Circular No. 11/2016/TT-BYT dated May 11, 2016 of the Ministry of Health on the regulations for tendering medicines at public health facilities

CIRCULAR

PROVISIONS ON BIDDING FOR MEDICINES AT PUBLIC HEALTH CARE FACILITIES

Pursuant to the Law on BiddingNo. 43/2013/QH13 dated November 26, 2013;

Pursuant to the Medicine LawNo. 105/2016/QH13 dated April 6, 2016;

Pursuant to Decree No. 63/2014/NĐ-CP dated June 26, 2014 of the Government detailing implementation of certain provisions of the Law on Bidding regarding selection of contractors;No. Article of the Law on Bidding concerning contractor selection;

Pursuant to Decree No. 63/2012/ND-CP dated August 31, 2012 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Decision No. 08/2016/QĐ-TTg dated February 26, 2016 of the Prime Minister on centralized procurement of state assets;

On the basis ofintention suggestions of the Ministry of Finance in CircularNo. 441/BTC-HCSN dated January 12, 2016; opinions of the Ministry of Planning and Investment in Circulary 10485/BKHĐT-QLĐT dated November 26, 2015;No. to issue this Circular on bidding for medicines at public health care facilities.

At the proposal of the Director of the Department of Planning and Finance,

a) Implementing activities to prevent and control infectious diseases, HIV/AIDS: monitoring, early detection, vaccination, preventive treatment, implementing epidemic control measures, and mitigating the consequences of epidemics; preventing and controlling risk factors for the emergence and spread of epidemics and diseases;policiesArticle 1. Scope of Regulation, Applicability

PART I

GENERAL PROVISIONS

1. This Circular specifies certain contents regarding bidding for medicines funded by state capital, from the health insurance fund, revenue from medical services, and other lawful sources of public health care facilities.

2. This Circular does not apply to the following cases:

a) Medicines ordered by the State and assigned production plans: implemented according to Decree No. 130/2013/NĐ-CP dated October 16, 2013 of the Government on production and supply of public goods and services;|||b) Medical oxygen, nitric oxide (NO), in vitro diagnostic reagents: implemented according to laws governing

 bids for goods and services procurement packages

 for maintaining regular operations of state agencies, units under the people's armed forces, public service organizations, political organizations, political-social organizations, social-professional organizations, social organizations, and social-professional organizations;of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home Affairsa) Tender Document Model for Non-Consulting Services No. 01 (Model No. 01) applies to open tender packages using a one-stage single-envelope method;ầ- Content of dispute.No.c) Whole blood and blood products meeting standards: implemented according to Circularầ33/2014/TT-BYT dated October 27, 2014 of the Minister of Health onắ determining maximum prices and costs for serving the determination of the price of a unit of whole blood and blood products meeting standards.logo3. This Circular applies to agencies, organizations, and individuals participating in or related to the bidding activities for medicines as stipulated in Clause 1 of this Article. 4. Private health care facilities participating in health insurance examination and treatment are subject to the provisions of this Circular.

In this Circular, the following terms are defined as follows:No.1. Original drug is the first drug approved based on complete data on quality, safety, and efficacy.y2. Generic drug is a drug with the same active ingredient, dosage form, and strength as the original drug and is often used as a substitute for the original drug.No.3. Bioavailability is the characteristic indicating the rate and extent to which the active ingredient or substance with therapeutic effect enters the body from a drug to reach the site of action within the body.

4. Bioequivalence is the similarity between two drugs in bioavailability when compared under the same test conditions.

5. Herbal medicine materials are natural raw materials from plants, animals, minerals, and meet the criteria for medicinal use.policies6. Traditional herbal medicine is herbal medicine processed according to the theory and methods of traditional medicine used to produce traditional medicines or for prevention and treatment.12. Leather shoes7. Herbal medicine is a medicine with components from herbal medicine and has effects based on scientific evidence, except traditional medicine.

Article 2. Interpretation of Terms

8. Traditional medicine (including traditional herbal medicine) is a medicine with herbal components processed, prepared, or compounded according to the theory and methods of traditional medicine or folk experience into traditional or modern preparations.đ9. Therapeutic equivalence refers to equivalent formulations and bioequivalent drugs, after being used at the same dose, their effects including efficacy and safety are the same.development10. A pharmaceutical manufacturing facility meeting EU-GMP or PIC/s-GMP standards is a pharmaceutical manufacturing facility certified by the competent authority of a country participating in the European Medicines Agency (EMA) or a country participating in the International Conference on Harmonisation (ICH) or a country participating in the Pharmaceutical Inspection Co-operation Scheme (PIC/s) to meet EU-GMP or PIC/s-GMP standards or equivalents.

11. ICH (International Conference on Harmonisation) is the International Conference on Harmonisation of Procedures for the Registration of Human Drugs.priority12. PIC/S (Pharmaceutical Inspection Co-operation Scheme) is the Pharmaceutical Inspection Co-operation Scheme.

2. Generic drugs are medicines that have the same active ingredient, dosage form, and strength as the original brand-name drug and are often used as substitutes for the original brand-name drug.

3. Bioavailability is the characteristic indicating the rate and extent to which the active ingredient or substance is absorbed from a drug into the body to reach the site of action.developmentto produce an effect.development.

4. Bioequivalence is the similarity in bioavailability between two drugs when compared under the same test conditions.

5. Herbal materials are natural raw materials from plants, animals, minerals, and meet the standards for making medicine.

6. Traditional herbal medicine ingredients are herbal materials processed according to the theory and methods of traditional medicine to produce traditional medicine or for disease prevention and treatment.development disease prevention,12. Leather shoesand treatment.

7. Herbal medicine is a medicine with components from herbal materials and its effects are based on scientific evidence, except for traditional medicine., amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CP8. Traditional medicine (including traditional herbal medicine ingredients) is a medicine with herbal material components processed, formulated, or compounded according to the theory and methods of traditional medicine or folk experience into traditional or modern preparations.

9. Therapeutic equivalence refers to drugs that are equivalent in formulation and bioequivalence, after being used at the same dose, their effects including efficacy and safety are the same.a10. A pharmaceutical manufacturing facility meeting EU-GMP or PIC/s-GMP standards is a pharmaceutical manufacturing facility certified by the competent authority of a country participating in the European Medicines Agency (EMA), the International Conference on Harmonisation (ICH), or the Pharmaceutical Inspection Co-operation Scheme (PIC/s) to meet EU-GMP or PIC/s-GMP standards or equivalents.policies11. ICH (International Conference on Harmonization) is the International Conference on Harmonization of Procedures for the Registration of Medicinal Products for Human Use.

12. PIC/S (Pharmaceutical Inspection Cooperation Scheme) is the Pharmaceutical Inspection Cooperation Scheme.12. Leather shoesb) Revenue from medical examination and treatment services (including revenue paid by the Social Insurance agency):on- Medical examination and treatment insurance contracts signed annually between healthcare facilities and the Social Insurance agency;No.- Actual purchase and use of medicines from the revenue of medical examination and treatment services of the previous consecutive year and the projected need for medicines in the planned year according to the technical tiering of the healthcare facility.

c) For medicines purchased from other sources of the unit: based on the actual purchase and use of medicines from other sources of the previous consecutive year and the projected need for medicines in the planned year according to the technical tiering of the healthcare facility.No.2. In cases where a healthcare facility has organized the selection of contractors and signed contracts but the usage demand exceeds 20% of the quantity in the signed contract (calculated per medicine), the healthcare facility must develop a supplementary contractor selection plan to meet the examination and treatment needs of the unit.No.b) Group 2: Traditional herbal medicine ingredients not meeting the criteria specified in Point a Clause 5 of this Article.

6. Imported drugs manufactured in Vietnam after completing registration procedures as prescribed shall be classified into corresponding groups based on technical criteria and technological standards certified by the competent authority of both the contracting party and the manufacturing party according to the principle of assessing the lower technical criteria. If both the contracting party's and the manufacturing party's drugs meet WHO-GMP standards, they will be classified into Group 5. If foreign drug manufacturing facilities contracted by the Ministry of Health of Vietnam are inspected and certified, they will be classified into Group 3.PIn cases where imported drugs meet EUGMP or PIC/s-GMP standards at production facilities in countries participating in ICH and Australia, after completing registration procedures, they will be classified into corresponding groups based on technical criteria and technological standards certified by the competent authority of the contracting party upon meeting the following conditions:

a) The manufacturing process must include all or some stages of the drug production process. The contract must clearly specify the timeline for the contracting party to transfer comprehensive technology to the manufacturing party, leading to full production in Vietnam within a maximum of five years;

Article 3. Responsibility for developing plans for drug usage and organizing the selection of contractors to supply drugs at healthcare facilities

1. The head of the healthcare facility shall base on the demand for drug usage and the advisory opinions of the Drug and Treatment Council to decide and be responsible for developing the drug usage plan of the unit, including all information prescribed in Article 6 of this Circular and the following provisions:

4. For investment projects specified in Clause 5, Article 38 of this Decree:No.i. For drugs listed in the Centralized Procurement Catalogue at the national level and the Negotiated Price Drug Catalogue: the plan shall be established according to the announcement of the National Centralized Drug Purchasing Unit, with a maximum duration of 36 months, divided into groups of drugs and supply progress quarterly and annually;No.ii. For drugs listed in the Centralized Procurement Catalogue at the provincial level: the plan shall be established according to the announcement of the Provincial Centralized Drug Purchasing Unit, with a maximum duration of 36 months, divided into groups of drugs and supply progress quarterly and annually;

iii. For the drug usage plan organized by the healthcare facility itself to select contractors: it shall be established periodically for a maximum duration of 12 months or ad hoc when there is a need, divided into groups of drugs.

2. Healthcare facilities are responsible for organizing the selection of contractors to supply drugs in accordance with the provisions of Chapter II of this Circular to ensure the regular operation of the unit for drugs outside the Centralized Procurement Catalogue at the national level, the Centralized Procurement Catalogue at the provincial level, and the Negotiated Price Drug Catalogue.

3. The Centralized Procurement Catalogue at the provincial level applies to healthcare facilities in the province and central-level healthcare facilities located in the province. Central-level healthcare facilities are responsible for developing drug usage plans and complying with centralized procurement regulations for drugs at the local level as required of healthcare facilities under local management. The Department of Health and the units purchasing centrally at the provincial level are responsible for consolidating and organizing the procurement of drugs for central-level healthcare facilities located in the province as they would for healthcare facilities under local management.

LAYOUT SELECTION OF CONTRACTORS TO SUPPLY DRUGS AT HEALTHCARE FACILITIESpoliciesSection 1. ESTABLISHING THE PLAN FOR SELECTING CONTRACTORS TO SUPPLY DRUGSắArticle 4. Basis for establishing the plan for selecting contractors

Chapter II

1. The plan for selecting contractors to supply drugs directly selected by the healthcare facility and submitted for approval by the authorized person. The plan is established annually or when there is a need to organize the selection of contractors based on the following grounds:

a. State budget funds: The drug purchase budget from state budget funds for the planning year assigned by the competent authority. In cases where the budget has not been assigned, the actual drug purchases and usage from state budget funds in the previous year and the projected drug usage needs for the planning year shall be the basis for establishing the plan;

b. Revenue from medical examination and treatment services (including revenue paid by the Social Insurance Authority):

- Medical examination and treatment service contracts for health insurance for the planning year signed between the healthcare facility and the Social Insurance Authority;

- Actual drug purchases and usage from medical examination and treatment service revenue in the previous year and the projected drug usage needs for the planning year according to the technical tiering of the healthcare facility.onc. For drugs purchased from other sources of revenue of the unit: based on the actual drug purchases and usage from other sources of revenue in the previous year and the projected drug usage needs for the planning year according to the technical tiering of the healthcare facility.No.2. In cases where the healthcare facility has organized the selection of contractors and signed contracts but the usage demand exceeds 20% of the quantity in the signed contract (calculated per drug), the healthcare facility must develop a supplementary plan for selecting contractors to meet the examination and treatment needs of its own unit.

b) For new drugs undergoing final stage manufacturing (packaging, labeling) for domestic consumption, the maximum duration for such manufacturing is three years; simultaneously, the contract must clearly specify the timeline for the comprehensive technology transfer from the contracting party to the manufacturing party as stipulated in Point a Clause 6 of this Article.

of the healthcare facility. The division of tender packages and drug groups must comply with the provisions of Article 5 of this Circular. If a tender package is divided into multiple parts, the name of each part must correspond to the content of that part. Specific information in the attached annex to the contractor selection plan includes:

If the original brand-name drug is listed in the List of Original Brand-Name Drugs, the Drug Name section must include all original brand names.thc) The name of each part in the traditional medicine and herbal medicine tender package includes the following information: drug name; route of administration, dosage form;

29 ||| d) The name of each part in the herbal medicine tender package and traditional herbal medicine tender package includes the following information: herbal material/traditional herbal medicine name; scientific name; origin; quality standard; initial processing/method of preparation; packaging specifications; technical grouping; unit of measurement; quantity; unit price and total value of the drug.

2. In cases where healthcare facilities have organized contractor selection and signed contracts but the usage demand exceeds 20% of the quantity specified in the signed contract (for each medicine), the healthcare facility must develop a supplementary contractor selection plan to meet its medical examination and treatment needs.

Article 5. Division of Bidding Packages, Groups of Medicines

The head of the healthcare facility shall decide on the division of bidding packages based on the demand for medicines. The bidding packages may be divided as follows:

1. Generic Medicine Bidding Package:

A generic medicine bidding package may include one or more generic medicines, each category of generic medicines must be divided into groups, with each generic medicine within a group being part of the bidding package. The division of these groups is based on technical criteria and technological standards approved as follows:

a) Division of medicine groups:

- Group 1 includes:

+ Medicines produced on production lines meeting EU-GMP or PIC/s-GMP standards at manufacturing facilities located in countries participating in ICH and Australia;

+ Medicines produced on production lines meeting WHO-GMP standards certified by the Ministry of Health of Vietnam and permitted for circulation by the competent national authority in countries participating in ICH or Australia;

- Group 2: Medicines produced on production lines meeting EU-GMP or PIC/s-GMP standards but not located in countries participating in ICH and Australia;

- Group 3: Medicines produced on production lines meeting WHO-GMP standards certified by the Ministry of Health of Vietnam;

- Group 4: Medicines proven to have bioequivalence announced by the Ministry of Health; - Group 5: Medicines that do not meet the criteria of Groups 1, 2, 3, and 4 as stipulated in Point a Clause 1 of this Article.

b) In the generic medicine bidding package, if a bidder has medicines meeting the technical criteria of a particular group, they can bid for that group. If a medicine meets the criteria of multiple groups, the bidder can bid for one or more groups where the medicine meets the technical criteria and must have a unified bid price across all groups they bid for, specifically:development- A bidder with medicines meeting the criteria of Group 1 can bid for Groups 1, 2, and 5;

- A bidder with medicines meeting the criteria of Group 2 can bid for Groups 2 and 5;

- A bidder with medicines meeting the criteria of Group 3 can bid for Groups 3 and 5; - A bidder with medicines meeting the criteria of Group 4 can bid for Group 4 or another group if it meets the criteria of that group;

- A bidder with medicines that do not meet the criteria of Groups 1, 2, 3, and 4 can only bid for Group 5. c) In cases where a bid involves multiple entities participating in the production process, all entities involved in the production of the medicine must meet the criteria of the medicine group to participate in the bidding.

2. Original Brand Name Medicine or Equivalent Treatment Bidding Package: a) The head of the healthcare facility may decide to purchase original brand name medicines or equivalent treatments upon recommendation by the Medicine and Treatment Council;

b) Medicines included in the original brand name medicine or equivalent treatment bidding package consist of original brand name medicines and medicines with equivalent treatment to original brand name medicines listed by the Ministry of Health.

3. Traditional Medicine or Herbal Medicine Bidding Package (excluding traditional herbal medicines specified in Clause 5 of this Article):

These are divided into groups based on technical and technological criteria approved as follows:êa) Group 1: Traditional medicines and herbal medicines produced on production lines meeting WHO-GMP standards for traditional medicines and herbal medicines and certified by the Ministry of Health of Vietnam;

b) Group 2: Traditional medicines and herbal medicines produced on production lines not yet certified by the Ministry of Health of Vietnam to meet WHO-GMP standards.

A bidder with traditional medicines and herbal medicines meeting the criteria of Group 1 can bid for Groups 1 and 2; if bidding for both groups, they must have a unified bid price for both groups.

4. Herbal Medicine Bidding Package:

a) Group 1: Herbal medicines cultivated and harvested meeting GACP-WHO standards;

b) Group 2: Herbal medicines not meeting the criteria of Point a Clause 4 of this Article.

A bidder with herbal medicines meeting the criteria of Group 1 can bid for Groups 1 and 2; if bidding for both groups, they must have a unified bid price for both groups.

5. Traditional Herbal Medicine Bidding Package:

a) Group 1: Traditional herbal medicines processed by facilities meeting conditions for processing herbal medicines, published on the Electronic Information Portal of the Traditional Medicine Management Department;

b) Group 2: Traditional herbal medicines not meeting the criteria of Point a Clause 5 of this Article.

A bidder with traditional herbal medicines meeting the criteria of Group 1 can bid for Groups 1 and 2 but must have a unified bid price for both groups. Add

6. Foreign Medicines Produced in Vietnam After Completing Registration Procedures As Per Regulations Are Divided Into Corresponding Groups Based On Technical Criteria And Technological Standards Already Certified By The Competent Authority Of Both The Commissioning Party And The Contract Manufacturer According To The Principle Of Evaluating Based On The Lower Technical Criteria. If Both The Commissioning Party And The Contract Manufacturer's Medicines Meet WHO-GMP Standards, They Will Be Classified Into Group 5. If Foreign Medicine Production Facilities Of The Commissioned Medicines Have Been Inspected And Certified By The Ministry Of Health Of Vietnam, They Will Be Classified Into Group 3.No.ument permittof the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home AffairsIn cases where foreign medicines produced in facilities located in countries participating in ICH and Australia, which meet EU-GMP or PIC/s-GMP standards, are manufactured in Vietnam after completing registration procedures as per regulations, they will be classified into corresponding groups based on technical criteria and technological standards certified by the competent authority of the commissioning party when the following conditions are met:

a) The manufacturing process must include the entire or some stages of the drug production process. The contract manufacturing agreement must clearly specify the timeline for the commissioning party to transfer comprehensive technology to the contract manufacturer, leading to full domestic production in Vietnam within a maximum period of five years;

b) For new drugs undergoing final stage manufacturing (packaging, labeling) for consumption in Vietnam, the maximum duration for final stage manufacturing is three years; simultaneously, the contract manufacturing agreement must clearly specify the timeline for the commissioning party to comprehensively transfer technology to the contract manufacturer according to the schedule specified in Point a Clause 6 of this Article.

When preparing the contractor selection plan, it must ensure that the planned price proposed by the healthcare facility does not exceed the current wholesale price declaration/re-declaration of the referenced drug. For drugs with few suppliers, less than three quotations or sales invoices, the head of the healthcare facility bases the quotation or invoice.Article this.

Contractors with traditional herbal medicines meeting the criteria in Group 1 may participate in bidding for both Group 1 and Group 2, but they must offer a unified price bid for both groups.

6. Foreign medicines manufactured in Vietnam, after completing registration procedures as prescribed, shall be classified into corresponding groups based on technical criteria and technological standards certified by the competent authority of the commissioning party and the manufacturing party according to the principle of assessing the lower technical criteria of the two parties.on. If both the foreign medicine and the domestic manufacturer meet WHO-GMP standards, they will be categorized into Group 5. Ipoliciesf the foreign medicine production facilities are inspected and certified by the Ministry of Healthpolicies of Vietnam, they will be categorized into Group 3.

In cases where foreign medicines meet EThe decision to switch the issuance of coats, overcoats, windbreakers, and down jackets to other uniforms for civil servants working at the National Market Management and Development Agency is decided by the Minister of Industry and Trade.-GMP or PIC/s-GMP standards at production sites in countries participating in ICH and Australia, which are manufactured in Vietnam, after completing registration procedures as prescribed, they will be categorized into corresponding groups based on technical criteria and technological standards certified by the competent authority of the commissioning party when meeting the following conditions: a) The manufacturing process must include all or some stages of the drug production process. The contract must clearly specify the timeline for the commissioning party to transfer comprehensive technology to the manufacturing party, aiming for full production in Vietnam within five years;

b) For new drugs that only undergo final processing (packaging, labeling) for sale in Vietnam, the maximum duration for this final processing stage is three years; the contract must also clearly specify the timeline for the comprehensive technology transfer from the commissioning party to the manufacturing party as stipulated in Point a, Clause 6 of this Article.

 ning party transfersdevelopment comprehensive technology to the manufacturing party according to the schedule set out in Point a, Clause 6 of this Article.development of the healthcare facility. The division of tender packages and classification of medicines should comply with the provisions of Article 5 of this Circular. When a tender package is divided into multiple parts, the name of each part must correspond to the content of that part. Specific information included in the appendix accompanying the contractor selection plan is as follows:

Article 6. Content of the tender selection plan

1. Name of the tender package: Must reflect the nature, content, and scope of work of the tender package; be consistent with usage needs and classification of medical facilities. The division of tender packages and groups of drugs must comply with the provisions set forth in Article 5 of this Circular. In cases where a tender package is divided into multiple parts, the name of each part must be consistent with the content of that part. Specific information included in the attached appendix to the tender selection plan is as follows:ỹ if the medicine is listed in the List of Original Brand Name Drugs, then the drug name must fully list all brand names;đc) For each part in the tender package for traditional medicines and herbal medicines, the following information must be provided: drug name; route of administration, form of preparation;

a) For each part in the generic drug tender package, the following information shall be provided: active ingredient name; drug group (or technical group); concentration/potency; route of administration, dosage form; unit of measurement; quantity; unit price and total value of the drug.

b) For each part in the original brand-name drug or equivalent treatment tender package, the following information shall be provided: drug name accompanied by the phrase "or equivalent treatment"; active ingredient name; concentration/potency; route of administration, dosage form; unit of measurement; quantity; unit price and total value of the drug. In cases where a single active ingredient has multiple brand names listed in the List of Original Brand-Name Drugs published by the Ministry of Health, the Drug Name section must include all brand names.No.unit of measurement; and the Drug and Treatment Regulation.

d) For each part in the tender package for herbal medicines and traditional medicines, the following information must be provided: name of herbal medicine/traditional medicine; scientific name; origin; quality standard; initial processing method/preparation method; packaging specifications; technical grouping; unit of measurement; quantity; unit price; and total value of the medicine. ctors must prepare a contractor selection plan; meanwhile, ensuring that the proposed planned price by the healthcare facility does not exceed the declared wholesale price of the referenced medicine. For medicines with few suppliers, less than three quotations or sales invoices, the head of the healthcare facility must base the quotation or invoice.In cases where the usage demand for medicines at healthcare facilities exceeds 20% of the quantity allocated in the framework agreement, a report must be submitted to the centralized purchasing unit to aggregate and adjust the quantity of medicines among healthcare facilities within the local supply area.policiesIn cases where the usage demand for medicines at localities or central healthcare facilities (excluding those participating in centralized medicine procurement with the locality) exceeds 20% of the quantity allocated in the framework agreement, a report must be submitted to the national centralized purchasing unit to aggregate and adjust the quantity of medicines among localities and central healthcare facilities, ensuring it does not exceed 20% of the quantity in the national centralized contractor selection plan or the negotiated price plan approved.No.b) Quantity; drug group; unit price and total value of the drug.

The naming of drugs in traditional medicine and herbal medicine tender packages shall be as follows:

- Only the components of the drug should be named, not the trade name;

- In cases where drugs have the same components and dosage forms, the concentration/potency of the drug component must be specified when differences in concentration/potency lead to differences in dosages and treatment indications, and such specifications must be based on the advice of the Pharmaceutical Council and Treatment.đThe validity period of centralized medicine purchase results (national, local) and negotiated prices is defined in the contractor selection plan approved by the competent authority but shall not exceed 36 months, starting from the date the centralized purchase results, negotiated price results, and framework agreements become effective.

The competent authority will review and approve the negotiated price results based on the report of the appraisal unit.

c) For each part in the herbal medicine or traditional medicine formula tender package, the following information shall be provided: herbal medicine/traditional medicine formula name; scientific name; origin; quality standards; initial processing/method of preparation; packaging specifications; technical grouping; unit of measurement; quantity; unit price and total value of the drug.

2. Tender Package Price:

a) The tender package price is the total value of the tender package, including all costs required to implement the tender package;gb) In cases where the tender package is divided into multiple parts, in addition to recording the total value of the tender package, each part must clearly state its unit price and total value according to the provisions of Clause 1 of this Article. The drug unit prices in the tender selection plan are proposed by the healthcare facility and they bear responsibility for them.

c) When preparing the tender selection plan, the entity must refer to the winning bid prices of drugs from the past 12 months of healthcare facilities updated and announced on the Electronic Information Portal by the Ministry of Health (Drug Administration Department, Traditional Medicine and Drug Administration Department) or the Vietnam Social Security to establish the unit price of each drug, specifically:

- Refer to the winning bid prices of drugs on the Electronic Information Portal of the Drug Administration Department, Traditional Medicine and Drug Administration Department, or the Vietnam Social Security to establish the unit price of each drug according to the principle: The planned price of each drug must not exceed the highest winning bid price of that drug within each drug group as announced;

- For drugs without announced winning bid prices or whose prices at the time of planning are higher than the winning bid prices announced by the Ministry of Health (Drug Administration Department, Traditional Medicine and Drug Administration Department) or the Vietnam Social Security within the past 12 months, healthcare facilities must refer to quotations or sales invoices from at least three drug suppliers in the market at the time of preparing the tender selection plan; while ensuring that the planned price proposed by the healthcare facility does not exceed the wholesale price declaration/re-declaration still in effect for the referenced drugs. For drugs with few suppliers, less than three quotations or sales invoices, the head of the healthcare facility must base the quotation or invoice of the supplier, explain, and take responsibility for the planned price proposed by the healthcare facility being appropriate to the market price of that drug at the time of preparing the tender selection plan.developmentWhen replacing medicines, contractors must provide all necessary information for the Inviting Party to evaluate the replacement, including: a copy (with the contractor's confirmation stamp) of the Product Registration Certificate (MA) or Pharmaceutical Product Certificate (CPP), any letters approving changes or additions from the state management agency (if applicable), sample labels or Instructions for Use with the approval agency's confirmation stamp, and a statement confirming that the quality standards of the tendered medicine and the replacement medicine remain unchanged.ầuprice quotation from the supplier, explain and be responsible for the planned price which must be consistent with the market price of that medicine at the time of preparing the tender selection plan.policiesandonmust clearly state the name of the sponsor and the capital structure, including the sponsored capital and domestic counterpart capital (if any).

3. Source of Funds: Healthcare facilities must clearly record the source of funds used to purchase drugs; if official development assistance funds or preferential loans are used, the name of the sponsor and the structure of the funding sources, including the sponsored funds and domestic counterpart funds (if any), must be clearly stated.ìmethod of selecting the contractor: the medical facility bases on the form of selecting the contractor,

4. Form and Method of Selecting Contractors:

a) Form of selecting contractors: Healthcare facilities must choose one of the forms of selecting contractors stipulated from Article 20 to Article 25 of the Bidding Law and detailed guidance provided in this Circular based on the scale and nature of each tender package.

b) Method of selecting contractors: Healthcare facilities must propose the method of selecting contractors according to the provisions of Article 28 and Article 29 of the Bidding Law and Decree No. 63/2014/NĐ-CP dated June 26, 2014 of the Government detailing the implementation of certain provisions.ograms andscale of the tender to propose the method of selecting the contractor in accordance with Article 28, Article 29 of the Bidding Law and Decree No. 63/2014/NĐ-CP dated June 26, 2014 of the Government detailing implementation.BB 1.6person with authority to review and decide;No. Article of the Bidding Law on selecting contractors (hereinafter referred to as Decree No. 63/2014/ND-CP) and specific guidance provided in this Circular. For small-scale drug procurement packages that require selection based on a combination of quality and price, the two-envelope bidding method shall be applied.

5. Time for organizing the selection of contractors: record the expected time for issuing tender documents or request for proposal documents in months or quarters within the year.

6. Type of contract: select and apply the form of contract according to the scale, nature of the package, and supply method as stipulated in Article 62 of the Bidding Law.

7. Contract implementation period: specified in the contractor selection plan but not exceeding 12 months from the effective date of the contract until all parties fulfill their obligations as prescribed in the contract.

Article 7. Approval of the contractor selection plan

1. Responsibility for submitting the approval of the contractor selection plan: at least three months before the previous drug supply contract expires, the head of the healthcare facility has the responsibility to submit the contractor selection plan for review and approval by the authorized person.

2. The document for approving the contractor selection plan for drug supply includes the following basic contents:

a)Basis for establishing the contractor selection plan for drug supply as stipulated in Article 4 of this Circular;

b)Contents of the contractor selection plan as stipulated in Article 6 of this Circular must be clearly stated:

- Names of each tender package, prices of individual parts and total package price, total value of all tender packages in the contractor selection plan, and the basis for dividing the tender packages. In cases where drugs are purchased from the state budget, the total value of all tender packages in the contractor selection plan must not exceed the approved total budget for drug purchases;

- Forms and methods of selecting contractors for each tender package according to one of the forms and methods of selecting contractors stipulated in Articles 10, 12, 13, 14, 15, 16, and 17 of this Circular. In cases where open bidding is not applied, the reasons for proposing the application of other forms of contractor selection must be clearly stated in the document submitted for approval of the contractor selection plan for the authorized person to consider and decide;developmentorganization to assess the tender selection plan;

- List and quantity of drugs in each part of the contractor selection plan must comply with the provisions of Article 3 of this Circular and have a roadmap to increase the proportion of domestically produced drugs.

3. Documents attached to the document for approving the contractor selection plan:

a)Summary report on the results of implementing the contractor selection plan, drug usage situation of the previous year, and a brief explanation of the contractor selection plan being submitted for approval;

b)Documents serving as the basis for establishing the contractor selection plan for drug supply as stipulated in Article 4 of this Circular;

c)Minutes of meetings and advisory opinions of the Drug and Treatment Council of the healthcare facility regarding the list, quantity of drugs, demand for original brand-name drugs or equivalents, recording the name and dosage of traditional medicine and herbal drugs in the drug tender package, and recording the source of herbal drugs and traditional medicines in the herbal drug tender package.

4. The document for approving the contractor selection plan shall be sent via postal service or directly to the competent authority responsible for approving the contractor selection plan for management in accordance with the law.

Article 8. Review of the Procurement Plan

The procurement plan for selecting suppliers to provide medicines must be reviewed before being submitted to the competent authority for examination and approval.

1. Reviewing organization:

a)For public health facilities under the management of Ministries, agencies at the ministerial level, and government agencies: The Minister, Head of the agency at the ministerial level, or government agency decides on the unit to organize the review of the procurement plan for selecting suppliers;ầfrom the date of receiving all relevant documents. In case of insufficient documents as prescribed, the unit

b)For public health facilities under local management: The Department of Health shall take the lead and coordinate with relevant agencies at the locality to organize the review of the procurement plan for selecting suppliers;

2. Tasks of the reviewing unit:

a)Check and evaluate the contents stipulated in Articles 4, 5, 6, and 7 of this Circular within twenty days from the date of receiving all related documents. In cases where the required documents are not complete, the reviewing unit has the responsibility to notify, request supplementation of documents, or return the dossier to the health facility within five working days from the date of receipt of the documents;developmentdetermined has the responsibility to notify, request supplementary documents or return therime Minister cdossier to the medical facilityồwithin five working days, counted from the date of receipt of the documents;policiesNo. 2 issued together with Circular

b)Prepare the review report according to Model 2 issued together with Circular /2015/TT-BKHĐT dated October 26, 2015 of the Ministry of Planning and Investment detailing the procurement plan for selecting suppliers, along with one set of the dossier for the review of the procurement plan for selecting suppliers of the health facility under review (original copy), and submit it to the competent authority specified in Article 9 of this Circular for examination and approval of the procurement plan for selecting suppliers.FUNCTIONS, DUTIES, POWERS, ORGANIZATIONAL STRUCTURE, OPERATIONAL REGULATIONS, AND RELATIONSHIPS OF MANAGEMENT BOARDS; DUTIES, POWERS OF THE CHAIRPERSON, VICE CHAIRPERSON (IF ANY), SECRETARY, AND MEMBERS OF MANAGEMENT BOARDS/2015/TT-BKHĐT dated October 26, 2015 of the Ministry of Planning and Investment10detailing about the tender selection plan accompanied by one set of dossier submitted for approval of the tender selection plan of the medical facility (original copy), to be reviewed by the personywith authority as stipulated in Article 9 of this Circular to approve the tender selection plan. within five working days, counted from the date of receipt of the assessment report and the dossier submitted for approval of the tender selection plan of the medical facility.yManufacturers and suppliers of medicines that have been preliminarily selected by the Ministry of Health into the list of manufacturers and suppliers of medicines meeting the requirements of capacity, experience, and reputation as prescribed in

Article 9. Approval of the Procurement Plan

1. Authority to approve the procurement plan for selecting suppliers:

a)The Minister, Head of the agency at the ministerial level, or government agency is responsible for approving the procurement plan for selecting suppliers to provide medicines for public health facilities under their jurisdiction;

b)The Chairman of the People's Committee of provinces and centrally-administered cities is responsible for approving the procurement plan for selecting suppliers to provide medicines for public health facilities under their jurisdiction;

c)The Minister, Head of the agency at the ministerial level, or government agency, and the Chairman of the People's Committee of provinces and centrally-administered cities may delegate the authority to approve the procurement plan for selecting suppliers in accordance with the laws on regular procurement.

2. The competent authority specified in Clause 1 of this Article is responsible for approving the procurement plan for selecting suppliers within five working days from the date of receiving the review report and the dossier for the review of the procurement plan for selecting suppliers of the health facility.organize credit institutions, foreign bank branches are responsible for organizing the implementation of this Circular.hThis Resolution takes effect from the date it is adopted by the National Assembly.Point d Clause 1 Article 77 of Decree No. 63/2014/NĐ-CP

3. The procurement plan for selecting suppliers to provide medicines must be published on the national bidding system in accordance with Article 8 of the Bidding Law and guiding documents.ướSection 2. PROCUREMENT METHODS

Article 10. Open Bidding

Open bidding shall be applied to all packages within the scope of adjustment of this Circular, except for the cases specified in Articles 11, 12, 13, 14, and 15 of this Circular.

Article 11. Restricted Bidding

Restricted bidding shall be applied in cases where the package for purchasing medicines requires high technical specifications or has special characteristics that only a few suppliers can meet the requirements of the package.

1. Manufacturers and suppliers of medicines that have been preliminarily selected by the Ministry of Health into the list of manufacturers and suppliers of medicines meeting the requirements of capacity, experience, and reputation as stipulated in Point d Clause 1 Article 77 of Decree No. 63/2014/NĐ-CPshallshall be invited to participate in the restricted bidding process if there are medicines suitable for the package.

2. shall be invited to participate in the limited bidding process if they have suitable medicines for the tender package.based on quality and price.requiredpoliciesif the imported medicine belongs to the group specified in the tender notice and request for proposal.

Article 12. Direct Assignment

1. The cases where direct assignment is allowed include:

a)Bids specified in Point a Clause 1 Article 22 of the Bidding Law;

b)Bids specified in Article 79 of Decree No. 63/2014/NĐ-CP.

If a level crossing meets the conditions for signal connection as stipulated in Clause 1, Point c of Article 4 of this Circular but cannot achieve signal connection, the organization managing traffic lights on roads and the project investor implementing investment, construction, and upgrading of roads and railways in the area of the level crossing must report to the Ministry of Transport for consideration and decision.nationalp ch无效Direct assignment according to Point a Clause 1 Article 22 of the Bidding Law (except for bids necessary to ensure state secrets), after the investor or the directly responsible management agency determines and assigns the bid to a contractor with sufficient capacity and experience, within seven working days from the date of assignment, the investor must complete the procedures to submit the plan for selecting contractors to the competent authority for approval;trIn this case, it is not mandatory to conduct an assessment of the plan for selecting contractors.

2. The process of direct assignment shall be carried out in accordance with the provisions of Articles 55 and 56 of Decree No. 63/2014/NĐ-CP.

Article 13. Competitive Quotation

1. Bids shall be implemented through competitive quotation when the following conditions are met:

a)The value of the bid does not exceed five billion VND;

b)Medicines listed in the Essential Medicines List issued by the Ministry of Health or commonly used medicines available on the market with standardized technical specifications and quality equivalent to those listed;gThere is a plan for selecting contractors approved by the competent authority;

c)In the case of purchasing from the state budget, there must be an approved budget for purchasing medicines. In the case of purchasing medicines from other sources,

d)the healthcare facility must ensure the funding source for payment according to the progress of implementing the bid.ì the healthcare facility must ensure the funding source for payment according to the progress of implementing the bid.development the healthcare facility must ensure the funding source for payment according to the progress of implementing the bid.

2. The process of competitive quotation shall be carried out in accordance with the provisions of Articles 58 and 59 of Decree No. 63/2014/NĐ-CP.

Article 14. Direct Purchase

1. Bids shall apply the direct purchase form when meeting the following conditions:

a)The contractor has won the bid to supply medicines through open bidding or restricted bidding and has signed a contract to implement the previous bid;

b)The bid includes similar medicines and has a smaller scale than 130% of the previous bid's scale. If the medicine in the direct purchase bid is one of many medicines in a similar bid previously signed, then the scale of the medicine subject to direct purchase must be smaller than 130% of the scale of the same type of medicine in the similar previous bid;ồ the direct purchase bid must be smaller than 130% of the scale of the same type of medicine in the similar previous bid;ồThe unit price of the medicines in the bid applying the direct purchase form must not exceed the price of corresponding medicines in the previous bid, while also being consistent with the winning bid price at the time of negotiating the contract;

c)The period from signing the contract of the previous bid to the approval of the direct purchase result shall not exceed twelve months. Within twelve months, the healthcare facility may only make a direct purchase once for each item in the previous bid, in special cases, the healthcare facility must have a document submitted to the competent authority specified in Clause 1 Article 9 of this Circular for consideration and decision.N ||| declaration of customs import procedures. the direct purchase bid must not exceed the price of corresponding medicines in the previous bid, while also being consistent with the winning bid price at the time of negotiating the contract;No. the direct purchase bid must not exceed the price of corresponding medicines in the previous bid, while also being consistent with the winning bid price at the time of negotiating the contract;ồ;

d)The period from signing the contract of the previous bid to the approval of the direct purchase result shall not exceed twelve months. Within twelve months, the healthcare facility may only make a direct purchase once for each item in the previous bid, in special cases, the healthcare facility must have a document submitted to the competent authority specified in Clause 1 Article 9 of this Circular for consideration and decision.ắ purchase directly.policies purchase directly.ồ purchase directly.policies the healthcare facility must have a document submitted to the competent authority specified in Clause 1 Article 9 of this Circular for consideration and decision.

2. If the contractor who implemented the previous contract is unable to continue implementing the direct purchase bid, direct purchase can be applied to another contractor if they meet the requirements of capacity, experience, technology, and price according to the tender documents and the results of the previous selection of contractors.No. If the contractor who implemented the previous contract is unable to continue implementing the direct purchase bid, direct purchase can be applied to another contractor if they meet the requirements of capacity, experience, technology, and price according to the tender documents and the results of the previous selection of contractors.ỹ If the contractor who implemented the previous contract is unable to continue implementing the direct purchase bid, direct purchase can be applied to another contractor if they meet the requirements of capacity, experience, technology, and price according to the tender documents and the results of the previous selection of contractors.

3. The process of direct purchase shall be carried out in accordance with the provisions of Article 60 of Decree No. 63/2014/NĐ-CP.

Article 15. Self-execution

1. Self-execution shall be applied to tender packages as stipulated in Article 25 of the Bidding Law when all conditions prescribed in Article 61 of Decree No. 63/2014/ND-CP are met.

2. The self-execution process shall be implemented in accordance with the provisions of Article 62 of Decree No. 63/2014/ND-CP.

Section 3. METHODS OF SELECTING SUPPLIERS FOR MEDICINES

Article 16. One-stage one-envelope method

The one-stage one-envelope method for selecting suppliers for medicines shall be applied in the following cases:

1. Tender packages for purchasing medicines under open bidding or restricted bidding but with small scale (the value of the tender package does not exceed 10 billion VND) as prescribed in Article 63 of Decree No. 63/2014/ND-CP.

2. Tender packages for purchasing medicines under competitive bidding.

3. Tender packages for purchasing medicines under direct procurement.

4. Tender packages for purchasing medicines under ordinary designated bidding.

Article 17. One-stage two-envelope method

The one-stage two-envelope method for selecting suppliers shall be applied in the following cases:

1. Tender packages for purchasing medicines under open bidding or restricted bidding with a value exceeding 10 billion VND.

2. Tender packages for purchasing medicines under open bidding or restricted bidding with a value not exceeding 10 billion VND but where the medicines need to be selected based on a combination of quality and price.12. Leather shoesdecision.

Section 4. INVITATION TO TENDER AND REQUEST FOR PROPOSAL FOR MEDICINES

Article 18. Preparation of Invitation to Tender and Request for Proposal

1. The preparation of the Invitation to Tender and Request for Proposal for medicines must be carried out in accordance with the Bidding Law, implementing guidelines, and the model Invitation to Tender for medicines using the one-stage one-envelope method prescribed in Appendix 03 or the model Invitation to Tender for medicines using the one-stage two-envelope method prescribed in Appendix 04 issued together with this Circular.

2. Based on the approved plan for selecting suppliers, the tenderer has the responsibility to prepare the Invitation to Tender and Request for Proposal for medicines and submit the approval dossier to the main unit responsible for reviewing the Invitation to Tender and Request for Proposal. Administrative Procedure: Recognition of forest tree planting seed sources Request amount specifically in the tender notice, rquarantine upon import.

3. For medicines listed in the Domestic Medicine Catalogue that meet treatment requirements, medicine prices, and supply capacity announced by the Ministry of Health under the technical criteria of a certain group of medicines, the Invitation to Tender and Request for Proposal must specify that bidders cannot offer imported medicines belonging to that group.gequest for proposal. The bid security value of the tender package is equivalent to 1% to 3% of the tender package value, for small-scale tender packages, the bid security value is from 1% to 1.5% of the tender package value.

Article 19. Review of Invitation to Tender and Request for Proposal

1. The Invitation to Tender and Request for Proposal for supplying medicines must be reviewed before being submitted to the head of the healthcare facility for examination and approval.

2. The review unit for the Invitation to Tender and Request for Proposal is decided by the head of the healthcare facility.policiesIf the bidder participates in multiple parts of the tender package, then the bid security value that the bidder must provide is the total bid security value of the parts in which the bidder participates.

3. Tasks of the reviewing unit:

a)Check the contents of the Invitation to Tender and Request for Proposal in accordance with the Bidding Law, implementing guidelines on selecting suppliers, and the provisions of this Circular;

b)Prepare a review report on the Invitation to Tender and Request for Proposal in accordance with the legal regulations on selecting suppliers, accompanied by one set of the Invitation to Tender and Request for Proposal (original), to be submitted to the head of the healthcare facility for examination and approval within 20 days from the date of receiving all relevant documents.

Article 20. Approval of Invitation to Tender and Request for Proposal

The head of the healthcare facility is responsible for approving the Invitation to Tender and Request for Proposal within a period not exceeding 10 days from the date of receipt of the complete dossier and the review report of the review unit for the Invitation to Tender and Request for Proposal.

Section 5. ORGANIZATION OF SELECTION OF PHARMACEUTICAL SUPPLIERS

Article 21. Bidding Guarantee, Submission of Bidding Documents, Proposal Documents

1. The head of the healthcare facility (or the tenderer) must specify the bidding guarantee value in specific currency in the tender invitation document, request document. The bidding guarantee value for the pharmaceutical tender package shall be equivalent to 1% to 3% of the tender package price, for small-scale tender packages, the bidding guarantee value shall be from 1% to 1.5% of the tender package price.No.prepare the tender notice and request for proposal in compliance with the provisions of the Bidding Law and the regulations of the Ministry of Health on preparing the tender notice and request for proposal for purchasing medicines in medical facilities.ồAppendix 03 or Appendix 04 issued together with this Circular and must be clearly stated in the tender notice and request for proposal. There is a responsibility to implement preferential treatment in selecting contractors as prescribed in Articles 3, 4, 5, and 6 of Decree No. 63/2014/NĐ-CP.

In cases where the pharmaceutical tender is divided into multiple parts, the bidding guarantee value for each part shall be expressed as a specific value equivalent to 1% to 3% of that part's price within the tender package price, for small-scale tender packages, the bidding guarantee value shall be from 1% to 1.5% of that part's price within the tender package price.

2. The bidder may participate in one or several or all parts of the tender package. If participating in one part of the tender package, the bidding guarantee value that the bidder must provide shall be equal to the total bidding guarantee value of the parts in which the bidder participates.No.The head of the medical facility approves the result of the contractor selection. In cases of open bidding and limited bidding under the two-envelope system, the evaluation period for the tender proposals is the sum of the technical proposal evaluation period (counted from the closing date to the date when the tenderer submits the list of technically qualified contractors to the head of the medical facility for approval) and the financial proposal evaluation period (counted from the opening date of the financial proposal to the date when the tenderer submits the result of the contractor selection to the head of the medical facility for approval). In cases of

3. The bidder may choose one of the following forms of bidding guarantee: Bidding Regulations detailed herein:

a)A letter of guarantee issued by a bank or credit institution operating legally in Vietnam;

b)Deposit by check.

4. The validity period of the bidding documents, proposal documents is determined by the tenderer in the tender invitation document, request document but not exceeding 180 days, starting from the bid closing date. If necessary, the validity period of the bidding documents, proposal documents can be extended and must ensure the supply progress of the healthcare facility. Bidders must submit at least two sets (one original and one copy) of the bidding documents or proposal documents according to the provisions in the tender invitation document, request document to the tenderer before the bid closing date.

Article 22. Evaluation of Bidding Documents, Proposal Documents

1. Depending on the nature, scale of the tender package, and the form, method of selecting bidders, the head of the healthcare facility selects the evaluation method of bidding documents, proposal documents stipulated in Articles 39 and 41 of the Bidding Law, as appropriate. The evaluation method of bidding documents, proposal documents must be specified in detail in the tender invitation document, request document.

2. The tenderer evaluates the bidding documents, proposal documents for each part of the tender package based on compliance with the provisions of the Bidding Law and the Ministry of Health's regulations on preparing tender invitation documents, request documents for purchasing medicines in healthcare facilities.ỗextension, the tender proposal evaluation period may be extended but not exceeding twenty days and must ensure the supply progress of medicines to the medical facility.

3. The criteria for evaluating bidding documents, proposal documents are implemented according to the provisions in the tender invitation document template in Appendix 03 or Appendix 04 issued together with this Circular and must be clearly stated in the tender invitation document, request document. There is a responsibility to implement preferential treatment in selecting bidders as prescribed in Decree No. 63/2014/ND-CP, Articles 3, 4, 5, and 6.gThe technical and price ranking first and invited to negotiate the contract.

4. The bidding document evaluation process, proposal document evaluation process: depending on the bidding method approved by the competent authority, specifically:

a)One-stage one-envelope method: carried out in accordance with the provisions of Decree No. 63/2014/ND-CP, Articles 15, 16, 17, and 18;

b)One-stage two-envelope method: carried out in accordance with the provisions of Decree No. 63/2014/ND-CP, Articles 27, 28, 29, and 30.

5. The maximum time for evaluating proposal documents is 30 days; for bidding documents, it is 45 days; for small-scale tender packages, the maximum time for evaluating bidding documents is 25 days, from the bid closing date to the date when the tenderer submits the selection results to the head of the healthcare facility for approval. For open tendering and restricted tendering using the one-stage two-envelope method, the time for evaluating bidding documents equals the sum of the time for evaluating technical proposal documents (from the bid closing date to the date when the tenderer submits the list of technically qualified bidders to the head of the healthcare facility for approval) plus the time for evaluating financial proposal documents (from the opening of financial proposal documents to the date when the tenderer submits the selection results to the head of the healthcare facility for approval). In other cases, the evaluation time for bidding documents, proposal documents may be extended but not more than 20 days and must ensure the supply progress of medicines for the healthcare facility.Deputy ministers of ministerial-level agencies,The lowest evaluated price for the lowest price method; the lowest evaluated price for the evaluated price method; the highest combined score for the technical and price combination method in that group of medicines.ầimplementation;policiesregarding bidding.onIf the quantity of medicines in a group of medicines in the signed contract cannot be supplied further due to force majeure reasons, in such cases, a written notification accompanied by supporting documents must be provided.

Article 23. Contract Negotiation and Bid Award Proposal

1. Contract negotiation shall be conducted prior to the bid award proposal by the tenderer. The tenderer shall propose the winning bid according to each part of the procurement plan that has been approved based on compliance with the provisions of the Bidding Law and guiding documents regarding drug quality management and drug price management.

For each medicine in the tender package or within each group of medicines (a part of the tender package), the bidder with the lowest corrected and adjusted bid price, after deducting the lowest discount value (if applicable) for the lowest price method; the lowest evaluated price for the evaluated price method; and the highest total score for the combined technical and price method, shall be ranked first and invited to negotiate the contract.ỹThe Minister of Health decides the unit under the Ministry of Health responsible for organizing the assessment of the tender selection plan for centralized national medicine supply and price negotiation plan.

2. For generic medicine tenders; traditional medicine and herbal medicine tenders; herbal material tenders; and traditional decoction medicine tenders: each medicine in a group (a part of the tender package) can only be proposed as a winning bid if it meets the technical requirements and specified quality standards in the tender documents, request documents, and has the lowest corrected and adjusted bid price, after deducting the lowest discount value (if applicable) for the lowest price method; the lowest evaluated price for the evaluated price method; and the highest total score for the combined technical and price method within that group of medicines.ỹThe Department of Health is responsible for organizing the assessment of the tender selection plan for centralized local medicine supply.

3. The conditions for considering the bid award proposal shall be implemented in accordance with Article 43 of the Bidding Law and the tender document model in Appendix 03 or Appendix 04 issued together with this Circular.

Article 24. Report on the Selection Results

1. The tenderer is responsible for sending one set of documents (original copy) reporting the selection results to the unit assigned the task of reviewing the selection results, including:

a)One original copy of the report evaluating the bidding documents and proposal documents;

b)One set of tender documents and request documents (copy) which have been reviewed and approved in accordance with Articles 18, 19, and 20 of this Circular and other relevant bidding laws.t TThe assessment of the tender selection plan for centralized medicine supply is carried out in accordance with Clause 1 Article 37 of the Bidding Law.

2. Documents for approval of the selection results include:

a)One original copy of the Report on Reviewing the Selection Results;

b)One set of documents for approval of the selection results (original copy) from the tenderer.

3. The process of reporting, reviewing, approving, and publicly announcing the selection results shall be carried out in accordance with Decree No. 63/2014/NĐ-CP, specifically:

a)One-stage, one-envelope method: carried out in accordance with Article 20 of Decree No. 63/2014/NĐ-CP;

b)One-stage, two-envelope method: carried out in accordance with Article 31 of Decree No. 63/2014/NĐ-CP.

Article 25. Review and Approval of the Selection Results

1. The head of the healthcare facility is responsible for establishing or assigning a unit to organize the review of the selection results for drug suppliers.

2. The tasks of the unit organizing the review:

a)Within twenty days (ten days for small-scale tenders), from the date of receiving all related materials, organize the inspection and evaluation of the selection process as stipulated in Articles 21, 22, and 23 of this Circular;

b)Prepare a review report, submit it to the head of the healthcare facility for consideration and approval of the selection results in accordance with this Circular and relevant bidding laws.

Article 26. Approval and announcement of tender selection results

1. The head of the healthcare facility shall be responsible for approving the tender selection results within ten days (five working days for small-scale tenders), starting from the day when all documents for approval of the tender selection results are received from the unit organizing the assessment as stipulated in Point b Clause 2 Article 25 of this Circular.

2. When the tender selection results are approved, the tender inviter shall be responsible for announcing in writing the tender selection results to the tenderers according to the relevant laws on bidding.

3. For tenderers not selected, the written announcement of the tender selection results must clearly state the reasons why the tenderer did not win the bid.

Article 27. Winning Bid Price for Medicines

The winning bid price for each medicine shall not exceed the price of that medicine in the procurement plan already approved by the authorized person and shall not exceed the declared wholesale price of that medicine still in effect, except in cases provided for in Clause 1 Article 35 of this Circular.

Article 28. Use of Winning Bid Medicines and Contract Signing

1. Healthcare facilities and winning tender suppliers shall be responsible for implementing the drug supply contracts in accordance with the relevant laws on economic contracts.

2. Healthcare facilities shall not purchase more quantities of medicines in one group than specified in the tender selection results if they have not yet purchased the full quantity of medicines in other groups of the same active ingredient that were won through signed contracts.

3. The following situations are permitted to purchase beyond the quantity but the amount shall not exceed 20% of the quantity of that medicine group in the signed contract and there is no need to submit a supplementary procurement plan for approval:

a)All quantities of medicines in other groups have been used up and only the quantity of medicines in the original brand drug or equivalent treatment tender package remains;

b)Other groups of the same active ingredient that were won through bids but are required to stop supplying due to expiration of registration (but not yet renewed) or the medicines are suspended from circulation or withdrawn from the list of medicines proven bioequivalent after winning the bid;

c)The supplier has not provided the full quantity of medicines in the signed contract but is unable to continue supplying due to force majeure, in which case a written notice accompanied by supporting documentation must be provided.policiesMedical facilities must comply with the provisions of Article 28 of this Circular in the use of medicines

Chapter III

PROVISIONS ON CONCENTRATED MEDICINE PURCHASE AND PRICE NEGOTIATION

Article 29. General Provisions on Concentrated Medicine Purchase

1. The centralized medicine purchasing unit shall be responsible for compiling the demand for medicine usage, preparing and submitting for approval the procurement plan, organizing the selection of suppliers, completing and signing contracts or framework agreements with selected suppliers, and announcing the selection results and framework agreements on the Ministry of Health's electronic information system and the Department of Health's electronic information website for healthcare facilities to use as a basis for completing and signing contracts with selected suppliers.CThe centralized medicine purchasing unit shall be responsible for supervising the implementation of framework agreements and contracts with selected suppliers. The functions, duties, organizational structure, and operation rules of the national-level centralized medicine purchasing unit shall be decided by the Minister of Health; the functions, duties, organizational structure, and operation rules of the provincial-level centralized medicine purchasing unit shall be decided by the Provincial People's Committee Chairman.

2. General provisions on national and provincial-level concentrated medicine purchases:policies Tender selection method: open domestic tendering;TheTender selection procedure: two-stage two-envelope process;

3. Bidding document evaluation: using a combined technical and price evaluation method for each medicine (part of the tender package).

a)Implementation method: centralized medicine purchase is implemented through framework agreements, except for the following cases which apply direct contract signing methods:

b)- Purchasing vaccines and medicines for expanded immunization programs funded by state budget funds as decided by the Minister of Health and the Provincial People's Committee Chair;

c)- Purchasing medicines for projects funded by ODA, grants, and donations from domestic and foreign organizations and individuals, sourced from the state budget, where the donor requires the application of direct contract signing methods;

d)The Minister of Health decides the unit under the Ministry of Health responsible for organizing the review of the procurement plan for centralized medicine supply at the national level and the price negotiation plan.

The Department of Health is responsible for organizing the review of the procurement plan for centralized medicine supply at the provincial level.

The review of the procurement plan for centralized medicine supply shall be carried out in accordance with Clause 1 Article 37 of the Bidding Law.

4. won the bid and signed the contract through centralized procurement and price negotiation.

5. If the demand for medicines of the medical facility exceeds 20% of the quantity allocated in the framework agreement, it must report to the centralized procurement unit for consolidation and adjustment of the quantity of medicines among medical facilities within the local supply area.

6. If the demand for medicines of the locality, of central medical facilities (excluding central medical facilities participating in centralized medicine bidding with the locality)

Article 30. General Provisions on Price Negotiations

1. The members of the Price Negotiation Council for Medicines include:

a)The Chairman and Vice-Chairman of the Price Negotiation Council for Medicines shall be decided by the Minister of Health;

b)Members of the Council are representatives from relevant agencies under the Ministry of Health, the Ministry of Finance, the Vietnam Social Security, and an independent expert in related fields, decided by the Minister of Health;No. 

2. The Price Negotiation Council for Medicines has the responsibility to:

a)Develop negotiation plans and negotiation schemes, submit them to the unit assigned by the Minister of Health to review and present to the Minister of Health for examination and approval of the negotiation plan;policiesImplement price negotiations for medicines according to the approved plan;

b)The centralized medicine procurement unit has the responsibility to:

3. Participate in all stages of the price negotiation process for medicines;

a)Publicize the results of price negotiations and framework agreements.

b)The National Advisory Council on Medicine Tendering has the responsibility to advise the Minister of Health on all stages of the price negotiation process for medicines when requested.

4. The Price Negotiation Council for Medicines operates under the head system. The Chairman decides and is responsible based on the opinions of the Council members. Council members work on a part-time basis, individuals participating in the National Advisory Council on Medicine Tendering shall not participate in the Price Negotiation Council. The operating expenses of the Price Negotiation Council are guaranteed by the state budget in accordance with the provisions of the law.organize credit institutions, foreign bank branches are responsible for organizing the implementation of this Circular.The Ministry of Health shall specify the tasks, powers, organizational regulations, and operational mechanisms of the Price Negotiation Council for Medicines.

5. Article 31. Responsibilities of Related Parties and Effectiveness of Framework Agreements

6. The Minister of the Ministry of Science and Technology issues this Circular on the issuance of National Technical Regulations on Radioactive Waste Containing Naturally Occurring Radioactive Materials.ưởMedical facilities requiring to purchase medicines listed in the Centralized Tender Medicine List and the Price Negotiation Medicine List must base their selection of contractors, negotiation results, and framework agreement contents to complete and sign contracts with selected contractors through centralized procurement and price negotiations, following the principle that the unit price in the signed contract does not exceed the price in the published framework agreement.

The lead unit specified in Clause 1, Article 32 of this Circular is responsible for consolidating and reviewing the needs for the list and quantity of medicines of each medical facility under its management and regulating the implementation of the plan to ensure the minimum use of 80% of the reported quantities of medicines to the Centralized Medicine Procurement Unit (excluding emergency medicines, antidotes, and rare medicines).

1. Contractors selected through centralized procurement and price negotiations have the responsibility to supply medicines according to the quantity and schedule recorded in the signed contract with each medical facility. During the contract execution period, medical facilities and contractors may negotiate and adjust the quantity increase or decrease compared to the quantity in the signed contract based on the tender documents issued by the Centralized Medicine Procurement Unit. The Centralized Medicine Procurement Unit is responsible for coordinating with the lead units and winning contractors to regulate the implementation of the plan to ensure sufficient medicine supply to medical facilities.

2. Medical facilities must comply with the provisions of Article 28 of this Circular in using medicines that have won tenders and signed contracts through centralized procurement and price negotiations.ứIn cases where the medicine usage needs of medical facilities exceed 20% of the quantity allocated in the framework agreement, they must report to the Centralized Medicine Procurement Unit for consolidation and regulation of the quantity of medicines among medical facilities within the local supply range.

3. In cases where the medicine usage needs of localities, central medical facilities (excluding central medical facilities participating in centralized medicine tenders with localities) exceed 20% of the quantity allocated in the framework agreement, they must report to the national-level Centralized Medicine Procurement Unit for consolidation and regulation of the quantity of medicines among localities and central medical facilities but ensuring it does not exceed 20% of the quantity in the national-level centralized contractor selection plan or the approved price negotiation plan.gThe validity period of the results of centralized medicine procurement (national level, local level) and price negotiations is stipulated in the contractor selection plan approved by the competent authority but shall not exceed 36 months, starting from the date the results of centralized medicine procurement, price negotiation results, and framework agreements become effective.

4. exceeds 20% of the quantity allocated in the framework agreement, it must report to the centralized national procurement unit for consolidation and adjustment of the quantity of medicines among localities and central medical facilities but ensuring that it does not exceed 20% of the quantity in the approved centralized national tender selection plan or price negotiation plan.đThe validity period of the results of centralized medicine procurement (national, local) and price negotiation is specified in the tender selection plan approved by the competent authority but not exceeding thirty-six months, counted from the effective date of the results of centralized medicine procurement, price negotiation, and framework agreement.

a) to propose.

b)Private healthcare facilities are eligible to participate in centralized medicine purchases (national, local, negotiated prices) in their location. In such cases, private healthcare facilities are responsible for developing a medicine usage plan and adhering to centralized medicine procurement regulations in the locality as if they were managed by the locality. The Department of Health and the local centralized purchasing unit are responsible for organizing medicine procurement for private healthcare facilities as they would for locally managed healthcare facilities. If a private healthcare facility fails to organize a contractor selection process for medicine procurement as prescribed in this Circular, the Social Insurance Agency will only reimburse based on the results of the centralized contractor selection for medicine procurement in the locality, the national centralized procurement results, and the published negotiated price results according to the criteria: correct trade name, registration number or import permit, concentration/content, route of administration, dosage form, packaging specifications, manufacturer, country of manufacture.

Thời hạn sử dụng kết quả mua thuốc tập trung (cấp quốc gia, cấp địa phương) và đàm phán giá được quy định trong kế hoạch lựa chọn nhà thầu được cấp có thẩm quyền phê duyệt nhưng tối đa không quá 36 tháng, kể từ ngày kết quả mua thuốc tập trung, kết quả đàm phán giá và thỏa thuận khung có hiệu lực.

Article 32. Centralized National Medicines Procurement Organization

1. Establishing and compiling medicine usage needs: Based on the medicine usage plan established in accordance with Point a, Clause 1, Article 3 of this Circular, healthcare facilities shall prepare registration documents for centralized procurement and submit them to the higher-level management authority according to the following procedures:

a)Healthcare facilities under the Ministry of Health's management: compile detailed needs down to each medicine, each group, and supply progress, and send them to the Centralized National Medicine Procurement Unit;

b)Healthcare facilities managed by various Ministries and sectors (excluding those participating in centralized medicine tendering with localities): the health management agency of the Ministry, the agency at the level of a ministry, or the government agency shall compile detailed needs down to each medicine, each group, and supply progress of each healthcare facility, and send them to the Centralized National Medicine Procurement Unit;

c)Healthcare facilities managed by localities (including central healthcare facilities participating in centralized medicine tendering at the locality as stipulated in Clause 3, Article 3 of this Circular): the local centralized medicine procurement unit shall compile detailed needs down to each medicine, each group, and supply progress of each healthcare facility under its management, report to the Department of Health, and send the locality’s medicine usage plan to the Centralized National Medicine Procurement Unit;

d)The list and quantity of medicines must be sent to the Centralized National Medicine Procurement Unit before August 15th each year or within a specific time frame announced by the Centralized National Medicine Procurement Unit in case of emergency;

d) The Centralized National Medicine Procurement Unit is responsible for:

- Compiling the quantity and supply progress of each medicine to develop the contractor selection plan;

- Developing and proposing in the contractor selection plan a percentage (%) option for additional purchases but not exceeding 30%, which must be specifically defined in the bidding invitation document for each medicine. In this case, the Centralized National Medicine Procurement Unit is responsible for publicly announcing and including it in the framework agreement so that healthcare facilities can be aware and implement it. Healthcare facilities may purchase additional amounts if they have used up the registered quantities but must not exceed the percentage (%) option for additional purchases specified in the contractor selection plan;policies||| The plan for selecting suppliers shall include an option to purchase additional quantities up to a maximum of 30%, with specific percentages clearly defined in the tender documentation for each medicine. In this case, the National Central Medicine Procurement Unit is responsible for publicly announcing and incorporating such options into framework agreements so that healthcare facilities are aware and can implement them. Healthcare facilities may purchase additional quantities if they exhaust their registered quantities but must not exceed the percentage specified in the procurement plan. ||| if they have used up the registered quantity of medicine A|||||| and must not exceed the percentage specified in the procurement plan.

2. Preparing, reviewing, and approving the contractor selection plan:

a)Preparing the contractor selection plan:

The Centralized National Medicine Procurement Unit bases on the results of compiling the list and quantity of medicines to divide the tender packages and develop the contractor selection plan according to the principle:

- Each medicine in the centralized national medicine procurement list constitutes a tender package or part of a tender package. If the demand for a medicine is large and a single contractor cannot provide the entire package, it is permissible to divide it into different tender packages based on regions or economic and social zones;shall||| In cases where demand is high and a supplier cannot provide the entire package, the package may be divided into different packages according to regions or economic zones.

For example, Medicine A is included in the centralized national medicine procurement list, with a total annual demand of 100 million tablets, but there is no contractor capable of supplying all 100 million tablets annually. It could be divided into several tender packages:No.||| into separate tenders:

- Dividing into three tender packages for the three regions: Package 1 for northern healthcare facilities: 40 million tablets; Package 2 for central region healthcare facilities: 20 million tablets; Package 3 for southern healthcare facilities: 40 million tablets;

- Or dividing into six tender packages based on economic and social zones: Red River Delta; Midland and Northern Mountainous Region; North Central Coast and Central Coastal Region; Central Highlands; Southeast Region; Mekong Delta;đổ||| Dr. Long.

- The Centralized National Medicine Procurement Unit is responsible for dividing the tender packages. The division of medicine groups within tender packages and the content of the contractor selection plan shall comply with the provisions of Articles 5 and 6 of this Circular;

b)Reviewing the contractor selection plan:

- The Centralized National Medicine Procurement Unit submits the application for review of the contractor selection plan for medicine provision to the unit designated by the Minister of Health for review of the contractor selection plan;policies||| by the Minister of Health.policies||| to review the procurement plan;policies||| on bidding for medicines (in cases where it is necessary)

- The reviewing unit is responsible for reviewing the list, quantity of tender packages, planned unit price, and quantity of medicines; the contractor selection plan for centralized medicine provision, seeking advice from the National Advisory Council on Medicine Tendering (if necessary) before submitting the plan to the Minister of Health for consideration and approval of the contractor selection plan;g||| before submitting it to the Minister of Health.ầimplementation;policies||| Based on the approved procurement plan, the National Central Medicine Procurement Unit will prepare the tender documentation, organize the review, and approve the tender documentation in accordance with Articles 18, 19, and 20 of this Circular.policiesThe Minister of Health reviews and approves the contractor selection plan based on the recommendation of the reviewing unit;

c)Preparing for contractor selection:

3. Based on the approved contractor selection plan by the Minister of Health, the Centralized National Medicine Procurement Unit develops the bidding invitation document, organizes the review and approval of the bidding invitation document in accordance with Articles 18, 19, and 20 of this Circular;

||| and Article 24 of this Circular. ||| Electronic Information Portal of the Ministry of Health

4. Organizing contractor selection:

The Centralized National Medicine Procurement Unit is responsible for organizing the contractor selection process, evaluating bidding documents, negotiating contracts or framework agreements, and recommending successful bidders, reporting the contractor selection results in accordance with Articles 21, 23, and 24 of this Circular; 22, ||| of Health and notify in writing all healthcare facilities under the Ministry of Health, health sectors, and provincial health departments.

5. Reviewing, approving, and publicizing the contractor selection results:

a)Based on the evaluation of bidding documents and negotiations with contractors, the Centralized National Medicine Procurement Unit organizes the review and approval of the contractor selection results. If necessary, it must seek advice from the National Advisory Council on Medicine Tendering before approving the contractor selection results;

b)The Centralized National Medicine Procurement Unit is responsible for publicly announcing the contractor selection results in accordance with the Bidding Law;

6. Completing and signing contracts or framework agreements:

a)The Centralized National Medicine Procurement Unit is responsible for completing and signing contracts or framework agreements with successful contractors in accordance with the Bidding Law; publicly announcing the framework agreement on the Ministry of Health's Electronic Information Portal and notifying in writing to healthcare facilities under the Ministry of Health, sectoral health departments, and provincial health departments;C||| exceed the winning bid price announced by the National Central Medicine Procurement Unit.||| health facilities;||| are responsible for settling payments and finalizing accounts with suppliers in accordance with current laws and the terms of the signed contracts.

b)The lead unit responsible for consolidating and proposing drug usage requirements as stipulated in Clause 1 of this Article shall be responsible for notifying the results of contractor selection and framework agreements to healthcare facilities within the supply scope of such framework agreements.

7. Completing and signing drug supply contracts:

The centralized procurement unit (in cases where direct contract signing methods are applied); healthcare facilities shall base their actions on the results of drug supplier selection, framework agreements, and the drug usage needs and plans registered with the lead unit to complete and sign contracts with suppliers according to the following principles:

a)In accordance with the supply conditions within the framework agreement;

b)The price of each drug in the contract shall not exceed the winning bid price announced by the national centralized drug procurement unit.g||| supply of medicines at healthcare facilities;

8. Payment and settlement of drug supply contracts: The centralized procurement unit (in cases where direct contract signing methods are applied); healthcare facilities shall have the responsibility to pay and settle accounts with suppliers in accordance with current legal regulations and the terms of the signed contracts.policies||| report to the National Central Medicine Procurement Unit on the quantity of medicines purchased and the unexecuted planned quantity to update on thepolicies||| Electronic Information Portal of the Ministry of Health;

9. Supervising and regulating the implementation of framework agreements:

The national centralized drug procurement unit and lead units consolidating drug usage plans shall be responsible for supervising and regulating the provision of drugs at healthcare facilities implementing framework agreements according to approved plans, specifically:policies||| Local healthcare facilities participating in centralized medicine procurement tenders at the local level periodically (quarterly, annually) or ad hoc must report to the Provincial Health Department on the quantity of medicines supplied and the unexecuted planned quantity topoliciesHealthcare facilities under the Ministry of Health and lead units consolidating drug usage plans shall periodically (quarterly, annually) or urgently report to the national centralized drug procurement unit on the quantity of drugs purchased and the unimplemented plan quantities to update on the Ministry of Health's electronic information system.

a)Healthcare facilities under localities, central healthcare facilities participating in local bidding shall periodically (quarterly, annually) or urgently report to the Department of Health on the quantity of drugs supplied and unimplemented plan quantities to send back to the national centralized drug procurement unit for updating on the Ministry of Health's electronic information system.ầu||| send back to theC||| National Central Medicine Procurement Unit to update on theđổ||| Electronic Information Portal of the Ministry of Health.

b)||| The Provincial People's Committee shall review and approve the procurement plan for centralized medicine supply at the local level.of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home Affairs||| if they exhaust their registered quantity of medicines Y||| but do not exceed the percentage specified in the procurement plan.g||| tender, report to the Provincial Health Department to organize the review and approval of the tender documentation in accordance with Articles 18, 19, and 20 of this Circular., amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CPforcemennational||| on the Public Electronic Information Portal of the Provincial People's Committee, the Public Electronic Information Portal of the Provincial Health Department, and notify all healthcare facilities within the scope of the framework agreement.o||| during the implementation of the framework agreement, the supply contracts between healthcare facilities and selected suppliers; periodically compile and update the quantity of medicines supplied and the unexecuted planned quantity on theC||| Electronic Information Portal of the Ministry of Health.

Article 33. Centralized Drug Procurement at the Local Level

1. Building and Consolidating Drug Usage Needs:

a)Based on the List of centrally tendered drugs at the local level, healthcare facilities directly under provinces and centrally administered cities (including central healthcare facilities participating in centralized procurement at the local level) shall build drug usage needs in accordance with Article 3 of this Circular and submit them to the local centralized drug procurement unit.

b)The List and quantity of drugs must be submitted to the local centralized drug procurement unit before August 15th each year or at specific times announced by the local centralized drug procurement unit in urgent cases.

c)The local centralized drug procurement unit shall consolidate the drug usage needs of participating healthcare facilities, report to the Department of Health for review, and submit to the Chairman of the Provincial People's Committee for approval of the plan to select drug suppliers for centralized procurement at the local level.in||| The Ministry of Health assigns the task of reviewing the negotiation price plan, which includes the quantity and specific purchasing conditions for each medicine subject to price negotiations.

2. Preparing, reviewing, and approving the contractor selection plan:

a)Preparing the contractor selection plan:

- The local centralized drug procurement unit shall base its actions on the consolidated results of drug usage needs, dividing the tender packages and building the plan to select drug suppliers according to the principle that each drug in each group is part of a tender package, the division of drug groups in tender packages, and the content of the plan to select drug suppliers shall comply with the provisions of Articles 5 and 6 of this Circular.

- Proposing in the plan to select drug suppliers a percentage (up to 30%) of optional additional purchases, which must be clearly specified in the tender invitation documents for each drug. In this case, the local centralized drug procurement unit shall publicly announce and include it in the framework agreement so that healthcare facilities are aware and can implement it. Healthcare facilities may purchase additional amounts if they exhaust their registered quantities but not exceeding the optional additional purchase percentage specified in the plan to select drug suppliers. ||| based on the approved negotiation price plan, when necessary, reference the following information:concerning the classification and determination of state management authority in the field of crop production||| time and place of receiving new bids, opening new bids simultaneously inviting pharmaceutical suppliers to attend the ceremony.utediocultural outed||| The National Central Medicine Procurement Unit is responsible for compiling the results of price negotiations and sending them to the agency under the Ministry of Health assigned to examine and approve the results of price negotiations based on the review report.

b)The Department of Health shall organize the review of the plan to select drug suppliers, submit it to the Chairman of the Provincial People's Committee for consideration and approval.

c)Approving the Plan to Select Drug Suppliers: The Chairman of the Provincial People's Committee shall consider and approve the plan to select drug suppliers for centralized procurement at the local level based on the Department of Health's proposal.

3. Based on the approved contractor selection plan by the Minister of Health, the Centralized National Medicine Procurement Unit develops the bidding invitation document, organizes the review and approval of the bidding invitation document in accordance with Articles 18, 19, and 20 of this Circular;

Based on the approved plan to select drug suppliers, the local centralized drug procurement unit shall prepare the tender invitation documents, report to the Department of Health for review and approval of the tender invitation documents in accordance with Articles 18, 19, and 20 of this Circular.o||| When replacing medicines, the supplier must provide all necessary information for the Tenderer to evaluate the replacement, including: a copy (with the supplier's confirmation stamp) of the Product Circulation Permit (MA) or Drug Product Certificate (CPP), any permits or supplements from regulatory authorities (if applicable), sample labels or Instructions for Use with stamps from the issuing authority and collected

4. Organizing contractor selection:

The local centralized drug procurement unit shall organize the selection of drug suppliers, evaluate tender documents, negotiate contracts, and propose winning bids in accordance with Articles 21, 22, 23, and 24 of this Circular.

5. Reviewing, approving, and publicizing the contractor selection results:

a)The local centralized drug procurement unit shall prepare reports, submit them to the Department of Health for review and approval of the results of selecting drug suppliers for centralized procurement at the local level.

b)The Department of Health shall be responsible for reviewing and approving the results of selecting drug suppliers for centralized procurement at the local level.

c)The local centralized drug procurement unit shall be responsible for publicly announcing the results of selecting drug suppliers in accordance with the Bidding Law.

6. Completing and Signing Framework Agreements:

a)Based on the approved results of selecting drug suppliers, the local centralized drug procurement unit shall be responsible for completing and signing framework agreements with winning bidders in accordance with the Bidding Law.

b)The local centralized drug procurement unit shall publicly announce the signed framework agreements in accordance with the Bidding Law on the provincial people's committee's electronic information system, the Department of Health's electronic information website, and notify healthcare facilities within the supply scope of the framework agreements.đ||| statement confirming the unchanged quality standards of the tendered medicine, collectedC||| to propose the replacement.

7. Completing and Signing Drug Supply Contracts: Implement in accordance with Clause 7 of Article 32 of this Circular.

8. Payment and Settlement of Drug Supply Contracts: Implement in accordance with Clause 8 of Article 32 of this Circular.

9. Supervising and regulating the implementation of framework agreements:

a)The local centralized drug procurement unit shall be responsible for supervising and regulating the implementation of framework agreements and drug supply contracts between healthcare facilities and selected suppliers; periodically compiling and updating the quantity of drugs supplied and unimplemented plan quantities on the Ministry of Health's electronic information system.BB 1.6||| Private healthcare facilities are eligible to participate in centralized medicine procurement (national, local, price negotiation) at the location of their headquarters.CThe Provincial People's Committee Electronic Information Portal, Health Department Electronic Information Portal;

b)Healthcare facilities shall report periodically (quarterly, annually) or report promptly the quantity of medicines that have been supplied and the quantity of plans not yet implemented to the centralized medicine procurement unit at the local level for monitoring and updating on the Provincial People's Committee Electronic Information Portal and the Health Department Electronic Information Portal.

Article 34. Price Negotiation Organization

1. Aggregate drug usage information:ầ||| In this case, private healthcare facilities are responsible for developing a

The process of aggregating, reviewing, and submitting drug usage requirements for the price negotiation list shall be carried out as stipulated for centrally tendered national-level drugs under Clause 1 of Article 32 of this Circular.

2. Develop a price negotiation plan:

The centralized national medicine procurement unit is responsible for developing a price negotiation plan and sending it to the unit assigned by the Ministry of Health to review the price negotiation plan, which includes:ưở||| medicine usage plan and adhering to centralized medicine procurement regulations in the locality as required of healthcare facilities managed by the locality. The Provincial Health Department and the local centralized medicine procurement unit are responsible for organizing

a)Requirements for the list and quantity of drugs to be negotiated;

b)Quality standards, packaging, storage conditions, delivery location and time, and the maximum expected price linked to the quantity and specific purchasing conditions for each drug to be negotiated;No.||| medicine procurement tenders for private healthcare facilities as with those managed by the locality.

c)A list of contractors including manufacturers and suppliers registered for the negotiation list drugs and their supply capacity;

d)Expected negotiation strategies and specific negotiation times for each contractor participating in the negotiation process;

d) Information on prices, specific economic and technical criteria expected to be applied during the drug price negotiation process, which the contractor must provide in the bidding documents, such as:

- The selling price of the drugs to healthcare facilities in the country of production and in ASEAN countries provided by the contractor;

- The selling price of equivalent drugs with the same quality standards and treatment effectiveness in the Vietnamese market;

- The contractor's commitment regarding the quantity, quality of the supply source, and delivery schedule if awarded the contract;

- Economic analysis data of new drugs added to the negotiation list, including cost-effectiveness, cost-benefit, and cost-utility provided by the contractor.

3. Approve the price negotiation plan: The Minister of Health will examine and approve the price negotiation plan based on the report of the unit responsible for determining it. In necessary cases, the Minister of Health will seek advice from the National Advisory Council on Medicine Tendering before approving.rime Minister c||| If a private healthcare facility does not select a supplier according to this Circular, the Social Insurance Authority will only pay according to the results of the centralized supplier selection of the locality, national centralized tender results, and published price negotiation results based on criteria: trade name, registration number or import permit, concentration/content, route of administration, dosage form, packaging specifications, manufacturer, country of manufacture.

4. Organize drug price negotiations:

a)Based on the approved price negotiation plan by the Minister of Health, the centralized national medicine procurement unit is responsible for assisting the Price Negotiation Council in organizing and implementing the price negotiation plan, specifically:

- Prepare the request dossier: The dossier should include all relevant contents about the drugs to be negotiated; instructions on preparing and submitting the proposal dossier; standards for contractor capability and experience; technical and financial evaluation criteria. The request dossier must be reviewed and approved according to Articles 18, 19, and 20 of this Circular;

- Send the negotiation invitation notice to drug suppliers (including manufacturers and suppliers) along with the price negotiation request dossier, specifying the location, time, and related information about the drugs to be negotiated as stated in Point b of Clause 2 of this Article;

- Receive the proposal dossiers from participating contractors: Contractors submit their proposal dossiers directly or through postal service to the centralized national medicine procurement unit. Each contractor can only submit one proposal dossier, which will not be publicly opened. The centralized national medicine procurement unit is responsible for maintaining confidentiality of the information in each contractor's proposal dossier;

- Evaluate the proposal dossiers: The Price Negotiation Council organizes the technical evaluation of the proposal dossiers according to the criteria specified in the request dossier. A contractor is considered qualified when they have a valid proposal dossier; meet the capability and experience requirements; achieve the technical points set forth in the request dossier; The Price Negotiation Council evaluates the financial proposals and ranks the contractors.

b)The Price Negotiation Council conducts negotiations with each supplier. Depending on the specific situation, the Price Negotiation Council decides on the negotiation method, either direct or through written communication, and negotiates only with ranked contractors to determine those meeting the quality, quantity, storage conditions, delivery requirements, and other technical and quality-related requirements, and to determine the bid price of the contractor.No.||| If the medicine is not included in the results of the centralized supplier selection of the locality, national centralized tender results, or published price negotiation results, payment will be made according to the winning bid price of public healthcare facilities

The Price Negotiation Council considers and decides whether to invite manufacturers to participate in the negotiations.

c)The winning bid price through negotiation is determined by the Price Negotiation Council and the supplier based on the price in the approved negotiation plan, and may refer to the following information if necessary:No.ument permittof the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home Affairs||| in the same province as publicly disclosed by the Vietnam Social Insurance Authority pursuant to Point b Clause 3 Article 77 of Decree No. 63/2014/ND-CP.

- The selling price of the drug to healthcare facilities in the country of production or in some ASEAN countries provided by the supplier;đ- The selling price to some healthcare facilities, pharmaceutical businesses, or the current winning bid price in Vietnam.

If two or more suppliers participate in the price negotiation, the Price Negotiation Council, based on the negotiation results, requests the suppliers to resubmit their bids in writing; the resubmission notice must clearly state the time, location, receipt of resubmitted bids, the opening time of the resubmitted bids, and invite the pharmaceutical suppliers to attend the bid opening ceremony.

d)When resubmitting bids, the supplier cannot offer a higher price than the previously negotiated price. The supplier with the lowest bid, not exceeding the declared wholesale price, will be considered and recommended for the winning bid by the Price Negotiation Council.g||| If a healthcare facility needs to use medicines listed in the Essential Medicines List,inThe centralized national medicine procurement unit is responsible for compiling the negotiation results and submitting them to the agency assigned by the Ministry of Health for review.

5. ||| Costs incurred during the organization of the supplier selection process shall be implemented in accordance with Article 9 of Decree No. 63/2014/ND-CP.policies||| Archiving of documents during the organization of the supplier selection process shall be implemented in accordance withrime Minister cThe Minister of Health will examine and approve the negotiation results based on the review report of the unit.policies xem xét, phê duyệt kết quả đàm phán giá trên cơ sở báo cáo của đơn vị thẩm định.

6. Publicizing the negotiation results: The national centralized drug purchasing unit is responsible for publicly disclosing the selection results of contractors through price negotiations as prescribed by law.

7. Completing, signing framework agreements and signing procurement contracts:

a)The national centralized drug purchasing unit is responsible for completing and signing framework agreements with winning contractors, publicly disclosing the contractor selection results and framework agreements on the Ministry of Health's electronic information system, and notifying the central units that consolidate demand.C||| electronic information system of the Ministry of Health and notify the central units that consolidate demand.

b)Medical facilities shall base their actions on the price negotiation results and framework agreements, usage needs, and drug usage plans of their units to sign contracts with contractors according to the principle that the drug prices in the contracts must not exceed the negotiated bid-winning drug prices and framework agreement prices announced by the national centralized drug purchasing unit.ỏPayment and settlement of supply contracts: Medical facilities are responsible for making payments and settlements with suppliers in accordance with the relevant laws and terms stipulated in the signed contracts.

8. The national centralized drug purchasing unit is responsible for supervising and regulating the provision of selected drugs through price negotiations, as stipulated for centralized tendered drugs, with the quantity of supplied drugs and the quantity of drugs in the plan yet to be implemented being regularly updated on the electronic information system of the Ministry of Health.

9. Article 35. Handling situations during the contractor selection processC||| Electronic Information Portal of the Ministry of Health.

Chapter IV

IMPLEMENTATION

If the bid price, after corrections and adjustments, minus any discount value (if applicable) of all contractors meeting technical requirements and listed in the ranking, exceeds the approved package price, then one of the following measures will be considered:

1. If the drug price in the approved contractor selection plan is deemed reasonable, the tenderer will request the contractor to resubmit the price according to Clause 8, Article 117 of Decree No. 63/2014/NĐ-CP;

a)If the drug price in the approved contractor selection plan is unreasonable, the tenderer must submit a report explaining and proposing an adjustment to the package price for review and decision by the competent authority;

b)In cases where it is necessary to ensure sufficient drugs to meet medical examination and treatment needs, the head of the medical facility may consider and decide to select winning drugs according to the ranking order of contractors when the following conditions are met:

c)- The winning bid price does not exceed the current valid wholesale price declaration of the drug;

- The total value of the proposed winning bids from bidding contractors does not exceed the total value of those parts in the approved contractor selection plan.Declaration, re-declarationIn cases where the drug tender has multiple separate parts and the time required to evaluate the tender documents could affect the supply progress of the medical facility, the head of the medical facility may consider and approve the selection results for one or more parts in different phases to ensure the supply progress.

When there are drugs in the tender without bidding contractors or winning contractors, or cannot be handled according to the provisions of this Clause, the head of the medical facility or the tenderer must cancel the tender for these drugs and submit to the competent authority for approval to adjust the contractor selection plan, thereby separating the drugs without bidding contractors or winning contractors into a new tender package for contractor selection. The contractor selection process for parts with participating contractors who have been evaluated as meeting the technical requirements will still follow the approved plan.

2. In cases where the tendered drugs change during the contractor selection process or the supply of winning drugs but the replacement drugs were not quoted in the tender documents, the project owner may consider allowing the contractor to replace the drugs, specifically:gChanges related to the drug name or manufacturing plant name during circulation but the registration number or import permit remains unchanged;

3. Changes to the registration number due to re-registration procedures or obtaining a new import permit, but other information remains unchanged (drug name, manufacturer, quality standards, shelf life, tender drug classification).ỹWhen replacing drugs, the contractor must provide all necessary information for the tenderer to assess the replacement, including: a copy (with the contractor's confirmation stamp) of the Product Circulation Permit (MA) or Drug Product Certificate (CPP), any change or addition approval letters from regulatory authorities (if applicable), sample labels or Instructions for Use with the authority's confirmation stamp, and a statement confirming that the quality standards of the tendered drug have not changed, and the replacement drug.

4. Private medical facilities can participate in centralized drug procurement (national, local, price negotiation) at their location. In such cases, private medical facilities are responsible for developing drug usage plans and complying with centralized drug tendering regulations in their locality as if they were managed by the local authority. The Department of Health and the centralized drug purchasing unit at the local level are responsible for organizing tenders for private medical facilities as they would for locally managed medical facilities.đIf a private medical facility does not organize a contractor selection process for drug supply according to this Circular, the Social Insurance agency will only pay based on the centralized contractor selection results of the locality, the national centralized tender results, and the published price negotiation results, according to criteria: correct trade name, registration number or import permit, concentration/dose, route of administration, dosage form, packaging specifications, manufacturer, country of manufacture.

a)If the drug is not included in the centralized contractor selection results of the locality, the national centralized tender results, or the published price negotiation results, payment will be made according to the winning bid price of public medical facilities in the same province disclosed by the Vietnam Social Insurance Authority as stipulated in Point b, Clause 3, Article 77 of Decree No. 63/2014/NĐ-CP.

b)In cases where medical facilities need to use drugs in the List of Essential Medicines

Khi thực hiện thay thế thuốc, nhà thầu phải cung cấp tất cả các thông tin cần thiết để Bên mời thầu có thể đánh giá việc thay thế, bao gồm: bản sao (có dấu xác nhận của nhà thầu) Giấy phép lưu hành sản phẩm (MA) hoặc Giấy chứng nhận sản phẩm dược (CPP), các công văn cho phép thay đổi, bổ sung của cơ quan quản lý nhà nước (nếu có), mẫu nhãn hoặc Tờ hướng dẫn sử dụng có dấu xác nhận của cơ quan cấp phép và thuyết minh về tiêu chuẩn chất lượng không thay đổi của thuốc dự thầu, thuNo.c đề xuof the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home Affairst thay thế.

5. Các cơ sở y tế tư nhân được tham gia mua thuốc tập trung (cấp quốc gia, cấp địa phương, đàm phán giá) tại địa phương nơi đóng trụ sin. Trường hợp này, cơ sở y tế tư nhân có trách nhiệm xây dựng kpolicies hoạch sử dụng thuốc, tuân thủ các quy định về đấu thầu thuốc tập trung tại địa phương như cơ sở y tế thuộc địa phương quản lý. Sở Y tpolicies và đơn vị mua thuốc tập trung cấp địa phương có trách nhiệm tổ chức đof the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home Affairsu thầu thuốc cho cơ sở y tpolicies tư nhân như đNo.i với cơ sở y tế thuộc địa phương quản lý.

Trường hợp cơ sở y tế tư nhân không tổ chức lựa chọn nhà thầu cung cấp thuốc theo quy định Thông tư này thì cơ quan Bảo hiểm xã hội chỉ thanh toán theo kết quả lựa chọn nhà thầu cung cấp thuốc tập trung của địa phương, kết quả đấu thầu tập trung cấp quốc gia, kết quả đàm phán giá đã được công bố theo các tiêu chí: đúng tên thương mại, số đăng ký hoặc giấy phép nhập khẩu, nồng độ/hàm lượng, đường dùng, dạng bào chế, quy cách đóng gói, hãng sản xuất, nước sản xuất.

In cases where the medicine is not included in the centralized tendering results for medicine suppliers at the local level, the national-level centralized tendering results, or the published price negotiation results, payment shall be made according to the winning bid price of public health facilities in the same province.policies||policiesoc Society of Vietnam publicly announced in accordance with Point b, Clause 3, Article 77 of Decree No. 63/2014/NĐ-CP.development||.

6. When healthcare facilities have a need to use medicines listed in the Medicine Catalogue, centralized bidding, List of drugs for price negotiation but without agreement framework announced or already signed supply contracts but the winning bidder cannot provide the drugs due to force majeure circumstances then the healthcare facilityof the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home Affairsis permitted topoliciesconduct bidding in accordance with this Circular with quantities not exceeding the usage needs for 12 months and in compliance with Clauses 5, 6, and 7 of Article 38 of this Circular.118/2025/NĐ-CP dated June 09, 2025 of the Government on implementing administrative procedures under the one-stop shop mechanism at the One-Stop Service Center and the National Public Service Portal;Article 36. Report on Implementation of Bidding After the results of the contractor selection are approved, the head of the healthcare facility shall be responsible for reporting the results of the contractor selection to the authority approving the plan for contractor selection. Hospitals and specialized hospitals under the Ministry of Health, health sectors, and provincial health departments directly under the central government shall submit reports on the results of the contractor selection according to the form at Appendix 01 issued together with this Circular to the Ministry of Health for publication on the

Ministry of Health's Electronic Information Portal, the Drug Administration's Electronic Information Website, and the Traditional Medicine Management Department's Electronic Information Website as a basis for reference in building planned prices, at the specific address:

1. - The Planning and Finance Department for all tender packages;

2. - The Drug Administration for generic drug tender packages, original brand-name drug tender packages or equivalent treatment packages, traditional medicine tender packages;C- The Traditional Medicine and Pharmaceutical Management Department for herbal medicine tender packages and traditional medicine packages.

Method of submitting reports: In writing and via email (to the address: [email protected] for all drug procurement tender packages; to the address [email protected] for generic drug tender packages, original brand-name drug tender packages or equivalent treatment packages, traditional medicine tender packages, and herbal medicine tender packages; to the address quanl

[email protected] for herbal medicine tender packages and traditional medicine packages).gBefore October 31 each year, the health management agencies of relevant ministries and sectors; hospitals and specialized hospitals under the Ministry of Health; and provincial health departments directly under the central government shall be responsible for summarizing and submitting reports on violations by contractors during the bidding and drug supply process in the previous period from healthcare facilities in their jurisdiction according to the form at Appendix 02 issued together with this Circular to the Ministry of Health (the Planning and Finance Department for all tender packages; the Drug Administration for generic drug tender packages, original brand-name drug tender packages or equivalent treatment packages, traditional medicine tender packages, and herbal medicine tender packages; the Traditional Medicine and Pharmaceutical Management Department for herbal medicine tender packages and traditional medicine packages) for consolidation and announcement, serving as a basis for units to consider and evaluate, select contractors for the next period.No.Article 37. Costs and Archiving of Documents in Contractor Selection, amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CPCosts incurred during the organization of contractor selection shall be implemented in accordance with Article 9 of Decree No. 63/2014/NĐ-CP.

Archiving of documents during the organization of contractor selection shall be implemented in accordance with Article 10 of Decree No. 63/2014/NĐ-CP.

The following documents cease to be effective from the date this Circular takes effect:organize credit institutions, foreign bank branches are responsible for organizing the implementation of this Circular.Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012, of the Ministry of Health and the Ministry of Finance guiding drug procurement bidding in healthcare facilities;yJoint Circular No. 36/2013/TTLT-BYT-BTC dated November 11, 2013, of the Ministry of Health and the Ministry of Finance amending and supplementing certain Articles of Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012, of the Ministry of Health and the Ministry of Finance guiding drug procurement bidding in healthcare facilities;

3. Decision No. 37/2013/TT-BYT dated November 11, 2013, of the Minister of Health guiding the preparation of tender documents for drug procurement in healthcare facilities;policiesDecision No. 31/2014/TT-BYT dated September 26, 2014, of the Minister of Health stipulating technical evaluation criteria tables in tender documents for drug procurement.No.Tender packages that have issued tender documents or request documents before the date this Circular takes effect shall be implemented in accordance with the provisions of the following circulars: Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012, of the Ministry of Health and the Ministry of Finance guiding drug procurement bidding in healthcare facilities; Joint Circular No. 36/2013/TTLT-BYT-BTC dated November 11, 2013, of the Ministry of Health and the Ministry of Finance amending and supplementing certain Articles of Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012, of the Ministry of Health and the Ministry of Finance guiding drug procurement bidding in healthcare facilities; Decision No. 37/2013/TT-BYT dated November 11, 2013, of the Minister of Health guiding the preparation of tender documents for drug procurement in healthcare facilities, and Decision No. 31/2014/TT-BYT dated September 26, 2014, of the Minister of Health stipulating technical evaluation criteria tables in tender documents for drug procurement.No.Healthcare facilities shall not organize contractor selection for drugs listed in the centralized procurement list at the national level, the centralized procurement list at the local level, and the price negotiation list if the results of the contractor selection and the framework agreement have been announced at the time of issuing the tender documents, except in cases provided for in Clause 7 of Article 35 of this Circular. If the healthcare facility still organizes contractor selection and signs a contract with another contractor, the contract will not be paid.No.Local centralized drug procurement units shall not organize contractor selection for drugs listed in the centralized procurement list at the national level and the price negotiation list if the results of the contractor selection and the framework agreement have been announced at the time of issuing the tender documents on the Ministry of Health's Electronic Information Portal.

When compiling and summarizing to report the demand for drugs listed in the centralized procurement list at the national level and the price negotiation list, healthcare facilities shall not compile and summarize the remaining quantity of drugs in contracts already signed with suppliers based on the previous contractor selection results of their own unit.

1. Costs incurred during the organization of the bidding process shall be implemented in accordance with Article 9 of Decree No. 63/2014/NĐ-CP.

2. The regulations stipulated inArticle 10 Decree No. 63/2014/NĐ-CP.

Article 38. Effective Date

1. This Circular takes effect from July 1, 2016.

2. The following documents shall cease to be effective from the date this Circular takes effect:

a)Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012 2012 of the Ministry of Health and the Ministry of Finance guiding bidding for purchasing medicines in healthcare facilities;

b)Joint Circular No. 36/2013/TTLT-BYT-BTC dated November 11, 2013 2013 of the Ministry of Health and the Ministry of Finance amending and supplementing certain Articles of Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012 of the Ministry of Health and the Ministry of Finance guiding bidding for purchasing medicines in healthcare facilities;toealth and the||| Healthpolicies - Ministry of Finance guiding bidding for purchasing medicines in healthcare facilities;

c)Circular No. 37/2013/TT-BYT dated November 11, 2013 of the Minister of Health guiding the preparation of tender invitation documents for purchasing medicines in healthcare facilities;

d)Circular No. 31/2014/TT-BYT dated September 26, 2014 of the Ministerưởof the Ministry of Health stipulating the Technical Evaluation Criteria Table in tender invitation documents for purchasing medicines;

3. For tenders that have issued tender invitation documents or request documents before the date this Circular takes effect, they shall be implemented according to the provisions of the following circulars: Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012 of the Ministry of Health and the Ministry of Finance guiding bidding for purchasing medicines in healthcare facilities; Joint Circular No. 36/2013/TTLT-BYT-BTC dated November 11, 2013 of the Ministry of Health and the Ministry of Finance amending and supplementing certain Articles of Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012 of the Ministry of Health and the Ministry of Finance guiding bidding for purchasing medicines in healthcare facilities; Circular No. 37/2013/TT-BYT dated November 11, 2013 of the Minister of Health guiding the preparation of tender invitation documents for purchasing medicines in healthcare facilities and Circular No. 31/2014/TT-BYT dated September 26, 2014 of the Minister of Health stipulating the Technical Evaluation Criteria Table in tender invitation documents for purchasing medicines;||| Health - Ministry of Finance guiding bidding for purchasing medicines in healthcare facilities; Joint Circular No.No. 36/2013/TTLT-BYT-BTC dated November 11, 2013 of the Ministry of Health and the Ministry of Finance amending and supplementing certain Articles of Joint Circular No.01/2012/TTLT-BYT-BTC dated January 19, 2012 of the Ministry of Health and the Ministry of Finance guiding bidding for purchasing medicines in healthcare facilities; Circular No. 37/2013/TT-BYT dated November 11, 2013 of the Minister of Health guiding the preparation of tender invitation documents for purchasing medicines in healthcare facilities and Circular No. 31/2014/TT-BYT dated September 26, 2014 of the Minister of Health stipulating the Technical Evaluation Criteria Table in tender invitation documents for purchasing medicines. 26 Health stipulating the Technical Evaluation Criteria Table in tender invitation documents for purchasing medicines.organize credit institutions, foreign bank branches are responsible for organizing the implementation of this Circular.Healthcare facilities shall not organize the selection of suppliers for medicines listed in the centralized procurement list at the national level, the centralized procurement list at the provincial level, and the price negotiation list if the results of the supplier selection and framework agreements have been announced on the Ministry of Health's electronic portal at the time of issuing the tender invitation documents, except in cases provided for in Clause 7, Article 35 of this Circular. In case the healthcare facility still organizes the selection of suppliers and signs contracts with other suppliers, such contracts shall not be paid.

4. Provincial centralized medicine procurement units shall not organize the selection of suppliers for medicines listed in the centralized procurement list at the national level and the price negotiation list if the results of the supplier selection and framework agreements have been announced on the Ministry of Health's electronic portal at the time of issuing the tender invitation documents.

5. When compiling and reporting the demand for medicines listed in the centralized procurement list at the national level and the price negotiation list, healthcare facilities shall not include the remaining quantity of medicines in contracts already signed with suppliers based on previous supplier selection results of their own units.12. Leather shoesof the province based on the proposal of the Director of the Department of Health of the province directly under the Central Government.policiesWhen purchasing medicines from the health insurance fund, the Social Insurance Agency shall be responsible for sending officials to participate in the following steps:No.Preparing and reviewing the plan for selecting suppliers;

6. Preparing and reviewing tender invitation documents;gEvaluating tender documents, reviewing the results of selecting suppliers.gWhen participating in the steps of the supplier selection process, if a participant has a different opinion from the others, it must be clearly recorded in the report for the competent authority to consider and decide.utedDuring implementation, if there are difficulties, agencies, organizations, and individuals are requested to reflect them to the Ministry of Health for consideration and resolution./.

7. When compiling and summarizing reports on the demand for medicines under the National Centralized Procurement Medicine Catalogue and the Price Negotiation Medicine Catalogue, healthcare facilities shall not include the remaining quantity of medicines in contracts already signed with suppliers based on previous bidding results of their own units.

Article 39. Reference Provisions

In cases where the documents referred to in this Circular are replaced or amended,, amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CP supplemented, the provisions shall be applied according to the replaced orpolicies amended and supplemented documents.

Article 40. Implementation organization

1. The Drug Management Department and the Traditional Medicine and Pharmaceutical Management Department shall be responsible for updating and publishing on the Electronic Information Website the following information:

a)List of countries participating in EMA, ICH, PIC/s; list of pharmaceutical production facilities meeting EU-GMP, PIC/s-GMP standards; list of pharmaceutical production facilities meeting WHO-GMP standards certified by the Ministry of Health of Vietnam; list of facilities engaged in herbal medicine processing inspected by the Ministry of Health of Vietnam;inList of original brand-name drugs, equivalent treatment drugs with biological equivalence documentation; List of drugs produced at pharmaceutical production facilities meeting WHO-GMP standards certified by the Ministry of Health of Vietnam and authorized for circulation by the competent authority of ICH participating countries; List of drugs produced in Vietnam meeting requirements for treatment, drug prices, and supply capacity;

b)List of drugs registered with a registration number or import permit; technology transfer roadmap for processed drugs in Vietnam; List of drugs and production facilities, suppliers violating quality requirements or bidding and supply regulations; data on declared drug prices/re-declared prices; winning bid drug prices at healthcare facilities; List of drugs manufactured from raw materials (active ingredients) produced in ICH participating countries and Australia, raw materials (active ingredients) certified with CEP; list of enterprises organizing Good Pharmacy Practice (GPP) pharmacy chains, list of enterprises organizing centralized drug distribution centers;BB 1.6List and prices of winning bid herbal medicines;

c)d) List of drugs required to be tendered; List of centrally tendered drugs at the national level and local level; List of drugs subject to price negotiation;developmentConduct preliminary selection on an annual basis to choose a list of manufacturers and suppliers of drugs that meet the requirements of capability, experience, and reputation as a basis for inviting participation in limited bidding.

d)Heads of central agencies shall direct subordinate healthcare facilities to select contractors for drug supply in accordance with this Circular and relevant laws on contractor selection.

The Chairman of the Provincial People's Committee shall be responsible for:toAssigning a unit to undertake centralized procurement of local-level tendered drugs for healthcare facilities participating in local centralized tenders in accordance with this Circular;

e)Directing healthcare facilities to organize the selection of contractors for drug supply from the list of drugs tendered by the unit in accordance with this Circular;

2. Based on the actual situation in the locality, the Chairman of the Provincial People's Committee, city shall decide to supplement the list of locally centralized tendered drugs with items not included in the list for use at healthcare facilities in the locality based on the proposal of the provincial or municipal Health Department under the Central Government;

3. When purchasing drugs from health insurance funds,

a) the Social Insurance Agency shall be responsible for assigning staff to participate in the following steps: Preparing and reviewing the plan for selecting contractors;mPreparing and reviewing the tender invitation documents;

b)Evaluating tender submissions, reviewing the results of contractor selection.

c)When participating in the steps of the contractor selection process, if a participant has a different opinion from other participants, it must be clearly recorded in the report for the competent authority to review and decide.developmentDuring implementation, if there are difficulties, agencies, organizations, and individuals are requested to reflect them to the Ministry of Health for consideration and resolution./.policies||

4. when purchasing medicines from the health insurance fund,ỹThe social insurance agency has the responsibility to assign staff to participate in the following steps:

a)Preparing and reviewing the plan for selecting suppliers;

b)Preparing and reviewing the tender invitation documents;

c)Evaluating tender documents and reviewing the selection results.

When participating in the supplier selection process, if a participant's opinion differs from those of the other participants, such differing opinions must be clearly recorded in the report for the competent authority to consider and decide.

During implementation, if there are any difficulties, agencies, organizations, and individuals are requested to reflect them to the Ministry of Health for consideration and resolution.development||