JOINT CIRCULAR NO. 01/2012/TTLT-BYT-BTC GUIDING THE PROCUREMENT OF MEDICINES IN HEALTH CARE FACILITIES

Joint Circular No. 01/2012/TTLT-BYT-BTC guides the procurement of medicines in health care facilities for units using state budget, health insurance funds, and other lawful sources of income. It provides detailed regulations on the authority to approve tender plans, divide tender packages, prepare tender documents, select contractors, and handle violations.

Document No.01/2012/TTLT-BYT-BTC
Document typeJoint Circular
Issuing authorityMinistry of Health
Signed byNguyễn Thị Minh Cơ Quan Ban Hành Bộ Y Tế Chức Danh Thứ Trưởng Người Ký Nguyễn Thị Xuyên — Thứ trưởng
Updated26/06/2026
SectorUnclassified
FieldBudget Management
Issued date19/01/2012
Effective date01/06/2012
Expiry date
StatusIn effect
✦ Smart summary

Joint Circular No. 01/2012/TTLT-BYT-BTC guides the procurement of medicines in health care facilities for units using state budget, health insurance funds, and other lawful sources of income. It provides detailed regulations on the authority to approve tender plans, divide tender packages, prepare tender documents, select contractors, and handle violations.

Scope of application

Public health institutions, related agencies, and private hospitals with health insurance contracts participate in the procurement process.

Key points

  • Public units are responsible for approving tender plans and tender documents, while non-public units with health insurance contracts self-approve according to current regulations.
  • Tender packages for medicines are divided based on generic names, brand names, and traditional medicine, detailing the contents and prices of each package.
  • Tender documents are prepared in accordance with current regulations without requiring contractors to submit drug product certificates (CPP) or GMP.
  • The lowest price among equivalent drugs is considered in awarding the contract, with preference given to domestically produced drugs.
  • The results of contractor selection are announced in accordance with current laws governing procurement.

🌐 Social impact of this document

  • Positive impact: Strengthened management, transparency in the procurement process, reduced costs, and increased efficiency in resource utilization.
  • Negative impact: May cause difficulties in selecting contractors in urgent cases requiring immediate procurement.

❓ Frequently asked questions

How many types of tender packages for medicines are specified?

This circular specifies three types of tender packages for medicines: based on generic names, brand names, and traditional medicine.

What can non-public units with health insurance contracts with the Social Security Office do?

These units self-approve tender plans and tender documents for medicine procurement according to current regulations.

Is it required for contractors to submit drug product certificates (CPP) or GMP?

No, this circular does not require contractors to submit such documents as CPP or GMP.

On what criteria is the successful bid determined?

The successful bid is determined based on the lowest price among equivalent drugs, giving priority to domestically produced drugs of equal quality and price not exceeding imported drugs.

How are violations handled?

Inspection, supervision, and handling of violations are carried out in accordance with current procurement laws. Handling varies depending on the nature and severity of the violation.

Full text

Ministry of Finance - Ministry of Health

SOCIALIST REPUBLIC OF VIET NAM
Independence – Freedom – Happiness

Number: 01/2012/TTLT-BYT-BTC
Hanoi, January 19, 2012

JOINT CIRCULAR

Guidelines for tendering to purchase medicines in healthcare facilities

____________________

 

Pursuant to the Medicine Law No. 34/2005/QH11 dated June 14, 2005;

Pursuant to the Tendering Law No. 61/2005/QH11 dated November 29, 2005; Law amending and supplementing certain articles of laws related to basic construction investment No. 38/2009/QH12 dated June 19, 2009;

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

Pursuant to Decree No. 85/2009/NĐ-CP dated October 15, 2009 of the Government guiding the implementation of the Tendering Law and the selection of contractors for construction under the Construction Law;

Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the Decree No. 118/2008/NĐ-CP dated November 27, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Finance;

The Ministry of Health and the Ministry of Finance jointly issue guidelines for tendering to purchase medicines in healthcare facilities (hereinafter referred to collectively as units) as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

1. These Circulars guide specific contents in the implementation of tendering to purchase medicines by units using state budget funds, health insurance funds, and other lawful sources of income to meet the needs of disease prevention, medical examination, and treatment, ensuring compliance with the special nature of medicines as stipulated by the Medicine Law and its guiding documents.

2. Other relevant contents concerning the implementation of tendering to purchase medicines by units using state budget funds, health insurance funds, and other lawful sources of income to meet the needs of disease prevention, medical examination, and treatment, which are not within the scope regulated by these Circulars, shall be implemented in accordance with current laws on tendering.

Article 2. Applicability

1. This Circular applies to:

a) Units using state budget funds, health insurance funds, and other lawful sources of income to purchase medicines for disease prevention, medical examination, and treatment activities.

b) Relevant agencies and units participating in the tendering process to purchase medicines in accordance with current regulations.

2. These Circulars do not apply in the following cases:

a) Medicines ordered by the State and paid for with state budget funds.

b) Traditional herbal medicines and traditional Chinese medicine ingredients.

c) Blood and blood products.

Article 3. Explanation of Terms

In this Circular, the following terms are understood as follows:

1. Original brand-name drug: A drug that has been licensed for circulation for the first time based on complete data regarding quality, safety, and efficacy.

2. Generic drug: A finished product intended to replace an innovator drug produced without a license from the innovator company and marketed after the expiration of the patent and other exclusive rights.

3. Bioequivalence: Two drugs are considered bioequivalent if they are equivalent formulations or follow-on versions of a formulation and their bioavailability after administration of the same dose under the same test conditions is similar, leading to essentially equivalent therapeutic effects.

4. Therapeutic equivalence: Two drugs are considered therapeutically equivalent if they are equivalent formulations and after being administered at the same dosage, their effects including efficacy and safety are essentially the same.

5. Drug and Treatment Council: An advisory body to the head of the unit on issues related to drugs and drug treatment within the unit. Abbreviations:

- EMA (European Medicines Agency): European Medicines Agency.

- ICH (International Conference on Harmonization): International Conference on Harmonization of Procedures for the Registration of Human Medicinal Products.

- PIC/S (Pharmaceutical Inspection Co-operation Scheme): Pharmaceutical Inspection Cooperation Scheme.

- WHO (World Health Organization): World Health Organization.

- VAT (Value Added Tax): Value Added Tax.

Chapter II

SPECIFIC PROVISIONS

Section 1

- BHYT: Health Insurance.

Article 4. Authority to Approve Procurement Plans for Purchasing Medicines

1. The Minister, Head of a Ministry-level agency, or Government-affiliated agency (referred to as the Head of a Central Agency), Chairman of the People's Committee of a province or centrally governed city (referred to as the Chairman of the Provincial People's Committee) shall be responsible for approving procurement plans for purchasing medicines for public units under their management.

2. The Chairman of the Board of Directors (for units with a Board of Directors) or the Head of a non-public unit shall be responsible for approving procurement plans for purchasing medicines when there is a contract to participate in health insurance medical examination and treatment with the Social Insurance Agency.

Article 5. Authority to Approve Tender Documents and Approval of the Results of the Selection of Suppliers Providing Medicines

1. The Heads of public units shall be responsible for approving tender documents and the results of the selection of suppliers providing medicines for their own units.

2. In cases where centralized tendering is organized according to the provisions at point a, Clause 3, Article 26 of this Circular, the Chairman of the Provincial People's Committee shall assign the Director of the Department of Health to act as the project owner and be responsible for approving tender documents and the results of the selection of suppliers providing medicines for units under their management.

3. The Head of a non-public unit that has a contract for health insurance medical examination and treatment with the Social Insurance Agency shall be responsible for approving tender documents and the results of the selection of suppliers providing medicines for their own unit.

Section 2

PROCUREMENT PLAN FOR PURCHASING MEDICINES

Article 6. Basis for Establishing the Procurement Plan

1. The procurement plan is established based on:

a) The state budget expenditure estimate for the planning year assigned by the competent state agency and other legitimate sources of income of the public unit.

b) The health insurance medical examination and treatment contract between the unit and the Social Insurance Agency.

c) The actual situation of medicine purchase and usage in the previous year.

d) The forecasted medicine demand for the planning year. In cases where the unit has not been assigned a state budget expenditure estimate for the planning year or has not signed a health insurance medical examination and treatment contract, the basis for establishing the procurement plan must ensure the remaining three bases stipulated in this Article.

2. The procurement plan must be established at least once per year.

Article 7. Division of Tenders

The Head of the unit specifies the division of medicine tenders according to the unit's usage needs as follows:

1. Medicine tender packages by generic name. A medicine tender package by generic name may include one or more medicines by generic name. Each medicine by generic name is divided into groups based on technical criteria and technological standards approved as follows:

a) Group of medicines produced in countries participating in the European Medicines Agency (EMA), International Council for Harmonisation (ICH), or Pharmaceutical Inspection Co-operation Scheme (PIC/S).

b) Group of medicines produced in manufacturing facilities meeting Good Manufacturing Practice (GMP) standards recommended by the World Health Organization (WHO) and certified by the Vietnamese Ministry of Health (Drug Administration).

c) Group of medicines not included in the groups mentioned in points a and b of this clause.

d) In cases where medicines are produced under license in Vietnam according to the law, the basis for transferring the right to produce medicines shall be used to classify these items into one of the groups of medicines specified in points a, b, and c of this clause as appropriate.

đ) Group of medicines with bioequivalence proven by the Ministry of Health.

2. Medicine tender packages by brand name. When the unit needs to use branded medicines to meet special treatment requirements during the year, based on the consensus of the unit's Drug and Treatment Council, the unit establishes a medicine tender package by brand name. Medicines included in the medicine tender package by brand name consist of:

a) Original branded medicines or medicines with therapeutic equivalence to original branded medicines announced by the Ministry of Health.

b) Medicines listed in the rare drug directory issued by the Ministry of Health.

3. Traditional medicine tender packages, herbal medicine tender packages.

Article 8. Content of each tender package in the bidding plan

1. Name and content of the tender package:

a) For tender packages of generic drugs, the content of the tender package includes the active ingredient name, concentration or content, dosage form, unit of measurement, quantity, and the planned price including VAT. If it is a mixed drug with multiple components, all components must be listed according to their generic names.

b) For tender packages of brand-name drugs, the content of the tender package includes the drug name, active ingredient name, concentration or content, dosage form, unit of measurement, quantity, and the planned price including VAT, and must include the phrase "or equivalent treatment."

c) For tender packages of traditional medicine or herbal drugs, the content of the tender package includes the drug name, dosage form, unit of measurement, quantity, and the planned price including VAT.

2. Tender Package Price

a) The tender package price is the total value of the drug items within the tender package.

b) The price of each drug item in the bidding plan shall not exceed the maximum price of that drug item published most recently by the Ministry of Health.

c) In cases where the maximum price has not been announced, when developing the bidding plan for purchasing drugs, the unit must:

- Refer to the winning bid prices of the drugs from the past 12 months of units updated and published by the Ministry of Health (Drug Administration Department) on the Drug Administration Department's electronic news site (address: http://www.dav.gov.vn) as the basis for establishing the planned price of each drug item.

- For drug items without winning bid prices or with planned prices higher than the winning bid prices announced by the Ministry of Health within the past 12 months, the unit must refer to quotations or sales invoices from at least three drug suppliers on the market at the time of developing the bidding plan; while ensuring that the planned price of the drug item in the bidding plan does not exceed the current declared wholesale price of the referenced drug item.

- For drug items with few suppliers, less than three quotations or sales invoices, the head of the unit bases the quotations or sales invoices of the supplier of that drug item, explaining that the planned price of the drug item proposed by the unit is consistent with the market price of that drug item at the time of developing the bidding plan.

3. Source of Funds

Units must clearly record the source of funds to be used for paying for drugs in the bidding plan.

4. Method of Selecting Contractors The bidding for drugs as stipulated in this Circular shall apply the open domestic tender method by item. In cases where other tender methods are used, a clear explanation must be provided for review and decision by the authorized person.

5. Bidding Method The bidding for drugs as stipulated in this Circular shall be conducted using the single-envelope method.

6. Time for Selecting Contractors for Each Tender Package shall be carried out in accordance with the provisions of the Law on Bidding.

7. Contract Form shall be implemented in accordance with the provisions of the Law on Bidding and Economic Contracts.

Article 9. Approval of the Bidding Plan

1. Responsibility for Approval: The head of the unit is responsible for submitting one set of approval documents (original) to the authorized person specified in Article 4 of this Circular for review and approval of the bidding plan for purchasing drugs, and sending one set of approval documents (original) to the agency or organization in charge of reviewing the bidding plan as stipulated in Clause 1, Article 10 of this Circular. Documents may be sent via postal service or directly through the office mailroom in accordance with current regulations.

2. Documents for Approval of the Bidding Plan for Purchasing Drugs Include:

a) Approval Document - A request for approval of the bidding plan for purchasing drugs containing all contents specified in Article 8 of this Circular and the total value of tender packages in the bidding plan submitted by the unit. - A summary report on the implementation results of the bidding plan for purchasing drugs in the previous year and a brief explanation of the bidding plan for purchasing drugs currently being submitted. When the quantity and value of drug items have changed compared to the previous year, the unit needs to explain the reasons.

b) Supporting Documents for the Approval Document - Documents serving as the basis for developing the bidding plan for purchasing drugs as stipulated in Article 6 of this Circular. - Minutes of the meeting of the Drug and Treatment Council of the unit regarding the bidding plan for purchasing brand-name drugs in the year as stipulated in Clause 2, Article 7 of this Circular. - Decision approving the list, quantity, and planned price of each drug item in each tender package by the head of the unit.

Article 10. Review of tendering plans

The tendering plan for purchasing medicines must be reviewed before being submitted to the competent authority for examination and approval.

1. Reviewing Agency or Organization

a) For central public units: The heads of central agencies decide on the agency or organization that will review the tendering plan for purchasing medicines.

b) For local public units (including cases where centralized tendering is organized at the Department of Health according to point a, Clause 3, Article 26 of this Circular): The Chairman of the Provincial People's Committee decides to assign the Department of Health to take the lead and coordinate with relevant agencies at the locality to organize the review of the tendering plan for purchasing medicines.

c) For non-public units that have signed contracts for health insurance medical services with the Social Security Agency: The Chairman of the Board of Directors (for units with a Board of Directors) or the head of the unit decides on the agency or organization that will review the tendering plan for purchasing medicines.

2. Duties of the reviewing agency or organization

a) The reviewing agency or organization is responsible for checking and evaluating the contents stipulated in Articles 6, 7, 8, and 9 of this Circular within a period not exceeding 10 working days from the date of receiving all related documents. In case of insufficient documents as prescribed, the reviewing agency or organization is responsible for guiding the supplementation of documents and returning the dossier to the unit within 5 working days from the date of receipt of the documents.

b) The reviewing agency or organization of the tendering plan for purchasing medicines must prepare a report on the results of the review based on compliance with the provisions of Article 65 of the Tendering Law, accompanied by one set of the tendering plan dossier of the reviewed unit (photocopy) to submit to the competent authority specified in Article 4 of this Circular for examination and approval of the tendering plan for purchasing medicines within three working days from the date of completing the inspection and evaluation as stipulated in point a, Clause 2, of this Article. The submission documents are sent through postal service or directly delivered to the office of the authority approving the tendering plan for management in accordance with current regulations.

Article 11. Approval of tendering plans

The competent authority for approving the tendering plan for purchasing medicines as stipulated in Article 4 of this Circular is responsible for approving the tendering plan for purchasing medicines within a period not exceeding five working days from the date of receiving the complete review report of the main reviewing agency or organization.

Section 3

TENDER DOCUMENTS

Article 12. Preparation of tender documents

The tender documents for medicines are established in accordance with the provisions of the Tendering Law, current guiding documents of the Law, and the guidelines of the Ministry of Health on preparing tender documents for purchasing medicines in healthcare facilities.

1. Responsibility for submission

Based on the approved tendering plan by the authorized authority, the Tendering Expert Group established by the head of the unit is responsible for building and submitting the tender documents to the head of the unit and the agency or organization reviewing the tender documents within a period not exceeding fifteen working days from the date of receiving the approved tendering plan.

2. Contents of the tender documents

Complying with current regulations and guidelines on tender documents for procurement of goods, the provisions of Articles 7 and 8 of this Circular, and the guidelines of the Ministry of Health; implementing in accordance with the provisions of Clause 72, Section I, Part I Simplification Plan of Administrative Procedures within the scope of the Ministry of Health's functional management issued together with Resolution No. 62/NQ-CP dated December 17, 2010 of the Government, specifically, the tender documents shall not require or stipulate that bidders must submit the following documents or conditions:

a) Product certification (CPP);

b) Good Manufacturing Practice (GMP) certificate;

c) Certificate of origin of raw materials, raw material standards, certified copy of product circulation permit in Vietnam;

d) Finished product quality standards and testing methods of the medicine;

đ) Requirement that the medicine must still be valid for more than six months from the registration number.

Article 13. Review of Tender Documents

1. The tender documents for purchasing medicines must be reviewed before being submitted to the competent authority for examination and approval.

2. The agency or organization responsible for reviewing the tender documents shall be determined by the head of the unit. In cases where centralized bidding is conducted according to point a, Clause 3, Article 26 of this Circular, the Department of Health Director decides on establishing the organization to review the tender documents.

3. Responsibilities of the agency or organization conducting the review

a) The agency or organization conducting the review is responsible for inspecting and evaluating the contents of the tender documents in accordance with the Bidding Law, current bidding guidance documents, and the provisions of this Circular within a period not exceeding ten working days from the date of receiving all relevant documents.

b) The agency or organization reviewing the tender documents for purchasing medicines must prepare a report on the results of the tender document review in accordance with the current bidding laws, accompanied by one set of tender documents (photocopies) to be submitted to the head of the unit for examination and approval of the tender documents within three working days from the completion of the inspection and evaluation as stipulated in point a, Clause 3, of this Article. The documents to be approved are sent through postal service or directly to the office of the authority responsible for approving the bidding plan for management in accordance with current regulations.

Article 14. Approval of Tender Documents

The head of the unit is responsible for approving the tender documents within five working days after receiving the complete review reports from the agency or organization primarily responsible for reviewing the tender documents.

Section 4

SELECTION RESULTS

Article 15. Evaluation of Bid Documents

Each bidder submits three sets of Bid Documents (one original and two photocopies) to the tenderer. The method of submission and the validity period of the bid documents are determined by the tenderer based on the provisions of the Bidding Law. The tenderer evaluates the bid documents item by item within each tender package, adhering to the provisions of the Bidding Law, guidance documents of the Law, and instructions of the Ministry of Health.

Article 16. Examination and Approval of Winning Bids

1. The examination and approval of winning bids must comply with the provisions of the Bidding Law, guidance documents of the Law, and instructions of the Ministry of Health.

2. For tenders of medicines by generic name: Each group of medicines specified in Clause 1, Article 7 of this Circular can only have one medicine item that meets the technical and quality requirements stipulated in the tender documents and has the lowest evaluated price in that group considered for approval as a winning bid.

3. For tenders of medicines by brand name and traditional Chinese medicine, herbal medicine: Each medicine can only have one item that meets the technical and quality requirements stipulated in the tender documents and has the lowest evaluated price among those items considered for approval as a winning bid.

4. Priority should be given to selecting domestic-produced medicines of equivalent quality and not higher in price than imported medicines at the time of bidding.

Article 17. Submission for Approval of Selection Results

1. Responsibility for submission for approval: The agency or organization entrusted by the head of the unit to organize the bidding process is responsible for examining and approving the winning bids and reporting the selection results to the head of the unit, simultaneously sending one set of documents for submission for approval of the selection results to the agency or organization responsible for reviewing the selection results as stipulated in Clause 1, Article 18 of this Circular within forty-five days from the opening of the bids.

2. Documents for submission for approval of selection results

a) One original Report on the evaluation of bid documents and proposal for winning bids.

b) One set of tender documents (photocopies) which have been reviewed and approved in accordance with Articles 12, 13, 14, 15, and 16 of this Circular and current legal provisions on bidding. The documents for submission for approval of the selection results are sent through postal service or directly to the office of the agency or organization responsible for reviewing the selection results for management in accordance with current regulations.

Article 18. Reviewing the Results of Contractor Selection

1. The authority to review the results of contractor selection shall be determined by the head of the unit.

2. Duties of the reviewing agency or organization The reviewing agency or organization shall have the duty to inspect, evaluate, and prepare a report on the results of the contractor selection according to the provisions of this Circular and current laws governing bidding within a period not exceeding fifteen working days from the date of receipt of all relevant documents for submission to the head of the unit for consideration and approval of the contractor selection results.

3. Documents for submitting the review of the contractor selection results include:

a) One original copy of the Report on the Review of the Results of Contractor Selection.

b) One set of documents for submitting the review of the contractor selection results (photocopies) of the agency or organization assigned the task of organizing the bidding as stipulated in Clause 2, Article 17 of this Circular. The documents for submitting the review of the contractor selection results shall be sent via postal service or directly through the office of the person authorized to approve the contractor selection results for management in accordance with current regulations.

Article 19. Approving and Announcing the Results of Contractor Selection

1. The head of the unit shall be responsible for approving the results of contractor selection according to current laws governing bidding within three working days from the date of receipt of all documents for submitting the review of the contractor selection results of the reviewing agency or organization as stipulated in Clause 3, Article 18 of this Circular.

2. The head of the unit shall be responsible for announcing the results of contractor selection according to current laws governing bidding.

Article 20. Winning Bid Price for Medicines

1. The winning bid price for each medicine item shall not exceed the price of that medicine item in the bidding plan already approved by the competent authority.

2. When there is a medicine item in the tender package where the bid prices of all participating contractors are higher than the planned price of that medicine item already approved by the competent authority, the head of the unit shall be responsible for issuing a written notice that no contractor has won the bid and cancel the bidding for that medicine item to reselect the contractor in accordance with current laws governing bidding. In cases of necessity, it must ensure sufficient medicines to meet the healthcare needs of the unit, the head of the unit (or the Director of the Health Department in cases where the Health Department organizes centralized bidding) may consider and decide to select the winning bid for the medicine item based on a written proposal from the Medicine and Treatment Council of the unit (or the agency or organization primarily responsible for reviewing the bidding results in cases where the Health Department organizes centralized bidding) if the following conditions are met:

a) The price of the reviewed winning bid for the medicine item does not exceed the maximum price of that medicine item published at the nearest time by the Ministry of Health. In cases where the maximum price has not been published, the price of the reviewed winning bid for the medicine item does not exceed the effective wholesale price of that medicine item.

b) The total value of the winning bid for medicines does not exceed the price of the tender package for medicines already approved by the competent authority in the bidding plan.

Section 5

OTHER PROVISIONS

Article 21. Reporting the Results of Contractor Selection

1. Within thirty working days after the results of contractor selection are approved, the head of the unit shall be responsible for reporting the results of contractor selection to the approving agency of the bidding plan.

2. Hospitals and institutes under the Ministry of Health, provincial hospitals, and non-public units that have signed contracts for health insurance medical services shall submit reports on the results of contractor selection according to the attached form of this Circular to the Ministry of Health (Drug Administration) to publish on the Drug Administration's website as a basis for reference in building the bidding plan price. Method of submission: By written document and email (address: [email protected]).

**Article 22**: 关于招标费用

**Article 23**: 其他选择承包商形式的适用情况

**Article 23,第1点**: 购买药品适用其他选择承包商形式的情况

**Article 23,第1点,a)**: 突发需求的罕见药品目录中的药品,但未纳入年度招标计划。

**Article 23,第1点,b)**: 年度采购计划之外的药品,以满足紧急专业需求,如:疫情、自然灾害或对患者健康的重大影响。

**Article 23,第1点,c)**: 已列入年度采购计划的药品,但尚未有招标结果或无法选择中标承包商,需紧急购买以满足紧急专业需求。

**Article 23,第1点,d)**: 年度使用量超过已批准计划的药品。超出部分不得超过中标数量的20%。所有药品超出计划的数量在医院内的限额取决于卫生部的分类;具体为:三级和四级医院不超过600万元;一级和二级医院不超过1亿元;特级医院不超过2亿元。

**Article 23,第2点**: 采购要求

**Article 23,第2点,a)**: 单位的医药和治疗委员会审查并书面提议给单位负责人。

**Article 23,第2点,b)**: 药品必须获得越南流通许可,并符合现行法规的质量和有效期要求。

**Article 23,第2点,c)**: 药品价格:单位参考三家供应商的报价或销售发票、批发价申报、重新申报以及国家药品监督管理局网站上公布的售价作为谈判和签订合同的基础。

**Article 23,第3点**: 在上述情况下,单位负责人决定适当的采购方式,符合现行招标法规定。

**Article 24**: 监督、审计和处理违规行为

**Article 24,第1点**: 本通知自2012年6月1日起生效。

**Article 24,第2点**: 废除2007年8月10日由卫生部和财政部联合发布的关于公立医疗机构药品招标采购实施办法的通知(联发〔2007〕10号)。

**Article 24,第1条,1)**: 卫生部负责公布参与EMA、ICH、PIC/S的国家名单;生产设施达到GMP-WHO标准,经越南卫生部(国家药品监督管理局)检查并颁发证书;原研药和证明生物等效性的仿制药清单;具有生物等效性文件的药品清单。

Chapter III

IMPLEMENTING PROVISIONS

Article 25. Effective Date

**Article 24,第1条,2)**: 中央机构负责人指导下属单位按照本通知和现行招标法的规定执行药品招标采购。

**Article 24,第1条,3)**: 省级人民政府主席决定组织下属单位的药品招标采购,具体形式如下:

Article 26. Implementation

**Article 24,第1条,3),a)**: 委托卫生部门为下属单位组织集中招标。各单位根据卫生部门的中标结果公告进行谈判和签订供应合同,依据现行规定。

**Article 24,第1条,3),b)**: 指导下属单位和与当地社会保险办公室签订医疗保险服务合同的非公立单位应用省级综合医院已获批准的承包商选择结果,直接采购药品,符合现行招标法规定。

**Article 24,第1条,3),c)**: 各单位根据自身需求自行组织药品招标采购。

**Article 24,第1条,4)**: 社会保险局参加评标委员会,参与评标小组,审核从医疗基金采购药品的单位的承包商选择结果,按总局长分配的任务执行。

**Article 24,第1条,5)**: 对于在本通知生效前已提交审批的招标计划,按照《招标投标法》、《关于修改和补充若干涉及基本建设投资法律条款的法律》、《国务院关于修改〈中华人民共和国招标投标法〉的决定》(国务院令第85号)、《中华人民共和国药品管理法》(2005年6月14日)和《国务院关于修改〈中华人民共和国药品管理法实施条例〉的决定》(国务院令第79号)、《卫生部、财政部关于公立医疗机构药品招标采购实施办法的通知》(联发〔2007〕10号)的规定执行,确保不违反《招标投标法》及其配套法规。在执行过程中如有问题,请向卫生部和财政部反映研究解决。

**Article 24,第2条**: 在执行过程中如有问题,请向卫生部和财政部反映研究解决。

4. The Social Insurance Office participates in the Evaluation Committees for tender plans, participates in bid evaluation teams, and reviews the results of contractor selection for units procuring medicines from the medical insurance fund according to the分级任务如下:

5. For tender packages that have submitted bidding plans for approval before the effective date of this Circular, implement according to the provisions of the Bidding Law, the Law Amending and Supplementing Certain Articles of Related Laws on Construction Investment, Decree No. 85/2009/ND-CP dated October 15, 2009 of the Government; the Medicine Law dated June 14, 2005 and Decree No. 79/2006/ND-CP dated August 9, 2006 of the Government; the provisions of Joint Circular No. 10/2007/TTLT-BYT-BTC dated August 10, 2007 of the Ministry of Health and the Ministry of Finance guiding the implementation of bidding for medicines in public health facilities to ensure compliance with the Bidding Law and its guiding documents. During the implementation process, if there are any difficulties, please reflect them to the Ministry of Health and the Ministry of Finance for study and resolution.

During the implementation process, if there are any difficulties, please reflect them to the Ministry of Health and the Ministry of Finance for study and resolution./.

DEPUTY MINISTER
MINISTRY OF FINANCE 
DEPUTY MINISTER

Nguyen Thi Minh
DEPUTY MINISTER
MINISTRY OF HEALTH 
DEPUTY MINISTER

Nguyễn Thị Xuyên

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01/2012/TTLT-BYT-BTC
JOINT CIRCULAR NO. 01/2012/TTLT-BYT-BTC GUIDING THE PROCUREMENT OF MEDICINES IN HEALTH CARE FACILITIES
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