Drug materials that are radioactive substances used in healthcare

List 6 — drug materials for export and import that are radioactive substances used in healthcare, with assigned HS codes: 80 numbered items. The table has only THREE columns (no., radiopharmaceutical name, HS code) — unlike the other lists in this cluster there is no “dosage form” column; instead the appendix prints a footnote: “Applies to all concentrations, strengths and dosage forms”. 79 of the 80 lines carry only the 4-digit code 2844; item 80 (18F-FDG 5.5-125mCi/ml) alone carries the 8-digit code 2844.43.00 — the list stops there and this page does not infer 8-digit codes from a 4-digit heading. 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 — the obligation sits in the Law on Pharmacy (as amended by Law 44/2024/QH15), Decree 163/2025/ND-CP and atomic-energy law.

Four things decide. (1) LEGAL SCOPE comes from a different instrument, not from the HS code: Article 29.1 of Decree 163/2025/ND-CP promulgates the list of radioactive drug materials in its Appendix IV; List 6 of this circular only ASSIGNS CODES to that group. The two lists do not carry the same number of lines, so check scope against Appendix IV of Decree 163 and check codes against the table below. (2) INTENDED USE — Article 3.3 of the circular: used as drugs or drug materials they follow pharmaceutical law, used otherwise they follow the relevant other law. (3) CONCENTRATION AND DOSAGE FORM DO NOT NARROW the list: the footnote reads “Applies to all concentrations, strengths and dosage forms”. (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 Chapter 28. 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. The import licence is issued by the MINISTRY OF HEALTH, not by the radiation-safety authority: Article 49.3 of Decree 332/2025/ND-CP carves this out — “the Ministry of Health issues export and import licences for radiopharmaceuticals and radioactive drug materials”. 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). Contents per Article 66.1 of Decree 163/2025/ND-CP; for radioactive drug materials point (e) of that clause waives the two documents at points (b) and (c) — the copy of the quality standard and test method, and the certified copy of the manufacturing licence or GMP certificate for materials. 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. A condition that comes BEFORE the dossier: the establishment must hold written approval to trade in specially controlled drugs (Article 34.1 of the Law on Pharmacy, procedure in Article 37 of Decree 163/2025/ND-CP) — recorded on the pharmacy business eligibility certificate itself, not on a separate paper; and for radiopharmaceuticals, Article 34.1(c) additionally requires meeting “the conditions prescribed by the Law on Atomic Energy”. — Drug Administration of Vietnam — Ministry of Health 2. A SEPARATE licence that does not replace the import licence above: Article 56.1 of the Law on Atomic Energy 94/2025/QH15 (in force 2026-01-01, replacing Law 18/2008/QH12) requires that “organisations and individuals conducting radiation work under Article 14 of this Law must hold a radiation-work licence”, save for cases exempted by the Government. Article 14.3 lists “using radiation equipment; using and storing radioactive sources” and Article 14.8 lists “importing and exporting radioactive substances”. Competence: Article 49.2 of Decree 332/2025/ND-CP assigns it to the Agency for Radiation and Nuclear Safety for cases outside provincial competence. Time limits under Article 50.4 of Decree 332/2025/ND-CP: 10 working days for import and export of category 3, 4 and 5 radioactive sources, and 25 working days for other radiation work. In addition, Article 55.2 of the Law on Atomic Energy requires a declaration within 10 working days from the date the establishment holds radioactive material above the exemption level. — Agency for Radiation and Nuclear Safety — Ministry of Science and Technology 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.