Toxic drugs and toxic drug materials

List 1 — toxic drugs and toxic drug materials for export and import, with assigned HS codes. It is the largest list in the cluster: TWO tables totalling 219 numbered items. Table I “material name”, 111 lines — toxic drug materials, codes across Chapters 28, 29 and 30; Table II “drug name”, 108 lines — toxic drugs, all codes in heading 3004. The content is largely oncology drugs plus anaesthetics, muscle relaxants and immunosuppressants: cisplatin, carboplatin, oxaliplatin, doxorubicin, methotrexate, paclitaxel, docetaxel, cyclophosphamide, propofol, thiopental, bupivacaine, tacrolimus, sirolimus… Table I is alphabetical; Table II is NOT, and the table below preserves the source order. This is limb (c) of the definition of “drugs and drug materials subject to special control” in Article 2.26 of the Law on Pharmacy 105/2016/QH13, where the Law tasks the Minister of Health with issuing the list. The circular only assigns HS codes as a declaration basis — the obligation sits in the Law on Pharmacy (as amended by Law 44/2024/QH15) and Decree 163/2025/ND-CP.

Four things decide. (1) THE RECEIVING AUTHORITY IS NOT ALWAYS THE DRUG ADMINISTRATION — this exception is specific to List 1. Circular 39/2025/TT-BYT delegates to the Drug Administration but carves out two limbs in its own words: Article 2.2 says “toxic drug materials except toxic medicinal herbs”, and Article 2.21 says “toxic drugs except toxic traditional medicines”. Toxic medicinal herbs and toxic traditional medicines go through the Administration of Traditional Medicine and Pharmacy — Ministry of Health (Article 3.7 and 3.23 of the same circular). Whether the shipment is a chemical drug or a traditional medicine, an active substance or a medicinal herb, decides where the dossier is filed. (2) INTENDED USE, not the HS code alone — Article 3.3 of the circular: these goods “beyond medicinal use may also be used for various other purposes”; used as drugs or drug materials they follow pharmaceutical law, used otherwise they follow the relevant other law. Article 1.2 also excludes excipients, capsule shells and goods not used for medicinal purposes from the circular’s scope. (3) SPECIAL-CONTROL STATUS: toxic drugs and toxic drug materials fall under Article 2.26(c) of the Law on Pharmacy, so they do not benefit from the licence waivers in Article 60.1 of the Law or Article 82.1–82.2 of Decree 163/2025/ND-CP — both expressly carve out specially controlled goods. In return, the dossier for the “toxic” group is LIGHTER than for the other special-control groups: Article 65.2 waives the business-results report “except toxic drugs”, Article 66.1(d) and (dd) waive the use report, the business-results report and the plan for “toxic drug materials”, and point (e) additionally waives the quality standard and the manufacturing licence. (4) ONLY WHEN imported under pharmaceutical law is the shipment free of the chemical declaration — Article 82.7 of Decree 163/2025/ND-CP: “Drug materials imported under the Law on Pharmacy and this Decree are not required to carry out the chemical declaration procedure”; the same HS code imported for another purpose still requires a chemical declaration under Article 6 of Decree 26/2026/ND-CP, which covers the whole of Chapters 28 and 29. Circular 28/2026/TT-BYT places this group in Appendix I — high risk level, with the management requirement stated verbatim as “Grant of marketing authorisation and/or import licence”.

1. A condition that comes BEFORE any dossier: an establishment trading in specially controlled drugs must obtain written approval from the competent pharmaceutical authority under Article 34.1 of the Law on Pharmacy — meeting the Article 33 conditions and having security measures against loss. The procedure is Article 37 of Decree 163/2025/ND-CP (filing an additional security-measures statement on Form 11 of Appendix II); an establishment that already holds the certificate follows the amendment procedure in Article 22. There is NO separate “certificate of eligibility to trade in specially controlled drugs” — it is a line recorded on the pharmacy business eligibility certificate itself. — Drug Administration of Vietnam — Ministry of Health 2. The route for chemical drugs and for toxic drug materials that are active substances — that is, most of the list. For TOXIC DRUG MATERIALS (Table I): administrative procedure code 1.014071, delegated by Article 2.2 of Circular 39/2025/TT-BYT for “toxic drug materials except toxic medicinal herbs”; contents per Article 66.1 of Decree 163/2025/ND-CP but with much SUBTRACTED: point (d) waives the use report on Form 37 and the business-results report on Form 38, point (dd) waives the production, use and business plan, and point (e) waives both the copy of the quality standard and test method and the certified copy of the manufacturing licence or GMP certificate for materials — leaving in practice the import order on Form 35, 36 or 41 of Appendix III. For TOXIC DRUGS holding a marketing authorisation (Table II): administrative procedure code 1.014079, delegated by Article 2.21 for “toxic drugs except toxic traditional medicines”; contents per Article 65 of Decree 163/2025/ND-CP are one original import order on Form 33 or three originals on Form 34, while Article 65.2 waives the business-results report “except toxic drugs” and Article 65.3 likewise applies its 150% explanation threshold to “specially controlled drugs except toxic drugs”. Both branches: one dossier, filed in person, by post or online; the time limit is 15 days from the date on the receipt slip (Article 67.3); where amendments are requested, the authority also has 15 days to reply and the establishment has 6 months to file the supplement, after which the dossier lapses. — Drug Administration of Vietnam — Ministry of Health 3. A SEPARATE branch for the two limbs carved out of the Drug Administration’s delegation. Article 2.2 of Circular 39/2025/TT-BYT gives the Drug Administration “toxic drug materials EXCEPT TOXIC MEDICINAL HERBS” and Article 2.21 gives it “toxic drugs EXCEPT TOXIC TRADITIONAL MEDICINES”; the carved-out limbs go to the Administration of Traditional Medicine and Pharmacy under Article 3.7 and 3.23 of the same circular, under the same procedure codes 1.014071 and 1.014079. In other words: toxic medicinal herbs and toxic traditional medicines within List 1 still need an import licence, still follow the dossiers in Articles 65 and 66 of Decree 163/2025/ND-CP and still take 15 days, but are filed with A DIFFERENT ADMINISTRATION. The split matches Article 5 of Circular 09/2024/TT-BYT itself, where the Drug Administration covers Lists 1–10 and 14 while the Administration of Traditional Medicine and Pharmacy covers Lists 11, 12 and 13 (medicinal herbs, herbal extracts and essential oils, traditional medicines). — Administration of Traditional Medicine and Pharmacy — Ministry of Health 4. At clearance, file under Article 83.2 of Decree 163/2025/ND-CP: the importer’s pharmacy business eligibility certificate (original, certified copy or copy bearing the importer’s stamp), the import licence for specially controlled drugs, the test certificate for each batch, and the letter of authorisation or sales licence or partnership certificate. Import may not exceed the quantity stated in the licence — Article 60.4 of the Law on Pharmacy. — Customs authority at the place of import

Effective from 2024-07-26. Data on this page reviewed 2026-08-16.