Circular No. 13/1999/TT-BYT guiding the implementation of the Ordinance on Private Practice in Traditional Medicine.

CIRCULAR

Guidelines for implementing the Ordinance

on private practice in traditional medicine and pharmacy

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Based on the Ordinance on private practice in medicine and pharmacy dated October 13, 1993;

Based on Decree No. 06/CP dated January 29, 1994 of the Government detailing certain provisions of the Ordinance on private practice in medicine and pharmacy.

Based on Decree No. 02/CP dated January 5, 1995 of the Government stipulating goods and services prohibited from commercial trade and goods and services subject to conditions for domestic market trading.

This Circular provides specific guidelines for private practice in traditional medicine and pharmacy.

PART I

GENERAL PROVISIONS

Article 1. The titles of those practicing traditional medicine and pharmacy privately as guided in this Circular shall be understood as follows:

1. General Traditional Medicine Practitioner: A person possessing sufficient expertise in traditional medicine and pharmacy to diagnose and treat general illnesses, certified by the Ministry of Health with a certificate as a General Traditional Medicine Practitioner.

2. Specialized Traditional Medicine Practitioner: A person possessing sufficient expertise in traditional medicine and pharmacy to diagnose and treat specialized diseases using traditional medicine methods (internal, external, gynecological, pediatric, acupuncture, massage, etc.), certified by the Ministry of Health.

3. Practitioner Using Family-Inherited Prescriptions: A person who has been taught family-inherited prescriptions that effectively treat a specific type of illness. Such practitioners must understand the composition of the prescription, dosage adjustments, preparation methods, usage (dosage, indications, contraindications), disease diagnosis, and must be certified by the provincial Department of Health or the Ministry of Health as a "Practitioner Treating Diseases with Family-Inherited Prescriptions" after obtaining the opinion of the Traditional Medicine Association at the provincial level.

4. Traditional Pharmacist: A person knowledgeable about traditional pharmaceutical theory, pharmacology, drug properties, functions, and techniques for preparing and compounding traditional medicines, certified by the Ministry of Health as a Traditional Pharmacist.

5. Seller and Compounder of Traditional Medicines and Opium Preparations: A person with knowledge of traditional pharmaceutical theory, understanding the properties and functions of raw materials and methods for preparing opium and traditional medicines, certified by the provincial Department of Health as having the qualifications to sell and compound opium preparations.

6. Seller of Raw Medicinal Materials: A person capable of identifying and classifying various medicinal materials, certified by the provincial Department of Health as having the qualifications to sell raw medicinal materials.

7. Agent for Traditional Medicines: A person knowledgeable about the properties and functions of various forms of traditional medicines, certified by the provincial Department of Health as having the qualifications to operate a traditional medicine agency.

8. Assistant to Traditional Medicine Practitioners: A person with knowledge of traditional medicine but not meeting the criteria and conditions to establish a private traditional medicine and pharmacy practice, including:

- Traditional Medicine Practitioners, Pharmacists, and Assistants who have not yet met the tenure requirements to register for practice.

- Traditional Medicine Practitioners who have studied traditional medicine during their training program.

- Individuals currently enrolled in traditional medicine courses organized by the Health Department in collaboration with the provincial Traditional Medicine Associations, supervised and mentored by Traditional Medicine Practitioners.

- Pharmacy Assistants and Intermediate-Level Pharmacists with knowledge of traditional medicine but not meeting the criteria and conditions to establish a private traditional medicine and pharmacy practice.

These individuals must be reviewed and certified as "Assistants" by the provincial Department of Health.

Article 2. This Circular applies to the following types of private traditional medicine and pharmacy practices:

- Private Traditional Medicine Hospitals.

- Private Traditional Medicine Clinics.

- Facilities providing treatment, rehabilitation, and functional recovery services through acupuncture, massage, qigong, herbal steam baths, and other traditional medicine methods.

Traditional medicine pharmaceutical production and trading establishments with capital below the statutory minimum include:

- Establishments producing and trading high-concentration decoctions, pills, powders, and other finished traditional medicine products.

- Establishments trading raw opium and finished traditional medicine products.

- Establishments trading raw medicinal materials (unprocessed).

- Establishments acting as agents for finished traditional medicine products.

Article 3. Each individual may only register for practice at one location and must operate within the scope defined by their permit.

Article 4. Advertising for traditional medicine treatments and medications via all mass media must be approved by the Ministry of Health or the provincial Department of Health according to regulations.

Article 5. During practice, practitioners must continue to study and improve their professional skills, thoroughly understand industry regulations, and comply with state laws. Based on local needs, the Ministry of Health will collaborate with the Vietnam Traditional Medicine Association to research and guide the classification of Traditional Medicine Practitioners and Pharmacists.

Chapter II

DETERMINATION OF PROFESSIONAL QUALIFICATIONS

Article 6. The Ministry of Health issues certificates for General Traditional Medicine Practitioners, Specialized Traditional Medicine Practitioners, and Traditional Pharmacists. Provincial Department of Health Directors issue certificates for other positions specified in Article 1 of this Circular.

Article 7. Those certified as General Traditional Medicine Practitioners, Specialized Traditional Medicine Practitioners, and Traditional Pharmacists under this Circular may register for practice nationwide.

Certificates of professional qualifications issued by provincial Departments of Health according to Circulars No. 11/BYT-TT dated April 23, 1991, Circular No. 05/BYT-TT dated May 15, 1993, and Circular No. 08/BYT-TT dated May 2, 1994 of the Ministry of Health remain valid for local registration; if holders wish to switch to certificates under this Circular, they must submit an application for certification change and a curriculum vitae along with a self-assessment of their practice history to the provincial Department of Health. The provincial Department of Health will compile a list and brief biographies of applicants to be sent to the Ministry of Health (Traditional Medicine Department) for review and resolution.

Article 8. Those certified as General Traditional Medicine Practitioners, Specialized Traditional Medicine Practitioners, and Traditional Pharmacists under this Circular must pass examinations organized by the Ministry of Health. Other individuals certified under this Circular must pass examinations organized by the provincial Department of Health.

Applicants for these examinations must meet the following criteria and conditions:

1. Regarding educational qualifications: Applicants for registration to practice the business of selling living medicines must have a certificate of completion of basic general education, while other applicants must have a high school graduation diploma or equivalent.

2. Regarding professional qualifications: They must possess all certificates for subjects according to the program and materials issued by the Ministry of Health in collaboration with the Central Association of Traditional Medicine Vietnam, provided by the School of Health Sciences in collaboration with Traditional Medicine Hospitals and Provincial Traditional Medicine Associations.

a- Criteria for eligibility to take the examination for a multi-specialty traditional medical practitioner:

- Certificate in the basic theory of traditional medicine.

- Certificate in internal medicine diseases and treatment.

- Certificate in surgical diseases and treatment.

- Certificate in pediatric diseases and treatment.

- Certificate in gynecological diseases and treatment.

- Certificate in otorhinolaryngological diseases and treatment.

- Certificate in non-pharmacological treatment methods.

- Certificate in herbal pharmacognosy.

- Certificate in pharmaceutical technology.

- Certificate in traditional prescriptions.

b- Criteria for eligibility to take the examination for a specialized traditional medical practitioner:

- Certificate in the basic theory of traditional medicine.

- Certificate in specialized diseases and treatment corresponding to the specialty applied for.

- Certificate in herbal pharmacognosy.

- Certificate in pharmaceutical technology.

- Certificate in traditional prescriptions.

c- Criteria for eligibility to take the examination for a traditional pharmacist:

- Certificate in the basic theory of traditional pharmacy.

- Certificate in herbal pharmacognosy (pharmacology, properties, and usage of each herb).

- Certificate in pharmaceutical technology.

- Certificate in traditional prescriptions.

- Certificate in quality control techniques for herbal materials and traditional medicines.

d- Criteria for eligibility to take the examination for the business of selling traditional medicines:

- Certificate in the basic theory of traditional medicine and pharmacy.

- Certificate in herbal pharmacognosy.

- Certificate in pharmaceutical technology.

- Certificate in traditional prescriptions.

- Certificate in the preservation of traditional medicines.

đ- Criteria for eligibility to take the examination for opening a traditional medicine retail agency:

- Certificate in the basic theory of traditional pharmacy.

- Certificate in traditional prescriptions.

- Certificate in the preservation of traditional medicines.

e- Criteria for eligibility to take the examination for opening a business of selling living medicines: Must have a certificate of study on herbal materials (classification, preliminary processing, preservation, etc.) for at least three months.

Article 9. Applicants for the examination must submit an application for examination recognition of professional qualifications, which should be sent to the Provincial Department of Health, the application includes:

- Application form for examination.

- Personal resume.

- Certified copy of high school graduation diploma or equivalent.

- Certified copies of certificates for relevant professional courses corresponding to each type of position as prescribed.

- Two envelopes with stamps and two 4x6 inch photos.

For positions certified by the Ministry of Health, the Provincial Department of Health will review the application, compile a list and attach a brief biography to send the application to the Ministry of Health (Department of Traditional Medicine).

Article 10. The Department of National Defense Education will cooperate with the hosting unit to establish the Competition Organizing Board.

1. Establishment of the Examination Board: After reaching consensus with the local Traditional Medicine Association, the Ministry of Health or the Provincial Department of Health will issue a decision to establish the Examination Board.

2. The Examination Board has the following tasks:

- Review applications, compile a list, and notify those who meet the criteria for the examination.

- Organize the examination:

+ The examination will be held once or twice a year.

+ Announce the date and time of the examination.

+ Conduct the examination in accordance with regulations.

- Subjects: Written (theory) and practical (clinical) examinations.

The examination for multi-specialty traditional medical practitioners, specialized traditional medical practitioners, and traditional pharmacists will be set by the Examination Board of the Ministry of Health, while other examinations will be set by the Examination Board of the Provincial Department of Health.

- Organize grading, prepare a record clearly stating the scores of each subject for each individual.

- Report to the Minister of Health or the Director of the Provincial Department of Health the list of successful candidates and the list of those who did not meet the requirements (if any).

- The Minister of Health or the Director of the Provincial Department of Health will issue a certificate to those who meet the requirements.

Chapter III

STANDARDS, CONDITIONS FOR ESTABLISHING AND SCOPE OF PRACTICE FOR PRIVATE TRADITIONAL MEDICINE PRACTICE FACILITIES:

Article 11. Standards and conditions for establishing and scope of practice for private Traditional Medicine Hospitals:

1. The person applying to establish a private Traditional Medicine Hospital must be a Traditional Medicine Doctor or a Traditional Medical Practitioner with at least five years of practice at a Traditional Medicine facility and not be prohibited from practicing under the law.

2. The organization, staffing levels, and equipment of a private Traditional Medicine Hospital shall comply with the functional tasks and organizational structure of a Traditional Medicine Hospital under the Provincial Department of Health as stipulated in Decision No. 1529/1999/QĐ-BYT of the Minister of Health.

3. A private Traditional Medicine Hospital must have the following departments and rooms:

+ Outpatient and treatment department.

+ Inpatient treatment department.

+ Pharmacy and equipment department.

+ Administrative, financial, and material management room.

4. The design of a private Traditional Medicine Hospital shall comply with the "Typical Design Task for Provincial Traditional Medicine Hospitals" issued together with Decision No. 165/BXD/VTC dated July 3, 1995, by the Minister of Construction.

5. Must have sufficient clean water to serve the needs of staff and patients.

6. Scope of operation:

- Diagnosing, treating, and rehabilitation for inpatients and outpatients using traditional medicine methods and combining traditional medicine with modern medicine.

- Producing traditional medicines for direct treatment of inpatients and outpatients.

Article 12. Standards, conditions, and scope of practice for traditional medicine clinics:

- The owner of the clinic must be a Traditional Medicine Doctor or a Traditional Medical Practitioner (multi-specialty or specialized) with at least two years of practice, in good health, and meeting other legal requirements.

- The consultation room must be separate (not shared with family living quarters or other commercial activities). The consultation room must have a minimum area of 10 square meters.

- If selling decoctions and producing some types of tinctures, pills, powders, and pastes for direct patient service, there must be facilities and equipment for production, approved by the Provincial Department of Health.

+ There must be a cabinet with compartments or bottles with lids on shelves, clearly labeled, placed in a well-ventilated and hygienic location.

- Scope of practice:

+ Outpatient diagnosis and treatment according to the level of expertise stated in the license (no bed reservation allowed).

+ Producing decoctions for direct patient service.

+ If producing tinctures, pills, powders, and pastes, the formula, production process (with supporting facilities and equipment), efficacy, dosage, and contraindications must be registered with the Provincial Department of Health. If the conditions are met, production will be permitted, and the medicine can only be used for direct patient service, not sold on the market.

+ A practitioner using traditional family medicine can only diagnose and treat patients with traditional family prescriptions.

+ Traditional Chinese Medicine doctors and physicians may combine the use of modern medical equipment to enhance diagnostic quality.

+ The owner of the practice must bear full responsibility for the safety and efficacy of the drugs under the law.

Article 13. Standards, conditions, and scope of practice for service establishments providing treatment, rehabilitation, and health recovery through acupuncture, massage, acupressure, exercise, qigong, and herbal steam baths in Traditional Chinese Medicine.

1. The owner must be a Traditional Chinese Medicine physician, a multi-specialty licensed practitioner, or a licensed specialist in acupuncture, massage, and acupressure, with at least two years of work experience, good health, and other qualifications as stipulated by law.

2. There must be premises and equipment suitable for the intended practice.

There must be a separate room for acupuncture, massage, and acupressure that is spacious, clean, well-ventilated, and has an average of four square meters of construction space per bed.

Acupuncture and massage beds must be 70 cm high, at least 70 cm wide, and 2 meters long.

Acupuncture tools: sterilized needle pot, sterile needle tray, non-sterile needle tray, clean cotton box, dirty cotton box, each patient must have their own set of needles, Kose forceps, and acupuncture machine (if available).

Herbal steam bath room and system for generating steam (if registered to provide herbal steam bath services).

3. Scope of practice: permitted to use appropriate methods of Traditional Chinese Medicine commensurate with their professional expertise and technical equipment to treat and improve the health of individuals.

Article 14. Standards and conditions for the scope of practice in operating live medicinal herbs (raw materials recently processed):

- The owner must be recognized by the Ministry of Health or the Provincial Health Department as knowledgeable about medicinal herbs.

- Clear business address, with a minimum business area (store) of 10 square meters, well-ventilated, hygienic, and capable of storing medicinal herbs.

- Storage facility for medicinal herbs.

- Scope of practice: specialized in selling live medicinal herbs.

Article 15. Standards, conditions, and scope of registration for operating Traditional Chinese Medicine drugs, tablets, and finished products (without producing finished Traditional Chinese Medicine products):

- The owner must have a degree in pharmacy or higher, with a certificate in traditional pharmacology studies or be certified by the Ministry of Health or the Provincial Health Department as having the necessary qualifications to operate Traditional Chinese Medicine pharmacies; must be in good health and meet other legal requirements.

- Clear business address, with a minimum business area of 10 square meters, clean, well-ventilated, hygienic, and equipped with a medicine cabinet or bottles with lids for storing medicines on shelves. Each bottle must clearly indicate the name of the medicine.

- Area and equipment for processing raw medicinal herbs into tablets.

- Scope of practice: allowed to process raw medicinal herbs into tablets and sell various Traditional Chinese Medicine preparations that have been registered for production and circulation by the Ministry of Health.

Article 16. Standards, conditions, and scope of practice for operating (processing, manufacturing, and selling) finished Traditional Chinese Medicine products.

1. The owner must have a bachelor's degree in pharmacy, a Traditional Chinese Medicine physician, or a licensed practitioner or pharmacist; must be in good health and meet other legal requirements.

2. The establishment must have the following departments:

- Raw material warehouse (medicinal herbs and semi-finished products): must be ventilated, with shelving to prevent mold and pests, and clearly labeled to avoid confusion.

- Processing and production area:

+ Must have a pre-processing and quality control area for medicinal herbs before production.

+ Pre-processing, processing, and production rooms.

+ Finished product quality control room.

+ Packaging room.

+ Finished product warehouse.

- Sales and finished product display room.

The processing and production area must be arranged in a unidirectional flow, well-ventilated but sealed against insects and dust. Walls in the processing, production, packaging, and finished product quality control rooms must be covered with white tiles up to a height of 2 meters, floors tiled with white tiles, ceilings painted white. The finished product warehouse must be spacious, sealed against insects, well-ventilated, clean, with shelves to prevent medicines from touching the floor and walls to avoid mold, pests, and insects.

- Clean water supply system meeting hygiene standards, regularly tested for quality to support drug production.

- Equipment suitable for the production registration application already approved.

- Fire prevention and firefighting systems as required.

Scope of practice: allowed to produce and operate stores selling various finished Traditional Chinese Medicine products of their own establishment that have been registered for production and circulation by the Ministry of Health; allowed to sign contracts to supply to units requiring usage or with trading functions; allowed to export to countries with demand.

Article 17. Standards, conditions, and scope of practice for Traditional Chinese Medicine drug agency establishments.

- The owner must hold a certificate of qualification issued by the provincial health department director to open a Traditional Chinese Medicine drug agency, must be in good health, and meet other legal requirements.

- Clear location, with a minimum business area of 10 square meters, and sufficient equipment to display and store medicines.

- Scope of practice: allowed to sign contracts for wholesale and retail sales of finished Traditional Chinese Medicine products that have been registered for production and circulation by the Ministry of Health.

Chapter IV

PROCEDURES AND AUTHORITY FOR REVIEWING AND ISSUING CERTIFICATES OF QUALIFICATION AND CONDITIONS FOR ESTABLISHING PRIVATE TRADITIONAL MEDICAL AND PHARMACEUTICAL PRACTICES

(referred to as the certificate of qualification and conditions for practice)

Article 18. Those applying to establish a private hospital must submit an establishment application form, which includes:

+ Application for establishing a private Traditional Chinese Medicine hospital.

+ List and brief resumes of each member of the Board of Directors (or management team).

+ Health examination report certifying fitness for duty.

+ Certificate of no criminal record for each member of the Board of Directors.

+ Hospital operation regulations.

+ Economic feasibility study.

Article 19. For other types of private Traditional Chinese Medical and Pharmaceutical practices, the application includes:

- Application for establishing a private traditional medicine practice facility. If the applicant is a civil servant, they may only register to practice outside their official working hours with the consent of their agency head. The application must clearly state the type of practice being established, the content of the requested practice, and the location of the requested practice.

- A curriculum vitae with a photograph attached and confirmed by the People's Committee of the commune or ward where the applicant resides, or by the head of the unit where the applicant is currently employed.

- Certified copies of academic certificates and qualifications (with notarization).

- An inventory of physical facilities, technical equipment, and investment capital.

- Business plan.

- Certificate confirming practical experience period.

- Summary record and certified copies of qualifications (with notarization) of co-participants and assistants (if any).

- Health examination report certifying the health standards of the applicant, co-participants, and assistants.

- Personal self-inspection report on the practice process with comments from the unit head or the director of the medical center or the chairman of the Traditional Medicine Association at the district or city level.

Article 20. Applications for establishing a private traditional medicine hospital and applications for establishing a preparation, production, and sale facility for finished traditional medicine products shall be submitted to the Department of Health of the provincial or centrally governed municipality. The Department of Health will review and provide comments in writing to the Ministry of Health (Department of Traditional Medicine).

For applications for establishing a private traditional medicine hospital, before submitting to the Ministry of Health, the Department of Health must seek opinions from the People's Committee of the province or centrally governed municipality and obtain written permission to establish the hospital.

Article 21. Authority to issue certificates of qualification and conditions for practice.

1. The Minister of Health shall issue certificates of qualification and conditions for practice for private traditional medicine hospitals and private facilities producing and trading in finished traditional medicine products.

The Ministry of Health shall establish an advisory council to assist the Minister in reviewing and issuing certificates of qualification and conditions for practice for private traditional medicine hospitals and private facilities producing and trading in finished traditional medicine products. The council members include:

Deputy Minister in charge of Traditional Medicine - Chair of the Council.

Director of the Department of Traditional Medicine - Vice-Chairman of the Council.

Representative of the Treatment Management Department - Member.

Representative of the Legal Affairs Department - Member.

Representative of the Financial Accounting Department - Member.

Representative of the Cadres and Civil Servants Organization Department - Member.

Representative of the Vietnam National Medicines Administration - Member.

Representative of the Medical Equipment and Construction Department - Member.

Representative of the Central Traditional Medicine Association - Member.

A staff member of the Department of Traditional Medicine - Secretary of the Council.

2. The Director of the Provincial or Centrally Governed Municipality Health Department shall issue certificates of qualification and conditions for practice for other private traditional medicine practice facilities as stipulated in Article 2 of this Circular.

The Health Department shall establish an advisory council to assist the Director of the Provincial or Centrally Governed Municipality Health Department in reviewing and issuing certificates of qualification and conditions for practice for other private traditional medicine practice facilities as stipulated in Article 2 of this Circular.

The council members shall include representatives from relevant departments of the Health Department, representatives from the Traditional Medicine Association of the province or centrally governed municipality, and representatives from the Board of Directors of the Traditional Medicine Hospital, with the Deputy Director of the Health Department responsible for Traditional Medicine serving as the Chairman of the Council.

3. After obtaining the certificate of qualification and conditions for practice, the owner of the facility must proceed with the necessary procedures to apply for establishment and business registration according to the provisions of the law.

Article 22. If the hospital does not operate within three years from the date of issuance of the certificate of qualification and conditions for practice, the Ministry of Health will revoke the certificate.

Article 23. The certificate of qualification and conditions for practice for a private traditional medicine hospital has a validity of five years from the date of issuance. Six months prior to expiration, if there is a request to continue operations, the owner of the facility must submit an application for re-registration through the Health Department to the Ministry of Health for review and issuance of a new certificate.

The certificate of qualification and conditions for practice for a facility preparing, producing, and trading in finished traditional medicine products has a validity of three years from the date of issuance. Three months prior to expiration, if there is a request to continue operations, the owner of the facility must submit an application for renewal through the Health Department to the Ministry of Health for review.

Certificates of qualification and conditions for practice for other types of traditional medicine practice facilities established as stipulated in Article 2 of this Circular have a validity of three years from the date of issuance. Three months prior to expiration, if there is a request to continue operations, the owner of the facility must submit an application for renewal to the Health Department of the province or centrally governed municipality for review.

Article 24. For doctors who are ethnic minority people applying to register to practice traditional medicine diagnosis and treatment in mountainous and island communes, the Health Department shall base its decision on:

- Application for permission to practice,

- Professional qualifications, and a declaration of practice history confirmed by the Traditional Medicine Association of the province or centrally governed municipality,

- Health examination report confirming health standards,

To issue a certificate of qualification and conditions for establishing a traditional medicine diagnosis and treatment practice facility for the applicant. The person holding this certificate is only permitted to practice within the commune where the practice was registered.

Chapter V

SOME PROVISIONS ON SPECIALIZATION

Article 25. Private traditional medicine hospitals and private traditional medicine practice facilities established under the Enterprise Law may enter into contracts with foreign experts or doctors to practice traditional medicine at their facilities in accordance with the Labor Code of Vietnam and must obtain written permission from the Ministry of Health of Vietnam.

Article 26. For individuals practicing traditional medicine diagnosis and treatment privately:

1. Individuals practicing traditional medicine diagnosis and treatment privately must strictly adhere to the professional regulations issued by the Ministry of Health and may only use traditional medicine diagnostic and treatment methods and tools that have been approved by the Ministry of Health. Traditional medicine doctors and physicians may combine traditional medicine with modern medicine to improve diagnostic and treatment quality.

Strictly implement sterile and antiseptic regulations of the Ministry of Health to prevent cross-infection and infection due to treatment.

2. Prescriptions for patients must follow the prescribed format.

3. Medicines must be weighed in the order listed on the prescription. Weigh each herb and mark it accordingly. It is permissible to weigh the total quantity of each herb and then divide it evenly among individual prescriptions.

For herbs classified under List A and List B poisons, they must be weighed individually for each prescription and two invoices must be issued. One invoice must be retained at the pharmacy for at least one year, while the other is given to the patient.

4. Medicines must be stored in compartments within a cabinet, in bottles with lids, clearly labeled with the name of the herb. Toxic herbs must be stored according to the regulations for toxic medicines established by the Ministry of Health. Selling counterfeit medicines or medicines that do not meet quality standards (moldy, infested with insects, etc.) to patients is strictly prohibited. The sale of medicines by unauthorized vendors is forbidden.

- Preparing raw medicinal materials (raw drugs) into processed medicines (patent medicines) must follow the traditional preparation methods of Traditional Medicine.

- Producing decoctions, pills, powders, and granules directly for patients (not for circulation in the market) must comply with the production procedures approved by the Provincial Department of Health.

5. Private healthcare establishments must maintain complete records to track their activities and record daily and monthly transactions. Quarterly summaries must be reported to the Provincial Department of Health, which will compile reports to submit to the Ministry of Health (Traditional Medicine Department).

Article 27.

1. Private traditional medicine practices are subject to state management by the Ministry of Health, Provincial Departments of Health, and are subject to inspection and auditing by relevant authorities as prescribed by law.

2. The Ministry of Health assigns the Provincial Departments of Health to directly manage private traditional medical practices in their respective localities.

Article 28. Regarding establishments producing and trading in traditional medicines:

1. Equipment and tools used in production must be suitable for each type of product, and should not be shared with household items, nor should they affect the quality of the medicine.

2. Preparing raw medicinal materials (raw drugs) into processed medicines (patent medicines) must follow the traditional preparation methods of Traditional Medicine.

3. Producing decoctions, pills, powders, and granules must adhere to the production processes and ensure quality standards approved by the Ministry of Health for registration and circulation.

4. There must be records to monitor production, medicine quality, and operational results:

+ Raw material input and output ledger.

+ Production process ledger.

+ Quality standard ledger.

+ Raw material and finished product quality inspection ledger.

+ Finished product input and output ledger.

+ Sales and purchase tracking ledger.

All ledgers must be fully and clearly recorded.

5. Only medicinal materials and finished Traditional Medicine products that meet quality standards and have been registered for production and circulation by the Ministry of Health may be released to the market and sold.

Article 29. Regarding signage:

Content: uniformly recorded as follows:

+ Line 1: Type of practice (in capital letters) as specified in Article 2 of this Circular.

+ Line 2: Business name (if applicable).

+ Line 3: Name of the practitioner.

+ Line 4: Scope of practice (as stated in the license).

+ Line 5: Practice address. Phone number (if applicable).

+ Line 6: License number - operating hours.

(A sample sign is attached).

Chapter VI

INSPECTION AND SUPERVISION

Article 30: Management and state inspection agencies in the health sector are responsible for coordinating with relevant departments to regularly inspect, audit, and guide private traditional medical practices to comply with the provisions of this Circular and other laws.

Article 31. Private traditional medical practices are responsible for complying with requirements and facilitating inspections by management and inspection agencies to fulfill their tasks and strictly implement decisions made by competent authorities.

Chapter VII

IMPLEMENTING PROVISIONS

Article 32. This Circular applies to private traditional medical practices.

Article 33. This Circular takes effect fifteen days from the date of issuance and replaces Circulars No. 11/BYT-TT dated April 23, 1991, Circular No. 05/BYT-TT dated May 15, 1993, and Circular No. 08/BYT-TT dated May 2, 1994, issued by the Ministry of Health.

Article 34. The Ministry of Health assigns the Director of the Traditional Medicine Department to coordinate with related departments to provide guidance, oversight, and monitoring of the implementation of this Circular.

Article 35. Directors of Provincial Health Departments, heads of subordinate units are responsible for implementing this Circular and reporting results periodically to the Ministry (Traditional Medicine Department). Any difficulties encountered during implementation should be reported in writing to the Ministry (Traditional Medicine Department) for research and resolution.

SAMPLE SIGNAGE TRADITIONAL MEDICINE CLINIC

LICENSED TRADITIONAL DOCTOR:...

Multidisciplinary diagnosis and treatment using Traditional Medicine

Practice Address:...Phone Number:...

License Number:...Operating Hours:...