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Special-Control Medicines in Vietnam — Narcotic, Psychotropic, Precursor, Radioactive

Lifecycle regulation of narcotic, psychotropic, precursor and radioactive medicines under the parallel Pharmacy Law and Anti-Drug Law chains — Decree 163/2025/NĐ-CP and Circular 18/2026/TT-BYT (effective 16 July 2026) for the pharmacy side, Law 73/2021/QH14 and Decree 28/2026/NĐ-CP for the substance lists, and Law 94/2025/QH15 (Atomic Energy) with Decree 332/2025/NĐ-CP overlaying radioactive medicines.

Overview

In Vietnam, "thuốc kiểm soát đặc biệt" — special-control medicines — is the umbrella category for four classes of substances and their combination products that the Pharmacy Law isolates from the ordinary medicine regime: addictive substances (dược chất gây nghiện), psychotropic substances (dược chất hướng thần), precursors used in medicine manufacture (tiền chất dùng làm thuốc), and radioactive medicines (thuốc phóng xạ). The same substance may appear in two different registers — the Ministry of Health's pharmacy-side list and the Ministry of Public Security's anti-drug-side list — and is subject to handling rules that escalate sharply above the ordinary GCN đủ điều kiện kinh doanh dược regime described in the Medibase Distribution & Retail page.

Two parallel legal chains:

  • Pharmacy chain (Bộ Y tế) — Pharmacy Law 105/2016 + 44/2024 → Decree 163/2025/NĐ-CP → Circular 18/2026/TT-BYT. Sets the rules for how licensed pharmaceutical establishments handle these substances: manufacture, import, wholesale, retail dispensing, hospital and clinic use, storage, transportation, records and reporting.
  • Anti-drug chain (Bộ Công an) — Law on Drug Prevention and Control 73/2021/QH14 → Decree 28/2026/NĐ-CP (effective 19 January 2026). Fixes the national lists of narcotic substances (Schedules I, II, III) and precursors (Schedule IV — IVA, IVB, IVC), governs enforcement against illicit traffic, and sits below the Penal Code for criminal liability.
  • Radiation overlay (Bộ Khoa học và Công nghệ) — Atomic Energy Law 94/2025/QH15 (effective 1 January 2026, replacing Law 18/2008) + Decree 332/2025/NĐ-CP (replacing Decree 142/2020). Imposes radiation-safety obligations on every facility that stores, handles or transports radioactive medicines, in addition to the pharmacy rules.

See: Medibase News — Circular 18/2026/TT-BYT overhauls the rules for narcotic, psychotropic, precursor and radioactive medicines (https://medibase.vn/news/thong-tu-18-2026-tt-byt-thuoc-kiem-soat-dac-biet/) — for the day-of-issuance analysis.

International framework: Vietnam acceded to the three core UN drug-control conventions on 1 September 1997 by Presidential Decision No. 798/QĐ-CTN: the 1961 Single Convention on Narcotic Drugs (as amended by the 1972 Protocol), the 1971 Convention on Psychotropic Substances, and the 1988 Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances. Vietnamese scheduling broadly aligns with UN scheduling but is adapted to domestic medical practice: a substance placed on UN Schedule I will sit in Vietnamese Schedule I or II depending on whether any legitimate medical or scientific use is recognised within Vietnam. There is no formal one-to-one crosswalk; reclassification follows INCB and CND actions but is enacted domestically by Government decree.

Substance lists (Decree 28/2026/NĐ-CP, effective 19 January 2026):

  • Schedule I — 58 substances (subdivided IA / IB). Most stringent control; very limited medical use.
  • Schedule II — 476 substances (subdivided IIA / IIB). Strict control; defined medical use.
  • Schedule III — 81 substances. Lower-tier control.
  • Schedule IV (precursors) — IVA: 31; IVB: 30; IVC: 18. Chemicals used in or for the manufacture of narcotic and psychotropic substances.

From 1 June 2026 onwards: Etomidate and Carisoprodol are classified as psychotropic substances under Circular 18/2026/TT-BYT, with immediate effect on the day of signing and retroactive application to existing stocks.

Regulated activities and licensing: Every step of the lifecycle requires a base GCN đủ điều kiện kinh doanh dược matching the form of pharmacy business, plus the special-control overlay specific to the substance class. The lifecycle in scope of Circular 18/2026 covers manufacture and compounding; import and export; wholesale; retail; prescribing and dispensing in healthcare facilities; clinical-trial use; testing services; storage; transportation between facilities; destruction of expired, recalled or surplus stock; transfer between facilities. Each activity has its own dossier and reporting requirements set in Circular 18/2026 and Decree 163/2025/NĐ-CP.

Storage requirements (Circular 18/2026, Chapter II):

  • Addictive, psychotropic and precursor medicines must each be stored in a dedicated locked area, by substance class.
  • Mixed storage is permitted only with physical segregation and clear labelling.
  • Radioactive medicines must be stored in a separate secure area built to radiation-protection standards under Decree 332/2025/NĐ-CP.
  • Ward-level emergency drug cabinets in hospitals must include a dedicated locked compartment for special-control medicines.
  • Transport between facilities must use sealed containers with continuous chain-of-custody documentation.

Personnel qualifications (Circular 18/2026):

  • Addictive substances handled at hospitals — minimum associate-degree pharmacy training (dược sĩ trung học); pharmacy-technician level may be accepted at non-hospital establishments.
  • Psychotropic substances and precursors — minimum associate-degree pharmacy training.
  • Radioactive medicines — a healthcare worker with formal radiation-safety qualification under the Atomic Energy Law chain.

Records and reporting (Circular 18/2026, Chapter IV):

  • Electronic records are now equivalent to paper records, provided the system guarantees encryption and integrity in transit and at rest, electronic signatures (or equivalent authenticated approval), a complete audit log of modifications, and retrievability on demand by inspecting authorities. This is the single largest operational change introduced by Circular 18/2026 and underpins the broader healthcare-sector digitalisation.
  • Monthly intake / output / stock ledgers per substance class.
  • Annual report by 15 January for the prior calendar year.
  • Provincial-level (or equivalent regional health authority) aggregated report by 15 February.
  • Emergency reports of loss, theft, mix-up or suspected diversion within 48 hours of discovery.
  • Standardised forms in Circular 18/2026 Annexes VIII–XIX cover monthly ledgers, manufacturing batch records, warehouse release forms, retail customer registers, and patient drug-return receipts.

Penalties:

  • Administrative — Decree 117/2020/NĐ-CP "on administrative penalties in the healthcare field" as amended by Decree 124/2021/NĐ-CP. Sanctions range from warnings and fixed-amount fines to suspension of the GCN ĐĐKKDD and revocation of the CCHND of the responsible person.
  • Criminal — Penal Code 2015 (Law 100/2015/QH13, as amended by Law 12/2017/QH14), Chapter XX "Narcotic-related crimes", Articles 247–259. The most directly relevant provision for pharmaceutical establishments is Article 259 — violation of regulations on the management or use of addictive substances, psychotropic substances, precursors and radioactive medicines — which can attach personal criminal liability to the responsible person of a licensed facility on top of administrative sanctions on the establishment itself.
  • International — Vietnam reports annually to the International Narcotics Control Board (INCB) on production, consumption, stocks and trade of substances under the 1961 and 1971 Conventions.

Key documents

Pharmacy chain — primary law and decrees:

  • Pharmacy Law No. 105/2016/QH13, as amended by Law No. 44/2024/QH15 (effective 1 July 2025). The umbrella statute defining the special-control category.
  • Decree 163/2025/NĐ-CP — implementing decree, effective 1 July 2025. Sets the procedural framework for licensing, dossiers and inspection of special-control substance activities .
  • Circular 18/2026/TT-BYT — current pharmacy-side implementing circular. Signed 1 June 2026 by Deputy Minister Nguyễn Tri Thức; effective 16 July 2026; replaces Circular 20/2017/TT-BYT and 27/2024/TT-BYT. Five chapters, nineteen articles, Annexes I–XIX.
  • Predecessors (replaced 16 July 2026): Circular 20/2017/TT-BYT (10 May 2017) and Circular 27/2024/TT-BYT (1 November 2024). Consolidated as Văn bản hợp nhất 10/VBHN-BYT.

Anti-Drug Law chain — primary law and substance lists:

  • Law on Drug Prevention and Control No. 73/2021/QH14 — passed 30 March 2021, effective 1 January 2022. Substantive law on narcotic substances and the broader anti-drug regime.
  • Decree 28/2026/NĐ-CP — issued and effective 19 January 2026. Replaces Decree 57/2022/NĐ-CP and Decree 90/2024/NĐ-CP. Fixes the national lists: Schedule I narcotics (58 substances, IA/IB), Schedule II (476, IIA/IIB), Schedule III (81), Schedule IV precursors (IVA 31, IVB 30, IVC 18).

Atomic Energy chain — radioactive medicines overlay:

  • Law on Atomic Energy No. 94/2025/QH15 — passed 27 June 2025, effective 1 January 2026. Replaces Law 18/2008/QH12.
  • Decree 332/2025/NĐ-CP — issued 18 December 2025, implementing radiation-safety detail. Replaces Decree 142/2020/NĐ-CP.

International conventions (acceded by Vietnam, 1 September 1997 under Presidential Decision 798/QĐ-CTN):

  • Single Convention on Narcotic Drugs 1961 (as amended by the 1972 Protocol).
  • Convention on Psychotropic Substances 1971.
  • United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances 1988.

Penalties:

  • Decree 117/2020/NĐ-CP — administrative penalties in the healthcare field; as amended by Decree 124/2021/NĐ-CP.
  • Penal Code 2015 (Law 100/2015/QH13, as amended by Law 12/2017/QH14), Chapter XX, Articles 247–259 — narcotic-related crimes; Article 259 specifically targets violations of management or use of addictive substances, psychotropic substances, precursors and radioactive medicines.

Source documents

Direct links to the official text on government portals.

Pharmacy chain:

Anti-Drug Law chain:

Atomic Energy chain:

International conventions (UN Treaty Collection):

Penalties:

Medibase cross-reference:

Recent updates

27 June 2025 — National Assembly passes Law on Atomic Energy 94/2025/QH15, replacing Law 18/2008/QH12.

29 June 2025 — Government issues Decree 163/2025/NĐ-CP, the new umbrella implementing decree for the Pharmacy Law (effective 1 July 2025).

18 December 2025 — Government issues Decree 332/2025/NĐ-CP on radiation safety (replacing Decree 142/2020/NĐ-CP).

1 January 2026 — Law 94/2025/QH15 (Atomic Energy) and Decree 332/2025/NĐ-CP enter into force.

19 January 2026 — Decree 28/2026/NĐ-CP enters into force, replacing Decree 57/2022/NĐ-CP and Decree 90/2024/NĐ-CP. New consolidated lists: Schedule I 58 substances, Schedule II 476, Schedule III 81, Schedule IV precursors IVA 31 / IVB 30 / IVC 18.

1 June 2026 — Circular 18/2026/TT-BYT signed by Deputy Minister Nguyễn Tri Thức. Etomidate and Carisoprodol classified as psychotropic substances with immediate effect.

16 July 2026 — Circular 18/2026/TT-BYT fully enters into force, replacing Circular 20/2017/TT-BYT and Circular 27/2024/TT-BYT. Electronic records become equivalent to paper. New standardised reporting forms in Annexes VIII–XIX apply.

Resources & links

Operational portals:

  • Drug Administration of Vietnam (DAV) — https://dav.gov.vn — main agency site for special-control medicine regulation; circulars, decisions and notices.
  • DAV public services portal — https://dichvucong.dav.gov.vn — online submission of dossiers for activities involving special-control substances.
  • Vietnam Ministry of Public Security — https://bocongan.gov.vn — leads the Anti-Drug Law chain; sources for Schedule updates and enforcement guidance.
  • Vietnam Atomic Energy Agency (Cục An toàn bức xạ và Hạt nhân — VARANS) — https://varans.gov.vn — radiation-safety licensing for radioactive medicine establishments.

Legal text portals:

  • Cổng thông tin điện tử Chính phủ — văn bản pháp luật — https://vanban.chinhphu.vn — primary publisher of decrees and laws.
  • Công báo điện tử — https://congbao.chinhphu.vn — Official Gazette.
  • Thư viện pháp luật — https://thuvienphapluat.vn — searchable archive; working English translations available for selected instruments.
  • Cổng pháp luật quốc gia (Bộ Tư pháp) — https://vbpl.vn — official national legal database; Ministry of Health subset at https://vbpl.vn/boyte.

International oversight:

  • International Narcotics Control Board (INCB) — https://www.incb.org — annual reports of the global drug control system; Vietnam reports here.
  • United Nations Office on Drugs and Crime (UNODC) — https://www.unodc.org — Conventions, World Drug Report, and technical assistance for national authorities.
  • Commission on Narcotic Drugs (CND) — https://www.unodc.org/unodc/en/commissions/CND/ — the UN policy-making body that updates Schedule additions.

Medibase cross-links:

  • News — Circular 18/2026/TT-BYT (announcement and analysis) — /news/thong-tu-18-2026-tt-byt-thuoc-kiem-soat-dac-biet/
  • Reference — Distribution & Retail — /medicine/distribution-retail/
  • Reference — Drug Registration Process — /medicine/registration/

Frequently asked questions

Which categories of medicines are "kiểm soát đặc biệt"?

Four classes, plus combination products containing any of them: addictive substances (dược chất gây nghiện), psychotropic substances (dược chất hướng thần), precursors used in medicine manufacture (tiền chất dùng làm thuốc), and radioactive medicines (thuốc phóng xạ). The Pharmacy Law isolates these from the ordinary GCN ĐĐKKDD regime; Circular 18/2026/TT-BYT and Decree 163/2025/NĐ-CP set the operational rules.

What is the difference between the Pharmacy Law chain and the Anti-Drug Law chain?

The Pharmacy Law chain (under the Ministry of Health, through Decree 163/2025/NĐ-CP and Circular 18/2026/TT-BYT) governs how licensed pharmaceutical establishments handle special-control substances — manufacture, import, wholesale, retail, hospital use, storage, transportation, records and reporting. The Anti-Drug Law chain (under the Ministry of Public Security, through Law 73/2021/QH14 and Decree 28/2026/NĐ-CP) governs the national lists of narcotic substances and precursors and the enforcement against illicit traffic, sitting below the Penal Code for criminal liability. The two chains overlap on substance definitions but address different actors and harms.

What changed on 16 July 2026?

Circular 18/2026/TT-BYT entered fully into force, replacing Circular 20/2017/TT-BYT and the 2024 amending Circular 27/2024/TT-BYT. The most operationally significant change is the recognition of electronic records as equivalent to paper, provided the system guarantees encryption, integrity, electronic signature, complete audit log and on-demand retrievability. Storage segregation rules were tightened, personnel-qualification rules standardised by substance class, combination-product classification thresholds codified in Annexes IV–VI, and a unified reporting calendar (15 January / 15 February annual; 48-hour emergency) put in place. One earlier change took effect on 1 June 2026 — the reclassification of Etomidate and Carisoprodol as psychotropic substances.

How does the regime for radioactive medicines differ from other special-control medicines?

Radioactive medicines sit at the intersection of two regimes. The Pharmacy chain treats them as kiểm soát đặc biệt and applies the licensing, storage and reporting rules of Circular 18/2026/TT-BYT. The Atomic Energy chain (Law 94/2025/QH15 and Decree 332/2025/NĐ-CP, effective 1 January 2026) adds radiation-safety obligations on every facility that stores, handles or transports them — a dedicated radiation-protected zone, personnel with formal radiation-safety qualifications, and oversight by the Vietnam Atomic Energy Agency (VARANS). Both regimes apply concurrently.

What are the penalties for non-compliance?

Three layers. Administrative penalties under Decree 117/2020/NĐ-CP (as amended by Decree 124/2021/NĐ-CP) range from warnings and fixed-amount fines to suspension of the GCN ĐĐKKDD and revocation of the responsible person's CCHND. Criminal liability under the Penal Code 2015, Articles 247–259 — Article 259 specifically targets violations of management and use of addictive substances, psychotropic substances, precursors and radioactive medicines, and can attach personal liability to the responsible person on top of administrative sanctions on the establishment. International oversight: Vietnam reports annually to the INCB on production, consumption, stocks and trade of controlled substances under the 1961 and 1971 Conventions.

Page changelog

2026-06-28: Initial publication. Reflects amended Pharmacy Law 44/2024/QH15, Decree 163/2025/NĐ-CP, Circular 18/2026/TT-BYT (signed 1 June 2026, effective 16 July 2026), Law on Drug Prevention and Control 73/2021/QH14, Decree 28/2026/NĐ-CP (effective 19 January 2026), Atomic Energy Law 94/2025/QH15 and Decree 332/2025/NĐ-CP (effective 1 January 2026), and the 1961 / 1971 / 1988 UN drug-control conventions.

Effective from:
2026-07-16
Last reviewed:
2026-06-28
Page updated:
2026-06-28

Reference information only; not legal or medical advice.