Circular No. 32/2025/TT-BYT stipulates the management of the quality of traditional medicine, traditional medicinal ingredients, and herbal materials issued by the Minister of Health.

CIRCULAR

Regulations on the Quality Management of Traditional Medicine Drugs, Traditional Medicine Ingredients, and Medicinal Materials

Pursuant to the Medicine Law dated April 6, 2016; the Law Amending and Supplementing Certain Provisions of the Medicine Law dated November 21, 2024;

Pursuant to Decree No. 163/2025/NĐ-CP dated June 29, 2025 of the Government detailing certain provisions and measures for organizing and guiding the implementation of the Medicine Law;

Pursuant to Decree No. 42/2025/NĐ-CP dated February 27, 2025 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Traditional Medicine Management Department;

The Minister of Health issues this Circular regulating the quality management of traditional medicine drugs, traditional medicine ingredients, and medicinal materials.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular details and guides the implementation of certain provisions of the Medicine Law dated April 6, 2016 and the Law Amending and Supplementing Certain Provisions of the Medicine Law dated November 21, 2024 (hereinafter referred to as the Medicine Law), including: Application of quality standards for traditional medicine drugs, traditional medicine ingredients, and medicinal materials; publication of quality standards for traditional medicine ingredients and medicinal materials; quality testing, traceability, origin, recall, and handling of non-compliant traditional medicine drugs, traditional medicine ingredients, and medicinal materials as stipulated in Clause 6 Article 65, Article 68, and Clause 3 Article 103 of the Medicine Law.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. Batch of medicinal materials is a determined quantity of medicinal materials from the same cultivation, planting, or harvesting place, processed and manufactured according to the same process within a defined period at the same facility and meeting the criteria for medicinal use.

2. Batch of traditional medicine ingredients is a determined quantity of traditional medicine ingredients processed, manufactured, and produced from medicinal materials according to the same process within a defined period at the same facility and meeting the criteria for medicinal use.

3. Quality standard for traditional medicine drugs, traditional medicine ingredients, and medicinal materials is a document specifying technical characteristics of traditional medicine drugs, traditional medicine ingredients, and medicinal materials, including quality indicators, quality levels, testing methods, and other technical and management requirements related to the quality of traditional medicine drugs, traditional medicine ingredients, and medicinal materials.

Chapter II

APPLICATION OF QUALITY STANDARDS

TRADITIONAL MEDICINE DRUGS, TRADITIONAL MEDICINE INGREDIENTS, AND MEDICINAL MATERIALS

Article 3. General Provisions

1. Pharmaceutical business establishments and medical examination and treatment facilities may choose to apply quality standards for traditional medicine drugs, traditional medicine ingredients, and medicinal materials according to one of the pharmacopoeias specified in Article 4 of this Circular or according to enterprise standards established by the establishment as specified in Article 5 of this Circular.

2. The Ministry of Health (Department of Traditional Medicine and Herbal Medicine Administration) shall organize the review of applications and approve quality standards for traditional medicine drugs in accordance with regulations on registering traditional medicine drugs; regulations on granting import permits for traditional medicine drugs that have not obtained circulation registration certificates.

3. The Department of Traditional Medicine and Herbal Medicine Administration or the People's Committee of the province (health administration agency under the provincial People's Committee) shall organize the review of applications and approve quality standards for traditional medicine ingredients and medicinal materials in accordance with regulations on registering traditional medicine ingredients and medicinal materials (if applicable) as prescribed in Clause 3 Article 22 of this Circular.

Article 4. Application of Pharmacopoeia

1. Pharmaceutical business establishments and medical examination and treatment facilities may apply the Vietnamese Pharmacopoeia or pharmacopoeias of other countries, provided that the quality indicators and quality levels specified in those pharmacopoeias are not lower than those in the Vietnamese Pharmacopoeia.

2. For imported traditional medicine drugs, traditional medicine ingredients, and medicinal materials, the exporting country’s pharmacopoeia or the Vietnamese Pharmacopoeia must be applied. In cases where the quality indicators and quality levels specified in the exporting country’s pharmacopoeia are lower than those in the Vietnamese Pharmacopoeia, the Vietnamese Pharmacopoeia must be applied.

3. The application of pharmacopoeia must fully comply with the quality indicators and quality levels specified in the corresponding monographs on traditional medicine drugs, traditional medicine ingredients, and medicinal materials and the testing methods specified in the pharmacopoeia.

4. In cases where a production facility announces the application of one of the pharmacopoeias specified in Clause 1 of this Article but uses a different testing method from the one recorded in the specific monograph of the traditional medicine drug, traditional medicine ingredient, or medicinal material in the selected pharmacopoeia, the production facility or the announcing facility must prove the equivalence between its testing method and the one recorded in the pharmacopoeia in the registration dossier or announcement dossier. The test results using the method recorded in the pharmacopoeia serve as the basis for concluding the quality of the traditional medicine drug, traditional medicine ingredient, or medicinal material.

In cases where the composition formula, preparation, or manufacturing method of the traditional medicine drug, traditional medicine ingredient, or medicinal material affects the accuracy and reliability of the test according to the method recorded in the pharmacopoeia, the production facility or the announcing facility of the traditional medicine drug, traditional medicine ingredient, or medicinal material must provide explanations and information in the registration dossier or announcement dossier of the quality standard. The test results using the method recorded in the approved quality standard in the registration dossier or announcement dossier serve as the basis for concluding the quality of the traditional medicine drug, traditional medicine ingredient, or medicinal material.

Article 5. Application of basic standards

1. Basic standards for traditional medicine drugs, traditional herbal medicines, and medicinal materials must comply with the provisions set out in point b, Clause 2, Article 102 of the Drug Law, specifically as follows:

a) Meeting the requirements of quality criteria and quality levels specified in the corresponding monographs of the Vietnamese Pharmacopoeia or reference pharmacopoeia, and quality criteria, quality levels, and common testing methods prescribed in the Appendices of the Vietnamese Pharmacopoeia or reference pharmacopoeia as stipulated in this Circular;

b) In cases where the Vietnamese Pharmacopoeia or reference pharmacopoeia does not have corresponding monographs on traditional medicine drugs, traditional herbal medicines, and medicinal materials, the entity must develop standards based on scientific research results, test results, evaluations, and analyses;

c) Pharmaceutical business entities must conduct verification and evaluation of the testing methods recorded in the basic standards for traditional medicine drugs, traditional herbal medicines, and medicinal materials that the entity applies but are not included in the pharmacopoeia at laboratories meeting Good Laboratory Practice (GLP) standards.

2. Basic standards for traditional medicine drugs, traditional herbal medicines, and medicinal materials processed, compounded, and produced at medical examination and treatment facilities shall be established by the facility, complying with the provisions of points a and b of Clause 1 of this Article, issued and announced by the head of the facility during the announcement process to meet the processing and compounding standards for traditional medicine drugs, traditional herbal medicines, and medicinal materials as prescribed in Circular No. 32/2020/TT-BYT dated December 31, 2020, of the Minister of Health on processing and compounding standards for traditional medicine in medical examination and treatment facilities using traditional medicine.

3. The quality standards for traditional medicine drugs, traditional herbal medicines, and medicinal materials shall be implemented according to Model No. 01 of Appendix I attached to this Circular.

Article 6. Updating Quality Standards and Applying Updated Pharmacopoeias

1. For traditional medicine drugs, traditional herbal medicines, and medicinal materials that have been granted circulation registration certificates or traditional herbal medicines and medicinal materials that have been announced quality standards, the entity must review the quality standards of the announced traditional medicine drugs, traditional herbal medicines, and medicinal materials against the current pharmacopoeia. If there are changes in quality criteria or quality levels compared to the current pharmacopoeia, the entity must update the quality standards for traditional medicine drugs, traditional herbal medicines, and medicinal materials in accordance with this Circular and follow the procedures for changes as prescribed in the Circular on the registration of circulation for traditional medicine drugs, traditional herbal medicines, and medicinal materials. The time frame for updating quality criteria or quality levels is as follows:

a) Within a maximum period of two years from the date the latest version of the pharmacopoeia becomes effective, the registration entity and the announcement entity are responsible for updating and applying the quality standards for traditional medicine drugs, traditional herbal medicines, and medicinal materials according to that version of the pharmacopoeia;

b) Within a maximum period of two years from the date of the first circulation registration certificate issuance for traditional medicine drugs, traditional herbal medicines, and medicinal materials or from the date of the first announcement of the quality standards for traditional medicine drugs, traditional herbal medicines, and medicinal materials, the registration entity and the announcement entity must update the quality standards according to the current version of the pharmacopoeia if the quality standards in the initial registration dossier or announcement dossier are based on a previous version of the pharmacopoeia.

2. For traditional medicine drugs, traditional herbal medicines, and medicinal materials proposed for circulation registration or quality standard announcement: At the time of submitting the registration dossier or announcement dossier, the quality standards for traditional medicine drugs, traditional herbal medicines, and medicinal materials must comply with the pharmacopoeia in one of the following cases:

a) The current version of the pharmacopoeia;

b) The previous version of the pharmacopoeia but not more than two years prior to the effective date of the current version of the pharmacopoeia.

3. During the course of business and use, if a business entity or unit discovers factors seriously affecting the quality, safety, and efficacy of traditional medicine drugs, traditional herbal medicines, and medicinal materials, or upon request by the Traditional Medicine and Herbal Medicine Management Department or health administrative bodies under provincial People's Committees, the production entity must update the quality criteria into the quality standards for traditional medicine drugs, traditional herbal medicines, and medicinal materials in accordance with this Circular and follow the procedures for changes as prescribed in the Circular on the registration of circulation for traditional medicine drugs, traditional herbal medicines, and medicinal materials to control such influencing factors.

Chapter III

ANNOUNCEMENT OF QUALITY STANDARDS FOR TRADITIONAL HERBAL MEDICINES,

MEDICINAL MATERIALS

Article 7. Objects and requirements for announcing quality standards of traditional medicine ingredients and medicinal materials

1. Traditional medicine ingredients and medicinal materials must announce their quality standards before circulation in any of the following cases:

a) Traditional medicine ingredients and medicinal materials that have not been specified in the Vietnamese Pharmacopoeia or reference pharmacopoeia as stipulated in Article 4 of this Circular;

b) Traditional medicine ingredients and medicinal materials that have quality standards specified in the Vietnamese Pharmacopoeia or reference pharmacopoeia as stipulated in Article 4 of this Circular but the entity wishes to announce higher quality criteria than those specified in the pharmacopoeia.

2. In cases where traditional medicine ingredients and medicinal materials have quality standard monographs in the Vietnamese Pharmacopoeia or reference pharmacopoeia, if a pharmaceutical business entity announces the application of quality standards according to the Vietnamese Pharmacopoeia or reference pharmacopoeia, it may immediately commence business operations after self-announcing without having to submit an application and follow the procedure for announcing quality standards of traditional medicine ingredients and medicinal materials as prescribed in Article 8 of this Circular.

3. Entities announcing quality standards of traditional medicine ingredients and medicinal materials include:

a) Businesses selling traditional medicine ingredients and medicinal materials in Vietnam;

b) Medical examination and treatment facilities that process and prepare traditional medicine ingredients and medicinal materials;

c) Foreign businesses selling traditional medicine ingredients and medicinal materials with representative offices in Vietnam.

Article 8. Documents and procedures for announcing quality standards of traditional medicine ingredients and medicinal materials

1. The documents for announcing quality standards of traditional medicine ingredients and medicinal materials include:

a) A quality announcement form for traditional medicine ingredients and medicinal materials according to Model No. 02 of Appendix I issued together with this Circular;

b) A copy of the test report for traditional medicine ingredients and medicinal materials meeting the announced quality standards, issued by a state testing facility that meets GLP standards or a business service testing facility certified to operate within the scope of pharmaceutical business services;

c) A copy of documentation proving the origin and source of traditional medicine ingredients and medicinal materials as stipulated in Clause 2 and Clause 3 of Article 12 of this Circular;

d) All documents in the announcement file must be in Vietnamese or English; the business entity selling traditional medicine ingredients and medicinal materials, and medical examination and treatment facilities shall bear full responsibility under the law for the accuracy, legality, and truthfulness of all documents in the announcement file.

2. Procedures for announcing quality standards of traditional medicine ingredients and medicinal materials:

a) The announcing entity submits one (01) set of self-announcement documents as prescribed in Clause 1 of this Article to the Department of Traditional Medicine and Pharmaceutical Management or specialized health agencies under provincial People's Committees in accordance with the provisions of Article 15 of Decree No. 118/2025/NĐ-CP dated June 9, 2025 of the Government on implementing administrative procedures through a single window mechanism at the One-Stop Service Center and National Public Service Portal;

b) Upon receiving complete self-announcement documents that meet the required format and payment of fees as prescribed, the Department of Traditional Medicine and Pharmaceutical Management or specialized health agencies under provincial People's Committees issue a receipt for the submitted documents to the announcing entity;

c) Immediately upon receiving the receipt, the announcing entity has the right to sell the announced traditional medicine ingredients and medicinal materials and bears full responsibility for their quality according to the announcement file;

d) Within seven working days, the Department of Traditional Medicine and Pharmaceutical Management or specialized health agencies under provincial People's Committees are responsible for publishing the self-announced quality standards according to Model No. 02 issued together with this Circular on the Electronic Information Website;

đ) In cases where there are changes to the quality criteria or levels of traditional medicine ingredients and medicinal materials, organizations or individuals must resubmit the quality standard announcement documents as prescribed in Clause 1 of this Article to go through the announcement procedure again.

Chapter IV

 QUALITY TESTING

TRADITIONAL MEDICINE DRUGS, TRADITIONAL MEDICINE INGREDIENTS, AND MEDICINAL MATERIALS

Article 9. Testing of traditional medicine drugs, traditional medicine ingredients, and medicinal materials

1. The testing must be carried out according to the approved or published quality standards for traditional medicine drugs, traditional medicine ingredients, and medicinal materials, specifically as follows:

a) In cases where the quality standards for traditional medicine drugs, traditional medicine ingredients, and medicinal materials have not been updated, the testing facility shall apply the corresponding pharmacopoeia as stipulated in Clause 1 and Clause 2 of Article 6 of this Circular to test the quality. The application of the pharmacopoeia is calculated from the production date of the batch of traditional medicine drugs, traditional medicine ingredients, and medicinal materials being tested;

b) In cases where traditional medicine drugs, traditional medicine ingredients, and medicinal materials are processed or produced at medical examination and treatment facilities, the testing shall be conducted according to the quality standards established and issued by such facilities;

c) In cases where there is suspicion regarding the origin or quality of traditional medicine drugs, traditional medicine ingredients, and medicinal materials as specified in Points a, b, c, d, and đ of Clause 3 of Article 20 of this Circular, or if there are errors in the testing methods recorded in the quality standards for traditional medicine drugs, traditional medicine ingredients, and medicinal materials that do not ensure accuracy or specificity, or if there is suspicion of additional drug substances/chemical substances (drugs with side effects, drugs with abnormal effects), or if information about traditional medicine drugs, traditional medicine ingredients, and medicinal materials containing impurities from foreign drug regulatory authorities, state testing facilities for traditional medicine drugs, traditional medicine ingredients, and medicinal materials shall apply analytical/testing methods prescribed in the pharmacopoeia or reviewed according to the guidelines for reviewing analytical methods prescribed in the Circular on registering the circulation of traditional medicine drugs, traditional medicine ingredients, and medicinal materials to conduct testing and issue the quality testing results of traditional medicine drugs, traditional medicine ingredients, and medicinal materials. The head of the traditional medicine drugs, traditional medicine ingredients, and medicinal materials testing facility shall be responsible for the testing results of their own facility before the law.

2. Provisions on sampling traditional medicine drugs, traditional medicine ingredients, and medicinal materials for testing:

a) Sampling traditional medicine drugs, traditional medicine ingredients, and medicinal materials for testing: State testing facilities and business establishments shall carry out according to the provisions set forth in Appendix I of Circular No. 30/2025/TT-BYT dated July 1, 2025, issued by the Minister of Health guiding the application of quality standards, testing of drugs and raw materials for drugs, and recalling and handling non-compliant drugs (hereinafter referred to as Circular No. 30/2025/TT-BYT);

b) The sampling record of traditional medicine drugs, traditional medicine ingredients, and medicinal materials shall be carried out according to Model No. 03 (03A, 03B) in Appendix I attached to this Circular.

3. Reporting analysis and testing results of traditional medicine drugs, traditional medicine ingredients, and medicinal materials shall be carried out according to the provisions of Clause 3 of Article 7 of Circular No. 30/2025/TT-BYT and the Testing Report according to the provisions of Model No. 04 (04A, 04B), and the Analysis Report according to the provisions of Model No. 05 in Appendix I attached to this Circular.

4. Complaints and resolution of complaints about testing results: In case of disagreement with the testing results, within five working days from the date of receipt of the notification of testing results, pharmaceutical business establishments or medical examination and treatment facilities may request the Traditional Medicine and Traditional Pharmaceutical Management Department or the specialized health authority under the provincial People's Committee to designate another testing facility to retest the disputed quality criteria on the sample taken for analysis and testing, in accordance with Clause 2 of Article 105 of the Drug Law.

5. Sample retention:

a) Traditional medicine drugs, traditional medicine ingredients, and medicinal materials, after quality testing and having been concluded on quality, must be retained as samples. Retained samples must be sealed and stored under suitable conditions indicated on the label;

b) Sample storage period:

- The retention period for traditional medicine drug samples is until the expiration date of the drug;

- The retention period for traditional medicine ingredient and medicinal material samples is until the expiration date of the traditional medicine ingredient or medicinal material or twelve months from the date of sampling for quality testing.

6. Record keeping and documentation:

a) Records and documents related to the quality control of traditional medicine drugs, traditional medicine ingredients, and medicinal materials must be retained in accordance with the Law on Archives, the Decree guiding the Law on Archives, and Circular No. 53/2017/TT-BYT dated December 29, 2017, issued by the Minister of Health, concerning the retention period for professional records in the health sector (hereinafter referred to as Circular No. 53/2017/TT-BYT);

b) Records and documents when the retention period has expired shall be disposed of in accordance with the laws on archives.

Article 10. The testing period for traditional medicine, traditional herbal ingredients, and medicinal materials of business establishments listed in the List of Business Establishments with Violating Traditional Medicine, Traditional Herbal Ingredients, and Medicinal Materials Quality

The testing period for traditional medicine, traditional herbal ingredients, and medicinal materials of the same type as violating traditional medicine, or with the same name as violating traditional herbal ingredients and medicinal materials, shall be calculated from the date when the first batch of violating traditional medicine, traditional herbal ingredients, and medicinal materials is imported or produced after the announcement of the List of Business Establishments with Violating Traditional Medicine, Traditional Herbal Ingredients, and Medicinal Materials Quality by the Traditional Medicine and Pharmaceutical Administration Department or the health authority under the provincial People's Committee, as follows:

1. For traditional medicine of business establishments listed in the List of Business Establishments with Violating Traditional Medicine Quality:

a) Six months for business establishments with one batch of traditional medicine violating level 3;

b) Twelve months for business establishments with one batch of traditional medicine violating level 2 or two batches of traditional medicine violating level 3 or higher;

c) Twenty-four months for business establishments with one batch of traditional medicine violating level 1 or two batches of traditional medicine violating level 2 or higher.

2. For traditional herbal ingredients of business establishments listed in the List of Business Establishments with Violating Traditional Herbal Ingredients Quality:

a) Six months for business establishments with one batch of traditional herbal ingredients violating level 3;

b) Twelve months for business establishments with one batch of traditional herbal ingredients violating level 2 or two batches of traditional herbal ingredients violating level 3 or higher;

c) Eighteen months for business establishments with one batch of traditional herbal ingredients violating level 1 or two batches of traditional herbal ingredients violating level 2 or higher or three batches of traditional herbal ingredients violating level 3 or higher.

3. For medicinal materials of business establishments listed in the List of Business Establishments with Violating Medicinal Materials Quality:

a) Six months for business establishments with one batch of medicinal materials violating level 2;

b) Twelve months for business establishments with one batch of medicinal materials violating level 1 or two batches of medicinal materials violating level 2 or higher.

4. In cases where business establishments have not been removed from the List of Business Establishments with Violating Traditional Medicine, Traditional Herbal Ingredients, and Medicinal Materials Quality but continue to produce or import traditional medicine, traditional herbal ingredients, and medicinal materials of the same type as those previously violating quality standards, they must extend testing according to cumulative methods.

5. Testing for traditional medicine, traditional herbal ingredients, and medicinal materials as stipulated in Clauses 1, 2, and 3 of this Article must be conducted at state testing facilities meeting GLP standards or other testing facilities certified to operate in the pharmaceutical testing service sector, specifically as follows:

a) For traditional medicine, traditional herbal ingredients, and medicinal materials violating level 1: Test 100% of imported or produced batches;

b) For traditional medicine, traditional herbal ingredients, and medicinal materials violating level 2: Test 50% of imported or produced batches;

c) For traditional medicine, traditional herbal ingredients, and medicinal materials violating level 3: Test 30% of imported or produced batches.

Article 11. Announcing and Removing from the List of Business Establishments Selling Traditional Medicines, Traditional Herbal Ingredients, and Medicinal Materials Violating Quality Standards

1. Announcing the List of Business Establishments Selling Traditional Medicines, Traditional Herbal Ingredients, and Medicinal Materials Violating Quality Standards:

a) The Traditional Medicine and Pharmaceutical Administration shall announce the List of Business Establishments Selling Traditional Medicines, Traditional Herbal Ingredients, and Medicinal Materials Violating Quality Standards on its Electronic Information Website (website: ydct.moh.gov.vn) within three working days from the date of issuance of the decision to recall traditional medicines, traditional herbal ingredients, medicinal materials, or the report of the health specialized agency under the provincial People's Committee regarding the list of business establishments selling traditional medicines, traditional herbal ingredients, and medicinal materials violating quality standards;

b) The health specialized agency under the provincial People's Committee shall announce the List of Business Establishments Selling Traditional Medicines, Traditional Herbal Ingredients, and Medicinal Materials Violating Quality Standards on its Electronic Information Website within three working days from the date of issuance of the decision to recall traditional medicines, traditional herbal ingredients, and medicinal materials;

c) The Traditional Medicine and Pharmaceutical Administration and the health specialized agency under the provincial People's Committee shall not announce on their respective electronic information websites for cases where business establishments selling traditional medicines, traditional herbal ingredients, and medicinal materials that have been recalled are permitted to rectify and reuse; traditional medicines, traditional herbal ingredients, and medicinal materials violating quality levels 2 and 3 but only subject to handling at the sampling location as stipulated in points a and b, Clause 6, Article 17, points a and b, Clause 3, Article 18, and Clauses 6 and 7, Article 19 of this Circular.

2. A business establishment may be removed from the List of Business Establishments Selling Traditional Medicines, Traditional Herbal Ingredients, and Medicinal Materials Violating Quality Standards when it meets the following requirements:

a) Fully implement quality testing according to the deadlines specified in Clauses 1, 2, and 3, Article 10 of this Circular;

b) Provide a report on sample collection and quality testing as prescribed in Form No. 06 of Appendix I accompanying this Circular, along with evidence proving the implementation of testing for all batches of traditional medicines, traditional herbal ingredients, and medicinal materials with the same name as the traditional herbal ingredients and medicinal materials violating quality standards during production and importation into Vietnam as stipulated in Clauses 1, 2, and 3, Article 10 of this Circular;

c) During the period of implementing the provisions of Clauses 1, 2, and 3, Article 10 of this Circular, the business establishment does not violate quality standards for traditional medicines, traditional herbal ingredients, and medicinal materials with the same name as those violating quality standards and voluntarily recalls such traditional medicines, traditional herbal ingredients, and medicinal materials due to quality issues.

3. Within seven working days from the receipt of the report results from the pharmaceutical business establishment, the Traditional Medicine and Pharmaceutical Administration and the health specialized agency under the provincial People's Committee shall conduct a review to remove business establishments meeting the requirements set forth in Clause 2 of this Article from the List of Business Establishments Selling Traditional Medicines, Traditional Herbal Ingredients, and Medicinal Materials Violating Quality Standards.

Chapter V

TRACKING THE ORIGIN AND PLACE OF ORIGIN OF TRADITIONAL MEDICINES,

TRADITIONAL HERBAL INGREDIENTS, AND MEDICINAL MATERIALS

Article 12. Documents proving the origin and place of production of traditional medicine, traditional herbal ingredients, and medicinal materials

1. Documents proving the origin and place of production of traditional medicine include the registration certificate for circulation of traditional medicine or the decision to issue the registration certificate for circulation.

2. Documents proving the origin and place of production of traditional herbal ingredients include:

a) The registration certificate for circulation of traditional herbal ingredients or the quality standard announcement number (including those issued by the establishment);

b) Documents proving the origin and place of production of medicinal materials used to produce traditional herbal ingredients.

3. Documents proving the origin and place of production of medicinal materials:

a) For imported medicinal materials, it is the certificate of origin and place of production for each batch of medicinal materials (Certificate of Origin - CO) issued by the competent authority of the exporting country;

b) For medicinal materials cultivated, harvested, or extracted domestically and meeting Good Agricultural and Collection Practices (GACP), it is the GACP medicinal material certification;

c) For medicinal materials cultivated, harvested, or extracted domestically but not meeting GACP requirements, it is a commitment statement regarding the cultivation and harvesting location of medicinal materials in the locality according to Model No. 07 of Appendix I attached to this Circular.

Article 13. Provisions on the storage of documents related to the origin and place of production of traditional medicine, traditional herbal ingredients, and medicinal materials

1. Business establishments must retain these documents either in paper form or in management software, ensuring that each import and export transaction of traditional medicine, traditional herbal ingredients, and medicinal materials includes the following complete and accurate information:

a) The documents proving the origin and place of production of traditional medicine, traditional herbal ingredients, and medicinal materials as stipulated in Article 12 of this Circular;

b) Information about the selling and purchasing organizations or individuals, including name, address, phone number, email (if available);

c) Information about traditional medicine, including: name of traditional medicine, dosage form, content, batch number, date of manufacture, expiration date;

d) Information about traditional herbal ingredients, including: name of traditional herbal ingredient, processing method, scientific name of traditional herbal ingredient, quality standard, batch number, date of manufacture, expiration date;

đ) Information about medicinal materials, including: name of medicinal material, scientific name, part used, origin and place of production, quality standard;

e) Quantity and weight imported and sold;

g) Date of import (day, month, year); date of sale (day, month, year).

2. Production establishments, importers implementing distribution activities, or wholesale establishments acting as distributors must cooperate with wholesale and retail establishments to establish a distribution system and monitoring measures to ensure traceability of origin and place of production, control of routes, and storage conditions for traditional medicine, traditional herbal ingredients, and medicinal materials.

3. Business establishments shall store records and documents in accordance with Circular No. 53/2017/TT-BYT.

Chapter VI

PROVISIONS ON THE RECALL AND HANDLING OF VIOLATIVE TRADITIONAL MEDICINE, TRADITIONAL HERBAL INGREDIENTS, AND MEDICINAL MATERIALS

TRADITIONAL MEDICINE, ILLEGAL DRUGS

Article 14. Forms, scope, and time limit for recall

1. Forms of recall:

a) Forms of recall of traditional medicine as prescribed in Clause 1, Article 63 of the Medicine Law;

b) Forms of recall of traditional herbal ingredients and medicinal materials as prescribed in Clause 1, Article 103 of Decree No. 163/2025/NĐ-CP dated June 29, 2025 of the Government detailing certain provisions and measures to organize and guide the implementation of the Medicine Law (hereinafter referred to as Decree No. 163/2025/NĐ-CP).

2. Scope and time limit for recall:

a) Scope and time limit for recall of traditional medicine as prescribed in Clause 3, Article 63 of the Medicine Law;

b) Scope and time limit for recall of traditional herbal ingredients and medicinal materials as prescribed in Clause 2, Article 103 of Decree No. 163/2025/NĐ-CP.

Article 15. Procedure for Compulsory Recall of Traditional Medicines, Traditional Herbal Ingredients, and Medicinal Materials

1. Receiving information on traditional medicines, traditional herbal ingredients, and medicinal materials that violate regulations from the Traditional Medicine and Pharmaceutical Administration Bureau:

a) Information on the evaluation of traditional medicines that do not ensure therapeutic efficacy and safety from the Advisory Council for Drug Registration;

b) Information on the quality of traditional medicines, traditional herbal ingredients, and medicinal materials that do not meet standards from drug testing facilities;

c) Information on traditional medicines, traditional herbal ingredients, and medicinal materials that violate regulations discovered by the Traditional Medicine and Pharmaceutical Administration Bureau and inspection agencies;

d) Notifications on traditional medicines, traditional herbal ingredients, and medicinal materials that violate regulations from management agencies and national drug quality control agencies of foreign countries;

đ) Information on traditional medicines, traditional herbal ingredients, and medicinal materials that violate regulations (including counterfeit traditional medicines, traditional herbal ingredients, and medicinal materials of unknown origin) discovered by public security agencies, customs, and market management agencies;

e) Information on traditional medicines that do not ensure safety and efficacy from the National Center for Drug Information and Adverse Drug Reaction Monitoring.

2. Receiving information on traditional medicines, traditional herbal ingredients, and medicinal materials that violate regulations from health-related agencies under provincial People's Committees:

a) Information on the quality of traditional medicines, traditional herbal ingredients, and medicinal materials that do not meet standards from drug testing facilities;

b) Information on traditional medicines, traditional herbal ingredients, and medicinal materials that violate regulations discovered by the Traditional Medicine and Pharmaceutical Administration Bureau and inspection agencies within their jurisdiction;

c) Information on traditional medicines, traditional herbal ingredients, and medicinal materials that violate regulations (including counterfeit medicines and medicines of unknown origin) discovered by public security agencies, customs, and market management agencies within the province or city.

3. Time limit for determining the level of violation:

a) Time limit for determining the level of violation of traditional medicines: Within 24 hours from the time of receiving information on traditional medicines that violate regulations as stipulated in Points a, c, d, đ, e Clause 1 and Points b, c Clause 2 of this Article, the Traditional Medicine and Pharmaceutical Administration Bureau and health-related agencies under provincial People's Committees shall conduct the determination of the level of violation of traditional medicines according to the provisions of Appendix II issued together with this Circular and conclude on the recall of violating traditional medicines based on the assessment of risks to the health of users. In cases where opinions of the Advisory Council for Drug Registration are required, the determination of the level of violation of traditional medicines must be completed within a maximum of seven working days;

b) Time limit for determining the level of violation of traditional herbal ingredients and medicinal materials: Within 48 hours from the time of receiving information on violating traditional herbal ingredients and medicinal materials as stipulated in Point a, c, d, đ, e Clause 1 and Points b, c Clause 2 of this Article, the Traditional Medicine and Pharmaceutical Administration Bureau and health-related agencies under provincial People's Committees shall conduct the determination of the level of violation of traditional herbal ingredients and medicinal materials according to the provisions of Appendices III and IV issued together with this Circular and conclude on the recall of violating traditional herbal ingredients and medicinal materials based on the assessment of risks to the health of users. In cases where opinions of organizations or individuals are required for the determination of the level of violation of traditional herbal ingredients and medicinal materials, it must be completed within a maximum of fifteen days;

c) For information on traditional medicines, traditional herbal ingredients, and medicinal materials that violate regulations as stipulated in Point b Clause 1 and Point a Clause 2 of this Article, the determination of the level of violation of traditional herbal ingredients and medicinal materials shall be carried out according to the provisions of Article 17 of this Circular, and the determination of the level of violation of traditional medicines shall be carried out according to the provisions of Article 18 of this Circular. In cases of quality violations, the Traditional Medicine and Pharmaceutical Administration Bureau and health-related agencies under provincial People's Committees shall only determine the level of violation when the quality testing conducted by state-owned testing facilities meeting GLP standards is completed. If state-owned testing facilities have not yet met GLP standards, the Traditional Medicine and Pharmaceutical Administration Bureau and health-related agencies under provincial People's Committees shall request samples to be sent to central-level drug testing facilities for quality testing.

4. Handling by health-related agencies under provincial People's Committees of traditional medicines, traditional herbal ingredients, and medicinal materials that violate regulations within their jurisdiction:

a) Within 24 hours from the time of receiving information on traditional medicines, traditional herbal ingredients, and medicinal materials that violate regulations as stipulated in Clause 2 of this Article, health-related agencies under provincial People's Committees shall issue documents for handling, recalling, remedial measures, and re-exportation (if applicable) of traditional medicines, traditional herbal ingredients, and medicinal materials within their jurisdiction and at sampling locations for traditional medicines, traditional herbal ingredients, and medicinal materials that violate levels 2 or 3;

b) Supervising the recall, remediation, and re-exportation (if applicable) of samples of traditional medicines, traditional herbal ingredients, and medicinal materials for quality testing within their jurisdiction.

5. Handling by the Traditional Medicine and Pharmaceutical Administration Bureau of traditional medicines, traditional herbal ingredients, and medicinal materials that violate regulations:

a) Within no more than 24 hours from the time of concluding on the recall of traditional medicines for cases of violation as stipulated in Clause 1 of Article 65 of the Pharmacy Law, the Traditional Medicine and Pharmaceutical Administration Bureau shall issue a recall notice for traditional medicines;

b) Within no more than 48 hours from the time of concluding on the recall of traditional herbal ingredients and medicinal materials, the Traditional Medicine and Pharmaceutical Administration Bureau shall issue a recall notice for traditional herbal ingredients and medicinal materials that violate levels 1 or 2 due to errors of production facilities, import facilities, or within two provinces or cities nationwide;

c) The recall notice for traditional medicines, traditional herbal ingredients, and medicinal materials must include the following information: product name, registration number for circulation or import permit number or quality standard announcement number, composition, dosage form, manufacturing method (if applicable), quantity recalled, batch number, expiration date, production facility or import facility, level of violation, remedial measures, re-exportation (if applicable), responsible entity for recall.

6. Notification of documents revoking traditional medicine, traditional herbal ingredients, and medicinal materials:

a) Documents revoking traditional medicine, traditional herbal ingredients, and medicinal materials as prescribed in Clause 5 of this Article, the Traditional Medicine and Herbal Medicine Administration shall notify the health-related agencies under the provincial People's Committees and business establishments.

b) Documents revoking traditional medicine, traditional herbal ingredients, and medicinal materials as prescribed in Clause 4 of this Article, the health-related agencies under the provincial People's Committees shall report to the Traditional Medicine and Herbal Medicine Administration and notify the business establishments.

c) For traditional medicines, traditional herbal ingredients, and medicinal materials that violate regulations immediately after the Traditional Medicine and Herbal Medicine Administration publishes the revocation document on its electronic information website, the health-related agencies under the provincial People's Committees shall publish information about the revocation document on their electronic information websites.

Business establishments must notify information about revoked traditional medicines, traditional herbal ingredients, and medicinal materials to other business establishments and users who have purchased such products; the revocation shall be carried out within the scope specified in the revocation decision.

d) For traditional medicines, traditional herbal ingredients, and medicinal materials that violate at level 1, in addition to implementing the provisions set forth in point c of this clause, the revocation document must be announced by the Traditional Medicine and Herbal Medicine Administration on Vietnam Television and Voice of Vietnam.

7. Implementation of revocation of traditional medicine, traditional herbal ingredients, and medicinal materials

a) Business establishments and users of traditional medicine, traditional herbal ingredients, and medicinal materials must stop supplying and using them; store remaining traditional medicines, traditional herbal ingredients, and medicinal materials at their premises; compile a list of business establishments, users, and individuals (if any) who have purchased and contacted for returned products; return the products to the supplier.

b) Production establishments and import establishments must cooperate with entrusted import establishments or main distribution establishments to take responsibility for revoking violated traditional medicines, traditional herbal ingredients, and medicinal materials. The revocation record of traditional medicines, traditional herbal ingredients, and medicinal materials shall comply with Model No. 08 attached as Appendix I of this Circular.

In cases where business establishments fail to carry out revocation or refuse to accept returned products, the purchasing and using entities shall report to the health-related agencies under the provincial People's Committees in their locality for handling according to regulations.

c) The revocation of traditional medicines must be completed within the time limit stipulated in Clause 3 of Article 63 of the Drug Law.

d) The revocation of traditional herbal ingredients and medicinal materials must be completed within thirty days from the date of the revocation decision.

8. Reporting on revocation results: Starting from the completion of the revocation process, within one working day for level 1 revocations, three working days for level 2 and level 3 revocations, the responsible entity must submit a written report on the revocation results to the Traditional Medicine and Herbal Medicine Administration and the health-related agencies under the provincial People's Committees, along with the following documents:

a) A report on revocation results as prescribed in Model No. 09 attached as Appendix I of this Circular.

b) A list of establishments directly supplied or supplied through distribution establishments, including address, phone number, email (if available), quantity supplied, and quantity of products recalled.

c) Delivery and receipt records, invoices for returned goods, or other evidence demonstrating the revocation.

d) Self-assessment results on the effectiveness of the revocation.

đ) Investigation and evaluation results on the causes, risk assessment for other batches of violated medicinal materials and/or other traditional herbal ingredients and traditional medicines produced on the same production line.

9. Evaluation of revocation effectiveness: The Traditional Medicine and Herbal Medicine Administration shall review the revocation result reports submitted by the responsible entities to evaluate the effectiveness of the revocation or assign the health-related agencies under the provincial People's Committees to conduct the evaluation. If the revocation effectiveness is assessed as insufficient, with the potential for continued circulation and use of the product and a risk of adverse effects on user health, the Traditional Medicine and Herbal Medicine Administration shall coordinate with the health-related agencies under the provincial People's Committees and relevant authorities to enforce the revocation.

Article 16. Procedures for Voluntary Recall of Traditional Medicines, Traditional Herbal Ingredients, and Medicinal Materials

1. Cases of voluntary recall:

a) Business establishments discover and conclude that traditional medicines, traditional herbal ingredients, and medicinal materials violate quality, safety, or efficacy standards or show signs of such violations.

b) Business establishments recall due to commercial reasons.

c) Business establishments take samples, test quality, or send samples and issue voluntary recall letters for traditional medicines, traditional herbal ingredients, and medicinal materials, and report in writing to the Traditional Medicine and Pharmaceutical Administration Bureau before the samples of traditional medicines, traditional herbal ingredients, and medicinal materials are tested by competent authorities.

2. Cases not considered as voluntary recall:

a) Traditional medicines, traditional herbal ingredients, and medicinal materials have been sampled by management or quality control agencies for testing and concluded to be in violation of quality standards.

b) Traditional medicines have severe side effects or harmful reaction chains reported by the National Center for Drug Information and Adverse Reaction Monitoring.

c) Traditional medicines, traditional herbal ingredients, and medicinal materials do not ensure treatment safety and efficacy according to the Council's conclusion.

3. Procedures for voluntary recall:

a) After discovering that traditional medicines, traditional herbal ingredients, and medicinal materials violate quality standards or show signs of such violations, business establishments self-assess and determine the level of violation according to Appendices II, III, or IV issued with this Circular.

b) Issue a recall notice sent to distribution and usage establishments: The recall notice must clearly state the scope of the recall within one or several provinces/cities or nationwide based on risk assessment and violation causes.

c) Organize the recall and accept traditional medicines, traditional herbal ingredients, and medicinal materials subject to recall.

d) Report to the Traditional Medicine and Pharmaceutical Administration Bureau and the health authority of the provincial People's Committee regarding traditional medicines, traditional herbal ingredients, and medicinal materials that violate quality standards, including information related to the violation, results of self-assessment of the level of violation, extent, and scope of the recall.

đ) Issue a replacement recall notice for the previously issued notice if the Traditional Medicine and Pharmaceutical Administration Bureau or the health authority of the provincial People's Committee deems the extent and scope of the recall inappropriate.

e) Report the results of the recall and handling of recalled traditional medicines, traditional herbal ingredients, and medicinal materials; investigation and evaluation results determining the cause and measures to prevent and ensure the quality of produced and imported traditional medicines, traditional herbal ingredients, and medicinal materials.

4. Responsibilities of the Traditional Medicine and Pharmaceutical Administration in the voluntary recall of traditional medicines, traditional herbal ingredients, and medicinal materials:

a) Review reports on the decision to recall traditional medicines, traditional herbal ingredients, and medicinal materials by pharmaceutical business establishments. In cases where the level and scope of the recall are deemed inappropriate, issue a notice requesting the pharmaceutical business establishment to adjust the level and scope of the recall to ensure user safety.

b) Provide opinions on proposals for recycling or re-exporting recalled traditional medicines, traditional herbal ingredients, and medicinal materials.

c) Conduct inspections of corrective actions by manufacturing establishments in cases of Level 1 violations or repeated violations as stipulated in the Circular on Good Manufacturing Practices for Drugs and Active Pharmaceutical Ingredients.

Article 17. Handling Traditional Medicines Not Meeting Quality Standards Announced by State Testing Facilities

1. In cases where samples of traditional medicines violating quality standards are taken from retail establishments or medical examination and treatment facilities (hereinafter referred to as retail establishments):

a) Within twenty-four hours from the time of receiving the Test Report or Analysis Report sent by the testing facility, the health administration agency under the provincial People's Committee shall seal the batch of traditional medicines not meeting quality standards at the establishment where the sample was taken.

b) Within forty-eight hours from the time of receiving the Test Report or Analysis Report sent by the testing facility, the health administration agency under the provincial People's Committee shall issue a document requesting the registration entity, production facility, or import facility to take responsibility for:

- Reporting the distribution situation of the non-compliant batch of medicines (production quantity, import quantity, distribution quantity; name, address of establishments that purchased the batch, quantity purchased, and remaining quantity at each establishment) to the Traditional Medicine Management Department and the health administration agency under the provincial People's Committee within seven working days from the date the health administration agency under the provincial People's Committee issues the request document.

 - Cooperating with the provincial or municipal medicine testing facility to take additional samples at relevant establishments according to Clause 5 of this Article and reporting to the Traditional Medicine Management Department and the health administration agency under the provincial People's Committee within fifteen days from the date the health administration agency under the provincial People's Committee issues the request document.

- Sending the collected samples to the central-level testing facility for quality inspection on non-compliant criteria.

c) Based on the test results of the supplementary collected samples of traditional medicines, the Traditional Medicine Management Department and the health administration agency under the provincial People's Committee shall handle according to Clause 6 of this Article.

2. In cases where samples of traditional medicines are taken from wholesale establishments:

a) Within twenty-four hours from the time of receiving the Test Report or Analysis Report sent by the testing facility, the health administration agency under the provincial People's Committee shall seal the batch of traditional medicines not meeting quality standards at the establishment where the sample was taken.

b) Within forty-eight hours from the time of receiving the Test Report or Analysis Report sent by the testing facility, the health administration agency under the provincial People's Committee shall determine the level of violation according to Appendix II issued together with this Circular, issue a document to recall and announce the recall of the batch of traditional medicines on the territory of the province or centrally-administered city where the sample was taken according to Clause 5 and Clause 6 of Article 15 of this Circular, and issue a document requesting the registration entity, production facility, or import facility to take responsibility for:

- Reporting the distribution situation of the non-compliant batch of medicines to the wholesale establishment and medical examination and treatment facilities (production quantity, import quantity, distribution quantity; name, address of establishments that purchased the medicine, quantity purchased, and remaining quantity at each establishment) to the Traditional Medicine Management Department and the health administration agency under the provincial People's Committee within a maximum of seven working days from the date the health administration agency under the provincial People's Committee issues the request document.

 - Cooperating with the provincial or municipal medicine testing facility to take additional samples at relevant establishments according to Clause 5 of this Article and reporting to the Traditional Medicine Management Department and the health administration agency under the provincial People's Committee within fifteen days from the date the health administration agency under the provincial People's Committee issues the request document.

- Sending the collected samples to the central-level testing facility for quality inspection on non-compliant criteria.

c) Based on the test results of the supplementary collected samples of traditional medicines, the Traditional Medicine Management Department and the health administration agency under the provincial People's Committee shall handle according to Clause 6 of this Article.

3. In cases where samples of traditional medicines are taken from production facilities, import facilities, service preservation business establishments, or traditional medicines are determined to violate quality standards due to reasons during the production process, or in cases where a batch of medicines has been sampled simultaneously at two wholesale establishments, the Traditional Medicine Management Department shall determine the level of violation and conclude the recall of the violating traditional medicines according to Appendix II issued together with this Circular. Issue a document to recall and announce the recall of the traditional medicines according to Clause 5 and Clause 6 of Article 15 of this Circular.

4. In cases where the violating traditional medicines are produced by medical examination and treatment facilities according to Clauses 1 and 2 of Article 70 of the Pharmacy Law, the health administration agency under the provincial People's Committee shall determine the level of violation and issue a document to recall the violating traditional medicines according to Clause 3 and Clause 4 of Article 15 of this Circular. The recall document shall be sent to the medical examination and treatment facility producing the violating traditional medicines for implementation of the recall. The result report shall be sent back to the health administration agency under the provincial People's Committee and the Traditional Medicine Management Department.

5. Requirements for taking additional samples for quality inspection as stipulated in Clause 1 and Clause 2 of this Article, the quality control agency shall determine the sampling plan based on the distribution situation report of the production facility, import facility, and the order of sampling as follows:

a) Samples of traditional medicines taken from wholesale establishments in different provinces or centrally-administered cities, including wholesale establishments that have supplied traditional medicines to the establishment where the initial sample was taken.

b) Samples of traditional medicines taken from wholesale establishments in different provinces or centrally-administered cities.

c) Samples of traditional medicines taken from wholesale establishments in the same province or centrally-administered city.

d) Samples of traditional medicines taken from wholesale establishments and retail establishments.

đ) Samples of traditional medicines taken from retail establishments (only applicable when the production facility or import facility proves that the traditional medicines are no longer stored at wholesale establishments). No additional sampling shall be conducted for recalled traditional medicines.

6. Handling the results of testing supplementary collected samples of traditional medicines:

a) In cases where all supplementary collected samples of traditional medicines meet quality standards, the health administration agency under the provincial People's Committee shall issue a document determining the level of violation and proceed to handle the quality violation of the initial retail establishment sampled under Clause 1 of this Article or the wholesale establishment that has recalled the batch on the provincial or centrally-administered city territory under Clause 2 of this Article.

b) In case at least one sample of traditional medicine collected for supplementary testing from a retail establishment does not meet quality standards, except for cases stipulated in point a of this clause, within one working day, the specialized health agency under the provincial People's Committee shall report to the Traditional Medicine Management Department to assess the risk and issue a document determining the level of violation and the entity responsible for the violation; handle the traditional medicines of the retail establishments from which samples were taken; warn about storage conditions and quality of the medicines.

c) In case at least one sample of traditional medicine collected for supplementary testing from a wholesale establishment or all samples collected for supplementary testing from retail establishments as prescribed in point đ of Clause 5 of this Article do not meet quality standards, within a maximum of 24 hours, the specialized health agency under the provincial People's Committee shall report to the Traditional Medicine Management Department, determine the level of violation according to Appendix II issued together with this Circular. Issue a document to recall and announce the recall of traditional medicines according to Clause 4 and Clause 6 of Article 15 of this Circular. In case the recalled traditional medicines have been rectified, the Traditional Medicine Management Department shall clearly state the corrective measures in the document.

d) In case the production facility or the importing entity reports that there are no remaining circulating or used samples, or the quality control management agency reports that it cannot collect supplementary samples or does not collect the required number of samples, but the collected supplementary samples meet quality standards, the Traditional Medicine Management Department shall issue a warning document to the specialized health agency under the provincial People's Committee and the drug testing system to review and collect supplementary samples according to regulations. The production facility or the importing entity must pay for the cost of collecting and purchasing samples and the testing fees.

Article 18. Handling of traditional medicines and medicinal materials that do not meet quality standards reported by the national testing facility

1. Within 24 hours from the time of receiving the Test Report or Analysis Report sent by the testing facility, the specialized health agency under the provincial People's Committee shall seal the traditional medicines and medicinal materials that do not meet quality standards at the sampling location.

2. Within 48 hours from the time of receiving the Test Report or Analysis Report sent by the testing facility, the specialized health agency under the provincial People's Committee shall issue a document requiring the business entity to be responsible for:

a) Reporting the distribution situation of traditional medicines and medicinal materials to wholesale, retail establishments, medical examination and treatment facilities (production quantity, import quantity; name, address of the establishment that purchased traditional medicines and medicinal materials, quantity purchased and quantity remaining at each establishment) to be submitted to the Traditional Medicine Management Department and the specialized health agency under the provincial People's Committee within seven working days from the date the specialized health agency under the provincial People's Committee issues the request document.

b) Cooperating with the provincial or city drug testing facility to take one sample of the batch of traditional medicines and medicinal materials that do not meet quality standards from the production facility or the importing entity and one sample from the wholesale establishment or retail establishment or medical examination and treatment facility in another province for quality testing on non-conforming indicators; submit the report on the implementation results to the Traditional Medicine Management Department and the specialized health agency under the provincial People's Committee within fifteen days from the date the specialized health agency under the provincial People's Committee issues the request document.

c) Sending the collected samples to the central-level drug testing facility for quality testing on non-conforming indicators.

3. Based on the test results of the supplementary collected samples of traditional medicines and medicinal materials, the Traditional Medicine Management Department and the specialized health agency under the provincial People's Committee shall handle specifically as follows:

a) In case the supplementary collected samples of traditional medicines and medicinal materials meet quality standards, the specialized health agency under the provincial People's Committee shall handle the traditional medicines and medicinal materials at the initial sampling location.

b) In case at least one supplementary collected sample of traditional medicines and medicinal materials from a retail establishment does not meet quality standards, the Traditional Medicine Management Department shall assess the risk, issue a document determining the level of violation and the entity responsible for the violation, instruct the specialized health agency under the provincial People's Committee to handle the traditional medicines and medicinal materials at the retail establishments from which samples were taken, and warn about storage conditions and quality of the medicines.

c) In case at least one supplementary collected sample of traditional medicines and medicinal materials from a production facility, importing entity, wholesale establishment, medical examination and treatment facility, or all supplementary collected samples from retail establishments do not meet quality standards, the Traditional Medicine Management Department shall determine the level of violation and conclude on the recall of traditional medicines according to Appendix III, and medicinal materials violating according to Appendix IV issued together with this Circular, issue a document recalling the medicines according to Clause 5 of Article 15 of this Circular.

d) In case the production facility or the importing entity reports that there are no remaining circulating or used samples, or the quality control management agency (police, customs, market supervision, Vietnamese diplomatic agencies abroad, foreign diplomatic agencies in Vietnam) reports that it cannot collect supplementary samples or does not collect the required number of samples, the specialized health agency under the provincial People's Committee shall determine the level of violation and conclude on the recall within its jurisdiction of traditional medicines according to Appendix III, and medicinal materials violating according to Appendix IV issued together with this Circular, issue a document recalling traditional medicines and medicinal materials according to Clause 4 of Article 15 of this Circular.

Article 19. Destruction of Traditional Medicines, Traditional Herbal Ingredients, and Medicinal Materials

1. Traditional medicines subject to recall must be destroyed in the following cases:

a) Traditional medicines have exceeded their expiration date;

b) Traditional medicines are damaged during production, storage, or transportation;

c) Traditional medicine samples that have exceeded the retention period as prescribed;

d) Traditional medicines recalled due to violation level 1 or level 2;

đ) Traditional medicines recalled due to non-reparable violation level 3;

e) Traditional medicines recalled due to violation level 3 that are permitted to be rectified or re-exported but fail to implement such actions;

g) Fake traditional medicines, smuggled traditional medicines, traditional medicines of unknown origin, or traditional medicines containing prohibited substances;

h) Traditional medicines required to be destroyed according to the provisions of Decree No. 117/2020/NĐ-CP dated September 28, 2020 on administrative penalties in the field of health;

i) Traditional medicines produced from raw materials not meeting quality standards, except when the non-compliance can be addressed during production without affecting the production process or the quality of the medicine (for example: moisture content...).

2. Traditional herbal ingredients and medicinal materials subject to recall must be destroyed in the following cases:

a) Traditional herbal ingredients and medicinal materials have exceeded their expiration date;

b) Traditional herbal ingredients and medicinal materials are damaged during production, storage, or transportation;

c) Traditional herbal ingredient and medicinal material samples that have exceeded the retention period as prescribed;

đ) Traditional herbal ingredients and medicinal materials recalled according to Clause 1, Article 102 of Decree No. 163/2025/NĐ-CP;

đ) Traditional herbal ingredients and medicinal materials recalled due to violation level 1 or level 2;

e) Traditional herbal ingredients and medicinal materials recalled due to non-reparable violation level 3 after examination by the health authority under the provincial People's Committee according to Clause 3 of this Article;

g) Traditional herbal ingredients and medicinal materials recalled due to violation level 3 that are permitted to be rectified or re-exported but fail to implement such actions.

3. Destruction of traditional medicines at manufacturing, import, wholesale establishments, pharmaceutical testing facilities, hospitals, and institutes with hospital beds:

a) The head of a pharmaceutical business entity with traditional medicines subject to destruction shall establish a destruction committee. The committee must consist of at least three members, including one representative responsible for technical matters;

b) The destruction of traditional medicines must ensure safety for people and animals and prevent environmental pollution in accordance with laws on environmental protection;

c) The entity destroying traditional medicines must report along with the minutes of the destruction to the health authority under the provincial People's Committee according to Model No. 10 of Appendix I issued together with this Circular;

d) A pharmaceutical business entity with traditional medicines violating regulations must bear responsibility for the costs of destruction.

4. Destruction of batches of traditional herbal ingredients and medicinal materials shall be carried out in accordance with Clause 5, Article 102 of Decree No. 163/2025/NĐ-CP;

The entity destroying traditional herbal ingredients and medicinal materials must report along with the minutes of the destruction to the health authority under the provincial People's Committee according to Model No. 10 of Appendix I issued together with this Circular.

5. The time limit for handling traditional medicines, traditional herbal ingredients, and medicinal materials subject to recall shall not exceed twelve months from the completion of the recall process as stipulated in Points a, b, and c of Clause 3, Article 63 of the Drug Law.

6. Violating traditional medicines may be rectified or re-exported in the following cases:

a) Traditional medicines violating level 3 and not falling within the cases specified in Point đ and e of Clause 1 of this Article;

b) Traditional medicines violating labeling and user guide requirements;

c) Traditional medicines packaged in outer packaging from component medicines packaged in different direct packaging (kits) where one or some components do not meet quality standards. Based on the degree of violation of the component medicine, it is permitted to recycle, re-export, or destroy the component medicine according to regulations. Other components meeting quality standards are permitted to be recycled and repackaged appropriately.

7. Traditional herbal ingredients and medicinal materials subject to recall may be rectified and reused according to Clause 2, Article 102 of Decree No. 163/2025/NĐ-CP.

Article 20. Suspension of Business, Use, and Sealing for Storage of Traditional Medicines, Traditional Herbal Ingredients, and Herbs with Signs of Being Unsafe for Users

1. The Traditional Medicine Management Department shall receive information along with relevant file materials (if available) concerning traditional medicines, traditional herbal ingredients, and herbs that have signs of being unsafe for users from:

a) Competent authorities (including police, customs, market management, inspection agencies, Vietnamese diplomatic missions abroad, foreign diplomatic missions in Vietnam);

b) The World Health Organization, drug regulatory agencies, or foreign health regulatory agencies;

c) Specialized health agencies under provincial People's Committees, and health sectors;

d) The National Center for Drug Information and Adverse Reaction Monitoring;

đ) Production, business, and usage establishments of traditional medicines, traditional herbal ingredients, and herbs, and other agencies, organizations, and individuals;

2. Forms of Information on Traditional Medicines, Traditional Herbal Ingredients, and Herbs with Signs of Being Unsafe for Users:

a) Official documents from the agencies specified in point a, c, and d of Clause 1 of this Article shall be sent directly or through official mail to the Ministry of Health or via the Ministry of Health's Electronic Document Management System;

b) In addition to the forms specified in point a of this clause, official documents from the agencies specified in point b of Clause 1 of this Article may be sent via email or posted on the official electronic information website of the agency;

c) Complaints, reports, or direct presentations at competent authorities according to the laws on complaints and denunciations by agencies, organizations, and individuals specified in point đ of Clause 1 of this Article;

3. Traditional medicines, traditional herbal ingredients, and herbs with signs of being unsafe for users include:

a) Traditional medicines, traditional herbal ingredients, and herbs with serious or repeated adverse reaction reports related to the medicine but not previously known adverse reactions;

b) Traditional medicines, traditional herbal ingredients, and herbs suspected of containing harmful substances or impurities exceeding safe limits for users;

c) Traditional medicines, traditional herbal ingredients, and herbs suspected of failing quality standards;

d) Traditional medicines, traditional herbal ingredients, and herbs suspected of being counterfeit or not of the correct origin or source;

đ) Traditional medicines and traditional herbal ingredients produced from raw materials of unknown origin or failing quality standards;

e) Traditional medicines, traditional herbal ingredients, and herbs produced at domestic production facilities with serious violations regarding drug production conditions as reported by competent authorities (Inspection, Police, Market Management) or by provincial Health Departments;

g) Traditional medicines, traditional herbal ingredients, and herbs produced at overseas production facilities with serious violations of Good Manufacturing Practices for drugs and active pharmaceutical ingredients, and where some batches of drugs produced by the facility have been recalled or suspended due to violations, as announced by foreign drug regulatory or health regulatory agencies;

4. Responsibilities of the Traditional Medicine Management Department in Handling Information and Announcing the Suspension of Business, Use, and Sealing for Storage of Drugs with Signs of Being Unsafe for Users:

a) Within seven working days from receiving information as stipulated in Clauses 1 and 2 of this Article, the Traditional Medicine Management Department shall review the received information, coordinate with at least one specialized agency (Council; Central Institute for Pharmaceutical Inspection; Ho Chi Minh City Institute for Pharmaceutical Inspection; Specialized Hospital Treatment Council) or inspection, police, customs, and market management agencies if necessary, to assess the risk of impact on user health, and determine the scope of suspension of business, use of traditional medicines, traditional herbal ingredients, and herbs with signs of being unsafe for users as defined in Clause 3 of this Article;

b) Within three working days from the conclusion that the drugs pose a risk to user health, the Traditional Medicine Management Department shall issue a notice suspending the production, importation, distribution, use, and sealing of one or more batches of traditional medicines, traditional herbal ingredients, and herbs or items of traditional medicines, traditional herbal ingredients, and herbs that are not assured to be safe for users;

c) The period for suspending business, use, and sealing for storage of traditional medicines, traditional herbal ingredients, and herbs with signs of not being safe for users to conduct verification shall be as follows:

The suspension period is two months from the date of issuance of the document. In complex cases or when domestic technical conditions for analyzing and testing traditional medicines, traditional herbal ingredients, and herbs are insufficient, the suspension period may be extended by an additional two months;

If beyond the aforementioned period, and if the police, market management, customs, or inspection agencies issue a request to continue suspending business and use to serve the investigation and verification process, the suspension period will be extended based on current regulations and the requirements of these agencies;

d) Within three working days from the conclusion that traditional medicines, traditional herbal ingredients, and herbs do not violate regulations or after the suspension announcement period as specified in point c of this clause has expired without concluding that traditional medicines, traditional herbal ingredients, and herbs violate regulations, the Traditional Medicine Management Department shall issue a notice allowing the establishment to continue producing, importing, distributing, using traditional medicines, traditional herbal ingredients, and herbs or batches of traditional medicines, traditional herbal ingredients, and herbs that meet quality standards and are within their shelf life.

In the case where traditional medicine drugs, traditional herbal medicines, and medicinal materials are found to violate regulations and fail to ensure safety for users, the Traditional Medicine and Herbal Medicine Administration shall issue a document to recall such traditional medicine drugs, traditional herbal medicines, and medicinal materials that have been temporarily suspended from distribution and use, and stop production and importation of traditional medicine drugs, traditional herbal medicines, and medicinal materials that do not ensure safety for users; administrative penalties shall be imposed or the case shall be transferred to competent authorities for criminal responsibility according to the provisions.

5. Responsibilities of the health specialized agencies under the provincial People's Committees in handling information and issuing temporary suspension notices for the sale and use of drugs with signs of being unsafe for users:

a) The health specialized agencies under the provincial People's Committees shall be responsible for disseminating the conclusions of the Ministry of Health to drug business establishments and users within their jurisdiction and supervise the temporary suspension of sales and use and sealing and storage of traditional medicine drugs, traditional herbal medicines, and medicinal materials that show signs of being unsafe for users;

b) Disseminate the conclusions of the Traditional Medicine and Herbal Medicine Administration allowing business establishments to continue selling and using or recalling traditional medicine drugs, traditional herbal medicines, and medicinal materials; supervise the business establishments' implementation of the recall as prescribed;

c) Coordinate with functional agencies on the local level to conduct inspections, verifications, and investigations related to traditional medicine drugs, traditional herbal medicines, and medicinal materials showing signs of failing to ensure safety as mentioned above occurring within their jurisdiction or upon request, and report the results to the Traditional Medicine and Herbal Medicine Administration;

6. Responsibilities of drug business establishments and drug user establishments:

a) Report to the Traditional Medicine and Herbal Medicine Administration or the health specialized agencies under the provincial People's Committees about cases of traditional medicine drugs, traditional herbal medicines, and medicinal materials showing signs of failing to ensure safety for users;

b) Implement the temporary suspension of sales and use and sealing and storage of traditional medicine drugs, traditional herbal medicines, and medicinal materials showing signs of being unsafe for users according to the conclusions of the Traditional Medicine and Herbal Medicine Administration; self-seal and store traditional medicine drugs, traditional herbal medicines, and medicinal materials in accordance with the storage conditions indicated on the label;

c) Cooperate with functional agencies during the verification process of traditional medicine drugs, traditional herbal medicines, and medicinal materials showing signs of being unsafe for users (providing relevant files, documents, and evidence to serve the verification process);

d) Continue selling and using drugs according to the notice of the Traditional Medicine and Herbal Medicine Administration concluding that traditional medicine drugs, traditional herbal medicines, and medicinal materials meet the regulations or implement the recall of traditional medicine drugs, traditional herbal medicines, and medicinal materials that do not ensure safety for users according to the recall document issued by the Traditional Medicine and Herbal Medicine Administration when required by regulation;

7. Specific provisions regarding cooperation between the Traditional Medicine and Herbal Medicine Administration and relevant functional agencies, organizations, and individuals to verify and conclude on the quality of traditional medicine drugs, traditional herbal medicines, and medicinal materials, and the degree of safety for users of traditional medicine drugs, traditional herbal medicines, and medicinal materials:

a) For cases of drug information specified in points a, b, c, and g of Clause 3 of this Article, the Traditional Medicine and Herbal Medicine Administration shall report to the Council for consideration and conclusion;

b) For cases of drug information specified in points c and d of Clause 3 of this Article, the Traditional Medicine and Herbal Medicine Administration shall direct and coordinate with the Central Institute of Pharmaceutical Inspection, Ho Chi Minh City Institute of Pharmaceutical Inspection to conduct analysis, testing, and conclude on the quality of traditional medicine drugs, traditional herbal medicines, and medicinal materials;

c) For cases of traditional medicine drugs, traditional herbal medicines, and medicinal materials suspected of being counterfeit; traditional medicine drugs, traditional herbal medicines, and medicinal materials of unknown origin or incorrect origin as specified in points d and e of Clause 3 of this Article, the Traditional Medicine and Herbal Medicine Administration shall issue a document transferring information to the competent authority (Police/Market Management/Customs/Inspectorate) along with relevant files and documents for investigation and verification according to their functions and responsibilities and in accordance with the law;

d) For cases of drug information specified in point f of Clause 3 of this Article, the Traditional Medicine and Herbal Medicine Administration shall organize surprise inspections and audits of domestic drug manufacturing and trading establishments to maintain production conditions as prescribed;

e) For cases of drug information specified in point g of Clause 3 of this Article, the Traditional Medicine and Herbal Medicine Administration shall contact and exchange with the drug management agency or the health management agency of the country of origin, the drug management agency that has issued the violation notice, and conduct an assessment of Good Manufacturing Practices at the facility if conditions permit;

f) When sufficient grounds are needed for a conclusion, the central state drug inspection agency shall be the focal point for conducting analysis and testing to determine the quality of the drug. Testing of certain or all quality indicators according to the drug quality standards shall be determined by the Traditional Medicine and Herbal Medicine Administration in coordination with the specialized agencies as stipulated in point a of Clause 4 of this Article based on risk assessment and correlation with signs of being unsafe for users, information on drug quality, usage situation, and information on adverse reactions and side effects of the drug.

Article 21. Responsibilities for Handling Traditional Medicines, Traditional Herbal Ingredients, and Medicinal Materials Violating Quality Standards

1. Responsibilities of the Traditional Medicine and Pharmaceutical Administration Bureau:

a) Receive information, determine the level of violation of traditional medicines, traditional herbal ingredients, and medicinal materials, and issue decisions to recall such items;

b) Announce decisions to recall traditional medicines, traditional herbal ingredients, and medicinal materials according to Clause 6, Article 15 of this Circular, publish information about recalled medicines on the Ministry of Health's Electronic Information Portal and the Traditional Medicine and Pharmaceutical Administration Bureau's Electronic Information Portal after issuing the recall decision. Coordinate with Vietnam Television and Voice of Vietnam to announce information about recalling traditional medicines, traditional herbal ingredients, and medicinal materials at Level 1 violations;

c) Review reports from production facilities and importers regarding voluntary recalls; provide opinions requiring adjustments to the level and scope of recalls when evaluating voluntary recalls that do not ensure user safety. Supervise voluntary recalls by facilities;

d) Coordinate with relevant units, health sector agencies under provincial People's Committees, health sectors, inspection, and supervision of the organization and implementation of recalls of traditional medicines, traditional herbal ingredients, and medicinal materials; handle violative facilities according to the law;

đ) Issue detailed guidelines on the process of handling, recalling medicines, and assessing the effectiveness of recall announcements of traditional medicines, traditional herbal ingredients, and medicinal materials by production and trading facilities;

2. Responsibilities of health sector agencies under provincial People's Committees:

a) Issue decisions to recall traditional medicines, traditional herbal ingredients, and medicinal materials within their jurisdiction in cases of Level 2 and 3 violations. Publish information about recall decisions on the Electronic Information Portal of the health sector agency under the provincial People's Committee;

b) Organize notifications and dissemination of recall information to pharmaceutical production and trading facilities, medical examination and treatment facilities within their jurisdiction;

c) Conduct sampling or instruct the Testing Center to conduct supplementary sampling in conjunction with facilities where traditional medicines, traditional herbal ingredients, and medicinal materials violate quality standards;

d) Organize supervision of the recall and destruction of traditional medicines, traditional herbal ingredients, and medicinal materials within their jurisdiction; handle and impose penalties on violative facilities according to their authority; report results to the Traditional Medicine and Pharmaceutical Administration Bureau;

đ) Participate or implement evaluations of the effectiveness of recalls of traditional medicines, traditional herbal ingredients, and medicinal materials by pharmaceutical trading facilities within their jurisdiction as directed by the Traditional Medicine and Pharmaceutical Administration Bureau. Report to the Traditional Medicine and Pharmaceutical Administration Bureau on cases where production facilities, importers, and wholesale distributors fail to fully implement recalls of traditional medicines, traditional herbal ingredients, and medicinal materials;

e) Organize or participate in forced recalls of traditional medicines, traditional herbal ingredients, and medicinal materials;

3. Responsibilities of pharmaceutical trading facilities, medical examination and treatment facilities, and users:

a) Implement provisions in Clauses 1, 2, and 3 of Article 64 of the Drug Law;

b) Regularly check and update information about recalls of traditional medicines, traditional herbal ingredients, and medicinal materials on the Electronic Information Portal of the Traditional Medicine and Pharmaceutical Administration Bureau and the health sector agency under the provincial People's Committee;

Chapter VII

IMPLEMENTING PROVISIONS

Article 22. Effectiveness

Article 32. Responsibilities of Agencies

2. Circular No. 38/2021/TT-BYT dated December 31, 2021, of the Minister of Health on the quality of medicinal materials and traditional medicines becomes invalid from the date this Circular takes effect;

3. The phased implementation of the delegation of authority to announce quality standards for traditional herbal ingredients and medicinal materials as stipulated in Points a and b of Clause 2, Article 8 of this Circular is as follows:

a) Before January 1, 2026, the Traditional Medicine and Pharmaceutical Administration Bureau will handle procedures to announce quality standards for traditional herbal ingredients and medicinal materials;

b) From January 1, 2026, the Traditional Medicine and Pharmaceutical Administration Bureau will handle procedures to announce quality standards for traditional herbal ingredients and medicinal materials for medical examination and treatment facilities directly under the Ministry;

c) From January 1, 2026, health sector agencies under provincial People's Committees will handle procedures to announce quality standards for traditional herbal ingredients and medicinal materials for trading facilities and medical examination and treatment facilities within their jurisdiction;

Article 23. Cross-referencing Provisions

In cases where the referenced documents in this Circular are replaced or amended, they shall be applied according to the replacement or amended documents.

Article 24. Transitional Provisions

Applications for announcing quality standards for medicinal materials submitted before this Circular takes effect shall continue to be processed according to Circular No. 38/2021/TT-BYT dated December 31, 2021, of the Minister of Health on the quality of medicinal materials and traditional medicines;

Article 25. Responsibility for implementation organization

1. The Traditional Medicine Management Department shall be responsible for:

a) Take the lead and coordinate with related units to organize publicity, dissemination, guidance, and implementation of this Circular;

b) Provide central-level drug testing facilities with quality standards of traditional medicines that have been granted registration permits;

c) Organize inspections of the quality of imported, cultivated, harvested, produced, processed, circulated, and used traditional medicines, traditional herbal ingredients, and medicinal materials nationwide; direct and supervise the national drug testing system to conduct tests on traditional medicines, traditional herbal ingredients, and medicinal materials; conclude on the quality of traditional medicines, traditional herbal ingredients, and medicinal materials based on test results from state testing facilities and related documents;

d) Lead or coordinate in performing state inspection functions, audits, and handling violations of laws concerning the quality of traditional medicines, traditional herbal ingredients, and medicinal materials according to their authority;

đ) Develop and implement a traceability system for the origin of traditional medicines, traditional herbal ingredients, and medicinal materials;

e) Coordinate with the Central Institute for Pharmaceutical Inspection, Ho Chi Minh City Institute for Pharmaceutical Inspection to develop plans for sampling traditional medicine drugs, traditional medicine ingredients, and medicinal materials for quality testing at production, compounding, import, export, storage, wholesale, retail, and usage facilities nationwide, submit these plans to the Ministry of Health for review, approval, and budget allocation for implementation according to authority;

Coordinate the implementation of sampling traditional medicine drugs, traditional medicine ingredients, and medicinal materials for quality testing according to approved plans and update information on sampled traditional medicine drugs, traditional medicine ingredients, and medicinal materials (including drug name, raw material, concentration, content, dosage form, batch number, expiration date, registration certificate or import permit number, production facility, import facility, sampling facility) and quality test results for traditional medicine drugs, traditional medicine ingredients, and medicinal materials into the Ministry of Health's quality inspection data system;

g) Provide scientific and technical information related to ensuring the quality of traditional medicine drugs, traditional medicine ingredients, and medicinal materials;

Provide the Central Institute for Pharmaceutical Inspection, Ho Chi Minh City Institute for Pharmaceutical Inspection with sample labels and quality standards of traditional medicine drugs, traditional medicine ingredients, and medicinal materials that have been issued a registration certificate or announced quality standards or import permits, and updates in case of changes;

2. Provincial People's Committee health administrative agencies shall be responsible for:

a) Organizing the implementation of quality inspections of traditional medicine drugs, traditional medicine ingredients, and medicinal materials within their province/city and handling violations according to the law;

b) Taking the lead or coordinating to perform state inspection functions, audits, and handling violations of laws regarding the quality of traditional medicine drugs, traditional medicine ingredients, and medicinal materials according to authority;

c) Directing provincial/city inspection centers to develop plans for sampling traditional medicine drugs, traditional medicine ingredients, and medicinal materials for quality testing;

d) Updating information on sampled traditional medicine drugs, traditional medicine ingredients, and medicinal materials into the Ministry of Health's quality inspection data system;

đ) Organizing the collection of information and updating the publication on the health administrative agency's electronic information website of the list of local facilities and locations for growing, harvesting, and exploiting medicinal materials;

e) Providing the pharmaceutical inspection agency and raw material inspection agency with quality standards of traditional medicine ingredients and medicinal materials that have been announced or issued a registration certificate;

3. Central-level pharmaceutical inspection facilities shall be responsible for:

a) Annually developing plans for sampling traditional medicine drugs, traditional medicine ingredients, and medicinal materials for quality testing, submitting these plans to the Minister of Health for review, approval, and budget allocation for implementation according to authority;

b) Implementing the sampling of traditional medicine drugs, traditional medicine ingredients, and medicinal materials for quality testing;

c) Conducting analysis and testing samples to determine the quality of imported traditional medicine drugs, traditional medicine ingredients, and medicinal materials; cultivated, harvested, exploited; produced, processed; circulated; used. Reporting the testing results to the Traditional Medicine and Herbal Medicine Management Department;

d) Researching, establishing, and publishing on the websites of Institutes a list of standard substances, reference substances, and impurity standards for the analysis and testing of imported traditional medicine drugs, traditional medicine ingredients, and medicinal materials; cultivated, harvested, exploited; produced, processed; circulated; used within Vietnam;

đ) Being responsible for providing provincial/city pharmaceutical inspection centers under their assigned areas with copies or electronic documents of the quality standards of traditional medicine drugs, traditional medicine ingredients, and medicinal materials;

4. Provincial/Central City Inspection Centers:

a) Annually developing plans for sampling traditional medicine drugs, traditional medicine ingredients, and medicinal materials for quality testing, submitting these plans to the Minister of Health for review, approval, and budget allocation for implementation according to authority;

b) Conducting analysis and testing samples to determine the quality of imported traditional medicine drugs, traditional medicine ingredients, and medicinal materials; cultivated, harvested, exploited; produced, processed; circulated; used. Reporting the testing results to the Traditional Medicine and Herbal Medicine Management Department and the health administrative agency of the provincial people's committee where the sampling was conducted;

Notifying the Traditional Medicine and Herbal Medicine Management Department and the Central-level Pharmaceutical Inspection Line about the list of tested indicators that have been reviewed and issued a Certificate according to regulations;

c) Recovering sampling fees from business establishments and units that refund and covering testing costs for traditional medicine drugs, traditional medicine ingredients, and medicinal materials that do not meet quality standards according to the law;

5. Drug Business Establishments shall be responsible for:

a) Organizing research to implement the provisions of the law on managing the quality of traditional medicine drugs, traditional medicine ingredients, and medicinal materials issued in this Circular;

b) Ensuring the quality of traditional medicine drugs, traditional medicine ingredients, and medicinal materials throughout the entire operation process of the establishment (growing, harvesting, exploiting; exporting, importing; processing, producing; storing; transporting; distributing) and within the scope of drug business operations authorized based on compliance with the law;

c) Regularly reporting before January 15th each year on the situation of growing, harvesting, and exploiting medicinal materials according to Form No. 11 of Appendix I attached to this Circular;

d) Self-updating and being fully responsible for the content and legality of documents proving the origin of traditional medicine drugs, traditional medicine ingredients, and medicinal materials on the Traditional Medicine and Herbal Medicine Management Department's electronic information website;

đ) Upon discovering counterfeit or substandard traditional medicine drugs, traditional medicine ingredients, and medicinal materials, immediately initiate source tracing and promptly notify the competent state management agency, national inspection agency, and other business establishments.

e) Maintain records, documents, and information related to each importation, purchase, sale, distribution, circulation of traditional medicine, traditional herbal medicine, and medicinal materials to ensure traceability of origin, place of manufacture, and quality control of traditional medicine, traditional herbal medicine, and medicinal materials throughout the entire process from cultivation, harvesting, extraction; export; import; processing, production; storage; transportation, and distribution;

g) Pay for testing costs and provide standard substances, reference substances to the testing agency when such substances are not available at the testing agency or have not been researched and established for samples of traditional medicine, traditional herbal medicine, and medicinal materials submitted for testing;

h) The business entity must pay for testing fees for supplementary samples taken upon request of the state management agency and for samples that violate quality standards;

i) Implement other provisions of the pharmaceutical laws to ensure the maintenance of quality of traditional medicine, traditional herbal medicine, and medicinal materials throughout the entire process of trading, circulation, and use;

k) The enterprise shall be fully responsible for the legality of all documents in the file;

6. Medical examination and treatment facilities shall be responsible for:

a) Using only traditional medicine, traditional herbal medicine, and medicinal materials with clear origins and places of manufacture as stipulated in Article 12 of this Circular and provided by businesses that have obtained certificates of eligibility for pharmaceutical business operations;

b) Regularly or randomly inspecting the quality of traditional medicine, traditional herbal medicine, and medicinal materials used by the facility. In case of discovering counterfeit or substandard traditional medicine, traditional herbal medicine, and medicinal materials, they shall propose isolation and immediately conduct traceability of origin and place of manufacture to proceed with subsequent handling according to regulations. Traditional medicine, traditional herbal medicine, and medicinal materials used at the facility must be inspected and imported through the hospital's Import Control Committee as stipulated in Circular No. 22/2011/TT-BYT dated June 10, 2011, issued by the Minister of Health on the organization and operation of the Hospital Pharmacy Department or the import control department of other medical examination and treatment facilities;

c) For traditional medicine produced by medical examination and treatment facilities in accordance with Article 70 of the Pharmaceutical Law and traditional herbal medicine processed and compounded by medical examination and treatment facilities for sale to other medical examination and treatment facilities as stipulated in Clause 2 of Article 70 of the Pharmaceutical Law, the facility must carry out quality testing at a State Testing Facility meeting Good Laboratory Practice (GLP) standards or a business providing testing services that has been certified as eligible for pharmaceutical business operations. If the medical examination and treatment facility has a GLP laboratory, the quality testing of traditional medicine, traditional herbal medicine, and medicinal materials will be conducted at the facility’s laboratory;

d) For traditional herbal medicine compounded and processed by medical examination and treatment facilities solely for their own use, the facility must implement monitoring of the compounding, processing, and production processes and quality control;

đ) The head of the medical examination and treatment facility is responsible for organizing regular inspections at least once every three months or random inspections when necessary regarding the compounding, processing, production, and quality inspection of traditional medicine, traditional herbal medicine, and medicinal materials compounded, processed, and produced at the facility. Inspection results must be recorded in a report and retained as required;

e) In case of factors that may affect or raise suspicion about the quality of traditional medicine, traditional herbal medicine, and medicinal materials, the medical examination and treatment facility must send samples to a State Testing Facility meeting GLP standards or a business providing testing services that has been certified as eligible for pharmaceutical business operations. In case the testing results do not meet quality standards, the facility must submit a report to the Traditional Medicine and Herbal Medicine Management Department for handling violations according to regulations;

g) The facility must pay for testing costs for supplementary samples requested by the state management agency and for samples that violate quality standards;

7. Responsibilities of management agencies (police, customs, market management, Vietnamese diplomatic agencies abroad, foreign diplomatic agencies in Vietnam) in combating counterfeit, untraceable traditional medicine, traditional herbal medicine, and medicinal materials:

a) Receive information reported by organizations and individuals;

b) Communicate and disseminate to the public and pharmaceutical businesses signs to recognize and prevent the buying and selling, use of untraceable, counterfeit, or substandard traditional medicine, traditional herbal medicine, and medicinal materials; methods to report suspected cases of untraceable, counterfeit, or substandard traditional medicine, traditional herbal medicine, and medicinal materials to state management agencies;

c) Publicize on the Electronic Information Portal and mass media information about untraceable, counterfeit, or substandard traditional medicine, traditional herbal medicine, and medicinal materials discovered in the market, and the results of handling such cases;

d) Conduct or coordinate with relevant functional agencies to implement inspection and supervision activities to promptly detect untraceable, counterfeit, or substandard traditional medicine, traditional herbal medicine, and medicinal materials being traded and circulated in the market;

đ) Coordinate and support functional agencies in investigating and tracing the origin and place of manufacture of counterfeit, substandard traditional medicine, traditional herbal medicine, and medicinal materials;

e) Handle cases of violation in trading untraceable traditional medicine, traditional herbal medicine, and medicinal materials, and smuggling according to regulations;

g) Coordinate, communicate, and exchange information about untraceable, counterfeit, or substandard traditional medicine, traditional herbal medicine, and medicinal materials with relevant international organizations and drug regulatory agencies of other countries.

Article 26. Responsibility for Implementation

The Director of the Traditional Medicine Management Department, the Head of the Ministry's Office, the Heads of Departments and Bureaus under the Ministry of Health, specialized agencies on health under provincial People's Committees, pharmaceutical business establishments, and other relevant organizations, individuals shall be responsible for implementing this Circular.

In the course of implementation, if there are difficulties or obstacles, please report to the Ministry of Health (Traditional Medicine Management Department) for consideration and resolution.

 

ANNEX I

SAMPLE FORMS
(Issued together with Circular No. 32/2025/TT-BYT dated July 1, 2025 of the Minister of Health)

 

Form No. 01A: Quality standard presentation form for herbal materials

Issued pursuant to Decision No...dated...month...year...

1. Technical Requirements

Clearly state each quality index and the corresponding quality requirements according to the structure of the Pharmacopoeia.

The technical requirements in this technical regulation are implemented according to the testing methods specified below:

Clearly describe the testing method for each quality index, including reagents, equipment, and detailed procedures.

If it is a common testing method included in the Pharmacopoeia, clearly specify the name of the Pharmacopoeia (version number) and the testing method used.

 

 

Form No. 01B: Quality standard presentation form for traditional medicine ingredients

Issued pursuant to Decision No...dated...month...year...

1. Technical requirements.

1.1. Processing formula:

Clearly state the name and quantity of each raw material and auxiliary material used in the formula.

1.2. Raw materials and auxiliary materials:

Clearly state the quality standards for each raw material and auxiliary material.

1.3. Quality requirements:

Clearly state each quality index and the corresponding requirements.

The technical requirements in this technical regulation are implemented according to the testing methods specified below:

Clearly describe the testing method for each quality index, including reagents, equipment, and detailed procedures.

If it is a common testing method included in the Pharmacopoeia, clearly specify the name of the Pharmacopoeia (version number) and the testing method used.

 

 

Form No. 01C: Quality standard presentation form for traditional medicine

Issued pursuant to Decision No...dated...month...year...

1. Technical requirements.

1.1. Production formula:

Clearly state the name and quantity of each raw material and auxiliary material used in the formula.

1.2. Raw materials and auxiliary materials:

Clearly state the quality standards for each raw material and auxiliary material.

1.3. Quality requirements:

Clearly state each quality index and the corresponding requirements.

The technical requirements in this technical regulation are implemented according to the testing methods specified below:

Clearly describe the testing method for each quality index, including reagents, equipment, and detailed procedures.

If it is a common testing method included in the Pharmacopoeia, clearly specify the name of the Pharmacopoeia (version number) and the testing method used.

 

 

Form No. 02: Self-declaration of quality standards for traditional medicine ingredients and herbal materials

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
-------------

SELF-DECLARATION OF QUALITY STANDARDS FOR TRADITIONAL MEDICINE INGREDIENTS/HERBAL MATERIALS

No.: …/Name of declaring entity/Year of declaration

I. Information about the entity declaring quality standards for traditional medicine ingredients/herbal materials

Name of declaring entity: …

Address: …

Phone: …

Business Registration Number: …

Food Safety Permit Number: …Date of Issue/Issuing Authority: …(for establishments required to obtain a Food Safety Permit under regulations)

Business Registration Certificate No......issued on......by......

1. Product Name: …

1. Name of traditional medicine ingredient/herbal material (scientific name): …

2. Origin: …

3. Packaging specifications: …

III. Declared quality level

1. Clearly state each quality index and the corresponding quality level according to the Quality Control Standard.

2. Comparison table of quality indices and levels when the traditional medicine ingredient/herbal material has a monograph specified in the Pharmacopoeia.

IV. Attached documents

1. Quality Control Standard of traditional medicine ingredient/herbal material of the declaring entity.

2. Copy of the Quality Testing Record for traditional medicine ingredient/herbal material meeting the Quality Control Standard issued by a national testing facility that meets GLP standards.

3. Copy of documentation proving the origin and source of herbal materials as stipulated in Article 13 of this Circular.

We hereby commit to bear full responsibility under the law for the legality of the declaration of quality standards for traditional medicine ingredients/herbal materials.

 

 

Form No. 03A: Sample Collection Record for Traditional Medicine

 

RECORD OF SAMPLE COLLECTION FOR TRADITIONAL MEDICINE TO DETERMINE QUALITY

Letter of introduction or inspection card (clearly stating number, date, month, year, issuing authority: ......

Names, positions, and agencies of those involved in sample collection:

1 ........................................................................................................................................

2 ........................................................................................................................................

3 ........................................................................................................................................

Name of sampled entity: …

Classification of sampled entity: …

Address:...Phone: ...

Conditions for sample preservation when taking samples: …

This record is made in three copies: one copy to be kept at the sampled entity, one copy to be kept at the testing facility, one copy to be kept at … (management agency, quality control agency).

 

 

Sample number 03B: Record of herbal medicine and traditional medicine ingredient sampling

BRECORD OF HERBAL MEDICINE/TRADITIONAL MEDICINE INGREDIENT SAMPLING
FOR QUALITY DETERMINATION

Introduction letter or inspection card (clearly state number, date, month, year, issuing authority): …

Names, positions, and agencies of those involved in sample collection:

1 ........................................................................................................................................

2 ........................................................................................................................................

3 ........................................................................................................................................

Name of sampled entity: …

Classification of sampled entity: …

Address:...Phone: ...

Conditions for sample preservation when taking samples: …

This record is made in three copies: one copy to be kept at the sampled entity, one copy to be kept at the testing facility, one copy to be kept at … (management agency, quality control agency).

 

 

Sample number 04A: Quality Testing Report for Traditional Medicine Ingredient/Herbal Medicine

 

TESTING REPORT

Number:

Name of traditional medicine/herbal medicine sample:                                           Scientific name:

Manufacturing facility:

Importing entity (for imported traditional medicine/herbal medicine from abroad):

Batch number:                                    Production date:                               Expiry date:

Registration number for circulation or import permit number:

Sampling location (sample sent):

Sample taker (sample sent):

Testing requirements (clearly state content, number, date, month, year of the sampling record or accompanying documents)

Date/month/year of receiving sample:

Testing registration number:

Sample giver:                                               Sample receiver:

Applied standards:

Condition of sample upon receipt and when unsealed for testing:

1.

2.

3…

Conclusion: (Clearly state whether the traditional medicine/herbal medicine sample/batch meets the quality criteria (specify the name of the criterion) according to the applied quality standard.)

 

 

Sample number 04B: Testing Report for Traditional Medicine

 

TESTING REPORT

Number:

Name of traditional medicine sample:

Manufacturing facility:

Importing entity (for foreign traditional medicine):

Batch number:                 Production date:              Expiry date:                    Registration number for circulation

Registration number for circulation or import permit number:

Sampling location (sample sent):

Sample taker (sample sent):

Testing requirements (clearly state content, number, date, month, year of the sampling record or accompanying documents)

Date/month/year of receiving sample:

Testing registration number:

Sample giver:                                               Sample receiver:

Applied standards:

Condition of sample upon receipt and when unsealed for testing:

1.

2.

3…

Conclusion: The traditional medicine sample/batch meets or does not meet the quality criteria (specify the name of the criterion) according to the applied quality standard.

 

 

Sample number 05: Analysis Report

 

ANALYSIS REPORT

Number:

Name of analysis sample:                        Scientific name (of traditional medicine/herbal medicine)

(Name of herbal medicine/traditional medicine ingredient/traditional medicine)

Manufacturing facility:

Importing entity (for imported analysis sample from abroad):

Batch number:                             Production date:                                    Expiry date:

Registration number for circulation or import permit number:

Location sending sample:

Sender of sample:

Analysis requirements (clearly state content, number, date, month, year of the sampling record or accompanying documents)

Date/month/year of receiving sample:

Analysis registration number:

Sample giver:                                         Sample receiver:

Applied standards:

Condition of sample upon receipt and when unsealed for analysis:

1.

2.

3...

 

 

Sample number 06: Report on Sampling for Quality Control of Traditional Medicine/Traditional Medicine Ingredient/Herbal Medicine

 

REPORT ON SAMPLING FOR QUALITY CONTROL OF TRADITIONAL MEDICINE/TRADITIONAL MEDICINE INGREDIENT/HERBAL MEDICINE

To: Ministry of Health (Traditional Medicine Management Department)

(*) Sampling and testing entities do not report these contents.

 

 

Sample number 07: Commitment regarding cultivation and harvesting sites of medicinal herbs in localities

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
-------------------

…, day …… month …… year …

COMMITMENT FORM
REGARDING THE CULTIVATION AND HARVESTING SITES OF MEDICINAL HERBS

The entity cultivating, harvesting, and exploiting medicinal herbs commits that the following medicinal herbs are cultivated and harvested in accordance with the following information:

LEGAL REPRESENTATIVE OF THE ENTITY

 

 

Name of entity implementing recall

 

Record of recall of traditional medicine, traditional medicine ingredients, and herbal materials

belonging to...

1/ .............................................................................................................................

2/ ............................................................................................................................

3/ .............................................................................................................................

assigned the task of recalling traditional medicine, traditional medicinal ingredients, herbal medicine that does not meet quality standards according to Circular No.:...dated...month...year...of...

Have carried out the recall at...quantity of traditional medicine, traditional medicinal ingredients, herbal medicine as follows:

Name of herbal medicine/traditional medicinal ingredient/traditional medicine (concentration) recalled

 

 

..., day____ month____ year____

 

Implementing Circular No... dated... month... year... of... concerning the recall of herbal medicine/traditional medicinal ingredients/traditional medicine...; registration certificate number/import permit number..., batch number...; date of manufacture...; expiry date... produced/imported by the entity (name of entity)...

Respectfully submitted to: ...

We hereby report the results of the recall as follows:

1. Information about the product being recalled:

- For traditional medicine: Name of medicine, registration certificate number or import permit number, names of components, concentration, dosage form, batch number, expiry date, place of production/importer;

- For traditional medicinal ingredients: Name of traditional medicinal ingredient (Vietnamese and Latin names), processing method, registration certificate number/quality standard announcement number/import permit number, batch number, expiry date, place of production/importer;

- For herbal medicine: Name of herbal medicine (Vietnamese and Latin names), import permit number (for imported herbal medicine), quality standard announcement number, batch number, expiry date, place of production or importer of herbal medicine;

- Time of entry into warehouse/exit from warehouse.

2. Results of the recall:

2.1. Results of the recall of products from pharmaceutical business entities:

Name of business entity that purchased the product

- Quantity of traditional medicine/traditional medicinal ingredients/herbal medicine produced/imported:

- Quantity of traditional medicine/traditional medicinal ingredients/herbal medicine put into market circulation:

- Quantity of traditional medicine/traditional medicinal ingredients/herbal medicine recalled:

Form No. 10: Record of Destruction of Traditional Medicine, Traditional Medicinal Ingredients, Herbal Medicine

 

 

Name of entity implementing destruction

Implementing Decision No.:...dated...month...year...of...regarding the destruction of traditional medicine/traditional medicinal ingredients/herbal medicine that does not meet quality standards or has exceeded the expiry date.

Today, day...month...year...at (name of destruction location):...

The committee for the destruction of traditional medicine/traditional medicinal ingredients/herbal medicine established by Decision No....dated...month...year...of..., consisting of:

has carried out the destruction of the following medicines:

1................................................................................................................................

2................................................................................................................................

3................................................................................................................................

..................................................................................................................................

Name of product destroyed

Method of destruction:

The record of destruction of traditional medicine/traditional medicinal ingredients/herbal medicine reports to...

.................................................................................................................................

..................................................................................................................................

This record is made in...copies, each party retains 01 copy, sending...copies for reporting

Participants in the destruction

 

 

REPORT ON CULTIVATION/HARVESTING AND BUSINESS ACTIVITIES OF TRADITIONAL MEDICINE/TRADITIONAL MEDICINAL INGREDIENTS/HERBAL MEDICINE

 

1. General information of the entity:

To: Ministry of Health (Traditional Medicine Management Department)

1.1.Name of entity:

1.2.Address:

1.3.Phone number:

1.4.Legal representative:

2. Report on cultivation/harvesting and business activities of traditional medicine/traditional medicinal ingredients/herbal medicine

2.1.Cultivation/harvesting activities

Cultivation/harvesting address

Name of traditional medicine/traditional medicinal ingredient/herbal medicine

 

 

ANNEX II

(Annexed to Circular No. 32/2025/TT-BYT dated July 1, 2025 of the Minister of Health)
I. Traditional medicine violating degree 1:

Violating medicine poses a serious risk to health or life of users, including the following cases: 1. Fake medicine, smuggled medicine, medicine of unknown origin or source;

2. Medicine containing substances banned for use in drug production;

3. Medicine whose finished products are made from raw materials of unknown origin or source;

4. Medicine made from raw materials not intended for human use;

5. Medicine with urgent recall notice issued by competent authorities of foreign countries;

6. Medicine containing herbal ingredients warned by the World Health Organization, competent authorities of Vietnam or exporting countries as unsafe or ineffective for users;

7. Expired medicine;

8. Medicine produced at facilities not certified to operate pharmaceutical businesses or not meeting production conditions or other business conditions.

8. Medicines produced at a facility that has not been issued a certificate of compliance with pharmaceutical business conditions or does not meet production conditions or other provisions regarding pharmaceutical business conditions;

9. Medicines that are not of the correct type due to confusion during issuance and handover, where traditional medicine formulations contain toxic herbal ingredients listed in Appendix III for mineral-based toxic herbs and non-starred (*) toxic herbs from the list of plant and animal-based toxic herbs in Appendices I and II issued with Circular No. 13/2024/TT-BYT dated August 26, 2024, by the Minister of Health regarding the List of Toxic Herbs Used in Medicine;

10. Medicines with confused herbal ingredient components that may result in serious consequences;

11. Medicines with confused raw material/herbal ingredient concentrations that may result in serious consequences;

12. Medicines with incorrect labeling regarding concentration, route of administration, dosage for medicines containing toxic herbs listed in Appendix III for mineral-based toxic herbs and non-starred (*) toxic herbs from the list of plant and animal-based toxic herbs in Appendices I and II issued with Circular No. 13/2024/TT-BYT dated August 26, 2024, by the Minister of Health regarding the List of Toxic Herbs Used in Medicine;

II. Traditional medicines violating Level 2: Medicines for which there is evidence that they do not fully ensure therapeutic efficacy or pose a risk of being unsafe for users but have not yet reached a level causing severe harm to health or affecting the lives of users, including the following cases:

1. Medicines concluded by competent state authorities to not meet the requirements for therapeutic efficacy;

2. Medicines produced from raw materials that do not meet quality standards;

3. Medicines without evidence or documentation proving quality testing during production and before release;

4. Medicines without circulation registration certificates or import permits;

5. Medicines with circulation registration certificates issued based on falsified files according to the conclusion of competent authorities;

6. Medicines produced from expired medicinal raw materials or raw materials subject to recall notices by competent state authorities;

7. Medicines produced or imported not in accordance with registration files or import permits;

8. Medicines failing microbial contamination control criteria;

9. Medicines with raw material/herbal ingredient concentrations outside the 5% limit specified in the registration file (For example: Medicine with component A registered at 100 mg ± 10% (meaning the acceptable range is from 90 to 110 mg). If the actual concentration of component A does not meet the requirement but falls within the range below 85.5 mg or above 115.5 mg);

10. Medicines with confused herbal ingredient components (excluding cases evaluated at Level 1);

III. Traditional medicines violating Level 3: Medicines not covered under Section I and Section II but due to other reasons that do not affect therapeutic efficacy and safety when used, including the following cases:

1. Medicines failing sensory quality criteria: color change;

2. Medicines failing specific gravity quality criteria;

3. Medicines failing impurity and moisture content quality criteria;

4. Medicines failing tablet weight variation quality criteria;

5. Medicines with raw material/herbal ingredient concentrations not meeting requirements but within the 5% limit specified in the registration file (For example: Medicine with component A registered at 100 mg ± 10% (meaning the acceptable range is from 90 to 110 mg). If the actual concentration of component A does not meet the requirement but falls within the range from 85.5 mg to less than 90 mg or from more than 110 mg to 115.5 mg);

6. Liquid oral medicines (extracts, solutions, suspensions, emulsions) failing sedimentation quality criteria;

7. Medicines not complying with drug labeling regulations stipulated in Article 61 of the Drug Law and other relevant laws;

8. Medicines not fully meeting labeling requirements, except for cases mentioned in Levels I and II;

9. Medicines with packaging materials and forms not meeting quality assurance requirements;

10. Medicines violating average weight criteria, produced not in accordance with drug registration files: changes in tablet weight, excipient ratio, or type of excipient;

IV. Other Violations: The Department of Traditional Medicine Management will conclude the level of violation of medicines after obtaining the advisory opinion of the Advisory Council for Herbal Medicine and Traditional Medicine Circulation Registration Certificates of the Ministry of Health. The opinion of the Council is determined based on the assessment of the risk of impact of the violated medicine on the health of users;

 

ANNEX III

LEVELS OF TRADITIONAL MEDICINE QUALITY VIOLATIONS
I. Traditional medicine violating degree 1:

I. Traditional medicines violating Level 1: Traditional medicines violating with a risk of causing severe harm to health or affecting the lives of users, including the following cases:

1. Fake, smuggled, or untraceable origin traditional medicines;

2. Traditional medicines containing prohibited herbs according to regulations;

3. Traditional medicines produced from untraceable origin herbs;

4. Traditional medicines and herbs subject to urgent recall notices by foreign competent state authorities;

5. Traditional medicines produced at facilities not certified to meet pharmaceutical business conditions or not meeting production conditions or other pharmaceutical business regulations;

6. Traditional medicines not of the correct type due to confusion during issuance and handover, where the formulation contains toxic herbs listed in Appendix III for mineral-based toxic herbs and non-starred (*) toxic herbs from the list of plant and animal-based toxic herbs in Appendices I and II issued with Circular No. 13/2024/TT-BYT dated August 26, 2024, by the Minister of Health regarding the List of Toxic Herbs Used in Medicine (hereinafter referred to as Circular No. 13/2024/TT-BYT);

7. Traditional medicines failing description and qualitative criteria, with testing results concluding that the herbs used for processing are not of the correct species;

II. Traditional medicines violating Level 2: Traditional medicine formulations that pose a risk of being unsafe for users but have not yet caused serious harm to health or endangered the lives of users fall under one of the following cases:

1. Traditional medicine formulations produced from medicinal materials or raw materials that do not meet quality standard level 2.

2. Traditional medicine formulations lack evidence or documentation proving they were quality-checked during production and before release.

3. Traditional medicine formulations contain medicinal materials recommended by the World Health Organization, competent authorities of Vietnam, or the exporting country as being unsafe or ineffective for users.

4. Traditional medicine formulations have exceeded their expiration date.

5. Traditional medicine formulations have been registered for circulation based on falsified documents according to the conclusion of a competent authority.

6. Traditional medicine formulations are produced from raw materials that have expired or have been recalled by a competent state authority.

7. Traditional medicine formulations are produced from toxic medicinal materials listed in the accompanying Circular No. 13/2024/TT-BYT dated August 26, 2024, which require processing in accordance with the guidelines and regulations of the Ministry of Health to reduce toxicity before use as medicine or as raw material for traditional medicine production, but have not been processed or have been processed incorrectly.

8. The content of raw material/medicinal components in traditional medicine formulations exceeds the limit of 5% outside the range specified in the registration dossier at the Ministry level (Example: (1) In the case where the content of component A has a limit of 100%, if the actual content of component A does not reach but is below 95%; (2) In the case where the content of component B is registered as 100 mg ± 10% (meaning the acceptable range is from 90 to 110 mg), if the actual content of component B does not reach but falls within the range below 85.5 mg or above 115.5 mg).

9. Traditional medicine formulations do not meet quality standards for descriptive or qualitative criteria, except for the cases stipulated in Clause 7, Section I of this Appendix.

10. Traditional medicine formulations do not meet quality standards for total ash and impurities criteria.

III. Traditional medicine formulations violating Level 3: Traditional medicine formulations that do not fall under the provisions of Sections I and II but are due to other reasons and do not affect treatment efficacy and safety when used fall under one of the following cases:

1. Traditional medicine formulations do not meet quality standards for descriptive criteria: color change.

2. Traditional medicine formulations do not meet quality standards for moisture content.

3. The content of raw material/medicinal components in traditional medicine formulations does not meet the requirements but is within the range of 5% outside the limits specified in the registration dossier (Example: (1) In the case where the content of component A has a limit of 100%, if the actual content of component A does not meet but is above 95%; (2) In the case where the content of component B is registered as 100 mg ± 10% (meaning the acceptable range is from 90 to 110 mg), if the actual content of component B does not meet but falls within the range from 85.5 mg to less than 90 mg or from more than 110 mg to 115.5 mg).

4. Traditional medicine formulations do not fully comply with labeling requirements as prescribed.

IV. Other Violations: The Traditional Medicine Management Department concludes the level of violation of traditional medicine formulations after obtaining the opinion of the Advisory Council for Registration of Circulation of Medicinal Materials and Traditional Medicine of the Ministry of Health. The opinion of the Council is determined based on the assessment of the risk of impact of the violated medicine on the health of users.

 

ANNEX IV

LEVELS OF QUALITY VIOLATIONS OF MEDICINAL MATERIALS
(Issued together with Circular No. 32/2025/TT-BYT dated July 1, 2025 of the Minister of Health)

I. Medicinal materials violating Level 1: Medicinal materials that pose a risk of causing serious harm to health or endangering the lives of users fall under one of the following cases:

1. Fake, smuggled, or untraceable medicinal materials.

2. Medicinal materials prohibited from trading, circulating, and using according to regulations.

3. Medicinal materials subject to urgent recall notices by foreign competent state authorities.

4. Medicinal materials traded or produced at facilities that have not obtained a certificate of compliance with conditions for trading in medicinal materials or do not meet production conditions or other conditions for trading in medicinal materials.

5. Medicinal materials that do not meet quality standards for descriptive and qualitative criteria and whose testing results conclude that they do not belong to the species of medicinal materials.

6. Medicinal materials whose active ingredient content or extractable substance content is outside the limit of 5% compared to the limit specified in the pharmacopoeia or enterprise standards.

II. Medicinal materials violating Level 2: Medicinal materials that pose a risk of being unsafe for users but have not yet caused serious harm to health or endangered the lives of users fall under one of the following cases:

1. Medicinal materials recommended by the World Health Organization, competent authorities of Vietnam, or the exporting country as being unsafe or ineffective for users.

2. Medicinal materials have exceeded their expiration date.

3. Medicinal materials whose active ingredient content or extractable substance content is within the limit of 5% compared to the limit specified in the pharmacopoeia or enterprise standards.

4. Medicinal materials that do not meet quality standards for descriptive, microscopic examination, or qualitative criteria, except for the cases stipulated in Clause 5, Section I of this Appendix.

5. Medicinal materials that do not meet quality standards for total ash and impurities criteria.

III. Medicinal materials violating Level 3: Medicinal materials that do not fall under the provisions of Sections I and II but are due to other reasons and do not affect treatment efficacy and safety when used fall under one of the following cases:

1. Medicinal materials that do not meet quality standards for moisture content.

2. Medicinal materials that do not fully comply with labeling requirements as prescribed.

IV. Other Violations: The Traditional Medicine Management Department concludes the level of violation of medicinal materials after obtaining the opinion of the Council established by the Traditional Medicine Management Department. The opinion of the Council is determined based on the assessment of the risk of impact of the violated medicinal materials on the health of users.