Circular No. 38/2021/TT-BYT stipulates on the quality of medicinal materials, traditional herbal medicines, and traditional medicines.

CIRCULAR

PROVISIONS ON THE QUALITY OF DRUG MATERIALS, TRADITIONAL MEDICINE INGREDIENTS, AND TRADITIONAL MEDICINES

Pursuant to the Drug Law No. 105/2016/QH13 dated April 6, 2016;

Pursuant to Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing certain provisions and implementation measures of the Law on Medicines;7 of the Government detailing one provision and measures for implementing the Drug Law; number The Minister of Health issues this Circular on the quality of drug materials, traditional medicine ingredients, and traditional medicines;

Pursuant to the Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain regulations related to investment and business conditions within the scope of management of the Ministry of Health;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 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,

This Circular provides for the application of quality standards; the announcement of the quality of drug materials; the testing of the quality of drug materials, traditional medicine ingredients, and traditional medicines; tracing the origin and place of manufacture, and procedures for recalling and handling non-compliant drug materials, traditional medicine ingredients, and traditional medicines. hereby,

Chapter I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the application of quality standards; the announcement of the quality of medicinal materials; the testing of the quality of medicinal materials, traditional herbal ingredients, and traditional medicines; tracing the origin and place of production; and procedures for recalling and handling non-compliant medicinal materials, traditional herbal ingredients, and traditional medicines.

Article 2. Applicability

This Circular applies to establishments engaged in cultivating, harvesting, extracting, producing, exporting, importing, wholesaling, and retailing drug materials, traditional medicine ingredients, and traditional medicines (hereinafter referred to as business establishments); medical examination and treatment facilities, and organizations, institutions, and individuals (collectively referred to as units) related to the management of the quality of drug materials, traditional medicine ingredients, and traditional medicines in Vietnam.

This Circular does not apply to business establishments selling semi-finished drug materials and herbal drugs; individuals engaged in cultivating, harvesting, and extracting drug materials.

Article 3. Explanation of Terms

In this Circular, certain terms are understood as follows:

1. Batch of drug materials is a defined quantity of drug materials from the same cultivation or harvesting location, processed through the same procedure within a specified time frame at the same facility.

2. Batch of traditional medicine ingredients is a defined quantity of traditional medicine ingredients produced through the same process within a specified time frame at the same facility and with consistent quality.

3. Batch of traditional medicines is a defined quantity of traditional medicines produced through the same process within a specified time frame at the same facility and with consistent quality.

4. Expiry date of drug materials, traditional medicine ingredients, and traditional medicines is the usage period determined for drug materials, traditional medicine ingredients, and traditional medicines beyond which they may not be used. The expiry date of drug materials, traditional medicine ingredients, and traditional medicines is expressed as a time period from the date of production to the expiration date or as the expiration day, month, year. If the expiry date only indicates the month and year, the expiry date is calculated until the last day of the expiration month.

5. Quality standard of drug materials, traditional medicine ingredients, and traditional medicines Affairs is the technical characteristic of drug materials, traditional medicine ingredients, and traditional medicines including quality criteria, quality levels, testing methods, and other technical and management requirements related to the quality of drug materials, traditional medicine ingredients, and traditional medicines. APPLICATION OF QUALITY STANDARDS FOR DRUG MATERIALS, TRADITIONAL MEDICINE INGREDIENTS, AND TRADITIONAL MEDICINES

Chapter II

Article 4. Application of quality standards for drug materials, traditional medicine ingredients, and traditional medicines

Clause 1. Drug materials, traditional medicine ingredients, and traditional medicines must apply quality standards according to the pharmacopoeia or base standards. The quality standards for drug materials, traditional medicine ingredients, and traditional medicines are presented in Model No. 01 of Appendix I attached to this Circular.

Clause 2. Business establishments dealing with drug materials, traditional medicine ingredients, and traditional medicines must conduct an assessment and evaluation of the testing methods that the establishment has announced for application. The assessment of standards and testing methods must be carried out at a laboratory that meets Good Laboratory Practice (GLP) standards or a business establishment providing testing services that has been certified to meet the conditions for operating pharmaceutical businesses.

Clause 3. The Ministry of Health (Traditional Medicine Management Department) shall organize the review of files and approve the quality standards for drug materials, traditional medicine ingredients, and traditional medicines in accordance with regulations on registering traditional medicine ingredients and traditional medicines; regulations on issuing import permits for drug materials, traditional medicine ingredients, and traditional medicines without circulation registration certificates; and regulations on announcing quality standards for drug materials.

3. The Ministry of Health (the Traditional Medicine Management Agency) shall organize the review of files and approve the quality standards for medicinal materials, traditional herbal ingredients, and traditional medicines according to the regulations on registering traditional herbal ingredients and traditional medicines; the regulations on granting import permits for medicinal materials, traditional herbal ingredients, and traditional medicines without circulation registration certificates; and the regulations on announcing quality standards for medicinal materials.

Article 5. Application of Pharmacopoeia

The application of the Vietnamese Pharmacopoeia and pharmacopoeias of other countries:

1. Businesses dealing with medicinal herbs, traditional herbal medicines, traditional drugs; medical examination and treatment establishments may apply the Vietnamese Pharmacopoeia or pharmacopoeias of other countries but the quality standards and levels specified in these pharmacopoeias must not be lower than those in the Vietnamese Pharmacopoeia.

2. Import businesses importing medicinal herbs, traditional herbal medicines, traditional drugs into Vietnam must apply the pharmacopoeia of the exporting country. In cases where the quality standards and levels specified in the exporting country's pharmacopoeia are lower than those in the Vietnamese Pharmacopoeia, the Vietnamese Pharmacopoeia or pharmacopoeias of countries with higher quality standards and levels than the Vietnamese Pharmacopoeia must be applied.

3. The application of pharmacopoeia must fully implement the provisions on quality standards and levels in the respective monographs on medicinal herbs, traditional herbal medicines, traditional drugs, and the general testing methods prescribed in that pharmacopoeia. The application of testing methods in each monograph of drugs, raw materials for drugs, and direct contact drug packaging recorded in the pharmacopoeia shall be carried out on a voluntary basis.

4. In cases where businesses declare their application according to the Vietnamese Pharmacopoeia or one of the pharmacopoeias of other countries but use testing methods different from those recorded in the specific monographs of medicinal herbs, traditional herbal medicines, traditional drugs in the applied pharmacopoeia, they must prove the equivalence between the testing methods. Testing results using the testing method recorded in the pharmacopoeia serve as the basis for concluding the quality of medicinal herbs, traditional herbal medicines, and traditional drugs.

Article 6. Application of Basic Standards

Basic standards for medicinal herbs, traditional herbal medicines, and traditional drugs established and applied by businesses must comply with the provisions set forth in point b, Clause 2, Article 102 of the Drug Law No. 105/2016/QH13 (hereinafter referred to as the Drug Law), specifically as follows:

1. They must meet the requirements of quality standards and levels in the corresponding monographs of the Vietnamese Pharmacopoeia or pharmacopoeias of other countries and the quality standards, levels, and general testing methods prescribed in the Appendices of the Vietnamese Pharmacopoeia or pharmacopoeias of other countries as stipulated in Article 5 of this Circular.

2. In cases where the Vietnamese Pharmacopoeia or pharmacopoeias of other countries do not have corresponding monographs on medicinal herbs, traditional herbal medicines, and traditional drugs, businesses must establish standards based on scientific research results, test results, evaluations, analyses, or foreign pharmacopoeia regulations. The approval and announcement of quality standards for medicinal herbs, traditional herbal medicines, and traditional drugs shall be carried out in accordance with Clause 3, Article 4 of this Circular.

Article 7. Updating Quality Standards and Applying Updated Pharmacopoeia

1. Within two years from the date when the current version of the pharmacopoeia becomes effective, businesses dealing with medicinal herbs, production establishments of traditional herbal medicines and traditional drugs, and medical examination and treatment establishments are responsible for updating the quality standards of medicinal herbs, traditional herbal medicines, and traditional drugs according to the provisions of that version of the pharmacopoeia.

2. For traditional herbal medicines and traditional drugs when applying for registration certificates: At the time of submitting the application, the quality standards of traditional herbal medicines and traditional drugs must comply with the current version of the pharmacopoeia or previous versions of the pharmacopoeia but not more than two years since the effective date of that version.

3. During the course of business and use, if businesses dealing with medicinal herbs, production establishments of traditional herbal medicines and traditional drugs, and medical examination and treatment establishments discover factors seriously affecting the quality, safety, and efficacy of medicinal herbs, traditional herbal medicines, and traditional drugs, or upon request by the Ministry of Health (Traditional Medicine Management Department), they must update the quality standards of medicinal herbs, traditional herbal medicines, and traditional drugs according to the new version of the pharmacopoeia to control such influencing factors.

Chapter III

ANNOUNCEMENT OF QUALITY STANDARDS FOR MEDICINAL HERBS

Article 8. Objects and Requirements for Announcing Quality Standards of Herbal Medicines

1. Herbal medicines must announce quality standards before circulation, including one of the following cases:

a) Herbal medicines that do not have quality standards specified in the Vietnamese Pharmacopoeia or pharmacopoeias of other countries as stipulated in Article 5 of this Circular;

b) Herbal medicines that have quality standards specified in the Vietnamese Pharmacopoeia or pharmacopoeias of other countries as stipulated in Article 5 of this Circular but the entity wishes to announce higher quality standards than those specified in the pharmacopoeia.

2. Entities entitled to announce quality standards include:

a) Domestic herbal medicine trading entities;

b) Foreign herbal medicine trading entities with representative offices in Vietnam.

Article 9. Documents and Procedures for Announcing Herbal Medicines

1. The announcement documents for herbal medicine quality include:

a) A quality announcement form for herbal medicines according to Model No. 02 of Appendix I issued together with this Circular;

b) A test report for herbal medicines meeting the announced quality standards issued by a drug testing facility that meets Good Laboratory Practice (GLP) standards;

c) Documentation proving the origin and source of the herbal medicines as stipulated in Article 13 of this Circular;

d) All documents in the announcement must be in Vietnamese; if there are documents in foreign languages, they must be translated into Vietnamese or English and certified in accordance with regulations. All documents must remain valid at the time of announcement. The enterprise bears full responsibility for the legality and content of the announcement documents.

2. Procedures for announcing herbal medicine quality:

a) Organizations and individuals submit one (01) set of documents via postal service, the Ministry of Health's electronic portal (Traditional Medicine Management Department) or directly to the Ministry of Health (Traditional Medicine Management Department);

b) After receiving the announcement documents from organizations and individuals, within five days, the Ministry of Health (Traditional Medicine Management Department) is responsible for reviewing and posting on the Traditional Medicine Management Department's website the following contents: name of organization or individual; name of announced herbal medicine; origin of herbal medicine; applied quality standards and sending to the testing agency to conduct quality control as prescribed;

c) Immediately after being posted on the Traditional Medicine Management Department's website, organizations and individuals are authorized to trade the aforementioned herbal medicines and bear full responsibility for their safety;

d) In case of changes in the origin or source of the herbal medicines, organizations and individuals must reannounce the information.

Chapter IV

QUALITY TESTING OF HERBAL MEDICINES, TRADITIONAL MEDICINE INGREDIENTS, AND TRADITIONAL MEDICINES

Article 10. Quality Testing of Herbal Medicines, Traditional Medicine Ingredients, and Traditional Medicines

1. Testing must be conducted according to approved and updated quality standards for herbal medicines, traditional medicine ingredients, and traditional medicines.

a) In cases where quality standards for herbal medicines, traditional medicine ingredients, and traditional medicines have not been updated, the testing facility applies corresponding pharmacopoeias as stipulated in Article 5 of this Circular for testing. Application of the pharmacopoeia is based on the production date of the batch of herbal medicines, traditional medicine ingredients, and traditional medicines being tested;

b) For traditional medicine ingredients and traditional medicines processed and produced at healthcare facilities, testing is conducted according to quality standards established and promulgated by the facility.

2. Regulations on Sampling Herbal Medicines, Traditional Medicine Ingredients, and Traditional Medicines for Testing:

a) Sampling traditional medicines for testing is carried out in accordance with the provisions of Appendix I of Circular No. 11/2018/TT-BYT dated May 4, 2018, of the Minister of Health on the quality of drugs and raw materials for drugs (hereinafter referred to as Circular No. 11/2018/TT-BYT);

b) State-owned drug testing facilities sample herbal medicines and traditional medicine ingredients for quality testing in accordance with the provisions of Appendix 12.1 of the Vietnamese Pharmacopoeia V;

c) Trading entities sample herbal medicines and traditional medicine ingredients for testing in accordance with the provisions of Section I, Clause 9, Diagram r of Appendix I of Circular No. 11/2018/TT-BYT;

d) The sampling record for herbal medicines, traditional medicine ingredients, and traditional medicines is made according to Model No. 03 of Appendix I issued together with this Circular.

3. Reporting Analysis and Testing Results of Herbal Medicines, Traditional Medicine Ingredients, and Traditional Medicines is carried out in accordance with Clause 3 of Article 7 of Circular No. 11/2018/TT-BYT. The Test Report and Analysis Report forms are provided according to Models No. 04 and No. 05 of Appendix I issued together with this Circular.

4. Complaints and Resolution of Testing Result Disputes:

If there is disagreement with the testing results, within five days from the date of receipt of the notification of testing results, trading entities of herbal medicines have the right to request the Ministry of Health (Traditional Medicine Management Department) to designate another testing facility to take additional samples for analysis and retesting to verify the testing results. Retesting of disputed quality indicators is carried out in accordance with Clause 2 of Article 105 of the Drug Law.

5. Sample Storage:

a) Herbal medicines, traditional medicine ingredients, and traditional medicines after quality inspection and quality conclusion must be stored as samples. Stored samples must be sealed and preserved under suitable conditions indicated on the label;

b) Sample storage period:

The storage period for traditional medicine formulations until the expiration date of the medicine or six months from the date of sampling for quality inspection.

The storage period for herbal medicines and traditional medicine ingredients until the expiration date of the herbal medicines and traditional medicine ingredients or twelve months from the date of sampling for quality inspection.

6. Record Keeping of Documents and Materials:

a) Documents and materials related to the quality inspection of herbal medicines, traditional medicine ingredients, and traditional medicines must be retained in accordance with the Law on Archives, Decrees guiding the Law on Archives, and Circular No. 53/2017/TT-BYT dated December 29, 2017, of the Minister of Health on the retention period for professional and technical documents in the health sector;

b) Documents and materials are handled according to current regulations when the retention period expires.

Article 11. Updating and Removing from the List of Business Establishments with Traditional Herbal Medicines, Traditional Medicines Violating Quality Standards

1. Updating the List of Business Establishments with Traditional Herbal Medicines, Traditional Medicines Violating Quality Standards:

a) The Department of Traditional Medicine Management shall update the List of Business Establishments with Traditional Herbal Medicines, Traditional Medicines Violating Quality Standards on the Department's official website (website: ydct.moh.gov.vn) within 72 hours from the date of issuing the decision to recall such traditional herbal medicines, traditional medicines.

b) The Department of Traditional Medicine Management shall not update the List on its official website for business establishments whose recalled traditional herbal medicines, traditional medicines are permitted to be rectified and reused in accordance with Clause 2, Article 20 and Clause 3, Article 21 of this Circular.

2. A business establishment may be removed from the List of Business Establishments with Traditional Herbal Medicines, Traditional Medicines Violating Quality Standards if it meets the following requirements:

a) Fully conducting quality testing in accordance with the time limit stipulated in Clause 1, Article 12 of this Circular;

b) Submitting a report on sampling and quality testing in accordance with Form No. 06 of Appendix I attached to this Circular, accompanied by evidence proving the implementation of quality testing for all batches of traditional herbal medicines, traditional medicines of the same type as those violating quality standards when produced or imported into Vietnam in accordance with Clause 1, Article 12 of this Circular;

c) During the period of implementing the provisions of Clause 1, Article 12 of this Circular, the business establishment does not violate quality standards for traditional herbal medicines, traditional medicines of the same type as those violating quality standards and voluntarily recalls such traditional herbal medicines, traditional medicines due to quality issues.

3. Monthly, based on the reports submitted by business establishments, the Ministry of Health (Department of Traditional Medicine Management) will review and remove the names of business establishments that meet the requirements set out in Clause 2 of this Article from the List of Business Establishments with Traditional Herbal Medicines, Traditional Medicines Violating Quality Standards.

Article 12. Time Limit for Testing Traditional Herbal Medicines, Traditional Medicines of Business Establishments Listed in the List of Business Establishments with Traditional Herbal Medicines, Traditional Medicines Violating Quality Standards traditional medicines violating quality standards.

1. The time limit for testing traditional herbal medicines, traditional medicines of the same type as those violating quality standards starts from the date of the first batch of traditional herbal medicines, traditional medicines being imported or produced after the Ministry of Health (Department of Traditional Medicine Management) publishes the List of Business Establishments with Traditional Herbal Medicines, Traditional Medicines Violating Quality Standards, as follows:

a) For traditional herbal medicines of business establishments listed in the List of Business Establishments with Traditional Herbal Medicines Violating Quality Standards:

- Six months for a business establishment with one batch of traditional herbal medicines violating level 2;

- Twelve months for a business establishment with one batch of traditional herbal medicines violating level 1 or two or more batches of traditional herbal medicines violating level 2 or higher.

b) For traditional medicines of business establishments listed in the List of Business Establishments with Traditional Medicines Violating Quality Standards:

- Six months for a business establishment with one batch of traditional medicines violating level 3;

- Twelve months for a business establishment with one batch of traditional medicines violating level 2 or two or more batches of traditional medicines violating level 3;

- Eighteen months for a business establishment with one batch of traditional medicines violating level 1 or two or more batches of traditional medicines violating level 2 or higher or three or more batches of traditional medicines violating level 3.

c) For traditional medicines of business establishments listed in the List of Business Establishments with Traditional Medicines Violating Quality Standards:

- Six months for a business establishment with one batch of traditional medicines violating level 3;

- Twelve months for a production business establishment with one batch of traditional medicines violating level 2 or two or more batches of traditional medicines violating level 3 or higher;

- Twenty-four months for a production business establishment with one batch of traditional medicines violating level 1 or two or more batches of traditional medicines violating level 2 or higher.

2. In cases where a business establishment has not been removed from the List of Business Establishments with Traditional Herbal Medicines, Traditional Medicines Violating Quality Standards but continues to have traditional herbal medicines, traditional medicines of the same type as those previously violating quality standards, it must conduct extended testing for such traditional herbal medicines, traditional medicines according to the cumulative method.

3. The testing of traditional herbal medicines, traditional medicines in accordance with Clause 1 of this Article must be conducted at a State testing facility meeting GLP standards.

Chapter V

TRACKING THE ORIGIN AND PLACE OF ORIGIN OF TRADITIONAL HERBAL MEDICINES, TRADITIONAL MEDICINES

Article 13. Documents Proving the Origin of Traditional Medicinal Materials, Traditional Herbal Preparations, and Traditional Medicines hereby,

1. Documents proving the origin for imported medicinal materials are the Certificate of Origin (C/O) issued by the competent authority of the exporting country for each batch of medicinal materials.

2. Documentation proving the origin of medicinal materials cultivated, harvested, or naturally extracted within the country and meeting Good Agricultural and Collection Practices (GACP) is a Certificate of GACP-compliant medicinal materials.

2. Documents proving the origin for medicinal materials cultivated, harvested, or extracted naturally within the country and meeting Good Agricultural and Collection Practices (GACP) standards are the Certificate of GACP-compliant medicinal materials.

4. Documentation proving the origin of traditional herbal ingredients includes:

3. Documents proving the origin for medicinal materials purchased from individuals within the country by business entities are the Commitment Statement on the location of cultivation and harvesting of medicinal materials at the local level as specified in Model No. 07 of Appendix I accompanying this Circular.

b) Registration certificate for circulation of traditional herbal ingredients.

4. Documents proving the origin for traditional herbal preparations include:

a) Documents proving the origin of medicinal materials used to produce traditional herbal preparations;

b) Registration certificate for circulation of traditional herbal preparations.

Article 14. Provisions on the storage of documents related to the origin and place of production of medicinal materials, traditional herbal ingredients, and traditional medicines

Article 14. Regulations on the Storage of Documents Related to the Origin and Source of Medicinal Materials, Traditional Herbal Preparations, and Traditional Medicines

1. Business entities must retain relevant documents either in paper form or in management software for each import and export transaction involving medicinal materials, traditional herbal preparations, and traditional medicines, ensuring completeness and accuracy of the following information:

a) Information about the selling and purchasing organizations/persons: name, address, phone number, email (if available);

b) Information about medicinal materials, including: name of medicinal material, scientific name, part used, origin, quality standard;

c) Information about traditional herbal preparations, including: name of traditional herbal preparation, processing method, scientific name of the preparation, quality standard, batch number, date of production, expiration date;

d) Quantity/volume imported and sold;

e) Date of import (day/month/year); date of sale (day/month/year).

2. Enterprises dealing in medicinal materials must have software for tracing the origin and place of production of medicinal materials.

2. Business entities dealing with medicinal materials must have a traceability software for the origin and source of medicinal materials.

4. Enterprises must store records and documents in accordance with the Law on Archives, the Government Decree guiding the Law on Archives, and Circular No. 53/2017/TT-BYT dated December 29, 2017 issued by the Minister of Health regarding the retention period for professional and technical records in the healthcare sector.

Chapter VI

3. Production and import enterprises that engage in distribution activities or wholesale entities acting as distribution hubs must cooperate with wholesale and retail entities to establish a distribution system and measures to monitor and ensure traceability of the origin, control the route of movement, and storage conditions of medicinal materials, traditional herbal preparations, and traditional medicines.

Article 15. Forms and scope of recall

4. Business entities must store records and documents 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, of the Minister of Health regarding the retention period for professional and technical records in the healthcare sector.

a) The form of recalling medicinal materials is as prescribed in Clause 1, Article 101 of Government Decree No. 54/2017/NĐ-CP dated May 7, 2017 detailing certain provisions and measures to implement the Drug Law (hereinafter referred to as Government Decree No. 54/2017/NĐ-CP);

RECALL AND HANDLING OF MEDICINAL MATERIALS, TRADITIONAL HERBAL PREPARATIONS, AND TRADITIONAL MEDICINES VIOLATING QUALITY STANDARDS

2. Scope of recall

Article 15. Forms and Scope of Recall

1. Forms of recall:

Article 16. Procedure for Compulsory Recall of Traditional Herbal Medicines, Traditional Formulas, and Traditional Drugs

1. Receiving Information on Violating Traditional Herbal Medicines, Traditional Formulas, and Traditional Drugs:

The Ministry of Health (Traditional Medicine Management Department) receives information on violating traditional herbal medicines, traditional formulas, and traditional drugs from:

a) Evaluation information on treatment efficacy and safety of traditional herbal medicines, traditional formulas, and traditional drugs provided by the Advisory Council for Drug Registration and Raw Material Registration;

b) Quality information on traditional herbal medicines, traditional formulas, and traditional drugs from drug testing facilities that meet Good Laboratory Practice (GLP) standards;

c) Violation information on traditional herbal medicines, traditional formulas, and traditional drugs reported by provincial health departments to the Traditional Medicine Management Department or discovered by the Traditional Medicine Management Department, Healthcare Inspection Authority, and Pharmaceutical Inspection Authority;

d) Notifications from national quality control agencies regarding violating traditional herbal medicines, traditional formulas, and traditional drugs from foreign countries;

đ) Violation information on traditional herbal medicines, traditional formulas, and traditional drugs discovered by public security, customs, and market management authorities;

e) Voluntary recall information on traditional herbal medicines, traditional formulas, and traditional drugs provided by pharmaceutical business establishments;

g) Evaluation information on treatment efficacy and safety of traditional herbal medicines, traditional formulas, and traditional drugs from the National Center for Drug Information and Adverse Reaction Monitoring.

2. Determining the Level of Violation:

a) Determining the level of violation of traditional drugs:

- Within 24 hours from the time of receiving information on violating traditional drugs as stipulated in points a, c, d, đ, e, and g of Clause 1 of this Article, the Ministry of Health (Traditional Medicine Management Department) shall conduct the determination of the level of violation of traditional drugs as specified in Appendix II issued together with this Circular and conclude on the compulsory recall of violating traditional drugs based on the assessment of risks to users' health.

- In cases where opinions of the Advisory Council for Drug Registration and Raw Material Registration are required, the determination of the level of violation of traditional drugs must be completed within a maximum period of 7 days.

b) Determining the level of violation of traditional herbal medicines and traditional formulas:

Within 72 hours from the time of receiving information on violating traditional herbal medicines as stipulated in points c, d, đ, e, and g of Clause 1 of this Article, the Ministry of Health (Traditional Medicine Management Department) shall conduct the determination of the level of violation of traditional herbal medicines and traditional formulas as specified in Appendices III and IV issued together with this Circular and conclude on the compulsory recall of violating traditional herbal medicines and traditional formulas based on the assessment of risks to users' health.

In cases where opinions of specialized experts are required, the determination of the level of violation of traditional herbal medicines and traditional formulas must be completed within a maximum period of 15 days.

c) For information on violating traditional herbal medicines, traditional formulas, and traditional drugs as stipulated in point b of Clause 1 of this Article, the determination of the level of violation shall be carried out according to Articles 18 or 19 of this Circular. The Ministry of Health (Traditional Medicine Management Department) shall only determine the level of violation when the quality testing is conducted by state-owned testing facilities meeting GLP standards.

3. Issuing Decisions on Recall of Traditional Herbal Medicines, Traditional Formulas, and Traditional Drugs:

a) Within no more than 48 hours from the conclusion on the recall of traditional herbal medicines, the Minister of Health authorizes the Director of the Traditional Medicine Management Department to issue decisions on recalling violating traditional herbal medicines in accordance with Clause 1 or Clause 2 of Article 102 of Decree No. 54/2017/NĐ-CP;

The decision on recalling traditional herbal medicines must include the following information: name of the traditional herbal medicine, import permit number or quality standard number, quantity, batch number, expiration date, manufacturing or importing establishment, level of violation, responsible entity for recall;

b) Within no more than 24 hours from the conclusion on the recall of traditional formulas and traditional drugs, the Minister of Health authorizes the Director of the Traditional Medicine Management Department to issue decisions on recalling violating traditional formulas and traditional drugs in accordance with Clause 1 or Clause 2 of Article 65 of the Drug Law;

The decision on recalling traditional formulas must include the following information: name of the traditional formula, registration permit number or import permit number, processing method, quantity recalled, batch number, expiration date, manufacturing or importing establishment, level of violation, responsible entity for recall.

The decision on recalling traditional drugs must include the following information: name of the traditional drug, registration permit number or import permit number, names of medicinal ingredients, quantity/batch number recalled, dosage form, batch number, expiration date, manufacturing or importing establishment, level of violation, responsible entity for recall.

4. Announcing Decisions on Recall:

a) Decisions on recalling traditional herbal medicines, traditional formulas, and traditional drugs of the Ministry of Health (Traditional Medicine Management Department) are announced to provincial health departments and business establishments through mail, fax, email, telephone, or mass media;

b) For traditional herbal medicines, traditional formulas, and traditional drugs violating at levels 2 and 3, immediately after issuing the recall decision, the Ministry of Health (Traditional Medicine Management Department) publishes the recall decision on the Traditional Medicine Management Department's website.

Provincial health departments publish information about the recall decision on their websites upon receipt of the recall decision.

Business establishments must inform other business establishments and users who have purchased the recalled traditional herbal medicines, traditional formulas, and traditional drugs about the recall; the recall must be implemented within the scope specified in the recall decision of the Ministry of Health.

c) For traditional herbal medicines, traditional formulas, and traditional drugs violating at level 1, in addition to the provisions in point b of this clause, the recall decision must also be announced by the Ministry of Health (Traditional Medicine Management Department) on Vietnam Television and Voice of Vietnam Radio.

5. Implementing the Recall of Traditional Herbal Medicines, Traditional Formulas, and Traditional Drugs

a) Business entities operating with traditional herbal medicines, traditional herbal remedies must cease supply and use; separately store remaining traditional herbal medicines, traditional herbal remedies at the premises; compile a list of business entities and individuals (if any) that have purchased and received returned products; return to the supplier.

b) Production facilities and importers cooperate with entrusted importers or primary distributors to be responsible for recalling non-compliant traditional herbal medicines, traditional herbal remedies. The recall record of traditional herbal medicines, traditional herbal remedies shall be carried out according to Model No. 08 in Appendix I issued together with this Circular.

In cases where business entities fail to carry out recalls or refuse to accept returned products, such entities and individuals purchasing and using the products shall report to the Health Department in their locality for handling in accordance with regulations.

c) The recall of traditional herbal remedies must be completed within the time limit specified in Clause 3, Article 63 of the Medicine Law.

d) The recall of herbal medicines must be completed within thirty days from the date of the recall decision.

6. Report on Recall Results

From the completion date of the recall, within one day for level 1 recalls, three days for level 2 and level 3 recalls, the entity responsible for the recall must submit a written report on the recall results to the Ministry of Health (Traditional Medicine Management Department) and the Health Department in the locality where the business entity responsible for the recall operates, including the following documents:

- A report on the recall results as prescribed in Model No. 09 in Appendix I issued together with this Circular;

- A list of entities directly supplied or supplied through distribution entities, along with information about addresses, phone numbers, emails (if available), quantities supplied, and quantities of products recalled;

- Delivery and receipt records, return invoices, or other evidence demonstrating the recall;

- Self-assessment results on the effectiveness of the recall;

- Investigation and evaluation results on the causes and risk assessment for other batches of non-compliant traditional herbal medicines, traditional herbal remedies, and/or other traditional herbal remedies produced on the same production line.

7. Evaluation of Recall Effectiveness

The Ministry of Health (Traditional Medicine Management Department) will review the recall result reports submitted by the entities responsible for the recall to evaluate or assign the Health Department to evaluate the effectiveness of the recall. If the recall effectiveness is assessed as insufficient, and there is a possibility that the product may continue to circulate and be used, posing a risk to user health, the Traditional Medicine Management Department will coordinate with the Health Department and relevant authorities to enforce the recall.

Article 17. Voluntary Recall Procedures for Herbal Medicines, Traditional Herbal Remedies

1. Business entities self-determine the level of violation of herbal medicines, traditional herbal remedies and report in writing to the Ministry of Health (Traditional Medicine Management Department) along with related documents, clearly stating information about the non-compliant herbal medicines, traditional herbal remedies, the level of violation determined by the entity, reasons for recall, and proposed measures for handling after recall as stipulated in Articles 20 and 21 of this Circular.

2. Within three days from the date of receiving the report from the herbal medicine business entity, the Ministry of Health (Traditional Medicine Management Department) will examine and determine the level of violation of herbal medicines, traditional herbal remedies according to Appendices II, III, and IV issued with this Circular:

a) In cases where it agrees with the business entity's proposal regarding level 3 violations of herbal medicines, traditional herbal remedies, the Ministry of Health (Traditional Medicine Management Department) will issue a written agreement allowing voluntary recall;

b) In cases where it determines level 1 or level 2 violations of herbal medicines, traditional herbal remedies, the Ministry of Health (Traditional Medicine Management Department) will implement the recall procedures as specified in Clauses 3, 4, 5, and 6 of Article 16 of this Circular;

c) In cases where additional or clarifying information is needed in the business entity's report, the Ministry of Health (Traditional Medicine Management Department) will request the entity to provide supplementary information or explanations. Within five days from the date of receiving the request from the Traditional Medicine Management Department, the entity must submit a written response or explanation.

Article 18. Determination of the Degree of Violation of Traditional Herbal Medicines and Traditional Prescription Drugs by State Testing Facilities Meeting GLP Standards

1. Within 48 hours after receiving the test report or analysis report sent by the testing facility, the Department of Health shall seal traditional herbal medicines and traditional prescription drugs that do not meet quality standards at the sampling location.

2. Within 72 hours after receiving the test report or analysis report sent by the testing facility, the Ministry of Health (Traditional Medicine Management Agency) shall determine the degree of violation of traditional herbal medicines and traditional prescription drugs according to the provisions set out in Appendix III and Appendix IV issued together with this Circular and conclude on the recall of non-compliant traditional herbal medicines and traditional prescription drugs based on an assessment of the risk to the health of users. In cases where the opinion of the Pharmacopoeia Council is required, the determination of the degree of violation of traditional prescription drugs must be completed within a maximum period of 15 days.

3. If necessary, the Ministry of Health (Traditional Medicine Management Agency) may request provincial or municipal testing facilities to take one additional sample from batches of traditional herbal medicines and traditional prescription drugs that do not meet quality standards at the production facility or import facility, and one additional sample from batches of traditional herbal medicines and traditional prescription drugs that do not meet quality standards at wholesale facilities or healthcare facilities in other provinces, and send these samples to central-level testing facilities for quality control on non-conforming criteria.

a) In case one additional sample of traditional herbal medicine or traditional prescription drug does not meet quality standards, the Ministry of Health (Traditional Medicine Management Agency) shall carry out:

- Determine the degree of violation according to the provisions set out in Appendix III and Appendix IV issued together with this Circular;

- Issue a Decision on Recall and a Notice of Recall according to the provisions of Clause 3 and Clause 4 of Article 16 of this Circular;

- Update the list of business establishments with traditional herbal medicines and traditional prescription drugs that violate quality standards according to the provisions of Article 11 of this Circular.

b) In case all additional samples of traditional herbal medicines and traditional prescription drugs meet quality standards, the Ministry of Health (Traditional Medicine Management Agency) shall only determine the degree of violation and follow the recall procedure for the initial sampling establishment, and will not update the list of business establishments with traditional herbal medicines and traditional prescription drugs that violate quality standards in this case.

4. In case the sample of traditional herbal medicine or traditional prescription drug taken from the production facility, import facility, service storage facility, or determined to have violated quality standards due to reasons during the production process, the Ministry of Health (Traditional Medicine Management Agency) shall determine the degree of violation according to the provisions set out in Appendix III and Appendix IV issued together with this Circular. Issue a decision on recall and a notice of recall for traditional prescription drugs according to the provisions of Clause 3 and Clause 4 of Article 16 of this Circular.

Article 19. Determination of the Degree of Violation of Traditional Prescription Drugs by State Testing Facilities Meeting GLP Standards

1. In case the sample of traditional prescription drug violating quality standards is taken from retail pharmacies, level III and IV medical examination and treatment facilities:

a) Within 24 hours from the time of receiving the test report or analysis report sent by the testing facility, the Department of Health shall seal the batch of non-compliant traditional prescription drugs at the sampling location.

b) Within 48 hours from the time of receiving the test report or analysis report sent by the testing facility, the Ministry of Health (Traditional Medicine Management Agency) shall issue a written request to the registration facility, production facility, or import facility to take responsibility for:

- Reporting the distribution situation of the non-compliant batch of drugs (production quantity, imported quantity, distributed quantity; name, address of facilities that purchased the batch of drugs, quantity purchased and remaining stock at each facility) to the Ministry of Health (Traditional Medicine Management Agency) and the local Department of Health within a maximum period of seven days from the date the Ministry of Health (Traditional Medicine Management Agency) issues the written request;

- Requesting the provincial or municipal testing facility to take additional samples from the non-compliant batch of domestic traditional prescription drugs produced or imported foreign traditional prescription drugs, and at least two wholesale facilities. The maximum time for requesting additional samples is 15 days from the date the Ministry of Health (Traditional Medicine Management Agency) issues the written request;

- Sending the collected samples to central-level testing facilities for quality control on non-conforming criteria.

c) Based on the results of testing the additional samples of traditional prescription drugs, the Traditional Medicine Management Agency shall handle according to the provisions of Clause 6 of this Article.

2. In case the sample is taken from wholesale facilities, level II and above medical examination and treatment facilities:

a) Within 24 hours from the time of receiving the test report or analysis report sent by the testing facility, the Department of Health shall seal the batch of non-compliant traditional prescription drugs at the sampling location.

b) Within 48 hours from the time of receiving the test report or analysis report sent by the testing facility, the Ministry of Health (Traditional Medicine Management Agency) shall determine the degree of violation according to the provisions set out in Appendix II issued in this Circular.

Issue a Decision on Recall and a Notice of Recall for the batch of traditional prescription drugs in the province or centrally-administered city where the sample was taken according to the provisions of Clause 3 and Clause 4 of Article 16 of this Circular;

Issue a written request to the registration facility, production facility, or import facility to take responsibility for:

- Reporting the distribution situation of the non-compliant batch of drugs to wholesale facilities and medical examination and treatment facilities (production quantity, imported quantity, distributed quantity; name, address of facilities that purchased the drugs, quantity purchased and remaining stock at each facility) to the Ministry of Health (Traditional Medicine Management Agency) and the local Department of Health within a maximum period of seven days from the date the Ministry of Health (Traditional Medicine Management Agency) issues the written request;

- Requesting the provincial or municipal testing facility to take at least two additional samples of traditional prescription drugs from another wholesale facility. The maximum time for requesting additional samples is 15 days from the date the Ministry of Health (Traditional Medicine Management Agency) issues the written request;

- Sending the collected samples to central-level testing facilities for quality control on non-conforming criteria.

c) Based on the results of testing the additional samples of traditional prescription drugs, the Traditional Medicine Management Agency shall handle according to the provisions of Clause 6 of this Article.

3. In the case where the traditional medicine samples taken from the production facility, import facility, service storage facility, or traditional medicine samples identified as violating quality due to reasons during the production process, the Ministry of Health (Traditional Medicine Management Department) shall determine the level of violation according to the provisions set out in Part II attached to this Circular. The decision to recall and announce the recall of traditional medicines shall be made in accordance with Clause 3 and Clause 4, Article 16 of this Circular.

4. In the case where the traditional medicine ingredients, traditional medicines that violate regulations are traditional medicine ingredients, traditional medicines produced by medical examination and treatment facilities in accordance with Clauses 1 and 2, Article 70 of the Drug Law, the Ministry of Health (Traditional Medicine Management Department) shall determine the level of violation and issue a decision to recall traditional medicines in accordance with Clause 2 and Clause 3, Article 16 of this Circular. The recall decision shall be sent to the medical examination and treatment facility producing the traditional medicine ingredients, traditional medicines that violate quality standards, and the Provincial Health Department where the medical examination and treatment facility operates for implementation of the recall. The report on the results of the recall shall be submitted to the Ministry of Health (Traditional Medicine Management Department) and the local Health Department.

5. Requirements for taking additional samples for quality testing as provided for in Clauses 1 and 2 of this Article:

The quality control agency shall determine the sampling plan based on the distribution situation report from the production facility, import facility; priority shall be given to sampling in the following order a, b, c, d, đ as follows:

a) Samples of medicines taken at wholesale facilities in different provinces and cities, including wholesale facilities that have supplied medicines to the sampled facility;

b) Samples of medicines taken at wholesale facilities in different provinces and cities;

c) Samples of medicines taken at wholesale facilities within the same province or city;

d) Samples of medicines taken at wholesale facilities and retail facilities;

đ) Samples of medicines taken at retail facilities;

e) Sampling according to option đ shall only be applied when the production facility, import facility proves that the medicine is no longer stored at the wholesale facility. Additional sampling shall not be conducted for recalled medicines.

6. Handling the results of supplementary traditional medicine sample testing:

a) In the case where all supplementary traditional medicine samples taken are found to meet quality standards, the Ministry of Health (Traditional Medicine Management Department) shall issue a document determining the level of violation and the responsible entity; instructing the Provincial Health Department to handle traditional medicines from retail facilities that were initially sampled under Clause 1 of this Article or wholesale traditional medicines that have been recalled in the province or city under Clause 2 of this Article. The scope and time limit for the recall shall be implemented in accordance with Clause 3, Article 63 of the Drug Law;

b) In the case where at least one supplementary traditional medicine sample taken from a retail facility does not meet quality standards, except as provided for in point a of this clause, the Ministry of Health (Traditional Medicine Management Department) shall assess the risk and issue a document determining the level of violation and the responsible entity; instructing the Provincial Health Department to handle traditional medicines from retail facilities that were sampled, warning about the storage conditions and quality of the medicines;

c) In the case where at least one supplementary traditional medicine sample taken from a wholesale facility or all supplementary traditional medicine samples taken from retail facilities as provided for in point đ of Clause 5 of this Article do not meet quality standards, the Ministry of Health (Traditional Medicine Management Department) shall determine the level of violation according to the provisions set out in Appendix II attached to this Circular. The decision to recall and announce the recall of traditional medicines shall be made in accordance with Clause 3 and Clause 4, Article 16 of this Circular.

Article 20. Handling of recalled medicinal materials

1. A batch of medicinal materials subject to recall must be destroyed in the following cases:

a) Medicinal materials recalled pursuant to point c, đ, e, g Clause 1 Article 104 Decree No. 54/2017/ND-CP.

b) Medicinal materials recalled due to violation at level 1 or level 2;

c) Medicinal materials recalled due to violation at level 3 that cannot be remedied after the Ministry of Health (Traditional Medicine Management Department) examines according to Clause 3 of this Article;

d) Medicinal materials recalled due to violation at level 3 which are permitted to be remedied or re-exported but fail to implement such remediation or re-exportation.

2. A batch of medicinal materials subject to recall may be remedied and reused in the following case:

a) Medicinal materials recalled pursuant to Clause 2 Article 104 Decree No. 54/2017/ND-CP;

b) Medicinal materials recalled due to violation at level 3 and not falling under the circumstances stipulated in point c Clause 1 of this Article.

3. The remediation, recycling, re-exporting, and change of purpose for medicinal materials shall be carried out in accordance with the provisions of Clause 4 Article 104 Decree No. 54/2017/ND-CP.

An entity having medicinal materials subject to recall wishing to change their purpose of use, remedy, recycle, or re-export must submit a written request along with the intended new use purpose or remedial measures or recycling procedures to the Ministry of Health (Traditional Medicine Management Department).

4. The destruction procedure for a batch of medicinal materials shall be implemented in accordance with the provisions of Clause 5 Article 104 Decree No. 54/2017/ND-CP. The entity destroying the medicinal materials must report along with the record of material destruction to the Provincial Health Department in accordance with Model No. 10 Appendix I issued together with this Circular.

Article 21. Handling of recalled traditional herbal medicines and traditional drugs

1. A batch of traditional herbal medicines and traditional drugs subject to recall must be destroyed in the following cases:

a) Traditional herbal medicines and traditional drugs recalled due to violation at level 1 or level 2;

b) Traditional herbal medicines and traditional drugs recalled due to violation at level 3 that cannot be remedied after the Ministry of Health (Traditional Medicine Management Department) examines according to Clause 3 of this Article;

c) Traditional herbal medicines and traditional drugs recalled due to violation at level 3 which are permitted to be remedied or re-exported but fail to implement such remediation or re-exportation.

2. Destruction of a batch of traditional herbal medicines and traditional drugs:

a) The head of the entity operating pharmaceuticals with traditional herbal medicines and traditional drugs subject to destruction issues a decision to establish a Committee to destroy the medicine. The Committee must have at least three members, including one representative responsible for professional matters;

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

c) The entity destroying traditional herbal medicines and traditional drugs must report along with the record of medicine destruction to the Provincial Health Department in accordance with Model No. 10 Appendix I issued together with this Circular;

d) The entity operating pharmaceuticals with traditional herbal medicines and traditional drugs in violation must bear responsibility for the costs of destroying the medicine;

3. A batch of traditional herbal medicines and traditional drugs subject to recall may be remedied or re-exported if the violation is at level 3 and does not fall under the circumstances stipulated in point b Clause 1 of this Article.

4. Procedure for requesting remediation of a batch of traditional herbal medicines and traditional drugs subject to recall:

a) An entity having traditional herbal medicines and traditional drugs subject to recall must submit a written request to the Ministry of Health (Traditional Medicine Management Department) along with the remediation process, risk assessment regarding the quality and stability of the drug, and a monitoring program for the quality, safety, and efficacy of the drug during circulation;

b) Within a maximum period of 30 days from the date of receipt of the remediation request from the entity, the Ministry of Health (Traditional Medicine Management Department) must examine and provide a written response agreeing or disagreeing with the remediation. If it disagrees, the reasons must be clearly stated;

c) In case additional information related to remediation needs to be supplemented or clarified, within a maximum period of 30 days from the date of receipt of the Ministry of Health (Traditional Medicine Management Department)'s document, the entity must submit supplementary documents and explanations. After this deadline, if the entity fails to submit supplementary documents and explanations, the remediation request will lose its validity.

5. Procedure for requesting re-exportation of a batch of traditional herbal medicines and traditional drugs subject to recall:

a) An entity having traditional herbal medicines and traditional drugs subject to recall must submit a written request to the Ministry of Health (Traditional Medicine Management Department) along with a re-export plan specifying the time and country of re-export;

b) Within a maximum period of 15 days from the date of receipt of the entity's request, the Ministry of Health (Traditional Medicine Management Department) must provide a written response agreeing or disagreeing with the re-exportation; if it disagrees, the reasons must be clearly stated.

6. Remediation and re-exportation of a batch of traditional herbal medicines and traditional drugs subject to recall can only be carried out after receiving written approval from the Ministry of Health (Traditional Medicine Management Department).

7. The handling period for traditional herbal medicines and traditional drugs subject to recall shall not exceed 12 months from the completion date of the recall as stipulated in points a, b, and c Clause 3 Article 63 of the Drug Law.

Article 22. Responsibility for the recovery of traditional herbal medicines, traditional medicinal ingredients, and traditional medicines

1. Responsibilities of business establishments, medical examination and treatment facilities, and users:

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

b) Regularly check and update information on the recovery of traditional herbal medicines, traditional medicinal ingredients, and traditional medicines on the Ministry of Health's electronic portal, the Traditional Medicine Management Department's website, and the provincial/municipal Health Department’s websites.

2. Responsibilities of the Traditional Medicine Management Department:

a) Receive information, determine the level of violation concerning traditional herbal medicines, traditional medicinal ingredients, and traditional medicines that violate the provisions stipulated in Article 17 of this Circular;

b) Review reports and respond to proposals for voluntary recovery, proposals for corrective actions, and re-exportation of recovered traditional herbal medicines, traditional medicinal ingredients, and traditional medicines from business establishments;

c) Coordinate with relevant units (Ministry Inspectorate, provincial/municipal Health Departments, health departments of various commissions and ministries) to inspect and supervise the organization and implementation of the recovery of traditional herbal medicines, traditional medicinal ingredients, and traditional medicines; handle business establishments violating regulations according to the law;

d) Issue detailed guidance documents on the procedures for handling and recovering traditional herbal medicines, traditional medicinal ingredients, and traditional medicines, and evaluate the effectiveness of recovery notifications issued by production and business establishments;

3. Responsibilities of provincial/municipal Health Departments:

a) Announce information on the recovery of traditional herbal medicines, traditional medicinal ingredients, and traditional medicines on the provincial/municipal Health Department’s website;

b) Notify business establishments selling medicines and medical examination and treatment facilities within their jurisdiction about information on the recovery of traditional herbal medicines, traditional medicinal ingredients, and traditional medicines within their area;

c) Conduct or direct testing centers to cooperate with establishments where traditional herbal medicines, traditional medicinal ingredients, and traditional medicines have quality violations to take additional samples according to the provisions of Articles 18 and 19 of this Circular;

d) Supervise the recovery of traditional herbal medicines, traditional medicinal ingredients, and traditional medicines within their jurisdiction; handle and impose penalties on medicine business establishments violating regulations within their authority;

đ) Participate or implement evaluations of the effectiveness of the recovery of traditional herbal medicines, traditional medicinal ingredients, and traditional medicines by business establishments within their jurisdiction according to the directives of the Ministry of Health (Traditional Medicine Management Department). Report to the Ministry of Health (Traditional Medicine Management Department) on cases where business establishments fail to implement or fully implement the recovery of traditional herbal medicines, traditional medicinal ingredients, and traditional medicines that violate regulations;

e) Organize or participate in forced recovery of traditional herbal medicines, traditional medicinal ingredients, and traditional medicines.

Chapter VII

IMPLEMENTING PROVISIONS

Article 23. Effectiveness of Implementation

1. This Circular takes effect from February 15, 2022.

2. Circular No. 13/2018/TT-BYT dated May 15, 2018, of the Minister of Health regarding the quality of traditional herbal medicines and traditional medicines becomes invalid from the date this Circular takes effect.

Article 24. 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 25. Transitional Provisions

By no later than May 15, 2022, traditional herbal medicine business establishments must implement the announcement of quality standards according to the provisions of this Circular.

Article 26. Responsibility for Implementation

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

a) Taking the lead and coordinating with relevant units to organize publicity, dissemination, and implementation of this Circular;

b) Taking the lead and coordinating with the Central Institute of Pharmaceutical Inspection, Ho Chi Minh City Institute of Pharmaceutical Inspection:

Annually, develop plans for sampling traditional herbal medicines, traditional medicinal ingredients, and traditional medicines for quality checks, submit to the Minister of Health for review, approval, and budget allocation according to authority;

Implement sampling of traditional herbal medicines, traditional medicinal ingredients, and traditional medicines for quality checks;

c) Provide the Central Institute of Pharmaceutical Inspection, Ho Chi Minh City Institute of Pharmaceutical Inspection with labels and quality standard documents of announced or registered circulation traditional herbal medicines, traditional medicinal ingredients, and traditional medicines;

d) Organize inspections of the quality of imported, cultivated, harvested, produced, processed, circulated, and used traditional herbal medicines, traditional medicinal ingredients, and traditional medicines nationwide; direct and supervise the national pharmaceutical inspection system to conduct inspections of traditional herbal medicines, traditional medicinal ingredients, and traditional medicines; conclude on the quality of traditional herbal medicines, traditional medicinal ingredients, and traditional medicines based on the results of pharmaceutical inspections conducted by state inspection facilities and related files;

đ) Take the lead or coordinate in performing state inspection functions, inspections, and handling violations of laws on the quality of traditional herbal medicines, traditional medicinal ingredients, and traditional medicines according to authority;

e) Update and post on the Traditional Medicine Management Department’s website lists of establishments with commitments regarding cultivation, harvesting, and exploitation sites of traditional herbal medicines in localities within thirty days of receiving such commitments from establishments;

g) Aggregate the number of types and quantities of imported traditional herbal medicines annually;

h) Aggregate and report on the use of traditional herbal medicines, traditional medicinal ingredients, and traditional medicines nationwide before December 31 each year;

i) Develop a traceability system for traditional herbal medicines, traditional medicinal ingredients, and traditional medicines.

2. Provincial/municipal Health Departments shall be responsible for:

a) Organizing the implementation of quality inspections of traditional herbal medicines, traditional medicinal ingredients, and traditional medicines within their jurisdiction and handling violations according to the law;

b) Directing provincial/municipal Testing Centers to develop annual plans for sampling traditional herbal medicines, traditional medicinal ingredients, and traditional medicines for quality checks and budget estimates, submit to the provincial/municipal Health Department for review and budget allocation;

c) Update the Ministry of Health’s database on quality inspections of traditional herbal medicines, traditional medicinal ingredients, and traditional medicines with information on sampled traditional herbal medicines, traditional medicinal ingredients, and traditional medicines (including information such as name, origin, content, form, quality standard, registration certificate number, import permit number, batch number, expiration date, name and address of the importing, producing, and sampling establishment).

d) Organize to collect information and update and publish on the Department of Health's provincial and municipal electronic information website a list of facilities and locations for growing, harvesting, and extracting medicinal materials in the locality.

3. The drug testing system shall be responsible for:

a) Central-level drug testing facilities (Central Institute for Drug Testing, Ho Chi Minh City Institute for Drug Testing):

- Conducting analysis and testing samples to determine the quality of medicinal materials, traditional herbal medicines, imported traditional medicines; cultivation, harvesting, extraction; production, processing; circulation; use. Report the testing results to the Ministry of Health (Department of Traditional Medicine Management) and the provincial and municipal health departments where the samples were taken;

- Researching, establishing, and publishing on the electronic information websites of the Institutes a directory of standard substances, reference substances, and standard impurities for the analysis and testing of imported medicinal materials, traditional herbal medicines, and traditional medicines; cultivation, harvesting, extraction; production, processing; circulation; use within the territory of Vietnam;

- Be responsible for providing copies or electronic documents of the quality standards of medicinal materials, traditional herbal medicines, and traditional medicines to the provincial and municipal drug testing centers under the central government according to the assigned areas.

b) Provincial and municipal drug testing centers under the central government:

- Conducting analysis and testing samples to determine the quality of imported medicinal materials, traditional herbal medicines, and traditional medicines; cultivation, harvesting, extraction; production, processing; circulation; use.

- Notifying the Ministry of Health (Department of Traditional Medicine Management) and the central-level drug testing institutes about the list of testing criteria that have been reviewed and issued with certificates in accordance with regulations.

- Reporting the testing results of medicinal materials, traditional herbal medicines, and traditional medicines to the provincial and municipal health departments and the Ministry of Health (Department of Traditional Medicine Management).

4. Business entities shall be responsible for:

a) Organizing research to implement the provisions of laws on the management of the quality of medicinal materials, traditional herbal medicines, and traditional medicines issued in this Circular;

b) Ensuring the quality of medicinal materials, traditional herbal medicines, and traditional medicines throughout the entire operation of the entity (cultivation, harvesting, extraction; export, import; processing, production; storage; transportation; distribution) and within the scope of business permitted based on compliance with legal regulations;

c) Regularly reporting the situation of cultivation, harvesting, and extraction of medicinal materials; the situation of domestic trade in medicinal materials, traditional herbal medicines, and traditional medicines according to Model No. 11 of Appendix I issued together with this Circular;

d) Participating in the traceability system to update documents proving the origin and source of medicinal materials, traditional herbal medicines, and traditional medicines;

đ) When discovering counterfeit or substandard medicinal materials, traditional herbal medicines, and traditional medicines, immediately initiate the traceability process and promptly notify the competent state management agencies, national testing agencies, and other business entities;

e) Retaining all relevant files, documents, and information related to each import, purchase, sale, distribution, and circulation of medicinal materials, traditional herbal medicines, and traditional medicines to ensure traceability of origin and source and quality control throughout the entire process from cultivation, harvesting, extraction; export; import; processing, production; storage; transportation, and distribution;

g) Paying for testing costs and providing standard substances and reference substances to the testing agency when the agency does not have such substances or has not researched and established them for the samples of medicinal materials, traditional herbal medicines, and traditional medicines sent for testing by the business entity;

h) Implementing other legal provisions on drugs to ensure the maintenance of the quality of medicinal materials, traditional herbal medicines, and traditional medicines throughout the trading, circulation, and usage processes;

a) Building a medicine list for use at their facility, including medicines self-manufactured or compounded by the facility (if applicable), and submitting it to the social insurance agency where the health insurance examination and treatment contract is signed along with the procurement plan, procurement results, compounding procedures, quality standards, and costs of compounded medicines for health insurance reimbursement purposes; ensuring transparency and rational selection of medicines with quality;

a) Only use medicinal materials, traditional herbal medicines, and traditional medicines with clear origins and sources as stipulated in Article 13 of this Circular and provided by business entities that have obtained certification of eligibility to operate pharmaceutical businesses;

b) Regularly or at random check the quality of medicinal materials, traditional herbal medicines, and traditional medicines used by the entity. In case of discovering counterfeit or substandard medicinal materials, traditional herbal medicines, and traditional medicines, immediately isolate them and promptly initiate the traceability process of origin and source to proceed with subsequent handling steps as prescribed. Medicinal materials, traditional herbal medicines, and traditional medicines used by the entity must be inspected and accepted through the Pharmacy Department's Inspection Committee of the hospital in accordance with 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 inspection department of other medical examination and treatment establishments;

c) For traditional medicines produced by medical examination and treatment establishments in accordance with Article 70 of the Drug Law and traditional herbal medicines processed and compounded by medical examination and treatment establishments to sell to other medical examination and treatment establishments in accordance with Clause 2 of Article 70 of the Drug Law, the establishment must conduct quality testing at a state testing facility meeting GLP standards or a business service testing facility that has been certified as eligible to operate pharmaceutical businesses. If the medical examination and treatment establishment has a GLP laboratory, the quality testing of medicinal materials, traditional herbal medicines, and traditional medicines will be conducted in the establishment's laboratory;

d) For traditional herbal medicines compounded and processed by medical examination and treatment establishments solely for their own use, the establishment must conduct inspections of the compounding, processing, and production processes and quality control.

đ) The head of the medical examination and treatment facility shall be responsible for organizing regular inspections at least once every three months or conducting spot checks when necessary regarding the preparation, processing, production, and quality control of traditional herbal medicines, traditional medicine ingredients, and traditional medicines at such facilities. Inspection results must be recorded in a report and retained according to regulations;

e) In cases where risk factors affecting the quality of traditional herbal medicines, traditional medicine ingredients, and traditional medicines are discovered, the medical examination and treatment facility must send samples to state testing facilities that meet GLP standards or commercial testing service providers that have been certified to operate pharmaceutical businesses;

6. Responsibilities of management agencies in preventing and combating traditional herbal medicines, traditional medicine ingredients, and traditional medicines of unknown origin, counterfeit, or substandard quality:

a) Receiving information reported by organizations and individuals;

b) Communicating and disseminating to the public and pharmaceutical business establishments signs to recognize traditional herbal medicines, traditional medicine ingredients, and traditional medicines of unknown origin, counterfeit, or substandard quality to prevent their purchase, sale, and use; methods for reporting suspected cases of traditional herbal medicines, traditional medicine ingredients, and traditional medicines of unknown origin, counterfeit, or substandard quality to relevant state management agencies;

c) Publicly announcing on the electronic portal/information website and mass media information about traditional herbal medicines, traditional medicine ingredients, and traditional medicines of unknown origin, counterfeit, or substandard quality detected in the market, and the results of handling such cases;

d) Implementing or coordinating with related competent authorities to carry out inspection and supervision activities to promptly detect traditional herbal medicines, traditional medicine ingredients, and traditional medicines of unknown origin, counterfeit, or substandard quality being traded and circulated in the market;

đ) Cooperating and supporting competent authorities in investigating and tracing the origin of counterfeit or substandard traditional herbal medicines, traditional medicine ingredients, and traditional medicines;

e) Handling cases of violations concerning the trading of traditional herbal medicines, traditional medicine ingredients, and traditional medicines of unknown origin or smuggling according to regulations;

g) The Traditional Medicine Management Department serves as the focal point for coordinating, communicating, and exchanging information about traditional herbal medicines, traditional medicine ingredients, and traditional medicines of unknown origin, counterfeit, or substandard quality with international organizations and drug regulatory agencies of other countries;

Article 27. Responsibility for Implementation

The Head of the Ministry's Office, the Inspector General of the Ministry, the Director of the Traditional Medicine Management Department, the Heads of units under and affiliated with the Ministry of Health, Provincial Health Departments, pharmaceutical business establishments, and other related agencies, organizations, and individuals are responsible for implementing this Circular;

During implementation, if there are difficulties or obstacles, agencies, organizations, and individuals are advised to promptly reflect them to the Traditional Medicine Management Department, Ministry of Health for consideration and resolution./.