CIRCULAR guide bidding to buy drugs in the medical establishment _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Pharmacy pursuant to the law No. 34/2005/QH11 on 14/6/2005;
Pursuant to the law the bidding No. 61/2005/QH11 on 29/11/2005; Law on amendments and supplements to some articles of the Law concerning the basic construction investment of 38/2009/QH12 on 19/6/2009;
Pursuant to Decree No. 79/2006/ND-CP dated 9/8/2006 detailing the Government's implementation of some articles of the law on Pharmaceuticals;
Pursuant to Decree No. 85/2009/ND-CP on 15/10/2009 of the Government Procurement Law Enforcement Guide and selection of building contractor construction law;
Pursuant to Decree No. 188/2007/ND-CP on December 27, 2007 of the Government functions, tasks, powers and organizational structure of the Ministry of health;
Pursuant to Decree No. 118/2008/ND-CP on November 27, 2008 of the Government functions, tasks, powers and organizational structure of the Ministry of finance;
Contact President Ministry of Health-Ministry of finance guide to bidding to buy drugs in the medical establishment (hereinafter referred to as the unit) as follows: chapter I GENERAL PROVISIONS article 1. Scope 1. This circular guide some specific content in the bidding to buy the drug unit of the use of funds from the State budget, the health insurance fund and the other legitimate revenue source needs prevention, examination and healing to ensure conformity with the particular nature of the drug as prescribed by the law on Pharmaceuticals and the text Pharmaceutical Law Guide. 2. Other content relevant to the practice of buying drugs bidding units have used funds from the State budget, the health insurance fund and the other legal revenues to service demand prevention, treatment and cure are not in the scope of this circular is made according to the current rules of the law of tenders.
Article 2. Application object 1. This circular applies to: a) the unit has used the funds from the State budget, the health insurance fund and the other legitimate revenue source to buy medications serve the prevention of diseases, and cure disease.
b) bodies, the relevant units to join the bidding process to buy the medication according to the current rules.
2. This circular does not apply in the following cases: a) Drugs by State commissioned the payment by the State budget resources.
b) pharmaceutical and medicine traditional medicine.
c) blood and blood products.
Article 3. Explanation of terms In this circular, the terms below are interpreted as follows: 1. the original drug: is smoking permitted to circulate for the first time, on the basis that there was full of data on quality, safety and efficacy.
2. generic Drugs: the drug product Is intended to replace a medicine invented was produced without license of the company that invented and marketed after patents and the monopoly has expired.
3. biological equivalent: Two drugs are considered equivalent if they are biologically equivalent drug dosage or dosage preparations and b. available of them after taking the same dose levels in the same experimental conditions are similar to lead to effective treatment of them basically to be considered would be equivalent to each other.
4. Equal treatment: Two smoking is considered the equivalent of treatment if they are the equivalent of patent medicine and after using the same dose, the effects of the drug include the validity and safety is essentially the same.
5. Drugs and treatment: Is the Organization to advise the head of the unit on issues related to drugs and drug treatment in the unit.
The abbreviations:-EMA (European Medicines Agency): pharmaceutical management agency in Europe.
-ICH (Internatinal Conference on Harmonization): International Convention on the harmonization of the procedures for registration of pharmaceuticals for human use.
-PIC/S (Pharmaceutical Inspection Co-operation Scheme): the system of pharmaceutical inspection cooperation.
-The WHO (World Health Organization): World Health Organization.
-VAT (Value Added Tax): value added Tax.
-HEALTH INSURANCE: health insurance.
-BHXH: social insurance.
-PPC: people's Committee.
Chapter II SPECIFIC PROVISIONS section 1 jurisdiction in bidding to buy pills article 4. The authority approved the plans in the bidding to buy the drug 1. Ministers, heads of ministerial agencies, government agencies (referred to as the heads Central), Chairman, central cities (referred to as the provincial PEOPLE'S COMMITTEE Chairman) is responsible for approving the plan, bidding to buy drugs for public units in range management.
2. The Chairman of the Board (for the units that the Board) or the head of unit also responsible public approval of the plan to buy the drug in case of a contract to join the doctor, cure HEALTH INSURANCE with BHXH Agency.
Article 5. Authority to approve the bid, approved contractor selection result provided smoking 1. The head of the unit responsible for public approval of the bid, approved contractor selection result provider of the unit.
2. in case of centralized bidding organization as defined in point a, paragraph 3, article 26 of this circular, the provincial PEOPLE'S COMMITTEE Chair Medical Director served as the owner and responsible bid approval, approved contractor selection result provided drugs for the units in range management.
3. Unit heads in addition to public consultation, contract INSURANCE and healing with BHXH agency responsible for approving bid, approved contractor selection result provider of the unit.
Section 2 of the plan, bidding to purchase medications for 6. Procurement planning base 1. The bidding plan was created based on: a) State budget estimates in the plan are the competent State agencies and other legal incomes of public units.
b) consultation contract, INSURANCE and healing between the unit and the Agency BHXH.
c) actual situation of drug purchase and use years ago.
d) drug demand expected in the plan.
Case units not yet delivered the State budget expenditure estimates in the plan or have not signed consultation, healing HEALTH INSURANCE then the bidding plan bases to ensure sufficient 3 remaining bases stipulated in this Article.
2. bidding plan established a minimum of once per year.
Article 7. Divide the package specified unit heads the Division of tenders in smoking according to needs of use of the unit as follows: 1. generic name drugs package.
Generic name drugs package can have one or more of the drug under the name generic. Each generic name drugs are divided into groups based on the technical criteria and standard technology is licensed as follows: a) class of drugs produced in the participating countries, EMA or ICH, or PIC/s. b) class of drugs produced in the manufacturing of drugs reach the GMP standard, principle-WHO as recommended by the WHO to be Vietnam Ministry of health (pharmaceutical Management Bureau) checked and the certification.
c) drug Groups not belonging to the groups referred to in points a and b of this paragraph.
d) drug production cases produced in Vietnam under the provisions of the law shall be based on the basis of the transfer of the right to produce the drug to dispense this medicine items into one of the Group of drugs prescribed in points a, b and c, the clause accordingly.
DD) Group are proved equivalent by the Ministry of Health announced.
2. Package the drug under the name miscellaneous cases in need of drug use to serve the needs of the particular treatment units, on the basis of the opinion of the Council, and the therapy of the unit, the unit build packages the drug under the name miscellaneous. The drug was brought into the package of the drug under the name miscellaneous include: a the original drug or smoking) have equal treatment with the drug by the Health Ministry announced.
b) Smoking in the category of rare drugs by the Health Ministry.
3. Package of Oriental medicine, the drug from medicinal herbs.
Article 8. The contents of each package within the bidding plan 1. The name and contents of package: a) for packages of drugs under generic names, contents of package includes the active ingredient, the concentration or concentration, dosage form, quantity, unit price, the projected plans already include VAT. If the mixture of multi-component must keep enough of the components of the drug under the name generic.
b) for packages under the name miscellaneous content package, including the name of the active ingredient, medicine, concentration or concentration, dosage form, quantity, unit price, expected plans include VAT and must be accompanied by the phrase "or equivalent".
c) for package of Oriental medicine, drugs from pharmaceutical content package, including the name of medication, dosage, unit price, amount, the plan was expected to include VAT.
2. Reviews requirement a) package Price is the total value of the items in the package of drugs.
b) Reviews each drug items in the plan not be higher than the maximum price of each item that was announced at the nearest point of the Ministry of health.
c) in cases not yet announced maximum prices, when the construction bidding to buy the drug unit are:-the reference drug prices have winning bid within 12 months of the unit by the Ministry of health (pharmaceutical Management Bureau) updated and published on the website of drug administration (address : http://www.dav.gov.vn) as the basis of building plan price of each item.
-For those items not yet have drug price winning bid or bid higher drug price plan winning bid was the Ministry of Health announced within 12 months before, the unit must reference quotes or bills of sale of at least 3 units of pharmaceuticals on the market at the time of construction bidding; at the same time ensuring price plan of drug items in bidding plan not pass wholesale price to declare, enumerate back force of drug items have references.
-These items are at least supply unit, not enough 3 quotes or bills of sale, heads of units based on quotes or bills of sale of units of the item that the drug supply, the price of the item by the drug plan units offer the price match items that drugs on the market at the time of construction of the bidding plan.
3. capital the unit must be specified using capital sources to pay for the drugs in the bidding plan.
4. contractor selection form
The bidding for the drug as prescribed in this circular are applied widely bidding forms in the water, consider the following items. Use cases in other bidding form should clearly explain to the person who has the authority to review the decision.
5. The method of bidding The auction spectacle smoking as prescribed in this circular are made according to method 1 profile bags.
6. Time selection of the contractor for each package are made according to the provisions of the law of tenders.
7. The form of the contract is made under the provisions of the law on economic contracts and tenders.
Article 9. Browse the bidding plan 1. Responsible for the browser: the heads of units are responsible to process 1 the browser profile bidding up (original) competent person specified in article 4 of this circular reviewed, approved the plan to buy medication and send 1 the browser profile bidding plan (original) for organ appraisal organizations, as defined in paragraph 1, article 10 of this circular. The profile can be sent by post or delivered directly through the clerical bodies to manage under the current rules.
2. browser profile bidding buy drugs include: a) the browser text-Sheet process of approval of the plan in the bidding to buy pills filled with content stipulated in article 8 of this circular and the total value of the package in the bidding due to browser unit.
-Summary of the results of the bidding plan to buy drugs last year and plan summary explanation of bidding to buy drugs is the browser. When the number and value of items of medicines have changed compared to the previous year, the adjacent should explain the reason.
b) documents attached browser text-these documents as a basis for planning in the bidding to buy the drugs specified in article 6 of this circular.
-Drug Council meeting minutes and the unit's treatment plan in the bidding to buy a brand name drug in the year prescribed in paragraph 2, article 7 of this circular.
-The decision of approval categories, number and price plan drug items in each package of unit heads.
Article 10. The bidding plan evaluation plan buying drugs must be appraised before the competent person review, approval.
1. The Agency, held a evaluation) for the central units: the heads of the agencies in central agency decisions, organizational evaluation plan to buy drugs.
b) for local government units (including the case of tender organization focused in the Medical Facility as defined in point a, paragraph 3, article 26 of this circular): Chairman level the decisions the Department of health, in collaboration with related agencies in organizing local appraisal bidding to buy the drug.
c external unit) for public consultation, contract INSURANCE and healing with BHXH: Chairman of the Board (for the units that the Board) or the head of agency decision-making unit, the Organization the evaluation plan of buying the drug.
2. The tasks of the Agency, held a evaluation) Agency, held responsible due diligence checks, reviews the content of the provisions of article 6, article 7, article 8 and article 9 of this circular within a period not exceeding 10 working days from the date of receipt of the relevant documents. Cases of incomplete documents according to the rules, agency, organization, evaluators are responsible for additional guidance documents and returned to the unit within 5 working days from the date of the document.
b) organs, the Organization the evaluation plan buying drugs must report the results of the evaluation on the basis of compliance with the provisions of article 65 of law tenders, accompanied by 7 plan browser profile Ministry auction of the unit be appraised (snapshot) the competent person specified in article 4 of this circular look approval of the plan, bidding to buy the drug within 3 working days from the date of completion of the inspection, assessment, as defined in point a, paragraph 2, of this Article. The browser document sent by post or submitted directly through clerical bodies who have authority to approve procurement plan to manage under the current rules.
Article 11. Plan approval authority approving the plan in the bidding to buy the drugs specified in article 4 of this circular are responsible for approving the plan, bidding to buy drugs in the time limit not exceeding 5 working days from the date of receiving the full report the Agency's evaluation, evaluation organizations.
Category 3 bid article 12. Established the tender bid is built according to the regulations of the law on tenders, the guidance documents applicable law and instructions of the Ministry of health about the bid to buy drugs in the medical establishment.
1. Responsible for the browser based on the bidding plan is approved by the authority, the expert in the bidding because the heads are responsible for establishing the unit build and browse bid up the heads of units and agencies, organized the bid assessment within a period of not more than 15 working days from the date of the planned tender has been issued approval authority.
2. Content of the bid comply with the rules and instructions current on outdoor bid shopping goods, the provisions of article 7 and article 8 of this circular and the instructions of the Ministry of health; made as prescribed in clause 72, section I, part I approach simplifies the administrative procedures within the management function of the Ministry of Health issued the attached resolution No. 62/NQ-CP on December 17, 2010 of the Government, specific bid is not compulsory or required the contractor to submit the papers , the following conditions: a) the certificate of pharmaceutical product (CPP);
b) certificate of good manufacturing practice (GMP);
c) certificate of the origin of raw materials, material standards, a notary license product circulation in Vietnam;
d) quality standards and product testing methods of drugs;
DD) prescribing the right medicine validity conditions of registration on May 6.
Article 13. Bid evaluation 1. Bid purchasing of drugs must be appraised before the competent person review, approval.
2. Agency, organized the bid evaluation by unit heads decided. In the case of centralized bidding organization as defined in point a, paragraph 3, article 26 of this circular, the Director of the Department of health decided to establish the Organization bid evaluation.
3. The tasks of the Agency, held a evaluation) Agency, the organization responsible for conducting due diligence checks, reviews the content of the tender according to the rules of the bidding Law, the text of the current guidelines on bidding and the provisions of this circular in the time limit of not more than 10 working days from the receipt of the relevant documents.
b) Agency, organized the appraisal bid buying drugs must report results evaluation bidding under the provisions of the current law on tenders, accompanied by the 1st bid (snapshot) the unit heads to review, approve the bid within 10 working days from the date of completion of the check. Guest reviews, as defined in point a, paragraph 3, of this Article. The browser document sent by post or submitted directly through clerical bodies who have authority to approve procurement plan to manage under the current rules.
Article 14. Approved bid unit heads are responsible for approving tender in less than 5 working days after receipt of the evaluation report enough bodies, organizations evaluation bid.
Item 4. Contractor selection results 15. Reviews bids the bidder submitting the 3rd tenders (1 original and 2 copies) to the bidder. The method of submission, and validity period of the tender side of the records prescribed pursuant to the provisions of the law of tenders. Tender side reviews bids for each item in each package, in compliance with the provisions of the law on tenders, the writing guide rules and instructions of the Health Ministry.
Article 16. Review of winning bid 1. Drug review winning bid must comply with the rules of the bidding Law, the text of the guidance law and instructions of the Health Ministry.
2. for packages of drugs under generic names: generic name drugs groups specified in clause 1 7 of this circular Thing just are bidding 1 drug items reach the technical requirements, the quality specified in the bidding and priced the lowest rating in that group.
3. for packages of drugs by name and distinctive package of Oriental medicine, drugs from pharmaceutical drug review only: each winning bid 1 items are priced the lowest rating among the items reach the technical requirements, the quality specified in the bid.
4. Priority Review select winning bid items of drugs produced in the water of equivalent quality and price is not higher than that of imported drugs at the time of bidding.
Article 17. Browse results select the contractor 1. Responsible agency browser, the Organization was assigned to unit heads held responsible tender bid review and report the results of choosing contractors unit heads up, and sent to the Agency, the organization responsible for evaluation of the results of selection contractor specified in clause 1 , Article 18 of this circular 1 the browser profile results selected the contractor within 45 days of the bid opening.
2. browser profile results choose a contractor) 1 main report reviews bids and proposals.
b) 1 set of tender (a shooting) has been approved and verified according to the provisions in articles 12, 13, 14, 15, 16 of this circular and the current rules of the law of tenders.
Browser profile results selected contractors to be sent by post or delivered directly through the clerical authority, the organization responsible for the evaluation results to the management contractor selection according to current rules.
Article 18. Evaluation of contractor selection result 1. The Agency, organization, evaluation of the results of selection of contractors by the unit heads decided.
2. The tasks of the Agency, held the appraisal
The Agency has the task of appraisal organization checks, reviews and reporting evaluation results choose the contractor according to the provisions of this circular and the current rules of the law of tenders within a period not exceeding 15 days from the date of receipt of the relevant documents to the review unit heads approved contractor selection result.
3. the browser profile results selected evaluation contractor include: a) 1 a valuation report primary results choosing contractors.
b) 1 the browser profile results selected contractor (snapshot) of organs, the Organization was tasked with organizing a tender prescribed in clause 2, article 17 of this circular.
Browser profile results selected evaluation contractor sent by post or delivered directly through the Agency of clerical authority approved contractor selection results to management under the current rules.
Article 19. Approved and announced the result of choosing the contractor 1. Heads of unit are responsible for approving the results of selection of contractors under the current rules of the law of tenders within 3 working days from receipt of application assessment results browser choose the Agency's contractor, the Organization the evaluation provided for in paragraph 3 , Article 18 of this circular.
2. The head of the unit responsible for the notification of results of selection of contractors under the current rules of the law of tenders.
Article 20. Drug price winning bid 1. Winning bid price of each item is not higher than the price of the drug found in the bidding plan that has been approved by the authority.
2. When you have found the drug in the drug package that the tender prices of all the contractors attend higher price plan of drug items which have been approved by the authority, the head of the unit responsible for the written notice no contractor would bid and cancel that item bidding to make a selection back to the contractor in accordance the current law on bidding.
Where necessary, to ensure enough drugs to meet the needs of patients, healing of the unit, the head of the unit (or the Director of the Department of health in the case of the Department of health tender focus) are considered, the decision to choose items of medicines on the basis of bid proposal in writing of the Council, and the therapy of the unit (or the Agency organizations, evaluation of the bidding results in case the bidding Organization Department of health focus) if it meets the following conditions: a review of drug items Price) winning bid does not exceed the maximum price of the item that was announced at the nearest point of the Ministry of health. In the case has not yet announced the price, the maximum price the drug item review of winning bid does not pass wholesale price to declare, enumerate, and the effect of drug items.
b) of the total value of drugs winning bid does not exceed the price of tenders the drugs have been approved by the authority in the bidding plan.
Section 5 other provisions article 21. Results reported selection of the contractor 1. Within 30 working days after the results of the approved contractor selection, unit heads are responsible for reporting the results of selection of contractors on the approved agency plan.
2. The Institute has hospitals, hospital bed directly under the Ministry of health, the provincial hospital and the outside unit have signed public examinations, cure HEALTH INSURANCE choice results report the contractor form annex attached to this circular to the Ministry of health (pharmaceutical Management Bureau) to be posted on the electronic pages of drug administration as a basis of reference build reviews the plan. Form send the report: by text and e-mail (address: firstname.lastname@example.org).
Article 22. Costs in bidding to follow the rules of the bidding Law and other applicable guidance documents.
Article 23. The case apply form other contractors selection In special cases, to avoid drug shortages affect professional activities, the unit is applied form of choosing other bidders to buy drugs with limited numbers; specifically the following: 1. The case of buying drugs is applied to other contractors selected form a) Drugs in the formulary of the rare unscheduled demand arise special treatment by the Ministry of Health issued not in the bidding plan.
b) Smoking is not yet in the category of drugs in the bidding to buy drugs in the year are approved by the authority in order to meet the needs of professional service in emergencies such as disease outbreaks, natural disasters, serious impact to the patient's health.
c) Drugs already in the formulary in bidding to buy drugs in the year to be approved by the authorized but not yet tender results or do not choose to be the contractor bid, need to buy the fold in order to meet the needs of professional service in case of urgency.
d) Smoking is in bidding to buy the drug approved, but in demand exceeded the number of plans has been approved by the authority. The amount of the drug be purchased beyond the plan during the year do not exceed 20% of the amount of the drug that has winning bid. Limits of the total drug items be purchased beyond the plan in the year in hospitals depending on hospital class according to the classification of the Ministry of health; specifically: The third class hospital, 4th was purchased no more than 600 (six hundred) million; 1st class, 2nd class hospital no more than 1 (one); special class hospital no more than 2 (two) billion.
2. Ask when shopping a) drugs and treatment of review unit, proposed in writing to the heads of units.
b) Smoking is allowed to circulate in Vietnam and meet quality requirements, the duration of use according to the current rules.
c) About drug purchase price: reference unit 3 quotes or sales invoice of the supplier, wholesale price Declaration, declare and reference price published on the website of drug administration as a base review, contracting with vendors.
3. When buying drugs in the above case, the heads of the Unit decided to form shops in accordance with the current rules of the law of tenders.
Article 24. Test, inspection and handling violation of inspection, test and process the breach made according to regulations of bidding.
During the inspection, the Inspector, if discovered violating the law, depending on the nature and extent of the violation that processed according to the rules of the bidding Law and the provisions of the law on the Ombudsman.
Chapter III the TERMS of the IMPLEMENTATION of article 25. Effect 1. This circular effect since June 1, 2012.
2. Abolish circular No. 10/2007/TTLT-BYT-BTC dated 10/08/2007 of the Ministry of health, Ministry of finance guidelines bidding to buy drugs in the public health facilities.
Article 26. Implementation 1. The Ministry of health is responsible for publication of the list of countries joining EMA, ICH, PIC/S; the basis of the production of the drug reaching GMP standards, guidelines-WHO as recommended by the WHO to be Vietnam Ministry of health (pharmaceutical Management Bureau) test and certification; the original drug category, drugs are equivalent to the original drug treatment; the formulary has documents proving the equivalent.
2. The heads central agencies directed the units made in the bidding to buy the drug as prescribed in this circular and the current rules of the law of tenders.
3. the provincial Council decided to organise a tender to buy drugs in the right units under one of the specific forms below: a) the Affairs of the Department of Health held a tender for the subdivisions. The units pursuant to the announcement of the bid results, the Department of health to negotiate, contract supplying the drug under current rules.
b) steer the subdivisions and other units also have contracted public examinations, cure HEALTH INSURANCE with BHXH province apply results of selection of contractors in a provincial hospital has been granted authority for approval to buy the drug in the form of shops directly according to the current rules of the law of tenders.
c) The unit itself hold a tender to buy the medication according to the needs of each unit.
4. BHXH agency participation in the authority plan, involved considering the tender and the evaluation results of selection of contractors bidding units buying drugs from HEALTH INSURANCE Fund according to the hierarchy of General Director Vietnam BHXH.
5. With regard to the requirement to have the bidding plan browser before the day this circular effect, follow the rules of the bidding, the law amending and supplementing some articles of the Law concerning the basic construction investment, Decree No. 85/2009/ND-CP on 15/10/2009 of the Government; Pharmaceutical law on 14/6/2005 and Decree No. 79/2006/ND-CP dated 9/8/2006 of Government; the provisions of circular No. 10/2007/TTLT-BYT-BTC dated 10/8/2007 of the Ministry of health, Ministry of finance guidelines bidding to buy drugs in the public health facilities to ensure no contrary to the regulations of the law on bidding and bidding Law Guide text.
In the process, if there are obstacles, the proposal reflects on the Union Health Ministry-the Ministry of finance to study the resolution./.