TT 11/2025/TT-BYT

Good Pharmacy Practice — consolidated text

Consolidated GPP text integrated with the electronic drug-records requirement.

Drug

2025-10-25

252 days ago

Circular TT 40/2025/TT-BYT

Public-hospital drug procurement — refreshed

Refines the 5-group tender framework first set by TT 15/2019/TT-BYT; updates mid-contract drug-substitution rules; signed and effective same day.

Drug Tender

2025-12-31

185 days ago

Treaty Hague Apostille Convention 1961

Vietnam deposits accession to the Hague Apostille Convention

Vietnam deposits the instrument of accession to the 1961 Hague Apostille Convention; replaces consular legalisation for most public documents from foreign signatories — major simplification for FSC / CPP / GMP packs.

Medical device Drug Treaty

2026

8 milestones

2026-01-01

184 days ago

Law Luật 112/2025/QH15

Terminology law for the medical-practitioner exam

Terminology update preparing the legal framework for the National Medical Licensing Examination (NMLE) pilot.

Practice

2026-01-26

159 days ago

Pivot

Decree NĐ 46/2026/NĐ-CP

Food-safety decree signed and originally effective

Signed and originally effective for 9 days before being suspended on 2026-02-04 (see next entry). Would have replaced NĐ 15/2018/NĐ-CP — self-declaration → conformity registration, packaging brought in-scope, HACCP / GMP / ISO 22000 mandate by 31 Dec 2026 — but none of those obligations are currently operating. NĐ 15/2018 continues to apply.

Food Supplement

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2026-02-04

150 days ago

Resolution NQ 09/2026/NQ-CP

NQ 09/2026 suspends NĐ 46/2026 (initially until 15 April 2026)

Resolution 09/2026/NQ-CP suspends Decree 46 (and Resolution 66.13/2026/NQ-CP on product declaration) following the customs-clearance crisis. NĐ 15/2018 continues to apply. The 75-day window was subsequently extended indefinitely by NQ 15/2026 — see the 6 April 2026 entry.

Food Supplement

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2026-02-27

127 days ago

Circular TT 50/2025/TT-BYT

Clinical-trial application procedure refreshed

Replaces Circular 50/2018; tightens timelines and aligns with ICH expectations for first-in-human and reference-product trials.

Drug

2026-04-06

89 days ago

Pivot

Resolution NQ 15/2026/NQ-CP

NQ 15/2026 extends suspension of NĐ 46/2026 indefinitely

Resolution 15/2026/NQ-CP extends the suspension of Decree 46/2026 (and Resolution 66.13/2026/NQ-CP) until the revised Food Safety Law and its implementing decrees take effect. NĐ 15/2018 continues to apply; dossiers filed before this resolution are handled per NĐ 15/2018. The revised Food Safety Law is expected at the September 2026 UBTVQH session (Resolution 119/2026/UBTVQH15).

Food Supplement

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2026-04-29

66 days ago

Resolution NQ 21/2026/NQ-CP

Food-advertising approval delegated to provinces

Delegates food-advertising approval authority from the central VFA to provincial UBND; takes operational effect 1 July 2026.

Food Supplement

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2026-06-01

33 days ago

Circular TT 18/2026/TT-BYT

Special-control medicines circular signed

Implementing circular for the special-control medicines regime. Etomidate and Carisoprodol reclassified as psychotropic effective immediately on signature; other provisions wait for 16 July 2026.

Drug

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2026-07-01

3 days ago

Pivot

Resolution NQ 21/2026/NQ-CP

Practice-licensing & advertising authority moves to provinces

CCHN KCB issuance moves from MOH to the provincial People's Committee Chairperson; food-advertising approval operationally devolves to provinces; partial BHYT cover begins for select cross-tier outpatient services.

Practice

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