Circular No. 14/2009/TT-BYT guides the implementation and application of the principles and standards of "Good Agricultural and Collection Practices for Medicinal Plants" (GACP-WHO) as recommended by the World Health Organization.

CIRCULAR

Guidelines for implementing and applying the principles and standards of "Good Agricultural and Collection Practices for Medicinal Plants" as recommended by the World Health Organization

"Good Agricultural Practices for Cultivation and Harvesting of Medicinal Plants" as recommended by the World Health Organization

_______________________________

Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the Drug Law dated June 14, 2005;

Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006;

Pursuant to the Law on Product Quality and Commodities dated November 21, 2007;

Pursuant to Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Medicine Law;

Based on Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing implementation of certain provisions

Pursuant to Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing certain provisions of the Law on Product Quality and Safety;

Pursuant to Decision No. 154/2006/QĐ-TTg dated June 30, 2006 of the Prime Minister approving the Project "State Management of Drugs, Food Safety, and Cosmetics from 2006 to 2015";

Pursuant to Decision No. 43/2007/QĐ-TTg dated March 29, 2007 of the Prime Minister approving the Project "Development of the Pharmaceutical Industry and Construction of a Drug Supply System in Vietnam from 2007 to 2015 with Vision to 2020";

Pursuant to Decision No. 24/2007/QĐ-BKHCN dated September 28, 2007 of the Ministry of Science and Technology promulgating the "Regulations on Conformity Assessment, Declaration of Conformity, and Public Announcement of Conformity";

At the proposal of the Director of the Drug Administration Department;

The Ministry of Health guides the implementation of the application of the principles and standards of "Good Agricultural and Collection Practices for Medicinal Plants" as recommended by the World Health Organization as follows:

PART I

GENERAL PROVISIONS

Article 1. Purpose of Issuance

To conserve and sustainably develop national natural resources, contribute to improving the quality of herbal medicines, and move towards harmonization in the region and globally regarding the business and import-export of pharmaceuticals, including traditional Chinese medicine and herbal medicines, the Ministry of Health decides to apply the principles and standards of "Good Agricultural and Collection Practices for Medicinal Plants" as recommended by the World Health Organization.

Article 2. Scope of Application

Clause 1. This Circular guides the implementation of the application of the principles and standards of "Good Agricultural and Collection Practices for Medicinal Plants" as recommended by the World Health Organization; the announcement and acceptance of declarations of herbal medicines produced according to these principles and standards; the organization of conformity assessments of the principles and standards of "Good Agricultural and Collection Practices for Medicinal Plants"; and activities to monitor compliance with the principles and standards of "Good Agricultural and Collection Practices for Medicinal Plants".

Clause 2. This Circular applies to establishments engaged in planting, harvesting, and processing herbal medicines operating within the territory of Vietnam that voluntarily implement GACP-WHO, state management agencies responsible for inspecting and supervising the implementation of GACP-WHO, and organizations and individuals related to the activity of assessing conformity with GACP-WHO.

Article 3. Explanation of Terms

In this Circular, the following terms shall be understood as follows:

1. Herbal medicine is medicine produced from natural raw materials of animal, plant, or mineral origin.

2. Traditional Chinese medicine is herbal medicine prepared according to the theory and methods of traditional Eastern medicine.

3. Herbal medicine production establishment is an organization or individual engaged in purchasing, planting, harvesting, and processing medicinal plants.

4. GACP-WHO (World Health Organization guidelines on Good Agricultural and Collection Practices for medicinal plants) are the principles and standards of "Good Agricultural and Collection Practices for Medicinal Plants" as recommended by the World Health Organization.

5. Conformity assessment organization in the field of GACP-WHO is an organization meeting the conditions specified by the Ministry of Health.

6. Planting, harvesting, and processing procedures for herbal medicines are technical documents containing the following contents: selection of land area, determination of planting time and harvest season; seed selection and propagation; soil treatment, sowing; fertilization, irrigation; pest control; harvesting, initial processing, processing; packaging, labeling, storage; quality requirements and methods for product quality inspection and control.

Chapter II

IMPLEMENTATION, ANNOUNCEMENT AND ACCEPTANCE OF DECLARATIONS FOR HERBAL MEDICINES PRODUCED IN ACCORDANCE WITH GACP-WHO

Article 4. Implementation of GACP-WHO

1. The Drug Administration shall take the lead and coordinate with relevant units:

a) To develop and promulgate the list of GACP-WHO inspection items.

b) To disseminate and train on GACP-WHO and the GACP-WHO inspection list to provincial health departments under central cities, health sectors, and medicinal plant production facilities.

2. Medicinal plant production facilities shall research, train GACP-WHO for their staff and implement GACP-WHO.

Article 5. Internal Inspection

1. When meeting the conditions for growing, harvesting, and processing medicinal plants according to GACP-WHO, medicinal plant production facilities shall conduct internal inspections to assess compliance with GACP-WHO.

2. Basis for inspection:

a) GACP-WHO documentation;

b) List of GACP-WHO inspection items;

c) Relevant regulations of state management agencies.

3. Medicinal plant production facilities may conduct self-inspections or invite a conformity assessment organization to participate in self-assessment.

4. Internal inspections shall be carried out during the implementation process and after completion of implementation.

5. Internal inspection records shall be kept at the medicinal plant production facility for inspection purposes.

Article 6. Announcement of Medicinal Plants Produced According to GACP-WHO

1. After conducting internal inspections and meeting the requirements stipulated by GACP-WHO, medicinal plant production facilities shall prepare and submit an announcement dossier for medicinal plants produced according to GACP-WHO to the Drug Administration (which can be sent via postal service or submitted directly to the Drug Administration).

2. The announcement dossier includes:

a) The announcement of medicinal plants produced according to GACP-WHO (in accordance with Form 1 attached);

b) A certified copy of the Decision on Establishment or Business Registration Certificate or Investment License;

c) An organizational chart and personnel roster of the facility (detailing key departments of the facility; names, positions, professional qualifications, and work experience of department heads);

d) A plot layout diagram, land division plan for cultivation and harvesting areas, and a description of cultivation areas, post-harvest processing, preliminary processing, manufacturing, and storage;

đ) In cases where the facility consists of multiple households, a list of names, addresses, locations, cultivated areas, and purchase contracts between the facility and households/family representatives must be included;

e) Training programs, lists of trained individuals, and training results regarding GACP-WHO;

f) Cultivation, harvesting, and processing procedures for medicinal plants (in accordance with Form 2) which have been reviewed and approved by the Institute of Herbal Medicine;

g) Inspection, control, and quality evaluation procedures for medicinal plants that have been established and implemented at the facility;

h) Test results (if available);

i) Fertilizer, soil, and irrigation water records;

k) List of machinery, equipment, and tools used for cultivation and harvesting of medicinal plants;

l) Fire prevention and firefighting confirmation letter or acceptance record from the competent authority where the medicinal plant production facility is located;

m) Environmental impact assessment report of the medicinal plant production facility that has been reviewed by the competent state management authority;

n) Conformity assessment organization's assessment results;

o) Results of the most recent internal assessment (within three months).

Article 7. Acceptance of Notification Documents

1. The authority shall check the submitted documents and issue a receipt form for the production facility (in accordance with Form 3 attached).

2. Within one month from the date of receiving complete valid documents, the Drug Administration shall examine and review the documents (if necessary, it will conduct on-site inspections to assess the actual situation at the facility).

a) In case the documents meet the requirements, the Drug Administration shall issue a Notification Receipt for the Herbal Medicine Production Notification in accordance with GACP-WHO to be sent to the facility.

The Notification Receipt for the Herbal Medicine Production Notification in accordance with GACP-WHO (in accordance with Form 4 attached) shall be valid for three years from the date of issuance.

b) In case the notification documents do not meet the requirements stipulated, the Drug Administration shall notify the facility in writing and specify the reasons. If within six months from the date of the Drug Administration's notification letter, the facility fails to complete the documents, submit a completion report, or provide a corrective action plan, the facility must resubmit the notification documents from the beginning.

Article 8. Resubmission/Supplementary Notification

1. Two months before the Notification Receipt for the Herbal Medicine Production Notification in accordance with GACP-WHO expires and/or in cases of supplementation or changes, the facility shall submit resubmission/supplementary notification documents.

2. Resubmission/supplementary notification documents shall include:

a) The Herbal Medicine Production Notification in accordance with GACP-WHO;

b) Updated training materials and list of trained personnel;

c) Report on the facility's activities over the past three years implementing GACP-WHO and/or report on changes compared to the previous notification (facilities, staff, area, planting and harvesting locations, cultivation and harvesting procedures, processing...);

d) Evaluation documents of the Institute of Medicinal Materials in cases where there are additions or changes to cultivation, harvesting, and processing procedures;

đ) Assessment results of the GACP-WHO Conformity Assessment Organization;

e) Results of the most recent internal inspection (within the last three months).

3. Within one month from the date of receiving complete valid documents, the Drug Administration shall issue a Notification Receipt for the Resubmission/Supplementary Notification to be sent to the facility. In case the requirements are not met, the Drug Administration must notify the facility in writing and specify the reasons.

Article 9. Labeling and Declaration of Origin of Herbal Medicines Produced According to GACP-WHO Principles and Standards

1. Labeling

a) Facilities with a Notification Receipt for the Herbal Medicine Production Notification in accordance with GACP-WHO must label their products in accordance with Circular No. 04/2008/TT-BYT dated May 12, 2008, guiding labeling of drugs issued by the Ministry of Health;

b) On the outer packaging label, the Notification Receipt number for the Herbal Medicine Production Notification in accordance with GACP-WHO and the serial number of the package (a)/total number of packages in one batch (A) (a/A) must be clearly marked.

2. Declaration of Origin

a) Each time goods are shipped out, facilities producing herbal medicines must prepare a declaration of origin document.

The declaration of origin document includes:

- Declaration of Origin Form (in accordance with Form 5 attached);

- A copy of the Notification Receipt for the Herbal Medicine Production Notification in accordance with GACP-WHO.

b) The declaration of origin document shall be made in two copies, one retained by the herbal medicine production facility and one by the buyer.

3. Each product item, the production facility must establish a warehouse card, clearly recording the product name, part used, batch number/start date/end date of production, quantity dispatched, received, sold, used, and remaining stock.

4. In cases where herbal medicines are purchased for resale, the buyer must maintain a record of receipts and dispatches for each consignment received and has the responsibility to provide information to their customers upon request from suppliers or competent state management authorities.

5. Declaration of origin documents and warehouse cards must be kept at the herbal medicine production facility for inspection purposes.

Chapter III

CONFORMITY ASSESSMENT ORGANIZATION IN THE FIELD OF GACP-WHO

Article 10. Designation of Conformity Assessment Organizations

The Ministry of Health designates Conformity Assessment Organizations in the field of GACP-WHO (hereinafter referred to as Conformity Assessment Organizations) to participate in activities serving state management in assessing compliance with GACP-WHO. The assessment results of these organizations are considered and recognized by the Drug Administration during the inspection and supervision process for GACP-WHO compliance.

Article 11. Conditions for designation as a Conformity Assessment Organization

1. Having a management system and professional capacity, organized by the Drug Administration to review and assess meeting the requirements for GACP-WHO conformity assessment;

2. Possessing sufficient capability to audit cultivation, harvesting, and processing of medicinal materials; evaluate the quality of medicinal plant seeds and finished medicinal products;

3. Having appropriate procedures and methods for assessment to ensure the objective and accurate results of GACP-WHO conformity assessment and the quality of products from production facilities.

Article 12. Procedures and formalities for registration and designation of Conformity Assessment Organizations

1. The Drug Administration leads and coordinates with relevant units to develop and issue detailed standards for application during the review and assessment process for organizations meeting the conditions for GACP-WHO conformity assessment.

2. Organizations meeting the conditions stipulated in Article 11 that wish to participate in GACP-WHO conformity assessment activities shall establish and submit registration files to be designated as Conformity Assessment Organizations at the Drug Administration.

3. The registration file includes:

a) Application for conducting GACP-WHO conformity assessment activities (according to Form 6 attached);

b) Copy of the Decision establishing the registering organization;

c) Documentation proving the capacity for GACP-WHO conformity assessment activities meeting the conditions stipulated in Article 11.

4. Within fifteen working days from the date of receiving complete valid files, the Drug Administration leads and coordinates with relevant units to organize the review and assessment of the files (if necessary, on-site inspections will be conducted) to evaluate the conditions of the registering organization.

a) In cases where the requirements are met, the Drug Administration will submit to the Minister of Health for signing the Decision designating the Conformity Assessment Organization, which will be sent to the registering organization.

b) In cases where the requirements are not met, the Drug Administration will notify the registering organization in writing and specify the reasons.

5. A designated Conformity Assessment Organization that needs to change or supplement must follow the registration procedures stipulated in Clause 1 and 2 of this Article.

Article 13. Supervision of Conformity Assessment Organization Activities

1. Every three years, the Drug Administration leads and coordinates with relevant agencies and units to conduct inspections of Conformity Assessment Organization activities.

2. Inspections are carried out at the Conformity Assessment Organization and at least one medicinal material production facility with which the organization has an assessment contract.

3. Inspection results serve as the basis for the Ministry of Health to decide whether to maintain or revoke the Decision designating the Conformity Assessment Organization.

Chapter IV

INSPECTION, SUPERVISION AND VIOLATION HANDLING

Article 14. Inspection and Supervision of GACP-WHO Compliance

1. Forms of inspection and supervision

a) Establishing an inspection team directly at medicinal material production facilities:

The Drug Administration establishes an inspection team on an ad hoc basis when there are complaints about medicinal material production facilities not complying with GACP-WHO or when it is discovered that medicinal materials produced according to GACP-WHO do not meet quality standards;

b) Supervision through the results of Conformity Assessment Organizations:

- The Drug Administration evaluates GACP-WHO compliance of medicinal material production facilities based on the inspection and supervision results of Conformity Assessment Organizations;

- Conformity Assessment Organizations inspect and supervise GACP-WHO compliance according to contracts signed with medicinal material production facilities or upon request of the Drug Administration.

2. Contents of inspection and supervision

a) Inspection of GACP-WHO compliance.

b) Inspection of labeling and origin declaration in accordance with this Circular.

3. Bases for inspection and supervision

a) GACP-WHO documentation;

b) List of GACP-WHO inspection items;

c) Medicinal material production announcement files under GACP-WHO, implementation files of GACP-WHO, origin declaration files;

d) Provisions set forth in this Circular and other regulations of relevant state management agencies.

Article 15. Handling Violations of Medicinal Plant Production Facilities and Organizations for Conformity Assessment

1. Handling Violations of Medicinal Plant Production Facilities

a) When discovering that a medicinal plant production facility does not comply with GACP-WHO, the Drug Administration shall issue a document requesting the facility to rectify the situation, and the facility must submit a written report on the completion of the rectification to the Drug Administration within the prescribed time limit.

b) During the period of rectifying existing issues, if the medicinal plant production facility fails to complete the rectification within the prescribed time limit, delays the rectification, intentionally refrains from rectifying, or refuses inspection and supervision, depending on the degree of impact on the ecological environment, labor safety, and product quality, the Drug Administration shall issue a document withdrawing the Receipt of Declaration of Medicinal Plants Produced According to GACP-WHO.

2. Handling Violations of Organizations for Conformity Assessment

The Ministry of Health shall revoke the Decision appointing an Organization for Conformity Assessment in the following cases:

a) Not meeting the conditions as stipulated;

b) Not ensuring honesty and objectivity in the conformity assessment activities according to GACP-WHO.

Article 16. Responsibilities and Authorities of Medicinal Plant Production Facilities, Organizations for Conformity Assessment, and State Management Agencies

1. Medicinal Plant Production Facilities

a) Implement the procedures and formalities for declaring medicinal plants produced according to GACP-WHO, labeling, origin declaration, and compliance with inspection and supervision as prescribed in this Circular;

b) Bear responsibility for the conformity of products declared to be produced according to GACP-WHO;

c) Maintain inspection, control, and quality evaluation activities of products according to the planned schedule;

d) Carry out the production and circulation of medicinal plants strictly in accordance with the declared dossier. Submit a written report to the Drug Administration when there are changes compared to the declared content;

đ) When detecting non-conformities that may affect the ecological environment, labor safety, or product quality, take appropriate measures such as recalling products, suspending production, identifying causes, implementing rectifications, and simultaneously informing the competent state management agency to take appropriate actions based on the degree of impact;

e) Pay publication fees and process review fees according to current Vietnamese laws;

f) Pay costs agreed upon in contracts with Organizations for Conformity Assessment and/or costs for product quality testing, pesticide residue testing, insecticide testing, etc., in product samples, soil samples, water samples, waste samples;

g) Have the right to reserve opinions and lodge complaints about inspection and supervision results, decisions of state management agencies, and results of Organizations for Conformity Assessment according to the law.

2. Organizations for Conformity Assessment

a) Conduct conformity assessments according to GACP-WHO in accordance with signed contracts with medicinal plant production facilities or at the request of competent state management agencies;

b) Supervise medicinal plant production facilities according to signed contracts to ensure the maintenance of GACP-WHO conformity;

c) Ensure honesty, objectivity, and fairness in assessment activities and bear responsibility for the results of GACP-WHO conformity assessments before competent authorities;

d) Report all changes affecting the ability to conduct GACP-WHO conformity assessments and submit annual reports on the status of GACP-WHO conformity assessments to the Ministry of Health (Drug Administration);

e) Propose the Drug Administration to withdraw the Receipt of Declaration of Medicinal Plants Produced According to GACP-WHO for facilities that do not comply with GACP-WHO.

3. Provincial Departments of Health under Central Cities

Proactively propose to the Drug Administration and participate in inspection and supervision activities to ensure compliance with GACP-WHO when violations that affect the quality of products of facilities holding Receipts of Declarations of Medicinal Plants Produced According to GACP-WHO are discovered within their jurisdiction.

4. Drug Administration

a) Inspect and supervise compliance with GACP-WHO;

b) Resolve complaints related to the implementation and application of GACP-WHO;

c) Direct the national testing system to collect samples of medicinal plants for quality testing;

d) Withdraw the Receipt of Declaration of Medicinal Plants Produced According to GACP-WHO for violators nationwide.

Article 17. Implementation Provisions

1. This Circular takes effect forty-five days from the date of issuance.

2. The Ministry of Health encourages medicinal plant production facilities to apply GACP-WHO in cultivation, harvesting, and processing of medicinal plants; encourages medicinal plant trading facilities, medicinal plant production facilities, and drug production facilities using medicinal plants to trade and use products from facilities that have achieved GACP-WHO.

3. The Directors of the Drug Administration, the Director of the Institute of Medicinal Materials, the Heads of units under the Ministry of Health, the Directors of Provincial Departments of Health under Central Cities, and relevant organizations and individuals are responsible for implementing this Circular.

4. In the course of implementation, if difficulties, obstacles, or new issues arise related to GACP-WHO, organizations and individuals are requested to report to the Ministry of Health (Drug Administration) for timely consideration and resolution./.