| THE MINISTRY OF HEALTH OF VIETNAM | THE SOCIALIST REPUBLIC OF VIETNAM |
| No.: 06/2023/TT-BYT | Hanoi, March 12, 2023 |
Pursuant to the Law on Bidding dated November 26, 2013;
Pursuant to the Law on Pharmacy dated April 06, 2016;
Pursuant to the Government’s Decree No. 63/2014/ND-CP dated June 26, 2014 providing guidelines for the Law on Bidding regarding contractor selection;
Pursuant to the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 providing guidelines for implementation of the Law on Pharmacy;
Pursuant to the Government’s Decree No. 95/2022/ND-CP dated November 15, 2022 defining functions, tasks, powers and organizational structure of the Ministry of Health of Vietnam;
Pursuant to the Official Dispatch No. 9134/BKHDT-QLDT dated December 15, 2022 of the Ministry of Planning and Investment of Vietnam regarding online bidding for contract packages of herbal materials and traditional medicinal materials;
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The Minister of Health of Vietnam promulgates a Circular providing amendments to certain Articles of the Circular No. 15/2019/TT-BYT dated July 11, 2019 of the Minister of Health of Vietnam prescribing bidding for supply of drugs for public health facilities.
1. Clause 1 Article 1 is amended as follows:
“1. This Circular introduces regulations on bidding for supply of the following drugs, including: modern drugs (including radioactive drugs and tracers), vaccines, biological, traditional drugs, herbal materials and traditional medicinal materials, for public health facilities, including: the division of contract packages and drug categories; planning, forms, methods and organization of selection of drug suppliers; centralized procurement and procurement of drugs by price negotiation using funding from state budget, health insurance fund, revenues from provision of medical examination and treatment services and other lawful funding sources of public health facilities.”.
2. Article 3 is amended as follows:
a) Clause 1 Article 3 is amended as follows:
“1. SRA (Stringent Regulatory Authority) and EMA (European Medicines Agency) refer to the drug regulatory authorities defined in Clause 9 Article 2 of the Circular No. 08/2022/TT-BYT dated September 05, 2022 of the Minister of Health of Vietnam.”.
b) Clause 1a is added to Clause 1 Article 3 as follows:
“1a. SRA or EMA country means a country in which a SRA or EMA is established.”.
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“6. GACP means Good agricultural and collection practice for cultivation, collection, harvesting, preliminary processing, processing, transport and storage of herbal materials and products of herbal origin in order to ensure their quality, safety and efficacy.
3. Article 4 is amended as follows:
“Article 4. Responsibility to develop and implement drug supplier selection plans
1. Responsibility to develop drug supplier selection plans
a) Regarding drugs included in the List of drugs procured through national centralized bidding or in the List of drugs procured through price negotiation:
- The National centralized drug procurement center shall develop plans for selection of suppliers of the drugs in Section A of the List of drugs procured through national centralized bidding promulgated by the Minister of Health of Vietnam and meeting technical requirements laid down in Clause 1 and Clause 2 Article 7 of this Circular, and the drugs included in the List of drugs procured through price negotiation promulgated by the Minister of Health of Vietnam (except HIV-AIDS medicines/antiretroviral drugs) based on demands for such drugs submitted by health facilities according to the notification of the National centralized drug procurement center;
- The National centralized drug procurement center shall develop plans for selection of suppliers of HIV-AIDS medicines/antiretroviral drugs in Section B of the List of drugs procured through national centralized bidding or in the List of drugs procured through price negotiation promulgated by the Minister of Health of Vietnam based on demands for such drugs submitted by health facilities according to the notification of the Vietnam Administration of HIV/AIDS Control;
- Units tasked with organizing national centralized drug procurement shall develop plans for selection of suppliers of the drugs in Section C of the List of drugs procured through national centralized bidding promulgated by the Minister of Health of Vietnam;
- The maximum duration of a framework agreement or a contract for drug supply is 36 months and shall be phased by drug category and supply schedule (quarterly and/or annually).
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- Provincial centralized drug procurement units shall develop drug supplier selection based on demands for such drugs submitted by health facilities according to the notification of the former;
- The maximum duration of a framework agreement or a contract for drug supply is 36 months and shall be phased by drug category and supply schedule (quarterly and/or annually).
c) Health facilities shall develop plans for selection of suppliers of drugs which are beyond the scope of responsibility of the National centralized drug procurement center, units tasked with organizing national centralized drug procurement and provincial centralized drug procurement units as prescribed in Point a and Point b of this Clause. The maximum duration of a drug supply contract is 12 months and is phased by drug category.
2. Responsibility to organize drug supplier selection
a) Regarding drugs included in the List of drugs procured through national centralized bidding or in the List of drugs procured through price negotiation:
- The National centralized drug procurement center shall organize the selection of suppliers of the drugs in Section A of the List of drugs procured through national centralized bidding promulgated by the Minister of Health of Vietnam and meeting technical requirements laid down in Clause 1 and Clause 2 Article 7 of this Circular, the drugs in Section B of the List of drugs procured through national centralized bidding, and the drugs included in the List of drugs procured through price negotiation promulgated by the Minister of Health of Vietnam in accordance with the provisions of Chapter IV and Chapter V of this Circular;
- Units tasked with organizing national centralized drug procurement shall organize the selection of suppliers of the drugs in Section C of the List of drugs procured through national centralized bidding promulgated by the Minister of Health of Vietnam in accordance with the provisions of Chapter IV of this Circular.
b) Regarding drugs included in the List of drugs procured through provincial-level centralized bidding:
Provincial centralized drug procurement units shall organize the selection of drug suppliers in accordance with the provisions of Chapter IV of this Circular.
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3. In case health facilities want to procure any drugs in Section C of the List of drugs procured through national centralized bidding promulgated by the Minister of Health of Vietnam to serve their medical examination and treatment activities, they shall comply with the provisions of Chapter III of this Circular.”.
4. Article 7 is amended as follows:
“Article 7. Generic drug contract packages
A generic drug contract package may contain one or several generic drugs. Each list of generic drugs must be sorted by category. Each generic drug in each category is a part of the contract package. A contract package of generic drugs is divided into 05 (five) categories based on technical criteria as follows:
1. Category 1 consists of the drugs satisfying 01 (one) of the 03 (three) following criteria:
a) The drug has been wholly manufactured on the production line fulfilling EU-GMP requirements or the production line fulfilling EU-GMP-equivalent requirements in a SRA or EMA country and announced by a drug authority of Vietnam to fulfill EU-GMP requirements or EU-GMP-equivalent requirements;
b) The drug is included in the list of original brand-name drugs or reference biologicals announced by the Ministry of Health of Vietnam, except those which are included in the list of drugs procured through price negotiation announced by the Minister of Health of Vietnam and for which price negotiation results have been announced;
c) The drug is wholly manufactured in Vietnam and meets all of the following criteria:
- It has been wholly manufactured on the production line fulfilling EU-GMP requirements or the production line fulfilling EU-GMP-equivalent requirements and announced by a drug authority of Vietnam to fulfill EU-GMP requirements or EU-GMP-equivalent requirements;
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- The drug sold in Vietnam and the drug granted certificate of marketing authorization by a drug authority of a SRA or EMA country must have the same dosage form, production process, specifications and testing methods; active ingredients and excipients must have the same specifications and manufactured at the same manufacturing facility or site as prescribed in Clause 8 Article 50 of this Circular.
2. Category 2 consists of drugs satisfying 01 (one) of the 02 (two) following criteria:
a) The drug has been wholly manufactured on the production line fulfilling EU-GMP requirements or the production line fulfilling EU-GMP-equivalent requirements and announced by a drug authority of Vietnam to fulfill EU-GMP requirements or EU-GMP-equivalent requirements.
b) The drug has been wholly manufactured on the production line in a country that is concurrently a member state of PIC/s and a member state of ICH, certified by a competent authority of this country to fulfill PIC/s-GMP requirements, and announced by a drug authority of Vietnam to fulfill PIC/s-GMP requirements.
3. Category 3 consists of drugs which have been granted certificate of marketing authorization or import license for sale in Vietnam and of which evidence of bioequivalence has been announced by a drug authority of Vietnam.
4. Category 4 consists of drugs which have been wholly manufactured in Vietnam on production lines fulfilling GMP requirements as certified by drug authorities of Vietnam.
5. Category 5 consists of drugs which have been granted certificate of marketing authorization or import license for sale in Vietnam.”.
5. Clause 2 Article 8 is amended as follows:
“2. A contract package of original brand-name drugs or drugs of therapeutic equivalence may contain one or several original brand-name drugs or drugs of therapeutic equivalence or reference biologicals. Each drug is a part of the contract package. A drug included in the contract package of original brand-name drugs or drugs of therapeutic equivalence is required to satisfy all of the 02 (two) following criteria:
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b) The drug has been wholly manufactured in a SRA or EMA country; or has undergone one or some manufacturing stages in Vietnam while other manufacturing stages are performed in a SRA or EMA country; or has been wholly manufactured in Vietnam; or has been granted certificate of marketing authorization by a drug authority of a SRA or EMA country.”.
6. Article 9 is amended as follows:
“Article 9. Contract packages of herbal drugs, drugs containing herbal materials combined with active pharmaceutical ingredients and traditional drugs (excluding traditional medicinal materials)
A contract package of herbal drugs, drugs containing herbal materials combined with active pharmaceutical ingredients and traditional drugs (excluding traditional medicinal materials) may contain one or several drugs. Each list of drugs must be sorted by the drug category. Each drug in a category is a part of the contract package. A contract package of herbal drugs, drugs containing herbal materials combined with active pharmaceutical ingredients and traditional drugs is divided into 04 (four) categories based on technical criteria as follows:
1. Category 1 consists of drugs which have been wholly manufactured in Vietnam on production lines fulfilling GMP requirements as certified by drug authorities of Vietnam and all herbal materials contained in which have been announced by a drug authority of Vietnam to fulfill GACP requirements.
2. Category 2 consists of drugs which have been wholly manufactured in Vietnam on production lines fulfilling GMP requirements as certified by drug authorities of Vietnam and at least 50% of herbal materials contained in which has been announced by a drug authority of Vietnam to fulfill GACP requirements.
3. Category 3 consists of drugs which have been wholly manufactured in Vietnam on production lines fulfilling GMP requirements as certified by drug authorities of Vietnam.
4. Category 4 consists of herbal drugs, drugs containing herbal materials combined with active pharmaceutical ingredients and traditional drugs which have been granted certificate of marketing authorization in Vietnam”.”
7. Article 10 is amended as follows:
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A contract package of traditional medicinal materials may contain one or several traditional medicinal materials. Each list of traditional medicinal materials must be sorted by category of traditional medicinal materials. Each traditional medicinal material in a category is a part of the contract package. A contract package of traditional medicinal materials is divided into 03 (three) categories based on technical criteria as follows:
1. Category 1 consists of traditional medicinal materials which have been wholly manufactured in Vietnam on production lines announced by drug authorities of Vietnam to fulfill GMP requirements for traditional medicinal materials and are made of herbal materials announced by a drug authority of Vietnam to fulfill GACP requirements.
2. Category 2 consists of traditional medicinal materials which have been wholly manufactured in Vietnam on production lines announced by drug authorities of Vietnam to fulfill GMP requirements for traditional medicinal materials.
3. Category 3 consists of traditional medicinal materials which fail to meet the criteria in Clause 1 and Clause 2 of this Article but have been granted certificate of marketing authorization in Vietnam.”.
8. Article 10a is added to Article 10 as follows:
“Article 10a. Contract packages of traditional medicinal materials in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly
A contract package of traditional medicinal materials in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly may contain one or several traditional medicinal materials. Each list of traditional medicinal materials must be sorted by category of traditional medicinal materials. Each traditional medicinal material in a category is a part of the contract package. A contract package of traditional medicinal materials in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly is divided into 03 (three) categories based on technical criteria as follows:
1. Category 1 consists of traditional medicinal materials which have been wholly manufactured in Vietnam on production lines fulfilling GMP requirements as certified by drug authorities of Vietnam and are made of herbal materials announced by a drug authority of Vietnam to fulfill GACP requirements.
2. Category 2 consists of traditional medicinal materials which have been wholly manufactured in Vietnam on production lines fulfilling GMP requirements as certified by drug authorities of Vietnam.
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9. Article 11 is amended as follows:
“Article 11. Contract packages of herbal materials (excluding semi-finished herbal materials in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly)
A contract package of herbal materials may contain one or several herbal materials. Each list of herbal materials must be sorted by category. Each herbal material in a category is a part of the contract package. A contract package of herbal materials is divided into 03 (three) categories based on technical criteria as follows:
1. Category 1 consists of herbal materials announced by drug authorities of Vietnam to fulfill GACP requirements.
2. Category 2 consists of herbal materials which have been wholly undergone preliminary processing on production lines announced by a drug authority of Vietnam to fulfill GMP requirements for medicinal materials of herbal origin.
3. Category 3 consists of herbal materials which fail to meet the criteria specified in Clauses 1 and 2 of this Article.”.
10. Article 11a is added to Article 11 as follows:
“Article 11a. Contract packages of semi-finished herbal materials in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly
A contract package of semi-finished herbal materials in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly may contain one or several semi-finished herbal materials. Each list of semi-finished herbal materials must be sorted by category. Each semi-finished herbal material in a category is a part of the contract package. A contract package of semi-finished herbal materials in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly is divided into 03 (three) categories based on technical criteria as follows:
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2. Category 2 consists of semi-finished herbal materials which have been wholly manufactured in Vietnam on production lines announced by a drug authority of Vietnam to fulfill GMP requirements for medicinal materials of herbal origin.
3. Category 3 consists of semi-finished herbal materials which fail to meet the criteria in Clause 1 and Clause 2 of this Article but have been granted certificate of marketing authorization in Vietnam.”.
11. Article 12 is amended as follows:
a) Clause 3 Article 12 is amended as follows:
“3. Contract packages of herbal drugs, drugs containing herbal materials combined with active pharmaceutical ingredients and traditional drugs (excluding traditional medicinal materials):
a) A bidder whose drug satisfies the criteria of category 1 shall be sorted into category 1, category 2, category 3 and category 4;
b) A bidder whose drug satisfies the criteria of category 2 shall be sorted into category 2, category 3 and category 4;
c) A bidder whose drug satisfies the criteria of category 3 shall be sorted into category 3 and category 4;
d) A bidder whose drug satisfies the criteria of neither of category 1, category 2 and category 3 shall be sorted into category 4.”.
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“4. Contract packages of traditional medicinal materials (excluding traditional medicinal materials in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly):
a) A bidder whose traditional medicinal material satisfies the criteria of category 1 shall be sorted into category 1, category 2 and category 3;
b) A bidder whose traditional medicinal material satisfies the criteria of category 2 shall be sorted into category 2 and category 3;
c) A bidder whose traditional medicinal material satisfies the criteria of neither of category 1 and category 2 shall be sorted into category 3.”.
c) Clause 4a is added to Clause 4 Article 12 as follows:
“4a. Contract packages of traditional medicinal materials in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly:
a) A bidder whose traditional medicinal material satisfies the criteria of category 1 shall be sorted into category 1, category 2 and category 3;
b) A bidder whose traditional medicinal material satisfies the criteria of category 2 shall be sorted into category 2 and category 3;
c) A bidder whose traditional medicinal material satisfies the criteria of neither of category 1 and category 2 shall be sorted into category 3.”.
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“5. Contract packages of herbal materials (excluding semi-finished herbal materials in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly):
a) A bidder whose herbal material satisfies the criteria of category 1 shall be sorted into category 1, category 2 and category 3;
b) A bidder whose herbal material satisfies the criteria of category 2 shall be sorted into category 2 and category 3;
c) A bidder whose herbal material satisfies the criteria of neither of category 1 and category 2 shall be sorted into category 3.”.
dd) Clause 5a is added Clause 5 Article 12 as follows:
“5a. Contract packages of semi-finished herbal materials in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly:
a) A bidder whose semi-finished herbal material satisfies the criteria of category 1 shall be sorted into category 1, category 2 and category 3;
b) A bidder whose semi-finished herbal material satisfies the criteria of category 2 shall be sorted into category 2 and category 3;
c) A bidder whose semi-finished herbal material satisfies the criteria of neither of category 1 and category 2 shall be sorted into category 3.”.
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“b) Funding from health insurance fund and revenues from provision of medical examination and treatment services:
Procurement and use of drugs covered by funding from the health insurance fund and revenues from provision of medical examination and treatment services in the preceding year and anticipated demand for drugs in the current year of the relevant health facility.”.
13. Article 14 is amended as follows:
a) Clause 2 Article 14 is amended as follows:
“2. Information about the dosage form of a drug in a contract package of generic drugs, herbal drugs, drugs containing herbal materials combined with active pharmaceutical ingredients or traditional drugs in the drug supplier selection plan shall be provided in accordance with Appendix 4 enclosed herewith. The dosage forms (marked (*)) shall be specified separately in the drug supplier selection plan on the condition that:
a) It has the same dosage form as the original brand-name drug or reference biological which has the same active ingredient and route of administration or the drug which has the same active ingredient and route of administration, and granted certificate of marketing authorization in a SRA or EMA country;
b) If a drug is not subject to the provisions of Point a Clause 2 of this Article, the health facility shall clearly state its demand for this dosage form in terms of necessity and estimated quantity, and shall only use it in case another dosage form cannot be used or does not respond to treatment.”.
b) Point c Clause 4 Article 14 is amended as follows:
"c) When developing the drug supplier selection plan, the procuring entity shall propose the price of each drug, herbal material or traditional medicinal material by referring to one of the following:
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- Quotations or sales invoices. To be specific:
+ For modern drugs, biologicals, vaccines, herbal drugs or traditional drugs: quotations or sales invoices of at least 03 drug suppliers at the time of preparation of the drug supplier selection plan shall be used. For a drug with fewer than 03 suppliers (fewer than 03 quotations or sales invoices), the head of the procuring entity shall propose the price according to quotations or sales invoices of at least 01 supplier at the time of preparation of the drug supplier selection plan, provide explanations, and take responsibility for its proposed price which must not exceed the effective wholesale price it refers to;
+ For herbal materials or traditional medicinal materials: quotations or sales invoices of at least 03 drug suppliers at the time of preparation of the drug supplier selection plan shall be used. For a herbal material or traditional medicinal material with fewer than 03 suppliers (fewer than 03 quotations or sales invoices), the head of the procuring entity shall propose the price according to quotations or sales invoices of at least 01 supplier at the time of preparation of the drug supplier selection plan, provide explanations, and take responsibility for the appropriateness of the proposed price.”.
14. Clause 1 Article 15 is amended as follows:
“1. Responsibility to submit a drug supplier selection plan for approval:
The head of the relevant health facility shall assume responsibility to prepare and submit its drug supplier selection plan to a competent officer or authorized authority or unit to consider giving approval in a manner ensuring that the supply of drugs can meet its medical examination and treatment requirements.”.
15. Clause 1 Article 16 is amended as follows:
“1. Organization of appraisal:
a) For ministerial agencies, Governmental agencies and other central-government authorities: the provisions of Clause 4 Article 104 of the Decree No. 63/2014/ND-CP shall apply;
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c) For public health facilities under the management of provincial governments: the provisions of Clause 3 Article 104 of the Decree No. 63/2014/ND-CP shall apply;
d) For health facilities other than those specified in Points a, b and c Clause 1 of this Article: their specialized units shall take charge of their drug supplier selection plans.".
16. Clause 1 Article 17 is amended as follows:
“1. Authority to give approval for drug supplier selection plans shall comply with the provisions of Clause 1 Article 76 of the Decree No. 63/2014/ND-CP.”.
17. Article 18 is amended as follows:
“Article 18. Selection of suppliers of drugs included in list of drugs procured through centralized bidding or list of drugs procured through price negotiation of health facilities
1. Health facilities shall be allowed to organize drug supplier selection according to the provisions of Article 13 through 17 of this Circular in respect of drugs included in the List of drugs procured through centralized bidding or the List of drugs procured through price negotiation according to the written notification of centralized drug procurement units in the following cases:
a) The health facility needs to use a drug included in the List of drugs procured through centralized bidding or the List of drugs procured through price negotiation but, at the time of approval for the drug supplier selection plan, centralized bidding or price negotiation results have not yet been published or the remaining validity of the signed framework agreement is only 03 months or shorter;
b) The health facility needs to use a drug included in the List of drugs procured through centralized bidding or the List of drugs procured through price negotiation for which a drug supply contract has been concluded but the selected supplier is unable to supply drugs;
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d) The health facility is established after the demand for drugs has been determined, and the increased demand exceeds the regulating capacity of centralized drug procurement units.
2. Centralized drug procurement units shall give notification of organization of drug supplier selection in the cases specified in Clause 1 of this Article by March 15 every year, if the procurement schedule has been missed, or at least 03 months before the expiration of the signed framework agreement so that health facilities can proactively organize the drug supplier selection to serve their medical examination and treatment requirements.”.
18. Appendix 14 and Appendix 15 are added in Appendix 01 and Appendix 02 enclosed herewith as follows:
a) Appendix 14: Forms of online bidding documents for contract packages of herbal materials and traditional medicinal materials (excluding those in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly) adopting the single stage-one envelope bidding procedure.
b) Appendix 15: Forms of online bidding documents for contract packages of herbal materials and traditional medicinal materials (excluding those in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly) adopting the single stage-two envelope bidding procedure.
19. Clause 1 Article 27 is amended as follows:
“1. Bidding documents or request for proposals shall be prepared in accordance with the Law on bidding, its guiding documents and the following provisions:
a) Regarding bidding documents for contract packages of original brand-name drugs or drugs of therapeutic equivalence; generic drugs; herbal drugs, drugs containing herbal materials combined with active pharmaceutical ingredients or traditional drugs (excluding traditional medicinal materials); traditional medicinal materials in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly; semi-finished herbal materials in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly:
- In case of online bidding, Form 7A and Form 7B enclosed with the Circular No. 08/2022/TT-BKHDT dated May 31, 2022 of the Minister of Planning and Investment of Vietnam prescribing provision and publishing of information on bidding and contractor selection on Vietnam National E-procurement System (hereinafter referred to as “Circular No. 08/2022/TT-BKHDT”) shall be used for preparing E-HSMT as prescribed in Article 35 of the Circular No. 08/2022/TT-BKHDT;
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b) Regarding bidding documents for contract packages of herbal materials (excluding semi-finished herbal materials in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly) and traditional medicinal materials (excluding those in the form of glue, granule, powder, extract, essential oil, resin, gum or jelly):
- In case of online bidding, forms of bidding documents in Appendix 01 and Appendix 02 enclosed herewith shall be used.
- In case of offline bidding, forms of bidding documents provided in the Circular No. 09/2022/TT-BYT dated September 09, 2022 of the Minister of Health prescribing bidding documents for procurement of herbal materials and traditional medicinal materials by health facilities.
c) Request for proposals for contract packages of drugs adopting the direct procurement, shopping or direct contracting method shall be prepared by reference to contents and forms of bidding documents and request for proposals issued by the Ministry of Health of Vietnam or the Ministry of Planning and Investment of Vietnam.”.
20. Clause 3 Article 30 is amended as follows:
“3. Forms of bid security:
Bidders shall furnish bid security by the bid closing date (except the case in Point c of this Clause) in one of the following forms:
a) In case of online bidding, bidders shall furnish bid security in the form of letters of guarantee issued banks or credit institution lawfully operating in Vietnam.
b) In case of offline bidding, bid security may be furnished in one of the following forms:
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- Collateral; or
- Letter of guarantee issued by a bank or credit institution lawfully operating in Vietnam.
c) For a contract package requiring a bid security of less than VND 10 million, bidders must not furnish the bid security before the bid closing date. In this case, the bidder is required to undertake that it will pay an amount of money as prescribed in the bidding documents or request for proposals if it refuses or fails to enter into contract negotiation as requested or it commits violations against regulations of law on bidding resulting in forfeiture of bid security. The violating bidder shall have its name published on the System and have its user account locked for 06 months from the day on which the Public Procurement Agency or Ministry of Planning and Investment of Vietnam receives the written request from the procuring entity.”.
21. Clause 2 Article 31 is amended as follows:
“2. The procuring entity shall evaluate bids or proposals for each part of the contract package which comprises multiple parts in accordance with the Law on bidding and guidelines of the Ministry of Planning and Investment of Vietnam and Ministry of Health of Vietnam regarding contractor selection, and on the basis of information on the drug (certificate of marketing authorization, import license), manufacturer’s fulfillment of GMP requirements under official documents or approving decisions of the Drug Administration of Vietnam, the Traditional Medicine Administration of Vietnam or published on the websites of these authorities and other information. The evaluation of capacity and experience of a bidder shall be based on the total parts of the contract package in which it participates.”.
22. Clause 1 and Clause 2 Article 32 are amended as follows:
“1. The contract negotiation shall be carried out in accordance with the provisions of Article 19 of the Decree No. 63/2014/ND-CP before the procuring entity proposes successful drug supplier.
The bidder whose bid after error correction and deviation adjustment minus (-) discount is the lowest bid (if the least-cost selection method is applied), or whose evaluated bid is the lowest bid (if the lowest evaluated bid selection method is applied), or whose total score is the highest score (if the quality- and cost-based selection method is applied) shall be ranked first and invited to the contract negotiation session. If the bidder who is invited to the contract negotiation session fails to be present or refuses the contract negotiation, the bid security furnished by that bidder for the relevant part of the contract package shall not be refunded.
2. Conditions to be satisfied by a proposed successful bidder are specified in Article 43 of the Law on bidding, the issued bidding documents or request for proposals and the following provisions:
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b) Regarding a contract package of various drugs procured and packaged according to the requested quantity to serve disaster preparedness and control, search and rescue, or epidemic prevention and control: the procuring entity shall propose the successful bidder for the requested quantity (comprising multiple parts, called contract package) if the bidder meets technical and quality requirements specified in the bidding documents or request for proposals and its submitted bid for each part of the contract package is not higher than the effective wholesale price and total value of the contract package after error correction and deviation adjustment minus (-) discount is the lowest bid (if the least-cost selection method is applied), or whose evaluated bid is the lowest bid (if the lowest evaluated bid selection method is applied). In this case, the value of the contract package includes costs of packaging for the requested quantity of drugs.”.
23. Clause 5 Article 35 is amended as follows:
“5. If one or several parts of a contract package does not receive any bids or there is no bidder satisfying the requirements laid down in the bidding documents or request for proposals or none of the options specified in Clause 3 Article 32 of this Circular is viable, the procuring entity shall separate such part(s) into separate contract package(s) and request the competent officer or authorized entity to consider approving the adjusted drug supplier selection plan. The drug supplier selection for the remaining parts of the contract package shall continue to be carried out in accordance with regulations.”.
24. Clause 6 Article 37 is amended as follows:
“6. If there are changes in a drug bidded for during the drug supplier selection or drug supply but the substitute drug is not offered in the bids, the investor may consider allowing the drug supplier to supply the substitute drug to meet its medical examination and treatment requirements. To be specific:
a) There are changes in any of the following information on the drug (including original brand-name drugs and reference biologicals) but the registration number or the import license number remains unchanged, including: name of the drug; name of the manufacturer; address of the manufacturer (but the manufacturing facility or site is unchanged); change in the manufacturing facility or site but the manufacturer’s fulfillment of GMP requirements remains unchanged; extended expiration date (shelf life) of the drug; changes in packing specifications. If there are changes in the manufacturing facility or site of the original brand-name drug or reference biological, the substitute drug or biological must be wholly manufactured in a SRA or EMA country;
b) There are changes in the registration number or a new import license is issued but other information (name of drug, manufacturer, shelf life, manufacturer’s fulfillment of GMP requirements, specifications; specifications may be changed provided that they shall not be lower than those of the selected drug or offered in the bid or updated on the Pharmacopoeia). If there are changes in the registration number of or a new import license is issued to an original brand-name drug or reference biological, such changes must be included in the List of original brand-name drugs and reference biologicals announced by the Ministry of Health of Vietnam;
c) There are changes in method for naming of herbal materials which do not influence their formula and are permitted by a competent authority;
d) When providing a substitute drug in the case prescribed in Points a, b or c of this Clause, the drug supplier shall provide all necessary information for the procuring entity for its evaluation of the substitute drug, including: decisions and official dispatches on the changes issued by competent authorities and explanations and/or commitments on unchanged specifications of the offered drug and the substitute drug.”.
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“5. Drug supplier selection method: Depending on the scale of the contract package and methods for evaluation of bids or proposals, a drug supplier selection method shall be proposed according to Article 28 and Article 29 of the Law on bidding.”.
26. Clause 1a is added Clause 1 Article 41 as follows:
“1a. Documents enclosed with an application for registration of centralized drug procurement demand:
a) Summary report on implementation of drug supplier selection result and drug use in the preceding year, the drug inventory and the planned quantity of drugs that have not been used at the planning date of the health facilities;
b) A brief explanation for the proposed drug procurement plan; detailed explanations about any change in the quantity of drugs by more than 30% of the quantity of drugs used in the preceding year;
c) The minutes of the meeting of the Drug and Treatment Council or the minutes of review meeting of health facilities on the list, quantity of drugs and demand for drugs of the health facilities under the management of provincial government, Ministry or regulatory authority and provincial health agencies.”.
27. Clause 5 Article 42 is amended as follows:
“5. Grounds for price negotiation and performance of price negotiation:
a) If the drug under price negotiation is one of the original brand-name drugs announced by the Ministry of Health, has been wholly produced in a SRA or EMA country and granted two (02) or more certificates of marketing authorization of Category 1 generic drug, the price negotiation plan and implementation thereof shall be based on the quantity of certificate of marketing authorization of generic drug, successful bid of the generic drug and the capacity to supply substitute drugs at the time of price negotiation.
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c) With regard to original brand-name drugs announced by the Ministry of Health, manufactured in Vietnam under processing contracts or technology transfer contracts, the price negotiation plan and implementation thereof shall be carried out according to the processing or technology transfer roadmap.”.
28. Point g Clause 4 Article 45 is amended as follows:
“g) The proposed successful bid shall be agreed upon by the Drug Price Negotiation Council and the bidder. The National centralized drug procurement center shall notify the bidder of the bid agreed upon after price negotiation within 07 working days from the day on which two parties reaches an agreement on the bid and conduct negotiation of the framework agreement with the successful bidder.”.
29. Point b Clause 2 Article 46 is amended as follows:
“b) With regard to the drugs included in the List of drugs procured through price negotiation for which the price negotiation is unsuccessful (including original brand-name drugs manufactured in Vietnam under processing contracts or technology transfer contracts), based on the opinions given by the price negotiation council, the National centralized drug procurement center shall notify health facilities of an alternative procurement plan or solution.
With regard to the original brand-name drugs which have been announced by the Ministry of Health, wholly produced in a SRA or EMA country, granted two (02) or more certificates of marketing authorization of Category 1 generic drugs as prescribed in Article 7 of this Article and for which the price negotiation is unsuccessful, health facilities may organize drug supplier selection through competitive bidding for generic drug contract packages according to the notification of the National centralized drug procurement center.”.
30. Article 50 is amended as follows:
a) Clause 2 Article 50 is amended as follows:
“2. The Minister of Health of Vietnam shall delegate authority to decide the procurement of drugs for agencies and units using funding under the management of the Ministry of Health of Vietnam to serve their operation and performance of tasks assigned by the Minister of Health of Vietnam.”.
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“4. The Drug Administration of Vietnam, and Traditional Medicine Administration of Vietnam shall update and publish the following information on their websites:
a) Lists serving the drug supplier selection, including:
- List of drug authorities of SRA or EMA countries and List of SRA or EMA countries;
- List of drug authorities of countries that are members of PIC/s and ICH;
- List of drug manufacturers in Vietnam fulfilling WHO-GMP requirements as certified by drug authorities of Vietnam;
- List of drug manufacturers fulfilling EU-GMP requirements or EU-GMP-equivalent requirements; List of drug manufacturers fulfilling PIC/s-GMP requirements; List of drug manufacturers fulfilling WHO-GMP requirements;
- List of drug manufacturers fulfilling GMP requirements for herbal drugs or traditional drugs as certified by the Ministry of Health of Vietnam;
- List of drug manufacturers in Vietnam fulfilling GMP requirements for herbal materials or traditional medicinal materials as certified by the Ministry of Health of Vietnam;
- List of drug manufacturers in Vietnam fulfilling GMP requirements for medicinal materials of herbal origin as certified by the Ministry of Health of Vietnam;
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b) Lists of drugs serving drug supplier selection, including:
- List of drugs granted certificate of marketing authorization or import license;
- List of original brand-name drugs;
- List of reference biologicals;
- List of drugs manufactured under processing contracts or technology transfer contracts in Vietnam;
- List of original brand-name drugs and reference biologicals manufactured under processing contracts or technology transfer contracts in Vietnam;
- List of drugs of bioequivalence proved by documentary evidences;
- List of drugs wholly manufactured in Vietnam on production lines fulfilling category-1 drug category criteria as prescribed in Point c Clause 1 Article 7 of this Circular;
- List of traditional medicinal materials in the following dosage forms: glue, granule, powder, extract, essential oil, resin, gum or jelly meeting quality standards according to the Ministry of Health of Vietnam’s regulations on management of quality of herbal materials and traditional drugs;
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- List of drugs included in the List of national products;
- List of drugs awarded the "Ngoi sao thuoc Viet” (“Star of Vietnamese medicines”) by the Ministry of Health of Vietnam;
- List of herbal materials which are planted, collected or obtained naturally and certified to fulfill GACP requirements by the Ministry of Health of Vietnam;
- List of drugs manufactured in Vietnam and satisfying treatment, pricing and supply requirements;
- List of drugs made of materials (active ingredients) manufactured in SRA or EMA countries or granted CEP certificate;
- List of drugs and manufacturers and suppliers committing violations against quality standards or regulations on bidding and drug supply;
c) Information on declared/re-declared drug prices;
d) Information on successful bids of drugs, traditional medicinal materials and herbal materials of health facilities;
dd) List of capable, experienced and reputable drug manufacturers and suppliers to be invited to selective bidding.”.
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“8. Health facilities applying for information disclosure as prescribed in Point c Clause 1 Article 7 of this Circular shall provide the following documents and be legally responsible for the accuracy of their provided documents:
a) Legal documents issued by drug authorities of SRA or EMA countries. These documents must bear full names and signatures of signatories and seals of competent authorities of the issuing countries and bear the consular legalization as prescribed (originals or certified true copies).
In case of electronic legal documents, including those without full names and signatures of signatories and seals of competent authorities of the issuing countries, the health facility shall send the documents obtained from the English website of the issuing authority to the Ministry of Health of Vietnam (via the Drug Administration of Vietnam). These documents shall bear the health facility’s seal and be accompanied with a document containing the download links. The health facility shall be legally responsible for the legitimacy and accuracy of these documents.
The legal documents shall have the following contents: drug name, active ingredients, their concentration or content, dosage form, name and address of the manufacturer, and certification that the drug is granted marketing authorization in that country.
b) Statements proving that the drug sold in Vietnam and the drug granted certificate of marketing authorization by a drug authority of a SRA or EMA country have the same dosage form, production process, specifications and testing methods; active ingredients and excipients have the same specifications, manufacturer and manufacturing facility or site as prescribed in Appendix 13 enclosed herewith.”.
d) Clause 10 is added to Article 50 as follows:
“10. Bidders for contract packages of herbal drugs, drugs containing herbal materials combined with active pharmaceutical ingredients or traditional drugs or contract packages of herbal materials, semi-finished herbal materials or traditional medicinal materials of herbal origin announced by drug authorities of Vietnam to fulfill GACP requirements shall wholly assume legal responsibility for the following contents:
a) The accuracy of documents proving that the drug, herbal material or traditional medicinal material bidded for is made of herbal materials which have been announced by drug authorities of Vietnam to fulfill GACP requirements.
b) The selected drug, traditional medicinal material or herbal material is manufactured or supplied from herbal materials which have been announced by drug authorities of Vietnam to fulfill GACP requirements and satisfies technical standards laid down in bidding documents.”.
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32. Appendix 4 is amended by Appendix 04 enclosed herewith.
33. Appendix 7 and Appendix 8 are amended as follows:
a) Part 4. Appendix on technical criteria of drugs is amended by Appendix 05 enclosed herewith.
b) Section 18.1 of Chapter I Part 1 is amended as follows:
“18.1. The bidder shall furnish a bid security by the bid closing date by providing a letter of guarantee issued by a bank or credit institution lawfully operating in Vietnam or pay a deposit as prescribed in Section 18.2 of the ITB (Instructions to bidders). If a letter of guarantee is provided, Form No. 04(a) or Form No. 04(b) Chapter IV - Bidding forms shall be used. If the value of the bid security is less than VND 10 million, the provisions of Point c Clause 3 Article 30 of this Circular shall apply. If the validity of a bid is extended for a specified additional period as prescribed in Section 17.2 of the ITB, the validity of the provided bid security shall be also extended for a corresponding additional period.
In case of consortium, the bid security shall be furnished adopting one of the following two options:
a) Each consortium member shall furnish a separate bid security provided that total amount of bid security shall not be lower than the one prescribed in Section 18.2 of the ITB. If the bid security provided by a consortium member is considered invalid, the bid of the consortium shall be rejected. If any member of the consortium commits violations against law resulting in forfeiture of the bid security as prescribed in Section 18.5 of the ITB, total amount of the bid security provided by all consortium members shall not be returned.
b) All consortium members reach an agreement to appoint a member to assume responsibility to provide the bid security for that member and all other members of the consortium. In this case, the bid security shall be furnished in the name of either the consortium or the member appointed to provide the bid security provided that total amount of the bid security shall not be lower than the one prescribed in Section 18.2 of the ITB. If any member of the consortium commits violations against law resulting in forfeiture of the bid security as prescribed in Section 18.5 of the ITB, the bid security shall not be returned.”.
c) Section 40.1 of Chapter I Part 1 is amended as follows:
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d) Point e Section 1.2 of Chapter III is amended as follows:
“e) The provided bid security does not fall in any of the cases specified in Section 18.3 of the ITB. If a letter of guarantee is provided as bid security as prescribed, it must bear the signature of the legal representative of the credit institution or foreign bank branch established under the law of Vietnam, and the correct value, validity period and name of the procuring entity (beneficiary) as prescribed in Section 18.2 of the ITB. If the bidder is required to pay a deposit as bid security, the procuring entity shall manage the received deposit in accordance with Section 18.4 and Section 18.5 of the ITB;”.
dd) The first en dash of Section 6.1 of Chapter VII is amended as follows:
“- Form of performance security: ____ [based on the nature and requirements of the contract package, the bidder is required to provide performance security in the form of a letter of guarantee issued by a bank or credit institution lawfully operating in Vietnam or a deposit. If a letter of guarantee issued by a bank or credit institution lawfully operating in Vietnam is submitted, it must be unconditional guarantee (i.e. payment is made at request, Form No. 15 of Chapter VIII - Contract forms shall be used)].”.
1. This Circular comes into force from April 27, 2023.
2. From the effective date of this Circular, the following regulations shall cease to have effect:
a) Clause 2 Article 3, Clause 4 Article 27, Point c Clause 3 Article 32, Point h Clause 4 Article 45 and Clause 9 Article 50 of the Circular No. 15/2019/TT-BYT dated July 11, 2019 of the Minister of Health of Vietnam;
b) Article 5 of the Circular No. 15/2020/TT-BYT dated August 10, 2020 of the Minister of Health of Vietnam;
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Contract packages for which drug supplier selection plans have been approved before the effective date of this Circular shall continue to be implemented in accordance with the provisions of the Circular No. 15/2019/TT-BYT dated July 11, 2019 of the Minister of Health of Vietnam which has been amended by:
a) The Circular No. 15/2020/TT-BYT dated August 10, 2020 of the Minister of Health of Vietnam;
b) The Circular No. 29/2020/TT-BYT dated December 31, 2020 of the Minister of Health of Vietnam;
c) The Circular No. 15/2021/TT-BYT dated September 24, 2021 of the Minister of Health of Vietnam.
If any legislative documents referred to in this Circular are superseded or amended, the new ones shall apply.
Article 5. Responsibility for implementation
The Director of the Department of Planning and Finance, the Director of Drug Administration of Vietnam, the Director of the Traditional Medicine Administration of Vietnam, the Director of the Vietnam Administration of HIV/AIDS Control, the Chief of the Ministry’s Office, the Ministry’s Chief Inspector, the Director of the National centralized drug procurement center, heads of departments of and affiliated to the Ministry of Health of Vietnam, Directors of Provincial Departments of Health, pharmacy business establishments and other relevant authorities, organizations and individuals are responsible for the implementation of this Circular./.
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PP. MINISTER
DEPUTY MINISTER
Do Xuan Tuyen
File gốc của Thông tư 06/2023/TT-BYT của Bộ Y tế về việc sửa đổi, bổ sung một số điều của Thông tư 15/2019/TT-BYT ngày 11/7/2019 của Bộ trưởng Bộ Y tế quy định việc đấu thầu thuốc tại các cơ sở y tế công lập đang được cập nhật.
Thông tư 06/2023/TT-BYT của Bộ Y tế về việc sửa đổi, bổ sung một số điều của Thông tư 15/2019/TT-BYT ngày 11/7/2019 của Bộ trưởng Bộ Y tế quy định việc đấu thầu thuốc tại các cơ sở y tế công lập
Tóm tắt
| Cơ quan ban hành | Bộ Y Tế |
| Số hiệu | 06/2023/TT-BYT |
| Loại văn bản | Thông tư |
| Người ký | Đỗ Xuân Tuyên |
| Ngày ban hành | 2023-03-12 |
| Ngày hiệu lực | 2023-04-27 |
| Lĩnh vực | Y tế |
| Tình trạng | Còn hiệu lực |