✦ 智能摘要
Circular No. 11/2012/TT-BYT provides detailed guidance on preparing tender documents for purchasing medicines in healthcare facilities, applicable to units using state budget funds, health insurance funds, and other lawful sources of revenue. The Circular specifies conditions for participating in tenders, contents of tender documents, evaluation criteria, winning bid conditions, and contract provisions.
适用范围
Organizations and individuals are responsible for preparing tender documents for purchasing medicines in units using funds from the state budget, health insurance funds, and other lawful sources of revenue to serve disease prevention, medical examination, and treatment activities.
要点
- Organizations and individuals participating in tenders must have certificates proving their eligibility to operate pharmaceutical businesses and be suitable for the tender package division as prescribed.
- Tender documents must include information about the bidder's legitimate status, capacity, and experience, as well as the legitimacy and suitability of the tendered pharmaceutical products.
- Evaluation criteria for the bidder's capacity and experience are conducted based on 'pass' or 'fail' standards.
- Technical evaluation criteria use a scoring method (out of 100 points) to determine the evaluated price.
- Winning tendered pharmaceutical products must meet management price and quality conditions, and have the lowest evaluated price.
🌐 本文件的社会影响
- Positive impact: Strengthening pharmaceutical quality management, reducing the risk of using low-quality medicines.
- Negative impact: May increase costs for healthcare units due to complex certification and tender document requirements.
❓ 常见问题
Which organizations need to comply with this Circular?
Organizations and individuals are responsible for preparing tender documents for purchasing medicines in units using funds from the state budget, health insurance funds, and other lawful sources of revenue.
What documents does a bidder need to provide to participate in a tender?
A bidder needs to provide a certificate proving eligibility to operate pharmaceutical businesses, information about their legitimate status, capacity, and experience, as well as documents proving the legitimacy and suitability of the tendered pharmaceutical products.
How are technical evaluation criteria implemented?
Technical evaluation criteria use a scoring method (out of 100 points) to determine the evaluated price, with a minimum score not lower than 70 points.
Which pharmaceutical products will be considered for awarding the tender?
Pharmaceutical products with the lowest evaluated price in the tender package or group of medicines will be considered for awarding the tender, prioritizing quality, effectiveness of use, and the bidder's reputation.
What should healthcare units pay attention to when preparing tender documents?
Healthcare units must ensure compliance with regulations regarding the bidder's legitimate status, capacity, and experience, as well as the legitimacy and suitability of the tendered pharmaceutical products.
全文
CIRCULAR
Guidelines for preparing tender documents for purchasing medicines in healthcare facilities
___________________
Pursuant to the Drug Law No. 34/2005/QH11 dated June 14, 2005 of the National Assembly;
Pursuant to the Bidding Law No. 61/2005/QH11 dated November 29, 2005 of the National Assembly; Amending and supplementing certain articles of laws related to basic construction investment No. 38/2009/QH12 dated June 19, 2009 of the National Assembly;ngày 19 tháng 6 năm 2009 của Quốc hội;
Pursuant to Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing implementation of certain Articles of the Medicine Law;
Pursuant to Government Decree No. 85/2009/NĐ-CP dated October 15, 2009 guiding the implementation of the Bidding Law and the selection of contractors under the Construction Law;
Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Health; Decree No. 22/2010/NĐ-CP dated March 9, 2010 of the Government amending and supplementing Article 3 of Decree No. 188/2007/NĐ-CP dated December 27, 2007 stipulating functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to Circular Joint No. 01/2012/TTLT-BYT-BTC dated January 19, 2012 of the Ministry of Health and the Ministry of Finance guiding bidding for purchasing medicines in healthcare facilities;
Pursuant to Circular No. 05/2010/TT-BKH dated February 10, 2010 of the Ministry of Planning and Investment detailing preparation of tender documents for procurement of goods;
The Ministry of Health guides the preparation of tender documents for purchasing medicines in healthcare facilities as follows:
PART I
GENERAL PROVISIONS
Article 1. Scope of Regulation
1. This Circular guides the preparation of tender documents when implementing open bidding and restricted bidding within the country to purchase medicines for disease prevention, diagnosis, and treatment from state budget funds, health insurance funds, and other lawful sources in healthcare facilities (hereinafter referred to collectively as units).
2. For tenders for purchasing medicines under projects using ODA funds, if approved by the donor, this Circular shall apply or may be amended and supplemented with some contents according to the bidding regulations in international treaties to which the Socialist Republic of Vietnam is a member or international agreements signed by competent authorities of the Socialist Republic of Vietnam.
Article 3. This Circular does not apply in the following cases:
a) Medicines ordered by the State and paid for with state budget funds.
b) Herbal medicines and traditional medicine ingredients.
c) Blood and blood products.
Article 2. Applicability
This Circular applies to organizations and individuals responsible for preparing tender documents for purchasing medicines in units using state budget funds, health insurance funds, and other lawful sources to purchase medicines for disease prevention, diagnosis, and treatment.
Article 3. Principles for Preparing Tender Documents for Purchasing Medicines
The preparation of tender documents for purchasing medicines in units shall be carried out in accordance with Circular No. 05/2010/TT-BKH dated February 10, 2010 of the Ministry of Planning and Investment detailing the preparation of tender documents for procurement of goods (hereinafter referred to as Circular No. 05/2010/TT-BKH), detailed guidance provided in this Circular, and other relevant legal documents.
Chapter II
GUIDELINES FOR SOME CONTENTS IN THE PREPARATION OF TENDER DOCUMENTS FOR PURCHASING MEDICINES
Article 4. Conditions for Participation in Bidding of Contractors
Implementing Section 2 Chapter I Part I of the Model Tender Document for Procurement of Goods issued together with Circular No. 05/2010/TT-BKH, in addition, it must ensure:
1. The bidder participating in the tender package must be consistent with the division of tender packages as stipulated in Article 7 of Circular Joint No. 01/2012/TTLT-BYT-BTC dated January 19, 2012 of the Ministry of Health and the Ministry of Finance guiding bidding for purchasing medicines in healthcare facilities (hereinafter referred to as Circular Joint No. 01/2012/TTLT-BYT-BTC).
2. For tender packages of medicines by generic name, the bidder must participate in the appropriate group of medicines consistent with the division of groups of medicines in the tender package of medicines by generic name as stipulated in Clause 1 of Article 7 of Circular Joint No. 01/2012/TTLT-BYT-BTC. Bidders producing medicines in countries participating in EMA, ICH, or PIC/s, or bidders producing medicines by facilities meeting GMP standards according to the principles of PIC/s or EU (PIC/s-GMP or EU-GMP) certified by competent authorities participating in EMA, ICH, or PIC/s can bid on the group of medicines produced in countries participating in EMA, ICH, or PIC/s.
Article 5. Provisions Regarding the Content of Bid Documents
Implementing Section 8 Chapter I Part I of the Model Tender Document for Procurement of Goods issued together with Circular No. 05/2010/TT-BKH, specific contents are implemented as follows:
1. Documentation and information proving the legitimate status, capacity, and experience of the contractor:
a) Certificate of eligibility for drug business:
The scope of business must clearly state manufacturing of drugs or wholesale of drugs.
b) Good Practice Certificate depending on the type of business:
- GSP (Good Storage Practices): For direct importers of drugs.
- GDP (Good Distribution Practices): For wholesalers of drugs.
- GACP (Good Agricultural and Collection Practices for herbal medicines): For herbal medicine cultivation facilities.
- GMP (Good Manufacturing Practices): For manufacturers of drugs.
c) Documents proving the bidder's capacity and experience (ongoing contracts and similar contracts executed by the bidder; the bidder's capacity and experience in the field of production and business; the bidder's financial capacity):
Implementing the provisions at Model No. 8, Model No. 9, Model No. 10, and Model No. 12 Chapter IV of the Model Tender Document for Procurement of Goods issued together with Circular No. 05/2010/TT-BKH.
2. Documentation and information proving the legitimacy and suitability of the tendered pharmaceutical products:
a) Information about the name of the pharmaceutical product participating in the bidding, registration number for circulation or import permit number for drugs without registration numbers issued by the Drug Administration of Vietnam and other related information:
The bidder must list all information in Appendix 1 attached to this Circular. Information must be consistent with the information about medicines that have been registered or granted import permits published by the Drug Administration on its website (address: http://www.dav.gov.vn);
b) A commitment statement regarding the bidder's compliance with the unit's requirements for delivery schedule and scope as evaluated in Section 4 of Appendix 2 attached to this Circular.
3. Other contents:
The contractor needs to provide the following documents (if applicable):
- Notification of successful tender, medicine sales invoices... to healthcare facilities to prove the bidder's experience in supplying medicines as evaluated in Section 2 of Appendix 3 attached to this Circular.
- Receipts for acceptance of Pharmaceutical Chain Store Declaration Meeting Good Pharmacy Practice Standards or Distribution Center Medicine Certification to evaluate in Sections 9 and 10 of Appendix 3 attached to this Circular.
- Documentation clearly stating the origin and source of herbal medicines for traditional Chinese medicines and medicines made from herbal medicines as evaluated in Section 11 of Appendix 3 attached to this Circular (legitimate invoices and receipts for purchasing herbal medicines from suppliers certified by the Ministry of Health or the Department of Health for manufacturing and trading in medicines made from herbal medicines or at herbal medicine cultivation facilities meeting WHO principles and standards).
- Legitimate invoices and receipts for purchasing domestically produced antibiotic raw materials for the manufacture of tendered medicines as evaluated in Section 13 of Appendix 3 attached to this Circular.
4. The documents provided by the bidder when participating in the tender shall be copies stamped with the bidder's confirmation seal. For the Certificate of Good Manufacturing Practice for Medicines (GMP), the bidder only needs to list the information in Appendix 1 of this Circular and it must correspond to the information published on the website of the Drug Administration Department (address: http://www.dav.gov.vn).www.dav.gov.vn).
Article 6. Precedent Conditions for Disqualification of Bid Documents
Pursuant to Clause 2 Section 24 Chapter I and Clause 2 Section 24 Chapter II Part One of the Model Tender Document for Procurement of Goods issued together with Circular No. 05/2010/TT-BKH, in addition, the following conditions are supplemented and clarified:
1. The Bid Document of the bidder will be disqualified in the following cases:
a) The bidder does not have a business operation qualification certificate for pharmaceuticals issued by the competent authority (in case the tender dossier lacks such a certificate, the tenderer shall request the bidder to supplement it in accordance with the regulations).
b) The Business Registration Certificate for Pharmaceutical Products does not include the scope of business as pharmaceutical production or wholesale pharmaceutical products.
2. The bid item of pharmaceutical products will be disqualified in the following cases:
a) The tendered pharmaceutical item does not comply with the provisions of Article 7 of Joint Circular No. 01/2012/TTLT-BYT-BTC and Article 4 Chapter II of this Circular.
b) The tendered pharmaceutical item is not legally permitted to circulate in Vietnam.
c) The tendered pharmaceutical item has been withdrawn from registration within the validity period of its registration number in accordance with Article 33 Chapter IV of Circular No. 22/2009/TT-BYT dated November 24, 2009 of the Ministry of Health on drug registration.
d) All products of the tendered pharmaceutical item have been suspended from circulation and recalled in accordance with Clause 1 Article 13 Chapter IV of Circular No. 09/2010/TT-BYT dated April 28, 2010 of the Ministry of Health guiding the management of drug quality.
e) In the tender dossier, the tendered pharmaceutical item has a non-fixed bid price, offering multiple price levels (except in cases where the bidder participates in tenders for multiple pharmaceutical items with the same active ingredient, concentration, dosage form, and produced by different manufacturers).
f) The bidder provides false information and documents regarding the tendered pharmaceutical item (providing information that differs from the drug registration dossier, drug pricing declaration, certificates issued by the Department of Health or the Ministry of Health).
Article 7. Evaluation Criteria and Content for Determination of Evaluated Price
Pursuant to Chapter III Part One of the Model Tender Document for Procurement of Goods issued together with Circular No. 05/2010/TT-BKH, in addition, the following specific contents are implemented as follows:
1. Evaluation Criteria for Bidder's Capacity and Experience:
a) The criteria for evaluating the bidder's capacity and experience include the contents in Appendix 2 attached to this Circular.
b) Evaluation Method: According to the criteria "satisfactory", "unsatisfactory", specifically:
- The bidder must meet all the requirements listed in Appendix 2 attached to this Circular to be considered as meeting the criteria for capacity and experience.
- Each evaluation content in Appendix 2 attached to this Circular will be considered "met" if all detailed contents within each requirement are evaluated as "met".
2. Evaluation Criteria for Technical Aspects:
a) The technical evaluation criteria include the contents in Appendix 3 attached to this Circular.
b) Evaluation Method: According to the scoring method (scale of 100 points), specifically:
- Within each Section in Appendix 3 attached to this Circular, if the bidder meets two or more contents simultaneously, only the highest scoring content will be counted.
- The minimum required score for technical criteria is determined based on the nature of each tender package or each item in the approved tender plan but must not be lower than 70 points.
- The Bid Document with a total score equal to or exceeding the minimum required score for technical aspects will be evaluated as meeting the technical requirements.
c) For small-scale pharmaceutical procurement packages (as defined in Clause 1 Article 33 Decree No. 85/2009/NĐ-CP dated October 15, 2009 of the Government guiding the implementation of the Law on Bidding and Selection of Contractors under the Construction Law):
Apply the pass/fail criteria based on the evaluation contents in Appendix 3 attached to this Circular and implement according to the provisions of Clause 2.2 Section 2 Chapter III Part One of the Model Tender Document for Procurement of Goods issued together with Circular No. 05/2010/TT-BKH.
3. Content for Determination of Evaluated Price:
a) Tender dossiers meeting the criteria for evaluating the bidder's capacity and experience and technical criteria shall continue to be reviewed to determine the evaluation price.
b) Tender dossiers meeting the requirements shall be determined the evaluation price in accordance with Section 26 Chapter I and Section 3 Chapter III Part One of the Model Tender Document for Procurement of Goods issued together with Circular No. 05/2010/TT-BKH.
Article 8. Conditions for Considering Tender Proposals
Pursuant to Section 31 Chapter I Part One of the Model Tender Document for Procurement of Goods issued together with Circular No. 05/2010/TT-BKH, in addition, the winning pharmaceutical item must meet the following conditions:
1. Tendered pharmaceutical products must comply with current price management regulations:
a) The proposed winning bid price of each pharmaceutical item must not exceed the price in the approved tender plan and must not exceed the current valid wholesale declared price or re-declared price by the pharmaceutical production and trading enterprises to the competent state management agency.
If the bid prices of all bidders for a pharmaceutical item are higher than the price in the approved tender plan, the project owner shall consider and decide on the winning bid in accordance with Clause 2 Article 20 of Joint Circular No. 01/2012/TTLT-BYT-BTC.
b) Adhere to other relevant price management regulations for pharmaceuticals and bidding for pharmaceuticals.
2. The tendered pharmaceutical product with the lowest evaluated price, specifically:
a) The pharmaceutical item of the bidder with the lowest evaluation price in the tender package of branded drugs or traditional medicine, or in each group of generic drugs in the tender package shall be considered for recommendation as the winning bid.
b) In case the evaluated prices are equal, the pharmaceutical product to be considered for the winning bid shall be selected in the following priority order:
- Pharmaceutical products with higher technical specifications or domestically produced pharmaceutical products of equivalent quality;
- Select the pharmaceutical item with good quality and effectiveness at healthcare facilities: based on the expiration date of the drug, violations of drug quality, the time the drug has been used at healthcare facilities...;
- Select the pharmaceutical item of the bidder with experience and reputation in supplying drugs to healthcare facilities: based on the bidder's supply experience, reputation in supplying drugs to healthcare facilities such as ensuring supply, implementing drug recalls, having a distribution system in the area, having a chain of GPP pharmacies...
Article 9. Provisions on Contracts
Pursuant to the provisions of Part Three of the Model Tender Document for Procurement of Goods issued together with Circular No. 05/2010/TT-BKH, in addition, the contract must clearly stipulate the following contents:
1. Obligations and responsibilities of the parties in the supply of drugs, payment, and ensuring sufficient drug supply according to the tender results to serve the examination and treatment work of healthcare facilities.
2. The compensation for breach of contract as stipulated in Article 16, Chapter VIII, Part III of the Model Tender Invitation Document for Procurement of Goods issued together with Circular No. 05/2010/TT-BKH shall be ensured to allow healthcare facilities to use the compensation amount proactively to source substitute medicines when suppliers fail to supply sufficient medicines as per the contract.
Chapter III
IMPLEMENTING PROVISIONS
Article 10. Implementation Organization
1. When submitting the tendering plan for approval, hospitals and institutes under the Ministry of Health with inpatient beds, and provincial Departments of Health under central cities shall have the responsibility to compile and submit reports on the violations by suppliers during the tendering and drug supply process in the previous period (as per Appendix 4 attached hereto) to the Ministry of Health (Medicine Administration Department) for consolidation and publication as a basis for units to consider and select suppliers for the next period.
2. The Medicine Administration Department shall be responsible for compiling and publishing the information on its electronic information website as a basis for units to organize and implement the procurement of medicines through tendering.
a) List of drugs registered with Registration Numbers or Import Permits;
b) List of drugs and pharmaceutical production establishments violating drug quality regulations;
c) List of countries participating in EMA, ICH, PIC/s;
d) List of pharmaceutical production establishments that meet the principles and standards of WHO-GMP, inspected and licensed by the Medicine Administration Department (Ministry of Health).
e) List of pharmaceutical production establishments with registered and circulating medicines in Vietnam that meet the Good Manufacturing Practice (GMP) standards of PIC/s-GMP, EU-GMP, inspected and certified by participating agencies of the European Medicines Agency (EMA), International Council for Harmonisation (ICH), or Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/s).
f) List of declared drug prices and winning bid prices at healthcare facilities.
g) List of suppliers who violated during the tendering and drug supply process to healthcare facilities.
3. The Chairperson of the People's Committee of provinces and centrally-administered cities; Directors of Provincial Health Departments under provinces and centrally-administered cities; Directors of healthcare facilities and heads of related units shall be responsible for implementing this Circular.
Article 11. Effective Date
1. This Circular shall take effect from September 1, 2012.
2. For tender invitation documents approved before the date this Circular takes effect, they shall be implemented according to the provisions of the Bidding Law; the Law amending and supplementing certain articles of relevant laws relating to basic construction investment; Decree No. 85/2009/NĐ-CP dated October 15, 2009 of the Government; Circular No. 05/2010/TT-BKH dated February 10, 2010 of the Ministry of Planning and Investment, and other related legal normative documents.
During implementation, if there are difficulties or obstacles, units are advised to report to the Ministry of Health (Medicine Administration Department, Planning and Finance Department) for consideration and resolution./.
原始文件（PDF）
关系图
↑ 依据及影响本文件的文件
依据 9
85/2009/NĐ-CP
Nghị định số 85/2009/NĐ-CP Hướng dẫn thi hành Luật Đấu thầu và lựa chọn nhà thầu xây dựng theo Luật Xây dựng
已失效
34/2005/QH11
Luật Dược số 34/2005/QH11
已失效
38/2009/QH12
Nghị quyết số 38/2009/QH12 Về phân bổ ngân sách trung ương năm 2010
已失效
01/2012/TTLT-BYT-BTC
THÔNG TƯ LIÊN TỊCH SỐ 01/2012/TTLT-BYT-BTC HƯỚNG DẪN ĐẤU THẦU MUA THUỐC TRONG CÁC CƠ SỞ Y TẾ
生效中
61/2005/QH11
Luật Đấu thầu số 61/2005/QH11
已失效
05/2010/TT-BKH
Thông tư số 05/2010/TT-BKH Quy định chi tiết lập hồ sơ mời thầu mua sắm hàng hóa
已失效
79/2006/NĐ-CP
Nghị định số 79/2006/NĐ-CP Quy định chi tiết thi hành một số điều của Luật Dược
已失效
22/2010/NĐ-CP
Nghị định số 22/2010/NĐ-CP Sửa đổi, bổ sung Điều 3 Nghị định số 188/2007/NĐ-CP ngày 27 tháng 12 năm 2007 của Chính phủ quy định chức năng, nhiệm vụ, quyền hạn và cơ cấu tổ chức của Bộ Y tế
已失效
188/2007/NĐ-CP
Nghị định số 188/2007/NĐ-CP Quy định chức năng, nhiệm vụ, quyền hạn và cơ cấu tổ chức của Bộ Y tế
已失效
11/2012/TT-BYT
Circular No. 11/2012/TT-BYT guides the preparation of tender documents for purchasing medicines in healthcare facilities.
Expired
点击文件即可打开。红色边框＝改变效力的关系。