Circular 09/2024/TT-BYT Lists of imported and exported drugs and drug materials for human use, and cosmetics whose HS codes have been assigned in Vietnam’s nomenclature of exports and imports

CIRCULAR

Promulgating Lists of imported and exported drugs and drug materials for human use, and cosmetics whose HS codes have been assigned in Vietnam’s nomenclature of exports and imports

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Pursuant to the Law on Customs No. 54/2014/QH13 dated June 23, 2014;

Pursuant to the Government’s Decree No. 08/2015/ND-CP dated January 21, 2015, detailing, and providing measures to implement the Customs Law regarding customs procedures and customs inspection, supervision and control;

Pursuant to the Government’s Decree No. 59/2018/ND-CP dated June 26, 2015, amending and supplementing a number of articles of the Government’s Decree No. 08/2015/ND-CP of January 21, 2015, detailing, and providing measures to implement, the Customs Law regarding customs procedures and customs inspection, supervision and control;

Pursuant to the Government’s Decree No. 95/2022/ND-CP dated November 15, 2022, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration of Vietnam and the Director of the Traditional Medicine Administration,

The Minister of Health hereby issues the Circular promulgating Lists of imported and exported drugs and drug materials for human use, and cosmetics whose HS codes have been assigned in Vietnam’s nomenclature of exports and imports.

Article 1. Scope of regulation

1. This Circular promulgates Lists of imported and exported drugs and drug materials, including pharmacochemical drugs, drugs made from medicinal materials, traditional drugs, vaccines and biological products; drug materials that are pharmaceutical ingredients, medicinal materials, extracts from medicinal materials and essential oils for drug manufacture purpose, and List of imported and exported cosmetics, whose HS codes have been assigned in Vietnam’s nomenclature of exports and imports attached to the Minister of Finance’s Circular No. 31/2022/TT-BTC dated June 8, 2022, on promulgation of Vietnam’s nomenclature of exports and imports, and application principles thereof.

2. This Circular does not apply to drug materials that are adjuvants and capsules; commodities not for the purposes of drug manufacture and commodities other than drug materials for human use.

Article 2. List promulgation

To promulgate together with this Circular Lists of imported and exported drugs and drug materials for human use, and cosmetics, whose HS codes have been assigned in Vietnam’s nomenclature of exports and imports (hereinafter referred to as Lists), including:

1. List 1: List of imported and exported toxic drugs and toxic drug materials whose HS codes have been assigned;

2. List 2: List of imported and exported drug materials that are habit-forming pharmaceutical ingredients whose HS codes have been assigned;

3. List 3: List of imported and exported drug materials that are psychotropic pharmaceutical ingredients whose HS codes have been assigned;

4. List 4: List of imported and exported drug materials that are pre-substances used as drugs whose HS codes have been assigned;

5. List 5: List of imported and exported drugs and pharmaceutical ingredients prohibited from use in a number of sectors and fields whose HS codes have been assigned;

6. List 6: List of imported and exported drug materials that are radioactive substances for medical use whose HS codes have been assigned;

7. List 7: List of imported and exported drug materials that are pharmaceutical ingredients and semi-finished drugs whose HS codes have been assigned;

8. List 8: List of imported and exported drugs containing 01 pharmaceutical ingredient whose HS codes have been assigned;

9. List 9: List of imported and exported combination drugs whose HS codes have been assigned;

10. List 10: List of imported and exported vaccines whose HS codes have been assigned;

11. List 11: List of imported and exported medicinal materials whose HS codes have been assigned;

12. List 12: List of imported and exported extracts from medicinal materials and essential oils for drug manufacture purpose whose HS codes have been assigned;

13. List 13: List of imported and exported traditional drugs and drugs made from medicinal materials whose HS codes have been assigned;

14. List 14: List of imported and exported cosmetics whose HS codes have been assigned.

Article 3. Principles for application of Lists

1. In case there are differences or inconsistencies in classifying and determining HS codes for commodities on the Lists promulgated together with this Circular, the determination of HS codes shall comply with the customs law.

2. For imported and exported drugs, drug materials, and cosmetics that have not yet been listed and have their HS codes assigned in the Lists promulgated together with this Circular, the determination of HS codes shall comply with the customs law. After customs clearance, individual and institutional exporters and importers shall send documents to the Ministry of Health (the Drug Administration of Vietnam and the Traditional Medicine Administration) to serve as a basis for coordinating with the Ministry of Finance to consider unifying, updating and promulgating the additional List.

3. Pharmaceutical ingredients, medicinal materials, extracts from medicinal materials and essential oils may be used for different purposes in addition to the purpose of drug manufacture. Accordingly, in case such commodities are used for the purpose of drug or drug material manufacture, provisions of the law on pharmacy shall prevail. In case they are used for other purposes, relevant laws shall be applied.

Article 4. Effect

1. This Circular takes effect from July 26, 2024.

2. The following Circulars cease to be effective from the effective date of this Circular:

a) Circular No. 06/2018/TT-BYT dated April 6, 2018, of the Minister of Health, on promulgating the nomenclature of imported and exported drugs and medicinal ingredients for human use and cosmetics whose HS codes have been assigned in Vietnam’s nomenclature of exports and imports.

b) Circular No. 48/2018/TT-BYT dated December 28, 2018, of the Minister of Health, on providing the List of imported and exported medicinal materials; extracts of medicinal materials and essential oils for making medicines; traditional drugs and herbal drugs whose HS codes identified under Vietnam’s nomenclature of exports and imports.

c) Circular No. 03/2021/TT-BYT dated March 4, 2021, of the Minister of Health, repealing a number of provisions of Appendix I to Circular No. 48/2018/TT-BYT dated December 28, 2018, of the Minister of Health, on providing the List of imported and exported medicinal materials; extracts of medicinal materials and essential oils for making medicines; traditional drugs and herbal drugs whose HS codes identified under Vietnam’s nomenclature of exports and imports.

Article 5. Implementation responsibility

The Drug Administration of Vietnam and the Traditional Medicine Administration, and their affiliated units, units under the Ministry of Health, Departments of Health of provinces and centrally run cities, and relevant agencies, organizations and individuals shall implement this Circular.

Any difficulties arising in the course of implementation should be reported to the Ministry of Health (the Drug Administration of Vietnam, for commodities on the Lists 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 14; the Traditional Medicine Administration, for commodities on the Lists 11, 12, and 13) for consideration and settlement./.

* All Appendices are not translated herein.