Circular 18/2026/TT-BYT — Ministry of Health overhauls the rules for narcotic, psychotropic, precursor and radioactive medicines

On 1 June 2026 the Ministry of Health issued Circular 18/2026/TT-BYT, signed by Deputy Minister Nguyễn Tri Thức, detailing how the Pharmacy Law and Decree 163/2025/NĐ-CP are to be applied to drugs and pharmaceutical materials requiring special control (thuốc và nguyên liệu làm thuốc phải kiểm soát đặc biệt). The circular takes effect on 16 July 2026 and supersedes Thông tư 20/2017/TT-BYT and the 2024 amending Thông tư 27/2024/TT-BYT. One exception applies immediately: the reclassification of Etomidate and Carisoprodol as psychotropic substances enters into force on the date of signing, 1 June 2026.

What the circular covers

The circular consolidates, into a single instrument, the operational rules for the entire population of substances grouped under "kiểm soát đặc biệt" — addictive substances (dược chất gây nghiện), psychotropic substances (dược chất hướng thần), precursors used to manufacture medicines (tiền chất dùng làm thuốc), radioactive medicines (thuốc phóng xạ), and combination products containing any of the above. Each activity in the lifecycle is in scope: storage, production, formulation, distribution, prescribing and dispensing, use in clinical care, destruction, transfer between facilities, transportation, record-keeping and periodic reporting.

The instrument addresses every regulated actor in this chain: manufacturers and compounding pharmacies, importers and exporters, wholesalers, retail pharmacies, public and private hospitals and clinics, clinical-trial providers, drug-testing services and dedicated controlled-substance warehouses.

Structure — five chapters, nineteen articles

• Chapter I (Articles 1–2). General provisions, scope, and the consolidated lists (danh mục) of substances that fall under each control category.
• Chapter II (Articles 3–7). Storage, production, distribution, use, destruction, transfer and transportation, with reporting obligations.
• Chapter III (Article 8). Supply of radioactive medicines, recognising the radiation-safety overlay.
• Chapter IV (Articles 9–15). Records and documentation — by actor type (manufacturer, importer/exporter, wholesaler, retailer, non-commercial healthcare facility), the rules on electronic versus paper documents, and retention periods.
• Chapter V (Articles 16–19). Implementation, transitional rules and effective dates.

Six changes worth flagging

1. Etomidate and Carisoprodol reclassified as psychotropic substances. The reclassification takes effect on 1 June 2026 rather than 16 July 2026, with retroactive application to existing stocks. This is the only provision that activates on signing; every other provision waits for the standard effective date.

2. Electronic records placed on equal footing with paper. Facilities may keep, sign and submit the regulated registers and reports in electronic form provided the system guarantees encryption and integrity in transmission and at rest, electronic signatures or authenticated approvals, complete auditability of modifications, and retrievability on demand by inspecting authorities. This is the single largest operational change for hospitals and wholesalers, and it underwrites the Ministry's wider digitalisation push.

3. Personnel qualifications standardised by substance class. Staff handling addictive substances at hospitals must hold at least an associate degree in pharmacy (technician level may be accepted at non-hospital sites); psychotropic and precursor handling requires associate-degree pharmacy training; radioactive medicines require a healthcare worker with formal radiation-safety qualification.

4. Storage segregation rules tightened. Addictive, psychotropic and precursor medicines must each have their own locked, dedicated storage area; mixed storage is permitted only with physical segregation and clear labelling. Radioactive medicines require a separate secure area built to radiation-protection standards. Ward-level emergency cabinets must include a dedicated locked compartment for controlled drugs.

5. New classification rules for combination products. Annexes IV–VI define thresholds on the active-ingredient content above which a combination product is treated as the controlled substance itself, and below which it remains a regular product. This replaces the prior, looser allocation regime that had left edge cases to interpretation by provincial inspectors.

6. Reporting cadence codified. Annual reports are due by 15 January for the prior calendar year; provincial-level (or regional health authority) aggregated reports are due by 15 February; emergency reports of loss, theft, mix-up or suspected diversion are required within 48 hours of discovery. Standardised forms are provided in Annexes VIII–XIX, covering monthly intake/output/stock ledgers, manufacturing batch records, warehouse release forms, retail customer ledgers, and patient drug-return receipts.

Why now

The circular is the Pharmacy Law's downstream guidance for the controlled-substance chapter, and it sits directly below Decree 163/2025/NĐ-CP. The 2017 instrument had drifted out of step with the new statute and with day-to-day digital practice: many hospitals already use electronic medication-administration systems, but the prior regime required parallel paper signatures, generating administrative load without adding control. The Ministry's accompanying communications frame Circular 18 as both a tightening of substantive control (clearer lists, stricter storage and qualification rules) and an administrative simplification (electronic records authorised, paper duplication retired where systems comply).

What facilities should do now

• Inventory: re-tag any Etomidate or Carisoprodol stock as psychotropic from 1 June 2026 and adjust storage, signing and reporting accordingly.
• Records: assess current ledgers and decide whether to keep them paper, move to electronic, or run mixed. If moving to electronic, document the encryption, audit-log and electronic-signature controls — these are the inspection points.
• Storage layout: audit locked-area segregation against the new tighter rules ahead of 16 July 2026.
• Personnel: verify that staff handling each substance class meet the new minimum qualifications; close any gaps before the effective date.
• Reporting calendar: rebuild the annual / aggregate / 48-hour incident reporting workflow against the new templates in Annexes VIII–XIX.
• Combination products: re-run the active-ingredient threshold check using Annexes IV–VI for every multi-component formulation currently on the shelf.

Caveats and open items

The full signed text of Circular 18/2026/TT-BYT is published on thuvienphapluat.vn behind a paywall, with the unsigned PDF mirrored on Ministry-aligned association sites (notably VNPCA). The reading above is consolidated from luatvietnam.vn (article 436248), vnpca.org.vn and VietnamPlus reporting. Where the underlying Pharmacy Law or Decree 163/2025/NĐ-CP and the circular diverge in detail, the higher-ranking instrument prevails.

References

• Bộ Y tế — Thông tư 18/2026/TT-BYT (01/6/2026), signed Nguyễn Tri Thức. Quy định chi tiết Luật Dược và Nghị định 163/2025/NĐ-CP về thuốc và nguyên liệu làm thuốc phải kiểm soát đặc biệt.
• Quốc hội — Luật Dược (and 2024 amendments).
• Chính phủ — Nghị định 163/2025/NĐ-CP.
• Repealed: Thông tư 20/2017/TT-BYT; Thông tư 27/2024/TT-BYT.
• Open commentary: luatvietnam.vn article 436248; vnpca.org.vn; vietnamplus.vn.