Circular 50/2011/ttlt-Byt-Btc-Bct: Guide The Implementation Of State Management Of Drug Prices For People

Original Language Title: Thông tư liên tịch 50/2011/TTLT-BYT-BTC-BCT: Hướng dẫn thực hiện quản lý nhà nước về giá thuốc dùng cho người

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IT ' S THE DEPARTMENT OF MEDICINE-THE DEPARTMENT OF COMMERCE
Number: 50 /2011/TTLT-BYT-BTC-BCT
THE SOCIALIST REPUBLIC OF VIETNAM.
Independence-Freedom-Happiness
Hanoi, December 30, 2011

FEDERAL INFORMATION

Guidelines for the implementation of the state management of the price of medication for the

________________________

The Code of Pharmacy. 34 /2005/QH11 June 14, 2005 of the National Assembly;

French Base Command 40 /2002/PL-UBTVQH10 April 26, 2002 of the Standing Committee of the National Assembly;

Base of Protocol 79 /2006/NĐ-CP August 9, 2006 of the Government Regulation Law enforcement of certain provisions of the Law of Pharmacy;

Base of Protocol 170 /2003/NĐ-CP December 25, 2003 The government rules out certain provisions of the Ordinal Ordination;

Base of Protocol 75 /2008/NĐ-CP June 9, 2008 by the Government on the amendment, added some of the provisions of the Digital Protocol. 170 /2003/NĐ-CP December 25, 2003 The government rules out certain provisions of the Ordinal Ordination;

Base of Protocol 84 /2011/NĐ-CP September 20, 2011 by the Government of the Government regulations on sanctions on administrative violations in the field of price;

Base of Protocol 93 /2011/NĐ-CP October 18, 2011 by the Government of the Government Regulations on Behavioral Sanctions on drugs, cosmetics, and medical equipment,

The President of the Ministry of Health, Ministry of Finance and Ministry of Public Affairs guide the implementation of the state administration on the price of the drug used for the person as follows:

Chapter I

GENERAL REGULATION

What? 1. The adjustment range

This information instructs the implementation of the state management of finished drug prices, including: prescribation, drug pricing; price listing; drug price management due to the state budget, paid health insurance and the source of fees; jurisdiction, responsibility of the funds. the agency, the basis in the implementation of the regulation of drug price management; inspectors, examination of the acceptance of state regulations on drug management in Vietnam.

What? 2. Subject applies

This privacy applies to organizations, Vietnamese individuals and organizations, foreign individuals who are allowed to operate manufacturing, importing, importing, registering medicines, or authorized to register for drugs, to order, sell, sell, sell, and sell drugs (after this, in general). is the drug business facility); the facilities of disease, healing in Vietnam; agencies, organizations, individuals involved in the management of the state on drug prices.

What? 3. State management principles on drug prices

1. The state manages the price of medicines in principle: the self-valued drug business, which competes in price, subject to inspection, control of the state governing body on the price of prescribed medicines at the Law of Pharmacy, Protocol No. 79 /2006/NĐ-CP August 9, 2006, the government rules out certain provisions of the Law of Pharmacy, This Information and other relevant legislation.

2. The state uses market-price normalization measures to meet the need for drug-intensive care, protection and health care.

3. The drug business facilities must fully implement the guidelines on prescribation, prescribation, drug prices and are accountable to the law on the price of testimony, reissue, listing and the prescribed sale price at the Law of Pharmacy, Protocol No. 79 /2006/NĐ-CP August 9, 2006, the government rules out certain provisions of the Law of Pharmacy, This Information and other relevant legislation.

4. The state governing body for drug prices (the Department of Health Management and the Department of Health of the Provinces, the Central City of China) is responsible for reviewing the rationalization of the drug price, not doing the approval of the drug price due to the basis of self-prescribation and reopening.

5. The management of the price of the drug is organized according to the hierarchy between the state governing body on the price of the drug in the central and local sectors by the venue and the sector.

What? 4. Explain the word

1. The types of drug prices include:

a) The import price is the price that has included the value of the drug at the cost of the export country, the cost of insurance, the cost of shipping from the export water to Vietnam port (called the CIF price) and does not include an import tax (if any).

b) The CIF price is expected to be the CIF price due to the basis of the drug production facility or the facility that is authorized to register prescriptions with the state governing body when filing a drug registration or repetition filing when there is a need to adjust the CIF price compared to the reported price, prescrip. Before that.

c) The actual CIF price is the CIF price that is inscribed on the import of imported goods at Customs.

The price of domestic production drugs: is the full price, calculated by the cost of raw materials, plus direct fuel (+) direct public cost (+) common production costs (+) financial costs (paying interest if there are) plus (+) administrative costs (+) The exception (-) the allocation costs for the by-product (if any).

The wholesale price is the sale price between the drug business facilities together or the sale price of the drug business facility for the facilities of the disease, healing.

e) The wholesale price is expected to be wholesale prices due to domestic production facilities, import facilities, import facilities facilities, prescribation facilities, repetitions with the state regulator of drug prices.

g) The expected retail price is the retail price expected to be sold to the user due to domestic production facilities, the basis of the importation basis, rescribes with the state governing body.

) The retail price is a direct selling price for users at retail facilities.

2. The price of the drug is the basis of the drug business that reports to the state governing body for import, price, sale prices expected, the retail price expected in the direction of this and the provisions of the relevant price.

3. The reopening of the drug is the basis of the drug business that reports to the state regulator of import prices, prices, expected wholesale prices, expected retail prices when there is a need to adjust the price of the drug compared to the reported price or repetition. It was earlier in the direction of this message and other provisions of the relevant price.

4. The price list is the basis of the drug business that publicly sells drugs by printing, pasting, selling on packaging containing drugs or packaging of the drug or public notice on board, on paper or by other forms set, to, for example. hung, pasted at the site of the sale, provided the drug in the direction of the Chapter III.

What? 5. The currency applies when carrying out the manifest, rescribes and listing the drug price

1. Prescribe CIF prices in Vietnamese coins accompanied by information on the exchange rate from the currency used to the Vietnamese currency at the time of the price of the price.

Foreign exchange rates are calculated at the actual rate the drug business has paid to the Bank (where the organization, the individual produces trading business) when borrowing or when buying foreign currency to buy goods. The case of an unpaid drug business with the Bank is calculated at the sale rates of the Commercial Bank where the organization, the individual has borrowed or purchased foreign currency at the time of price.

2. Prescribe, reopening and listing wholesale prices, the expected retail price in Vietnam by the Vietnam currency (which is the price that has included the valuing value tax).

Chapter II

PRESCRIP INSTRUCTIONS, REPRESCRIBATION

What? 6. Records, sequence and procedures for drug pricing

1. The sequence and procedure prescribes the price of the drug for the imported imported medicine, imported into Vietnam:

a) When filing a new register of foreign medicines, a foreign drug production facility (or drug registration facility in the authorized case) makes the prescribation of the CIF prices are expected to be imported to the port of Vietnam.

b) When filing a reregistration case, the CIF pricing case is increased compared to the expected CIF price, the repetition is still in effect, the basis of foreign drug production (or drug registration facility in the authorized case) makes the prescrip of the CIF price. expected to follow the provisions of this Article 7.

c) When the drug has been granted a registration number (or has been issued an import license for the unregistered drug), the drug importation facility makes prescribes the following price before taking the drug out of the first shipment in the Vietnamese market:

-The actual CIF price in Vietnam port;

-The sale prices are expected;

-The expected retail price (if the facility has a retail business form);

The next import shipment, the import base does not have to implement prescribation if there are no valuing adjustments.

d) For the case of a fidget import drug, the import mandate base must perform the prescribed prescribation at the point of paragraph 1 Article 6 Chapter II of this Information.

2. The sequence and procedure of prescribation for the drug produced in Vietnam:

a) When the drug has been granted the registration number, the domestic drug production facility (or the drug registration facility in the authorized case) performs prescribation of the following prices before taking the drug out of circulation for the first time in the market:

-The price.

-The sale prices are expected;

-The expected retail price (if the basis of a retail business form).

The next batch of production, domestic production facilities or the authorized base of the drug register do not have to make a price manifest if there are no price increases.

b) For the domestic drug case produced by the manufacturer, the drug ordering facility must perform the prescribed price at the point of paragraph 2 Article 6 Chapter II of this Information.

3. Drug price manifest:

The deposit profile is set up to 2 sets: 01 Department of Health-Ministry of Health Management, 01 set at the facility. The case of the prescriptions for the drug is available as follows:

a) The value of the drug value when filing a new registration of the imported drug:

-Number 1-GT.

b) The value of the imported drug before making the circulation in the market:

-Drug price manifest: 2-GT.

c) The price of drug production in Vietnam before the introduction of the first time on the market:

-Drug price manifest: 3-GT.

What? 7. File, sequence and procedure rescribes drug prices

1. The drug business facility must make the resale of the drug price when there is a need to adjust prices compared to the price of medication that has been prescribe or prescribated earlier with the state regulatory authority on the price of drugs in the cases:

a) The adjustment of the CIF price increase of the imported drug (when the CIF price follows foreign currency changes);

b) The adjustment of wholesale price increases or retail price (if available) of the drug imported into Vietnam;

c) The adjustment of wholesale price increases or retail price (if available) of the drug produced in Vietnam;

2. The refiling of the drug price:

The records of the reopening of the drug are set up to 2 sets: 01 Ministry of Pharmacology-Ministry of Health or Department of Health, 01 sets at the facility. The file refiling the drug prices include the following documents:

a) The CIF price of the drug imported into Vietnam:

-The work on resale of the drug price: 4-GT number;

-Tablet reopening: Model 5-GT;

b) The reopening of wholesale prices, retail prices (if available) of the drug imported to Vietnam:

-The work on resale of the drug price: 4-GT number;

-Number six GT.

c) re-reopening wholesale prices, retail prices (if available) of the production drug in Vietnam:

-The work on resale of the drug price: 4-GT number;

-7-GT.

What? 8. Authority, the responsibility of the state regulatory agencies on drug prices, the business base in the implementation of the regulation of prescribation, prescribation of drug prices

1. The authority to take on the manifest profile, rescribes the drug price:

a) Department of Pharmacology-Ministry of Health reception:

-File records import imported imported, imported to Vietnam.

-File records import import.

-Drug mining records in Vietnam.

b) The Central City Health Department, the Central City of the Central City, receives a production of the drug produced in Vietnam based on the site.

c) The state governing body for the price of the drug (Department of Health and Health Department of the provinces, central city) pays a paper reception on the day of working for business facilities at the start of filing a manifest, refiling The drug. The paper receives a prescrip profile, represcribation of the price of the medication by the 8-GT and the 9-GT.

2. The responsibility of the state governing body for drug prices:

The state governing body for drug prices does not perform the approval of the drug price due to the self-prescribed facilities that carry out the monitoring of the prescribation and prescribation of the drug prices as follows:

a) For the case of prescribation

In the time since the timing of the drug's prescriptions to the expiration of the validity of the registration number or the unregistered drug import license, the case of the discovery of the prescribed drug is not reasonable, the Department of Pharmacology-the Ministry of Health will have a written opinion. Well, the reason for this is to ask for the basis of the review.

b) For the case of reopening of the drug price:

At least 17 days of work since the date of receiving enough records, if the price of a reissued drug is not reasonable, the Department of Health Management, or the Department of Health, the Central City of Central City will have a written opinion. You know, about the price of the drug reopening and stating the reason.

c) Base to consider the validity of the manifest drug price, remanifest:

-The import cost, the full price, the cost of the drug circulation determined by existing law regulations.

-The face of the price of drugs on the domestic market, the region and the world.

-The volatility of input cost factors such as raw materials, fuel, and a number of other costs.

3. The state governing body for the price of the drug, who has jurisdiction during the inspection, controls the price of the drug if the drug business ' s discovery of a drug business violates regulations on drug price management.

Processing, transferring the agency with the jurisdiction of the prescribed violation at Article 17 Digital Protocol 93 /2011/NĐ-CP October 18, 2011, the Government's October 18, 2011, is about the regulation of sanctions on drugs, cosmetics, and medical equipment and other legal documents related to the regulatory breach of the management of the drug.

During the transfer of the agency with jurisdiction to handle the breach, depending on the nature and extent of the violation (violation multiple times or multiple items or have many violations of the regulation of drug price management), the state management agency on the price of the drug. consider the application of the measure:

a) Continue to accept, review: drug registration records, active registration records of foreign enterprises on drugs and drug-making materials in Vietnam, information registration records, drug advertising for manufacturing facilities or registered facilities drug in cases:

-No prescribation, no revisions; no more than prescribed medicines.

-Do not conduct a review of the revised price after a written opinion by the state governing body on the price of the drug;

-The sale of the drug is higher than the reported price or prescribation is in effect;

-Do not inform the customer of the prescriptions, the manifest is in effect.

b) Continue to accept, consider an unregistered drug import profile for import or import facilities in the case:

-No prescribation, no revisions; no more than prescribed medicines.

-Do not conduct a review of the revised price after a written opinion by the state governing body on the price of the drug;

-The sale of the drug is higher than the reported price or represcrip is in effect.

-Do not inform the customer of the prescriptions, the manifest is in effect.

c) The case of higher-cost drug-selling facilities, represcriing is in effect without conducting reopening in accordance with regulations, the state governing body for drug prices applies the treatment measures at point a, b paragraph 3 Article 8 This message, copper. Requiring the base to adjust the appropriate sale price, no higher than the reported price, the resale is in effect before the price hike.

4. The Ministry of Health established the interdisciplinary organization considering the prescribation, prescribation of the cost of the facility, proposed the initiative, the opinion of the handling of the manifest cases, rescribes the unreasonable price. The interdisciplinary partnership consists of: the Department of Health (Department of Drug Administration, Regulatory Affairs, Financial Planning), the Department of Finance (Bureau of Price Management, Corporate Finance Bureau) and the Ministry of Trade in the Ministry of Trade (the domestic market case).

5. The Department of Health of the Provinces, the Central City of the Central Committee to establish the Interdisciplinary Task Group considering the repetition of the drug prices of domestic manufacturing facilities based at the local table, proposes to timely notice of unincorporated repetition cases. Yeah. Local Interdisciplinary Works include: Department of Health-presided over, representative of the Department of Finance and the Department of Trade.

6. The rights and responsibilities of the drug business facilities:

a) The drug business facility has the right to self-valuation the drug due to the business base, while it is responsible for implementing the full implementation of prescribation regulations, price prescriptions, price listing, and other regulations on drug price management at this Information and other regulatory documents. The law is relevant; it is accountable to the law of the manifest price, the reissue, the listing price, and the figures, the report document, the information on the price provided by the supply base.

b) The case of the state regulatory agency on the price of the drug is opinion on the price of drugs issued by the drug business facility, repetition, in the 30-day period since the date of the basis of the opinion by the state governing body, the drug business facility. The right to petition, the interpretation of the opinion of the state governing body, after the deadline on if the facility has no opinion, the manifest, the repetition is no longer value and the basis must follow the opinion of the state governing body for the price of the drug. Declare, report back to the facility.

c) During the course of the drug business:

-The import facility, the domestic drug manufacturing facility, the import trust facility, the drug-ordering facility must provide its customers with information on the expected wholesale price, the expected retail price (if any) is in effect that the facility has already prescribes, rescribes. by the form of notification on paper or written on the sales bill.

-The basis for the sale of the wholesale price on the sale price is expected by the basis of the drug supply and information on the price of prescriptions, the repetition was published on the Department of Pharmacology's electronic information site-the Ministry of Health for self-valuing the drug due to the non-premium basis. less than the expected sale price due to the import facility, domestic production facilities, import or export facilities, or the basis of prescribation, prescribation is in effect.

-The case where the sale of the drug at a lower price than the price has been reported, the restatement must comply with the laws of the anti-semi-sale legislation.

7. The periodic report on prescribation of drug prices:

Before October 10, the Health Department reported the Department of Health (Department of Health Management) in writing and by email (according to email address: quanlygiathuoc@dav.gov.vn) on the condition of republishing the drug prices of domestic manufacturing facilities based in the local site. (Form 10-GT).

Chapter III

DRUG PRICE LISTING GUIDE

What? 9. The price list at the wholesale facility

The wholesale facilities carry out the listing of the wholesale price each drug by announcing publicly on the board, on paper or by other forms set, to, hang, paste at the trading place, selling drugs, conveniing the customer ' s observation. and not sold higher than the listed price. The wholesale price of the sale of the wholesale facility is not higher than the expected wholesale price due to the production base, the imported imported, reserving with the state regulator of drug prices.

What? 10. The price list at the drug retail facility

The drug retail facilities perform a retail price listing each of the drugs by printing or writing or pasting the retail price on the drug containing the drug or outer packaging of the drug, ensuring no cover of the contents of the original label and not being sold higher than the cost. listing.

What? 11. Nêm. list of drug prices at retail facilities in the examination facility, healing

1. The drug-selling facility in the facility of the disease, curing the treatment for the listing of the retail price according to the guidelines at Article 10 of this Information.

2. The retail price of drugs due to the basis of drug sales in the facility of the disease, the treatment of the listing must carry out the regulation on the minimum retail surplus of the Ministry of Health.

3. The director of the medical examination facility, curing the disease responsible for the implementation of the retail facility ' s drug management regulations are in the facility of the disease, treating the disease as he manages.

Chapter IV

MANAGEMENT OF DRUG PRICES DUE TO THE STATE BUDGET, COST HEALTH INSURANCE AND WASTE COLLECTION

What? 12. Drug-based price management, payment from the state budget source:

1. The Ministry of Finance rules out the payment price on the assignment of the central budget after the opinion of a written appraisal of the Ministry of Health; the provincial department of provincial finance department UBND, the central city of the central city which regulates payment prices for limb duties the local budget after a written opinion of the Department of Health.

2. The principle base of the State ' s Pharmacy Price Management Principles in Article 3 This Information and the Regulation of Property Price, goods, Board services are accompanied by Digital Information. 154 /2010/TT- BTC on 1 October 2010 of the Ministry of Finance, the facilities ordered by the State, planned to plan the state agency's agency for the jurisdiction of regulation at 1 Article to be determined and enacted under jurisdiction.

What? 13. Drug price management due to state budget, paid health insurance and the source of a fee

1. Drug category primarily used at clinics, public treatment facilities, and outside public health facilities have a contract to examine health insurance with the Social Insurance agency, which is paid by the state budget and the source of the fees required by the government. make the bidding under the regulation of the law of bidding and other regulations concerning the bid to buy drugs in the medical facilities.

2. The reported drug prices were not higher than the current maximum price issued by the Ministry of Health at the latest time. The case has not yet announced the maximum price, upon the construction of the procurement plan to purchase the drug, the unit to follow the provisions of the law on the guidance of the bid to purchase drugs in the medical facilities of the United States Medical and Ministry of Finance.

3. During the 30-day period of work since the result of bidding results, hospitals, hospital beds are directly subordinate to the Ministry of Health, provincial hospitals, Central City (or the Department of Health of the Provinces, the central direct city in the case). Centralized bidding organization) and public outposts have contracted medical records, treating health insurance reports that reported drug prices to the Health-Ministry of Health to conduct updates, announcements on electronic pages. The form of the report sent: text and email by email address: quanlygiathuoc@dav.gov.vn (Form 11-GT).

Chapter V.

INSPECTOR, CHECK AND DEAL.

What? 14. Inspector, check out the implementation of the state management guidelines on drug prices

1. The Ministry of Health, Ministry of Finance, Ministry of Commerce within the scope of duty, its powers to hold inspection, check or coordinate inspection, check and process violations of the State ' s regulations on drug management at drug business facilities and at the public health care facilities. The basis of the disease, the treatment in the country by law.

2. The ministries, the industry with the basis of drug business and the facilities of the disease, treat periodically or mutate tests, inspect and handle cases of violation on duty, their powers.

3. The people 's committee within the scope of the mandate, its powers to direct the authorities on the site of the inspection, check or co-ordinate to inspect, test and dispose of the State' s regulations on the management of the drug costs of the agencies. The drug business and the medical facilities, treat local diseases by law.

What? 15. Waste Processing

The organization, the individual who acts in violation of the regulations governing the management of the drug at this time, and the relevant laws that are relevant, are subject to the nature, the extent of which the breach will be executed or be prosecuted for criminal responsibility. for consumers, states and other businesses are compensated by the rule of law.

Chapter VI

CO-ORDINATED DISTRIBUTION

STATE MANAGEMENT OF DRUG PRICES

What? 16. Ministry of Health Responsibility

1. Ministry of Health presided in coordination with the Ministry of Finance, Ministry of Commerce and ministries, the relevant sector:

a) Direcing, guiding the Department of Health and manufacturing facilities, importing, importing trusts, ordering drugs, wholesalers, drug sales, medical treatment facilities, healing practices implementing guidelines at this Smart, and other law enforcement texts that are available. It's about the management of the drug.

b) A yearly term or in cases with an unusual fluctuation on the price of the drug, which is a maximum price statement for the medicines given by the state budget and the health insurance.

2. The Ministry of Health, Ministry of Finance and Ministry of Commerce under the authority to direct the Health, Financial, Market Management of Grants Regularly Coordination, examination of the acceptance of laws of law on circulation, export, drug imports and regulations. The law of the management of the drug.

3. Ministry of Health delivered to the Department of Pharmacology:

a) presided over, in collaboration with the Vietnam Trade in the countries that surveyed drug prices in the countries of the region and around the world to serve state management of the drug prices in the country.

b) Update, the announcement of the price of drug prices due to the basis of prescriptions, reopening on the Ministry of Health's electronic information page (Bureau of Pharmacology), specialized journals, other suitable news media.

c) Updated, posted on the price of the registered drug of the disease facilities, cured the disease within 12 months ago on the Department of Health ' s electronic website (Department of Pharmacy Management).

What? 17. Finance Ministry Accountability

The Ministry of Finance delivered the following units:

1. The Directorate General of Customs provides the actual CIF price information of the imported drug, circulated in the Vietnam market (the slowest day of 25 months) sent to the Department of Pharmacy Management-the Ministry of Health Information imports of the last month under the regulation of Digital Federal Information 98 /2010/TTLT-BTC-BNNPTNT-BYT July 8, 2010 by the Ministry of Finance, the Ministry of Agriculture of Rural Development and the Ministry of Health guidelines for the implementation of the provision, exchange of information relating to taxpayers, state management of customs, agriculture, and health. Forms of supply: text and email under email address: quanlygiathuoc@dav.gov.vn.

2. The Directorate General of Customs in coordination with the Department of Pharmacology-the Ministry of Health to gather information on the CIF price of the drug in the countries in the region and around the world to serve the state management work on drug prices.

3. The Directorate General of Tax Authority in the Local Tax Authority examines the implementation of the certificate regime from the management of the management of the drug business.

What? 18. Ministry of Commerce

1. Coordinate with the disciplines, localities in combing the market segment of the market segment pushing the price of the drug to high aim to gain instability and test, monitor competition activity, antitrust and other acts that violate competition law, breach of law. the laws of price and other violations of law.

2. Vietnam Business Scouts in countries in coordination with the Department of Health-Health Survey surveys in countries in the region, the world and support of the Department of Pharmacy Management, General Department of Customs in coordination of the provision of drug price information importing countries. in the area and the world to serve the state management of the price of medicine.

Chapter VII.

EXECUTION CLAUSE

What? 19.

This message has the enforcement effect since 01/6/2012 and replaces the Information and Digital Federal Information. 11 /2007/TTLT/BYT- BTC-BCT on August 31, 2007 of the Ministry of Health, Ministry of Finance and Ministry of Commerce directed the implementation of the management of the use of the drug charge.

The manifest records, represcribation of the prescriptions made before this message took effect (made in accordance with the guidelines at the Digital Federal Information). 11 /2007/TTLT/BYT-BTC-BCT August 31, 2007 instructs the implementation of the management of the drug price for the person) still has a valid value.

What? 20. The organization performs

1. The drug business facilities, the medical facility, treat the disease to implement the necessary measures to make the right guidelines at this level.

2. Associations, professional associations, career members within the scope of their responsibility perform propaganda, dissemings, oversight of the implementation of management regulations on the price of medicines for members, members, and feedback in time of the price volatility situation. The drug, which suggests and proposes measures to stabilize the price of drugs with the state regulatory agencies of the price of the drug.

3. In the course of execution if there is difficulty entanging, suggesting the facilities and localities reflect promptly on the Ministry of Health to associate the Health, Finance, Research Industry, to resolve.

KT. Minister of Health.
Chief.

KT. MINISTER OF FINANCE
Chief.

KT. MINISTER OF COMMERCE
Chief.

(signed)

(signed)

(signed)

Ming Ming

Xiaowen Chen

Xiao Tú