Circular 09/2024/TT-BYT on the List of Drugs, Raw Materials for Drugs, and Cosmetics for Export and Import, which have been assigned commodity codes according to the List of Goods for Export and Import of Vietnam, issued by the Minister of Health.

CIRCULAR

ISSUING THE LIST OF DRUGS AND RAW MATERIALS FOR DRUGS FOR HUMAN USE AND COSMETICS FOR EXPORT AND IMPORT WITH COMMODITY CODES ALREADY DETERMINED IN THE VIETNAM EXPORT AND IMPORT GOODS LIST

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

Pursuant to Decree No. 08/2015/NĐ-CP dated January 21, 2015 of the Government detailing and providing implementation measures for the Law on Customs regarding customs procedures, inspection, supervision, and control;

Pursuant to Decree No. 59/2018/NĐ-CP dated April 20, 2018 of the Government amending and supplementing certain articles of Decree No. 08/2015/NĐ-CP dated January 21, 2015 of the Government detailing and providing implementation measures for the Law on Customs regarding customs procedures, inspection, supervision, and control;

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

At the proposal of the Director of the Drug Administration Department and the Director of the Traditional Medicine Management Department,

The Minister of Health issues this Circular to issue the List of Drugs and Raw Materials for Drugs for Human Use and Cosmetics for Export and Import with Commodity Codes Already Determined in the Vietnam Export and Import Goods List.

Article 1. Scope of Regulation

1. This Circular issues the lists and principles for applying the lists of drugs and raw materials for drugs including chemical drugs, herbal drugs, traditional drugs, vaccines, biological products; raw materials for drugs such as drug substances, herbs, extracts from herbs, essential oils for drugs; and the List of Cosmetics for Export and Import with Commodity Codes Already Determined in the Vietnam Export and Import Goods List issued together with Circular No. 31/2022/TT-BTC dated June 8, 2022 of the Minister of Finance on issuing the Vietnam Export and Import Goods List.

2. This Circular does not apply to excipients and empty capsules: goods not intended for use as drugs, goods that are not raw materials for drugs for human use.

Article 2. Issuing the List

Issued together with this Circular are the Lists of Drugs and Raw Materials for Drugs for Human Use and Cosmetics for Export and Import with Commodity Codes Already Determined in the Vietnam Export and Import Goods List (hereinafter referred to collectively as the Lists), including:

1. List 1: List of toxic drugs and raw materials for drugs for export and import with commodity codes already determined;

2. List 2: List of raw materials for drugs for export and import that are narcotic drug substances with commodity codes already determined;

3. List 3: List of raw materials for drugs for export and import that are psychotropic drug substances with commodity codes already determined;

4. List 4: List of raw materials for drugs for export and import that are precursor chemicals for drugs with commodity codes already determined;

5. List 5: List of drugs and drug substances for export and import belonging to the Prohibited Substances List for Certain Industries and Fields with commodity codes already determined;

6. List 6: List of radioactive materials for medical use for export and import with commodity codes already determined;

7. List 7: List of raw materials for drugs for export and import that are drug substances and intermediates with commodity codes already determined;

8. List 8: List of single-component drug substances for export and import with commodity codes already determined;

9. List 9: List of combination drugs for export and import with commodity codes already determined;

10. List 10: List of vaccines for export and import with commodity codes already determined;

11. List 11: List of medicinal herbs for export and import with commodity codes already determined;

12. List 12: List of extracts from medicinal herbs and essential oils for drugs for export and import with commodity codes already determined;

13. List 13: List of traditional drugs and herbal drugs for export and import with commodity codes already determined;

14. List 14: List of cosmetics for export and import with commodity codes already determined.

Article 3. Principles for Applying the List

1. In case there are discrepancies or inconsistencies in classifying and determining commodity codes for goods listed in the Lists issued together with this Circular, the determination of commodity codes shall be carried out in accordance with the provisions of the law on customs.

2. For drugs, raw materials for drugs, and cosmetics for export and import not listed and not assigned commodity codes in the Lists issued together with this Circular, the determination of commodity codes shall be carried out in accordance with the provisions of the law on customs. After clearance, organizations and individuals exporting and importing these goods shall submit written documents to the Ministry of Health (Drug Administration Department, Traditional Medicine Management Department) to serve as the basis for cooperation with the Ministry of Finance to review, unify, update, and issue supplementary Lists.

3. Drug substances, herbs, extracts from herbs, and essential oils can be used for purposes other than making drugs. Accordingly, when these items are used as drugs or raw materials for drugs, they must comply with the regulations under the law on drugs; when used for other purposes, they must comply with relevant laws.

Article 4. Effective date

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

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

a) Circular No. 06/2018/TT-BYT dated April 6, 2018 of the Minister of Health issuing the List of Drugs and Raw Materials for Drugs for Human Use and Cosmetics for Export and Import with Commodity Codes Already Determined in the Vietnam Export and Import Goods List.

b) Circular No. 48/2018/TT-BYT dated December 28, 2018 of the Minister of Health issuing the List of Medicinal Herbs; Extracts from Medicinal Herbs and Essential Oils for Drugs; Traditional Drugs and Herbal Drugs for Export and Import with Commodity Codes Already Determined in the Vietnam Export and Import Goods List.

c) Circular No. 03/2021/TT-BYT dated March 4, 2021 of the Minister of Health Abolishing Part of the Provisions at Appendix 1 issued together with Circular No. 48/2018/TT-BYT dated December 28, 2018 of the Minister of Health on issuing the List of Medicinal Herbs: Extracts from Medicinal Herbs and Essential Oils for Drugs; Traditional Drugs and Herbal Drugs for Export and Import with Commodity Codes Already Determined in the Vietnam Export and Import Goods List.

Article 5. Responsibilities for Implementation

The Drug Administration, the Traditional Medicine Management Department, units under and directly under the Ministry of Health, provincial and centrally governed city Health Departments, relevant agencies, organizations, and individuals shall be responsible for implementing this Circular.

In the course of implementation, if there are difficulties or obstacles, agencies, organizations, and individuals shall report to the Ministry of Health (the Drug Administration for goods listed in Categories 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 14; the Traditional Medicine Management Department for goods listed in Categories 11, 12, and 13) for consideration and resolution./.