Circular No. 37/2013/TT-BYT guides the preparation of tender documents for purchasing medicines in healthcare facilities.

CIRCULAR

Guidelines for preparing tender documents for purchasing medicines in healthcare facilities.policies

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Pursuant to the Medicine Law No. 34/2005/QH11 dated June 14, 2005;

Pursuant to the Bidding Law No. 61/2005/QH11 dated November 29, 2005; and the Law Amending and Supplementing Certain Provisions of Laws Related to Basic Construction Investment No. 38/2009/QH12 dated June 19, 2009;

Pursuant to the Government Decree No. 79/2006/NĐ-CP dated August 9, 2006 detailing the implementation of certain provisions of the Medicine Law; and the Government Decree No. 89/2012/NĐ-CP dated October 24, 2012 amending and supplementing certain provisions of the Government Decree No. 79/2006/NĐ-CP dated August 9, 2006 detailing the implementation of certain provisions of the Medicine Law;

Pursuant to the Government Decree No. 85/2009/NĐ-CP dated October 15, 2009 guiding the implementation of the Bidding Law and the selection of contractors for construction under the Construction Law;

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

Pursuant to the Circular Joint No. 01/2012/TTLT-BYT-BTC dated January 19, 2012 of the Minister of Health and the Minister of Finance guiding bidding for purchasing medicines in healthcare facilities; and the Circular Joint No. 36/2013/TTLT-BYT-BTC dated November 11, 2013 of the Minister of Health and the Minister of Finance amending and supplementing certain provisions of the Circular Joint No. 01/2012/TTLT-BYT-BTC dated January 19, 2012 of the Minister of Health and the Minister of Finance guiding bidding for purchasing medicines in healthcare facilities;

Pursuant to the Circular No. 05/2010/TT-BKH dated February 10, 2010 of the Minister of Planning and Investment detailing the preparation of tender documents for purchasing goods;

The Minister of Health issues this Circular guiding the preparation of tender documents for purchasing medicines in healthcare facilities as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

Article 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).

Article 2. For tenders for purchasing medicines under projects using ODA funds, if approved by the donor, this Circular shall apply or may be supplemented with certain contents according to bidding regulations stipulated in international treaties to which the Socialist Republic of Vietnam is a member or international agreements concluded 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) Traditional medicinal materials and traditional herbal medicines;

c) Blood and blood products;

d) Medical oxygen.

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 the Circular No. 05/2010/TT-BKH dated February 10, 2010 of the Minister of Planning and Investment detailing the preparation of tender documents for purchasing 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

In addition to meeting the provisions set out in Section 2 Chapter I Part I of the Model Tender Document for Procurement of Goods issued together with Circular No. 05/2010/TT-BKH, contractors must also meet the following additional conditions:

1. The contractor must register to bid on the tender package in accordance with the division of tender packages stipulated in Article 7 of the Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012 of the Minister of Health and the Minister of Finance guiding bidding for drug procurement in healthcare facilities (hereinafter referred to as Joint Circular No. 01/2012/TTLT-BYT-BTC) and Article 3 of the Joint Circular No. 36/2013/TTLT-BYT-BTC dated November 11, 2013 of the Minister of Health and the Minister of Finance amending and supplementing certain articles of Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012 of the Minister of Health and the Minister of Finance guiding bidding for drug procurement in healthcare facilities (hereinafter referred to as Joint Circular No. 36/2013/TTLT-BYT-BTC).

2. For tender packages of drugs under their generic names, contractors may participate in bidding for one or more groups of drugs if they meet the criteria specified in Article 3 of Joint Circular No. 36/2013/TTLT-BYT-BTC, specifically as follows:

a) A contractor having drugs that meet the criteria in Group 1 can participate in bidding for Groups 1, 2, and 5;

b) A contractor having drugs that meet the criteria in Group 2 can participate in bidding for Groups 2 and 5;

c) A contractor having drugs that meet the criteria in Group 3 can participate in bidding for Groups 3 and 5;

d) A contractor having drugs that meet the criteria in Group 4 can participate in bidding for Group 4 and/or other groups if they meet the criteria of those groups;

đ) A contractor having drugs that do not meet the criteria of Groups 1, 2, 3, and 4 can only participate in bidding for Group 5.

3. For tender packages of traditional medicine and herbal drugs:

a) A contractor having drugs that meet the criteria in Group 1 can participate in bidding for Groups 1 and 2;

b) A contractor having drugs that meet the criteria in Group 2 can only participate in bidding for Group 2.

4. In cases where the drugs participating in the bidding are produced by multiple entities involved in the production process to bid for a group of drugs, all entities involved in the production process of the pharmaceutical products must meet the criteria of that group of drugs.

Article 5. Provisions Regarding the Content of Bid Documents

In addition to complying with the provisions set out in Section 8 Chapter I Part I of the Model Tender Document for Procurement of Goods issued together with Circular No. 05/2010/TT-BKH, some specific contents of the bid documents must be 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 Certificates according to each 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 growers of medicinal herbs.

- GMP (Good Manufacturing Practices): For manufacturers of drugs.

c) Documentation proving the capacity and experience of the contractor (current contracts being executed and similar contracts previously executed by the contractor; the contractor's capacity and experience in the field of production and business; financial capacity of the contractor):

Implement according to the provisions at Model Forms 8, 9, 10, and 12 of 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 legality and compliance with requirements of the pharmaceutical products participating in the bidding:

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 contractor must provide complete information as prescribed in Appendix 1 issued together with this Circular. The information must be consistent with the information about the drug already registered or granted an import permit by the Drug Administration of Vietnam published on the Drug Administration of Vietnam’s website (address: http://www.dav.gov.vn);

b) Commitment letter confirming compliance with the requirements of the unit regarding delivery schedule and scope of supply as stipulated in Section 4 of Appendix 2 issued together with this Circular.

c) The contractor's commitment that the remaining shelf life of the winning bid drug from the time it is supplied to healthcare facilities must ensure a minimum of six months for drugs with an expiration date of two years or more; three months for drugs with an expiration date between one and two years; one quarter of the expiration date for drugs with an expiration date less than one year.

3. Other contents:

The contractor needs to provide the following documents (if applicable):

a) Notification of winning bid or sales invoice or supply contract for pharmaceutical products to healthcare facilities or other documents to prove the experience in supplying pharmaceutical products as stipulated in Section 10 of Appendix 3 issued together with this Circular;

b) Certificate of enterprise chain pharmacy GPP declaration, distribution center certificate for evaluation according to the provisions in Sections 13 and 14 of Appendix 3 issued together with this Circular;

c) Documentation clearly stating the origin and source of herbal medicines for traditional medicine and herbal drugs (valid invoices and receipts purchasing herbal medicines from suppliers certified by the Ministry of Health or Provincial Health Departments for producing and trading herbal medicines; Receipt of declaration of herbal medicine production according to WHO-GACP of the herbal medicine producer) for evaluation according to the provisions in Section 8 of Appendix 3 issued together with this Circular;

d) Valid invoices and receipts purchasing domestic antibiotic raw materials for the production of bidding pharmaceutical products for evaluation according to the provisions in Section 7 of Appendix 3 issued together with this Circular.

4. Documentation provided by the contractor when participating in the bidding shall be copies stamped with the contractor's confirmation seal. Specifically, for the Certificate of Compliance with GMP Standards, the contractor only needs to provide information as prescribed in Section 1 of Appendix 3 issued together with this Circular (Information on the Certificate of Compliance with GMP Standards must be consistent with the information published by the Drug Administration of Vietnam on its website (address: http://www.dav.gov.vn).

Article 6. Precedent Conditions for Disqualification of Bid Documents

In addition to complying with the provisions stipulated in Clause 2, Section 24, Chapter I and Clause 2, Section 24, Chapter II, Part I of the Model Tender Invitation Document for Goods Procurement issued together with Circular No. 05/2010/TT-BKH, the precedent conditions for disqualification of Bid Documents are clarified as follows:

1. The Bid Document of the bidder will be disqualified in the following cases:

a) The bidder does not have a Business Registration Certificate for Pharmaceutical Products issued by the competent authority (in case the Bid Document lacks the Business Registration Certificate for Pharmaceutical Products, the tenderer shall request the bidder to supplement it according to 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 bid item of pharmaceutical products does not comply with the provisions of Article 4 of this Circular regarding the tender package or group of pharmaceutical products.

b) The bid item of pharmaceutical products is not legally allowed to circulate in Vietnam (not produced for domestically manufactured pharmaceutical products or not imported for foreign pharmaceutical products within the validity period of the registration for circulation or import permit).

c) The bid item of pharmaceutical products has been withdrawn from registration during the validity period of the registration according to Article 33, Chapter IV of Circular No. 22/2009/TT-BYT dated November 24, 2009, issued by the Minister of Health on the registration of pharmaceutical products.

d) All products of the bid item of pharmaceutical products have been suspended from circulation and recalled according to Clause 1, Article 13, Chapter IV of Circular No. 09/2010/TT-BYT dated April 28, 2010, issued by the Minister of Health guiding the management of pharmaceutical product quality.

đ) In the Bid Document, the bid price of the bid item of pharmaceutical products is not fixed, but offered at multiple prices (except in cases where the bidder participates in bidding for multiple items of pharmaceutical products with the same active ingredient, concentration, dosage form from different manufacturers).

e) The bidder provides false information and documents about the bid item of pharmaceutical products (providing incorrect information compared to the drug registration dossier, drug pricing declaration dossier, certificates issued by the Department of Health, Ministry of Health that distort the selection results of the bidder).

Article 7. Evaluation Criteria and Content for Determination of Evaluated Price

Comply with the provisions stipulated in Chapter III, Part I of the Model Tender Invitation Document for Goods Procurement issued together with Circular No. 05/2010/TT-BKH, in addition, some specific contents are implemented as follows:

1. Evaluation Criteria for Bidder's Capacity and Experience:

a) The evaluation criteria for bidder's capacity and experience include the criteria specified in Appendix 2 issued together with this Circular.

b) Evaluation Method: According to the criteria "satisfactory", "unsatisfactory", specifically:

- The bidder satisfies all the criteria specified in Appendix 2 issued together with this Circular, then it is evaluated as meeting the requirements for capacity and experience.

- The criteria specified in Appendix 2 issued together with this Circular are considered "satisfactory" when all detailed criteria within each criterion are evaluated as "satisfactory".

2. Evaluation Criteria for Technical Aspects:

a) The evaluation criteria for technical aspects include the criteria specified in Appendix 3 issued together with this Circular.

b) Evaluation Method: According to the scoring method (scale of 100 points), specifically:

- Within each section specified in Appendix 3 issued together with this Circular, if the bidder meets two or more criteria simultaneously, only the highest scoring criterion will be counted.

- The minimum required score for technical aspects 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 tenders (as defined in Clause 1, Article 33 of Decree No. 85/2009/NĐ-CP dated October 15, 2009, issued by the Government guiding the implementation of the Law on Bidding and the selection of construction contractors under the Construction Law):

Apply the evaluation according to the criteria "satisfactory", "unsatisfactory" based on the evaluation contents specified in Appendix 3 issued together with this Circular and implement according to the provisions of Clause 2.2, Section 2, Chapter III, Part I of the Model Tender Invitation Document for Goods Procurement issued together with Circular No. 05/2010/TT-BKH.

3. Content for Determination of Evaluated Price:

a) Bid Documents that meet the evaluation criteria for bidder's capacity and experience and technical evaluation criteria will continue to be reviewed for determination of evaluated price.

b) Bid Documents that meet the requirements will be determined for evaluated price according to the provisions of Section 26, Chapter I and Section 3, Chapter III, Part I of the Model Tender Invitation Document for Goods Procurement issued together with Circular No. 05/2010/TT-BKH.

Article 8. Conditions for Considering Tender Proposals

Implement according to the provisions at 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, tendered pharmaceutical products must meet the following conditions:

1. Tendered pharmaceutical products must comply with current price management regulations:

a) The proposed winning bid price for each pharmaceutical product shall not be higher than the price in the bidding plan approved by the competent authority and shall not exceed the wholesale price declared or re-declared by pharmaceutical production and trading establishments that remain valid.

In case all tenderers' bidding prices for a pharmaceutical product are higher than the price in the bidding plan approved by the competent authority, the project owner shall consider and decide on the winning bid according to 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 product from the bidder with the lowest evaluated price in the tender package by brand name or within each group of generic drugs and traditional medicine packages shall be considered for the winning bid proposal.

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 pharmaceutical products with quality and effectiveness used at healthcare facilities based on the expiration date of the drug, the status of quality violations, and the duration of use at healthcare facilities;

- Select pharmaceutical products from bidders with experience and reputation in supplying drugs to healthcare facilities based on the bidder's supply experience, reputation in supplying drugs at healthcare facilities such as ensuring supply, implementing drug recalls, having a distribution system in the area, and organizing a Good Pharmacy Practice (GPP) pharmacy chain.

Article 9. Provisions on Contracts

Implement according to the provisions at 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 specify the following contents:

1. Obligations and responsibilities of the parties regarding the supply of drugs, payment, and ensuring sufficient drug supply according to the tender results to serve medical examination and treatment activities at healthcare facilities.

2. Compensation for breach of contract shall be implemented according to Article 16, Chapter VIII, Part Three of the Model Tender Document for Procurement of Goods issued together with Circular No. 05/2010/TT-BKH to ensure that in case the bidder fails to supply the required amount of drugs according to the contract, the healthcare facility can use the compensation amount to proactively secure alternative drug supplies for the unfulfilled contract content.

Chapter III

IMPLEMENTING PROVISIONS

Article 10. Implementation Organization

When submitting the bidding plan for approval, hospitals and institutes under the Ministry of Health with hospital beds; provincial and municipal health departments directly under the central government shall be responsible for compiling and sending reports on the violation situation of bidders during the bidding and supply process in the previous period of healthcare facilities in their jurisdiction according to Appendix 4 issued together with this Circular to the Ministry of Health (Medicine Administration Department) for consolidation and publication, serving as a basis for units to consider and evaluate, select bidders for the next period.

The Medicine Administration Department shall be responsible for consolidating and publishing the above information on the electronic information website of the Medicine Administration Department as a basis for units to organize and implement the procurement bidding process for drugs:

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 meeting WHO-GMP standards certified by the Vietnamese Ministry of Health (Medicine Administration Department);

đ) List of pharmaceutical production establishments registering and circulating drugs in Vietnam meeting PIC/s-GMP, EU-GMP standards certified by participating agencies in EMA, ICH, or PIC/s;

e) List of drug declaration prices and winning bid prices at healthcare facilities;

g) List of bidders violating during the bidding and supply process for healthcare facilities;

h) List of drugs produced by pharmaceutical production establishments certified by the Vietnamese Ministry of Health (Medicine Administration Department) to meet WHO-GMP standards and authorized for circulation by the competent authority of participating ICH countries;

i) List of drugs produced from active ingredients manufactured in ICH-participating countries; active ingredients certified with CEP certificates;

k) List of licensed drugs from pharmaceutical production establishments meeting EU-GMP or PIC/s-GMP standards in ICH-participating countries and produced in pharmaceutical production establishments certified by the Vietnamese Ministry of Health (Medicine Administration Department) to meet WHO-GMP standards;

l) List of enterprises with organized GPP pharmacy chains;

m) List of enterprises with organized drug distribution centers.

Article 11. Effective Date

1. This Circular takes effect from January 1, 2014.

Circular No. 11/2012/TT-BYT dated June 28, 2012, guiding the preparation of tender documents for drug procurement in healthcare facilities becomes invalid from the date this Circular takes effect.

For tender documents approved before the date this Circular takes effect, they shall be implemented according to the provisions of Circular No. 11/2012/TT-BYT dated June 28, 2012, guiding the preparation of tender documents for drug procurement in healthcare facilities.

Chairmen of People's Committees of provinces and centrally-administered cities; Directors of Provincial and Municipal Health Departments; Directors of healthcare facilities and heads of related units are responsible for enforcing this Circular.

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./.