Drugs and active substances on the list of substances banned from use in certain sectors
Goods in List 5 of 09/2024/TT-BYT: Banned from USE in other sectors, not from import: an establishment approved for specially controlled drugs applies to the Drug Administration for an import licence, 15 days. 118 goods lines, transcribed verbatim from the appendix with their HS codes. Receiving authority: Drug Administration of Vietnam — Ministry of Health. 09/2024/TT-BYT has been in force since 2024-07-26.
Promulgating the lists of drugs, drug materials for human use and cosmetics for export and import with HS codes assigned under Vietnam’s export-import nomenclature. Issued by Ministry of Health, in force from 2024-07-26.
Banned from USE in other sectors, not from import: an establishment approved for specially controlled drugs applies to the Drug Administration for an import licence, 15 days.
✓Banned from use in other sectors, NOT banned from import
The list’s name reads like an import ban. It is not. Under Article 29.2 of Decree 163/2025/ND-CP, other ministries issue lists of substances banned from use in their own sector and send them to the Ministry of Health, which “reviews those that are drugs or active substances” in order to control them tightly within the pharmaceutical sector — the ban attaches to USING the substance in another sector, not to importing it. Decree 163/2025/ND-CP itself lays down the import licensing procedure for this group in Articles 65 and 66, and Article 2.2 and 2.21 of Circular 39/2025/TT-BYT assign the licensing to the Drug Administration. The import-ban list is a different one — Appendix V to Decree 163/2025/ND-CP; cross-checking the 78 substances of Decision 3235/QD-BYT against it yields exactly one overlap.
✕The single exception: gatifloxacin
Gatifloxacin is the ONLY substance that sits both on this list (Decision 3235/QD-BYT item 31; List 5 Table I item 24 and Table II item 24) and on Appendix V to Decree 163/2025/ND-CP — the “list of drugs and drug materials banned from import and manufacture” — at item 80. Appendix V reads verbatim: “Gatifloxacin (except eye drops and materials for manufacturing eye drops)”. So gatifloxacin eye drops and materials for manufacturing eye drops remain importable under licence; every other form is banned from import. The other 77 substances on the list do not appear in Appendix V.
–Imported under pharmaceutical law, no chemical declaration is required
Every code in Table I sits in Chapter 29 (and partly Chapter 28), so at first glance it falls into the pre-clearance chemical declaration of Article 6 of Decree 26/2026/ND-CP. But Article 82.7 of Decree 163/2025/ND-CP is explicit: “Drug materials imported under the Law on Pharmacy and this Decree are not required to carry out the chemical declaration procedure”. The condition lives in the words “under the Law on Pharmacy and this Decree” — the exemption attaches to importing for medicinal use under pharmaceutical law, not to the HS code. A shipment under the same code imported for another purpose still owes the chemical declaration before clearance.
HS code list
118 lines of List 5, transcribed verbatim
Grouped by tariff chapter. An 8-digit code applies to that code alone; a line covering a whole heading is marked separately. A line with no code is a heading row of the appendix — this page does not assign codes. Select a code to open the full HS lookup.
The one thing to read correctly: this is a list of substances banned from USE in certain sectors — NOT a list of goods banned from IMPORT. Article 29.2 of Decree 163/2025/ND-CP sets out the mechanism: other ministries (Agriculture and Environment, Industry and Trade, Construction…) issue lists of substances banned from use in their own sector and send them to the Ministry of Health, which then “reviews those that are drugs or active substances in order to issue the list of drugs and active substances on the list of substances banned from use in certain sectors”. The ban attaches to USING the substance in another sector; in the pharmaceutical sector, Decree 163/2025/ND-CP itself lays down the import LICENSING procedure for this group (Article 65 for drugs, Article 66 for active substances). The import-ban list is a DIFFERENT list: Appendix V to Decree 163/2025/ND-CP, invoked by Article 82.13. Cross-checking the 78 substances of Decision 3235/QD-BYT (the source list behind List 5, still in force under Article 17.2 of Circular 18/2026/TT-BYT) against Appendix V yields EXACTLY ONE substance on both — gatifloxacin, and Appendix V adds “except eye drops and materials for manufacturing eye drops”. Three further things decide a shipment. (1) 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. (2) SPECIAL-CONTROL STATUS: this group falls under Article 2.26(d) of the Law on Pharmacy, so it does 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. (3) 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”.
What being absent from this list does not mean
This appendix is one of many specialised-management lists. Goods absent from it may still fall under another ministry's list, or be controlled on other conditions. This page does not replace a full check before filing.
Validity & transition
Validity milestones for this list
2024-07-26
09/2024/TT-BYT takes effect
The list starts to apply on this date.
Responsible authorityDrug Administration of Vietnam — Ministry of Health · Customs authority at the place of import
FAQ
Frequently asked questions about List 5 09/2024/TT-BYT
Which goods does List 5 of 09/2024/TT-BYT cover?
List 5 — drugs and active substances for export and import that appear on the list of substances banned from use in certain sectors, with assigned HS codes. It comprises TWO tables totalling 118 numbered items: Table I “active substance name”, 59 lines, codes in headings 2903–2941; Table II “drug name”, 59 lines, codes in heading 3004. The two tables list almost the same substances — ciprofloxacin, levofloxacin, moxifloxacin, metronidazole, vancomycin, colchicine, chloramphenicol, salbutamol, nandrolone… — one as material, one as finished product. Table II carries 42 continuation lines where a single item splits its codes by dosage form (“oral or ointment form” and “other forms”); the table below folds those back into the item they belong to. This is limb (d) of the definition of “drugs and drug materials subject to special control” in Article 2.26 of the Law on Pharmacy 105/2016/QH13. 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.
How do I tell whether my goods fall in List 5 of 09/2024/TT-BYT?
The one thing to read correctly: this is a list of substances banned from USE in certain sectors — NOT a list of goods banned from IMPORT. Article 29.2 of Decree 163/2025/ND-CP sets out the mechanism: other ministries (Agriculture and Environment, Industry and Trade, Construction…) issue lists of substances banned from use in their own sector and send them to the Ministry of Health, which then “reviews those that are drugs or active substances in order to issue the list of drugs and active substances on the list of substances banned from use in certain sectors”. The ban attaches to USING the substance in another sector; in the pharmaceutical sector, Decree 163/2025/ND-CP itself lays down the import LICENSING procedure for this group (Article 65 for drugs, Article 66 for active substances). The import-ban list is a DIFFERENT list: Appendix V to Decree 163/2025/ND-CP, invoked by Article 82.13. Cross-checking the 78 substances of Decision 3235/QD-BYT (the source list behind List 5, still in force under Article 17.2 of Circular 18/2026/TT-BYT) against Appendix V yields EXACTLY ONE substance on both — gatifloxacin, and Appendix V adds “except eye drops and materials for manufacturing eye drops”. Three further things decide a shipment. (1) 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. (2) SPECIAL-CONTROL STATUS: this group falls under Article 2.26(d) of the Law on Pharmacy, so it does 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. (3) 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”.
What does import licence involve?
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. This list has two tables and therefore two dossier branches, and Circular 39/2025/TT-BYT delegates BOTH to the Drug Administration. For ACTIVE SUBSTANCES (Table I): the import licence for specially controlled drug materials, administrative procedure code 1.014071, delegated by Article 2.2 — which names “active substances on the list of drugs and active substances banned from use in certain sectors”; contents per Article 66.1 of Decree 163/2025/ND-CP (the import order on Form 35, 36 or 41 of Appendix III; the quality standard and test method; the manufacturing licence or GMP certificate for materials, consularised; a use report on Form 37 and a business-results report on Form 38; the production, use and business plan with an explanation where the request exceeds 150% of actual demand in the preceding reporting period). For DRUGS holding a marketing authorisation (Table II): administrative procedure code 1.014079, delegated by Article 2.21 — which names “drugs on the list of drugs and active substances banned from use in certain sectors”; contents per Article 65 of Decree 163/2025/ND-CP (one original import order on Form 33 or three originals on Form 34; a business-results report on Form 18; a written explanation with supporting evidence where the 150% threshold is exceeded, or a projected business plan for a first-time import). 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. 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. Gatifloxacin alone must also be checked against Appendix V to Decree 163/2025/ND-CP (the list of drugs banned from import and manufacture), where it appears as item 80 with the words “except eye drops and materials for manufacturing eye drops”. — Customs authority at the place of import
When did 09/2024/TT-BYT take effect, and has it been amended?
Effective from 2024-07-26. Data on this page reviewed 2026-08-16.
Send us the HS code and the goods description — we will check it against the list
The Avenir declaration team checks codes against the real document set and replies within the working day.
This page summarises and quotes List 5 of 09/2024/TT-BYT, reviewed 2026-08-16. The HS table is transcribed verbatim from the appendix — not normalised, and no codes are inferred. This is not legal advice: for a specific consignment, check against the original text and the view of the customs office handling it.