Circular No. 27/2025/TT-BYT stipulates principles, criteria for building, updating, recording information, structure of the list, and guidance on payment for traditional medicine drugs, drugs combining medicinal substances with herbs, traditional drugs within the scope of health insurance benefits, issued by the Minister of Health.

 CIRCULAR

Regulations on principles, criteria for building, updating, recording information, structure of the list, and guidance on payment for herbal medicines, medicines combining drug substances with herbs, traditional medicines, and herbs within the scope of benefits for health insurance participants

On the basis of The Health Insurance Law in 2008 has been amended and supplemented in 2014 and 2024;

Decree No. Decree No. 146/2018/NĐ-CP dated October 17, 2018 of the Government detailing and guiding methods to implement certain provisions of the Health Insurance Law amended and supplemented by Decree No. 75/2023/NĐ-CP dated October 19, 2023 and Decree No. 02/2025/NĐ-CP dated January 1, 2025;

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

At the proposal of the Director of the Health Insurance Department, Ministry of Health,

The Minister of Health issues this Circular regulating principles, criteria for building, updating, recording information, structure of the list, and guidance on payment for herbal medicines, medicines combining drug substances with herbs, traditional medicines, and herbs within the scope of benefits for health insurance participants.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular regulates principles, criteria for building, updating, recording information, structure of the list, and guidance on payment for herbal medicines, medicines combining drug substances with herbs, traditional medicines, and herbs (including traditional herbal medicines) within the scope of benefits for health insurance participants (hereinafter referred to as traditional medicine).

Article 2. Principles for Building and Updating the List

1. Promote the implementation of reasonable, safe, and effective drug usage policies and the development of traditional medicine.

2. Meet the needs of treatment using traditional medicine, suitable for Vietnam's disease pattern; encourage the use of herbal medicines and traditional medicines produced from domestically cultivated raw materials; integrate traditional medicine with modern medicine.

3. Ensure the rights of health insurance participants, contributing to gradually reducing the direct payment ratio of health insurance participants.

4. Ensure the ability of the health insurance fund to pay out in each period.

5. Inherit and selectively apply existing drug lists issued by the Minister of Health.

6. Refer to the list of essential medicines in Vietnam.

7. Create conditions for the development of primary healthcare.

Chapter II
CRITERIA FOR BUILDING AND UPDATING THE LIST OF MEDICINES

Article 3. Criteria for Including Herbal Medicines and Medicines Combining Drug Substances with Herbs in the List

Herbal medicines and medicines combining drug substances with herbs will be considered for inclusion in the list when they meet all of the following criteria:

1. Not falling under the cases specified in Article 7 of this Circular.

2. Having a registration number for circulation or import permit valid in Vietnam.

3. Providing evidence of safety and efficacy based on one of the following documents in priority order:

a) Guidelines for diagnosis and treatment according to traditional medicine, integrating traditional medicine with modern medicine issued by the Ministry of Health;

b) Reports on safety and efficacy assessments of scientific and technological tasks approved by national, ministerial, provincial-level or equivalent councils in accordance with laws on science and technology;

c) Studies evaluating the safety and efficacy of the medicine published in journals listed in the Web of Science/Scopus database or domestic journals with annual points approved by the State Council of Professors.

4. Providing cost analysis reports or budget impact assessment reports in Vietnam.

Article 4. Criteria for including traditional medicine in the list

Traditional medicine will be included in the list when it meets all of the following criteria:

1. Not falling under the cases specified in Article 7 of this Circular.

2. Having a registration number for circulation or import permit valid in Vietnam.

3. There is documentation proving safety and treatment efficacy based on one of the documents prioritized as specified in Clause 3, Article 3 of this Circular, except in cases where the medicine's formula components originate from any of the following situations:

a) Prescriptions exempted from clinical trials as issued by the Minister of Health;

b) Prescriptions of Hải Thượng Lãn Ông, Tuệ Tĩnh published by the Medical Publishing House;

c) Prescriptions listed in the latest edition of the Vietnamese Pharmacopoeia or pharmacopoeias of other countries;

d) Inherited prescriptions that have been certified according to the provisions of the law.

4. Providing cost analysis reports or budget impact assessment reports in Vietnam.

Article 5. Criteria for including herbal medicines in the list

Herbal medicines will be considered for inclusion in the list when they meet all of the following criteria:

1. The herbal medicine does not fall under the circumstances stipulated in Article 8 of this Circular.

2. There is documentation proving safety and treatment efficacy based on one of the following prioritized documents:

a) The latest edition of the Vietnamese Pharmacopoeia or pharmacopoeias of other countries;

b) Documentation proving the safety and treatment efficacy of the herbal medicine based on one of the documents prioritized as specified in Clause 3, Article 3 of this Circular.

3. There is a cost analysis report or a budget impact assessment report in Vietnam.

Article 6. Criteria for considering the regulation of conditions and reimbursement rates for health insurance

Traditional medicine, herbal medicine combined with active ingredients, and herbal medicines will be considered for regulations or adjustments regarding the scope of indications, objects, or healthcare facilities eligible for reimbursement or the reimbursement rate in the following cases:

1. It is consistent with the payment capacity of the health insurance fund according to the principle stipulated in Article 2 of this Circular.

2. The medicine has higher treatment costs compared to other medicines with the same indication or similar therapeutic effects in the current list of traditional medicine.

Article 7. Criteria for considering the removal of traditional medicine, herbal medicine, and combined herbal medicine from the list

Traditional medicine, herbal medicine, and combined herbal medicine will be considered for removal from the list if they fall under any of the following circumstances:

1. The medicine does not have a registration number for circulation or an import permit in Vietnam.

2. The medicine has a registration number for circulation or an import permit in Vietnam but has expired at the time the list was issued.

3. The medicine contains components produced from herbs derived from animals or plants listed in the Red Book for conservation or endangered species requiring protection announced by the World Society for the Protection of Animals (WSPA) (excluding animals or plants used for medicinal purposes that have been legally cultivated or harvested).

4. The medicine has recommendations against its use or warnings about safety or treatment efficacy.

Article 8. Criteria for considering the removal of herbal medicines from the health insurance list

Herbal medicines will be considered for removal from the list if they fall under any of the following circumstances:

1. The herbal medicine is produced from herbs or animals listed in the Red Book for conservation or endangered wildlife requiring protection announced by the World Society for the Protection of Animals (WSPA) (excluding herbs or animals used for medicinal purposes that have been legally cultivated or harvested).

2. The herbal medicine has recommendations against its use or warnings about safety or treatment efficacy.

Chapter III
STRUCTURE OF THE LIST AND PROVISIONS FOR RECORDING MEDICINE INFORMATION IN THE LIST

Article 9. Structure of the herbal medicine and traditional medicine drug list

1. The structure includes five columns as follows:

a) Column 1 records the serial number of the drug in the list;

b) Column 2 records the serial number of the drug within each group;

c) Column 3 records the name of the drug group and the components of the drugs in the group;

d) Column 4 only records the route of administration of the drug, without recording the dosage or the form of preparation of the drug;

đ) Column 5 provides notes on conditions, payment ratios, alternative names for drug components, or other remarks (if applicable).

2. The classification of drugs in column 3 is arranged according to traditional medical theory.

Article 10. Structure of the drug list combining chemical substances with herbal medicines

1. The structure includes four columns as follows:

a) Column 1 records the serial number of the drug in the list;

b) Column 2 records the name of the drug component;

c) Column 3 only records the route of administration of the drug, without recording the dosage or the form of preparation of the drug;

d) Column 4 provides notes on conditions, payment ratios, alternative names for drug components, or other remarks (if applicable).

2. Drugs are not classified into groups.

Article 11. Structure of the herbal medicine list

1. The structure includes five columns:

a) Column 1 records the serial number of the herbal medicine in the list;

b) Column 2 records the serial number of the herbal medicine within each group;

c) Column 3 records the name of the group and the name of the herbal medicine;

d) Column 4 records the scientific name of the herbal medicine;

đ) Column 5 provides notes on conditions, payment ratios, or other remarks (if applicable).

2. The classification in column 3 is arranged according to traditional medical theory.

Article 12. Recording information on herbal medicines, drugs combining chemical substances with herbal medicines, traditional medicines, herbal medicines, and the route of administration of the drug

1. The recording of drug names is carried out as follows:

a) For herbal medicines and traditional medicines:

Record the name of the herbal medicine or traditional medicine ingredient in the drug according to the name of the herbal medicine or traditional medicine recorded in the circulation registration certificate or import permit.

b) For drugs combining chemical substances with herbal medicines:

- For herbal medicines or traditional medicine ingredients in the drug: Record according to the provisions at point a of this clause;

- For chemical substances in the drug: Record according to the guidelines in Clause 1, Article 6 of Circular No. 37/2024/TT-BYT dated November 16, 2024, issued by the Minister of Health, stipulating principles, criteria for building, updating, recording information, structure of the list, and guidance on payment for chemical drugs, biological products, radioactive drugs, and labeling substances within the scope of health insurance benefits.

c) Do not record the drug name based on pharmacological effects or the trade name of the drug.

2. The recording of herbal medicine names is carried out as follows:

Record according to the guidelines in Clause 3, Article 16 of Circular No. 01/2018/TT-BYT dated January 18, 2018, issued by the Minister of Health, stipulating labeling of drugs, raw materials for drugs, and instructions for drug use, excluding traditional medicine names.

3. The recording of the route of administration of the drug is unified as follows:

a) Oral route includes swallowing, sucking, chewing, placing under the tongue;

b) External use route includes applying externally, rubbing externally, patching on the skin, spraying externally, soaking, steaming, gargling.

Chapter IV
PAYMENT REGULATIONS

Article 13. Payment Principles

1. The health insurance fund pays for the cost of herbal medicines, drugs combining chemical substances with herbal medicines, traditional medicines, herbal medicines, and decoctions used at healthcare facilities and drugs self-manufactured and prepared by healthcare facilities based on the actual quantity used for patients, purchase price of the facility in accordance with laws on bidding, loss costs during storage, transportation, distribution, compounding, weighing, dose division, and drug usage as prescribed by the Minister of Health, and other costs (if any) within the scope of rights and benefits stipulated by laws on health insurance.

2. For management costs and depreciation costs of machinery for herbal medicines and drugs self-manufactured and prepared by healthcare facilities as stipulated in this Circular, the health insurance fund will pay according to the adjustment process of factors constituting the price of health insurance medical services and apply simultaneously with the price of health insurance medical services as prescribed.

3. In cases where herbal medicines and drugs have payment ratios and conditions specified in column 4 or column 5 notes of the appendices issued together with the Circular promulgating the list of traditional medicine drugs within the scope of health insurance benefits, the health insurance fund will pay according to the payment ratios and conditions stipulated in the Circular promulgating the list of traditional medicine drugs within the scope of health insurance benefits.

4. The health insurance fund will pay for herbal medicines, traditional medicines, and drugs combining chemical substances with herbal medicines listed in the list of traditional medicine drugs within the scope of health insurance benefits or according to the drug component names stipulated in Article 12 of this Circular in cases where drug components have different naming methods.

5. The health insurance fund will pay for herbal medicines listed in the herbal medicine list in the Circular promulgating the list of traditional medicine drugs within the scope of health insurance benefits or according to the herbal medicine names stipulated in Article 12 of this Circular in cases where herbal medicines have different naming methods.

Article 14. Payment for Traditional Medicines, Herbal Medicines, and Medicines Combined with Herbal Ingredients

1. The Health Insurance Fund shall pay the cost of traditional medicines, herbal medicines, and medicines combined with herbal ingredients used for patients, including the actual cost of medicine used for patients and the loss cost of such medicine (if any) at medical examination and treatment facilities, specifically as follows:

a) The actual cost of medicine used for patients in one medical examination and treatment session shall be paid by the Health Insurance Fund based on the purchase price of the medical examination and treatment facility according to the legal provisions on bidding and the level of benefit and scope of entitlement under the legal provisions on health insurance;

b) The loss cost of medicine during storage, preservation, transportation, distribution, preparation, dosage division, and usage shall be paid by the Health Insurance Fund according to the regulations stipulated in Circular No. 55/2017/TT-BYT dated December 29, 2017, issued by the Minister of Health regarding the rate of medicine loss and the payment of loss costs of medicine at medical examination and treatment facilities.

The Health Insurance Fund shall pay the loss cost annually as follows: Loss cost of medicine paid by the Health Insurance Fund = (Rate of medicine loss) x (Total payment cost of health insurance for that medicine).

2. The Health Insurance Fund shall pay in cases where the medicine is prescribed in accordance with one of the following documents:

a) The drug usage guide attached to the drug registration dossier approved by the Ministry of Health;

b) Guidelines for diagnosis and treatment according to traditional medicine and the combination of traditional medicine with modern medicine issued by the Ministry of Health.

3. Medicine classified in this category of traditional medical theory but used to treat diseases belonging to another category of traditional medical theory shall be paid by the Health Insurance Fund if it is prescribed in accordance with the provisions of Clause 2 of this Article.

4. The Health Insurance Fund shall pay according to the conditions and payment ratio specified in Column 4 or Column 5 of the Appendices issued together with the Circular promulgating the list of traditional medicines within the scope of entitlement for health insurance participants.

5. The Health Insurance Fund shall not pay for the following cases:

a) Medicine or batch of medicine that has been suspended from circulation or recalled by the competent authority. The time and scope of non-payment for health insurance shall be calculated according to the time and scope of suspension or recall stated in the suspension or recall document;

b) Medicine costs already included in the service fee for medical examination and treatment or the package fee per case according to current regulations;

c) The portion of medicine costs covered by the state budget or other sources of funding.

Article 15. Payment for Herbal Ingredients

1. Medical examination and treatment facilities purchasing herbal ingredients for use shall have the Health Insurance Fund pay the following costs:

a) Direct costs include:

- The cost of herbal ingredients at the purchase price of the medical examination and treatment facility. The herbal ingredients must be listed in the herbal ingredient directory stipulated in the Circular promulgating the list of health insurance medicines;

- The cost of auxiliary materials, electricity, water, fuel used in preliminary processing (if any);

- The loss cost during preliminary processing, preservation, weighing and dividing (if any);

- Packaging material costs (if any);

- Costs of materials, chemicals, auxiliary materials serving quality control activities before testing, testing costs according to Circular No. 38/2021/TT-BYT dated December 31, 2021, issued by the Minister of Health regarding the quality of herbal ingredients, traditional medicinal herbs, and traditional medicines (if any);

- Other costs (if any);

b) Labor costs (if any);

c) Management costs according to the adjustment schedule of factors constituting the price of medical examination and treatment services under health insurance;

d) Depreciation costs of machinery according to the adjustment schedule of factors constituting the price of medical examination and treatment services under health insurance.

2. The head of the medical examination and treatment facility shall be responsible for approving the preliminary processing procedures, herbal ingredient costs, and other costs stipulated in Clause 1 of this Article (if any), and submit them to the social insurance agency where the medical examination and treatment health insurance contract is signed as the basis for payment.

Article 16. Payment for Traditional Medicinal Ingredients

1. In cases where healthcare facilities purchase traditional medicinal ingredients that have been processed or compounded from herbal medicines listed in the Herbal Medicine Catalogue issued by the Circular on the List of Traditional Medicines within the scope of coverage for health insurance beneficiaries: The Health Insurance Fund shall base its payment on the purchase price of the traditional medicinal ingredients and the loss incurred during storage, weighing, and distribution (if applicable).

2. In cases where healthcare facilities purchase herbal medicines to process into traditional medicinal ingredients that are covered by the Health Insurance Fund, the following costs shall be reimbursed:

a) Direct costs include:

- Costs of herbal medicines based on the purchase price of the healthcare facility. The herbal medicines must be included in the Herbal Medicine Catalogue stipulated in the Circular on the List of Traditional Medicines within the scope of coverage for health insurance beneficiaries;

- Costs of excipients, electricity, water, and fuel used in preliminary processing and compounding;

- Losses incurred during preliminary processing, compounding, storage, and weighing/distribution (if applicable);

- Packaging material costs (if any);

- Costs of materials, chemicals, and excipients used for quality control activities prior to testing, and testing costs according to Circular No. 38/2021/TT-BYT (if applicable);

- Other costs (if any);

b) Labor costs for implementation;

c) Management costs according to the adjustment schedule of factors constituting the price of medical examination and treatment services under health insurance;

d) Depreciation costs of machinery according to the adjustment schedule of factors constituting the price of medical examination and treatment services under health insurance.

3. The head of the healthcare facility shall be responsible for approving the preliminary processing and compounding procedures, quality standards, costs of herbal medicines, and other costs specified in Clause 2 of this Article and submit them to the Social Insurance Authority at the location where the health insurance treatment contract is signed for reimbursement purposes.

Article 17. Payment for Decoction Medicines

For decoction medicines containing components from herbal medicines or traditional medicinal ingredients processed or compounded from herbal medicines listed in the Herbal Medicine Catalogue issued by the Circular on the List of Traditional Medicines within the scope of coverage for health insurance beneficiaries, the Health Insurance Fund shall reimburse the following costs:

1. Costs of purchasing herbal medicines or traditional medicinal ingredients as stipulated in Articles 15 and 16 of this Circular.

2. Costs of decocting medicine when the healthcare facility performs decoction at the facility for inpatient or outpatient patients according to the service fee for decoction approved by the competent authority for use at the healthcare facility.

3. Packaging costs (if applicable).

Article 18. Payment for Pharmaceutical Preparations Produced by Healthcare Facilities

1. The Health Insurance Fund shall reimburse the following costs:

a) Direct costs include:

- Costs of herbal medicines or traditional medicinal ingredients based on the purchase price of the healthcare facility. The herbal medicines and traditional medicinal ingredients compounded from herbal medicines must be included in the Herbal Medicine Catalogue stipulated in the Circular on the List of Traditional Medicines within the scope of coverage for health insurance beneficiaries;

- Costs of pharmaceutical excipients and materials for preparation;

- Costs of electricity, water, and fuel for preliminary processing, compounding, and preparation of medicines;

- Packaging costs;

- Losses (if applicable);

- Costs of materials, chemicals, and excipients used for quality control activities prior to testing, and testing costs according to Circular No. 38/2021/TT-BYT (if applicable);

- Other costs (if any);

b) Labor costs for implementation;

c) Management costs according to the adjustment schedule of factors constituting the price of medical examination and treatment services under health insurance;

d) Depreciation costs of machinery according to the adjustment schedule of factors constituting the price of medical examination and treatment services under health insurance.

2. In cases where pharmaceutical preparations contain components not included in the Herbal Medicine Catalogue stipulated in the Circular on the List of Traditional Medicines within the scope of coverage for health insurance beneficiaries: The Health Insurance Fund shall reimburse according to the provisions of Clause 1 of this Article, excluding the costs of components not included in the Herbal Medicine Catalogue stipulated in the Circular on the List of Traditional Medicines within the scope of coverage for health insurance beneficiaries.

3. The head of the healthcare facility shall be responsible for approving the production procedures, quality standards, and costs of pharmaceutical preparations produced by the facility and submit them to the Social Insurance Authority at the location where the health insurance treatment contract is signed for reimbursement purposes.

4. Pharmaceutical preparations produced by healthcare facilities may only be used at those facilities.

Article 19. Medicines to be reimbursed in special cases

Special medicines serving political tasks, urgent situations in disease prevention and control, war, natural disasters, national disasters:

1. The provisions of Articles 3, 4, 5, 6, 7, and 8 of this Circular shall not apply.

2. Health insurance reimbursement shall be carried out according to the guidelines of the Ministry of Health based on the political tasks directly assigned by the Party, State, and Government to the Ministry of Health in emergency situations.

Chapter V
IMPLEMENTING PROVISIONS

Article 20. Effective Date

1. This Circular takes effect from September 1, 2025.

2. The provisions of Articles 9, 10, and 11 of this Circular shall not apply in health insurance reimbursement for medical examination and treatment costs until the Minister of Health issues a Circular establishing the list, ratio, and conditions for reimbursement of herbal medicines, medicines containing drug substances combined with herbs, traditional medicines, and herbs within the scope of health insurance benefits.

3. Circulars No. 05/2015/TT-BYT dated March 17, 2015, issued by the Minister of Health on the list of traditional medicines, medicines from herbs, and traditional herbal medicines within the scope of health insurance fund reimbursement, and Circular No. 27/2020/TT-BYT dated December 31, 2020, issued by the Minister of Health amending and supplementing Article 5 of Circular No. 05/2015/TT-BYT shall cease to be effective from the date this Circular takes effect.

Article 21. Reference Provisions

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

Article 22. Implementation organization

1. The Health Insurance Department, Ministry of Health shall be responsible for:

a) Organizing the implementation and guiding the execution of this Circular;

b) Receiving, compiling, researching, and evaluating proposals for updating the medicine list submitted by medical examination and treatment facilities, pharmaceutical businesses, and other organizations, individuals; seeking opinions from specialized councils and experts regarding safety, efficacy, cost analysis, and budget impact assessments of proposed medicines when necessary for building and updating the medicine list;, c) Serving as the coordinating body with relevant agencies and organizations to refer to recommendations for building and updating the medicine list to ensure compliance with criteria.

2. Other Departments, Bureaus, units under the Ministry of Health, and the National Center for Drug Information and Adverse Drug Reaction Monitoring shall be responsible for coordinating the implementation of this Circular according to their functions, duties, and authorities.

3. Provincial and municipal health departments shall be responsible for:

a) Directing, guiding, disseminating, and implementing this Circular within their authority;

b) Reviewing, screening, and assessing practical needs and compiling recommendations from medical examination and treatment facilities within their jurisdiction to propose the Ministry of Health to amend and supplement the health insurance medicine list;

c) Directing medical examination and treatment facilities within their jurisdiction to build a medicine list for use at their facilities and implement measures to ensure timely supply of traditional medicines, guarantee quality, meet treatment needs, and protect the rights of health insurance participants.

4. Social Insurance Agencies shall be responsible for:

a) Providing complete and timely information and data related to health insurance reimbursement for medical examination and treatment costs to the Ministry of Health for review during the process of building and updating the medicine list;

b) Organizing health insurance reimbursement for medicines in medical examination and treatment according to the provisions of this Circular.

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

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

b) Submitting any revised or supplemented medicine lists to the social insurance agency where the health insurance examination and treatment contract is signed for reimbursement purposes if there are changes or additions to the medicine list used at the facility;

c) Ensuring adequate and timely supply of traditional medicines to meet treatment needs and protect the rights of health insurance participants; complying with laws on ensuring the quality, safety, and effectiveness of medicines, and preventing counterfeit and substandard goods;

d) Reviewing the use of medicines and assessing the need for medicines at the facility to propose inclusion or exclusion of medicines from the list and submitting these proposals to the Health Insurance Department, Ministry of Health (for facilities under the Ministry of Health and other ministries) or the provincial health department (for facilities under the provincial health department and private facilities in the locality);

e) Ensuring the scientific accuracy of information related to the medicine list and its alignment with the Ministry of Health's professional guidelines.

6. Medicine production facilities, registration facilities, import facilities, and distribution facilities shall be responsible for providing information about medicines under their responsibility when adjustments or supplements are needed, ensuring the scientific accuracy of information related to the medicine list and aligning with the Ministry of Health's expertise, and complying with laws on ensuring the quality, safety, and effectiveness of medicines, and preventing counterfeit and substandard goods.

During the implementation process, any difficulties or obstacles should be reported to the Ministry of Health (Health Insurance Department) for consideration and resolution.

- Office of the Government (Legal Affairs Department, Official Gazette; Electronic Portal)