This Circular guides the state management of drug prices for human use, applicable to organizations and individuals producing, importing, trading in drugs, and healthcare facilities. It provides detailed regulations on price declaration, price display, and drug pricing management from the state budget, health insurance, and hospital revenue sources.
Đối tượng áp dụng
Organizations and individuals producing, importing, entrusting importation, registering drugs or being authorized to register drugs, commissioning production, wholesaling, retailing drugs; healthcare facilities in Vietnam; relevant agencies and organizations involved in state management of drug prices.
Các điểm cốt lõi
- Drug business entities set their own prices and display them according to the regulations, subject to inspection by the state management agency for drug prices.
- Declare and re-declare the prices of imported and domestically produced drugs in accordance with the guidelines set out in this Circular.
- Display wholesale and retail drug prices at business establishments.
- Management of drug prices from the state budget, health insurance, and hospital revenue sources must be conducted through bidding.
- The state management agency for drug prices has the authority to review the reasonableness of declared and re-declared drug prices.
🌐 Tác động xã hội từ văn bản này
- Positive: Helps stabilize drug prices in the market, ensuring that people can access drugs at reasonable prices.
- Negative: May cause difficulties for businesses in quickly adjusting drug prices in response to market fluctuations.
❓ Câu hỏi thường gặp
When must drug business entities declare or re-declare drug prices?
Drug business entities must declare or re-declare drug prices when there is a need to adjust the price upwards compared to the previously declared or re-declared price.
How is the exchange rate for foreign currency conversion in drug price declarations calculated?
The exchange rate for foreign currency conversion is calculated based on the actual exchange rate that drug business entities have settled with the Bank (where the organization or individual conducting business transactions borrowed or purchased foreign currency to buy goods). If not yet settled, it is calculated based on the selling rate of commercial banks.
What rights do drug business entities have to make representations or explanations regarding the opinions of the state management agency for drug prices?
Within thirty days from the date of receipt of the written opinion of the state management agency, drug business entities have the right to make representations or explanations. After this period, if there is no response, the declaration and re-declaration files lose their validity, and the entity must comply with the opinions of the state management agency.
How must retail drug outlets display retail prices?
Retail drug outlets must print, write, or affix retail prices on the packaging containing the drug or the outer packaging of the drug, ensuring that the original label content is not obscured and that they do not sell above the displayed price.
What penalties will drug business entities face for violating state management regulations on drug prices?
Organizations and individuals who violate state management regulations on drug prices will be subject to administrative penalties or criminal liability if they cause damage to consumers, the state, and other businesses.
Toàn văn
JOINT CIRCULAR
Guidelines for State Management of Drug Prices for Human Use
________________________
Pursuant to the Drug Law No. 34/2005/QH11 dated June 14, 2005 of the National Assembly;
Pursuant to the Price Ordinance No. 40/2002/PL-UBTVQH10 dated April 26, 2002 of the Standing Committee of the National Assembly;
Pursuant to the Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing implementation of certain provisions of the Medicine Law;
Pursuant to the Decree No. 170/2003/NĐ-CP dated December 25, 2003 of the Government detailing implementation of certain provisions of the Price Ordinance;
Pursuant to the Decree No. 75/2008/NĐ-CP dated June 9, 2008 of the Government amending and supplementing certain provisions of the Decree No. 170/2003/NĐ-CP dated December 25, 2003 of the Government detailing implementation of certain provisions of the Price Ordinance;
Pursuant to the Decree No. 84/2011/NĐ-CP dated September 20, 2011 of the Government on administrative penalties for violations in the field of prices;
Pursuant to the Decree No. 93/2011/NĐ-CP dated October 18, 2011 of the Government on administrative penalties for violations concerning drugs, cosmetics, and medical devices;
The Ministry of Health, the Ministry of Finance, and the Ministry of Industry and Trade jointly issue guidelines for state management of drug prices for human use as follows:
PART I
GENERAL PROVISIONS
Article 1. Scope of Regulation
These guidelines regulate state management of finished drug prices, including price declaration, re-declaration of drug prices; price display; management of drug prices paid by the state budget, health insurance, and hospital revenue; authorities' and entities' responsibilities in implementing regulations on drug pricing; inspection and supervision of compliance with state regulations on drug pricing in Vietnam.
Article 2. Applicability
These guidelines apply to organizations and individuals in Vietnam and foreign organizations and individuals permitted to engage in drug production, importation, consignment importation, registration, or authorized registration, contract manufacturing, wholesale, and retail sales of drugs (hereinafter referred to collectively as drug business entities); healthcare facilities in Vietnam; and agencies, organizations, and individuals related to state management of drug prices.
Article 3. Principles of State Management of Drug Prices
Clause 1. The State manages drug prices based on the principle that drug business entities 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 Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing implementation of certain provisions of the Medicine Law, these guidelines, and other relevant legal documents.
Clause 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.
Clause 3. Drug business entities must fully comply with guidelines on price declaration, re-declaration, and price display, and bear legal responsibility for declared, re-declared, displayed, and selling prices according to the Medicine Law, the Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing implementation of certain provisions of the Medicine Law, these guidelines, and other relevant legal documents.
Clause 4. State management agencies regarding drug prices (the Department of Medicine Administration under the Ministry of Health and the Health Departments of provinces and centrally-administered cities) are responsible for reviewing the reasonableness of drug prices and shall not approve prices declared and re-declared by entities.
Clause 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 sector.
Article 4. Definitions
Point 1. Types of drug prices include:
Subpoint a) Import price is the price including the value of the drug based on the export price of the exporting country, insurance costs, and transportation fees from the exporting country to Vietnamese ports (referred to as CIF price), excluding import taxes (if applicable).
Subpoint b) Estimated CIF price is the CIF price declared by the drug manufacturer or the entity authorized to register the drug when submitting the registration dossier or re-declaring it when there is a need to increase the CIF price compared to the previously declared or re-declared price.
Subpoint c) Actual CIF price is the CIF price recorded on the customs declaration form.
Cost of domestically produced drugs: is the total cost, calculated as direct raw material and fuel costs plus direct labor costs plus common production costs plus financial costs (interest payments if any) minus costs allocated to by-products (if any).
Subpoint d) Wholesale price is the price between drug business entities or the price at which a drug business entity sells to healthcare facilities.
Subpoint e) Estimated wholesale price is the wholesale price declared or re-declared by domestic manufacturers, importers, consignment importers, or contract manufacturers to the state management agency regarding drug prices.
Subpoint g) Estimated retail price is the estimated price sold to end-users declared or re-declared by domestic manufacturers or importers to the state management agency.
Subpoint h) Retail price is the price directly sold to end-users at retail outlets.
Point 2. Price declaration of drugs is the act of drug business entities reporting import prices, costs, estimated wholesale prices, and estimated retail prices to the state management agency regarding drug prices according to these guidelines and relevant laws on prices.
Point 3. Re-declaration of drug prices is the act of drug business entities reporting import prices, costs, estimated wholesale prices, and estimated retail prices when there is a need to increase prices compared to previously declared or re-declared prices according to these guidelines and other relevant laws on prices.
Point 4. Price display of drugs is the act of drug business entities publicly displaying drug selling prices by printing, pasting, or writing prices on drug packaging or outer packaging or publicly announcing them on boards, paper, or other forms placed, hung, or pasted at drug selling or supply locations according to Chapter III of these guidelines.
Article 5. Currency to be applied when declaring, re-declaring, and posting drug prices
1. Declare and re-declare CIF price in Vietnamese currency along with information on the exchange rate from foreign currency to Vietnamese currency at the time of price declaration.
The exchange rate for foreign currency conversion shall be calculated based on the actual exchange rate that pharmaceutical business establishments have paid to banks (where the organizations or individuals conducting transactions borrow or purchase foreign currency) when borrowing or purchasing foreign currency for goods. In cases where pharmaceutical business establishments have not yet settled with the bank, the selling rate of the commercial bank where the organization or individual borrowed or purchased foreign currency at the time of pricing shall be used.
2. Declare, re-declare, and post wholesale and retail prices expected in Vietnam in Vietnamese currency (including value-added tax).
Chapter II
GUIDELINES FOR DECLARING DRUG PRICES
Article 6. Documents, procedures, and formalities for declaring drug prices
1. Procedures and formalities for declaring drug prices for imported drugs registered and imported into Vietnam:
a) When submitting new registration documents for foreign drugs, foreign pharmaceutical production establishments (or registration establishments in case of authorization) shall declare the expected CIF price for importation to Vietnamese ports.
b) When resubmitting registration documents, if the CIF price adjustment increases compared to the previously declared and valid CIF price, foreign pharmaceutical production establishments (or registration establishments in case of authorization) shall re-declare the expected CIF price according to the provisions of Article 7 of this Circular.
c) After the drug has been assigned a registration number (or obtained an import permit for drugs without a registration number), the importing establishment shall declare the following prices before releasing the first batch onto the Vietnamese market:
- Actual CIF price at Vietnamese ports;
- Expected wholesale price;
- Expected retail price (if the establishment registers retail sales).
For subsequent imports, the importing establishment does not need to declare if there is no increase in price.
d) For entrusted imported drugs, the entrusting establishment must comply with the declaration requirements stipulated in point c, Clause 1, Article 6, Chapter II of this Circular.
2. Procedures and formalities for declaring drug prices for domestically produced drugs:
a) After the drug has been assigned a registration number, domestic pharmaceutical production establishments (or registration establishments in case of authorization) shall declare the following prices before releasing the drug onto the market for the first time:
- Cost price;
- Expected wholesale price;
- Expected retail price (if the establishment registers retail sales).
For subsequent production batches, domestic production establishments or authorized registration establishments do not need to declare prices if there is no increase in price.
b) For domestically produced drugs manufactured under contract, the establishment placing the contract for drug manufacturing must declare prices according to the provisions of point a, Clause 2, Article 6, Chapter II of this Circular.
3. Declaration documents for drug prices:
Declaration documents are prepared in two sets: one set sent to the Drug Administration Department-Ministry of Health, one set retained by the establishment. The declaration documents for drug prices are carried out as follows:
a) Declaration of drug prices when submitting new registration documents for imported drugs:
- Declaration form for drug prices: Form No. 1-GT.
b) Declaration of imported drug prices before release onto the market:
- Declaration form for drug prices: Form No. 2-GT.
c) Declaration of domestic drug prices before release onto the market for the first time:
- Declaration form for drug prices: Form No. 3-GT.
Article 7. Documents, Procedures, and Formalities for Resubmitting Drug Prices
1. Pharmaceutical business establishments must resubmit drug prices when there is a need to adjust the price upwards compared to the previously submitted price or the most recent resubmitted price with the competent state management agency on drug pricing in the following cases:
a) Adjusting the increase in the CIF price of imported drugs (when the CIF price calculated in foreign currency changes);
b) Adjusting the increase in wholesale or retail prices (if applicable) of imported drugs into Vietnam;
c) Adjusting the increase in wholesale or retail prices (if applicable) of domestically produced drugs;
2. Documents for Resubmitting Drug Prices:
The documents for resubmitting drug prices shall be prepared in two sets: one set sent to the Department of Medicine Management - Ministry of Health or the Provincial Health Departments, and one set retained at the establishment. The documents for resubmitting drug prices include the following materials:
a) Resubmission of the CIF price of imported drugs into Vietnam:
- A letter regarding the resubmission of drug prices: Form No. 4-GT;
- A table for resubmitting drug prices: Form No. 5-GT;
b) Resubmission of wholesale and retail prices (if applicable) of imported drugs into Vietnam:
- A letter regarding the resubmission of drug prices: Form No. 4-GT;
- A table for resubmitting drug prices: Form No. 6-GT.
c) Resubmission of wholesale and retail prices (if applicable) of domestically produced drugs:
- A letter regarding the resubmission of drug prices: Form No. 4-GT;
- A table for resubmitting drug prices: Form No. 7-GT.
Article 8. Competent State Management Agencies' Authorities and Responsibilities in Implementing Regulations on Submitting and Resubmitting Drug Prices
1. Authority to Accept Submission and Resubmission of Drug Price Documents:
a) The Department of Medicine Management - Ministry of Health accepts:
- Documents for submitting prices of registered imported drugs into Vietnam.
- Documents for resubmitting prices of imported drugs.
- Documents for submitting prices of domestically produced drugs.
b) Provincial Health Departments accept documents for resubmitting prices of domestically produced drugs with production facilities located within their jurisdiction.
c) Competent state management agencies on drug pricing (the Department of Medicine Management - Ministry of Health and Provincial Health Departments) issue receipt of submission and resubmission of drug price documents on the same working day when businesses submit such documents. Receipts for submission and resubmission of drug price documents are implemented according to Form No. 8-GT and Form No. 9-GT.
2. Responsibilities of Competent State Management Agencies on Drug Pricing:
Competent state management agencies on drug pricing do not approve drug prices submitted by businesses but monitor the submission and resubmission of drug prices as follows:
a) For the case of submitting drug prices:
Within the period from the date of submitting drug prices to the expiration date of the registration number or import permit without a registration number, if unreasonable drug prices are discovered, the Department of Medicine Management - Ministry of Health will provide written comments specifying the reasons and requesting the business to reconsider the submitted drug prices.
b) For the case of resubmitting drug prices:
Within no more than 17 working days from the date of receiving complete resubmission documents in accordance with the guidelines, if unreasonable resubmitted drug prices are found, the Department of Medicine Management - Ministry of Health or Provincial Health Departments will provide written comments on the resubmitted drug prices and specify the reasons.
c) Basis for Assessing the Reasonableness of Submitted and Resubmitted Drug Prices:
- Import costs, total cost, and drug circulation costs determined according to current laws and regulations.
- Market drug prices in the country, region, and globally.
- Fluctuations in input factors such as raw materials, fuel, exchange rates, and other costs.
3. Competent state management agencies on drug pricing and authorized persons during the process of inspecting and supervising drug prices, if they discover violations of drug pricing regulations by pharmaceutical business establishments, shall handle them as follows:
Process and transfer to the competent authority to handle violations according to Article 17 of Decree No. 93/2011/ND-CP dated October 18, 2011 of the Government on the regulation of administrative penalties for violations related to drugs, cosmetics, and medical devices and other relevant legal documents concerning violations of drug pricing regulations.
During the period of transferring to the competent authority to handle violations, depending on the nature and severity of the violation (repeated violations or involving multiple items or multiple violations of drug pricing regulations), the competent state management agency on drug pricing may consider applying measures:
a) Temporarily suspend acceptance and review: drug registration documents, foreign enterprise operation registration documents for drugs and drug ingredients in Vietnam, drug information and advertising registration documents for manufacturing establishments or authorized registration establishments in the following cases:
- Failure to submit or resubmit prices as required;
- Failure to adjust the previously submitted prices after receiving written comments from the competent state management agency on drug pricing;
- Selling drugs at higher prices than those submitted or resubmitted and currently effective;
- Failing to inform customers about the submitted or resubmitted prices currently in effect.
b) Temporarily suspend acceptance and review of importation documents for drugs without registration numbers for importing establishments or entrusted importers in the following case:
- Failure to submit or resubmit prices as required;
- Failure to adjust the previously submitted prices after receiving written comments from the competent state management agency on drug pricing;
- Selling drugs at higher prices than those submitted or resubmitted and currently effective.
- Failing to inform customers about the submitted or resubmitted prices currently in effect.
c) In cases where establishments sell drugs at higher prices than those submitted or resubmitted and currently effective without resubmitting prices as required, the competent state management agency on drug pricing applies the measures stipulated in point a and b, Clause 3 of this Article, while requiring the establishment to adjust selling prices appropriately, not exceeding the submitted or resubmitted prices currently in effect before the price increase.
4. The Ministry of Health establishes an Inter-ministerial Working Group to examine the submission and resubmission of drug prices by establishments, and propose policies and opinions on handling cases of unreasonable submission and resubmission of drug prices. The composition of the Inter-ministerial Working Group includes representatives from the Ministry of Health (Department of Medicine Management - the leading agency, Planning and Finance Department), the Ministry of Finance (Price Management Department, Corporate Financial Department), and the Ministry of Industry and Trade (Domestic Market Department).
5. Provincial Health Departments shall establish Inter-ministerial Working Groups to examine the resubmission of drug prices by domestic production establishments located within their jurisdiction, and promptly propose handling opinions for unreasonable resubmissions. The composition of the local Inter-ministerial Working Group includes representatives from the Health Department (in charge), the Finance Department, and the Industry and Trade Department.
6. Rights and responsibilities of pharmaceutical business establishments:
a) Pharmaceutical business establishments have the right to independently set drug prices, while also having the responsibility to fully comply with regulations on price declaration, resubmission, pricing display, and other management regulations concerning drug prices stipulated in this Circular and related legal documents; they are liable under the law for declared prices, resubmitted prices, displayed prices, and data and information provided by the establishment regarding prices.
b) In cases where the state management agency for drug prices provides comments on the prices declared or resubmitted by pharmaceutical business establishments, within thirty days from the date the establishment receives the written comments from the state management agency, the pharmaceutical business establishment has the right to petition and explain the comments of the state management agency. After this period, if the establishment does not provide comments, the declaration and resubmission forms will lose their validity, and the establishment must implement the comments of the state management agency regarding the declared and resubmitted prices.
c) During the process of selling drugs:
- Import establishments, domestic production establishments, entrusted import establishments, and commissioned manufacturing establishments must provide their customers with information about the current effective wholesale price and expected retail price (if applicable) through written notifications or by noting it on sales invoices.
- Wholesale establishments base their pricing on the expected wholesale price announced by the supplying establishment and the published information on declared and resubmitted drug prices on the website of the Drug Administration under the Ministry of Health, ensuring that the prices of drugs sold by the establishment do not exceed the current effective expected wholesale prices declared or resubmitted by import establishments, domestic production establishments, entrusted import establishments, or commissioned manufacturing establishments.
- If an establishment sells drugs at a lower price than the declared or resubmitted price, it must comply with laws against dumping.
7. Periodic Reports on Resubmission of Drug Prices:
By the tenth day of each month, the Health Department shall report to the Ministry of Health (Drug Administration under the Ministry of Health) in writing and via email (at the address: [email protected]) on the situation of resubmitted drug prices by domestic production establishments located within their jurisdiction (Form No. 10-GT).
Chapter III
GUIDELINES ON PRICING DISPLAY OF DRUGS
Article 9. Pricing Display at Wholesale Drug Establishments
Wholesale drug establishments shall publicly announce the wholesale prices of individual drugs through notices posted, placed, hung, or affixed at transaction and sale locations, making them easily observable by customers and ensuring that they do not sell at a higher price than the announced price. The wholesale prices announced by wholesale drug establishments must not be higher than the expected wholesale prices declared or resubmitted by production or import establishments to the state management agency for drug prices.
Article 10. Price Display at Retail Outlets for Medicines
Retail outlets for medicines shall display the retail prices of each type of medicine by printing, writing, or affixing the retail price on the packaging containing the medicine or on the outer packaging of the medicine, ensuring that the original label's content is not obscured and that the medicine is not sold at a higher price than the displayed price.
Article 11. Price Display of Medicines at Retail Outlets within Healthcare Facilities
1. Retail outlets for medicines within healthcare facilities shall implement the price display of medicines according to the guidance provided in Article 10 of this Circular.
2. The retail prices of medicines displayed by retail outlets for medicines within healthcare facilities must comply with the maximum retail mark-up regulations set forth by the Ministry of Health.
3. The Director of healthcare facilities shall be responsible for implementing the regulations concerning the management of medicine prices at retail outlets within the healthcare facilities under their management.
Chapter IV
MANAGEMENT OF PRICES FOR MEDICINES FUNDED BY THE STATE BUDGET, HEALTH INSURANCE, AND INPATIENT FEES
Article 12. Management of Prices for Medicines Ordered by the State and Paid from the State Budget
1. The Ministry of Finance shall establish payment prices for expenditures from the central government budget after receiving a written review opinion from the Ministry of Health; the Department of Finance shall submit to the People's Committee of the province or centrally-administered city for establishing payment prices for expenditures from the local government budget after receiving a written review opinion from the Department of Health.
2. Based on the principles of state-managed medicine prices stipulated in Article 3 of this Circular and the Regulation on Pricing of Assets, Goods, and Services issued together with Circular No. 154/2010/TT-BTC dated October 1, 2010, by the Ministry of Finance, entities ordered by the state and assigned plans to develop pricing schemes shall submit these schemes to the competent authority specified in Clause 1 of this Article for review and issuance according to their authority.
Article 13. Management of Prices for Medicines Funded by the State Budget, Health Insurance, and Inpatient Fees
1. Medicines listed in the main medicine usage catalogues for public healthcare facilities and non-public healthcare facilities with health insurance contracts with social insurance agencies, medicines funded by the state budget, and inpatient fees must be procured through bidding in accordance with the laws on bidding and other relevant regulations concerning drug procurement in healthcare facilities.
2. The winning bid price for medicines shall not exceed the current maximum price published by the Ministry of Health at the nearest time point. In cases where the maximum price has not been published, when developing the bidding plan for purchasing medicines, the entity shall follow the legal guidelines for drug procurement bidding in healthcare facilities issued jointly by the Ministry of Health and the Ministry of Finance.
3. Within thirty working days from the date of the bidding results, hospitals and institutes directly under the Ministry of Health, provincial-level hospitals in centrally-administered cities (or the Department of Health in centrally-administered cities in cases of centralized bidding), and non-public entities with health insurance contracts shall submit reports on the winning bid prices for medicines to the Drug Administration Department of the Ministry of Health for updating and announcement on the electronic website. The report format shall be in both written form and email to the address: [email protected] (Form No. 11-GT).
Chapter V
INSPECTION, AUDIT AND VIOLATION HANDLING
Article 14. Inspection and supervision of the implementation of state management guidelines on drug prices
1. The Ministry of Health, the Ministry of Finance, and the Ministry of Industry and Trade within their respective duties and authorities shall organize inspections and supervision or coordinate inspections and supervision and handle violations of state regulations on drug price management at pharmaceutical business establishments and medical examination and treatment facilities nationwide in accordance with the law.
2. Ministries and sectors with pharmaceutical business establishments and medical examination and treatment facilities shall periodically or unexpectedly inspect, supervise, and handle violations according to their duties and authorities.
3. People's Committees at all levels within their respective duties and authorities shall direct competent agencies in their areas to organize inspections and supervision or coordinate to conduct inspections and supervision and handle violations of state regulations on drug price management at pharmaceutical business establishments and medical examination and treatment facilities in their localities in accordance with the law.
Article 15. Handling Violations
Organizations and individuals who violate the provisions on drug price management set forth in this Circular and related legal normative documents shall be subject to administrative penalties or criminal liability pursued, if they cause damage to consumers, the State, and other businesses, they must compensate in accordance with the law.
Chapter VI
ASSIGNMENT AND COOPERATION TO IMPLEMENT
STATE MANAGEMENT OF DRUG PRICES
Article 16. Responsibilities of the Ministry of Health
1. The Ministry of Health shall take the lead in coordinating with the Ministry of Finance, the Ministry of Industry and Trade, and relevant ministries and sectors:
a) Direct and guide provincial health departments and production establishments, importers, entrusted importers, contract manufacturers, wholesalers, retailers, and medical examination and treatment facilities to implement the guidelines in this Circular and other legal normative documents related to drug price management.
b) Annually or in cases of abnormal fluctuations in drug prices, publish the maximum price for drugs funded by the state budget and health insurance.
2. The Ministry of Health, the Ministry of Finance, and the Ministry of Industry and Trade, within their respective authorities, shall direct health, finance, and market management agencies at all levels to regularly coordinate in inspecting and supervising compliance with laws on drug circulation, export, and import, and laws on drug price management.
3. The Ministry of Health assigns the Drug Administration:
a) To take the lead and coordinate with Vietnam Trade Offices in countries to survey drug prices in countries in the region and worldwide to serve state management of drug prices domestically.
b) To update and publicly announce drug prices declared and re-declared by establishments on the Ministry of Health’s electronic information website (Drug Administration), specialized journals, and other appropriate mass media.
c) To update and post winning bid drug prices from medical examination and treatment facilities on the Ministry of Health’s electronic information website (Drug Administration) within twelve months prior.
Article 17. Responsibilities of the Ministry of Finance
The Ministry of Finance assigns the following units:
1. General Department of Customs shall provide actual CIF price information of imported drugs circulating in the Vietnamese market (by the 25th of each month) to the Drug Administration - Ministry of Health regarding drug imports of the previous month in accordance with Joint Circular No. 98/2010/TTLT-BTC-BNNPTNT-BYT dated July 8, 2010, issued by the Ministry of Finance, the Ministry of Agriculture and Rural Development, and the Ministry of Health guiding the provision and exchange of information related to taxpayers, customs administration, agriculture, and health. The form of provision: written and email to [email protected].
2. The General Department of Customs shall cooperate with the Drug Administration - Ministry of Health to collect information on CIF prices of drugs in countries in the region and worldwide to serve state management of drug prices.
3. The General Taxation Department shall direct local tax agencies to inspect the implementation of invoice and receipt systems by pharmaceutical business establishments under their jurisdiction.
Article 18. Responsibilities of the Ministry of Industry and Trade
1. Coordinate with relevant sectors and localities in combating speculative activities that disrupt the market, driving up drug prices for illicit gains, and monitoring and supervising competitive activities, anti-monopoly measures, and other actions violating competition laws, pricing laws, and other legal violations.
2. Direct the Vietnam Trade Office in various countries to cooperate with the Drug Administration under the Ministry of Health in surveying drug prices in regional and global markets, and support the Drug Administration and the General Department of Customs in providing information on drug import prices from regional and global markets to serve state management of drug pricing.
Chapter VII
IMPLEMENTING PROVISIONS
Article 19. Effective Date
This Circular shall take effect from June 1, 2012, and replace Circular Jointly Issued No. 11/2007/TTLT/BYT-BTC-BCT dated August 31, 2007, issued by the Ministry of Health, the Ministry of Finance, and the Ministry of Industry and Trade guiding the implementation of drug price management.
Price declaration and re-declaration files for drugs completed before this Circular takes effect (in accordance with the guidance provided in Circular Jointly Issued No. 11/2007/TTLT/BYT-BTC-BCT dated August 31, 2007, guiding the implementation of drug price management) shall remain valid.
Article 20. Implementation
1. Drug business establishments and medical examination and treatment facilities shall immediately implement necessary measures to comply with the guidance provided in this Circular.
2. Associations, professional organizations, and trade unions within their scope of responsibility shall carry out publicity, dissemination, and supervision of the implementation of regulations governing drug pricing for their members, and promptly reflect changes in drug prices, provide comments, and propose measures to stabilize drug prices to relevant state agencies responsible for drug pricing.
3. In case of difficulties during implementation, it is requested that establishments and localities promptly report to the Ministry of Health so that the joint ministries of Health, Finance, and Industry and Trade can study and resolve them.
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