Joint Circular No. 10/2007/TTLT-BYT-BTC guides the bidding for purchasing medicines in public health facilities.

JOINT CIRCULAR

Guidelines for Tendering to Purchase Medicines in Public Health Facilities

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Based on the Medicine Law dated June 14, 2005 and Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain Articles of the Medicine Law;

Based on the Bidding Law dated November 29, 2005 and Decree No. 111/2006/NĐ-CP dated September 29, 2006 of the Government guiding the implementation of the Bidding Law and the selection of contractors under the Construction Law;

The Ministry of Health and the Ministry of Finance jointly issue guidelines for tendering to purchase medicines in public health facilities as follows:

I. GENERAL PROVISIONS

2. Applicability:

These guidelines regulate the tendering process for purchasing medicines to meet preventive healthcare, medical examination, and treatment needs in public health facilities.

第二条 组织和实施奖励工作的支出水平，如政府第152/2025/NĐ-CP号决定关于分级授权和奖励领域的分权规定

Public health facilities that utilize state budget funds and other lawful sources of revenue (collectively referred to as the state budget) to purchase medicines shall comply with these guidelines and related regulatory documents.

3. These guidelines do not apply in the following cases:

a) Medicines ordered by the State and paid for from the state budget shall be implemented according to current regulations on price management by the State.

b) Blood and blood products shall be implemented according to Decision No. 28/2007/QĐ-BYT dated May 10, 2007 of the Minister of Health regarding the maximum prices of certain volumes of whole blood and blood products meeting standards.

II. SPECIFIC PROVISIONS

1. Authority in tendering to purchase medicines:

a) Authority to approve the bidding plan for purchasing medicines:

The Minister, Heads of Ministries, agencies equivalent to ministries, central government agencies, and other central-level agencies (hereinafter referred to as heads of central-level agencies), Chairpersons of Provincial People's Committees, and Municipal People's Committees directly under the Central Government are responsible for approving the bidding plans for purchasing medicines for public health facilities under their jurisdiction according to current regulations.

b) Authority to approve tender documents and to approve the results of contractor selection for supplying medicines:

Heads of public health facilities (hereinafter referred to as heads of units) are responsible for approving tender documents and approving the results of contractor selection for supplying medicines of their units according to current regulations.

2. Bidding Plan for Purchasing Medicines:

a) Basis for preparing the bidding plan for purchasing medicines:

- The annual state budget expenditure estimate assigned by the competent state agency, including: state budget funds, hospital fee revenues (including those settled by the Social Insurance Agency) and other lawful sources of revenue of the unit.

- The actual situation of medicine purchases in the previous year.

- Anticipated medicine purchase requirements for the planning year.

- The bidding plan must be prepared at least once a year.

In cases where the unit has not been assigned an annual state budget expenditure estimate, the basis for preparing the bidding plan must ensure the remaining three conditions stipulated herein.

b) Content of each tender package in the bidding plan:

- Name of the tender package.

- Plan for quantities, concentrations, contents, units of measurement, and dosage forms of each medicine item to be tendered according to the generic name. If it is a multi-component compound medicine, all components must be listed according to the generic name. In cases of tendering by brand name, the phrase "or equivalent therapy" must be included in the bidding plan (Equivalent therapy means equivalent formulation and, when used at the same dose, the effects of the medicine, both efficacy and safety, are essentially the same). The list of brand-name medicines must be approved in the annual bidding plan for purchasing medicines by the competent state agency (as specified in point a, Clause 1, Section II of this Circular) based on a written proposal by the head of the unit after being unanimously agreed upon by the unit's Medicine and Treatment Council. The head of the unit shall bear responsibility for their decision.

- Price of the tender package: The price of each medicine item in the bidding plan shall not exceed the maximum price published most recently by the Ministry of Health. For items not yet published with a maximum price, when preparing the bidding plan, units must refer to the prices of winning bids within the last 12 months from public health facilities updated and announced on the website of the Vietnam Drug Administration.

- Source of funding.

- Method of selecting contractors and bidding method applicable to each tender package.

- Timeframe for organizing the selection of contractors for each tender package.

- Contract form to be applied.

- Contract execution period.

c) Submission for approval of the bidding plan:

- The head of the unit is responsible for submitting the bidding plan for review and approval by the authority with the power to approve the bidding plan for purchasing medicines (as specified in point a, Clause 1, Section II of this Circular); simultaneously sending it to the organization in charge of reviewing (as specified in point d, Clause 2, Section II of this Circular).

- Documents for submission for approval:

+ Approval document: Follow the provisions of point a, Clause 2, Article 10, Decree No. 111/2006/NĐ-CP dated September 29, 2006 of the Government.

+ Supporting documents attached to the approval document: When submitting the bidding plan for purchasing medicines for approval, the head of the unit must attach copies of the documents serving as the basis for preparing the bidding plan for purchasing medicines as specified in points a and b, Clause 2, Section II of this Circular.

d) Review of the bidding plan:

- Organization in charge of reviewing:

+ At the central level: The organization in charge of reviewing the bidding plan for purchasing medicines is determined by the heads of central-level agencies.

+ At the local level: The Chairman of the Provincial People's Committee or the Municipal People's Committee directly under the Central Government decides to assign the Department of Health to be in charge of reviewing the bidding plan for purchasing medicines.

- Responsibilities of the organization in charge of reviewing:

+ The organization in charge of reviewing is responsible for inspecting and evaluating the contents specified in points a, b, and c, Clause 2, Section II of this Circular.

+ The organization in charge of reviewing the bidding plan must prepare a report on the review results based on compliance with the Bidding Law and submit it to the authority with the power to approve the bidding plan for purchasing medicines (as specified in point a, Clause 1, Section II of this Circular) for review and approval.

đ) Approval of the bidding plan:

The person authorized to approve the bidding plan for purchasing medicines as specified in Point a, Clause 1, Section II of this Circular shall be responsible for approving the bidding plan within a period not exceeding ten days from the date of receipt of the report of the Head of the unit, the assessment report of the leading assessment agency, and the opinion of other relevant agencies (if any).

3. Tender documents:

a) Preparing tender documents:

Implement in accordance with the provisions of the Bidding Law and Decree No. 111/2006/NĐ-CP dated September 29, 2006 of the Government. In addition, ensure the following conditions and requirements:

- Quantity, concentration, content, unit of measurement, form of preparation of each item of medicine that has been approved by the competent authority in the bidding plan.

- Requirements on the quality of medicines:

+ Ensuring compliance with the quality standards registered with the Vietnam National Medicines Administration.

+ Expiry date: Adhering to the regulations on the expiry date of medicines under the Medicine Law and the regulations of Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government guiding the implementation of the Medicine Law.

+ Medicine label: in accordance with the labeling regulations, including a Vietnamese language drug usage guide (including imported drugs).

- Requirements on the bidder's conditions:

+ The bidder may participate in one, several, or all items of medicines in a tender package if the bidder has the ability to supply them.

+ Commitment to supply sufficient medicines if awarded the bid;

+ Commitment to recall medicines in case the supplied medicines do not meet quality standards or there is a recall notice from the competent authority, and the cause is not due to the fault of the tenderer;

+ Commitment to ensure the ability to supply medicines according to the quality requirements at the winning bid price (including in cases where medicines are supplied in multiple batches throughout the year).

- Evaluation of tender documents:

The tenderer evaluates the tender documents for each item in each tender package.

b) Reviewing tender documents:

- The leading review agency for tender documents is determined by the Head of the unit.

- Responsibilities of the organization in charge of reviewing:

+ The leading review agency is responsible for inspecting and evaluating the contents in accordance with the provisions of the Bidding Law and Decree No. 111/2006/NĐ-CP dated September 29, 2006 of the Government and the provisions of Point a, Clause 3, Section II of this Circular.

+ The leading review agency for tender documents must prepare a report on the results of the review based on compliance with Article 65 of the Bidding Law and submit it to the Head of the unit for approval of the tender documents.

c) Approving tender documents:

The Head of the unit (as stipulated in Point b, Clause 1, Section II of this Circular) is responsible for approving the tender documents based on the review report of the leading review agency.

4. Results of selecting bidders:

a) Submitting for approval the results of selecting bidders:

- A specialized organization with sufficient capacity and experience as stipulated in Article 9 of the Bidding Law, assigned by the Head of the unit to organize bidding in accordance with the laws on bidding, is responsible for submitting the results of selecting bidders for approval.

- The documents for submitting the results of selecting bidders are implemented in accordance with Article 58 of Decree No. 111/2006/NĐ-CP dated September 29, 2006 of the Government.

b) Reviewing the results of selecting bidders:

- The leading review agency for the results of selecting bidders is determined by the Head of the unit.

- Responsibilities of the organization in charge of reviewing:

+ Conduct inspections and evaluations of the review contents as stipulated in Clause 1, Article 59 of Decree No. 111/2006/NĐ-CP dated September 29, 2006 of the Government.

+ Prepare a report on reviewing the results of selecting bidders based on the report on the results of selecting bidders by the specialized organization conducting the review and submit it to the Head of the unit for decision on approving the results of selecting bidders. The review report includes the contents stipulated in Clause 2, Article 59 of Decree No. 111/2006/NĐ-CP dated September 29, 2006 of the Government.

c) Approving the results of selecting bidders: The Head of the unit is responsible for approving the results of selecting bidders in accordance with Clause 2 and Clause 3, Article 40 of the Bidding Law.

d) Announcing the results of selecting bidders in accordance with Article 41 of the Bidding Law and Clause 3, Article 19 of Decree No. 111/2006/NĐ-CP dated September 29, 2006 of the Government.

đ) Winning bid price: The winning bid price for medicines shall not exceed the price of the tender package in the bidding plan and shall not exceed the maximum current price of each item of medicine published at the latest time by the Ministry of Health.

e) Reporting the results of selecting bidders: Within fifteen days after the results of selecting bidders have been approved, the Head of the unit is responsible for reporting in writing the results of selecting bidders to the Ministry of Health along with the following documents:

- Report on reviewing the results of selecting bidders.

- Decision on approving the results of selecting bidders.

5. Costs in bidding:

Implemented in accordance with the provisions of Section VII, Part II, Circular No. 63/2007/TT-BTC dated June 15, 2007 of the Ministry of Finance guiding the implementation of bidding for procurement to maintain the regular operation of state agencies using state funds.

6. In cases where additional needs arise during the year for small quantities of certain items of medicines not included in the bidding plan, with a total value below 100 million dong, the Head of the unit is authorized to decide on procurement after obtaining consensus from the Medicine and Treatment Council of the unit, provided that quality is ensured and the purchase price does not exceed the maximum current price of the medicine item published at the latest time by the Ministry of Health. If the medicine item has not been published with a maximum price, then the purchase price must not exceed the winning bid price of the same medicine item in the last twelve months of public hospitals updated and announced on the website of the Vietnam National Medicines Administration.

III. INSPECTION, AUDIT AND SANCTIONS FOR VIOLATIONS

The organization of inspection, audit, and sanctions for violations in bidding for purchasing medicines at public health facilities is regulated as follows:

1. The Ministries, agencies at the level of ministries, and agencies under the Government that have public health facilities shall take the lead in coordinating with the Ministry of Health and related units to organize inspections on bidding for purchasing medicines for public health facilities under their management. The Department of Health shall take the lead in coordinating with related units to inspect bidding for purchasing medicines at public health facilities within their locality. Inspections on bidding for purchasing medicines for public health facilities shall be conducted regularly according to plans or suddenly (when there are issues or recommendations) pursuant to the decision of the competent authority.

2. The content of inspections and reporting the results of inspections on bidding for purchasing medicines at public health facilities shall be carried out in accordance with the provisions of the Bidding Law and Decree No. 111/2006/NĐ-CP.

3. The Inspectorates of Ministries and sectors, the Health Departments' Inspectorate, Planning and Investment Departments, and Finance Departments shall conduct inspections on bidding for purchasing medicines of public health facilities according to their functions, tasks, and authorities as prescribed by law.

4. The content of inspections shall be implemented in accordance with Article 71 of the Bidding Law.

5. Handling violations: During the inspection and audit process, if violations of the law are discovered, they shall be handled according to the provisions of Article 75 of the Bidding Law, Articles 50, 51, 52, and 53 of Decree No. 111/2006/NĐ-CP, and the provisions of the Inspection Law, depending on the nature and degree of violation.

IV. IMPLEMENTATION

1. Guidance on implementation:

a) The Chairman of the People's Committee of provinces and centrally governed cities decides on organizing bidding for purchasing medicines at public health facilities in the following forms, specifically:

- Assigning the Department of Health to organize centralized bidding for types of medicines with regular and stable demand and large quantities for all public health facilities within the locality. Public health facilities in the locality shall base their procurement contracts on the bidding results to purchase medicines according to their needs immediately in the year.

- Directing one of the provincial general hospitals to organize bidding in the first quarter of each year. Other units shall apply the selection of contractors through direct procurement as stipulated by the Bidding Law based on the bidding results of that general hospital.

- Public health facilities organizing bidding for purchasing medicines according to their drug usage needs.

b) For tender packages that have issued tender documents before this Circular takes effect, they shall be implemented according to the provisions of the Bidding Law, Decree No. 111/2006/NĐ-CP dated September 29, 2006 of the Government; the Medicine Law dated June 14, 2005 and Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government; the provisions of Circular No. 20/2005/TTLT-BYT-BTC dated July 27, 2005 of the Joint Ministry of Health - Ministry of Finance guiding the implementation of bidding for purchasing medicines in public health facilities ensuring compliance with the provisions of the Bidding Law and guiding documents of the Bidding Law.

c) For tender packages issuing tender documents after this Circular takes effect, they shall be organized in accordance with this Circular and relevant legal regulations.

2. Heads of central agencies, Chairmen of the People's Committees of provinces and centrally governed cities shall organize inspections on bidding for purchasing medicines according to the current Bidding Law and guidance in this Circular for units under their management.

3. Heads of units shall be responsible for organizing bidding for purchasing medicines in accordance with current regulations, ensuring sufficient and timely supply of medicines for patient treatment needs.

4. Annually, public health facilities shall report in writing to the supervising agency about the situation of implementing bidding for purchasing medicines.

5. Annually, Ministries, agencies at the level of ministries, agencies under the Government, and People's Committees of provinces and centrally governed cities shall be responsible for compiling and sending reports on the implementation of bidding for purchasing medicines of their departments and localities to the Ministry of Health and Finance before December 31 for consolidation and reporting to the Prime Minister.

V. IMPLEMENTATION PROVISIONS

This Circular shall take effect 15 days from the date of publication in the Official Gazette. Circular No. 20/2005/TTLT-BYT-BTC dated July 27, 2005 of the Joint Ministry of Health - Ministry of Finance guiding the implementation of bidding for supplying medicines in public health facilities is hereby abolished.

In the course of implementation, if there are difficulties, please reflect them to the Joint Ministry of Health - Ministry of Finance for research and resolution./.