VietnameseCircular 28/2026/TT-BYT list of high-risk and medium-risk drugs, vaccines, biological products
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ATTRIBUTE
| Issuing body: | Ministry of Health | Effective date: | Known Please log in to a subscriber account to use this function. Don’t have an account? Register here |
| Official number: | 28/2026/TT-BYT | Signer: | Nguyen Tri Thuc |
| Type: | Circular | Expiry date: | Updating |
| Issuing date: | 01/07/2026 | Effect status: | Known Please log in to a subscriber account to use this function. Don’t have an account? Register here |
| Fields: | Food and drug, Health |
The Effect status of this document is known.This feature is available to Advanced account holders. Please log in to a subscriber account to view Effect status. Don’t have an account? Register here
THE MINISTRY OF HEALTH
No. 28/2026/TT-BYT | THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness
Hanoi, July 01, 2026 |
CIRCULAR
Promulgating the List of pharmacochemical drugs, drugs made from medicinal materials, vaccines, biological products, drug materials, semi-finished drug products, and semi-finished medicinal material products classified as high-risk or medium-risk products under the Ministry of Health’s management
Pursuant to the Law on Product and Goods Quality No. 05/2007/QH12, as amended and supplemented under Law No. 78/2025/QH15;
Pursuant to the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15;
Pursuant to the Government’s Decree No. 37/2026/ND-CP detailing a number of articles of, and prescribing measures for the implementation and guidance of the Law on Product and Goods Quality;
Pursuant to the Government’s Decree No. 163/2025/ND-CP detailing a number of articles of, and prescribing measures for the implementation and guidance of the Law on Pharmacy;
Pursuant to the Government’s Decree No. 42/2025/ND-CP defining the functions, tasks, powers, and organizational structure of the Ministry of Health;
At the proposal of the Director General of the Drug Administration;
The Minister of Health promulgates this Circular promulgating the List of pharmacochemical drugs, drugs made from medicinal materials, vaccines, biological products, drug materials, semi-finished drug products, and semi-finished medicinal material products classified as high-risk or medium-risk products under the Ministry of Health’s management.
Article 1. Scope of regulation
1. This Circular regulates pharmacochemical drugs, drugs made from medicinal materials, vaccines, biological products, drug materials, semi-finished drug products, and semi-finished medicinal material products (soft extracts, granules, powders, liquid extracts, essential oils, resins, gums, and gels) under the management of the Ministry of Health.
2. This Circular does not regulate drug materials that are medicinal materials.
Article 2. Promulgation of the List of pharmacochemical drugs, drugs made from medicinal materials, vaccines, biological products, drug materials, semi-finished drug products, and semi-finished medicinal material products classified as high-risk or medium-risk products under the Ministry of Health’s management
1. The List of pharmacochemical drugs, drugs made from medicinal materials, vaccines, biological products, drug materials, semi-finished drug products, and semi-finished medicinal material products classified as high-risk products under the management of the Ministry of Health is detailed in Appendix I enclosed with this Circular.
2. The List of pharmacochemical drugs, drugs made from medicinal materials, vaccines, biological products, drug materials, semi-finished drug products, and semi-finished medicinal material products classified as medium-risk products under the management of the Ministry of Health is detailed in Appendix II enclosed with this Circular.
Article 3. Responsibilities for implementation
1. The Drug Administration shall have responsibilities:
a) To organize the implementation of, the provision of guidance on, and the inspection of compliance with this Circular throughout the country;
b) To review and propose to the Ministry of Health the amendment, updating, and supplementation of the Lists prescribed in Article 2 of this Circular.
2. The People’s Committees of provinces and centrally run cities shall have responsibilities:
a) To organize the implementation of, the provision of guidance on, and the inspection of compliance with this Circular within their respective administrative areas;
b) To direct relevant agencies in the management and quality inspection of pharmacochemical drugs, drugs made from medicinal materials, vaccines, biological products, drug materials, semi-finished drug products, and semi-finished medicinal material products classified as high-risk or medium-risk products in accordance with the law on pharmacy.
3. State drug testing establishments and drug material testing establishments shall be responsible for conducting quality inspection of pharmacochemical drugs, drugs made from medicinal materials, vaccines, biological products, drug materials, semi-finished drug products, and semi-finished medicinal material products classified as high-risk or medium-risk products in accordance with the law on pharmacy.
Article 4. Effect
This Circular takes effect on July 01, 2026.
During the implementation, if any difficulties or issues arise, agencies, organizations, and individuals are requested to report them to the Ministry of Health (the Drug Administration) for consideration and resolution./.
| FOR THE MINISTER
Nguyen Tri Thuc |
Appendix I
LIST OF PHARMACOCHEMICAL DRUGS, DRUGS MADE FROM MEDICINAL MATERIALS, VACCINES, BIOLOGICAL PRODUCTS, DRUG MATERIALS, SEMI-FINISHED DRUG PRODUCTS, AND SEMI-FINISHED MEDICINAL MATERIAL PRODUCTS CLASSIFIED AS HIGH-RISK PRODUCTS UNDER THE MANAGEMENT RESPONSIBILITY OF THE MINISTRY OF HEALTH
(Promulgated together with Circular No. 28/2026/TT-BYT dated July 01, 2026 of the Minister of Health)
No. | Name of goods group | HS Code | Corresponding quality management requirements |
1 | Toxic drugs, toxic drug materials, and semi-finished drug products containing toxic drug materials. | Lists 1 and 7 promulgated together with Circular No. 09/2024/TT-BYT of the Minister of Health promulgating the 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. | Grant of a marketing authorization and/or an import license, application of quality management measures in the manufacture, importation, and distribution in accordance with the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15, Decree No. 163/2025/ND-CP detailing a number of articles, and prescribing measures for organizing and guiding the implementation, of the Law on Pharmacy, and other relevant legal documents applicable to the group of toxic drugs, toxic drug materials, and semi-finished drug products containing toxic drug materials. |
2 | Habit-forming drugs, drug materials being habit-forming pharmaceutical ingredients, and semi-finished drug product containing drug materials being habit-forming pharmaceutical ingredients | Lists 2, 7, 8, and 9 promulgated together with Circular No. 09/2024/TT-BYT. | Grant of a marketing authorization and/or an import license, application of quality management measures in the manufacture, importation, and distribution in accordance with the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15, Decree No. 163/2025/ND-CP, and other relevant legal documents applicable to the group of habit-forming drugs, drug materials being habit-forming pharmaceutical ingredients, and semi-finished drug product containing drug materials being habit-forming pharmaceutical ingredients. |
3 | Psychotropic drugs, drug materials being psychotropic pharmaceutical ingredients, and semi-finished drug products containing drug materials being psychotropic pharmaceutical ingredients. | Lists 3, 7, 8, and 9 promulgated together with Circular No. 09/2024/TT-BYT. | Grant of a marketing authorization and/or an import license, application of quality management measures in the manufacture, importation, and distribution in accordance with the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15, Decree No. 163/2025/ND-CP, and other relevant legal documents applicable to the group of psychotropic drugs, drug materials being psychotropic pharmaceutical ingredients, and semi-finished drug products containing drug materials being psychotropic pharmaceutical ingredients. |
4 | Pre-substance drugs, drug materials being pre-substances used as drugs, and semi-finished drug products containing drug materials being pre-substances used as drugs. | Lists 4, 7, 8, and 9 promulgated together with Circular No. 09/2024/TT-BYT. | Grant of a marketing authorization and/or an import license, application of quality management measures in the manufacture, importation, and distribution in accordance with the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15, Decree No. 163/2025/ND-CP, and other relevant legal documents applicable to the group of pre-substance drugs, drug materials being pre-substances used as drugs, and semi-finished drug products containing drug materials being pre-substances used as drugs. |
5 | Radioactive drugs, drug materials being radioactive substances used in the health sector, and semi-finished drug products containing drug materials being radioactive substances used in the health sector. | List 6 promulgated together with Circular No. 09/2024/TT-BYT. | Grant of a marketing authorization and/or an import license, application of quality management measures in the manufacture, importation, and distribution in accordance with the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15, Decree No. 163/2025/ND-CP, and other relevant legal documents applicable to the group of radioactive drugs, drug materials being radioactive substances used in the health sector, and semi-finished drug products containing drug materials being radioactive substances used in the health sector. |
6 | Vaccines for human use. | List 10 promulgated together with Circular No. 09/2024/TT-BYT. | Grant of a marketing authorization or an import license, application of quality management measures in the manufacture, importation, and distribution in accordance with the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15, Decree No. 163/2025/ND-CP, and other relevant legal documents applicable to the group of vaccines for human use. |
7 | Biological products for human use, including antisera, bio-drugs, and similar bio-drugs (excluding drugs and drug materials containing probiotics). | Lists 8 and 9 promulgated together with Circular No. 09/2024/TT-BYT. | Grant of a marketing authorization or an import license, application of quality management measures in the manufacture, importation, and distribution in accordance with the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15, Decree No. 163/2025/ND-CP, and other relevant legal documents applicable to the group of biological products for human use, including antisera, bio-drugs, and similar bio-drugs (excluding drugs and drug materials containing probiotics). |
8 | Cytotoxic drugs, drug materials being cytotoxic active pharmaceutical ingredients, and semi-finished drug products containing drug materials being cytotoxic active pharmaceutical ingredients. | Lists 7, 8, and 9 promulgated together with Circular No. 09/2024/TT-BYT. | Grant of a marketing authorization or an import license, application of quality management measures in the manufacture, importation, and distribution in accordance with the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15, Decree No. 163/2025/ND-CP, and other relevant legal documents applicable to the group of cytotoxic drugs, drug materials being cytotoxic active pharmaceutical ingredients, and semi-finished drug products containing drug materials being cytotoxic active pharmaceutical ingredients. |
9 | Sex hormone drugs, drug materials being sex hormone drugs, and semi-finished drug products containing drug materials being sex hormone drugs. | Lists 7, 8, and 9 promulgated together with Circular No. 09/2024/TT-BYT. | Grant of a marketing authorization or an import license, application of quality management measures in the manufacture, importation, and distribution in accordance with the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15, Decree No. 163/2025/ND-CP, and other relevant legal documents applicable to the group of sex hormone drugs, drug materials being sex hormone drugs, and semi-finished drug products containing drug materials being sex hormone drugss. |
10 | Anesthetic drugs, preanesthetic drugs, drug materials being anesthetic or preanesthetic pharmaceutical ingredients, and semi-finished drug products containing drug materials being anesthetic or preanesthetic pharmaceutical ingredients. | Lists 7, 8, and 9 promulgated together with Circular No. 09/2024/TT-BYT. | Grant of a marketing authorization or an import license, application of quality management measures in the manufacture, importation, and distribution in accordance with the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15, Decree No. 163/2025/ND-CP, and other relevant legal documents applicable to the group of Anesthetic drugs, preanesthetic drugs, drug materials being anesthetic or preanesthetic pharmaceutical ingredients, and semi-finished drug products containing drug materials being anesthetic or preanesthetic pharmaceutical ingredients. |
11 | Injectable infusion medicinal products/infusion solutions (excluding electrolyte infusion solutions). | Lists 8 and 9 promulgated together with Circular No. 09/2024/TT-BYT. | Grant of a marketing authorization or an import license, application of quality management measures in the manufacture, importation, and distribution in accordance with the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15, Decree No. 163/2025/ND-CP, and other relevant legal documents applicable to the group of Injectable infusion medicinal products/infusion solutions (excluding electrolyte infusion solutions). |
12 | Drugs for spinal, intrathecal, intramedullary, intraocular, and emergency cardiovascular injection; injectable drugs containing beta-lactam antibiotics. | Lists 8 and 9 promulgated together with Circular No. 09/2024/TT-BYT. | Grant of a marketing authorization or an import license, application of quality management measures in the manufacture, importation, and distribution in accordance with the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15, Decree No. 163/2025/ND-CP, and other relevant legal documents applicable to the group of Drugs for spinal, intrathecal, intramedullary, intraocular, and emergency cardiovascular injection; injectable drugs containing beta-lactam antibiotics. |
13 | Drugs, drug materials, and semi-finished drug products containing substances included in the List of substances prohibited from use in certain sectors and fields. | List 5 promulgated together with Circular No. 09/2024/TT-BYT. | Grant of a marketing authorization and/or an import license, application of quality management measures in the manufacture, importation, and distribution in accordance with the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15, Decree No. 163/2025/ND-CP, and other relevant legal documents applicable to the group of drugs, drug materials, and semi-finished drug products containing substances included in the List of substances prohibited from use in certain sectors and fields. |
Appendix II
LIST OF PHARMACOCHEMICAL DRUGS, DRUGS MADE FROM MEDICINAL MATERIALS, VACCINES, BIOLOGICAL PRODUCTS, DRUG MATERIALS, SEMI-FINISHED DRUG PRODUCTS, AND SEMI-FINISHED MEDICINAL MATERIAL PRODUCTS CLASSIFIED AS MEDIUM-RISK PRODUCTS UNDER THE MANAGEMENT RESPONSIBILITY OF THE MINISTRY OF HEALTH
(Promulgated together with Circular No. 28/2026/TT-BYT dated July 01, 2026 of the Minister of Health)
No. | Name of Goods Group | HS Code | Corresponding quality management requirements |
1 | Pharmacochemical drugs (excluding the drugs specified in Appendix I promulgated together with this Circular). | Lists 8 and 9 promulgated together with Circular No. 09/2024/TT-BYT. | Grant of a marketing authorization or an import license, application of quality management measures in the manufacture, importation, and distribution in accordance with the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15, Decree No. 163/2025/ND-CP, and other relevant legal documents applicable to the group of pharmacochemical drugs (excluding the drugs specified in Appendix I promulgated together with this Circular). |
2 | Drug materials, semi-finished drug products, and semi-finished medicinal material products (excluding the drug materials and semi-finished drug products specified in Appendix I promulgated together with this Circular). | Lists 7 and 12 promulgated together with Circular No. 09/2024/TT-BYT. | Grant of a marketing authorization or an import license, application of quality management measures in the manufacture, importation, and distribution in accordance with the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15, Decree No. 163/2025/ND-CP, and other relevant legal documents applicable to the group of drug materials, semi-finished drug products, and semi-finished medicinal material products (excluding the drug materials and semi-finished drug products specified in Appendix I promulgated together with this Circular). |
3 | Drugs made from medicinal materials (excluding the drug materials, semi-finished drug products, and semi-finished medicinal material products specified in Appendix I promulgated together with this Circular). | List 13 promulgated together with Circular No. 09/2024/TT-BYT. | Grant of a marketing authorization or an import license, application of quality management measures in the manufacture, importation, and distribution in accordance with the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15, Decree No. 163/2025/ND-CP, and other relevant legal documents applicable to the group of drugs made from medicinal materials (excluding the drug materials, semi-finished drug products, and semi-finished medicinal material products specified in Appendix I promulgated together with this Circular). |
4 | Drugs containing probiotic microorganisms, drug materials containing probiotic microorganisms, and semi-finished drug products containing probiotic microorganisms. | Lists 7, 8, and 9 promulgated together with Circular No. 09/2024/TT-BYT. | Grant of a marketing authorization or an import license, application of quality management measures in the manufacture, importation, and distribution in accordance with the Law on Pharmacy No. 105/2016/QH13, as amended and supplemented under Law No. 44/2024/QH15, Decree No. 163/2025/ND-CP, and other relevant legal documents applicable to the group of drugs containing probiotic microorganisms, drug materials containing probiotic microorganisms, and semi-finished drug products containing probiotic microorganisms. |
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