Joint Circular No. 11/2007/TTLT-BYT-BTC guides the state management of drug prices for human use.

 JOINT CIRCULAR
Guidelines for State Management of Drug Prices for Human Use

Pursuant to the Medicine Law No. 34/2005/UBTVQH11 dated August 9, 2005;

Pursuant to the Price Ordinance No. 40/2002/UBTVQH10 dated April 26, 2002;

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

Pursuant to the Government Decree No. 170/2003/NĐ-CP dated December 25, 2003 detailing certain provisions of the Price Ordinance;

The Ministry of Health, the Ministry of Finance, and the Ministry of Industry and Trade hereby issue guidelines for state management of drug prices for human use as follows:

This technical regulation sets out technical requirements, testing methods, sampling procedures; management requirements; responsibilities of organizations and individuals producing, trading, and importing cigarettes.

Thông tư này quy định chi tiết khoản 4 Điều 38 Luật Thủy sản số 18/2017/QH14 đã được sửa đổi, bổ sung tại điểm c khoản 21 Điều 14 Luật số 146/2025/QH15.

These Circulars guide the implementation of state management of drug prices for human use including: price declaration, re-declaration of drug prices; price display; management of drug prices paid by the state budget and the Health Insurance Fund; authorities and responsibilities of agencies and entities in implementing regulations on managing finished drug prices approved for circulation and use in Vietnam (hereinafter referred to as drugs); inspection and supervision of compliance with state regulations on drug pricing in Vietnam.

Thông tư này áp dụng đối với tổ chức, cá nhân có liên quan đến hoạt động kinh doanh đối tượng thủy sản nuôi chủ lực trên lãnh thổ Việt Nam.

These Circulars apply to organizations and individuals in Vietnam and foreign organizations and individuals permitted to engage in drug production, importation, wholesale, and retail (hereinafter referred to as entities); medical examination and treatment facilities in Vietnam; and agencies, organizations, and individuals related to state management of drug prices.

3. Principles of State Management of Drug Prices

3.1. The State manages drug prices based on the principle that entities producing, importing, wholesaling, and retailing drugs set their own prices, compete on price, and are subject to price inspection and control by state management agencies according to the Medicine Law, the Government Decree No. 79/2006/NĐ-CP dated August 9, 2006 detailing certain provisions of the Medicine Law, these Circulars, and other relevant legal documents.

3.2. The State uses measures to stabilize drug prices in the market to meet the demand for drugs serving health care, protection, and improvement of people's health.

3.3. Entities engaged in drug business must fully comply with guidance on price declaration, re-declaration, price display, and bear responsibility under the law for declared prices, re-declared prices, displayed prices, and selling prices according to the Medicine Law, the Government Decree No. 79/2006/NĐ-CP dated August 9, 2006 detailing certain provisions of the Medicine Law, these Circulars, and other relevant legal documents.

3.4. State management agencies regarding drug prices (the National Pharmaceutical Administration and Provincial Health Departments) have the responsibility to examine the reasonableness of drug prices and do not approve prices declared and re-declared by entities.

3.5. Management of drug prices is organized through a decentralization mechanism between central and local state management agencies regarding drug prices based on geographical area and field.

4. Definitions.

4.1. Types of drug prices include:

a) Import price is the price including the value of the drug based on the export country's selling price, insurance costs, and freight from the exporting country to Vietnam's port (referred to as CIF), and does not include import tax (if applicable).

- Actual CIF price is the CIF price recorded on the customs declaration form.

b) Wholesale price is the price between drug business entities; between drug business entities and medical examination and treatment facilities.

c) Projected wholesale price is the projected wholesale price declared and re-declared by domestic manufacturing entities and import entities to the state management agency regarding drug prices.

d) Projected retail price is the projected retail price intended to be sold directly to end-users by domestic manufacturing entities and import entities.

e) Retail price is the price of drugs sold directly to end-users at retail outlets.

4.2. Declaration of drug prices is the act of drug business entities reporting import prices, projected wholesale prices, and projected retail prices to the state management agency regarding drug prices according to these Circulars and relevant laws on prices. Declaration of drug prices is carried out when submitting the Foreign Drug Registration Application Form and before circulating imported drugs and domestically produced drugs on the Vietnamese market. Declared drug prices are calculated per smallest unit of packaging.

4.3. Re-declaration of drug prices is the act of drug business entities reporting import prices, projected wholesale prices, and projected retail prices when there is a need to increase drug prices compared to previously declared or re-declared prices. Re-declaration of drug prices is conducted prior to applying new prices. Re-declared drug prices are calculated per smallest unit of packaging.

4.4. Display of drug prices is the act of drug business entities publicly displaying drug selling prices by printing, affixing, or writing prices on drug packaging or outer packaging, or publicly announcing prices on boards, paper, or other forms placed, hung, or affixed at drug sales and supply locations according to Section III of these Circulars.

5. Currency applied when declaring, re-declaring, and displaying drug prices

5.1. Declare and re-declare CIF prices in Vietnamese Dong. Conversion from foreign currency to Vietnamese Dong is based on the average inter-bank exchange rate published by the State Bank of Vietnam at the time of submitting the Declaration Form.

5.2. Declare, re-declare, and display projected wholesale and retail prices in Vietnam in Vietnamese Dong. Declared, re-declared, and displayed prices include Value Added Tax (VAT).

II. GUIDELINES ON DECLARATION AND RE-DECLARATION OF DRUG PRICES

1. Documents, procedures, and formalities for declaring drug prices

1.1. When submitting the Foreign Drug Registration Application Form

Overseas drug manufacturers or authorized registration entities shall perform:

- Declaration of CIF price at Vietnam's port Male;

- Provide actual CIF price of the drug item (same active ingredient, concentration or content, and packaging specification) that the entity has sold to some countries within the reference price range for drugs as guided in Point 1.2 Clause 1 Section VI of these Circulars.

In the case of new drugs that are only imported for circulation in the Vietnamese market, the foreign drug manufacturing facility shall commit and be responsible for the commitment regarding the absence of actual CIF price information of such drug items sold to some countries within the reference price range as specified in Point 1.2 Clause 1 Section VI of this Circular.

1.2. Prior to circulating drugs in the Vietnamese market, Male

a. Drug importers with registration numbers and those without registration numbers shall perform:

- Declaration of the actual CIF price at the Vietnamese port. Male;

For drug importers without registration numbers: provide the actual CIF price of the drug item (with the same active ingredient, concentration or content and packaging specifications) sold by the drug manufacturer to some countries within the reference price range as specified in Point 1.2 Clause 1 Section VI of this Circular. In the case of new drugs that are only imported for circulation in the Vietnamese market, the drug importer shall make a commitment and be responsible for the absence of actual CIF price information of such drug items.

- Declaration of the expected wholesale price;

- Declaration of the expected retail price (if the entity registers for retail business);

Declaration time: from the time of importing the first shipment until before the drug is circulated in the Vietnamese market Male of drugs with registration numbers or newly registered drugs without registration numbers. For subsequent shipments, the importer does not need to declare if there is no increase in price.

b. Domestic drug manufacturers or authorized entities registering drugs shall declare the following prices:

- Expected wholesale price;

- Expected retail price in Vietnam Male (if the entity registers for retail business).

Declaration time: from the time of producing the first batch of newly registered drugs until before the drug is circulated in the Vietnamese market Male. For subsequent batches, domestic manufacturers do not need to declare if there is no increase in price.

1.3. The declaration form consists of two copies: one copy sent to the Department of Medicine Management of Vietnam, one copy retained by the entity. The declaration form includes the following documents: Malea. Foreign drug manufacturers or authorized entities registering drugs

- Declaration form of drug prices: Form No. 1-GT;

- Table providing the actual CIF selling price to some countries within the reference price range as specified in Point 1.2 Clause 1 Section VI of this Circular: Form No. 2-GT or Commitment Letter (if applicable).

b. Drug importers

- Declaration form of drug prices and detailed declared prices: Form No. 3-GT;

- Table providing the actual CIF selling price to some countries within the reference price range as specified in Point 1.2 Clause 1 Section VI of this Circular: Form No. 2-GT for importers without registration or Commitment Letter (if applicable).

c. Domestic drug manufacturers or authorized entities registering drugs.

- Declaration form of drug prices and detailed declared prices: Form No. 4-GT;

2. Documents, procedures, and formalities for re-declaring drug prices

2.1. Entities shall re-declare drug prices when there is a need to adjust the price upwards compared to the previously declared price or the most recent re-declaration with the competent state management agency on drug pricing.

2.2. The re-declaration form consists of two copies: one copy sent to the Department of Medicine Management of Vietnam

or the Health Department, one copy retained by the entity. The re-declaration form includes the following documents: Male a). Foreign drug manufacturers or authorized entities registering drugs

- Notification letter about re-declaring drug prices: Form No. 5-GT;

- Re-declaration form of drug prices: Form No. 6-GT;

- Table providing the actual CIF selling price to some countries within the reference price range as specified in Point 1.2 Clause 1 Section VI of this Circular: Form No. 2-GT.

- Re-declaration form of drug prices and detailed re-declared prices: Form No. 7-GT.

- Declaration form of drug prices and detailed declared prices: Form No. 3-GT;

- Re-declaration form of drug prices: Form No. 6-GT;

c. Domestic drug manufacturers or authorized entities registering drugs

- Re-declaration form of drug prices and detailed re-declared prices: Form No. 8-GT.

- Re-declaration form of drug prices: Form No. 6-GT;

3. Authority and responsibilities of state agencies and business entities in implementing regulations on declaring and re-declaring drug prices.

3.1. Agencies receiving declaration forms:

a) The Department of Medicine Management of Vietnam receives:

- Declaration forms of drug prices according to the guidance in Point 1.3 Clause 1 of this Section.

- Declaration forms of re-declared imported drug prices according to the guidance in Subpoint a and b of Point 2.2 Clause 2 of this Section.

b) The Health Department receives declaration forms of re-declared prices according to the guidance in Subpoint c of Point 2.2 Clause 2 of this Section.

3.2. State management agencies on drug pricing do not approve drug prices declared by entities but supervise the declaration and re-declaration of drug prices as follows:

a) For declarations of drug prices

From the time of declaring drug prices to the expiration date of the registration number or import permit without a registration number, if unreasonable declared prices are discovered, the Department of Medicine Management of Vietnam will issue a written opinion specifying the reasons and requesting the entity to reconsider the declared drug prices.

b) For re-declarations of drug prices

Within 17 working days from the date of receiving complete re-declaration forms in accordance with the guidelines, if unreasonable re-declared prices are found, the Department of Medicine Management of Vietnam or the Health Department will issue a written opinion on the re-declared prices and specify the reasons.

c) Basis for assessing the reasonableness of declared and re-declared drug prices:

- Import, production, and distribution costs determined according to current laws;

- Market price levels for drugs domestically and regionally. For imported drugs circulating in the Vietnamese market, the declared or re-declared drug prices at the time of declaration or re-declaration must not exceed the average actual CIF price of such drugs (with the same active ingredient, concentration or content and packaging specifications) sold by foreign manufacturers to some countries within the reference price range as specified in Point 1.2 Clause 1 Section VI of this Circular.

- Fluctuations in input factors such as raw materials, materials, exchange rates.

- Fluctuations in input cost factors such as raw materials, materials, exchange rates.

d) In case domestic pharmaceutical production facilities, foreign pharmaceutical production facilities, or authorized registration entities fail to comply with the guidelines on declaration and re-declaration of drug prices, the Vietnam National Medicines Administration shall handle the matter as follows:

- Temporarily suspend issuance of registration numbers for drugs produced abroad during the period awaiting issuance of registration numbers where the declaring entity's declared price is unreasonable but does not proceed to review and adjust the declared price after receiving written comments from the competent state management agency on drug prices.

- Temporarily suspend issuance of registration numbers and cease acceptance of information and advertising materials for drug products where it is discovered that the declared or re-declared price of the product circulating in the market is unreasonable and the declaring entity does not proceed to review and adjust the declared or re-declared price after receiving written comments from the competent state management agency on drug prices, or sells the drug at a higher price than the declared or re-declared price currently in effect.

- For importers of drugs, the Vietnam National Medicines Administration may temporarily suspend issuance of drug import orders for products without registration numbers where the declaring entity's declared price is unreasonable and does not proceed to review and adjust the declared price after receiving written comments from the competent state management agency on drug prices, or sells the drug at a higher price than the declared or re-declared price currently in effect.

3.3. Where necessary, the Ministry of Health shall establish an inter-ministerial working group to examine the declaration and re-declaration of drug prices by entities, and propose recommendations for handling cases of unreasonable declarations and re-declarations. The composition of the inter-ministerial working group includes representatives from the Ministry of Health (Vietnam National Medicines Administration - the leading agency, Department of Planning and Finance) and representatives from the Ministry of Finance (Price Management Department, State Enterprise Financial Department).

3.4. Where necessary, the Department of Health shall establish an inter-ministerial working group to examine the re-declaration of drug prices by domestic production entities located within its jurisdiction, and promptly propose recommendations for handling cases of unreasonable re-declarations. The composition of the inter-ministerial working group includes representatives from the Department of Health (the leading agency) and representatives from the Department of Finance.

3.5. Authorities and responsibilities of entities:

a) Entities engaged in the production, importation, wholesale, and retail sale of drugs have the right to set their own drug prices, while also being responsible for fully complying with the guidelines on declaration and re-declaration of drug prices stipulated in this Circular and related regulatory documents; they are liable under the law for the declared and re-declared prices and all reported data and provided information.

b) Entities have the right to request the Vietnam National Medicines Administration or the Department of Health for comments from the competent state management agency on drug prices regarding the entity's declared and re-declared prices.

c) During the course of drug business operations:

- Importing entities and domestic pharmaceutical production entities must provide their customers with information on the current effective wholesale price that has been declared or re-declared through written notification or recorded on sales invoices.

- Wholesale entities base their pricing on the wholesale price forecast communicated by the supplying entity or available on the Vietnam National Medicines Administration’s website, ensuring that the price of drugs sold by the wholesale entity does not exceed the declared or re-declared wholesale price forecast by domestic production or importing entities.

- If an entity sells drugs at a lower price than the declared or re-declared price, it must comply with laws against predatory pricing.

3.6. Periodic reporting on re-declaration of drug prices.

By the 10th day of each month, the Department of Health shall report to the Ministry of Health (Vietnam National Medicines Administration) in writing and via email (at the address: quanlygia [email protected]) on the situation of re-declaration of drug prices by domestic production entities located within its jurisdiction (Form No. 9-GT).

III. GUIDELINES ON PRICING AND DISPLAY OF DRUGS

1. Wholesale entities shall publicly announce the wholesale price of each type of drug on boards, paper, or other forms placed, hung, or affixed at transaction and selling locations, making it convenient for customer observation, and shall not sell at a higher price than the announced price. The wholesale price announced by the wholesale entity shall not be higher than the wholesale price forecast declared or re-declared by the production or importing entity to the competent state management agency on drug prices.

2. Retail entities shall print, write, or affix the retail price of each type of drug on the packaging or outer packaging of the drug, and shall not sell at a higher price than the announced price.

3. Display of drug prices at retail outlets within healthcare facilities:

3.1. Retail entities within healthcare facilities shall display the retail price of drugs according to the guidelines in Clause 2 of this Section. The retail price displayed by the entity shall not be higher than the prevailing retail price of the drug (same active ingredient, concentration, or dosage form and packaging) in the same area at the same time.

3.2. The Director of the healthcare facility is responsible for compliance with the guidelines on displaying drug prices at retail outlets within the healthcare facility managed by them.

In cases where the retail outlet within a healthcare facility is owned by a business entity, the Director of the healthcare facility and the business entity jointly bear responsibility for compliance with the guidelines on displaying drug prices at retail outlets within the healthcare facility.

IV. MANAGEMENT OF DRUG PRICES FUNDED BY THE STATE BUDGET AND HEALTH INSURANCE FUNDS

1. Management of drug prices ordered by the State and paid from the State budget

1.1. The Ministry of Finance shall determine the payment price for tasks funded from the central government budget after receiving written comments from the Ministry of Health; the provincial Department of Finance shall determine the payment price for tasks funded from the local government budget after receiving written comments from the provincial Department of Health.

1.2. Pursuant to Clause 3, Section I of this Circular and the Regulation on Pricing of Assets, Goods, Services issued together with Decision No. 06/2005/QĐ-BTC dated January 18, 2005 of the Minister of Finance, entities commissioned by the State to prepare pricing plans for submission to competent state agencies as stipulated in Point 1.1 above for review and issuance within their authority shall base themselves on the principle of State management of drug prices.

2. Management of drug prices paid from the State budget and the Health Insurance Fund:

2.1. Drugs listed in the main drug directory for use at public health facilities and private healthcare facilities with contracts for health insurance services with the Social Insurance Agency, drugs funded by the State budget must be tendered in accordance with the laws on bidding. The winning bid price must not exceed the maximum price currently published by the Ministry of Health at the nearest time point.

2.2. Every six months for drugs tendered every six months and annually for drugs tendered annually, hospitals and institutes under the Ministry of Health and provincial general hospitals within central cities shall submit reports on the winning bid prices of the previous period to the Vietnam National Medicines Administration within fifteen working days from the date of the tender results. The report format is in writing and via email to [email protected] (Form No. 10-GT).

V. INSPECTION, AUDIT AND HANDLING OF VIOLATIONS

1. Inspection and audit of the implementation of guidelines for State management of drug prices

1.1. The Ministry of Health, the Ministry of Finance, and the Ministry of Industry and Trade within their respective mandates organize inspections and audits or coordinate inspections and audits and handle violations of State regulations on drug price management at drug production, import, wholesale, retail establishments and healthcare facilities nationwide in accordance with the law.

1.2. Ministries and sectors with drug import, production, wholesale, retail establishments and healthcare facilities regularly or suddenly inspect, audit and handle violations according to their functions and responsibilities.

1.3. People's Committees at all levels within their mandates direct relevant functional agencies in their areas to organize inspections and audits or coordinate inspections and audits and handle violations of State regulations on drug price management at drug production, import, wholesale, retail establishments and healthcare facilities in their localities in accordance with the law.

2. Administrative penalties in the field of drug price management.

2.1. Organizations and individuals who violate the guidelines on drug price management in this Circular and related legal documents will be subject to administrative penalties or criminal prosecution depending on the nature and severity of the violation, and if damage is caused, they must compensate in accordance with the law.

2.2. Administrative penalties in the field of drug price management are implemented in accordance with Decree No. 169/2004/NĐ-CP dated September 22, 2004 of the Government on administrative penalties in the field of prices; Clause 1, Article 14 of Decree No. 120/2004/NĐ-CP dated February 12, 2004 of the Government on drug price management for disease prevention and treatment; Decree No. 45/2005/NĐ-CP dated April 6, 2005 of the Government on administrative penalties in the field of health, and other current legal provisions.

2.3. Specific authority to impose penalties, procedures and formalities for imposing penalties are carried out in accordance with the Administrative Violation Handling Law 2002 and other related legal documents.

VI. ASSIGNMENT AND COORDINATION TO IMPLEMENT STATE MANAGEMENT OF DRUG PRICES

1. The Ministry of Health leads and coordinates with the Ministry of Finance, the Ministry of Industry and Trade, and related ministries and sectors

1.1. Direct and guide provincial health departments and drug production, import, wholesale, retail establishments, and healthcare facilities to implement the guidelines in this Circular and other related legal documents on drug price management.

1.2. Annually, unify and notify in writing the list of countries in the region to be referenced for drug pricing for entities to declare and re-declare drug prices in accordance with the guidelines in this Circular.

1.3. Annually, publish the maximum prices of drugs paid from the State budget and the Health Insurance Fund; publish reference prices for drug items won in the previous tender period by healthcare facilities. In case of abnormal price fluctuations, publish the maximum prices to stabilize the drug market.

2. The Ministry of Health, the Ministry of Finance, and the Ministry of Industry and Trade within their respective authorities direct health, finance, and market management agencies at all levels to regularly coordinate inspections and audits of compliance with laws on drug circulation, export, import, and drug price management laws.

3. The Ministry of Health delegates to the Vietnam National Medicines Administration Male

3.1. Lead and coordinate with the Vietnam Trade Office in countries to periodically survey drug prices in countries in the region to serve the State management of drug prices domestically.

3.2. Update and publicly announce drug prices declared and re-declared by entities on the Vietnam National Medicines Administration’s website, specialized magazines, and other appropriate mass media.

4. The Ministry of Finance delegates to

4.1. The General Department of Customs to provide actual CIF prices of imported drugs circulating in the Vietnamese market (by the 25th of each month) to the Vietnam National Medicines Administration for the previous month's import prices (Form No. 11-GT). Format: written and email to [email protected].

4.2. The General Department of Taxation directs tax agencies at local levels to check the implementation of invoice and receipt systems by drug business entities under their jurisdiction.

5. Ministry of Industry and Trade

5.1. Coordinate with sectors and localities in combating speculation and monopolistic practices that push up drug prices for illicit gains.

5.2. Monitor competitive activities, prevent monopolies, and handle violations of competition laws.

VII. EFFECTIVE PROVISIONS

1. Effective date

This Circular shall take effect fifteen days from the date of publication in the Official Gazette and shall replace Circular Joint Circular No. 08/2003/TTLT/BYT-BTC dated July 25, 2003 guiding the declaration of drug prices for disease prevention and treatment. All previous State management regulations on drug pricing that conflict with this Circular are hereby abolished.

2. Implementation Organization:

2.1. Drug production facilities, import facilities, wholesale and retail drug distribution facilities, and medical examination and treatment establishments shall immediately implement necessary measures to comply with the guidance provided in this Circular.

2.2. For drugs that have been registered prior to the effective date of this Circular, the responsible facility must supplement the drug price declarations according to the guidance in this Circular and submit them to the Vietnam National Medicines Administration before December 31, 2007. Male The submission format shall be in writing and via email to the address: [email protected].

2.3. Associations, professional associations, and trade unions within their scope of responsibility shall carry out publicity, dissemination, and supervision of the implementation of drug pricing management regulations for their members and promptly reflect price fluctuations, provide comments, and propose measures to stabilize drug prices to relevant State management agencies.

2.4. In case of difficulties during implementation, facilities and localities are requested to promptly report to the Ministry of Health so that the Ministry of Health, Ministry of Finance, and Ministry of Industry and Trade can study and resolve the issues.