Circular No. 15/2019/TT-BYT on bidding for medicines at public healthcare facilities

 

SIGNATUREMR. IV

REGULATION This Circular promulgates the Regulation on Distance Learning for Bachelor's Degree Programs.The Director bears responsibility before the law, before the BureauPROCUREMENT OF MEDICINES AT PUBLIC HEALTH CARE FACILITIESouncil Cof public health facilities

_______________________________

 

BASED ON THE BID LAWS energyON NOVEMBER 26, 2015;June 2,

BASED ON THE DRUG LAWS energyON APRIL 6, 2016;as of 2016;

BASED ON DECREE NUMBER 63/2014/NĐ-CP OF JUNE 26, 2014 ISSUED BY THE GOVERNMENT PROVIDING GUIDELINES FOR IMPLEMENTATION OF CERTAIN PROVISIONS OF THE BID LAWS ON SELECTION OF CONTRACTORS;

BASED ON DECREE NUMBER 54/2017/NĐ-CP OF MAY 8, 2017 ISSUED BY THE GOVERNMENT PROVIDING FOR SOME PROVISIONS AND GUIDELINES FOR IMPLEMENTATION OF THE DRUG LAWS;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

AT THE SUGGESTION OF THE DIRECTOR OF THE DRUG MANAGEMENT CIRCUMSTANCE AND THE HEAD OF THE PLANNING AND FINANCE DEPARTMENT;

THE MINISTER OF HEALTH ISSUES THIS CIRCULAR TO REGULATE THE PROCUREMENT OF MEDICINES AT PUBLIC HEALTH CARE FACILITIES.

PART I

REGULATION REGARDINGGENERAL PROVISIONS

Article 1. Scope of Regulation

1. THIS CIRCULAR REGULATES THE PROCUREMENT OF MEDICINES (CHEMICAL DRUGS, HERBAL DRUGS, TRADITIONAL MEDICINES, VACCINES, AND BIOPRODUCTS) AND HERBAL MATERIALS AT PUBLIC HEALTH CARE FACILITIES INCLUDING: THE DIVISION OF TENDERS AND GROUPS OF MEDICINES; THE FORMULATION OF PROCUREMENT PLANS, PROCUREMENT METHODS, PROCEDURES, AND ORGANIZATION OF SELECTION OF CONTRACTORS SUPPLYING MEDICINES; THE REGULATION OF CONCENTRATED PROCUREMENT OF MEDICINES AND NEGOTIATIONS ON PRICES OF MEDICINES FUNDED BY STATE CAPITAL, HEALTH INSURANCE FUNDS, REVENUE FROM HEALTH SERVICES, AND LEGAL INCOME OF PUBLIC HEALTH CARE FACILITIES.

2. THE PURCHASE OF MEDICINES FROM RETAIL PHARMACIES WITHIN THE PREMISES OF PUBLIC HEALTH CARE FACILITIES SHALL BE CONDUCTED IN ACCORDANCE WITH THE PROVISIONS OF CLAUSE 76, ARTICLE 5 OF DECREE NUMBER 155/2018/NĐ-CP OF NOVEMBER 12, 2018 ISSUED BY THE GOVERNMENT AMENDING AND COMPLEMENTING CERTAIN PROVISIONS RELATED TO INVESTMENT CONDITIONS UNDER THE MANAGEMENT OF THE MINISTRY OF HEALTH. IN CASE A HEALTH CARE FACILITY ORGANIZES A TENDER TO PURCHASE MEDICINES FOR A RETAIL PHARMACY WITHIN ITS OWN PREMISES, IT SHALL FOLLOW THE GUIDELINES SET OUT IN THIS CIRCULAR.

3. THE PURCHASE OF MEDICINES ORDERED BY THE STATE OR ASSIGNED THROUGH PLANS SHALL BE CONDUCTED IN ACCORDANCE WITH DECREE NUMBER 32/2019/NĐ-CP OF APRIL 10, 2019 ISSUED BY THE GOVERNMENT REGULATING THE ASSIGNMENT OF TASKS, ORDERING, OR TENDERING FOR THE SUPPLY OF PRODUCTS AND SERVICES USING THE STATE BUDGET FROM CURRENT EXPENSE FUNDS.

4. THE PURCHASE OF MEDICINES USED IN HEALTH CARE AT MILITARY HEALTH FACILITIES AND POLICE HEALTH FACILITIES SHALL BE CONDUCTED IN ACCORDANCE WITH THE GUIDELINES OF THE MINISTRY OF NATIONAL DEFENSE AND THE MINISTRY OF PUBLIC SECURITY.

5. THE PURCHASE OF MEDICAL OXYGEN, NITRIC OXIDE (NO), AND IN-VITRO DIAGNOSTIC BIOLOGICAL MATERIALS SHALL BE CONDUCTED IN ACCORDANCE WITH THE PROVISIONS OF CIRCULAR NUMBER 58/2016/TT-BTC OF MARCH 29, 2016 ISSUED BY THE MINISTER OF FINANCE DETAILING THE USE OF STATE CAPITAL FOR MAINTENANCE PURCHASES TO SUPPORT THE REGULAR OPERATIONS OF GOVERNMENT AGENCIES, UNITS OF THE PEOPLE'S ARMED FORCES, PUBLIC SERVICE UNITS, POLITICAL ORGANIZATIONS, POLITICAL-SOCIAL ORGANIZATIONS, PROFESSIONAL POLITICAL-SOCIAL ORGANIZATIONS, SOCIAL ORGANIZATIONS, AND PROFESSIONAL SOCIAL ORGANIZATIONS.

6. THE PURCHASE OF WHOLE BLOOD AND QUALIFIED BLOOD PRODUCTS SHALL BE CONDUCTED IN ACCORDANCE WITH CIRCULAR NUMBER 05/2017/TT-BYT OF APRIL 14, 2017 ISSUED BY THE MINISTER OF HEALTH REGULATING THE MAXIMUM PRICE AND COSTS FOR DETERMINING THE PRICE OF A UNIT OF WHOLE BLOOD AND QUALIFIED BLOOD PRODUCTS AND CIRCULAR NUMBER 20/2018/TT-BYT OF AUGUST 30, 2018 ISSUED BY THE MINISTER OF HEALTH AMENDING AND COMPLEMENTING CERTAIN PROVISIONS OF CIRCULAR NUMBER 05/2017/TT-BYT OF APRIL 14, 2017 ISSUED BY THE MINISTER OF HEALTH REGULATING THE MAXIMUM PRICE AND COSTS FOR DETERMINING THE PRICE OF A UNIT OF WHOLE BLOOD AND QUALIFIED BLOOD PRODUCTS.

7. FOR ANTI-HIV MEDICATIONS FUNDED BY THE HEALTH INSURANCE FUND, THE FORMULATION, REVIEW, APPROVAL OF PROCUREMENT PLANS, SELECTION OF CONTRACTORS, AND SIGNING OF FRAMEWORK AGREEMENTS WITH WINNING CONTRACTORS SHALL BE CONDUCTED IN ACCORDANCE WITH THE PROVISIONS OF THIS CIRCULAR. OTHER CONTENTS RELATING TO THE FORMULATION OF NEEDS PLANS; CONTRACTING WITH SUPPLIERS; MANAGEMENT OF USE, ADVANCE PAYMENTS, SETTLEMENT, AND FINAL ACCOUNTING OF COSTS FOR ANTI-HIV MEDICATIONS; REGULATIONS, SOURCES OF FUNDS, AND METHODS OF CO-PAYMENT FOR ANTI-HIV MEDICATIONS FOR HIV-INFECTED PERSONS WITH HEALTH INSURANCE CARDS SHALL BE CONDUCTED IN ACCORDANCE WITH CIRCULAR NUMBER 28/2017/TT-BYT OF JUNE 28, 2017 ISSUED BY THE MINISTER OF HEALTH REGULATING THE MANAGEMENT OF ANTI-HIV MEDICATIONS FUNDED BY THE HEALTH INSURANCE FUND AND SUPPORT FOR CO-PAYMENT FOR ANTI-HIV MEDICATIONS FOR HIV-INFECTED PERSONS WITH HEALTH INSURANCE CARDS AND CIRCULAR NUMBER 08/2018/TT-BYT OF APRIL 18, 2018 ISSUED BY THE MINISTER OF HEALTH AMENDING AND COMPLEMENTING CERTAIN PROVISIONS OF CIRCULAR NUMBER 28/2017/TT-BYT OF JUNE 28, 2017 ISSUED BY THE MINISTER OF HEALTH REGULATING THE MANAGEMENT OF ANTI-HIV MEDICATIONS FUNDED BY THE HEALTH INSURANCE FUND AND SUPPORT FOR CO-PAYMENT FOR ANTI-HIV MEDICATIONS FOR HIV-INFECTED PERSONS WITH HEALTH INSURANCE CARDS.

Article 2. Applicability

1. THIS CIRCULAR APPLIES TO ORGANIZATIONS, INDIVIDUALS PARTICIPATING IN OR ASSOCIATED WITH THE PROCUREMENT OF MEDICINES.

2. HEALTH CARE FACILITIES OPERATING UNDER THE BUSINESS LAW WITH STATE CAPITAL SHALL IMPLEMENT THIS CIRCULAR.

3. PRIVATE HEALTH CARE FACILITIES PARTICIPATING IN HEALTH INSURANCE SHALL IMPLEMENT THIS CIRCULAR IN ACCORDANCE WITH ARTICLE 52 OF THE BID LAWS AND CLAUSE 7, ARTICLE 50 OF THIS CIRCULAR.

Article 3. Explanation of Terms

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

1. STRICT REGULATORY AUTHORITY (SRA) IS THE DRUG REGULATORY AUTHORITY DEFINED IN CLAUSE 10, ARTICLE 2 OF CIRCULAR NUMBER 32/2018/TT-BYT OF NOVEMBER 12, 2018 ISSUED BY THE MINISTER OF HEALTH REGULATING THE REGISTRATION AND CIRCULATION OF MEDICINES AND RAW MATERIALS FOR MEDICINES.

2. Cơ AGENCY MANAGINGREFERENCE MANAGEMENT AUTHORITY IS THE DRUG REGULATORY AUTHORITY DESIGNATED BY THE MINISTRY OF HEALTH OF VIETNAM IN CLAUSE 9, ARTICLE 2 OF CIRCULAR NUMBER 32/2018/TT-BYT OF NOVEMBER 12, 2018 ISSUED BY THE MINISTER OF HEALTH REGULATING THE REGISTRATION AND CIRCULATION OF MEDICINES AND RAW MATERIALS FOR MEDICINES.

3. ICH (INTERNATIONAL CONFERENCE ON HARMONIZATION) IS THE ENGLISH ABBREVIATION FOR THE INTERNATIONAL CONFERENCE ON HARMONIZATION OF DRUG REGULATORY REQUIREMENTS FOR HUMAN PHARMACEUTICALS.

4. PIC/S (PHARMACEUTICAL INSPECTION COOPERATION SCHEME) IS THE ENGLISH ABBREVIATION FOR THE SYSTEM FOR COOPERATION IN PHARMACEUTICAL INSPECTIONS.

5. GOOD MANUFACTURING PRACTICE (GMP) PRINCIPLES AND STANDARDS ARE THE PRINCIPLES AND STANDARDS OF GOOD MANUFACTURING PRACTICE FOR PHARMACEUTICALS.

6. PRINCIPLES AND STANDARDSGACP ARE THE PRINCIPLES AND STANDARDS OF GOOD AGRICULTURAL AND COLLECTION PRACTICES FOR HERBAL MATERIALS. MEDICINE PRODUCTION LINE MEETING EU-GMP PRINCIPLES AND STANDARDS

7. IS A MEDICINE PRODUCTION LINE THAT HAS BEEN ISSUED A CERTIFICATE OF COMPLIANCE WITH EU-GMP PRINCIPLES AND STANDARDS BY THE COMPETENT AUTHORITY OF A MEMBER STATE OF THE EUROPEAN MEDICINES AGENCY (EMA). PRODUCTION LINE MEETING EU-GMP PRINCIPLES AND STANDARDS

8. PRODUCTION LINEonn CLASS MONOCOTYLEDONn l2. A fine of VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts:of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home AffairsCOLLECTINGNo.c đ ||| c đperiodMATERIALS MEETINGắPRINCIPLES AND STANDARDSrime Minister cEQUIVALENT TO EU-GMP is a drug production line certified by the competent authority of a country listed in the SRA to meet Good Manufacturing Practice (GMP) principles and standards.

9. Drug production line meeting the prắinciple, PIC/s-GMP standard is a drug production line certified by the competent authority of a country participating in the Pharmaceutical Inspection Cooperation Scheme (PIC/s) to meet the PIC/s-GMP principles and standards.

10. Import price is the value of goods delivered alongside ship, including transportation costs from the manufacturer to the port or final destination before the cargo-carrying vessel departs. includes the drug price based on the selling price of the exporting country, insurance costs, and transportation fees from the exporting country to Vietnam's port.

11. Reference biological product (also known as reference biologic drug) is a biological product authorized for circulation in Vietnam based on complete data regarding quality, safety, and efficacy.

12. Pharmaceutical Equivalence (refers to drugs containing the same type of active ingredient at the same dosage in the same pharmaceutical form, with the same route of administration and meeting the same level of quality standards. 13. Therapeutic Equivalence

refers to a drug that has been proven bioequivalent and when used on patients under specific conditions according to the drug usage instructions, it demonstrates the same clinical effectiveness and safety. Article 4. Responsibilities for developing plans and organizing the selection of drug suppliers

1. The head of healthcare facilities shall organize the development of plans for selecting drug suppliers in accordance with Article 14 of this Circular and the following provisions:a) For drugs included in the National Centralized Bidding List and the Negotiated Price List: The National Centralized Procurement Center for Drugs shall be responsible for developing plans for selecting drug suppliers. These plans shall be based on the drug usage needs of healthcare facilities as reported by the National Centralized Procurement Center for Drugs. The contract execution period shall not exceed 36 months, divided into groups of drugs and supply schedules quarterly and annually.b) For drugs included in the Provincial Centralized Bidding List: The Provincial Centralized Procurement Unit for Drugs shall be responsible for developing plans for selecting drug suppliers. These plans shall be based on the drug usage needs of healthcare facilities as reported by the Provincial Centralized Procurement Unit for Drugs. The contract execution period shall not exceed 36 months, divided into groups of drugs and supply schedules quarterly and annually.

c) For drugs selected by healthcare facilities themselves: Healthcare facilities shall be responsible for developing plans for selecting drug suppliers. These plans shall be developed periodically or urgently when needed. The contract execution period shall not exceed 12 months, divided into groups of drugs.

2. The head of healthcare facilities shall organize the selection of drug suppliers in compliance with the following requirements:

a) For drugs included in the National Centralized Bidding List and the Negotiated Price List: The National Centralized Procurement Center for Drugs shall be responsible for organizing the selection of drug suppliers in accordance with Chapters IV and V of this Circular.

b) For drugs included in the Provincial Centralized Bidding List: The Provincial Centralized Procurement Unit for Drugs shall be responsible for organizing the selection of drug suppliers in accordance with Chapter IV of this Circular.

c) For drugs outside the National Centralized Bidding List, the Provincial Centralized Bidding List, and the Negotiated Price List: Healthcare facilities shall be responsible for organizing the selection of drug suppliers in accordance with Chapter III of this Circular.

a) For medicines listed in the National Centralized Bidding Procurement Catalogue and the Price Negotiation Catalogue: The National Centralized Medicine Procurement Center shall be responsible for organizing the selection of suppliers according to the provisions of Chapters IV and V of this Circular;

b) For medicines listed in the Provincial Centralized Bidding Procurement Catalogue: The local centralized procurement unit shall be responsible for organizing the selection of suppliers according to the provisions of Chapter IV of this Circular;

c) For medicines not listed in the National Centralized Bidding Procurement Catalogue, the Provincial Centralized Bidding Procurement Catalogue, and the Price Negotiation Catalogue: The healthcare facility shall be responsible for organizing the selection of suppliers according to the provisions of Chapter III of this Circular.

Article 5. Report on the Implementation of Tendering

1. Within a maximum period of 10 days from the date the contractor selection results are approved, the head of the healthcare facility shall be responsible for reporting the contractor selection results as follows:

a) Hospitals and institutes under the Ministry of Health with hospital beds shall report the contractor selection results for medicines to the Ministry of Health.

b) Centralized procurement units at the provincial level, healthcare facilities conducting medicine tenders within the management scope of the People's Committee of the province (hereinafter referred to as the Provincial People's Committee) shall report the contractor selection results to the Department of Health in their respective provinces.

c) Healthcare facilities under the health sector and other healthcare facilities shall report the contractor selection results to the authority that has approved the contractor selection plan.

2. Within a maximum period of 10 days from the date of receiving the contractor selection results reports from units as stipulated in point b Clause 1 of this Article, the Departments of Health of provinces and centrally-administered cities shall aggregate and report to the Ministry of Health.

3. Method of submitting reports:

a) The report format shall be implemented according to ANNEX 1 and Appendix 2 attached hereto;

b) The report shall be sent in writing and via email to the Ministry of Health as follows:

- One copy to the Department of Planning and Finance, Ministry of Health, email address: [email protected] for all tender packages for purchasing medicines;

- One copy to the Drug Administration, Ministry of Health, email address: [email protected] for tender packages for original brand-name drugs or equivalent therapeutic drugs; tender packages for generic drugs;

- One copy to the Traditional Medicine Management Agency, Ministry of Health, email address: [email protected] for tender packages for herbal medicines, traditional medicines; tender packages for medicinal herbs; tender packages for traditional decoctions.

4. Before October 31 each year, the health management agencies of ministries and sectors; hospitals and institutes under the Ministry of Health with hospital beds; Departments of Health of provinces and centrally-administered cities shall be responsible for aggregating and sending reports on violations by contractors during the tendering and supply process in the previous period of healthcare facilities in their respective areas as stipulated in Tel: issued together with this Circular to the Ministry of Health (Department of Planning and Finance for all tender packages; Drug Administration for tender packages for generic drugs, tender packages for original brand-name drugs or equivalent therapeutic drugs; Traditional Medicine Management Agency for tender packages for herbal medicines, traditional medicines, tender packages for traditional decoctions, tender packages for medicinal herbs) for aggregation and publication, serving as a basis for units to consider and evaluate, select contractors in the next period.

Article 6. Costs and Archiving of Documents in Contractor Selection

1. Costs incurred during the organization of contractor selection shall be implemented according to Article 9 of Decree No. 63/2014/ND-CP dated June 26, 2014 of the Government detailing the implementation of certain provisions of the Law on Bidding regarding contractor selection (hereinafter referred to as Decree No. 63/2014/ND-CP).

2. Archiving of documents during the organization of contractor selection shall be implemented according to Article 10 of Decree No. 63/2014/ND-CP.

Chapter II

PACKAGE DIVISION AND DRUG GROUPS

Article 7. Tender Package for Generic Drugs

A tender package for generic drugs may include one or more generic drugs, each category of generic drugs must be divided into groups, each generic drug in a group is part of the tender package. A tender package for generic drugs is divided into five (5) groups based on technical criteria, specifically as follows:

1. Group 1 includes drugs meeting one (1) of the following three (3) criteria:

a) Produced entirely on a drug production line meeting EU-GMP principles and standards or a drug production line meeting equivalent EU-GMP principles and standards in countries listed in the SRA list;

b) Included in the list of original brand-name drugs or reference biological products published by the Ministry of Health, except for original brand-name drugs included in the list of drugs subject to price negotiation by the Ministry of Health and whose price negotiation results have been announced;

c) Produced entirely in Vietnam and must meet the following criteria simultaneously:

- Produced entirely on a drug production line meeting EU-GMP principles and standards or equivalent EU-GMP principles and standards and evaluated by the Vietnamese drug administration as meeting EU-GMP principles and standards or equivalent EU-GMP principles and standards;

- Approved for circulation by the drug administration of a country listed in the SRA list according to Clause 8, Article 50 of this Circular;

- Drugs circulating in Vietnam and those approved for circulation in countries listed in the SRA list must have the same formulation, production process, quality standards, testing methods; active ingredients and excipients must have the same quality standards, manufacturing sites according to Clause 8, Article 50 of this Circular.

2. Group 2 includes drugs meeting one (1) of the following two (2) criteria:

a) Produced entirely on a drug production line meeting EU-GMP principles and standards or equivalent EU-GMP principles and standards and evaluated by the Vietnamese drug administration as meeting EU-GMP principles and standards or equivalent EU-GMP principles and standards.

b) Produced entirely on a drug production line in a country that is a member of PIC/s and ICH, certified by the competent authority of that country as meeting PIC/s-GMP principles and standards and evaluated by the Vietnamese drug administration as meeting PIC/s-GMP principles and standards.

3. Group 3 includes drugs produced on a drug production line evaluated by the Vietnamese drug administration as meeting GMP principles and standards and having bioequivalence studies published by the Vietnamese drug administration.

4. Group 4 includes drugs produced entirely on a drug production line in Vietnam evaluated by the Vietnamese drug administration as meeting WHO-GMP principles and standards.

5. Group 5 includes drugs produced on a drug production line evaluated by the Vietnamese drug administration as meeting WHO-GMP principles and standards and not falling under the cases specified in Clauses 1, 2, 3, and Clause 4 of this Article.

Article 8. Tender Package for Original Brand-Name Drugs or Equivalent Therapeutic Drugs

1. The head of the healthcare facility decides to purchase original branded drugs or equivalent treatment drugs based on the recommendation of the drug and treatment council of the healthcare facility.

2. A tender package for original branded drugs or equivalent treatment drugs may include one or more original branded drugs or equivalent treatment drugs with original branded drugs or reference biological products, each drug being part of the tender package. Drugs tendered for the original branded drugs or equivalent treatment drugs tender package must meet the following two criteria simultaneously:

a) Belonging to the list of original branded drugs, equivalent treatment drugs with original branded drugs, and reference biological products published by the Ministry of Health, except for original branded drugs included in the list of drugs subject to price negotiation formality issued by the Ministry of Health and whose price negotiation results have been announced.

b) Being entirely produced in countries listed in the SRA list, except in cases where the entity requesting publication provides proof that the original branded drug or reference biological product was first circulated in a country not listed in the SRA list or was partially produced in Vietnam.

Article 9. Tender Package for Traditional Medicine Drugs and Traditional Chinese Medicine Drugs (excluding traditional herbal medicines)

A tender package for traditional medicine drugs and traditional Chinese medicine drugs may include one or more traditional medicine drugs and traditional Chinese medicine drugs, each category of drug must be divided into groups, each drug within a group being part of the tender package. The tender package for traditional medicine drugs and traditional Chinese medicine drugs is divided into three groups according to technical criteria as follows:

1. Group 1 includes drugs meeting the following two criteria simultaneously:

a) Entirely produced from medicinal herbs cultivated, harvested, or naturally extracted, evaluated by the Vietnamese Ministry of Health as meeting Good Agricultural and Collection Practices (GACP) principles and standards;

b) Entirely produced on pharmaceutical production lines in Vietnam, evaluated by the Vietnamese Ministry of Health as meeting Good Manufacturing Practices (GMP) principles and standards for traditional medicine drugs or traditional Chinese medicine drugs.

2. Group 2 includes traditional medicine drugs and traditional Chinese medicine drugs entirely produced on pharmaceutical production lines in Vietnam, evaluated by the Vietnamese Ministry of Health as meeting GMP principles and standards for traditional medicine drugs or traditional Chinese medicine drugs.

3. Group 3 includes traditional medicine drugs and traditional Chinese medicine drugs that do not meet the criteria set out in Clause 1 and Clause 2 of this Article.

Article 10. Tender Package for Traditional Herbal Medicines

A tender package for traditional herbal medicines may include one or more traditional herbal medicines, each category of herbal medicine must be divided into groups, each herbal medicine within a group being part of the tender package. The tender package for traditional herbal medicines is divided into three groups according to technical criteria as follows:

1. Group 1 includes traditional herbal medicines meeting the following two criteria simultaneously:

a) Produced from medicinal herbs cultivated, harvested, or naturally extracted, evaluated by the Vietnamese Ministry of Health as meeting GACP principles and standards;

b) Entirely produced on pharmaceutical production lines in Vietnam, evaluated by the Vietnamese Ministry of Health as meeting GMP principles and standards for traditional herbal medicines (including those prepared in forms such as: extract, powder, decoction, essential oil, resin, gum, standardized gel).

2. Group 2 includes traditional herbal medicines entirely produced on pharmaceutical production lines in Vietnam, evaluated by the Vietnamese Ministry of Health as meeting GMP principles and standards for traditional herbal medicines (including those prepared in forms such as: extract, powder, decoction, essential oil, resin, gum, standardized gel).

3. Group 3 includes traditional herbal medicines that do not meet the criteria set out in Clause 1 and Clause 2 of this Article.

Article 11. Herbal Medicine Tender Package

The herbal medicine tender package may include one or more herbal medicines, each category of herbal medicine must be divided into groups, each herbal medicine within a group is part of the tender package. The herbal medicine tender package is divided into three (3) groups based on technical criteria as follows:

1. Group 1 includes cultivated, harvested, or naturally extracted herbal medicines that have been evaluated by the Ministry of Health of Vietnam to meet the principles and standards of GACP.

2. Group 2 includes semi-finished herbal medicines such as extracts, powders, granules, decoctions, essential oils, resins, gums, jellies standardized produced on production lines in Vietnam and evaluated by the Ministry of Health of Vietnam to meet the principles and standards of GMP for raw materials used in drug manufacturing from herbal medicines.

3. Group 3 includes herbal medicines that do not meet the criteria set out in Clause 1 and Clause 2 of this Article.

Article 12. Provisions on Bidding for Drug Groups

1. Principles of bidding for drug groups in the tender package

a) A bidder with drugs meeting the technical criteria of a particular group may bid for that group. Drugs meeting the technical criteria of multiple groups shall allow the bidder to bid for one or more groups where the drug meets the technical criteria, and the bidder must have a unified bid price for all groups in which they bid.

b) If a drug being bid involves multiple entities participating in its production process, all entities involved in the production process must meet the technical criteria of the drug group being bid.

2. Tender package for generic drugs:

a) Drugs meeting the criteria of Group 1 can be bid for Groups 1, 2, and 5;

b) Drugs meeting the criteria of Group 2 can be bid for Groups 2 and 5;

c) Drugs meeting the criteria of Group 3 can be bid for Groups 3 and 5;

d) Drugs meeting the criteria of Group 4 can be bid for Groups 4 and 5;

e) Drugs not meeting the criteria of Groups 1, 2, 3, and 4 can only be bid for Group 5.

3. Tender package for herbal medicine and traditional medicine:

a) Drugs meeting the criteria of Group 1 can be bid for Groups 1, 2, and 3;

b) Drugs meeting the criteria of Group 2 can be bid for Groups 2 and 3;

c) Drugs not meeting the criteria of Groups 1 and 2 can only be bid for Group 3.

4. Tender package for traditional medicine ingredients:

a) Traditional medicine ingredients meeting the criteria of Group 1 can be bid for Groups 1, 2, and 3;

b) Traditional medicine ingredients meeting the criteria of Group 2 can be bid for Groups 2 and 3;

c) Traditional medicine ingredients not meeting the criteria of Groups 1 and 2 can only be bid for Group 3.

5. Tender package for herbal medicines:

a) Herbal medicines meeting the criteria of Group 1 can be bid for Groups 1 and 3;

b) Herbal medicines meeting the criteria of Group 2 can only be bid for Group 2;

c) Herbal medicines not meeting the criteria of Groups 1 and 2 can only be bid for Group 3.

6. Bidding for foreign-produced drugs manufactured under contract or technology transfer in Vietnam for the generic drug tender package and the original brand drug tender package or equivalent treatment implementation is as follows:

a) Foreign-produced drugs manufactured under contract or technology transfer in Vietnam can be bid for drug groups according to the provisions of point b of this Clause when simultaneously meeting the following criteria:

- Must have a technology transfer contract specifying in detail the comprehensive technology transfer roadmap for the contractor to eventually produce all stages of the finished drug production process in Vietnam within a maximum period of five years from the date of issuance of the registration certificate for circulation in Vietnam;

- Contract-manufactured drugs and drugs before contract manufacturing must have the same formulation, production process, and quality standards for raw materials and finished products;

- Drugs not included in the list of domestically produced drugs meeting requirements for treatment, drug prices, and supply capacity issued by the Ministry of Health according to technical criteria subcategories (except for cases where full production is carried out in Vietnam upon issuance of the registration certificate for circulation in Vietnam).

b) The bidding for foreign-produced drugs manufactured under contract or technology transfer in Vietnam meeting the provisions of point a of this Clause is implemented as follows:

- Foreign-produced drugs listed in the original brand drug directory or reference biological product directory by the Ministry of Health and meeting the provisions of point b of Clause 2 of Article 8 of this Circular can be bid for the original brand drug tender package or equivalent treatment tender package. In cases included in the drug price negotiation list issued by the Ministry of Health, the procurement of these drugs will be carried out through price negotiation procedures;

- Foreign-produced drugs specified in Clause 1, Article 7 of this Circular manufactured under contract or technology transfer in Vietnam on production lines meeting the principles and standards of EU-GMP or equivalent EU-GMP standards and evaluated by the Vietnamese drug regulatory authority as meeting the principles and standards of EU-GMP or equivalent EU-GMP standards can be bid for Groups 1, 2, 4, and 5;

- Foreign-produced drugs specified in Clause 2, Article 7 of this Circular manufactured under contract or technology transfer in Vietnam on production lines meeting the principles and standards of EU-GMP or equivalent EU-GMP standards and evaluated by the Vietnamese drug regulatory authority as meeting the principles and standards of EU-GMP or equivalent EU-GMP standards can be bid for Groups 2, 4, and 5;

- Other drugs manufactured under contract or technology transfer in Vietnam can be bid for Groups 4 and 5.

c) In cases where foreign-produced drugs manufactured under contract or technology transfer do not meet the criteria stipulated in point a of this Clause, the bidding shall be carried out according to the provisions of Clause 1 and Clause 2 of this Article.

Chapter III

PROVISIONS ON PROCUREMENT OFDRUGS AT HEALTH CARE FACILITIES

Section 1

ESTABLISHING THE PLAN FOR SELECTING SUPPLIERS OF DRUGS

Article 13. Basis for preparing the plan to select contractors

1. The plan to select contractors shall be prepared annually or when there is a need to organize the selection of contractors based on the following grounds:

a) State budget funds:

The annual budget estimate for purchasing medicines from state budget funds that have been assigned by the competent authority. In cases where the budget estimate has not been assigned, it shall be based on the actual purchase and use of medicines from state budget funds in the immediately preceding year and the anticipated needs for medicine use in the planning year to prepare the plan;

b) Revenue from medical examination and treatment services and revenue paid by the Social Insurance agency:

- Medical examination and treatment insurance contracts signed between healthcare facilities and the Social Insurance agency;

- Actual purchases and use of medicines from revenue generated by medical examination and treatment services in the immediately preceding year and the anticipated needs for medicine use in the planning year at healthcare facilities.

c) For medicines purchased from other legitimate sources of income of the unit: based on the actual purchases and use of medicines from other legitimate sources of income in the immediately preceding year and the anticipated needs for medicine use in the planning year at healthcare facilities.

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

Article 14. Content of the plan to select contractors

1. Name of the tender package:

The division of tender packages and groups of medicines shall comply with the provisions from Article 7 to Article 12 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 included in the plan to select contractors is as follows:

a) Each part of the tender package for generic medicines includes the following information: active ingredient name; concentration or content; route of administration, dosage form; group of medicines; unit of measurement; quantity; unit price and total value of the medicine;

b) Each part of the tender package for original brand-name medicines or equivalent therapeutic substitutes includes the following information: medicine name accompanied by the phrase "or equivalent therapeutic substitute"; active ingredient name; concentration or content; route of administration, dosage form; unit of measurement; quantity; unit price and total value of the medicine. In cases where an active ingredient has multiple original brand-name medicine names or therapeutic equivalents of original brand-name medicines or reference biological products listed in the Catalogue of Original Brand-Name Medicines or the Catalogue of Therapeutic Equivalents of Original Brand-Name Medicines or the Catalogue of Reference Biological Products published by the Ministry of Health, the medicine name section must include all original brand-name medicine names or therapeutic equivalents of original brand-name medicines or reference biological products;

c) Each part of the tender package for herbal medicines and traditional medicines includes the following information: medicine name; route of administration, dosage form; unit of measurement; quantity; group of medicines; unit price and total value of the medicine. The recording of medicine names shall be carried out according to the provisions of Clause 3 of this Article.

d) Each part of the tender package for herbal materials and traditional medicine ingredients includes the following information: name of herbal material or traditional medicine ingredient; scientific name; quality standard; initial processing method or preparation method; group of medicines; unit of measurement; quantity; unit price and total value of the medicine.

2. The recording of dosage forms of medicines in the tender package for generic medicines, herbal medicines, and traditional medicines in the plan to select contractors shall be carried out according to the provisions set forth in Appendix 4 issued together with this Circular. Dosage forms marked ⁽*⁾shall be recorded separately in the plan to select contractors according to the following principle:

a) They can only be separated if they have the same dosage form as original brand-name medicines or reference biological products with the same active ingredient and route of administration, or medicines with the same active ingredient and route of administration that have been approved for circulation in the SRA country;

b) In cases where medicines do not fall under point a of Clause 2 of this Article, healthcare facilities must clearly explain the necessity of using such dosage forms regarding their essentiality, the expected quantity to be used, and their use only in necessary situations when other dosage forms cannot be used or when other dosage forms do not meet the treatment requirements;

3. Recording the names of medicines in the tender package for herbal medicines and traditional medicines shall be carried out as follows:

a) Only the components of the medicine shall be recorded, without recording trade names;

b) In cases where medicines have the same components and dosage forms: the concentration or content of the medicine component shall be recorded when differences in concentration or content lead to differences in dosages or treatment indications, and must have the advisory opinion of the Medicine and Treatment Council.

4. 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;

b) 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 record the unit price and total value of that part according to the provisions of Clause 1 of this Article. The unit price of medicines in the plan to select contractors proposed by healthcare facilities and are responsible for the appropriateness of the medicine unit prices;

c) When preparing the plan to select contractors, units must refer to the winning bid prices of medicines and herbal materials within the last 12 months announced on the electronic information website by the Ministry of Health (the Drug Administration Department, the Traditional Medicine and Drugs Management Department) to establish the unit price of each medicine and herbal material specifically:

- Refer to the winning bid prices of medicines and herbal materials on the electronic information websites of the Drug Administration Department and the Traditional Medicine and Drugs Management Department to establish the unit price of each medicine according to the principle: The planned price of each medicine and herbal material must not exceed the highest winning bid price of that medicine and herbal material in each technical criteria group that has been announced.

- For medicines and medicinal materials that have not been announced with winning bid prices or whose prices at the time of planning are higher than the winning bid prices announced by the Ministry of Health (the Drug Administration Department, the Traditional Medicine Management Department) within the previous 12 months, healthcare facilities must refer to quotations or sales invoices from at least three suppliers on the market at the time of planning for selecting contractors; while ensuring that the planned price proposed by the facility does not exceed the wholesale selling price declared and re-declared of the referenced medicine (except for medicinal materials and traditional herbal medicines). For medicines and medicinal materials with few suppliers, less than three quotations or sales invoices, the head of the healthcare facility shall base the quotations or sales invoices of the supplier, provide explanations, and be responsible for the suitability of the planned price proposed by the facility with the market price of such medicines and medicinal materials at the time of planning for selecting contractors.

d) The construction of planned prices for items with the same active ingredient, concentration, or content, and dosage form in the generic drug tender package must ensure the following principles:

- The planned price of Group 1 shall not be higher than the planned price of the original brand-name drug or reference biologic.

- The planned price of Groups 2 and 3 shall not be higher than the planned price of the original brand-name drug or reference biologic and Group 1.

- The planned price of Group 4 shall not be higher than the planned price of the original brand-name drug or reference biologic; Group 1; Group 2 produced in Vietnam and Group 3.

- The planned price of Group 5 shall not be higher than the planned price of the original brand-name drug or reference biologic; Group 1; Group 2; Group 3 and Group 4.

5. Source of funds: healthcare facilities must clearly state the source of funds used to purchase medicines, and if official development assistance funds or preferential loans are used, they must clearly state the name of the sponsor and the structure of the funding sources, including grant funding, domestic counterpart funding (if any).

6. Form and method of selecting contractors:

a) Form of selecting contractors:

Healthcare facilities shall base on the scale and nature of each tender package to select one of the forms of selecting contractors prescribed from Article 20 to Article 25 of the Bidding Law and detailed guidance provided in this Circular.

b) Method of selecting contractors:

Healthcare facilities shall base on the form of selecting contractors and the scale of the tender package to propose the method of selecting contractors according to the provisions of Article 28 and Article 29 of the Bidding Law, Decree No. 63/2014/NĐ-CP, and detailed guidance provided in this Circular. For small-scale medicine procurement packages that require selection based on a combination of quality and price, the two-envelope bidding method shall be applied.

7. Time to start organizing the selection of contractors:

Record the expected issuance time of the tender documents or request for proposal according to month or quarter in the year.

8. Type of contract:

Base on the scale, nature of the tender package, and supply method to choose and apply the contract form according to the provisions of Article 62 of the Bidding Law appropriately.

9. Contract execution period:

Shall be specified in the plan for selecting contractors but shall not exceed 12 months from the date the contract becomes effective.

Article 15. Approval of the Plan for Selecting Contractors

1. Responsibility for approving the plan for selecting contractors:

a) The head of the healthcare facility shall be responsible for preparing the plan for selecting contractors to purchase medicines to ensure the supply of medicines for treatment activities at medical examination and treatment facilities.

b) At the latest three months before the expiration of the validity of the previously signed medicine supply contract, the head of the healthcare facility has the responsibility to submit the annual plan for selecting contractors to the authorized person or the person delegated to approve the plan for selecting contractors under Clause 1 of Article 17 of this Circular for review and approval.

2. Content of the document for approving the plan for selecting contractors to supply medicines includes the following basic contents:

a) Basis for preparing the plan for selecting contractors to supply medicines implemented according to the provisions of Article 13 of this Circular;

b) Content of the plan for selecting contractors implemented according to the provisions of Article 14 of this Circular and must be recorded specifically as follows:

- Names of tender packages, prices of each part and the total price of the tender package, total value of tender packages in the plan for selecting contractors, and the basis for dividing tender packages. In cases where medicines are purchased from the state budget allocation, the total value of tender packages in the plan for selecting contractors shall not exceed the approved total budget for medicine purchases;

- Form and method of selecting contractors for each tender package according to one of the forms and methods of selecting contractors prescribed from Article 19 to Article 26 of this Circular. In cases where open bidding is not applied, the document for approving the plan for selecting contractors must clearly state the reasons for proposing the application of other forms of contractor selection for the authorized person to consider and decide;

- Explanation about increasing the proportion of domestically produced medicines according to the guidelines of the Ministry of Health.

3. Documents attached to the document for approving the plan for selecting contractors:

a) Summary report on the results of implementing the plan for selecting contractors, the situation of medicine usage in the previous year, and a summary explanation of the plan for selecting contractors being submitted for approval;

b) Documents serving as the basis for preparing the plan for selecting contractors to supply medicines as stipulated in Article 13 of this Circular;

c) Minutes of the meeting of the Medicine and Treatment Council of the healthcare facility regarding the list, quantity of medicines, demand for using original brand-name drugs or equivalent drugs to treat original brand-name drugs or reference biologics, demand for using medicines with dosage forms recorded separately in the plan for selecting contractors as prescribed in Clause 2 of Article 14 of this Circular, the recording of the name of the medicine and the concentration or content of the medicine in the tender package of herbal medicines and traditional medicines;

d) Decision of the Project Owner approving the source of funds, approving the list, quantity, and planned price of goods in the plan for selecting contractors.

4. The approval file for the plan for selecting contractors shall be sent via postal service or directly through the office or online according to the guidance of the competent authority to the unit assigned to assess the plan for selecting contractors. The document for approving the plan for selecting contractors shall be implemented according to the prescribed model at … (Name of economic organization) requests to change the Certificate of Registration for Currency Exchange Agent with the following content: promulgated together with this Circular.

Article 16. Review of Procurement Plan

The procurement plan for selecting suppliers to provide medicines must be reviewed before being submitted to the authorized person specified in Clause 1, Article 17 of this Circular for approval.

1. Reviewing organization:

a) Public health facilities under the management of Ministries, ministerial-level agencies, and government agencies: The authorized person specified at point a, Clause 1, Article 17 of this Circular decides on the unit responsible for organizing the review of the procurement plan.

b) Public health facilities under local management:

- For medicine procurement packages approved by the Chairman of the Provincial People's Committee, the Department of Health shall be responsible for organizing the review of the procurement plan.

- For medicine procurement packages where the Chairman of the Provincial People's Committee delegates authority to approve the procurement plan, the delegate designates a unit with functions and tasks suitable to the nature of the package to organize the review of the procurement plan before approval.

c) For health facilities not covered by points a and b of Clause 1 of this Article, the person responsible for the facility under the law or the person authorized by the person responsible for the facility under the law decides on the unit responsible for organizing the review of the procurement plan.

2. Tasks of the reviewing unit:

a) Check and evaluate the contents according to Articles 7 to 15 of this Circular within 20 days from the date of receiving all relevant documents. In case of insufficient documents as required, the reviewing unit has the responsibility to notify, request supplementary documents, or return the dossier to the health facility within five working days from the date of receipt of the documents.

b) Prepare a report on the review of the procurement plan for selecting suppliers to purchase medicines according to the model prescribed in Certificate of Registration for Change of Currency Exchange Agent No…. date….) issued together with this Circular. The review report accompanies one set of the dossier submitted by the health facility for approval of the procurement plan (original copy) to be submitted to the authorized person specified in Clause 1, Article 17 of this Circular for examination and approval of the procurement plan.

Article 17. Approval of Procurement Plan

1. Authority to Approve Procurement Plan:

a) The Minister, Head of a ministerial-level agency, or Head of a government agency is responsible for approving the procurement plan for selecting suppliers to provide medicines for health facilities under their management. The Minister, Head of a ministerial-level agency, or Head of a government agency delegated authority to approve procurement plans for some medicine supply packages may delegate to the heads of health facilities under their management. In such cases, the delegate designates a unit with functions and tasks suitable to the nature of the package to organize the review of the procurement plan before approval.

b) The Chairman of the Provincial People's Committee is responsible for approving the procurement plan for selecting suppliers to provide medicines for health facilities under provincial management. The Chairman of the Provincial People's Committee delegated authority to approve procurement plans for some medicine supply packages may delegate to the heads of health facilities under provincial management. In such cases, the delegate designates a unit with functions and tasks suitable to the nature of the package to organize the review of the procurement plan before approval.

c) The person responsible for the health facility under the law or the person authorized by the person responsible for the health facility under the law is responsible for approving the procurement plan for selecting suppliers to provide medicines for health facilities not covered by points a and b of Clause 1 of this Article.

d) The delegation of authority to approve procurement plans for purchasing medicines for health facilities under the armed forces shall be carried out in accordance with the guidelines of the Ministry of National Defense and the Ministry of Public Security.

2. Within five working days from the date of receiving the review report and the dossier submitted by the health facility for approval of the procurement plan, the authorized person specified in Clause 1 of this Article is responsible for approving the procurement plan.

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 related implementing regulations.

Article 18. Provisions on self-organizing selection of contractors for medicines listed in the Centralized Bidding Medicine List and the Price Negotiation Medicine List of healthcare facilities

1. Healthcare facilities may self-organize the selection of contractors for medicines listed in the Centralized Bidding Medicine List and the Price Negotiation Medicine List and must ensure that the time and quantity do not exceed the usage needs within 12 months (counting from the date the centralized procurement unit notifies in writing) under one of the following circumstances:

a) Healthcare facilities have a need to use medicines listed in the Centralized Bidding Medicine List and the Price Negotiation Medicine List but have not yet received the results of centralized bidding or price negotiation announcements;

b) Medicines listed in the Centralized Bidding Medicine List and the Price Negotiation Medicine List have been contracted but the winning contractor cannot supply the medicines and there is an announcement from the centralized procurement unit allowing the healthcare facility to self-organize the selection of contractors to ensure medicine supply for medical services;

c) Healthcare facilities have used up the allocated quantity of medicines in the framework agreement and exceeded the adjustment capacity specified in Clause 5, Article 37, Clause 13, Article 40, and Clause 12, Article 41 of this Circular;

d) Healthcare facilities established after the completion of the compilation of medicine purchase requirements, exceeding the adjustment capacity of the National Centralized Procurement Center and the local centralized procurement units.

2. Healthcare facilities shall not organize the selection of contractors for medicines listed in the National Centralized Bidding Medicine List, the Local Centralized Bidding Medicine List, and the Price Negotiation Medicine List if at the time of issuing the tender documents, the results of the selection of contractors and the framework agreement have been announced, except in cases stipulated in points b, c, and d of Clause 1 of this Article. In case healthcare facilities still organize the selection of contractors and sign contracts with other contractors, such contracts shall not be paid.

Section 2

FORMS OF SELECTION OF CONTRACTORS

Article 19. Open Bidding

Open bidding shall be applied to all packages within the scope regulated by this Circular, except for cases stipulated from Article 20 to Article 24 of this Circular.

Article 20. Restricted Bidding

1. Restricted bidding shall be applied in cases where special control medicines listed by the Ministry of Health and medicines with specific characteristics, which can only be met by a limited number of contractors, are purchased.

2. Manufacturers and suppliers of medicines preliminarily selected by the Ministry of Health into the list of manufacturers and suppliers meeting the requirements of capacity, experience, and reputation as stipulated in point d, Clause 1, Article 77 of Decree No. 63/2014/ND-CP shall be invited to participate in restricted bidding if they have suitable medicines for the package.

Article 21. Direct Award

1. Cases of direct award and simplified direct award:

a) Direct award applies to packages of purchasing medicines with a limit not exceeding VND 1 billion as stipulated in point e, Clause 1, Article 22 of the Bidding Law;

b) Simplified direct award applies to packages in cases stipulated in point a, Clause 1, Article 22 of the Bidding Law and Article 79 of Decree No. 63/2014/ND-CP.

2. Procedures for direct award and simplified direct award:

a) The procedure for direct award shall be implemented according to the provisions of Article 55 of Decree No. 63/2014/ND-CP.

b) The procedure for simplified direct award shall be implemented according to the provisions of Article 56 of Decree No. 63/2014/ND-CP after the plan for selecting contractors has been approved.

In the case of direct award as stipulated in point a, Clause 1, Article 22 of the Bidding Law, except for packages required to be carried out to ensure state secrets, it shall be implemented according to the provisions of Clause 8, Article 6 of Circular No. 10/2015/TT-BKHĐT dated October 26, 2015, issued by the Minister of Planning and Investment detailing the plan for selecting contractors.

Article 22. Competitive Bidding

1. Tender packages shall be implemented through competitive bidding when fully meeting the following requirements:

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

b) Medicines belong to the Essential Medicine List issued by the Ministry of Health or commonly available medicines on the market with standardized technical specifications and quality equivalent to those listed;

c) There is a procurement plan for contractors approved by the authorized person;

d) In cases of purchasing from state budget sources, there must be an approved budget for medicine purchases. In cases of purchasing medicines from other revenue sources, healthcare facilities must ensure sufficient funds to pay according to the progress of implementing the tender package.

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

Article 23. Direct Procurement

1. A tender package shall apply direct procurement when fully meeting the following requirements:

a) The contractor has won the bid to supply medicines through open tendering or restricted tendering and has signed a contract to implement the tender package previously;

b) The tender package has similar content and nature, and its scale is less than 130% compared to the previous tender package that was contracted. In cases where the medicines in the direct procurement tender package are one of many medicines in a similar tender package previously contracted, the quantity of medicines subject to direct procurement must be less than 130% of the quantity of the same type of medicines in the similar previously contracted tender package;

c) The unit price of medicines in the tender package applying direct procurement shall not exceed the unit price of corresponding medicines in the previously contracted tender package, while also being consistent with the winning bid price published at the time of approving the procurement plan for contractors;

d) The period from signing the contract of the previous tender package to the date of approving the direct procurement result shall not exceed twelve months. Within twelve months, healthcare facilities may only directly procure once for each item in the previously contracted tender package. In special cases, healthcare facilities must submit a document to the authorized person specified in Clause 1 of Article 17 of this Circular for consideration and decision.

2. If the contractor implementing the previous contract is unable to continue executing the direct procurement tender package, direct procurement can be applied to another contractor if they meet the requirements regarding capacity, experience, technology, price according to the tender invitation documents and the results of the previous contractor selection.

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

Article 24. Self-execution

1. Self-execution shall be applied to tender packages stipulated in Article 25 of the Public Procurement Law when fully meeting the requirements prescribed in Article 61 of Decree No. 63/2014/NĐ-CP.

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

Section 3

METHODS FOR SELECTING CONTRACTORS TO SUPPLY MEDICINES

Article 25. One-stage One-envelope Method

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

1. Medicine tender packages conducted through open tendering or restricted tendering but with small scale as defined in Article 63 of Decree No. 63/2014/NĐ-CP;

2. Medicine tender packages conducted through competitive bidding;

3. Medicine tender packages conducted through direct procurement;

4. Medicine tender packages conducted through ordinary designated tendering.

Article 26. One-stage two-envelope method

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

1. Procurement packages for purchasing medicines through open tendering or restricted tendering with a package value exceeding 10 billion VND.

2. Procurement packages for purchasing medicines through open tendering or restricted tendering with a package value not exceeding 10 billion VND but where the medicines need to be selected based on a combination of quality and price.

 

Section 4

BID INVITATION DOCUMENTS, PROCUREMENT REQUIREMENTS FOR MEDICINES

Article 27. Preparation of bid invitation documents and procurement requirements

1. The preparation of bid invitation documents and procurement requirements for purchasing medicines must be carried out in accordance with the provisions of the Public Procurement Law, detailed implementing regulations, and the following provisions:

a) Bid invitation documents and procurement requirements for original brand drug procurement packages, equivalent treatment drug procurement packages, generic drug procurement packages, and traditional medicine procurement packages shall be prepared according to the model bid invitation document for purchasing medicines under the one-stage one-envelope method as prescribed at Appendix 7 or the model bid invitation document for purchasing medicines under the one-stage two-envelope method as prescribed at ANNEX 8 promulgated together with this Circular.

b) Bid invitation documents and procurement requirements for traditional medicine ingredient procurement packages and medicinal herb procurement packages shall be prepared in accordance with the guidelines of the Ministry of Health detailing the model bid invitation document for purchasing medicinal herbs and traditional medicine ingredients at healthcare facilities.

2. Based on the approved procurement plan, the tenderer shall be responsible for preparing the bid invitation documents and procurement requirements for purchasing medicines and submitting them for review to the unit in charge of reviewing the bid invitation documents and procurement requirements.

3. For medicines listed in the Domestic Medicine Production Catalogue that meet the requirements for treatment, medicine prices, and supply capacity issued together with Circular No. 03/2019/TT-BYT dated March 28, 2019 of the Minister of Health (hereinafter referred to as Circular No. 03/2019/TT-BYT), when preparing the bid invitation documents and procurement requirements, healthcare facilities must clearly stipulate that imported medicines with the same technical criteria shall not be tendered, specifically:

a) Medicines with technical criteria listed in the Catalogue attached to Circular No. 03/2019/TT-BYT that are WHO-GMP, the contractor shall not tender imported medicines with technical criteria group 5 as prescribed in Clause 5, Article 7 of this Circular.

b) Medicines with technical criteria listed in the Catalogue attached to Circular No. 03/2019/TT-BYT that are EU-GMP, the contractor shall not tender imported medicines with technical criteria group 2 as prescribed in Clause 2, Article 7 of this Circular.

4. For medicinal herbs listed in the Domestic Cultivation and Collection Herbal Medicine Catalogue that meet the requirements for treatment and supply capacity, reasonable prices announced by the Ministry of Health under which technical criteria group, in the bid invitation documents and procurement requirements, imported medicinal herbs from that group shall not be tendered.

5. For medicines listed in the Domestic Medicine Production Catalogue that meet the requirements for treatment, medicine prices, and supply capacity or medicinal herbs listed in the Domestic Cultivation and Collection Herbal Medicine Catalogue that meet the requirements for treatment, supply capacity, and reasonable prices, if there is a sudden increase in demand exceeding the supply capacity of domestic production facilities, healthcare facilities need to use imported medicines or medicinal herbs to meet treatment needs, then based on reports from healthcare facilities and the supply situation of medicines, the Minister of Health shall decide on tendering imported medicines or medicinal herbs with the same technical criteria group as medicines listed in the Domestic Medicine Production Catalogue that meet the requirements for treatment, medicine prices, and supply capacity or medicinal herbs listed in the Domestic Cultivation and Collection Herbal Medicine Catalogue that meet the requirements for treatment, supply capacity, and reasonable prices within a specified period to ensure sufficient supply of medicines or medicinal herbs to meet treatment needs.

Article 28. Review of tender invitation documents and request documents

1. Tender invitation documents and request documents for drug supply must be reviewed before being submitted to the head of the healthcare facility for examination and approval.

2. The unit responsible for reviewing tender invitation documents and request documents shall be determined by the head of the healthcare facility.

3. Responsibilities of the review unit:

a) Check the contents of the tender invitation documents and request documents in accordance with the Bidding Law, guiding documents on selecting contractors, and provisions set forth in this Circular;

b) Prepare a review report on the tender invitation documents and request documents in compliance with the legal regulations on selecting contractors, along with one set of tender invitation documents and request documents (original), to submit to the head of the healthcare facility for examination and approval within twenty days from the date of receiving all relevant documents.

Article 29. Approval of tender invitation documents and request documents

The head of the healthcare facility is responsible for approving tender invitation documents and request documents within ten days from the date of receipt of such documents and the review report of the review unit.

Section 5

SELECTION OF CONTRACTORS FOR DRUG SUPPLY

Article 30. Guaranteeing tender participation, submitting tender documents and proposal documents

1. The head of the healthcare facility (or the tender inviter) must specify the amount of tender guarantee in the tender invitation documents and request documents according to the following principles:

a) The tender guarantee amount for a tender package should be equivalent to 1% to 3% of the value of the tender package, and for small-scale tender packages, it should be 1% to 1.5% of the value of the tender package.

b) In cases where a tender package is divided into several parts, the tender guarantee amount for each part should be expressed as a specific value equivalent to 1% to 3% of the value of that part in the tender package, and for small-scale tender packages, it should be 1% to 1.5% of the value of that part in the tender package.

2. Contractors may participate in one or some or all parts of the tender package. If participating in some parts of the tender package, the contractor must provide a tender guarantee amount equal to the total tender guarantee amount of the parts they are participating in.

3. Contractors may choose one of the following forms of tender guarantee:

a) Deposit;

b) Escrow;

c) Letter of guarantee issued by credit organizations or branches of foreign banks established under Vietnamese law.

The investor shall not compel contractors to implement any specific form among the three forms mentioned above.

4. The validity period of tender documents and proposal documents shall be stipulated by the tender inviter in the tender invitation documents and request documents but shall not exceed 180 days from the closing date of the tender. In necessary cases, the validity period of tender documents and proposal documents can be extended while ensuring the progress of drug supply by the healthcare facility. Contractors must submit at least two sets (one original and one copy) of tender documents or proposal documents in accordance with the tender invitation documents and request documents to the tender inviter before the closing date.

Article 31. Evaluation of tender documents and proposal documents

1. Depending on the nature, scale of the tender package, and the form and method of selecting contractors, the head of the healthcare facility shall select the evaluation method for tender documents and proposal documents as prescribed in Articles 39 and 41 of the Bidding Law, as appropriate. The evaluation method for tender documents and proposal documents must be clearly specified in the tender invitation documents and request documents.

2. The tender inviter shall evaluate tender documents and proposal documents separately for each part of the tender package if it consists of multiple parts, based on compliance with the Bidding Law and the Ministry of Health's regulations on preparing tender invitation documents and request documents for drug procurement in healthcare facilities. For the evaluation of the contractor's capacity and experience, it shall be conducted based on the total parts of the tender package in which the contractor participates.

3. Criteria for evaluating tender documents and proposal documents shall be implemented according to the model tender invitation document prescribed in Appendix 7 send a text message ANNEX 8 issued together with this Circular and must be specifically recorded in the tender invitation documents and request documents. The tender inviter must have the responsibility to implement preferential treatment in selecting contractors as prescribed in Articles 3, 5, and 6 of Decree 63/2014/NĐ-CP.

4. Evaluation process of tender documents and proposal documents: depending on the tender selection method approved by the competent authority, specifically:

a) One-stage one-envelope method: carried out in accordance with the provisions from Article 15 to Article 18 of Decree 63/2014/NĐ-CP;

b) One-stage two-envelope method: carried out in accordance with the provisions from Article 27 to Article 30 of Decree 63/2014/NĐ-CP.

5. The maximum time for evaluating proposal documents is thirty days; for tender documents, it is forty-five days; for small-scale tender packages, the maximum time for evaluating tender documents is twenty-five days, from the closing date to the date when the tender inviter submits the results of the contractor selection to the head of the healthcare facility for approval. In cases of open bidding and restricted bidding using the one-stage two-envelope method, the evaluation time for tender documents equals the sum of the technical proposal document evaluation time (from the closing date to the date when the tender inviter submits the list of contractors meeting technical requirements to the head of the healthcare facility for approval) plus the financial proposal document evaluation time (from the opening date of the financial proposal documents to the date when the tender inviter submits the results of the contractor selection to the head of the healthcare facility for approval). In necessary cases, the evaluation time for tender documents and proposal documents may be extended but not more than twenty days and must ensure the progress of drug supply to the healthcare facility.

Article 32. Contract Negotiation and Bid Award Proposal

1. Contract negotiation shall be conducted in accordance with the provisions of Article 19 of Decree No. 63/2014/NĐ-CP and shall take place prior to the bid award proposal by the tender inviter.

The bidder with the lowest corrected and adjusted bid price, minus the lowest discount value (if applicable), for the lowest price method; the lowest evaluated price for the evaluated price method; and the highest combined technical and price score for the combined technical and price method shall be invited to negotiate the contract.

In cases where a bidder invited to negotiate the contract does not attend the negotiation or refuses to negotiate the contract, the bidder will not be entitled to have their bid bond returned.

2. Conditions for considering the bid award proposal shall be implemented in accordance with the provisions of Article 43 of the Bidding Law and the bidding invitation document template prescribed at Appendix 7 send a text message ANNEX 8 promulgated together with this Circular.

The tender inviter shall propose the winning bid for each part of the procurement plan that has been approved based on compliance with the provisions of the Bidding Law, this Circular, and detailed regulations on drug quality management and drug pricing management. Each part of the tender package may only propose one drug or medicinal material that meets the technical and quality requirements specified in the bidding invitation document, request document, and has the lowest corrected and adjusted bid price, minus the lowest discount value (if applicable), for the lowest price method; the lowest evaluated price for the evaluated price method; and the highest combined technical and price score in that group of drugs.

3. In cases where the corrected and adjusted bid prices, minus the lowest discount value (if applicable), of all bidders meeting the technical requirements and ranked in the list exceed the price of that part of the tender package that has been approved, the following actions shall be taken:

a) If the price of that part of the procurement plan that has been approved and determined to be reasonable, the tender inviter shall require the bidder to resubmit the price according to Clause 8 of Article 117 of Decree No. 63/2014/NĐ-CP;

b) If the price of that part of the procurement plan is deemed unreasonable, the tender inviter must submit a report explaining and proposing adjustments to the price of that part and the tender package for review and decision by the competent authority;

c) In cases where it is necessary to ensure sufficient drugs to meet the healthcare needs of medical facilities, the tender inviter may consider and decide to select the winning drug according to the ranking order of bidders when the following conditions are met:

- The reviewed winning drug price does not exceed the current declared wholesale price of that drug;

- The total value of proposed winning drugs from parts with bidders does not exceed the total value of those parts in the approved procurement plan.

Article 33. Report for Reviewing the Procurement Results

1. The tender inviter is responsible for submitting one set of documents to the entity tasked with reviewing the procurement results, which includes:

a) One original copy of the bid evaluation report and proposal evaluation report;

b) One set of the bidding invitation document and request document (photocopies) that have been reviewed and approved in accordance with Articles 27, 28, and 29 of this Circular and other relevant bidding laws.

2. The procedures for reporting, reviewing, approving, and publicly announcing the procurement results shall be carried out in accordance with the provisions of Article 20 of Decree No. 63/2014/NĐ-CP.

Article 34. Review and Approval of Tender Selection Results

1. The head of the healthcare facility shall be responsible for establishing or assigning tasks to an organization to review the results of selecting contractors providing medicines.

2. Tasks of the reviewing organization:

a) Within twenty days (ten days for small-scale tenders), from the date of receiving all relevant documents, the reviewing organization shall organize inspections and evaluations of the tender selection process as stipulated in Articles 30, 31, and 32 of this Circular;

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

3. Documents for approval of tender selection results include:

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

b) One set of documents for approval of tender selection results (original) submitted by the tender inviter.

Article 35. Approval and Notification of Tender Selection Results

1. Within ten days (maximum five working days for small-scale tenders), from the date of receiving all documents for approval of tender selection results from the reviewing organization as stipulated in Clause 3 of Article 34 of this Circular, the head of the healthcare facility shall be responsible for approving the tender selection results.

2. When the tender selection results are approved, the tender inviter shall notify the tender selection results in writing to the contractors according to the relevant laws on bidding.

3. For contractors not selected, the notification of tender selection results in writing must clearly state the reasons why they did not win the bid.

4. In cases where a medicine tender has several separate parts and the evaluation time of the tender documents may affect the supply progress of medicines at the healthcare facility, the tender inviter may consider and approve the tender selection results for one or more parts in different phases to ensure the supply progress of medicines.

5. If there are medicines in the tender without bidders or without winning bidders or cannot be handled according to Clause 3 of Article 32 of this Circular, the tender inviter shall cancel the tender for those medicines and separate them into another tender package to submit to the authorized person for approval to adjust the tender selection plan. The review and approval time for the adjusted plan shall be carried out in accordance with Articles 16 and 17 of this Circular. In cases where the information of the medicine items in the tender package includes: active ingredient name; concentration or content; route of administration, formulation type; drug group; unit of measurement; quantity; unit price and total value of the medicine does not change compared to the previously approved plan, the authorized person for approval of the adjustment plan does not need to review the tender selection plan again.

Article 36. Winning Bid Price for Medicines

The winning bid price of each medicine shall not exceed the price of that medicine in the approved tender selection plan and shall not exceed the wholesale price declaration or re-declaration still in effect for that medicine, except in cases stipulated in Clause 3 of Article 32 of this Circular.

Article 37. Signing Contracts, Ensuring Contract Execution, and Using Winning Bids

1. Before signing the contract, the tender inviter has the right to increase or decrease the maximum quantity by no more than 10% compared to the quantity of medicines in the tender plan, provided that there are no changes in the unit price or other conditions and terms of the tender documents and tender invitation documents.

2. The selected contractor must implement measures to ensure contract execution before the contract becomes effective. The amount of contract performance guarantee is specified in the tender invitation documents and request documents at a level from 2% to 10% of the contract value. For small-scale tenders, the amount of contract performance guarantee is specified in the tender invitation documents and request documents at a level from 2% to 3% of the contract value.

3. The head of the healthcare facility and the winning bidder are responsible for implementing the medicine supply contract in accordance with the relevant laws on economic contracts, and must execute at least 80% of the value of each part in the signed contract. For emergency medicines, antidote medicines, rare medicines, specially controlled medicines, infusions, and other situations reported to the competent authority, the healthcare facility ensures the execution of at least 50% of the value of each part in the signed contract.

In cases where the healthcare facility does not execute at least 80% of the value of each part in the signed contract, the head of the healthcare facility must report and explain the reasons to the authorized person.

4. The healthcare facility shall not purchase more than the quantity of medicines in a group in the tender selection results if it has not purchased the full quantity of medicines in other groups of the same active ingredient, concentration or content, and the same formulation type that have won bids under signed contracts.

5. The following cases are allowed to purchase more but the quantity shall not exceed 20% of the quantity of that group of medicines in the signed contract and do not need to submit a supplementary tender selection plan for approval:

a) All quantities of medicines in other groups with the same active ingredient, concentration or content have been used up, and only the quantity of medicines in the original brand or equivalent treatment tender package remains;

b) Other groups of medicines with the same active ingredient, concentration or content have won bids but must stop supplying or have been suspended from circulation, withdrawn from the list of medicines with proven bioequivalence after winning the bid;

c) The contractor has not supplied the full quantity of medicines in a group in the signed contract but is unable to continue supplying due to force majeure, in which case a written notice accompanied by supporting documents must be provided.

6. In cases where the tendered medicine changes during the tender selection process or the supply of the winning bid medicine changes but the substitute medicine was not offered in the tender documents, the project owner may consider allowing the contractor to replace the medicine to ensure sufficient supply to meet the timely medical examination and treatment needs of the unit, specifically:

a) Changes related to the medicine name; manufacturer name; packaging specifications during circulation but the registration certificate or import permit number does not change;

b) Changing the registration circulation number or obtaining a new import permit but other information remains unchanged (drug name, manufacturer, quality standard, shelf life, bidding drug category; only the quality standard may change but must not be lower than that of the winning bid drug (or listed in the bidding proposal) or updated to a new version of the Pharmacopoeia).

When replacing drugs, the contractor 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 Circulation Permit (MA) or Drug Product Certificate (CPP), any official letters approving changes or additions from state management agencies (if any), and an explanation that the quality standards of the bidding drug and the proposed replacement drug have not changed.

c) Original brand-name drugs or reference biological products that won the bid (or were listed in the bidding proposal) have changed their registration circulation number or other information, and the replacement drug has been announced in the List of Original Brand-Name Drugs or the List of Reference Biological Products by the Ministry of Health.

d) Changing the way herbal medicine names are recorded without altering the nature of the ingredients in the formula, provided such changes have been approved by the competent state management agency.

Chapter IV

REGULATIONS ON CONCENTRATED PURCHASEOF DRUGS

Article 38. General Provisions on Concentrated Drug Purchases

1. Entities responsible for concentrated drug purchases shall:

a) Aggregate drug usage needs, prepare and submit for approval the plan to select contractors, organize the selection of contractors, complete and sign contracts or framework agreements with selected contractors, announce the results of the contractor selection and framework agreements on the Ministry of Health's Electronic Information Portal and the Department of Health's Website for healthcare facilities to use as a basis to finalize and sign contracts with selected contractors.

b) Supervise the implementation process of framework agreements and contracts with selected contractors.

2. Local-level entities purchasing drugs centrally shall not organize the selection of contractors for drugs included in the National Central Bidding Drug List or the Negotiated Price Drug List if at the time of issuing the tender invitation, the results of contractor selection and framework agreements have already been published on the Ministry of Health's Electronic Information Portal.

3. When compiling and summarizing reports on drug usage needs included in the National Central Bidding Drug List and the Negotiated Price Drug List, healthcare facilities shall not include the remaining quantities of drugs under existing contracts signed with suppliers based on previous contractor selection results of their own entity.

4. Method of selecting contractors: open domestic tendering.

5. Tendering method: two-envelope system.

6. Evaluation of tender proposals: use a combined technical and price evaluation method for each component of the tender package.

7. Implementation method: centralized drug purchases shall be conducted through framework agreements, except for the following cases which shall be implemented through direct contracting:

a) Purchase of drugs and vaccines for expanded immunization programs using state budget funds according to decisions by the Minister of Health or the Chairman of the Provincial People's Committee.

b) Purchase of drugs for programs and projects funded by ODA, grants, and donations from domestic and foreign organizations and individuals using state budget funds where the donor requires direct contracting.

8. Review of the contractor selection plan:

a) The Department of Planning and Finance is responsible for organizing the review of the plan to select contractors for national-level centralized drug supply.

b) The Department of Health is responsible for organizing the review of the plan to select contractors for local-level centralized drug supply.

c) The review of the plan to select contractors for centralized drug supply shall be carried out in accordance with Clause 1 of Article 37 of the Bidding Law and Article 16 of this Circular.

9. Contract negotiation:

Contract negotiations shall be conducted in accordance with Clause 1 of Article 32 of this Circular. During centralized contractor selection, to ensure the economic efficiency of the tender package, contract negotiations shall be conducted in accordance with Clause 3 of Article 19 of Decree 63/2014/NĐ-CP and may consider handling situations as follows:

a) In cases where a large quantity of a single drug item is divided into several tender packages as stipulated in Point a of Clause 4 of Article 40 of this Circular, and the same drug item is proposed as a winner in multiple tender packages with different bid prices, it may be considered to require the contractor to analyze the factors constituting the bid price, explain, and clarify the price difference of the same drug item supplied at different locations. These analyses will serve as the basis for negotiating towards the lowest bid price of the drug item in the tender package to ensure the economic efficiency of the tender package.

b) In cases where a drug item in a group of drugs has only one registration circulation certificate on the market, resulting in only one contractor participating without price competition, and the bid price in this group is higher than the bid price of the same active ingredient, concentration, or dosage form, route of administration in another group with higher technical standards and competitive prices due to multiple contractors participating, contract negotiations with the contractor regarding the bid price may be considered to ensure consistency with the drug grouping criteria based on technical standards according to the following principles:

- The winning bid price of Group 1 shall not exceed the winning bid price of original brand-name drugs or reference biological products.

- The winning bid price of Groups 2 and 3 shall not exceed the winning bid price of original brand-name drugs or reference biological products and Group 1.

- The winning bid price of Group 4 shall not exceed the winning bid price of original brand-name drugs or reference biological products; Group 1; Group 2 produced in Vietnam and Group 3.

- The winning bid price of Group 5 shall not exceed the winning bid price of original brand-name drugs or reference biological products; Group 1; Group 2; Group 3 and Group 4.

10. In the event that tendered drugs undergo changes during the selection process of contractors or drug supply for winning bids but replacement drugs have not been offered in the tender dossier, the drug substitution shall be carried out in accordance with the provisions of Clause 6, Article 37 of this Circular to ensure adequate drug supply in a timely manner for medical examination and treatment activities.

11. The functions, tasks, organizational regulations, and operations of the National Central Procurement Center for Drugs shall be decided by the Minister of Health; the functions, tasks, organizational regulations, and operations of the centralized drug procurement units at the provincial level shall be decided by the Chairman of the Provincial People's Committee based on the proposal of the Department of Health.

Article 39. Responsibilities of related parties and effectiveness of framework agreements

1. Medical facilities requiring to purchase drugs listed in the centralized tender directory must base their actions on the results of contractor selection and the contents of the framework agreement to complete and sign contracts with the selected contractors through centralized procurement according to the principle that the unit price agreed upon in the contract shall not exceed the price stipulated in the published framework agreement. Contractors must implement measures to ensure contract performance in accordance with Article 66 of the Bidding Law and Clause 2, Article 37 of this Circular before the contract becomes effective.

2. The lead units specified in Clause 1, Article 40 and Clause 2, Article 41 of this Circular are responsible for reviewing and consolidating the drug catalog and quantity requirements of each medical facility under their management and regulating the implementation of plans to ensure the minimum usage of 80% of the reported quantities for centralized drug procurement units. For emergency drugs; antidotes; rare drugs; specially controlled drugs; infusions; and other drugs used in urgent situations, after reporting to the competent authority, medical facilities must ensure the execution of at least 50% of the value of each part of the signed contract.

3. Contractors selected through centralized drug procurement are responsible for supplying drugs according to the quantity and schedule recorded in the signed contract with each medical facility. During the contract implementation 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 provisions in the tender invitation issued by the centralized drug procurement unit. The centralized drug procurement unit is responsible for coordinating with the lead units and winning contractors to regulate the implementation of plans to ensure adequate drug supply for medical facilities.

4. The duration of centralized drug procurement contracts (national and local levels) is specified in the contractor selection plan approved by the competent authority but shall not exceed 36 months from the date the centralized drug procurement results and framework agreements become effective.

Article 40. Organization of national-level centralized drug procurement

1. The establishment and consolidation of drug usage needs shall be conducted as follows:

a) Medical facilities directly under the Ministry of Health shall establish detailed needs regarding the drug catalog, quantity down to each individual drug, group, and delivery schedule, and send them to the National Central Procurement Center for Drugs along with the documents specified in Clause 2 of this Article.

b) Medical facilities managed by localities, ministries, and agencies shall establish detailed needs regarding the drug catalog, quantity down to each individual drug, group, and delivery schedule, and send them to the centralized drug procurement units at the provincial level.

The provincial-level centralized drug procurement units shall consolidate the needs; report to the Department of Health for review and submit the drug usage plan to the National Central Procurement Center for Drugs along with the documents specified in Clause 2 of this Article.

c) The deadline for submitting the consolidated drug procurement needs table to the National Central Procurement Center for Drugs is before June 15th each year or at a specific time announced by the National Central Procurement Center for Drugs.

2. Documents accompanying the registration of centralized drug procurement needs:

a) Summary report on the results of contractor selection, drug usage situation of the previous year, stock quantities, and unexecuted quantities in the planning stage of medical facilities;

b) Summary explanation of the proposed drug procurement plan; if there is an increase or decrease of more than 30% in quantity compared to the previous year's usage, a detailed explanation must be provided;

c) Documents serving as the basis for establishing the drug procurement plan as stipulated in Article 13 of this Circular;

d) Minutes of the Drug and Treatment Council meeting of medical facilities under the Ministry of Health or the review minutes of the Department of Health regarding the drug catalog, quantity, and usage needs of medical facilities managed by localities, ministries, and agencies within their jurisdiction.

3. The National Central Procurement Center for Drugs shall organize reviews of the drug catalog and quantity needs of medical facilities under the Ministry of Health's management; consolidate the drug catalog, quantity, and delivery schedule needs of each drug to develop the contractor selection plan.

4. The contractor selection plan shall be established according to the following principles:

a) In cases where there is a large demand for drugs, and a single contractor cannot provide the entire tender package, it can be divided into different packages based on regions or economic zones or tender package size to ensure competition in bidding;

Example: Drug A is included in the national centralized drug procurement list, with a total annual usage requirement of 100 million tablets, but no contractor has the capacity to supply all 100 million tablets annually, then the quantity of Drug A can be divided into several packages:

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

- Or it could be divided into seven economic zone packages: Northeast, Northwest, Red River Delta; North Central; South Central; Southeast; Mekong Delta.

b) The division of drug groups within tender packages, the content of the contractor selection plan shall be implemented in accordance with Articles 7 to 14 of this Circular. The contract implementation period shall be carried out in accordance with Clause 4, Article 39 of this Circular.

5. Organizing the review of the contractor selection plan:

a) The National Medicines Procurement Center submits the dossier for approval of the plan to select contractors to supply medicines to the Department of Planning and Finance, Ministry of Health.

b) The review of the plan to select contractors to supply medicines listed in the centralized national tendering directory shall be carried out in accordance with Clause 2, Article 16 of this Circular. The Department of Planning and Finance is the lead unit responsible for reviewing the list of items, quantity of tenders, planned unit prices, and quantity of medicines; the centralized procurement plan for selecting contractors to supply medicines. In cases where necessary, the Department of Planning and Finance shall seek advice from the National Advisory Council on Medicine Tendering before submitting the plan to select contractors to the Minister of Health for consideration and approval.

6. Approving the plan to select contractors:

The Minister of Health considers and approves the plan to select contractors based on the proposal of the Department of Planning and Finance.

7. Preparing to select contractors:

Based on the approved plan to select contractors by the Minister of Health, the National Medicines Procurement Center prepares the tender invitation documents, organizes reviews, and approves the tender invitation documents in accordance with Articles 27, 28, and 29 of this Circular.

8. Organizing the selection of contractors:

The National Medicines Procurement Center is responsible for organizing the selection of contractors, evaluating tender documents, negotiating contracts, and recommending successful bids, reporting and submitting the results of the contractor selection process for review in accordance with Articles 30, 31, 32, and 33 of this Circular.

9. Reviewing, approving, and publicly announcing the results of the contractor selection:

a) Based on the evaluation results of tender documents and contract negotiations or framework agreements with contractors, the National Medicines Procurement Center organizes the review and approval of the results of the contractor selection in accordance with Articles 34 and 35 of this Circular. In cases where necessary, it must seek advice from the National Advisory Council on Medicine Tendering before approving the results of the contractor selection;

b) The National Medicines Procurement Center is responsible for announcing and publicly disclosing the results of the contractor selection in accordance with the Bidding Law.

10. Completing and signing contracts or framework agreements:

a) The National Medicines Procurement Center is responsible for completing and signing contracts or framework agreements with winning contractors in accordance with the Bidding Law; publicly disclosing framework agreements on the Ministry of Health's Electronic Information Portal and notifying in writing to healthcare facilities under the Ministry of Health, health sectors, and provincial health departments;

b) The lead unit responsible for consolidating and proposing medicine usage needs in accordance with Clause 1 of this Article is responsible for informing healthcare facilities within the scope of the framework agreement about the results of the contractor selection and framework agreements.

11. Completing and signing supply contracts:

The National Medicines Procurement Center (in cases where direct contract signing is applied); healthcare facilities base their actions on the results of the contractor selection for supplying medicines, framework agreements, needs, and plans for using medicines registered with the lead unit to complete and sign contracts with contractors according to the following principles:

a) Complying with supply conditions within the scope of the framework agreement;

b) The price of each medicine in the contract shall not exceed the winning bid price announced by the National Medicines Procurement Center;

c) Contract execution period: specified in the approved contractor selection plan but not exceeding 36 months, from the date when the centralized procurement results and framework agreements become effective until all parties fulfill their obligations as stipulated in the contract.

12. Reporting on the implementation of the results of centralized national contractor selection:

a) Before the 10th day of each month and the first day of each quarter or at any time upon request, contractors report on the implementation of supply contracts for medicines listed in the centralized national tendering directory according to the form prescribed in Appendix 9 and Appendix 10 issued together with this Circular to the National Medicines Procurement Center.

b) Before the first day of each quarter or at any time upon request, healthcare facilities managed by localities, healthcare facilities managed by ministries and sectors in the locality send reports to the corresponding centralized medicine procurement units at the local level according to the form prescribed in Appendix 11 issued together with this Circular.

c) Before the 15th day of the first month of each quarter or at any time upon request, centralized medicine procurement units at the local level, healthcare facilities directly under the Ministry of Health report on the implementation of supply contracts for medicines listed in the centralized national tendering directory according to the form prescribed in Appendix 11 issued together with this Circular to the National Medicines Procurement Center.

13. Supervising and regulating the implementation of framework agreements:

The National Medicines Procurement Center and centralized medicine procurement units at the local level are responsible for supervising and regulating the supply of medicines at healthcare facilities implementing signed framework agreements in accordance with the guidelines of the National Medicines Procurement Center on the following principles:

a) If healthcare facilities managed by localities, healthcare facilities managed by ministries and sectors in the locality have a need to use medicines that exceeds 20% of the quantity allocated in the framework agreement, they must report to the centralized medicine procurement unit at the local level for consolidation and regulation of the quantity of medicines among healthcare facilities within the supply scope in the locality but ensuring that it does not exceed 20% of the total quantity allocated in the framework agreement for units within the supply scope in the locality. Within 10 days from the date of receipt of the request for regulation from the healthcare facility, the centralized medicine procurement unit at the local level must respond to the unit.

b) In case the demand for drugs of healthcare facilities under the Ministry of Health exceeds the quantity of drugs allocated in the framework agreement or the demand of healthcare facilities managed by local authorities, healthcare facilities managed by ministries and sectors exceeds the capacity to regulate drug quantities of centralized procurement units at the local level, or healthcare facilities generate a need to use drug items but have not yet compiled such needs when building the plan for selecting suppliers to purchase drugs, they must report to the National Centralized Drug Procurement Center for regulation of drug quantities among units. Within five days from the date of receiving the report requesting regulation from healthcare facilities on the territory, the centralized procurement unit at the local level must report to the National Centralized Drug Procurement Center according to the prescribed form. Appendix 12 promulgated together with this Circular.

Within ten days from the date of receiving the request for regulation from healthcare facilities, the National Centralized Drug Procurement Center must issue a reply to the unit.

The quantity of regulated drugs by the National Centralized Drug Procurement Center must ensure that it does not exceed 30% of the total quantity approved in the plan for selecting drug suppliers belonging to the List of centrally tendered drugs at the national level. The regulation process follows the regulation procedure for drugs in the List of centrally tendered drugs at the national level issued by the National Centralized Drug Procurement Center.

14. Payment and settlement of contracts for drug supply:

The National Centralized Drug Procurement Center (in cases where direct contract signing is applied); healthcare facilities (in cases where framework agreements are applied) are responsible for payment and settlement with suppliers in accordance with current legal regulations and the terms of the signed contracts.

The approval document for drug regulation between units of centralized procurement is a component of the drug purchase and sale contract and serves as the basis for healthcare facilities and contractors to sign supplementary contract appendices (for regulated items already allocated in the framework agreement) or sign contracts (for regulated items not yet allocated in the framework agreement).

Article 41. Organization of centralized drug procurement at the local level

1. Building and compiling drug usage requirements:

a) The list of centrally tendered drugs at the local level applies to healthcare facilities located in the locality including local healthcare facilities, central healthcare facilities, healthcare facilities under the management of ministries and sectors, and health services of agencies stationed in the locality. Central healthcare facilities, healthcare facilities under the management of ministries and sectors, and health services of agencies are responsible for building plans for drug usage, complying with regulations on centralized drug supplier selection at the local level as required for local healthcare facilities. The centralized drug procurement unit at the local level is responsible for compiling requirements and organizing the selection of drug suppliers for local healthcare facilities, central healthcare facilities, healthcare facilities under the management of ministries and sectors, and health services of agencies stationed in the locality as required for local healthcare facilities.

b) Based on the list of centrally tendered drugs at the local level, healthcare facilities directly under provinces and centrally administered cities (including local healthcare facilities, central healthcare facilities, healthcare facilities under the management of ministries and sectors, and health services of agencies) build their drug usage requirements and send them to the centralized drug procurement unit at the local level;

c) The list and quantity of drugs sent to the centralized drug procurement unit at the local level before July 15th each year or at a specific time notified by the centralized drug procurement unit at the local level;

2. The centralized drug procurement unit at the local level organizes the review of drug lists and quantities for each participating healthcare facility in centralized drug procurement at the local level; compiles the requirements for drug lists, quantities, and supply progress for each drug to develop the plan for selecting suppliers.

3. Developing the plan for selecting suppliers: The centralized drug procurement unit at the local level implements the division of drug groups within tenders, and the content of the plan for selecting suppliers is carried out according to the provisions from Article 7 to Article 14 of this Circular. The contract implementation period is carried out according to the provisions of Clause 4, Article 39 of this Circular.

4. Organizing the review of the plan for selecting suppliers:

a) The centralized drug procurement unit at the local level sends the file for reviewing the plan for selecting suppliers providing drugs to the Department of Health.

b) The review of the plan for selecting suppliers providing drugs in the list of centrally tendered drugs at the local level is carried out according to the provisions of Clause 2, Article 16 of this Circular. The Department of Health organizes the review of the plan for selecting suppliers, reports to the Chairman of the Provincial People's Committee for consideration and approval of the plan for selecting suppliers;

5. Approving the plan for selecting suppliers:

The Chairman of the Provincial People's Committee considers and approves the plan for selecting suppliers providing centralized drug supply in the locality based on the proposal of the Department of Health.

6. Preparing for supplier selection:

Based on the approved plan for selecting suppliers, the centralized drug procurement unit at the local level prepares the tender invitation document, reports to the Department of Health to organize the review and approve the tender invitation document according to the provisions of Articles 27, 28, and 29 of this Circular.

7. Organizing the selection of suppliers:

The centralized drug procurement unit at the local level organizes the selection of suppliers, evaluates tender documents, negotiates contracts, and proposes successful bids, reporting to review the results of the selection of suppliers according to the provisions of Articles 30, 31, 32, and 33 of this Circular.

8. Reviewing, approving, and publicizing the results of the selection of suppliers:

a) The centralized drug procurement unit at the local level prepares a report, submits it to the Department of Health to organize the review and approval of the results of the selection of suppliers providing centralized drug supply in the locality;

b) The Department of Health is responsible for reviewing and approving the results of the selection of suppliers providing centralized drug supply in the locality according to the provisions of Articles 34 and 35 of this Circular;

c) The centralized drug procurement unit at the local level is responsible for announcing and publicizing the results of the selection of suppliers according to the provisions of the Bidding Law.

9. Completing and signing contracts or framework agreements:

a) On the basis of the approved tender selection results, the centralized drug procurement unit at the provincial level shall be responsible for completing and signing contracts or framework agreements with successful tenderers in accordance with the Bidding Law.

b) The centralized drug procurement unit at the provincial level shall publicly announce the signed framework agreements in accordance with the Bidding Law on the Provincial People's Committee Electronic Portal, the Department of Health's website, and notify healthcare facilities within the supply scope of the framework agreement.

10. Completing and Signing Supply Contracts for Medicines:

In cases where direct contract signing is applied, the centralized procurement unit at the provincial level; healthcare facilities shall base their completion and signing of contracts with suppliers on the tender selection results for medicine suppliers, framework agreements, needs, and registered usage plans of medicines to complete and sign contracts with suppliers according to the following principles:

a) Complying with supply conditions within the scope of the framework agreement;

b) The price of each medicine in the contract shall not exceed the winning bid price announced by the centralized procurement unit at the provincial level.

c) Contract execution period: specified in the approved contractor selection plan but not exceeding 36 months, from the date when the centralized procurement results and framework agreements become effective until all parties fulfill their obligations as stipulated in the contract.

11. Reporting on the Implementation of Centralized Provincial Tender Selection Results

a) Before the first day of each quarter or at any time upon request, suppliers shall report on the implementation of contracts for medicines listed in the centralized provincial tendering catalog according to the form prescribed in Appendix 10 this Circular to the centralized provincial drug procurement unit.

b) Before the first day of each quarter or at any time upon request, healthcare facilities managed by the locality, healthcare facilities under the Ministry of Health, and healthcare facilities managed by ministries and sectors on the local territory shall submit reports to the centralized provincial drug procurement unit for consolidation according to the form prescribed in Appendix 11 promulgated together with this Circular.

12. Supervising and Regulating the Implementation of Framework Agreements:

The centralized drug procurement unit at the provincial level shall be responsible for supervising and regulating the supply of medicines at healthcare facilities implementing signed framework agreements according to the following principles:

a) In cases where the healthcare facility's demand for medicines exceeds 20% of the quantity allocated in the framework agreement or if the healthcare facility generates a need for a medicine item that was not included in the tender plan when building the tender selection plan, they must report to the centralized provincial drug procurement unit according to the form prescribed in Appendix 12 this Circular for consolidation and regulation of the quantity of medicines among healthcare facilities within the supply range in the locality. Within ten days from the date of receipt of the request for regulation from the healthcare facility, the centralized provincial drug procurement unit will issue a response document.

The quantity of regulated medicines by the centralized provincial drug procurement unit must not exceed 30% of the total quantity already approved in the tender selection plan for medicines in the centralized provincial tendering catalog. The regulation process follows the regulation procedure for medicines in the centralized provincial tendering catalog issued by the centralized provincial drug procurement unit.

13. Payment and Settlement of Medicine Supply Contracts: Healthcare facilities are responsible for making payments and settlements with suppliers in accordance with current laws and the terms of the signed contracts. The approval document for the regulation of medicines between units issued by the centralized procurement unit is part of the Medicine Purchase Contract and serves as the basis for healthcare facilities and suppliers to sign supplementary contract appendices (for items regulated and allocated in the framework agreement) or new contracts (for items regulated but not allocated in the framework agreement).

Chapter V

PROVISIONS ON PRICE NEGOTIATIONS

Article 42. General Provisions on Price Negotiations

1. The Price Negotiation Council for Medicines:

a) The Price Negotiation Council for Medicines shall be established by the Minister of Health. The Minister of Health shall specify in detail the functions, tasks, powers, and operational mechanisms of the Price Negotiation Council for Medicines. The operating funds of the Price Negotiation Council shall be sourced from the state budget allocated to the National Centralized Procurement Center for Medicines and other lawful sources as prescribed by law.

b) The composition of the Price Negotiation Council for Medicines includes:

- The Chairman of the Council is the Leader of the Ministry of Health;

- Two Vice Chairmen of the Council are the Leaders of the Vietnam Social Security and the Director of the National Centralized Procurement Center for Medicines.

- Members of the Council include representatives from relevant Departments, Bureaus under the Ministry of Health, the Ministry of Planning and Investment, the Ministry of Finance, the Vietnam Social Security, and some independent experts in related fields.

c) Tasks of the Price Negotiation Council for Medicines:

- Reviewing and deciding on the negotiation price plans developed by the National Centralized Procurement Center for Medicines;

- Conducting price negotiations according to the approved negotiation plan;

2. The National Centralized Procurement Center for Medicines is the standing unit of the Price Negotiation Council for Medicines with the following responsibilities:

a) Developing negotiation plans and timelines;

b) Organizing the development, review, and approval of request files;

c) Organizing the evaluation of proposal files;

d) Developing anticipated negotiation price plans;

đ) Publicizing the results of price negotiations;

e) Monitoring and regulating the supply and use of selected medicines through price negotiations;

g) Participating in all stages of the price negotiation process and compiling and providing relevant information during the negotiation process;

h) Performing other tasks assigned by the Chairman of the Council.

3. 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. In cases where tendered medicines undergo changes during the selection of contractors or the supply of winning bids but substitute medicines have not been offered in the tender documents, the entity specified in Clause 1, Article 40 of this Circular shall consider allowing the contractor to replace the medicine in accordance with Clause 6, Article 37 of this Circular to ensure adequate supply of medicines.

Article 43. Building, reviewing, and approving the negotiation price plan

1. Aggregating the demand for medicines included in the list of negotiable medicines:

The National Centralized Procurement Center for Medicines aggregates the demand for medicines in accordance with Clause 1, Article 40 of this Circular.

2. Establishing the negotiation price plan for medicines:

The National Centralized Procurement Center for Medicines is responsible for developing the negotiation price plan. The content of the negotiation price plan for medicines shall comply with the provisions of Article 14 of this Circular and must include the following specific information:

a) Names of tender packages, tender package prices, total value of tender packages, and individual values of parts within each tender package in the procurement plan;

b) Anticipated planned prices for each negotiable medicine item as stipulated in Clause 4, Article 14 of this Circular;

c) Requirements regarding quality standards and delivery times, specific purchase conditions for each medicine subject to negotiation;

d) Anticipated timeframes for conducting price negotiations for each medicine in the list of negotiable medicines;

đ) In necessary cases, the National Centralized Procurement Center for Medicines shall seek advisory opinions from the Price Negotiation Council on the negotiation price plan before submitting it to the entity tasked with reviewing the plan.

3. Reviewing the negotiation price plan:

a) The National Centralized Procurement Center for Medicines shall submit the application file for approval of the procurement plan to the Department of Planning and Finance for review of the procurement plan;

b) The Department of Planning and Finance shall be responsible for reviewing the list of items, number of tender packages, planned unit prices, and quantity of medicines. The review of the negotiation price plan shall be conducted in accordance with Clause 2, Article 16 of this Circular.

4. Approving the negotiation price plan: The Minister of Health shall examine and approve the negotiation price plan based on the report of the Department of Planning and Finance. If necessary, the Minister of Health shall seek advisory opinions from the National Advisory Council on Medicine Tendering before approving.

Article 44. Preparation, Review, and Approval of Request Documents

Based on the tender selection plan for contractors through price negotiation form that has been approved by the Minister of Health, the National Centralized Procurement Center for Medicines shall prepare request documents, organize reviews, and approve the request documents.

1. Preparation of Request Documents:

a) The preparation of request documents for purchasing medicines through price negotiation form shall be carried out in accordance with the Bidding Law, detailed regulations of the Bidding Law, and the National Centralized Procurement Center for Medicines;

b) The content of the request documents includes summary information about the tender package; instructions on preparing and submitting proposal documents; standards regarding the capacity and experience of contractors; technical evaluation criteria and determination of the tender package price. Use pass/fail criteria to evaluate capacity, experience, and technical assessment;

c) The request documents guide contractors to provide information on prices, specific economic and technical criteria expected to be applied during the price negotiation process, which the contractor must provide in the bidding offer document, specifically:

- Factory price, CIF price, and selling price to healthcare facilities in the producing country and in countries within the Association of Southeast Asian Nations (ASEAN) provided by the contractor;

- Factory price, CIF price, and selling price to healthcare facilities in the Vietnamese market;

- Prescription designation of the medicine and clinical effectiveness evaluation of the medicine in treatment; Comparative clinical effectiveness evaluation report when using the medicine compared to standard medicines (if applicable);

- Pharmaceutical economic analysis data of the medicine including cost-effectiveness, cost-benefit, and cost-utility provided by the contractor (if applicable);

- Commitments and plans of the contractor regarding quantity, quality of supply sources, and delivery schedule if awarded the contract.

2. Review of Request Documents:

a) Request documents for providing medicines through price negotiation form must be reviewed before being submitted to the Director of the National Centralized Procurement Center for Medicines for consideration and approval.

b) The composition of the unit responsible for reviewing the request documents shall be decided by the Director of the National Centralized Procurement Center for Medicines.

3. Approval of Request Documents

Based on the review report of the unit responsible for reviewing the request documents, the Director of the National Centralized Procurement Center for Medicines is responsible for approving the request documents in accordance with the regulations.

Article 45. Organizing Price Negotiations for Medicines

1. Announcements inviting the provision of medicines through price negotiation form and request documents are publicly issued.

2. Contractors prepare and submit proposal documents according to the requirements of the request documents.

a) The implementation of bid guarantee and submission of proposal documents shall comply with the provisions of Article 30 of this Circular;

b) Contractors base on the announcement inviting the provision of medicines and request documents through price negotiation form to prepare proposal documents and send them to the National Centralized Procurement Center for Medicines either directly or via postal service.

3. Evaluation of Proposal Documents and Preparation of Negotiation Plans

a) The National Centralized Procurement Center for Medicines organizes the evaluation of proposal documents in accordance with the request documents. These proposal documents will be opened publicly. During the evaluation process, the tenderer may invite contractors to discuss, clarify, or modify and supplement necessary information in the proposal documents to demonstrate compliance with the requirements regarding capacity, experience, progress, quantity, quality, technical solutions, and organizational measures for implementing the tender package.

b) The National Centralized Procurement Center for Medicines bases on the proposal documents of contractors and the evaluation report of the proposal documents by the expert team to develop negotiation plans. In case of necessity, the Center invites clinical and pharmaceutical economic experts to participate in developing negotiation plans for each type of medicine. The negotiation plan needs to summarize information about the pharmacological effects of the medicine, the proposed price of the negotiated medicine, the winning bid price of the negotiated medicine and other medicines with the same active ingredient, concentration, or dosage form but different tender groups and substitutable medicines with the same pharmacological effect group in treatment (if applicable), factors related to the negotiation plan and clauses of the framework agreement to be negotiated.

c) The Chairman of the Negotiation Committee approves the negotiation plan for medicines before conducting negotiations.

4. Negotiation and Decision:

a) The National Centralized Procurement Center for Medicines sends negotiation invitation letters to contractors who fully meet the conditions of the request documents. In case of necessity, the National Centralized Procurement Center for Medicines may invite representatives of the medicine manufacturing company or the owner's representative in Vietnam (including representative offices) to clarify contents related to the negotiated goods;

b) Contractors invited to negotiate must meet the following conditions: Legitimate status, meeting the request requirements regarding capacity, experience, and technical proposals in the request documents, and proposing a price not exceeding the approved budget of the tender package;

c) Depending on specific cases, the Medicine Negotiation Committee decides to choose direct negotiation or negotiation through documents. The content of the negotiation of the Medicine Negotiation Committee is based on the contractor's proposal documents, the evaluation report of the proposal documents, relevant information, and the approved negotiation plan;

d) In case there are two or more contractors providing medicines participating in the price negotiation of medicines with the same active ingredient, concentration, or dosage form, after negotiation, based on the negotiation results, the Negotiation Committee proposes contractors to re-quote; in the re-quotation proposal document, it must clearly state the deadline, location for receiving re-quotation documents, time to open re-quotation documents simultaneously inviting contractors to attend the opening ceremony of re-quotation documents. When re-quoting, the contractor cannot quote a higher price than the previously negotiated price. The contractor with the lowest re-quote price is recognized as the winner.

d) In case the first round of negotiations does not succeed, the Negotiation Council will decide, depending on specific circumstances, whether to invite or not to invite the bidder for a second round of price negotiation. The National Centralized Procurement Center for Medicines will notify each bidder of the formal conclusion of the Negotiation Council following the first negotiation session;

e) If the bidder is invited for another round of negotiations, the bidder must submit a new quotation and proposal within the time frame specified in the negotiation invitation letter from the National Centralized Procurement Center for Medicines;

g) The bid-winning price through price negotiation is agreed upon by the Negotiation Council and the supplier. After agreeing on the price, the Negotiation Council and the supplier finalize the framework agreement and conditions;

h) After the Negotiation Council and the bidder's representative sign the negotiation record, the National Centralized Procurement Center for Medicines sends a document to the bidder requesting confirmation of the negotiated price within seven days;

Articleonu 46. Thrime Minister cLess than 100 million VNDcouncillORSnh, approveệb) The list of equipment for preventing unauthorized access through the Internet network, including at least the following information: name of equipment, configuration, year of production, manufacturer, country of production, quantity, quality (new/used), installation location, management/staff operating, function/feature usage;policies2- The information does not belong to the priority list of warning signs.n l the negotiation process and the, amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CP c Quứpowers as prescribed by law and other tasksitselfc hiệsive cpolicies2- The information does not belong to the priority list of warning signs.n l negotiation price resultNo.of

1. Review and Approve the Results of Price Negotiations:

The National Centralized Procurement Center for Medicines is responsible for compiling the results of price negotiations and sending them to the Department of Planning and Finance for review. The maximum review period is twenty days, starting from the date when all documents are received. The Minister of Health will examine and approve the results of price negotiations based on the report from the Department of Planning and Finance.

- If the Negotiation Council and the bidder cannot agree on the price after multiple negotiation sessions, the National Centralized Procurement Center for Medicines is responsible for reporting to the Department of Planning and Finance and informing the bidder and healthcare facilities nationwide.

2. Publicize the Results of Price Negotiations:

a) The National Centralized Procurement Center for Medicines is responsible for publicizing the results of selecting bidders through price negotiations and guiding the implementation of the negotiation results for all healthcare facilities according to the law.

b) For medicines included in the list of price negotiation items that were unsuccessful in negotiations, the National Centralized Procurement Center for Medicines will propose procurement solutions or alternative measures based on the Negotiation Council's opinion to be submitted for consideration and decision by the Ministry's leadership. For original brand drugs with multiple registration certificates belonging to Group 1 as stipulated in Article 7 of this Circular issued by the Ministry of Health, healthcare facilities may organize the selection of bidders through open tendering at the generic drug tender package according to the announcement of the Ministry of Health.

3. Payment, Contract Signing, and Settlement of Supply Contracts:

a) The National Centralized Procurement Center for Medicines is responsible for completing and signing the framework agreements with winning bidders, publicly announcing the negotiation results and framework agreements on the Ministry of Health's Electronic Information Portal. The responsibilities of the parties involved and the effectiveness of the framework agreement shall be implemented in accordance with Article 39 of this Circular. The selected bidder must implement measures to ensure contract performance as stipulated in Clause 1 of Article 39 of this Circular;

b) Healthcare facilities shall base their contract signing with the bidder on the negotiation results and framework agreement, the quantity of medicines allocated, and the approved budget plan for medicine usage of the unit, ensuring that the medicine prices in the contracts do not exceed the negotiated winning bid prices and framework agreements announced by the National Centralized Procurement Center for Medicines;

For ongoing supply contracts, healthcare facilities must adjust medicine prices without exceeding the published negotiated prices, effective from the date the framework agreement becomes effective.

c) Bidders selected through price negotiations are responsible for supplying medicines according to the quantities, schedules, and terms stipulated in the framework agreements and contracts signed with each healthcare facility;

d) Duration of the contract: As specified in the approved negotiation plan but not exceeding thirty-six months from the date the negotiation results and framework agreement become effective until the completion of obligations as stipulated in the contract;

e) The Health Insurance Authority will unify payments across all public healthcare facilities based on the published negotiation results;

4. Report on the Implementation of Negotiation Results for Medicines:

Bidders providing medicines through price negotiations and healthcare facilities are responsible for reporting the implementation of supply contracts through price negotiations to the National Centralized Procurement Center for Medicines in accordance with Clause 12 of Article 40 of this Circular;

5. Supervise and Regulate the Execution of Framework Agreements:

The National Centralized Procurement Center for Medicines is responsible for supervising and regulating the supply and use of medicines selected through price negotiations according to the signed framework agreements in accordance with Clause 13 of Article 40 of this Circular;

Chapter VI

IMPLEMENTING PROVISIONS

Article 47 |||. Effectiveness

1. This Circular takes effect from October 1, 2019;

2. Circular No. 11/2016/TT-BYT dated May 11, 2016, of the Minister of Health regarding bidding for medicines at public healthcare facilities ceases to be effective from the date this Circular takes effect;

Article 48. Transitional Provisions

1. Tender packages that have been approved for bidder selection plans before the effective date of this Circular shall continue to be implemented in accordance with Circular No. 11/2016/TT-BYT dated May 11, 2016, of the Minister of Health regarding bidding for medicines at public healthcare facilities, except where the entity stipulated in Article 2 of this Circular voluntarily implements the provisions of this Circular from the date of issuance;

2. For pharmaceutical production facilities meeting EU-GMP principles and standards; facilities meeting equivalent EU-GMP principles and standards; and facilities meeting PIC/s-GMP principles and standards recognized by the drug regulatory authority of a member country of PIC/s which is also a member of ICH, which have been announced on the Drug Administration Bureau's website before the effective date of this Circular, these facilities are exempted from being assessed for EU-GMP compliance, equivalent EU-GMP compliance, or PIC/s-GMP compliance by the Vietnamese Drug Regulatory Authority within six months from the date this Circular takes effect.

Article 49. Reference Provisions

In case the referenced documents in this Circular are replaced or amended, they shall be applied according to the replaced or amended documents.

Article 50. Implementation organization

1. The heads of central agencies shall direct subordinate healthcare facilities to implement the selection of contractors for the supply of medicines in accordance with this Circular and other laws on contractor selection.

2. The Minister, the head of a ministerial-level agency shall decide on the delegation of authority and supervise the implementation of such delegation for certain medicine procurement packages of healthcare facilities under their management in accordance with the law.

3. The Chairman of the Provincial People's Committee shall be responsible for:

a) Assigning a unit to perform centralized medicine procurement at the provincial level to purchase medicines listed in the Centralized Procurement Medicine List for local healthcare facilities participating in centralized procurement in accordance with this Circular;

b) Directing healthcare facilities to organize the selection of contractors for the supply of medicines listed in the tender list organized by the unit in accordance with this Circular;

c) Based on the actual situation in the locality, the Chairman of the Provincial People's Committee shall decide to supplement the Centralized Procurement Medicine List with items not included in the list (except for medicines subject to negotiation pricing and national centralized procurement) for use in local healthcare facilities based on the proposal of the Director of the Provincial Health Department. The contract implementation period shall be carried out in accordance with Clause 4, Article 39 of this Circular..

In this case, if central-affiliated healthcare facilities, healthcare facilities under the management of ministries and health services of agencies located in the locality use the supplemented medicine list of the locality (outside the Centralized Procurement Medicine List issued by the Ministry of Health), then the management agencies of ministries, ministerial-level agencies, and government agencies (Health Sector Management Agencies) and the direct management agencies of healthcare facilities under the management of ministries and health services of agencies shall unify in writing with the Provincial Health Department to report to the Provincial People's Committee to organize the selection of contractors in accordance with regulations.

d) Based on the actual situation in the locality, the Chairman of the Provincial People's Committee shall decide on the delegation of authority and supervise the implementation of such delegation for certain medicine procurement packages of healthcare facilities under their management based on the proposal of the Director of the Provincial Health Department.

4. The Drug Administration, Traditional Medicine Administration shall be responsible for updating and publishing on the electronic information website the following information:

a) Lists serving the selection of contractors, including:

- Reference management agency list;

- List of drug regulatory agencies of countries in the SRA list;

- List of drug regulatory agencies of countries that are members of PIC/s and ICH;

- List of Vietnamese pharmaceutical production facilities evaluated by the Vietnamese drug regulatory agency to meet WHO-GMP principles and standards;

- List of production facilities meeting EU-GMP principles and standards or equivalent EU-GMP principles and standards;

- List of production facilities meeting PIC/s-GMP principles and standards in countries that are members of both PIC/s and ICH and evaluated by the Vietnamese drug regulatory agency to meet PIC/s-GMP principles and standards;

- List of pharmaceutical production facilities in Vietnam evaluated by the Vietnamese Ministry of Health to meet GMP principles and standards for herbal drugs or traditional drugs;

- List of pharmaceutical production facilities in Vietnam evaluated by the Vietnamese Ministry of Health to meet GMP principles and standards for traditional herbal preparations;

- List of pharmaceutical production facilities in Vietnam evaluated by the Vietnamese Ministry of Health to meet GMP principles and standards for raw materials from herbal drugs;

b) Medicine lists serving the selection of contractors, including:

- List of medicines granted circulation registration certificates or import permits;

- List of original brand-name medicines;

- List of reference biological products;

- List of medicines therapeutically equivalent to original brand-name medicines;

- List of medicines produced through technology transfer in Vietnam;

- List of original brand-name medicines and reference biological products produced through technology transfer in Vietnam;

- List of medicines with bioequivalence documentation;

- List of medicines approved for circulation by reference management agencies;

- List of medicines approved for circulation by drug regulatory agencies of countries in the SRA list;

- List of medicines fully produced on production lines in Vietnam meeting Group 1 criteria specified in Point c, Clause 1, Article 7 of this Circular;

- List of traditional herbal preparations formulated as: extract, powder, decoction, essential oil, resin, gum, jelly ensuring quality in accordance with the Ministry of Health's regulations on herbal drug and traditional medicine quality management;

- List of semi-finished herbal products: extract, powder, decoction, essential oil, resin, gum, jelly ensuring quality in accordance with the Ministry of Health's regulations on raw material quality management for drug production;

- List of national product medicines;

- List of medicines winning the "Vietnamese Medicine Star" award from the Ministry of Health;

- List of medicinal herbs cultivated, harvested, or naturally sourced from facilities evaluated by the Vietnamese Ministry of Health to meet Good Agricultural and Collection Practices (GACP) principles and standards;

- List of medicines produced in Vietnam meeting treatment requirements, drug prices, and supply capacity;

- List of medicinal herbs cultivated, harvested domestically meeting treatment requirements and supply capacity, reasonable prices;

- List of medicines produced from active ingredients (drug substances) produced in countries in the SRA list, active ingredients (drug substances) holding Certificate of Suitability (CEP);

- List of medicines and production facilities, suppliers violating quality requirements or bidding and supply regulations;

c) Information on declared drug prices, re-declared prices;

d) Information on winning bid drug prices, herbal drug prices at healthcare facilities;

đ) List of manufacturers and suppliers of medicines meeting requirements for capability, experience, and reputation as a basis for inviting participation in restricted bidding;

5. When purchasing medicines from the health insurance fund, the Social Insurance Agency shall be responsible for dispatching staff to participate in the following steps:

a) Preparing and reviewing the plan for selecting contractors;

b) Preparing and reviewing the tender invitation documents;

c) Evaluating tender documents, reviewing the results of contractor selection.

6. Medical facilities or units organizing steps in the process of selecting contractors must send documents (excluding those not to be disclosed according to the Bidding Law) to members participating in the Board or Expert Group at the steps specified in points a, b, and c of Clause 5 of this Article before convening a meeting within five days (except in urgent cases requiring immediate procurement of medicines for treatment needs). After this period, medical facilities or units organizing steps in the selection process shall convene meetings of the Board or Expert Group. Members participating in these Boards or Expert Groups must comply with the operational regulations of the Board or Expert Group as stipulated and assigned by the Chairman of the Board or the Head of the Expert Group.

When participating in the steps of the contractor selection process, members must provide their opinions immediately during the meeting. If a member's opinion differs from those of the other members, such differing opinions must be clearly recorded in the report, evaluation report, or review report for the competent authority to consider and decide.

7. Private medical facilities purchasing health insurance medicines shall follow the provisions below:

a) Private medical facilities may participate in centralized medicine procurement (national level, provincial level, price negotiation) in the locality where they are headquartered. In this case, private medical facilities are responsible for developing plans for medicine usage and complying with centralized bidding regulations for medicines in the locality as if they were under local management; the Department of Health and the unit responsible for centralized procurement at the provincial level shall organize the procurement of medicines for private medical facilities as they would for those under local management.

b) In cases where private medical facilities do not participate in centralized medicine procurement (national level, provincial level, price negotiation), they may independently organize the selection of contractors to supply medicines in accordance with the Bidding Law, guiding documents for the Bidding Law, and this Circular.

c) Where private medical facilities do not organize the selection of contractors to supply medicines as prescribed in points a and b of this Clause, the Social Insurance agency will only pay for medicines based on the results of centralized procurement at the local level, national-level centralized procurement results, and published price negotiation results according to criteria including: correct trade name, registration number for circulation or import permit, concentration or dosage, route of administration, formulation, packaging specifications, manufacturing facility, country of manufacture.

For medicines not included in the results of local centralized procurement, national-level centralized procurement, or published price negotiations, payment will be made according to the winning bid prices of public medical facilities at the provincial level in the same area, as publicly announced by the Vietnam Social Insurance Agency pursuant to point b of Clause 3, Article 77 of Decree No. 63/2014/NĐ-CP.

8. The entity requesting the publication of information as stipulated in point c of Clause 1 of Article 7 of this Circular shall provide and bear legal responsibility for the accuracy of the following documents:

a) Medicine circulation permits issued by drug regulatory authorities of countries listed in the SRA list and legalized by consular certification (original or certified true copy).

b) A declaration listing information to prove that the medicine circulating in Vietnam and the medicine approved for circulation by countries listed in the SRA have the same formula, production process, quality standards, testing methods; active ingredients and excipients must have the same quality standards, manufacturing facility, and production location. Appendix 13 promulgated together with this Circular.

9. The entity requesting proof of the first circulation of an original brand-name drug or reference biological product in a country not listed in the SRA list as stipulated in point b of Clause 2 of Article 8 of this Circular shall provide and bear legal responsibility for the accuracy of the following documents:

a) Patent granted by one of the authorized intellectual property offices for the active substance of a chemical drug containing one active substance or a combination of multiple active substances (original or certified true copy) along with a citation establishing protection for the corresponding drug;

b) Periodic Safety Update Reports (PSURs) clearly indicating the first global market entry date (International Birth Date) of the drug;

c) Other supporting documents (if any).

 

Article 51. Responsibility for Implementation

The Director of the Drug Administration, the Director of the Traditional Medicine Administration, the Director of the Planning and Finance Department, the Director of the Ministry’s Office, the Inspector General of the Ministry, the Director of the National Centralized Medicine Procurement Center, the Heads of units under and affiliated with the Ministry of Health, the Directors of Provincial Departments of Health, pharmaceutical business entities, and other relevant agencies, organizations, and individuals are responsible for implementing this Circular.

During implementation, if there are any difficulties, please reflect them to the Ministry of Health (Drug Administration, Traditional Medicine Administration, Planning and Finance Department) for consideration and resolution./.