Circular No. 19/2019/TT-BYT stipulates Good Agricultural and Collection Practices for medicinal plants and the principles and standards for harvesting natural medicinal materials.

CIRCULAR

REGULATIONS ON GOOD AGRICULTURAL AND COLLECTION PRACTICES FOR DRUG MATERIALS AND PRINCIPLES AND STANDARDS FOR THE HARVESTING OF NATIVE DRUG MATERIALS

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

Pursuant to Decree No. 75/2017/NĐ-CP dated June 20, 2017 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 to regulate Good Agricultural and Collection Practices for drug materials and principles and standards for the harvesting of native drug materials.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the issuance, announcement, and application of Good Agricultural and Collection Practices for drug materials and principles and standards for the harvesting of native drug materials, as well as the evaluation of compliance with these practices; the implementation timeline for entities engaged in the cultivation, collection, and harvesting of native drug materials.

Article 2. Applicability

1. This Circular applies to entities involved in the cultivation, collection, and harvesting of drug materials (hereinafter referred to collectively as entities) and organizations related to the management of the cultivation, collection, and harvesting of drug materials.

2. This Circular does not apply to individuals engaged in the cultivation, collection of drug materials, and the harvesting of native drug materials.

Article 3. Explanation of Terms

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

1. Good Agricultural and Collection Practices for drug materials are appropriate principles and technical standards implemented during the cultivation, collection, initial processing, manufacturing, transportation, and storage of drug materials to ensure their quality, safety, and efficacy, as well as those of products derived from them.

2. Principles and Standards for the Harvesting of Native Drug Materials are appropriate methods and techniques implemented during the harvesting, initial processing, manufacturing, transportation, and storage of native drug materials to ensure their quality, safety, and efficacy, as well as those of products derived from them.

Article 4. Fees and Charges

Entities requesting assessment, periodic assessment, change assessment, and supplementary assessment for drug materials meeting Good Agricultural and Collection Practices for drug materials and principles and standards for the harvesting of native drug materials must pay the examination fee as prescribed in Circular No. 277/2016/TT-BTC dated November 14, 2016, issued by the Ministry of Finance on the levels of fees, collection, payment, management, and utilization in the pharmaceutical and cosmetic sectors.

Chapter II

ISSUANCE AND ANNOUNCEMENT OF APPLICATION OF GOOD AGRICULTURAL AND COLLECTION PRACTICES FOR DRUG MATERIALS AND PRINCIPLES AND STANDARDS FOR THE HARVESTING OF NATIVE DRUG MATERIALS

Article 5. Issuance and Announcement of Application of Good Agricultural and Collection Practices for drug materials and principles and standards for the harvesting of native drug materials

1. Issue the "Good Agricultural and Collection Practices for drug materials and principles and standards for the harvesting of native drug materials" of Vietnam (GACP Vietnam) as Appendix III attached to this Circular.

2. Announce the "Good Agricultural and Collection Practices for drug materials" according to the recommendations of the World Health Organization (GACP-WHO) as Appendix IV attached to this Circular.

Article 6. Application of Good Agricultural and Collection Practices for drug materials and principles and standards for the harvesting of native drug materials

1. By no later than January 1, 2030, entities engaged in the cultivation, collection of drug materials, or harvesting of native drug materials must comply with the GACP Vietnam principles and standards as set out in Appendix III attached to this Circular.

2. The application of the GACP-WHO principles and standards as set out in Appendix IV of this Circular and updated documents published on the Ministry of Health's website or the Traditional Medicine Management Department's electronic information portal is voluntary for entities.

Article 7. Updating GACP - WHO Documentation

1. In case the World Health Organization amends or supplements the principles and standards of "Good Agricultural and Collection Practices for Medicinal Plants" attached as Appendix IV to this Circular, the Traditional Medicine Management Department shall organize the translation and publication of the amended and supplemented contents on the Ministry of Health's electronic portal and the Traditional Medicine Management Department's website for relevant parties to search, update, and apply.

2. The application of updated GACP - WHO documentation by entities shall not be later than twelve months from the date of publication on the Ministry of Health's electronic portal or the Traditional Medicine Management Department's website.

Chapter III

EVALUATION OF COMPLIANCE WITH GOOD AGRICULTURAL AND COLLECTION PRACTICES FOR MEDICINAL PLANTS AND PRINCIPLES AND STANDARDS FOR THE HARVESTING OF NATURAL MEDICINAL PLANTS

Article 8. Cases for Evaluation, Maintenance Evaluation, Change and Supplement Evaluation, Revocation of GACP Certified Medicinal Plant Certificates, and the Validity of GACP Certified Medicinal Plant Certificates

1. Entities request evaluation for GACP certification in the following cases:

a) Entities have medicinal plants that have not been evaluated and announced as meeting GACP or issued a GACP certified medicinal plant certificate or a receipt for announcing the entity as meeting GACP before the effective date of this Circular;

b) Entities have medicinal plants that have been announced or issued a GACP certified medicinal plant certificate but have changes or supplements in planting, harvesting, and exploitation locations in different geographic areas, soil types, and climates compared to the previously GACP-certified locations or changes in the entire process of planting, harvesting, exploiting, and processing medicinal plants.

2. Entities request maintenance evaluation when the validity period announced on the Traditional Medicine Management Department's website or the GACP certified medicinal plant certificate expires.

3. Entities request change and supplement evaluation during the validity period of the announcement or GACP certified medicinal plant certificate when there are changes or supplements, except for changes or supplements as stipulated in point b, Clause 1, Article 8 of this Circular.

4. Revocation of the GACP certified medicinal plant certificate or removal of the announcement of GACP compliance published on the Traditional Medicine Management Department's website in the following cases:

a) Entities do not comply with GACP principles and standards;

b) Entities fail to implement corrective actions within the prescribed time limit or delay or intentionally avoid implementing corrective actions.

5. The validity period of the announcement of GACP compliance or the GACP certified medicinal plant certificate is three years from the date of announcement or issuance.

Article 9. Documents as Basis for Evaluation of Compliance with GACP

1. Application form for evaluation according to Model No. 1A in Appendix I of this Circular.

2. A certified copy of the decision on establishment or business registration certificate or investment permit of the entity (for cases stipulated in Point a, Clause 1, Article 8 of this Circular).

3. Organizational structure and personnel list of the entity (specifying key departments of the entity: name, position, professional qualifications, and work experience of department heads). If the entity consists of multiple households, it must also submit a list of household names, addresses, cultivation and exploitation sites, area, and purchase contracts between the entity and households or household representatives.

4. Layout diagram of cultivation and exploitation zones and descriptions of cultivation and exploitation zones, preliminary processing, processing, and storage.

5. Training plan, content, and results regarding GACP for entity staff in the year of submission.

6. Cultivation, exploitation, and processing procedures for medicinal plants researched and developed by the entity or applied based on scientific research results or published documents.

7. Self-evaluation results according to the assessment criteria table specified in Appendix II of this Circular.

8. A certified copy of the list of forest products confirmed by the forestry authority according to Circular No. 27/2018/TT-BNNPTNT dated November 26, 2018, of the Minister of Agriculture and Rural Development on management and traceability of natural medicinal plant forest products.

Article 10. Documents serving as the basis for periodic assessment of compliance with GACP

1. A request form for periodic assessment of compliance with GACP according to Model No. 1B in Appendix I of this Circular.

2. An activity report of the facility after three years of implementing GACP according to Model No. 5A in Appendix I of this Circular. The report must clearly reflect any changes during the operation that affect the maintenance and adherence to GACP (if any).

Article 11. Documents serving as the basis for assessment of changes and supplements for medicinal materials that have achieved GACP

1. A request form for assessment of changes and supplements according to Model No. 1C in Appendix I attached to this Circular.

2. A report on the contents changed compared to the previous assessment according to Model No. 5B in Appendix I attached to this Circular. The report must clearly reflect any changes in activities affecting the maintenance and adherence to GACP.

3. Any documents specified in Clauses 2, 3, 4, 5, 6, 7, and Clause 8 of Article 9 of this Circular if there are changes from the previous assessment.

Article 12. Procedures and processes for assessing compliance with GACP

1. Receiving documents:

The facility requesting the assessment of compliance with GACP submits one set of documents and one CD or USB containing corresponding documents as stipulated in Article 9 of this Circular, along with the evaluation fee as prescribed by the Minister of Finance, to the Traditional Medicine Management Department (the receiving agency) through direct submission, postal submission, or online submission via the Ministry of Health's online public service system.

2. Procedures for receiving and evaluating documents:

a) Upon receipt of complete and valid documents as prescribed, the receiving agency issues a document receipt form to the facility according to Model No. 02 in Appendix I of this Circular. In cases where the submitted documents are incomplete, the receiving agency requests the facility to supplement the documents within ten working days upon direct submission, or within ten working days from the date of receipt in case of postal or online submission.

b) Within five working days from the date of receiving complete and valid documents, the receiving agency establishes an Assessment Team and sends the facility a Decision on Establishing the Assessment Team, including a tentative schedule for the actual assessment at the facility.

Within fifteen working days from the date of the Decision on Establishing the Assessment Team, the actual assessment at the facility shall be conducted.

3. Assessment process:

a) Step 1. The Assessment Team announces the Decision on Establishing the Assessment Team, the purpose, content, and plan of the assessment at the facility;

b) Step 2. The facility presents a summary of its organizational structure, personnel, and implementation and application of GACP or specific content according to the assessment period;

c) Step 3. The Assessment Team conducts an actual assessment of the implementation and application of GACP at the facility according to specific content. If the facility performs one or several stages of the production process, the assessment content will only include requirements corresponding to the production stages carried out by the facility;

d) Step 4. The Assessment Team meets with the facility to inform about any issues discovered during the assessment (if any); discusses with the facility in cases where the facility does not agree with the Assessment Team's assessment of each issue or regarding the degree of compliance with GACP principles and standards;

e) Step 5. Drafting and signing the assessment record:

Immediately after completing the actual assessment at the facility, the Assessment Team drafts the assessment record according to Model No. 4A in Appendix I of this Circular. The assessment record must reflect the members of the Assessment Team, location, time, scope of the assessment, and unresolved issues between the Assessment Team and the facility (if any). The facility's leader and the head of the Assessment Team sign to confirm the assessment record. The record is made in three copies: one copy retained by the facility, two copies retained by the receiving agency.

f) Step 6. Completing the Assessment Report:

The Assessment Team is responsible for drafting the GACP assessment report according to Model No. 4B in Appendix I attached to this Circular.

Within twenty days, the Assessment Team is responsible for completing the assessment.

4. Degree of Compliance with GACP:

The degree of compliance with GACP of the facility is defined in Appendix V issued together with this Circular, including the following levels:

a) The facility complies with GACP at Level 1;

b) The facility complies with GACP at Level 2;

c) The facility complies with GACP at Level 3.

Article 13. Handling the Results of GACP Compliance Assessment

1. In the case where the GACP compliance assessment report concludes that the facility complies with GACP at level 1 as stipulated in point a, Clause 4, Article 12 of this Circular:

Within ten working days from the date of signing the assessment record, the receiving agency shall publish on its electronic information website the list of medicinal materials that have been assessed as meeting GACP requirements according to Model No. 06 in Appendix I attached to this Circular. If the facility requests issuance of a GACP-compliant medicinal material certificate in the application for assessment, the receiving agency shall issue a GACP-compliant medicinal material certificate according to Model No. 03 in Appendix I attached to this Circular.

2. In the case where the GACP compliance assessment report concludes that the facility complies with GACP at level 2 as stipulated in point b, Clause 4, Article 12 of this Circular:

a) Within five working days from the date of signing the assessment record, the receiving agency shall send the GACP compliance assessment report to the facility;

b) After completing the rectification and correction, within thirty days, the facility must submit a rectification report in writing including a plan and evidence (document files, images, videos, or other proof documents) demonstrating the rectification and correction of the issues noted in the GACP compliance assessment report;

c) Within twenty days from the date of receipt of the rectification report, the receiving agency shall evaluate the results of the rectification by the facility and conclude on the facility's compliance with GACP requirements:

- In the case where the facility's rectification meets the requirements, the receiving agency shall publish on its electronic information website the list of medicinal materials that have been inspected and assessed as meeting GACP requirements according to Model No. 06 in Appendix I attached to this Circular. If the facility has requested it in the application for assessment, the receiving agency shall issue a GACP-compliant medicinal material certificate according to Model No. 03 in Appendix I of this Circular;

- In the case where the facility's rectification does not meet the requirements, the receiving agency shall notify the facility in writing and specify the reasons;

d) Within six months from the date the receiving agency sends the assessment report containing the requirement for modification and supplementation, the facility must submit the modified and supplemented dossier. After this period, if the facility does not modify or supplement the dossier or if the modified and supplemented dossier submitted twelve months after the initial application does not meet the requirements, the submitted application will lose its validity.

3. In the case where the GACP compliance assessment report concludes that the facility complies with GACP at level 3 as stipulated in point c, Clause 4, Article 12 of this Circular, within five working days from the date of signing the assessment record, the receiving agency shall issue a notification of non-compliance with GACP along with the GACP compliance assessment report to the facility.

4. In the case where the facility disagrees with the contents of the assessment by the assessment team, within thirty days from the date the assessment team submits the GACP compliance assessment report or the corrective action assessment report, the facility must submit a written explanation to the receiving agency accompanied by evidence (document files, images, videos, or related documents).

Within ten working days from the date of receipt of the facility's written explanation, the receiving agency shall review the GACP compliance assessment report and the facility's explanation, seek expert advice if necessary, and issue a written response to the facility. The response must clearly state whether it accepts or rejects the facility's explanation. This time is not included in the assessment period.

Article 14. Procedure and process for periodic assessment of compliance with GACP

1. Thirty days prior to the expiration date of the Certificate of Good Agricultural and Collection Practices (GACP) for medicinal materials or the announced expiration date on the Electronic Information Portal of the Department of Traditional Medicine Management, the entity shall submit one set of application documents for periodic assessment of continued compliance with GACP as stipulated in Article 10 of this Circular to the receiving authority through direct submission, postal service, or online submission via the Ministry of Health's online public service system.

2. In case the entity fails to submit the periodic assessment application documents within the time limit specified in Clause 1 of this Article, within fifteen days from the expiration date of the GACP Certificate, the receiving authority shall issue a document requesting the entity to comply with the submission of the periodic assessment application documents as prescribed.

3. Within forty-five days from the issuance date of the request document by the receiving authority, the entity must submit the periodic assessment application documents for continued compliance with GACP along with an explanation for the delay in submission. If the entity fails to submit the documents beyond this period, the receiving authority will conduct inspections and audits according to regulations, prepare a record in accordance with Model Form 4C in Appendix I of this Circular.

The procedures for receiving, examining, and processing the application documents and the periodic assessment process for continued compliance with GACP shall be carried out in accordance with Clause 2 and Clause 3 of Article 12 of this Circular.

4. After submitting the periodic assessment application documents for continued compliance with GACP within the time limit stipulated in Clause 1 of this Article, the entity may continue its production activities in accordance with GACP until the results of the periodic assessment are available.

Article 15. Handling of Results of Periodic Assessment of Continued Compliance with GACP

1. In the case where the GACP compliance assessment report concludes that the facility complies with GACP at level 1 as stipulated in point a, Clause 4, Article 12 of this Circular:

Within ten working days from the signing date of the assessment record, the receiving authority shall publish the results of the GACP assessment on the Electronic Information Portal of the receiving authority using Model Form 06 in Appendix I of this Circular. In case the entity requests issuance of a GACP Certificate for medicinal materials in the assessment application form, the receiving authority shall issue a GACP Certificate for medicinal materials using Model Form 03 in Appendix I of this Circular.

2. In the case where the GACP compliance assessment report concludes that the facility complies with GACP at level 2 as stipulated in point b, Clause 4, Article 12 of this Circular:

a) Within five working days from the signing date of the assessment record, the receiving authority shall send the GACP assessment report to the entity for corrective actions and submit a report on the corrective actions back to the receiving authority.

b) Within thirty days from the date the receiving authority sends the GACP assessment report, the entity must provide a written report on corrective actions including plans and evidence (documentary files, images, videos, certificates, or other proof) demonstrating the corrective actions recorded in the GACP assessment report.

c) Within twenty days from the receipt of the corrective action report, the receiving authority shall evaluate the entity’s corrective actions and conclude on the status of continued compliance with GACP.

- In case the entity’s corrective actions meet the requirements: The receiving authority shall update information about the entity’s continued compliance with GACP on the Electronic Information Portal of the receiving authority. In case the entity requests issuance of a GACP Certificate for medicinal materials in the assessment application form, the receiving authority shall issue a GACP Certificate for medicinal materials using Model Form 03 in Appendix I of this Circular.

- In case the entity’s corrective actions do not meet the requirements: The receiving authority shall issue a document specifying the necessary further corrective actions and submission of supplementary reports. The extension period for further corrective actions and reporting is forty-five days from the issuance date of the request document.

d) Within ninety days from the signing date of the assessment record, if the entity does not submit a corrective action report or if the corrective actions still do not meet the requirements after the period specified in Point c of this Clause, the receiving authority shall issue a document announcing non-compliance with GACP and take appropriate measures as stipulated in Points a and b of Clause 3 of this Article based on the nature and severity of the violation.

3. In case the GACP assessment report concludes that the entity complies with GACP at Level 3 as stipulated in Point c of Clause 4 of Article 12 of this Circular, depending on the nature and severity of the violation, within ten working days from the issuance date of the assessment report, the receiving authority shall implement one or more of the following measures:

a) Issue a decision to revoke the issued GACP Certificate for medicinal materials and remove the published announcement of the GACP assessment result from the Electronic Information Portal of the receiving authority.

b) Administer administrative penalties in accordance with laws on handling administrative violations.

4. Within five working days from the conclusion that the entity meets the requirement for continued compliance with GACP or from the issuance date of the decision to revoke the GACP Certificate for medicinal materials due to failure to maintain compliance with GACP, the receiving authority shall update the status of compliance or non-compliance with GACP on the Electronic Information Portal of the receiving authority for entities meeting GACP requirements or provide information for entities failing to maintain compliance with GACP.

5. In case samples of medicinal materials collected during the assessment are found to violate quality standards, the receiving authority shall handle the violation in accordance with the law.

Article 16. Procedure for evaluating and handling results of changes and supplements to GACP compliance

1. Receiving documents:

The entity requesting evaluation of changes and supplements to GACP compliance shall submit one set of documents and one CD or USB containing corresponding documents as prescribed in Article 11 of this Circular, along with the examination fee as stipulated by the Minister of Finance, directly to the Traditional Medicine Management Department (receiving agency) through direct submission, postal service, or online submission on the Ministry of Health's online public service system.

2. Procedures for receiving and evaluating documents:

Upon receiving complete and valid documents as prescribed, the receiving agency shall issue the entity a Receipt Form according to Model No. 02 of Appendix I issued together with this Circular. In cases where the documents are incomplete, the receiving agency shall request the entity to supplement the required documents immediately if submitted directly, or within ten days if submitted via postal service or online.

3. The entity may implement changes and supplements immediately after the receiving agency issues the entity a Receipt Form under any of the following circumstances:

a) Changes and supplements to the Decision on Establishment or Business Condition Certificate;

b) Changes and supplements to the organizational structure and personnel of the entity while still meeting the requirements and conditions of the technical department responsible for cultivating and harvesting medicinal herbs.

4. Within one month from the date of receipt of complete and valid documents, the receiving agency shall conduct an examination of the documents and evaluate the actual situation at the entity according to Clause 2 and Clause 3 of Article 12 of this Circular under any of the following circumstances:

a) Changes and supplements to the area of cultivation and harvesting of medicinal herbs in regions with similar soil and climate conditions;

b) Changes and supplements to the variety and seed selection and propagation procedures;

c) Changes during the cultivation process of medicinal herbs: fertilizer/feed ratio, fertilization/supplementation timing;

d) Changes during the harvesting and processing process of medicinal herbs: harvesting time, harvesting method, processing conditions (temperature, humidity, excipient/additive ratio);

đ) Other changes that significantly affect the quality of medicinal herbs;

e) Changes and supplements not covered by Clause 3 of this Article.

5. Where an actual evaluation is required as prescribed in Clause 4 of this Article, the handling of the results of changes and supplements to GACP compliance shall be carried out according to Article 13 of this Circular.

Article 17. Reissuing the GACP Compliance Certificate for Medicinal Herbs in Case of Loss or Damage

1. The entity shall submit an Application for Reissue of the GACP Compliance Certificate for Medicinal Herbs according to Model No. 1D of Appendix I accompanying this Circular.

2. Within five working days from the date of receipt of the Application for Reissue of the GACP Compliance Certificate for Medicinal Herbs from the entity, the receiving agency shall reissue the GACP Compliance Certificate for Medicinal Herbs according to Model No. 03 of Appendix I accompanying this Circular.

Chapter IV

EVALUATION TEAM FOR GOOD AGRICULTURAL AND COLLECTION PRACTICES OF MEDICINAL HERBS AND PRINCIPLES AND STANDARDS FOR HARVESTING NATURAL MEDICINAL HERBS

Article 18. Composition and Qualification Standards of Evaluation Team Members

1. The composition of the Evaluation Team includes:

a) The Team Leader and Secretary from the receiving agency;

b) At least one member representing the Institute of Herbal Medicine;

c) One member representing the Provincial Health Department (hereinafter referred to as the Health Department) of the province or centrally administered city where the cultivation, harvesting, extraction, processing, and storage of medicinal herbs take place;

d) At least one member from the receiving agency;

e) Other members as required by the Team Leader.

2. Staff participating in the Evaluation Team must meet the following standards:

a) Hold a bachelor's degree or higher and have been trained in pharmacy or plant cultivation, plant protection, agronomy, herbal medicine quality management, and pharmaceutical administration;

b) Have received training and instruction on GACP, GACP inspection, and evaluation, and thoroughly understand the principles and standards of GACP;

c) Be honest, impartial, and strictly comply with all regulations and laws during the evaluation process without having conflicts of interest with the evaluated entity as prescribed in Clause 3 of this Article;

d) The Team Leader must have at least two years of experience in pharmaceutical or traditional medicine management.

3. Conflict of Interest Evaluation Principle: An Evaluation Team member is considered to have a conflict of interest with the evaluated entity if they fall under any of the following circumstances:

a) Have worked or provided consultancy services for the evaluated entity in the past five years;

b) Currently have financial interests with the evaluated entity;

c) Have a spouse, child, parent, sibling, parent-in-law, or spouse's parent employed by the evaluated entity.

Article 19. Responsibilities and Authorities of the Inspection Team

1. Responsibilities of the Inspection Team:

a) Evaluate all activities of the facility according to the principles and standards of Good Agricultural and Collection Practices (GACP) as stipulated in Article 5 of this Circular, the updated version of GACP principles and standards, and related professional regulations; record specific contents of the evaluation, identified issues, draft the inspection report, and the GACP Evaluation Report;

b) Report the results of the evaluation or provide explanations for the GACP Evaluation Report when the evaluated facility disagrees with the content of the GACP Evaluation Report;

c) Maintain confidentiality over all information related to the evaluation content and all information related to cultivation, harvesting, extraction, quality control, storage, and distribution of medicinal materials, except with the consent of the facility or upon request of the competent state authority.

2. Authorities of the Inspection Team:

a) Inspect all areas related to the cultivation, harvesting, extraction, processing, and storage of medicinal materials at the evaluated facility;

b) Request the facility to provide relevant files and documents;

c) Collect files and documents, evidence (photocopies of documents, photographs, videos, etc.) regarding issues discovered during the evaluation process;

d) Take samples of medicinal materials for quality testing as prescribed by law;

đ) Draft minutes, require the facility to temporarily suspend one or more parts or all activities related to violations if the Inspection Team discovers serious violations affecting the quality of medicinal materials during the evaluation process; report to the authorized person to issue a formal decision on handling.

Chapter V

IMPLEMENTING PROVISIONS

Article 20. Effective Date

1. This Circular takes effect from September 27, 2019.

2. Circular No. 14/2009/TT-BYT dated September 3, 2009, issued by the Minister of Health on guiding the implementation and application of the principles and standards of "Good Agricultural and Collection Practices" as recommended by the World Health Organization, shall cease to be effective from the date this Circular takes effect.

Article 21. Transitional Provisions

1. Applications submitted before the date this Circular takes effect shall be implemented according to the provisions of Circular No. 14/2009/TT-BYT dated September 3, 2009, issued by the Minister of Health on guiding the implementation and application of the principles and standards of "Good Agricultural and Collection Practices" as recommended by the World Health Organization.

2. For facilities that have been granted the Acceptance Notice for the Declaration of Medicinal Materials Produced According to GACP-WHO before the date this Circular takes effect:

a) May continue to use it until its expiration date;

b) From the date this Circular takes effect, if a facility requests issuance of a Certificate of Medicinal Materials Meeting GACP instead of the valid Acceptance Notice for the Declaration of Medicinal Materials Produced According to GACP-WHO, the facility shall reissue the Certificate of Medicinal Materials Meeting GACP according to the provisions of Article 17 of this Circular. The Certificate of Medicinal Materials Meeting GACP shall remain valid until the expiration date of the previously issued Acceptance Notice for the Declaration of Medicinal Materials Produced According to GACP-WHO.

Article 22. Reference Provisions

In case the regulatory legal documents and provisions cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new regulatory legal documents.

Article 23. Responsibility for Implementation

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

a) Organize the implementation, inspection, and supervision of this Circular nationwide;

b) Issue Certificates of Medicinal Materials Meeting GACP;

c) Update the list of facilities meeting GACP on the Ministry of Health's electronic portal or the Traditional Medicine Management Department's website;

d) Handle complaints related to the certification of medicinal materials meeting GACP according to the law;

đ) Handle violations by facilities engaged in cultivation and harvesting of medicinal materials according to GACP standards nationwide according to the law.

2. Provincial Departments of Health under the central government are responsible for:

a) Organizing the implementation, inspection, and supervision of this Circular within their jurisdiction;

b) Participate in the GACP Inspection Team for facilities located in their jurisdiction upon the request of the receiving agency.

3. Facilities engaged in cultivation, harvesting, and extraction of medicinal materials shall annually report the yield of medicinal materials that have been evaluated and declared to meet GACP.

4. The Heads of the Ministry's Office, the Inspector General of the Ministry, the Directors of the General Departments, the Heads of the Bureaus and Departments under the Ministry of Health, the Directors of Provincial Departments of Health under the central government, and related agencies, organizations, and individuals are responsible for implementing this Circular.

During the implementation process, if there are difficulties or obstacles, agencies, organizations, and individuals should promptly reflect them to the Traditional Medicine Management Department of the Ministry of Health for research and appropriate amendments./.