DEPARTMENT OF HEALTH CARE
Number: 01 /2012/TTLT-BYT-BTC
THE SOCIALIST REPUBLIC OF VIETNAM.
Hanoi, January 19, 2012
The bidding guide to buy drugs in medical facilities
The Code of Pharmacy. 34 /2005/QH11 14 June 2005;
The base of the bidding law. 61 /2005/QH11 November 29, 2005; Law amended, the addition of some of the provisions of the Laws related to basic building investment. number 38 /2009/QH12 June 19, 2009;
Base of Protocol 79 /2006/NĐ-CP August 9, 2006 of the Government Regulation Law enforcement of certain Articles of the Law of Pharmacy;
Base of Protocol 85 /2009/NĐ-CP October 15, 2009 of the Government's Guide to the Bidding Act and the selection of contractors built under the Law of Construction;
Base of Protocol 188 /2007/NĐ-CP December 27, 2007 the Government regulates the functions, duties, powers, and organizational structure of the Ministry of Health;
Base of Protocol 118 /2008/NĐ-CP November 27, 2008 of the Government Regulation, mandate, authority, and organizational structure of the Ministry of Finance;
The President of the Ministry of Health-The Ministry of Finance instructs the bid to purchase drugs in the medical facilities (the following collectively as units) as follows:
1. This information guides some specific content in the implementation of the purchase bid of the units that use funding from the state budget, the health insurance fund, and other legal sources that serve the need for the prevention, disease, and treatment of patients. The disease is consistent with the specific nature of the drug in accordance with the laws of the Pharmacy and the Laws of the Law.
2. Other content is involved in the implementation of the purchase bid of the units that use funding from the state budget, the health insurance fund and other legal sources to serve the need for the prevention, disease, and treatment of the disease. of the course of the adjustment in this Smart Act is done under the current rules of the law of bidding.
1. This information applies to:
a) The unit has the use of funding from the state budget, health insurance funds, and other legal sources for the purchase of medical care, disease, and healing.
b) The agencies, the unit involved in the bidding process purchase by the current regulation.
2. This message does not apply in the following cases:
a) The State of the State is paid off by the state budget.
b) Medicines and medicinal medicines.
c) Blood and blood preparations.
In this Information, the words below are understood as follows:
1. The original generic medication: is the licensed drug that circulated for the first time, on the basis that there was full of data on quality, safety and efficiency.
2. generic drugs: The product medication to replace an invention drug that is produced without the invention of the invention company and is given to the market after its patents and monopoles have expired.
3. bioequipability: Two drugs are considered bioequipability if they are cytoplasm or their cytoplasm and their availability after using the same dose in the same test conditions is similar to one another. The effect of their treatment is essentially equivalent.
4. The treatment equivalent: The two drugs are considered to be equivalent to treatment if they are cytosimilar drugs and after being used at the same dose the effects of the drug include the effect and safety are the same.
5. Medication and Treatment Council: A consultative organization for the Prime Minister on matters related to the drug and treatment of drugs in the unit.
-The European Medicines Agency.
-ICH (International Conference on Harmonization): The international conference on harmonization of pharmaceutical registration procedures for human use.
-PIC/S (Pharmaceutical Inspection Co-operation Scheme): Pharmaceutical inspection systems.
-WHO: World Health Organization.
-VAT (Value Added Tax): Value added tax.
-The People's Committee.
The authority in the bid to buy drugs
What? 4. Authority approx plans to buy drugs
1. The minister, peer-agency chief, agency of the Government (called off as the Head of the Agency in Central), President of the province of UBND, the central city-based city (called the provincial UBND chairman) is responsible for approving the tender bidding plan. for the public units of the management range.
2. Chairman of the Board of Directors (for the unit with the Board of Directors) or the Prime Minister of the Foreign Office who is responsible for approval of a plan to purchase the purchase of the drug in case of a contract to enter the medical examination, cure BHYT with the agency BHXH.
What? 5. The authority approx bids, approx the results of selecting the contractor providing drugs.
1. The head of public units responsible for approving the tender offer, approx the results of the selection of the contractor that provides the drug of its unit.
2. The case of a bidding organization focused on regulation at point a, paragraph 3, Article 26 of this Investment, Chairman of UBND level the provincial office of the Department of Health as the investment owner and responsible for approval of the tender offer, approx the result of the contractor selection. provide the medicines to the units within the management range.
3. The Premier of the external unit has a contract to examine the disease, cure BHYT with the agency BHXH responsible for approx.
The plan to buy drugs
1. The bidding plan is based on:
a) The planned state budget bill of five plans was given by the state authority to hand over and other legal sources of the public unit.
b) The contract to examine the disease, cure BHYT between the unit and the BHXH agency.
c) The actual situation buying and using the drug of the previous year.
d) Expected the need for five plans.
The unit case has not yet been assigned to a planned or unsigned state budget of the state budget, which is to treat BHYT, and the planned base of the bidding must ensure that the remaining 3 bases are regulated at this point.
2. The bid plan is set a minimum of 1 time/year.
The unit chief regulates the division of the drug tender in accordance with the use of the unit as follows:
1. The drug package under the generic name.
Generic prescriptions for generic names may have one or more drugs under the generic name. Each drug under the generic name is divided into groups based on technical criteria and the standard of technology is licensed as follows:
a) The drug group produced in the EMA, or ICH, or PIC/S.
b) The drug group produces at the basis of drug production in principle, the GMP-WHO standard according to the WHO recommendation is examined by the Ministry of Health of Vietnam (Bureau of Pharmacology) and issued certificates.
c) The drug group is not of the groups stating at the point a and b this paragraph.
d) The case of drug-producing drugs produced in Vietnam under the rule of law, based on the basis of the transfer of the right to produce drugs to divide this drug on one of the prescribed drug groups at point a, b, and c, paragraph Come on.
The drug group has a biological equivalent, published by the Ministry of Health.
2. Drug-based tender
The case in the year needs to use the placebo to serve the needs of the unit's specific treatment, on the basis of the uniform opinion of the Drug Council and the Treatment of the unit, the unit construction of the drug-based drug procurement package. The drugs are included in the drug package under the placebo name:
a) The original drug or drug equivalent to treatment with the original drug medication published by the Ministry of Health.
b) Drug portfolio issued by the Ministry of Health.
3. The medical treatment package, the drug from the pharmaceutical.
What? 8. The contents of each bid in the bidding plan
1. The name and package contents:
a) For the generic drug-based procurement package, the tender package content includes the name of the activity, concentration or function, the form of the cell, the unit count, the number, the expected plan price has included VAT. If it is a multi-component mixer that must record all the components of the drug under the generic name.
b) For the tender under the placebo package, the bid content includes the name of the drug, the active name, concentration or function, the conformation, the unit, the number, the expected plan price has included VAT and must be accompanied by the phrase "or treatment equivalent".
c) For the drug prescriptions package, the drug from the drug, the package content includes the name of the drug, the cell form, the unit count, the number, the expected plan price has included VAT.
2. Bid price
a) The bid price is the total value of the drug items in the bid.
b) The sale prices of the drug in the bidding plan are not higher than the maximum price of each item of that drug was announced at the latest time of the Ministry of Health.
c) In the absence of a maximum price of unpublished, when the bidding plan to purchase the right-right pill:
-Refer to the price of the drug that took the bid in the last 12 months of the units issued by the Ministry of Health (Bureau of Pharmacy) updated and published on the Department of Pharmacology (address: http://www.dav.gov.vn ) It ' s a plan to build a plan for every single item.
-For drug items that have not yet been bid or higher plan prices than the bid for the Ministry of Health announced in the previous 12 months, the unit must consult the price or sales invoice of at least 03 units of the drug supply on the market. At the time of the planning of the bidding; at the same time ensuring the cost of the drug item in the bidding plan did not exceed the sale of the sale sale, the resale is still in effect the item of the drug involved.
-These drug items have few supply units, not enough 3 times the price or bill of sale, the unit of the unit base at the price of the bill or the sales bill of that drug supply unit, the program on the plan price of the proposed unit. suited to the price of that drug on the market at the time of the planning of bidding.
Units must write specific sources of capital used to pay the prescriptions in the bidding plan.
4. Contractor selection form
The prescribed drug bidding at this is applied in a wide form of public bidding, according to the item. The case using another form of bidding should be clear to the person with the authority to review, decide.
5. The Bidding method
The treatment of the prescribed drug at this is done in the form of a form of 1 case file.
6. The timing of the selection of the contractor for each of the bids is made in accordance with the laws of the bidding law.
7. The contract form is made in accordance with the laws of the bidding and economic contract.
What? 9. Pretender Planning Browser
1. Browser responsibility:
The unit chief is responsible for the task of presenting the first set of bids (the main version) to the competent authority at Article 4 of this Information, which approx the plan to purchase the purchase and send 01 sets of bids for the bidding plan (version). For the agency, the presiding organization is prescribed at paragraph 1, Article 10 of this Information. The profile can be sent via post office or sent directly through the office of the agency to administer under the current regulation.
2. The filing plans for the purchase bid for the purchase of the drug:
-The application approved the bid to purchase the drug with the full set of rules specified at Article 8 of this Notice and the total value of the bids in the bidding plan due to the browser unit.
-A summary of the results of the results of a pre-adjacent year's buy-to-buy bidding plan and a summary of the plan for the purchase of a repurchase bid. When the number and value of the drug items varies from the previous year, the unit needs a reason for the reason.
b) The document accompanying the browser text
-Documents as a planning base for the purchase of a prescribed drug at Article 6 of this Smart.
-The application of the Board of the Drug Council and the treatment of the unit of the bidding plan to purchase the placebo in the year stipulated at paragraph 2, Article 7 of this Information.
-The decision to approve the catalogue, the number and price of each drug item in each of the unit's prime ministers ' bids.
What? 10. Planning the bidding
The bid to purchase the drug must be determined before the person has the authority to review, approve.
1. Agency, appraisal organization
a) For central public units: The head of the agencies in the central government decides the agency, the organization of the appraisal plan to buy the drug.
b) For local public units (including the case of a joint bid held at the Health Department under regulation at point a, paragraph 3, Article 26 of this Information): Chairman of the provincial UBND decides to deliver the presiding Health, in coordination with the relevant agencies. I mean, the local officials are planning a plan to buy drugs.
c) For external units that have contracted the medical examination, cure BHYT with the agency BHXH: Chairman of the Board (for the unit with the Board of Directors) or the Chief Minister of the Organ Decision, the organization appraisal plans to purchase the drug.
2. The agency ' s mission, the organization of the appraisal
a) Agency, organization of the appraisal responsible for examination, evaluation of regulatory content at Article 6, Article 7, Article 8 and Article 9 of this Notice in no more than 10 days. Calculating dates from the date of receiving sufficient documents. In the absence of sufficient documentation, the agency, the organization of the appraisal is responsible for the addition of the document, and returns the profile to the unit within five working days since the date of the document's receiving.
b) Agency, organization planning a bid for the purchase of a drug purchase must be set to report the results of the appraisal on the basis of compliance at Article 65 Law of Bidding, accompanied by 1 set of bids of the unit's bid planning (the photograph) the person has. the regulatory authority at Article 4 of this privacy review, approx the plan to bid for the drug within three days of work since the date of the completion of the examination, judging by regulation at point a, paragraph 2, this. The browser document is sent via a post office or sent directly through the office of the authority of the competent person to approve the bidding plan to administer under the current regulations.
The person with the authority to approve a plan to purchase a prescribed drug at Article 4 of this is responsible for approving the plan to purchase the drug in a period of not over 5 working days, since the date of receiving enough agency's appraisal report, the presiding organization. Appraisal.
The tender invitation filing was built under the regulations of the Bidding Law, the Existing Law guidelines and the Ministry of Health ' s guidance on the filing of the procurement of the purchase of the drug in medical facilities. .
Based on the approved bid plan, the Professional Contracting Organization is responsible for the construction and planning of the application of the application to the Prime Minister and the Agency, the organization of the appraisal of bids for the deadline. No more than 15 days of work since the date of the bid was approved by the competent authorities.
2. The filing of the bids
Compliance with the current regulations and guidelines on the procurement of procurement bids, regulations at Article 7 and Article 8 of this Notice and the Section of the Ministry of Health; executed in accordance with regulation at paragraph 72, Section I, Part I The Method of simplification of action procedures. The main extent of the Department of Health's management functions accompanying the Government's Resolution 62 /NQ-CP on December 17, 2010, specifically the filing of a bid is not required or stipulated to require the contractor to submit the papers, the following conditions:
a) Certificate of pharmaceutical products (CPP);
b) Good practice certificate production (GMP);
c) The certificate of raw materials, raw materials standards, the license for the license to circulate products in Vietnam;
d) The quality of quality and method of testing the product of the drug;
Regulation of the drug must be valid for registration on 6 months.
1. The purchase of a bid to purchase the drug must be predetermined before the person has the authority to review, approve.
2. The agency, the organization of the appraisal of the bids for the bid by the prime minister. In the event that the bidding organization focuses on the stipulation at the point a, paragraph 3, Article 26 of this Information, the Director of the Health Department decided to establish the organization for the appraisal of the tender bids.
3. The Agency ' s mission, the organization of the appraisal
a) The agency, the organization of the appraisal responsible for conducting the examination, evaluated the contents of the tender invitation filing under the provisions of the Bidding Law, the existing instructions for the bidding and regulations at this Notice in the period of no more than 10 years. the day of employment since receiving sufficient documents.
b) The agency, the organization of the appraisal of the filing of an invitation to purchase the order to report the results of the filing of a bid by the existing law on the bidding, accompanied by 1 set of bids (the photograph) the unit chief review, approx the filing of the bid. in the 03-day period of work since the date of the completion of the inspection, judging by regulation at point a, paragraph 3, this. The browser document is sent via a post office or sent directly through the office of the authority of the competent person to approve the bidding plan to administer under the current regulations.
The unit chief has the responsibility to approve the tender for the tender during the period of no more than 5 working days after receiving enough of the agency's appraisal report, the organization presiding over the appraisal of the bid.
Section 4. Contractor selection results
Contractors filed 3 bids (1 main and 02 screenshots) for the tender. The method of filing and the validity period of the case provided by the invitation to rule the base on the provisions of the Bidding Law. The invitation to bid to evaluate the bids by each item in each of the bids, comply with the provisions of the Bidding Law, the Law Guide documents, and the Ministry of Health guidelines.
1. The review of the registered drug must comply with the provisions of the Bidding Law, the Law Guide documents and the Ministry of Health guidelines.
2. For the generic drug package under the generic name: Each drug group under the generic name specified at 1 Article 7 This is only to be awarded a payment of 1 item per drug to the requirements of engineering, the quality of regulation in the filing of the bid and the lowest rating price. It's in the drug group.
3. For the drug tender under the placebo and the drug-related drug package, the drug from the pharmacy: Each pill is only awarded a bid for the lowest-rated drug in the number of items that reach technical requirements, the quality of regulation in the filing. Come on.
4. The option of selecting a production of the domestic product item in the country has the equivalent quality and the price is not higher than the imported drug at the time of the bidding.
What? 17. Browser results browser
Agency, the organization was tasked with organising the bid for a bid to review the bid and report the result of a contractor selection to the unit's head, the co-sending to the agency, the organization responsible for appraisal of the decision-making. In paragraph 1, Article 18 of which 01 sets the browser to choose the contractor option within 45 days from the date of the bid.
2. The browser results browser selection
a) 01 main report reviews the bids for bids and proposed bids.
b) 01 The filing of the tender tender (the photograph) has been specified and approved by regulation at Articles 12, 13, 14, 15, 16 of this Information and the current provisions of the law of bidding.
The browser profile results the selection of the contractor that is sent through the post or sent directly through the office of the agency, the organization is responsible for the appraisal of the contractor selection to administer under the current regulation.
What? 18. The decision to result in contractor selection
1. The agency, the organization that judges the selection of the contractor selected by the unit chief.
2. The agency ' s mission, the organization of the appraisal
The agency, the organization of the appraisal tasked with examining, evaluation and reporting results appraisal of the contractor selection under the regulations at this Notice and the existing regulations of the law on bidding in the period of no more than 15 years. Working days from the date of receiving enough relevant documents for the driver of the unit to review, approve the result of the contractor selection.
3. Case browser results appraisal selection of the contractor:
a) 01 main report appraisal results of the contractor selection.
b) 01 sets of the browser's browser selection results (a photo) of the agency, the organization tasked with organizing a bid for regulation at paragraph 2, Article 17 of this.
The results browser profile appraisal selection of the contractor is sent through the post or sent directly through the agency's office of authority approving the result of a contractor selection to administer under the current regulation.
What? 19. Approx and announce the result of the contractor selection
1. The unit chief has the responsibility to approve the results of the contractor selection under the existing regulations of the bidding law in the 3-day period of work since the date of receiving enough browser records the decision to select the agency ' s contractor, the judge. I'm going to make a statement at paragraph 3, Article 18 of this.
2. The unit chief is responsible for announcing the results of the contractor selection under the existing regulations of the law on bidding.
1. The bid price of each item of drugs is not higher than the price of that drug item in the bid plan that has been granted jurisdiction approval.
2. When there is a drug item in the drug package that the bids price of all participating bidders are higher than the price of the drug item that has been granted authority approval, the unit chief is responsible for a written notice without a contractor. Take the bid and cancel the bid for that drug to make a selection of the contractor in accordance with the laws of the bidding law.
The necessary case, which must ensure enough drugs to meet the need for medical discovery, cure of the unit, the unit chief (or the Director of the Health Department in the case of a concentration bid organization) is considered, the decision to choose the item on the bid on the item. the proposed basis by the Order of the Medication and the Treatment of the unit (or the agency, the presiding organization which results in the appraisal of the bid results in the case of the Health Organization to hold a centralized bid) if the following conditions are met:
a) The price of a review of the tender in the bid does not exceed the maximum price of that drug item published at the latest time of the Ministry of Health. In the case of the unannounced maximum price, the price of the commercial for a bid does not exceed the value of the sale, revaluing the effectiveness of the item.
b) The total value of the drug on the bid does not exceed the drug bid that has been granted the authority to approve in the bidding plan.
What? 21. Report results select bidders
1. Within 30 working days after the result of the selected bidders selection, the unit chief is responsible for reporting the result of a contractor selection on the agency approving the bidding plan.
2. Hospitals, hospital beds in the Ministry of Health, provincial hospitals and public outposts have contracted medical examination, BHYT treatment sent a result of the result of a contractor selection according to this Attached Information to the Department of Health (Department of Management). pharmacy) to post on the Department of Pharmacy's electronics page as a reference to the planning price. Reporting form: By text and email (address: email@example.com).
Follow the rules current of the Laws of Bidding Law and the text that guides the current Law.
What? 23. The case applies another form of contractor selection
In the special case, to avoid the lack of medication that affects professional activity, the unit is applied in the form of other contractor selection to buy drugs in limited quantities; in particular, the following:
1. The cases of buying drugs are adopted in the form of another contractor option
a) A rare drug-based drug-based drug-based drug issued by the Ministry of Health has not yet included a bidding plan.
b) The drug is not in the category of drug-buying planning drugs during the year granted by the approved authority to meet the needs of professional activity in the case of urgency as: disease, natural disasters, severe health effects. Sick people.
c) The drug already in the category of drug planning to buy drugs during the year is granted approved by the authority but has not yet had a bid result or no option selected by the contractor, which is urgently required to meet the needs of professional operations. in case of urgency.
d) The drug was in the bid to purchase the approved drug, but in the year the need to use beyond the number of plans was granted the authority to approve. The number of drugs purchased over the plan in the year no more than 20 percent of that drug was already in the bid. The limit of all the drug items purchased in the year at the hospitals depending on the hospital class by the Ministry of Health; in particular: Third, 4th grade hospitals were purchased not more than 600 (six hundred) million; first class, second class. no more than 01 (a) billion; special class hospital is not more than 02 (two) billion.
2. Request when shopping
a) The Medication Council and the Treatment of the review unit, which proposes in writing with the unit chief.
b) The drug is allowed to circulate in Vietnam and meet the quality requirements, the shelf life in accordance with the existing regulations.
c) In terms of the purchase price: A unit of reference 3 papers or the sales bill of suppliers, sale prices for sale, reopening and refereing published on the Bureau of Pharmacology as a review base, signing with the supplier.
3. When purchasing drugs in the above cases, the unit chief decides the form of procurement in accordance with the existing regulations of the law of bidding.
What? 24. Check, inspect and dispose of the breach
Inspection, inspection, and execution of violations by the current implementation of the Bidding Act.
During the examination, the inspector, if there is a violation of the law, depends on the nature and extent of the breach that is handled by the current regulations of the Contracting Law and the provisions of the Law of Inspects.
1. This message has been in effect since 1 June 2012.
2. Repeal Digital League 10 /2007/TTLT-BYT-BTC October 10, 2007 of the United Health-Ministry of Health, the Ministry of Finance is instructed to carry out a bid to purchase drugs in the public health facilities.
1. The Ministry of Health is responsible for the publication of the list of countries participating in the EMA, ICH, PIC/S; drug-producing facilities in principle, GMP-WHO standards as recommended by the WHO are examined by the Ministry of Health of Vietnam (Bureau of Pharmacy) and issued certificates; drug portfolio The generic medication is equivalent to the generic medication; the drug catalog has a bioequipative proof.
2. The Prime Minister of Central agencies directing the subordinated units of the bid to purchase prescribed medicines at this level and the existing provisions of the law of bidding.
3. The chairman of the provincial UBND determines the organization bidding to buy drugs in units of the right in one of the specific forms below:
a) The Health Service organizes the bid to focus on the units of subordination. The base units report the results of the medical department's bid to negotiate, signing the contract to supply the drug according to the current regulation.
b) Direcing the subordinated units and public external units that have contracted the medical examination, cure BHYT with the agency BHXH on the province applying the result of selecting the contractor of a provincial multi-department hospital that has been granted the authority approved for purchase. The drug is in the form of direct procurement according to the current law of bidding law.
c) The self-organizing units bid to buy drugs according to the use of each unit's use.
4. The BHXH Agency is involved in the Board of Planning Planning, participating in the bid and appraisal of bids of bids from the bidding units purchased from the BHYT fund under the allocation of the Director General of BHXH Vietnam.
5. For the bids that have approved the bidding plan before this Fourth Day of Approval comes into effect, implementing the regulations of the Bidding Law, Law amended, the addition of some of the provisions of the Laws related to basic building investment. , decree number. 85 /2009/NĐ-CP October 15, 2009 of the Government; Law of Pharmacy on 14 June 2005 and Decree No. 79 /2006/NE-CP on 09/8/2006 of the Government; the provisions of the Digital Information 10 /2007/TTLT-BYT-BTC August 10, 2007 of the United Health-Ministry of Health-Finance sets the implementation of the bid to purchase drugs in the public health facilities that guarantee no contrary to the regulations of the Bidding Law and the Registered Contracting Laws.
In the course of execution, if there is an entangrium, the offer reflects on the medical contact-the Ministry of Finance for the study of the ./.
KT. Minister of Health.
KT. MINISTER OF FINANCE
Nguyen Thu Minh