Circular 07/2024/TT-BYT bidding for drugs at public health facilities

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Circular No. 07/2024/TT-BYT dated May 17, 2024 of the Ministry of Health on the bidding for drugs at public health facilities
Issuing body: Ministry of HealthEffective date:
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Official number:07/2024/TT-BYTSigner:Le Duc Luan
Type:CircularExpiry date:Updating
Issuing date:17/05/2024Effect status:
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Fields:Bidding - Competition , Medical - Health
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Effect status: Known

THE MINISTRY OF HEALTH

_______

No. 07/2024/TT-BYT

THE SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

________________

Hanoi, May 17, 2024

CIRCULAR

On the bidding for drugs at public health facilities

 

Pursuant to the Law on Bidding dated June 23, 2023;

Pursuant to the Government's Decree No. 24/2024/ND-CP dated February 27, 2024, detailing a number of articles and measures to implement the Law on Bidding regarding contractor selection;

Pursuant to the Government's Decree No. 95/2022/ND-CP dated November 15, 2022, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Department of Planning and Finance, the Director of the Drug Administration of Vietnam, the Director of the Traditional Medicine Administration;

The Minister of Health promulgates a Circular on the bidding for drugs at public health facilities.

 

Chapter I

GENERAL PROVISIONS

 

Article 1. Scope of regulation

1. This Circular provides for the bidding for drugs using state budget funds, health insurance funds, and other lawful revenues of state administrative agencies on healthcare and public health non-business units (hereinafter referred to as public health facilities), including:

a) Classification of bidding packages and drug groups;

b) The process and procedures for selecting contractors to supply drugs;

c) Centralized drug procurement.

2. This Circular applies to the bidding for pharmacochemical drugs, radioactive drugs, tracers, vaccines, biological products, drugs made from medical materials, traditional medicines, medicinal materials, traditional medicament, and gases that have been granted marketing authorization as drugs for medical examination and treatment.

3. The procurement of drugs ordered or assigned by the state shall be implemented in accordance with the Government's Decree No. 32/2019/ND-CP dated April 10, 2019, prescribing the assignment of tasks, placement of orders, or bidding for provision of public products and services covered by state budget funds for regular expenditures.

4. The procurement of drugs used in medical examination and treatment at military medical units of agencies, healthcare services of agencies, and healthcare services at detention facilities under the armed forces shall be implemented under the guidance of the Ministry of National Defence and the Ministry of Public Security.

5. The procurement of whole blood and standard blood products shall be implemented in accordance with the provisions of Circular No. 15/2023/TT-BYT dated July 20, 2023, of the Minister of Health, regulating the maximum price and service costs for determining the price of a unit of whole blood and standard blood products.

Article 2. Interpretation of terms

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

1. National centralized procurement unit means the unit assigned by the Ministry of Health to conduct the national centralized procurement of drugs.

2. Local centralized procurement unit means the unit assigned by the provincial-level People’s Committee to conduct the local centralized procurement of drugs.

Article 3. Responsibilities for preparing the contractor selection plan and organizing the contractor selection

1. The national centralized procurement unit is responsible for preparing the contractor selection plan and organizing the contractor selection in accordance with the provisions of Chapter IV of this Circular, the maximum implementation period of the framework agreement and the bidding package is 36 months, classified into drug groups and the progress of supply by quarter, year for drugs falling into one of the following cases:

a) Drugs on the national centralized procurement list promulgated by the Minister of Health and meeting the technical criteria of group 1, group 2 as prescribed in Article 4 of this Circular;

b) Drugs on the list of rare drugs promulgated by the Minister of Health;

c) Drugs need to be procured in small quantities to ensure sufficient drugs to serve the needs of medical examination and treatment as prescribed in Clause 1, Article 53 of the Law on Bidding.

2. The local centralized procurement unit is responsible for preparing the contractor selection plan and organizing the contractor selection in accordance with the provisions of Chapter IV of this Circular, the maximum implementation period of the framework agreement and the bidding package is 36 months, classified into drug groups and supply schedules by quarter and year for drugs falling into one of the following cases:  

a) Drugs on the list of local centralized procurement, except for drugs specified at Point a, Clause 1 of this Article;

b) Drugs on the list of rare drugs promulgated by the Minister of Health;

c) Drugs need to be procured in small quantities to ensure sufficient drugs to serve the needs of medical examination and treatment as prescribed in Clause 1, Article 53 of the Law on Bidding.

3. The procurement of drugs as prescribed in Clause 5, Article 53 of the Law on Bidding shall be implemented as follows:

a) In cases where agencies, organizations, and units (hereinafter referred to as units) have an agreement designating one unit to act as the focal point for procurement, that unit shall consolidate the needs of the remaining units in the agreement and conduct the procurement in accordance with the provisions of law on bidding.

The agreement must be in writing and must include the contents of the responsibility for preparing and sending procurement needs and the responsibility for paying expenses.

b) In cases where units do not have an agreement and cannot organize the contractor selection or have organized the contractor selection but unsuccessful, they shall submit their drug procurement needs to the management agency which is:

- The Ministry of Health for units under the management of the Ministry of Health or in the case of 02 provinces or more requesting;

- The Ministry of National Defence for units under the management of the Ministry of National Defence;

- The Ministry of Public Security for units under the management of the Ministry of Public Security;

- The Department of Health for units in the area and not under the management of the Ministry of Health, the Ministry of National Defence, and the Ministry of Public Security.

After receiving the request from the unit, within 10 days, the management agency is responsible for assigning a unit to conduct the procurement. In case of non-assignment, there must be a written response to the unit, clearly specifying the reason.

4. Public health facilities are responsible for preparing the contractor selection plan and organizing the contractor selection that are not planned and organized by the national centralized procurement unit and the local centralized procurement unit. The preparation of the contractor selection plan and the organization of contractor selection at public health facilities are implemented in accordance with the provisions of Chapter III of this Circular, the maximum implementation of the bidding package is 36 months, classified into bidding packages and drug groups.

 

Chapter II

CLASSIFICATION OF BIDDING PACKAGES AND DRUG GROUPS

 

Article 4. Generic drug bidding packages

A bidding package for generic drug may contain one or several generic drugs; each generic drug category must be classified into groups; each generic drug in a group is a part of the bidding package. Bidding packages for generic drug are classified into 05 groups in accordance with technical criteria as follows:

1. Group 1 includes drugs that are granted marketing authorization or import licenses for circulation in Vietnam and meet one of the following criteria:

a) Being entirely manufactured on production lines that meet EU-GMP principles and standards or production lines that meet equivalent EU-GMP principles and standards in a country on the SRA or EMA list and are announced by the drug regulatory authority of Vietnam as meeting EU-GMP or equivalent EU-GMP principles and standards;

b) Drugs on the list of brand name drugs or reference biological products announced by the Ministry of Health;

c) Being entirely manufactured in Vietnam and must meet all of the following criteria:

- Being entirely manufactured on production lines that meet EU-GMP principles and standards or production lines that meet equivalent EU-GMP principles and standards and are announced by the drug regulatory authority of Vietnam as meeting EU-GMP or equivalent EU-GMP principles and standards;

- Being granted marketing authorization by the drug regulatory authority of a country on the SRA or EMA list as prescribed in Clause 4, Article 40 of this Circular;

- Drugs circulating in Vietnam and drugs that are granted marketing authorization by the drug regulatory authority of a country on the SRA or EMA list must have the same formulation, production process, quality standards, testing methods; pharmaceutical ingredients, excipients must have the same quality standards, manufacturing facility, and production location as prescribed in Clause 4, Article 40 of this Circular.

2. Group 2 includes drugs that are granted marketing authorization or import licenses for circulation in Vietnam and meeting one of the following criteria:

a) Being entirely manufactured on production lines that meet EU-GMP principles and standards or production lines that meet equivalent EU-GMP principles and standards and are announced by the drug regulatory authority of Vietnam as meeting EU-GMP principles and standards or equivalent EU-GMP principles and standards;

b) Being entirely manufactured on production lines in a country that is a PIC/s member and also an ICH member, certified by the competent authority of that country as meeting PIC/s-GMP principles and standards, and announced by the drug regulatory authority of Vietnam as meeting PIC/s-GMP principles and standards.

3. Group 3 includes drugs that are granted marketing authorization or import licenses for circulation in Vietnam and are announced by the drug regulatory authority of Vietnam as having evidence of bioequivalence.

4. Group 4 includes drugs that are granted marketing authorization in Vietnam and are entirely manufactured on production lines in Vietnam announced by the drug regulatory authority of Vietnam as meeting GMP principles and standards.

5. Group 5 includes drugs that are granted marketing authorization or import licenses for circulation in Vietnam.

Article 5. Bidding packages for brand name drugs

1. Heads of public health facilities shall decide on the procurement of brand name drugs or reference biological products based on the advice of the Drug and Therapeutics Council for hospitals or the Professional Council for other public health facilities (hereinafter referred to as the Council).

2. Bidding packages for brand name drugs may contain one or more brand name drugs or reference biological products, each drug is a part of the bidding package. The drugs in bidding packages for brand name drugs are on the list of brand name drugs and reference biological products announced by the Ministry of Health, except for brand name drugs and reference biological products manufactured in countries not on the SRA or EMA list announced by the competent authority before the effective date of Circular No. 08/2022/TT-BYT dated September 5, 2022, of the Minister of Health regulating the marketing authorization of drugs and medicinal ingredients.

Article 6. Bidding packages for drugs made from medicinal materials, drugs combining pharmaceutical ingredients with medicinal materials, traditional medicines

Bidding packages for drugs made from medicinal materials, drugs combining pharmaceutical ingredients with medicinal materials, traditional medicines (not applicable to traditional medicament) may contain one or more drugs, each drug category must be classified into groups, each drug in a group is a part of the bidding package. Bidding packages for drugs made from medicinal materials, drugs combining pharmaceutical ingredients with medicinal materials, traditional medicines are classified into 04 groups in accordance with technical criteria as follows:

1. Group 1 includes drugs that are entirely manufactured on production lines in Vietnam announced by the drug regulatory authority of Vietnam as meeting GMP principles and standards, and all medicinal materials in the drug formula are announced by the drug regulatory authority of Vietnam as meeting GACP principles and standards.

2. Group 2 includes drugs that are entirely manufactured on production lines in Vietnam announced by the drug regulatory authority of Vietnam as meeting GMP principles and standards, and 50% or more of the medicinal materials in the drug formula are announced by the drug regulatory authority of Vietnam as meeting GACP principles and standards.

3. Group 3 includes drugs that are entirely manufactured on production lines in Vietnam announced by the drug regulatory authority of Vietnam as meeting GMP principles and standards.

4. Group 4 includes drugs that have been granted marketing authorization or import licenses for circulation in Vietnam.

Article 7. Bidding packages for traditional medicament

Bidding packages for traditional medicament may contain one or more traditional medicament (not applicable to traditional medicament in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies), each traditional medicament category must be classified into groups, each medicament in a group is a part of the bidding package. Bidding packages for traditional medicament are classified into 03 groups in accordance with technical criteria as follows:

1. Group 1 includes traditional medicament that are entirely manufactured on production lines in Vietnam announced by the drug regulatory authority of Vietnam as meeting GMP principles and standards for traditional medicament and are manufactured from medicinal materials announced by the drug regulatory authority of Vietnam as meeting GACP principles and standards.

2. Group 2 includes traditional medicament that are entirely manufactured on production lines in Vietnam announced by the drug regulatory authority of Vietnam as meeting GMP principles and standards.

3. Group 3 includes traditional medicament that do not meet the criteria prescribed in Clauses 1 and 2 of this Article but have been granted marketing authorization or import licenses for circulation in Vietnam.

Article 8. Bidding packages for traditional medicament in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies

Bidding packages for traditional medicament in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies may contain one or more traditional medicament, each traditional medicament category must be classified into groups, each medicament in a group is a part of the bidding package. Bidding packages for traditional medicament in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies are classified into 03 groups in accordance with technical criteria as follows:

1. Group 1 includes traditional medicament in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies that are entirely manufactured on production lines in Vietnam announced by the drug regulatory authority of Vietnam as meeting GMP principles and standards and are manufactured from medicinal materials announced by the drug regulatory authority of Vietnam as meeting GACP principles and standards.

2. Group 2 includes traditional medicament in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies that are entirely manufactured on production lines in Vietnam announced by the drug regulatory authority of Vietnam as meeting GMP principles and standards.

3. Group 3 includes traditional medicament in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies that do not meet the criteria prescribed in Clauses 1 and 2 of this Article but have been granted marketing authorization or import licenses for circulation in Vietnam.

Article 9. Bidding packages for medicinal materials

Bidding packages for medicinal materials may contain one or more medicinal materials (not applicable to semi-finished medicinal materials in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies), each medicinal materials category must be classified into groups, each medicinal material in a group is a part of the bidding package. Bidding packages for medicinal materials are classified into 03 groups in accordance with technical criteria as follows:

1. Group 1 includes medicinal materials announced by the drug regulatory authority of Vietnam as meeting GACP principles and standards.

2. Group 2 includes medicinal materials that are entirely preliminary processed on production lines announced by the drug regulatory authority of Vietnam as meeting GMP principles and standards for drug ingredients from medicinal materials.

3. Group 3 includes medicinal materials that do not meet the criteria specified in Clauses 1 and 2 of this Article.

Article 10. Bidding packages for semi-finished medicinal materials in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies

Bidding packages for semi-finished medicinal materials in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies may contain one or more semi-finished medicinal materials, each semi-finished medicinal materials category must be classified into groups, each semi-finished medicinal material in a group is a part of the bidding package. Bidding packages for semi-finished medicinal materials in the form of extracts, granules, powders, extracts, essential oils, resins, and gums are classified into 03 groups in accordance with technical criteria as follows:

1. Group 1 includes semi-finished medicinal materials in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies that are entirely manufactured on production lines in Vietnam announced by the drug regulatory authority of Vietnam as meeting GMP principles and standards for drug ingredients from medicinal materials and are manufactured from medicinal materials announced by the drug regulatory authority of Vietnam as meeting GACP principles and standards.

2. Group 2 includes semi-finished medicinal materials in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies that are entirely manufactured on production lines in Vietnam announced by the drug regulatory authority of Vietnam as meeting GMP principles and standards for drug ingredients from medicinal materials.

3. Group 3 includes semi-finished medicinal materials in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies that do not meet the criteria specified in Clauses 1 and 2 of this Article but have been granted marketing authorization or import licenses for circulation in Vietnam.

Article 11. Regulations on bidding for drug groups

1. Principles of bidding for drug groups in bidding packages:

a) Bidders whose drugs meet technical criteria of any group are eligible to bid for that group. If drugs meet technical criteria of multiple groups, the bidders are eligible to bid for one or more groups that the drugs meet the technical criteria, provided that the bid price of the same drug is consistent in all categories in which it is participating.

b) If drugs offered for bidding have multiple manufactures participating in the production process, all manufactures participating in the production process must meet the technical criteria of that drug groups.

2. Bidding packages for generic drug

a) Drugs that meet the criteria in group 1 shall be classified into groups 1, 2, and 5;

b) Drugs that meet the criteria in group 2 shall be classified into groups 2 and 5;

c) Drugs that meet the criteria in group 3 shall be classified into groups 3 and 5;

d) Drugs that meet the criteria in group 4 shall be classified into groups 4 and 5;

dd) Drugs that do not meet the criteria in groups 1, 2, 3, and 4 shall only classified into group 5.

In cases where drugs meet the technical criteria of multiple groups at the same time, the drugs shall be classified into the groups as prescribed above.

For example: Drugs that meet the criteria in group 3 and at the same time meet the criteria of group 4 shall be classified into groups 3, 4, and 5; Drugs that meet the criteria in group 2 and at the same time meet the criteria of group 3 shall be classified into groups 2, 3, and 5.

3. Bidding packages for drugs made from medicinal materials, drugs combining pharmaceutical ingredients with medicinal materials, traditional medicines:

a) Drugs that meet the criteria in group 1 are allowed to bid for groups 1, 2, 3, and 4;

b) Drugs that meet the criteria in group 2 are allowed to bid for groups 2, 3, and 4;

c) Drugs that meet the criteria in group 3 are allowed to bid for groups 3 and 4;

d) Drugs that do not meet the criteria in groups 1, 2, and 3 are only allowed to bid for group 4.

4. Bidding packages for traditional medicament

a) Traditional medicament that meet the criteria in group 1 are allowed to bid for groups 1, 2, and 3;

b) Traditional medicament that meet the criteria in group 2 are allowed to bid for groups 2 and 3;

c) Traditional medicament that do not meet the criteria in groups 1 and 2 are only allowed to bid for group 3.

5. Bidding packages for traditional medicament in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies:

a) Traditional medicament that meet the criteria in group 1 are allowed to bid for groups 1, 2, and 3;

b) Traditional medicament that meet the criteria in group 2 are allowed to bid for groups 2 and 3;

c) Traditional medicament that do not meet the criteria in groups 1 and 2 are only allowed to bid for group 3.

6. Bidding packages for medicinal materials

a) Medicinal materials that meet the criteria in group 1 are allowed to bid for groups 1, 2, and 3;

b) Medicinal materials that meet the criteria in group 2 are allowed to bid for groups 2 and 3;

c) Medicinal materials that do not meet the criteria in groups 1 and 2 are only allowed to bid for group 3.

7. Bidding packages for semi-finished medicinal materials in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies:

a) Semi-finished medicinal materials that meet the criteria in group 1 are allowed to bid for groups 1, 2, and 3;

b) Semi-finished medicinal materials that meet the criteria in group 2 are allowed to bid for groups 2 and 3;

c) Semi-finished medicinal materials that do not meet the criteria in groups 1 and 2 are only allowed to bid for group 3.

8. The bidding for contract-manufactured foreign drugs, drugs manufactured under technology transfer in Vietnam in bidding packages for generic drug and bidding packages for brand name drugs shall be implemented as follows:

a) Contract-manufactured foreign drugs and drugs manufactured under technology transfer in Vietnam are eligible to bid in drug groups specified at Point b of this Clause when they simultaneously meet the following criteria:

- Drugs are announced by the Ministry of Health in the list of contract-manufactured drugs (with technology transfer) that have been granted or renewed marketing authorization in accordance with Point a, Clause 1, Article 6 of Circular No. 16/2023/TT-BYT dated August 15, 2023, of the Minister of Health regulating the marketing authorization for contract-manufactured drugs and drugs manufactured under technology transfer in Vietnam (hereinafter referred to as Circular No. 16/2023/TT-BYT), or the list of drugs manufactured under technology transfer that have been granted or renewed marketing authorization in accordance with Point a, Clause 1, Article 10 of Circular No. 16/2023/TT-BYT;

- Drugs are not included in the list of drugs announced by the Ministry of Health in accordance with the provisions of Clause 2, Article 56 of the Law on Bidding (except for drugs that are entirely manufactured in Vietnam when granted marketing authorization in Vietnam);

b) The bidding for contract-manufactured foreign drugs and drugs manufactured under technology transfer in Vietnam that meet the provisions of Point a of this Clause shall be implemented as follows:

- Drugs are eligible to bid for the bidding packages for brand name drugs if the drugs are drugs manufactured under technology transfer or the contract-manufactured drugs announced by the Ministry of Health in the list of brand name drugs and reference biological products and meets the provisions of Clause 2, Article 5 of this Circular. In cases where drugs on the list of drugs subject to price negotiation issued by the Ministry of Health, the procurement of these drugs shall be carried out in the price negotiation method;

- Drugs are eligible to bid for groups 1, 2, 4, and 5 if they simultaneously meet the following criteria: Drugs that include drugs manufactured before technology transfer or contract-manufactured drugs meeting the provisions of Point a, Clause 1, Article 4 of this Circular; drugs manufactured under technology transfer or contract-manufactured drugs in Vietnam are entirely manufactured on production lines meeting the EU-GMP or equivalent EU-GMP principles and standards and announced by the drug regulatory authority of Vietnam as meeting the EU-GMP or equivalent principles and standards.

- Drugs are eligible to bid for groups 2, 4, and 5 if they simultaneously meet the following criteria: Drugs that include pre-technology transfer drugs or contract-manufactured drugs meeting the provisions of Clause 2, Article 4 of this Circular; drugs manufactured under technology transfer or contract-manufactured drugs in Vietnam fully manufactured on production lines meeting the EU-GMP or equivalent EU-GMP principles and standards and announced by the drug regulatory authority of Vietnam as meeting the EU-GMP or equivalent EU-GMP principles and standards.

- The remaining cases are eligible to bid for groups 4 and 5.

c) In cases where contract-manufactured foreign drugs and drugs manufactured under technology transfer do not meet the criteria specified at Point a of this Clause, the bidding shall be implemented in accordance with the provisions of Clauses 1 and 2 of this Article.

 

Chapter III

PROCESS AND PROCEDURES FOR CONTRACTOR SELECTION

 

Article 12. Contractor selection plan

The content of contractor selection plan shall be implemented in accordance with the provisions of Article 39 of the Law on Bidding, in which:

1. Bidding package name:

The specification of names of bidding packages shall be implemented in accordance with the classification of bidding packages and drug groups in accordance with the provisions of Articles 4 to 10 of this Circular. In cases where bidding packages are classified into multiple parts, the name of each part must correspond to the content of that part. Information about the bidding package in the contractor selection plan must include at least the following information:

a) Each part in the bidding packages for generic drug shall include the following information: active ingredient name; concentration or content; route of administration, dosage form; drug group; unit; quantity; unit price and total value of that drug;

b) Each part in the bidding packages for brand name drugs includes the following information: drug name accompanied by the phrase "or equivalent" as prescribed at Point c, Clause 9, Article 24 the Government’s Decree No. 24/2024/ND-CP dated February 27, 2024, detailing a number of articles and measures to implement the Law on Bidding on contractor selection (hereinafter referred to as Decree No. 24/2024/ND-CP); active ingredient name; concentration or content; route of administration, dosage form; unit measure; quantity; unit price and total value of that drug. In cases where an active ingredient has multiple names of brand name drugs or reference biological products that have been announced by the Ministry of Health in the list of brand name drugs and reference biological products, the drug name section must list all the names of the brand name drugs or reference biological products;

c) Each part in the bidding packages for drugs made from medicinal materials, drugs combining pharmaceutical ingredients with medicinal materials, traditional medicines, semi-finished medicinal materials, traditional medicament in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies shall include the following information: drug name or the name of the semi-finished medicinal materials or traditional medicament in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies; route of administration, dosage form; unit of measure; quantity; drug group; unit price. The specification of names of drugs made from medicinal materials, drugs combining pharmaceutical ingredients with medicinal materials, traditional medicines, semi-finished medicinal materials, traditional medicament in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies in bidding packages shall be implemented in accordance with the provisions of Clause 3 of this Article;

d) Each part in the bidding packages for medicinal materials, bidding packages for traditional medicament shall include the following information: the name of the medicinal materials or traditional medicament; scientific name; quality standards; used part; preliminary processing form or processing method; drug group; unit of measure; quantity; unit price and total value of that drug.

In cases where public health facilities add other information about the bidding package prescribed in this Clause, the unit is responsible for explaining this additional information.

2. The specification of dosage forms of drugs belonging to the generic drug bidding packages, the drugs made from bidding packages for medicinal materials, drugs combining pharmaceutical ingredients with medicinal materials, and traditional medicines in the contractor selection plan shall be implemented in accordance with the provisions in Appendix I issued together with this Circular. The dosage forms (with the sign (*)) are specified separately in the contractor selection plan in accordance with the following principles:

a) Separation is only allowed when there is the same dosage form as the brand name drugs or reference biological products with the same active ingredient, route of administration, or drugs with the same active ingredient and route of administration that has been granted marketing authorized in SRA or EMA countries;

b) In cases where drugs do not meet Point a of this Clause, the health facility must clearly explain the necessity and usage need for this dosage form and only use it in necessary cases when other dosage forms are not able to be used or other dosage forms are used but do not meet the treatment requirements.

3. The specification of names of drugs made from medicinal materials, drugs combining pharmaceutical ingredients with medicinal materials, traditional medicines, semi-finished medicinal materials, traditional medicament in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies in the bidding package shall be implemented as follows:

a) Only specifying the names of ingredients of drugs made from medicinal materials, drugs combining pharmaceutical ingredients with medicinal materials, traditional medicines, semi-finished medicinal materials, traditional medicament in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies; trade names shall not be specified;

b) In cases where drugs made from medicinal materials, drugs combining pharmaceutical ingredients with medicinal materials, traditional medicines, semi-finished medicinal materials, traditional medicament in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies that have the same ingredients and the same dosage form: concentration and content of the ingredients shall only be specified when the difference in concentration and content leads to a difference in dosage, treatment indication, and must have the expert opinion of the Council.

4. Bidding package price:

a) The bidding package price shall be implemented in accordance with the provisions of Clause 1, Article 16 of Decree No. 24/2024/ND-CP;

b) In cases where bidding packages are classified into multiple parts, each part must clearly specify the unit price and total value of that part in accordance with the provisions of Clause 1 of this Article. The unit price of drugs in the contractor selection plan shall be proposed by the public health facility preparing the plan and the public health facility shall be responsible for it;

c) The basis for determining the bidding package price shall be implemented in accordance with the provisions of Clause 2, Article 16 of Decree No. 24/2024/ND-CP. In addition, public health facilities may base on the price information of drugs, medicinal materials, and traditional medicament that have won bids in the same technical criteria group as other public health facilities or in local centralized procurement within 12 months before the submission date for approval of the contractor selection plan, or on the prices of drugs awarded in national centralized procurement, price negotiation under the framework agreement that are still valid and published on the Ministry of Health's electronic portal; the website of the National Centralized Procurement Unit; extracted from the Vietnam National E-Procurement System or collected by themselves as a basis for determining the price of the bidding package;

d) The establishment of planned prices for items with the same active ingredient, concentration or content, route of administration, and dosage form in the bidding packages for generic drug must ensure the following principles:

- The planned price of group 1 shall not exceed the planned price of the brand name drugs or reference biological product;

- The planned price of groups 2 and 3 shall not exceed the planned price of the brand name drugs or reference biological product and group 1;

- The planned price of group 4 shall not exceed the planned price of the brand name drugs or reference biological product; group 1; group 2 manufactured in Vietnam and group 3;

- The planned price of group 5 shall not exceed the planned price of the brand name drugs or reference biological product; groups 1, 2, 3, and 4.

5. Funding source: Clearly specifying the funding source as prescribed in Clause 3, Article 39 of the Law on Bidding. In cases where bidding packages have an implementation period of more than 01 year, the funding source may be determined based on the procurement estimate of the current budget year and the projected procurement estimates of the subsequent budget years.

6. Forms and methods of contractor selection:

a) Forms of contractor selection: Based on the bidding package price and the nature of each bidding package, select one of the following forms of contractor selection: open bidding, restricted bidding, direct appointment, competitive negotiation, direct procurement, online bidding, online procurement;

b) Methods of contractor selection: Applying the single stage - one envelope method as prescribed in Article 30 of the Law on Bidding. Public health facilities shall only apply the single stage - two envelope method contractor selection method when there is guidance from the law on science and technology.

7. Time to organize contractor selection: Clearly specifying the start time of organizing the contractor selection and the time to organize the contractor selection in accordance with the provisions of Clause 5, Article 39 of the Law on Bidding.

8. Types of contract: Must specifically determine the type of contract as prescribed in Article 64 of the Law on Bidding to serve as a basis for preparing bidding dossiers and dossiers of requirements; and for signing the contract.

9. Implementation period of the bidding package: The implementation period of the bidding package shall be implemented in accordance with the provisions of Clause 7, Article 39 of the Law on Bidding, but not exceeding 36 months.

10. Optional additional purchase (if any):

a) In cases where the bidding package applies the optional additional purchase, the quantity and estimated value of the optional additional purchase must be clearly specified;

b) Additional purchase option shall be implemented when all of the following conditions are met: the bidder has won the bid through open bidding; the additional purchase quantity does not exceed 30% of the corresponding quantity of drugs specified in the contract; there is an approved estimate for the additional purchase quantity; the unit price of the additional purchase of drugs does not exceed the unit price of the corresponding drugs in the contract; applicable only during the contract's validity period.

11. Supervision of bidding activities (if any).

Article 13. Submission, appraisal, and approval of the contractor selection plan

1. The document for submission of the contractor selection plan shall be in accordance with the form prescribed in Appendix II issued together with this Circular.

In cases where the open bidding method is not applied, the document for submission of the contractor selection plan must clearly specify the reason for proposing to apply another form of contractor selection for the competent authority to consider and decide.

2. The appraisal of the contractor selection plan shall be implemented in accordance with the provisions of Article 128 of Decree No. 24/2024/ND-CP. The appraisal report shall be prepared in accordance with the form prescribed in Appendix III issued together with this Circular.

3. The approval of the contractor selection plan shall be implemented in accordance with the provisions of Articles 40 and 41 of the Law on Bidding.

4. For procurement cases as prescribed in Clause 3, Article 3 of this Circular, the head of the focal unit for procurement or the unit assigned the procurement task shall organize the appraisal and approval of the contractor selection plan.

Article 14. Preparation of bidding dossiers and dossiers of requirements

1. The preparation of bidding dossiers and dossiers of requirements shall be implemented as follows:

a) For bidding dossiers for bidding packages for drugs made from medicinal materials and bidding packages for traditional medicament: Health facilities apply the form prescribed in Appendix IV issued together with this Circular;

b) For bidding dossiers for bidding packages for brand name drugs; bidding packages for generic drug; bidding packages for drugs made from medicinal materials, drugs combining pharmaceutical ingredients with medicinal materials, traditional medicines; bidding packages for traditional medicament in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies; bidding packages for semi-finished medicinal materials in the form of standardized extracts, granules, powders, extracts, essential oils, resins, gums, and jellies: Health facilities shall apply the form prescribed in Appendix V issued together with this Circular;

c) For bidding dossiers for the procurement of drugs, medicinal materials, and traditional medicament in the form of competitive negotiation: Health facilities shall use the bidding dossier form prescribed in Appendices IV and V issued together with this Circular and the provisions at Point c, Clause 1, Article 45 of the Law on Bidding, Clause 1, Article 79 of Decree No. 24/2024/ND-CP to tailor accordingly.

d) For dossiers of requirements for bidding packages for drug in the form of direct procurement and direct appointment following the standard procedures: Health facilities shall refer to the content and the bidding dossiers and dossiers of requirements forms issued by the Ministry of Health and the Ministry of Planning and Investment to tailor accordingly.

2. Based on the contractor selection plan approved by the competent authority, the expert group is responsible for preparing the bidding dossiers and dossiers of requirements for drug procurement and submitting the submission dossier to the unit in charge of appraisal for appraisal.

Article 15. Evaluation of bid dossiers, dossiers of proposals, recommendations of award, and use of awarded drugs

1. The evaluation of bid dossiers and dossiers of proposals shall be implemented in accordance with the Law on Bidding, especially for information about drugs, in addition to the documents provided by the bidder, the procuring entity is allowed to use information about drugs (marketing authorization, import license), information about GMP principles and standards of the manufacturing facility, and other information in official dispatches and approval decisions of the Drug Administration of Vietnam; the Traditional Medicine Administration or information published on the websites of the Drug Administration of Vietnam and the Traditional Medicine Administration.

2. Conditions to be considered recommendations of award shall be implemented in accordance with the provisions of Article 61 of the Law on Bidding, the bidding dossiers and dossiers of requirements that have been issued, and the following provisions:

a) The procuring entity shall recommend awards according to each part in the approved contractor selection plan (except for the bidding package prescribed at Point b of this Clause). Each part of the bidding package shall only be recommended for award to 01 drug or medicinal material, traditional medicament that meets the technical and quality requirements specified in the bidding dossiers and dossiers of requirements, and has the lowest bid price after error correction and adjustment, minus the discount value (if any) for the lowest price method; has the lowest evaluated price for the evaluated price method in that group of drugs;

b) For bidding packages serving disaster prevention, response, search and rescue, epidemic prevention and control, which are designated for procurement in accordance with a pre-determined list and must be packaged in accordance with the pre-determined list consisting of multiple drug items: the procuring entity may consider recommending awards based on the pre-determined list (including multiple parts, collectively referred to as the bidding package) when the parts in the bidding package meet the technical and quality requirements specified in the bidding dossiers, dossiers of requirements, and have the biding price of each item and the total bid price for the package after error correction and adjustment, minus the discount value (if any) is the lowest for the lowest price method; has the lowest evaluated price for the evaluated price method. In this case, the bidding package price must include the cost of packaging based on the pre-determined list.

3. In cases where the bidding drug undergoes changes during the contractor selection process or in the supply of awarded drugs, but the substitute drug was not included in the bid dossier or the dossier of proposals, the project owner may consider allowing the bidder to substitute the drug to ensure sufficient drug supply for timely medical examination and treatment at the unit, provided that the following conditions are met:

a) For brand name drugs and reference biological products, when there are changes in information compared to the information in the Decision on Marketing Authorization:

- In cases where the changed information is not among the information previously announced in the Decision announcing the list of brand name drugs and reference biological products, this information must be approved or announced by the drug regulatory authority following the procedure for changing the marketing authorization.

- In cases where the changed information is among the information previously announced in the Decision announcing the list of brand name drugs and reference biological products, this information must be updated and announced in the list of brand name drugs and reference biological products.

b) For generic drugs with no change in the marketing authorization number but with one or more changes in drug-related information, including: drug name; name of the manufacturing facility or method of specifying the address of the manufacturing facility (but the production location remains unchanged); change in production location but the compliance with GMP principles and standards of the manufacturing facility remains unchanged; extension of the drug's shelf life; change in packaging but no change in the content, concentration, or volume of the drug as per the bidding dossier or the dossier of requirements; change in the quality standard of the drug due to an updated version of the pharmacopoeia as regulated; change in the quality standard but the new standard is not lower than the quality standard of the awarded drug or the drug included in the bid dossier or the dossier of proposals.

c) For generic drugs with a change in the marketing authorization number or new import license issued, and other information remains unchanged.

d) For generic drugs with a change in the marketing authorization number or new import license issued, and with one or more changes in drug-related information, including: drug name; name of the manufacturing facility or method of specifying the address of the production location (but the production location remains unchanged); change in manufacturing site but the compliance with GMP principles and standards of the manufacturing facility remains unchanged; extension of the drug's shelf life; change in packaging but no change in the content, concentration, or volume of the drug as per the bidding dossier or the dossier of requirements; change in the quality standard of the drug due to an updated version of the pharmacopoeia as regulated; change in the quality standard but the new standard is not lower than the quality standard of the awarded drug or the drug included in the bid dossier or the dossier of proposals.

4. When substituting drugs in accordance with the cases prescribed in Clause 3 of this Article, the contractor must provide the necessary information for the procuring entity to assess the substitution, including: decisions and official dispatches of approval regarding changes, supplements, or announced information from the competent state management agency, and explanations, commitments regarding that the quality standards of the proposed substitute drugs remain unchanged.

5. The head of the health facility and the winning bidder are responsible for performing the drug supply contract in accordance with the relevant provisions of the law on economic contracts, and must perform at least 80% of the value of each part of the signed contract. For controlled drugs, infusion solutions, and other situations after reporting to the competent authority, the health facility shall ensure to perform of at least 50% of the value of each part of the signed contract. For emergency medicines, antidotes, and rare drugs, public health facilities shall act in accordance with the actual situation.

In cases where the health facility does not perform at least 80% of the value or 50% of the value for controlled drugs and infusion solutions of each part of the signed contract, the head of the health facility must report and explain the reasons to the competent authority.

Article 16. Organization of contractor selection at retail drug pharmacies within the premises of public health facilities

The procurement of drugs at retail pharmacies within the premises of public health facilities shall be carried out as follows:

1. For drugs on the list of drugs covered under health insurance as stipulated by the law on health insurance:

a) Public health facilities are allowed to prepare separate contractor selection plan and choose one of the contractor selection methods prescribed in Clause 1, Article 20 of the Law on Bidding, the detailed implementing documents, and this Circular to conduct the procurement;

b) In cases where drugs have the same active ingredient, concentration, dosage form, and trade name as drugs that has been awarded and supplied at the health facility (including centrally procured drugs and price-negotiated drugs), the purchase price must not exceed the price already supplied or being supplied at that public health facility.

2. For drugs not included in the cases prescribed in Clause 1 of this Article:
 Public health facilities shall independently decide on the procurement on the basis of ensuring publicity, transparency, economic efficiency, and accountability.

 

Chapter IV

REGULATIONS ON CENTRALIZED DRUG PROCUREMENT

 

Section 1

GENERAL PROVISIONS

 

Article 17. Notification of centralized drug procurement roadmap and progress

1. In order for public health facilities to proactively organize contractor selection to ensure the supply of drugs for medical examination and treatment, the centralized procurement unit is responsible for timely notifying public health facilities of the organization of contractor selection in the following cases:

a) The contractor selection has been organized in accordance with the contractor selection plan approved by the competent authority, but by the time the previously signed framework agreement has at least 03 months of validity remaining, there is still no result of contractor selection;

b) The contractor selection has been organized, but there is no contractor participating in the bidding, or all contractors fail to meet the technical requirements, or the bidding price after error correction and adjustment, minus the discount value (if any) of all bidders meeting the technical requirements and ranked in the list exceeds the bidding package price without being able to handle the situation as prescribed in Clause 8, Article 131 of Decree No. 24/2024/ND-CP.

Within a maximum of 10 days from the time of determining the contents prescribed in this Point, the centralized procurement unit is responsible for notifying the health facilities under its management and relevant units.

 If the consolidation of procurement needs and the establishment of a contractor selection plan have been completed, but the drugs are removed from the centralized bidding list, the centralized procurement unit shall proceed as follows:

- In cases where the bidding dossiers and dossiers of requirements have been issued, the centralized procurement unit shall continue to organize the contractor selection in accordance with the approved procurement plan.

- In cases where the bidding dossiers and dossiers of requirements have not been issued, the centralized procurement unit is responsible for notifying the public health facilities that have submitted procurement needs and relevant units within a maximum of 5 working days from the date of receiving information about changes in the centralized bidding list.

2. The national centralized procurement unit is responsible for notifying in writing the progress of national centralized procurement to health facilities and the Departments of Health of provinces and centrally-run cities (hereinafter referred to as the Department of Health) so that these units can proactively determine their procurement needs and organize contractor selection for drug supply when the adjustment cannot be done as regulated in Article 33 of this Circular in one of the following cases:

- Public health facilities have used up the allocated quantity of drugs in the framework agreement or there is an increased demand that exceeds the adjustment capacity of the national centralized procurement unit;

- Public health facilities are established after the completion of the consolidation of drug procurement needs and exceed the adjustment capacity of the national centralized procurement unit;

For anti-HIV drugs, anti-tuberculosis drugs, and vaccines: The national centralized procurement unit shall coordinate with the focal unit to consolidate and is responsible for procurement needs as prescribed at Points a, b, and c, Clause 1, Article 22 of this Circular (hereinafter referred to as the focal unit) to notify public health facilities so that they can proactively organize contractor selection to ensure drug supply for disease prevention and treatment.

3. The local centralized procurement unit is responsible for notifying in writing the progress of local centralized procurement to health facilities under local management so that these units can proactively determine their procurement needs and organize contractor selection for drug supply when the adjustment cannot be done as regulated in Article 34 of this Circular in one of the following cases:

a) Public health facilities have used up the allocated quantity of drugs in the framework agreement or there is an increased demand that exceeds the adjustment capacity of the local centralized procurement unit;

b) Public health facilities are established after the completion of the consolidation of drug procurement needs and exceed the adjustment capacity of the local centralized procurement unit;

4. Public health facilities are allowed to procure drugs on the centralized procurement list in accordance with the notification of the centralized procurement unit to meet the needs for drugs as prescribed in Clause 2, Article 94 of Decree No. 24/2024/ND-CP.

Article 18. Forms and Methods of Contractor Selection

1. Forms of contractor selection:

a) Open domestic bidding: Applicable to all bidding packages;

b) Direct appointment: Applicable to bidding packages for drug on the centralized procurement list but required to be procured in accordance with Point c, Clause 1, Article 23 of the Law on Bidding and Clause 1, Article 94 of Decree No. 24/2024/ND-CP.

2. Methods of contractor selection: The single stage - one envelope method shall be applied as prescribed in Article 30 of the Law on Bidding, except for the bidding package prescribed at Point b, Clause 1 of this Article, where the project owner decides on direct appointment under a simplified procedure. The centralized procurement unit shall only apply the single-stage two-envelope method when there is guidance from law on science and technology.

Article 19. Methods of implementation

Centralized drug procurement shall be implemented through framework agreements, except for the following cases where direct contracting is applied:

1. Procurement of drugs and vaccines for expanded immunization programs under programs and projects using state budget funds as decided by the Minister of Health or the Chairperson of the provincial-level People’s Committee.

2. Procurement of drugs under programs and projects using ODA funds, aid, or sponsorships from domestic and foreign organizations and individuals, which are sourced from the state budget, where the sponsors require direct contract conclusion.

Article 20. Responsibilities of relevant parties and validity of framework agreements, contract performance

1. Health facilities in need of procuring drugs listed in the centralized drug procurement list must base on the results of contractor selection and the contents of the framework agreement to finalize and execute contracts with the selected bidders through centralized procurement, following the principle that the unit price in the contract must not exceed the unit price in the announced framework agreement. The bidder must provide contract performance security as prescribed in Article 68 of the Law on Bidding.

2. The bidder selected through centralized procurement is responsible for supplying drugs in the quantity and schedule specified in the signed contract with each health facility.

The centralized procurement unit is responsible for coordinating with the focal units and the winning bidders to adjust contract performance to ensure sufficient drug supply for health facilities.

3. The contract period for centralized drug procurement (national or local level) is specified in the contractor selection plan approved by the competent authority, but shall not exceed 36 months from the effective date of the contract to the date of acceptance and completion of obligations as prescribed in the contract.

4. Departments of Health, health facilities, focal units, and local centralized procurement units are responsible for reviewing and consolidating the needs for the list and quantity of drugs of each health facility under their management, and adjusting contract performance to ensure the use of at least 80% of the quantity of drugs of each item in the framework agreement or signed contract. For controlled drugs, infusion solutions, and other situations after reporting to the competent authority, the health facility shall ensure the use of at least 50% of the quantity of drugs of each item in the framework agreement or signed contract. For emergency medicines, antidotes, and rare drugs, public health facilities shall act in accordance with the actual situation.

Article 21. Changes in information and drug substitution during contractor selection or contract performance

In cases where bidding drugs undergo changes during the contractor selection process or the supply of awarded drugs, but the substitute drugs was not included in the bid dossiers or dossiers of proposals, the centralized procurement unit shall carry out drug substitution in accordance with Clauses 3 and 4 of Article 15 of this Circular to ensure sufficient drug supply for timely medical examination and treatment.

 

Section 2

PREPARATION, APPRAISAL, AND APPROVAL OF CONTRACTOR SELECTION PLANS, BIDDING DOSSIERS, AND DOSSIERS OF REQUIREMENTS

 

Article 22. Determination of national centralized procurement needs

1. Focal units responsible for consolidating procurement needs:

a) For anti-HIV drugs:

The HIV/AIDS Prevention and Control Department shall preside over and coordinate with the national centralized procurement unit to guide the determination and consolidation of procurement needs in accordance with the following principles:

- Public health facilities under the Ministry of Health, public health facilities under the management of ministries, sectors located in the area, and public health facilities under local management shall determine their procurement needs, specifying the list of drugs, detailed quantity of each drug, technical criteria for each group, optional additional purchase quantity (if any), and supply schedule, and send these to the provincial HIV/AIDS Prevention and Control Focal Point where the public health facility is headquartered.

- The provincial HIV/AIDS Prevention and Control Focal Point shall review, consolidate, and be responsible for the procurement needs of public health facilities in the area, and send these to the Department of Health for consideration and decision.

- The Department of Health shall send a written proposal on procurement needs to the HIV/AIDS Prevention and Control Department, accompanied by the documents prescribed in Article 24 of this Circular.

- The HIV/AIDS Prevention and Control Department shall consolidate and be responsible for the procurement needs, and send a written proposal to the national centralized procurement unit.

b) For anti-tuberculosis drugs:

The National Lung Hospital shall preside over and coordinate with the national centralized procurement unit to guide the determination and consolidation of procurement needs, or base on the actual usage of health facilities, the supplier's capacity in the previous procurement periods, and the estimated number of patients to determine procurement needs, optional additional purchase quantity (if any), and be responsible for the procurement needs and send a written proposal to the national centralized procurement unit.

c) For vaccines:

The Preventive Medicine Department shall preside over and coordinate with the National Institute of Hygiene and Epidemiology and the national centralized procurement unit to guide the determination and consolidation of procurement needs, or base on the actual usage of health facilities, the supplier's capacity in the previous procurement periods, and the estimated number of users to determine procurement needs and optional additional purchase quantity (if any). The Preventive Medicine Department shall be responsible for the procurement needs and send a written proposal to the national centralized procurement unit.

d) For drugs on the centralized procurement list not included in the cases prescribed at Points a, b, and c of this Clause:

The national centralized procurement unit shall guide the determination and consolidation of procurement needs as follows:

- Public health facilities under the Ministry of Health shall determine their procurement needs, specifying the list of drugs, detailed quantity of each drug, including the optional additional purchase quantity (if any), be responsible for the procurement needs, and send these to the national centralized procurement unit;

- Public health facilities under the management of ministries, sectors, agencies, and private health facilities shall determine their procurement needs, specifying the list of drugs, detailed quantity of each drug, including the optional additional purchase quantity (if any), and send them to the Department of Health where the health facility is headquartered for consolidation and submission to the national centralized procurement unit. The health facility shall be responsible for the procurement needs sent to the national centralized procurement unit;

- Public health facilities under the management of the Department of Health shall determine their procurement need, specifying the list of drugs, detailed quantity of each drug, including the optional additional purchase quantity (if any), and send them to the local centralized procurement unit. The local centralized procurement unit shall consolidate the procurement needs and report to the Department of Health. The Department of Health shall review, decide, and be responsible for the procurement needs, and send a written proposal to the national centralized procurement unit.

2. Consolidation of procurement needs

a) The deadline for Departments of Health, health facilities, and focal units to consolidate and submit centralized procurement needs shall be determined by the national centralized procurement unit, but shall not exceed 45 days.

b) After a maximum period of 45 days from the date of the first written request by the national centralized procurement unit for consolidation of procurement needs, Departments of Health, health facilities, and focal units that have not submitted their procurement needs shall be deemed to have no procurement needs.

c) In cases where Departments of Health, health facilities, or focal units submit procurement needs but fail to submit the documents as prescribed in Article 24 of this Circular, the national centralized procurement unit shall issue a written request for supplementary documents. Within 5 working days from the date of the national centralized procurement unit's written request for supplementary documents, if the Departments of Health, health facilities, or focal units do not submit the documents or submit incomplete documents, the national centralized procurement unit may determine and consolidate the procurement needs of that unit based on the quantity of drugs used and the proposal of the Department of Health, health facility, or focal unit, but the quantity shall not increase by more than 30% compared to the corresponding quantity used in the previous period or in the previous 12 months as per the notification of consolidated procurement needs.

d) In necessary cases, to ensure timely supply of drugs for the medical examination and treatment needs of public health facilities, the national centralized procurement unit is allowed to determine the procurement needs, including the optional additional purchase quantity (if any), based on the actual quantity used in the immediately preceding period or in the previous 12 months immediately preceding the time of determining the procurement needs, but the quantity shall not increase by more than 30% compared to the corresponding quantity used in the previous period or in the previous 12 months immediately preceding the time of determining the procurement needs. On that basis, the national centralized procurement unit shall send a written request to public health facilities under the management of the Ministry of Health, public health facilities under the management of ministries, sectors, and local centralized procurement units to review and verify the procurement needs. After a maximum of 30 days from the date of the national centralized procurement unit's written request for review and verification of procurement needs, if the public health facilities under the management of the Ministry of Health, public health facilities under the management of ministries, sectors, and local centralized procurement units do not submit a written confirmation of their needs, they shall be deemed to have no procurement needs;

dd) After consolidating the procurement needs of Departments of Health, health facilities, and focal units, the national centralized procurement unit shall submit a written request for comments to Vietnam Social Security on the procurement needs.

Within 10 days from the date of the national centralized procurement unit's written request for comments, Vietnam Social Security must provide a written response regarding the procurement needs. If Vietnam Social Security fails to provide a written response within the above-mentioned period or provides a written response after the deadline, it shall be deemed that Vietnam Social Security agrees with the procurement needs consolidated and requested for comments by the national centralized procurement unit.

In cases where Vietnam Social Security disagrees with the procurement needs requested for comments by the national centralized procurement unit: The national centralized procurement unit shall acknowledge and explain the comments of Vietnam Social Security. In cases where there is disagreement with the comments of Vietnam Social Security, within 05 working days from the date of receiving the comments from Vietnam Social Security, the national centralized procurement unit must organize a meeting with Vietnam Social Security to reach an agreement. When attending the meeting, the opinion of the person appointed by Vietnam Social Security to attend the meeting shall be the official opinion of Vietnam Social Security. In cases where opinions are not agreed upon at the meeting, the matter shall be reported to the Ministry of Health for consideration and decision.

In cases where Vietnam Social Security does not send a representative to attend the meeting, it shall be deemed that Vietnam Social Security agrees with the procurement needs finalized by the national centralized procurement unit after acknowledging and explaining the comments of Vietnam Social Security.

Article 23. Determination of local centralized procurement needs

1. The determination of local centralized procurement needs shall be carried out as follows:

a) Public health facilities under local management shall establish their procurement needs, specifying the list of drugs and the detailed quantity of each drug, including the optional additional purchase quantity (if any), and send them to the local centralized procurement unit.

b) Private health facilities participating in local centralized procurement shall determine their procurement needs, specifying the list of drugs and the detailed quantity of each drug, including the optional additional purchase quantity (if any), and send them to the local centralized procurement unit and shall be responsible for the procurement needs sent to the local centralized procurement unit.

2. Consolidation of local centralized procurement needs

a) The deadline for submission of needs shall be determined by the local centralized procurement unit, but shall not exceed 30 days. After a maximum period of 30 days from the date of the first written request for consolidation of procurement needs by the local centralized procurement unit, health facilities that have not submitted their procurement needs shall be deemed to have no procurement needs.

b) In cases where a health facility submits procurement needs but fails to submit the documents as prescribed in Article 24 of this Circular, the local centralized procurement unit shall determine and consolidate the procurement needs of that health facility based on the facility's proposal, but the quantity shall not exceed 30% of the quantity used in the immediately preceding period or in the previous 12 months immediately preceding the time of the notification for consolidated procurement needs.

c) After consolidating the procurement needs, the local centralized procurement unit shall submit a written request for comments to the provincial social security agency regarding the procurement needs of public health facilities under its management as follows:

- Within 10 days from the date of the local centralized procurement unit's written request for comments, the provincial social security agency must provide a written response to the local centralized procurement unit; if the local centralized procurement unit fails to provide a written response within the above-mentioned period or provides a written response after the deadline, it shall be deemed that the provincial social security agency agrees with the content of the request for comments from the local centralized procurement unit.

- In cases where the local centralized procurement unit disagrees with the content of the request for comments from the local centralized procurement unit: The local centralized procurement unit shall acknowledge and explain the comments of the local centralized procurement unit. In cases where there is disagreement with the comments of the local centralized procurement unit, within 05 working days from the date of receiving the comments of the provincial social security agency, the local centralized procurement unit must organize a meeting with the provincial social security agency to reach an agreement. When attending the meeting, the opinion of the person appointed by the provincial social security agency to attend the meeting shall be the official opinion of the provincial social security agency.
 In cases where opinions are not agreed upon at the meeting, the matter shall be reported to the competent authority at the local level for consideration and decision.

In cases where the provincial social security agency does not send a representative to attend the meeting, it shall be deemed that the provincial social security agency agrees with the content finalized by the local centralized procurement unit after acknowledging and explaining the comments of the provincial social security agency.

Article 24. Documentation for registering centralized drug procurement needs

Health facilities, when sending their proposed centralized drug procurement needs, must enclose the following documents:

1. A summary report on the implementation of contractor selection results, drug usage in the 12 months immediately preceding and the immediately preceding period up to the time of the consolidated procurement needs notification, inventory levels, and quantities in the previous period's plan not yet implemented at the time of determining the procurement needs.

2. A summary explanation of the procurement needs for the drugs being requested. In cases where the quantity increases by more than 30% compared to the quantity used in the immediately preceding period or in the previous 12 months immediately preceding the time of determining the procurement needs, a detailed explanation and justification must be provided.

3. Documents serving as the basis for preparing the contractor selection plan for drug supply as regulated.

4. Minutes of the meeting to review and agree on the list and quantity of drug procurement needs of:

- The Drug and Therapeutics Council regarding the list, quantity of drugs, and drug usage needs of health facilities.

- The Department of Health for drugs on the centralized procurement list of health facilities under the management of the Department of Health, including private health facilities and health facilities under the management of ministries, sectors located in the area (except for health facilities under the Ministry of Health).

For newly established health facilities or those requesting procurement for the first time, the document prescribed in Clause 1 of this Article is not required when sending the consolidated procurement needs.

Article 25. Preparation, appraisal, and approval of contractor selection plan

1. Preparation of Contractor Selection Plans

Contractor selection plans shall be prepared in accordance with the following principles:

a) In the case where drug products have high demand and a single bidder is not able to supply the total quantity of such products, the bidding package may be classified into different bidding packages by region or by socio-economic zone to ensure competition in bidding. In case it is necessary to select more than one winning bidder for a part of the bidding package, it must be clearly specified in the contractor selection plan;

b) The classification of bidding packages and the contents of the contractor selection plan shall be implemented in accordance with the provisions of Articles 4 to 12 of this Circular.

2. Organization of Appraisal for the Contractor Selection Plan

a) The centralized procurement unit shall submit the submission dossier for the contractor selection plan in accordance with Clause 1, Article 13 of this Circular (not required to include the procurement estimate) to the organization assigned the task of appraising the contractor selection plan as prescribed in Clause 3, Article 41 of the Law on Bidding and Clause 2, Article 88 of Decree No. 24/2024/ND-CP (hereinafter referred to as the appraisal unit for the contractor selection plan);

b) The appraisal unit for the contractor selection plan is responsible for presiding over the appraisal of the contractor selection plan for the supply of centrally procured drugs as prescribed in Clause 2, Article 13 of this Circular;

c) Vietnam Social Security shall participate in the appraisal of the contractor selection plan for centralized drug procurement as prescribed in Clause 4, Article 94 of Decree No. 24/2014/ND-CP, specifically as follows:

Within 10 days from the date of receiving the contractor selection plan, the appraisal unit for the contractor selection plan is responsible for sending a written request for comments to Vietnam Social Security (for national centralized procurement) or provincial Social Security agency (for local centralized procurement) (hereinafter referred to as the Social Security agency) on the contractor selection plan, except for the contents of procurement needs already agreed upon as prescribed at Point dd, Clause 2, Article 22 and Point c, Clause 2, Article 23 of this Circular;

Within 10 days from the date the appraisal unit for the contractor selection plan submits a written request for comments, the Social Security agency must provide a written response regarding the contractor selection plan. If the Social Security agency does not provide a written response or provides a written response within the aforementioned period, it shall be deemed that the Social Security agency agrees with the contractor selection plan consolidated and requested for comments by the appraisal unit for the contractor selection plan.

In cases where the Social Security agency disagrees with the contractor selection plan requested for comments by the appraisal unit for the contractor selection plan: The appraisal unit for the contractor selection plan shall coordinate with the centralized procurement unit to acknowledge and explain the comments of the Social Security agency. In cases where there is disagreement with the comments of the Social Security agency, within 5 working days from the date of receiving the comments of the Social Security agency, the appraisal unit for the contractor selection plan shall organize a meeting with the Social Security agency to reach an agreement. When attending the meeting, the opinions of the person appointed by the Social Security agency to attend the meeting shall be the official opinions of the Social Security agency. In cases where opinions are not agreed upon at the meeting, the matter shall be reported to the Ministry of Health (for national centralized procurement) or the local competent authority (for local centralized procurement) for consideration and decision.

In cases where Social Security agency does not send a representative to attend the meeting, it shall be deemed that the Social Security agency agrees with the contractor selection plan finalized by the centralized procurement unit after acknowledging and explaining the comments of the Social Security agency.

3. Approval of the contractor selection plan:

a) The Ministry of Health shall review and approve the contractor selection plan for national centralized procurement based on the submission dossier for the contractor selection plan submitted by the national centralized procurement unit, the appraisal report, and the recommendations of the appraisal unit for the contractor selection plan;

b) The local competent authority shall review and approve the contractor selection plan for local centralized procurement based on the submission dossier for the contractor selection plan submitted by the local centralized procurement unit, the appraisal report, and the recommendations of the appraisal unit for the contractor selection plan.

Article 26. Preparation, appraisal, and approval of bidding dossiers and dossiers of requirements

1. Based on the approved contractor selection plan, the centralized procurement unit shall organize the preparation, appraisal, and approval of the bidding dossiers and dossiers of requirements in accordance with Article 14 of this Circular.

2. In cases where it is necessary to select more than one winning bidder for a part of a bidding package or for an unclassified bidding package, the bidding dossiers and dossiers of requirements must specify bidding conditions, contractor evaluation and ranking methods, including provisions allowing contractors to submit bids based on their supply capacity in accordance with the bidding package, enabling contractors to calculate their bidding options based on their supply capacity.

 

Section 3

ORGANIZATION OF CONTRACTOR SELECTION

 

Article 27. Evaluation of bid dossiers and dossiers of proposals

1. Depending on the nature of the bidding package and the form and method of contractor selection, the procuring entity shall select an appropriate method for evaluating bid dossiers and dossiers of proposals as prescribed in Article 58 of the Law on Bidding. The method for evaluating bid dossiers and dossiers of proposals must be specified in the bidding dossier and the dossier of requirements.

2. The evaluation of bid dossiers and dossiers of proposals for each part of multi-part bidding packages shall be based on the provisions of the law on bidding, except for cases prescribed at Point b, Clause 2, Article 15 of this Circular, in which:

a) Drug information shall be based on the marketing authorization or import license; information about GMP principles and standards of the manufacturing facility, and other information in official dispatches and approval decisions of the Drug Administration of Vietnam; the Traditional Medicine Administration or information published on the websites of the Drug Administration of Vietnam and the Traditional Medicine Administration, the national centralized procurement unit (if any); the local centralized procurement unit (if any);

b) The evaluation of the contractor’s capacity and experience shall be based on the total of all parts of the bidding package in which the contractor participates.

Article 28. Contractor ranking and recommendations of award

1. Contractor ranking

The expert group shall prepare a report on the evaluation results of bid dossiers and dossiers of proposals and submit it to the centralized procurement unit for consideration and contractor ranking.

2. Recommendations of award:

The conditions for considering a recommendation award shall be implemented in accordance with the provisions of Article 61 of the Law on Bidding, the issued bidding dossiers, and requests for proposal.

 

Section 4

APPRAISAL, APPROVAL, PUBLIC DISCLOSURE, AND IMPLEMENTATION OF CONTRACTOR SELECTION RESULTS

 

Article 29. Submission for appraisal and approval of contractor selection results

Based on the report on the evaluation results of bid dossiers and dossiers of proposals, the centralized procurement unit shall be responsible for appraising and approving the contractor selection results in accordance with Article 13 of this Circular.

Article 30. Finalization, signing and publication of the framework agreement

1. The centralized procurement unit and the winning bidder shall finalize the contents of the framework agreement as prescribed at Point e, Clause 1, Article 89 of Decree No. 24/2024/ND-CP, as the basis for signing the framework agreement.

2. In cases where a contractor wins a bid for the same item in multiple bidding packages, the contractor must submit a commitment to ensure sufficient capacity and experience to complete the supply of drugs in accordance with the quality and timeline specified in the contract; this commitment is a part of the framework agreement.

3. The national centralized procurement unit is responsible for:

a) Publishing the framework agreement on the Ministry of Health's electronic portal, the website of the national centralized procurement unit, and posting information about the contractor selection results as prescribed at Point a, Clause 1 and Clause 4, Article 8 of the Law on Bidding;

b) Sending a written notification of the contractor selection results to participating contractors within 05 working days from the date the contractor selection results are approved;

c) Notifying in writing to public health facilities under the management of the Ministry of Health; public health facilities under the management of other Ministries, and sectors; Departments of Health and focal points.

4. Departments of Health, health management agencies of ministries and sectors, and focal points shall be responsible for notifying the contractor selection results and the framework agreement to the health facilities within the scope of supply of the framework agreement.

5. The local centralized procurement unit shall be responsible for:

a) Publishing the framework agreement on the electronic portal of the provincial-level People’s Committee, the website of the Department of Health, and the website of the local centralized procurement unit (if any) and posting information about the contractor selection results as prescribed at Point a, Clause 1 and Clause 4, Article 8 of the Law on Bidding;

b) Sending a written notification of the contractor selection results to participating bidders within 05 working days from the date the contractor selection results are approved;

c) Notifying in writing to the health facilities under the management of the local authorities.

Article 31. Finalization and signing of drug supply contracts

The centralized procurement unit (in the case of direct contracting) or health facilities (in the case of framework agreements), based on the contractor selection results, the framework agreement, drug usage needs and plans of health facilities registered with the Departments of Health, focal points for national centralized procurement, or local centralized procurement unit, shall finalize and sign contracts with contractors in accordance with the following principles:

1. The contract terms shall be consistent with the supply conditions of the framework agreement.

2. The price of each drug product in the contract shall not exceed the winning bid price announced by the centralized procurement unit.

3. Implementation period of the bidding package: is specified in the contractor selection plan approved by the competent authority but shall not exceed 36 months from the effective date of the contract to the date the parties meet their obligations as prescribed in the contract.

4. The unit with procurement needs shall report to the centralized procurement unit in cases where the bidder does not sign the contract.

Article 32. Payment and settlement of drug supply contracts

1. The centralized procurement unit (in the case of direct contracting) or health facilities (in the case of framework agreements) shall be responsible for making payments and settling accounts with the supplier in accordance with current legal regulations and the terms of the signed contract.

2. The approval document for the adjustment of drugs among the units of the centralized procurement unit shall be a part of the drug supply contract and shall be the basis for health facilities and bidders to sign a (for adjusted items already allocated in the framework agreement) or sign a contract (for adjusted items not yet allocated in the framework agreement).

Article 33. Adjustment of the implementation of the national centralized procurement framework agreement

1. The focal points consolidating drug usage needs as prescribed in Clause 1, Article 22 of this Circular, is responsible for adjusting the use of drugs selected through national centralized bidding under the framework agreement or signed contract.

2. The adjustment of awarded drugs includes additional purchases within the optional additional purchase limits and transfers among health facilities. The adjustment shall be carried out in accordance with the procedures for adjusting awarded drugs under the national centralized procurement form issued by the national centralized procurement unit. Health facilities are only allowed to adjust awarded drugs under the national centralized procurement form when meeting one of the following conditions:

a) The entire quantity of all generic drugs with the same active ingredient, concentration, or content that have won bids has been received;

b) Drugs belonging to other groups with the same active ingredient, concentration, or content that have won bids but are forced to stop supply, drugs that have been suspended from circulation, or drugs that are no longer in the list of drugs having evidence of bioequivalence;

c) The contractor has not yet supplied the full quantity of drugs of a drug group under the signed contract but is not able to continue supplying due to force majeure reasons, in which case there must be a written notification from the contractor accompanied by supporting documents;

d) Other necessary cases to ensure the effectiveness of treatment, in which case the health facility must provide a specific explanation and justification.

3. In cases where drug usage needs of health facilities under the management of ministries and sectors or health facilities under the management of local authorities exceeds the quantities allocated in the framework agreement, a report must be submitted to the local centralized procurement unit or the focal point for consolidating procurement needs at the local level (for anti-HIV drugs, anti-tuberculosis drugs, and vaccines) for consolidation and adjustment of drug quantities among health facilities within the local supply scope, ensuring not to exceed the total quantity allocated in the framework agreement within the area. Within 10 days from the date of receiving the written request for adjustment from the health facility, the local centralized procurement unit or the focal point for consolidating procurement needs at the local level must provide a written response to the unit or carry out the adjustment.

In cases where the drug usage needs of health facilities under the management of ministries and sectors, and health facilities under the management of local authorities exceed the adjustment capacity of the local centralized procurement unit or the focal point for consolidating procurement needs at the local level (for anti-HIV drugs, anti-tuberculosis drugs, and vaccines), or the drug usage needs of health facilities under the management of the Ministry of Health exceed the quantity allocated in the framework agreement, or health facilities have arising drug usage needs but have not yet consolidated demand when developing the bidder selection plan, the local centralized procurement unit or the focal point for aggregating procurement demand at the local level (for anti-HIV drugs, anti-tuberculosis drugs, and vaccines), health facilities under the management of the Ministry of Health must report to the focal points for consolidating procurement needs to adjust the quantity of drugs among the units.

Within 05 working days from the date of receiving the written request for adjustment from health facilities in the area, the local centralized procurement unit or the focal point for consolidating procurement needs at the local level (for anti-HIV drugs, anti-tuberculosis drugs, and vaccines) shall report to the focal points for consolidating procurement needs.

Within 15 days from the date of receiving the written request for adjustment from the local centralized procurement unit or the focal point for consolidating procurement needs at the local level (for anti-HIV drugs, anti-tuberculosis drugs, and vaccines), health facilities under the management of the Ministry of Health, the focal points for consolidating procurement needs must provide a written response to the unit or carry out the adjustment. In cases where the adjustment is not carried out, the written response must clearly specify the reasons for not carrying out the adjustment.

4. After the entire quantity of drugs in the national centralized procurement framework agreement has been adjusted, the national centralized procurement unit and the focal points for consolidating procurement needs shall carry out adjustments within the optional additional purchase limits. The total quantity of adjusted drugs shall not exceed the total quantity approved in the contractor selection plan, including the optional additional purchase quantity.

5. The adjustment of drugs aims to ensure that the drug usage needs of health facilities are met and that the contract is implemented in accordance with Clause 4, Article 20 of this Circular.

6. The written request for drug adjustment shall follow the form prescribed in Appendix VI issued together with this Circular.

Article 34. Adjustment of the implementation of the local centralized procurement framework agreement

1. The local centralized procurement unit is responsible for adjusting the use of drugs selected through local centralized bidding under the framework agreement or signed contract.

2. The adjustment of awarded drugs includes additional purchases within the optional additional purchase limits and transfers among health facilities. The adjustment shall be carried out in accordance with the procedures for adjusting awarded drugs under the local centralized procurement form issued by the local centralized procurement unit (if any).

3. In cases where the drug usage needs of health facilities exceed the quantity allocated in the framework agreement or health facilities have arising drug usage needs but have not yet consolidating needs when establishing the contractor selection plan, a report must be submitted to the local centralized procurement unit for consolidation and adjustment of drug quantities among health facilities within the local supply scope, ensuring not to exceed the total quantity allocated in the framework agreement.

Within 10 days from the date of receiving the written request for adjustment from health facilities, the local centralized procurement unit must provide a written response to the health facilities or carry out the adjustment. In cases where the adjustment is not carried out, the written response must clearly specify the reasons for not carrying out the adjustment.

4. After the entire quantity of drugs in the framework agreement has been adjusted, the local centralized procurement unit shall carry out adjustments within the optional additional purchase limits, ensuring that the total quantity of adjusted drugs does not exceed the total quantity approved in the contractor selection plan, including the optional additional purchase quantity.

5. The adjustment of drugs aims to ensure that the drug usage needs of health facilities are met and that the use of awarded drugs in accordance with Clause 4, Article 20 of this Circular.

6. The written request for drug adjustment shall follow the form prescribed in Appendix VI issued together with this Circular.

Article 35. Optional additional purchase in centralized procurement

The centralized procurement unit is responsible for providing specific guidance on the procedures for implementing optional additional purchases in centralized procurement to ensure compliance while meeting the following requirements:

1. The centralized procurement unit may apply the optional additional purchase with the maximum quantity specified in the approved the contractor selection plan for supplement and adjustment to health facilities.

2. In cases where health facilities need to purchase additional drugs within the framework agreement and the adjustment capacity exceeds the allocated quantity, after receiving written approval from the centralized procurement unit, it may purchase additional drugs within the optional additional purchase quantity.
 In this case, the contract or contract addendum must clearly specify the quantity, value, and implementation timeline.

3. The centralized procurement unit and health facilities may apply the optional additional purchase multiple times, but the total quantity shall not exceed the maximum specified in the approved contractor selection plan.

Article 36. Reporting on the implementation of national centralized bidder selection results

1. Before the 10th of each month and the 10th of the first month of each quarter, or on an ad hoc basis upon request, contractors shall report on the implementation of the drug supply contract under the list of national centralized bidding drugs, using the form prescribed in Appendix VII issued together with this Circular, to the national centralized procurement unit and the HIV/AIDS Prevention and Control Department for anti-HIV drugs.

2. Before the 10th of the first month of each quarter, or on an ad hoc basis upon request, health facilities under the management of local authorities, and health facilities under the management of ministries and sectors in the area shall submit a report on the implementation of the drug supply contract under the list of national centralized bidding drugs, using the form prescribed in Appendix VII issued together with this Circular, to the local centralized procurement unit and the provincial HIV/AIDS Prevention and Control agency for anti-HIV drugs.

3. Before the 15th of the first month of each quarter, or on an ad hoc basis upon request, the local centralized procurement unit and health facilities under the management of the Ministry of Health shall report on the implementation of the drug supply contract under the list of national centralized bidding drugs, using the form prescribed in Appendix VII issued together with this Circular, to the national centralized procurement unit and the HIV/AIDS Prevention and Control Department for anti-HIV drugs.

Article 37. Reporting on the implementation of local centralized contractor selection result

1. Before the 10th of the first month of each quarter, or on an ad hoc basis upon request, contractors shall report on the implementation of the drug supply contract under the list of local centralized bidding drugs, using the form prescribed in Appendix VII issued together with this Circular, to the local centralized procurement unit.

2. Before the 10th of the first month of each quarter, or on an ad hoc basis upon request, the public health facilities under the management of local authorities shall submit a report on the implementation of the drug supply contract under the list of local centralized bidding drugs, using the form prescribed in Appendix VII issued together with this Circular, to the local centralized procurement unit.

 

Chapter V

IMPLEMENTATION PROVISIONS

 

Article 38. Effect

1. This Circular takes effect from May 17, 2024

2. The following regulations shall cease to be effective from the effective date of this Circular:

a) Circular No. 15/2019/TT-BYT dated July 11, 2019 of the Minister of Health regulating the bidding for drugs at public health facilities;

b) Article 5 of Circular No. 15/2020/TT-BYT dated August 10, 2020 of the Minister of Health promulgating the List of drugs for bidding, the List of drugs subject to centralized bidding, and the List of drugs subject to price negotiation;

c) Clause 8, Article 1 of Circular No. 29/2020/TT-BYT dated December 31, 2020 of the Minister of Health amending, supplementing, and annulling a number of legal documents promulgated or jointly promulgated by the Minister of Health;

d) Circular No. 15/2021/TT-BYT dated September 24, 2021 of the Minister of Health amending and supplementing a number of articles of Circular No. 15/2019/TT-BYT dated July 11, 2019 of the Minister of Health regulating the bidding for drugs at public health facilities;

dd) Circular No. 06/2023/TT-BYT dated March 12, 2023 of the Minister of Health amending and supplementing a number of articles of Circular No. 15/2019/TT-BYT dated July 11, 2019 of the Minister of Health regulating the bidding for drugs at public health facilities;

e) Circular No. 22/2020/TT-BYT dated December 2, 2020 of the Minister of Health regulating the management of anti-HIV drugs centrally procured at the national centralized procurement using health insurance funds and providing co-payment support for anti-HIV drugs for people living with HIV who have health insurance cards;

g) Chapter III of Circular No. 36/2021/TT-BYT dated December 31, 2021 of the Minister of Health regulating medical examination and treatment and payment of medical examination and treatment expenses under health insurance related to medical examination and treatment of tuberculosis;

h) Circular No. 09/2022/TT-BYT dated September 9, 2022 of the Minister of Health detailing the form of the bidding dossiers for the procurement of medicinal materials and traditional medicament at public health facilities.

Article 39. Reference provisions

In cases where the documents referenced in this Circular are replaced, amended, or supplemented, the replaced documents or the amended and supplemented documents shall apply.

Article 40. Implementation organization

1. Heads of central agencies shall direct public health facilities under their management to implement the contractor selection in accordance with the provisions of this Circular and the law on contractor selection.

2. The Minister of Health shall decentralize the authority to decide on drug procurement to agencies and units directly using funds under the management of the Ministry of Health to procure drugs for the operation of such agencies and units and to serve tasks assigned by the Minister of Health.

3. The Drug Administration of Vietnam, the Traditional Medicine Administration is responsible for updating and publishing the following information on their websites:

a) List for contractor selection purposes, including:

- List of drug regulatory authorities of countries on the SRA or EMA list and list of countries on the SRA or EMA list;

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

- List of drug manufacturing facilities in Vietnam assessed by the drug regulatory authority of Vietnam as meeting WHO-GMP principles and standards;

- List of drug manufacturing facilities meeting EU-GMP principles and standards or drug manufacturing facilities meeting equivalent EU-GMP principles and standards; List of drug manufacturing facilities meeting PIC/s-GMP principles and standards; List of drug manufacturing facilities meeting WHO-GMP principles and standards;

- List of drug manufacturing facilities assessed by the Ministry of Health of Vietnam as meeting GMP principles and standards for drugs from medicinal materials or traditional medicines;

- List of drug manufacturing facilities in Vietnam assessed by the Ministry of Health of Vietnam as meeting GMP principles and standards for medicinal materials, traditional medicament;

- List of drug manufacturing facilities in Vietnam assessed by the Ministry of Health of Vietnam as meeting GMP principles and standards for drug ingredients from medicinal materials.

b) Lists of drugs for contractor selection purposes, including:

- List of drugs, traditional medicament, and semi-finished medicinal materials granted marketing authorization or import licenses;

- List of brand name drugs and reference biological products;

- List of brand name drugs and reference biological products processed and transferred technology in Vietnam;

- List of drugs having evidence of bioequivalence;

- List of drugs entirely manufactured on production lines in Vietnam that meet the Group 1 criteria specified at Point c, Clause 1, Article 4 of this Circular;

- List of traditional medicaments in dosage forms: extracts, granules, powders, extracts, essential oils, resins, gums, jellies ensuring quality in accordance with the Ministry of Health's regulations on quality management of medicinal materials and traditional medicament;

- List of drugs on the National Product List;

- List of drugs awarded the "Vietnamese Medicine Star" by the Ministry of Health;

- List of medicinal materials cultivated, harvested, or collected naturally by facilities assessed by the Ministry of Health of Vietnam as meeting GACP principles and standards;

- List of contract-manufactured drugs (without technology transfer);

- List of contract-manufactured drugs (with technology transfer); List of drugs with technology transfer granted or renewed marketing authorization;

- List of drugs manufactured from materials (active pharmaceutical ingredients) manufactured in countries on the SRA or EMA list, materials (active pharmaceutical ingredients) granted CEP certificates;

- List of drugs and manufacturing facilities, suppliers with violations of drug quality.

c) Lists of manufacturing facilities and drug suppliers meeting the requirements of capacity, experience, and reputation to serve as a basis for inviting to participate in restricted bidding.

4. Facilities requesting the publication of information as prescribed at Point c, Clause 1, Article 4 of this Circular shall provide and be held legally liable for the accuracy of the following documents:

a) Legal documents issued by the drug regulatory authority of a country on the SRA or EMA list with full signatures, names of signatories, seals of the competent state management agency of the country issuing the legal documents, and must be consular legalized in accordance with regulations (original or certified copy);

In cases where the issued legal documents are in electronic form, including cases where there are not enough signatures, names of signatories, and seals of the competent state management agency of the country issuing the legal documents, the facility shall submit the results of self-retrieval the legal documents from the English website of the issuing agency, affixed with the facility’s seal of confirmation, accompanied by a document providing information on the online search link to the Ministry of Health (Drug Administration of Vietnam). The registering facility must be held legally liable for the legality and accuracy of these documents, information, and the facility's self-retrieval results;

Legal documents must include the following minimum contents: drug name, active ingredients, concentration or content of the active ingredients, dosage form, name and address of the manufacturing facility, with confirmation that the drug has been granted marketing authorization in that country.

b) A list of information to prove that the drug marketed in Vietnam and the drug are granted marketing authorization by the drug regulatory authority of a country on the SRA or EMA list have the same formulation, manufacturing process, quality standards, and testing methods; pharmaceutical ingredients and excipients must have the same quality standards, manufacturing facility, and production location as prescribed in Appendix VIII issued together with this Circular.

5. The centralized procurement unit is responsible for acting as the focal point for monitoring and expediting the drug supply by the bidders, the use of drugs by health facilities, and the adjustments made under the framework agreement.

6. Contractors participating in bidding packages for drugs from medicinal materials, drugs combining pharmaceutical ingredients with medicinal materials, and traditional medicines; bidding packages for medicinal materials, semi-finished medicinal materials, and traditional medicament manufactured from medicinal sources announced by the drug regulatory authority of Vietnam as meeting GACP principles and standards must be held legally liable for the following contents:

a) The accuracy of the dossiers and documents proving that the drugs, medicinal materials, and traditional medicament participating in the bidding are manufactured from medicinal sources announced by the drug regulatory authority of Vietnam as meeting GACP principles and standards;

b) The winning drugs, traditional medicament, and medicinal materials are manufactured and supplied from medicinal sources announced by the drug regulatory authority of Vietnam as meeting GACP principles and standards and in accordance with the technical standards in the bidding dossier and the dossier of requirements.

7. In cases where the drugs included in the approved contractor selection plan no longer meet the principles and criteria for inclusion in the centralized procurement list as prescribed, the following procedures shall be followed:

a) In cases where the bidding dossier and the dossier of requirements have already been issued, the centralized contractor selection shall be continued in accordance with the approved contractor selection plan;

b) In cases where the bidding dossier and the dossier of requirements have not yet been issued, the centralized procurement unit shall handle the situation using one of the following methods:

- Propose to the competent authority for consideration and approval to proceed as prescribed in Clause 5, Article 53 of the Law on Bidding;

- Notify the discontinuation of centralized procurement and request units and localities to proactively procure the drugs.

8. When drugs in the list of drugs with at least 03 domestic manufacturers manufacturing on production lines meeting EU-GMP or equivalent EU-GMP principles and standards, and meeting the technical criteria prescribed by the Ministry of Health, does not meet the principles and criteria regarding quality, price, and supply capacity as prescribed, the unit organizing the contractor selection shall consider and decide in accordance with one of the following cases:

a) In cases where the bidding dossier and the dossier of requirements have already been issued, the contractor selection shall be continued in accordance with the approved contractor selection plan and the issued bidding dossier and the dossier of requirements;

b) In cases where the bidding dossier and the dossier of requirements have not yet been issued, the project owner is not required to implement the preferential treatment as prescribed at Point b, Clause 1, Article 56 of the Law on Bidding.

Article 41. Responsibility for implementation

The Director of the Drug Administration of Vietnam, the Director of the Traditional Medicine Administration; the Director of the Planning and Finance Department, the Chief of the Ministry Office, the Chief of the Inspector of the Ministry; the Head of the national centralized procurement unit, Heads of units under and directly under the Ministry of Health, Directors of Departments of Health of provinces and centrally-run cities, pharmaceutical business establishments, and other relevant agencies, organizations, and individuals are responsible for the implementation of this Circular.

During the implementation process, if any difficulties arise, agencies, organizations, and individuals are requested to report to the Ministry of Health for consideration and resolution./.

 

 

FOR THE MINISTRY
THE DEPUTY MINISTRY




Le Duc Luan

 

 

* All Appendices are not translated herein.

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