Drug materials that are drug precursors

List 4 — drug materials for export and import that are drug precursors, with assigned HS codes: 8 numbered items (4 columns: no., material name, dosage form, HS code). All 8 lines read “all forms” and all carry codes in heading 2939 — ephedrine, pseudoephedrine and their N-alkyl derivatives, ergometrine, ergotamine. This is one limb 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 — it imposes no obligation itself; the obligation sits in the Law on Pharmacy (as amended by Law 44/2024/QH15) and Decree 163/2025/ND-CP. Article 1.2 excludes excipients, capsule shells and goods not used for medicinal purposes.

Three things decide whether a shipment takes this route. (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: drug precursors fall under Article 2.26(b) of the Law on Pharmacy, so they do not benefit from the licence waivers in Article 60.1 of the Law and Article 82.1–82.2 of Decree 163/2025/ND-CP — both expressly carve out “drug materials subject to special control”. (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. 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. File one dossier for an import licence for specially controlled drug materials (administrative procedure code 1.014071, delegated to the Drug Administration by Article 2.2 of Circular 39/2025/TT-BYT) in person, by post or online. Contents per Article 66.1 of Decree 163/2025/ND-CP: the import order on Form 35, 36 or 41 of Appendix III; a copy of the manufacturer’s quality standard and test method; a certified copy of the manufacturing licence or GMP certificate for materials issued by the foreign authority, consularised; a use report on Form 37 and a business-results report on Form 38; the production, use and business plan, plus a written explanation where the requested quantity exceeds 150% of actual demand in the preceding reporting period. 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 precursors may NOT be licensed for import for display at exhibitions or fairs (Article 66.4). — 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. — Customs authority at the place of import

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