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THE MINISTRY OF
HEALTH OF VIETNAM
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THE SOCIALIST
REPUBLIC OF VIET NAM
Independence-Freedom-Happiness
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No. 07/2024/TT-BYT
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Hanoi, May 17,
2024
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CIRCULAR
PRESCRIBING
BIDDING FOR SUPPLY OF DRUGS FOR PUBLIC HEALTH FACILITIES
Pursuant to the Law on Bidding dated June 23,
2023;
Pursuant to the Government’s Decree No.
24/2024/ND-CP dated February 27, 2024 elaborating and providing guidelines for
implementation of the Law on Bidding regarding contractor selection;
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;
At the request of the Director of the Department
of Planning and Finance, the Director of the Drug Administration of Vietnam and
the Director of Traditional Medicine Administration of Vietnam;
The Minister of Health of Vietnam promulgates a
Circular prescribing bidding for supply of drugs for public health facilities.
Chapter I
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Article 1. Scope
1. This Circular provides regulations on bidding
for supply of drugs funded by state budget, health insurance fund and other
lawful funding sources of health administrative authorities and public health
service providers (hereinafter referred to as “public health facilities”),
including:
a) Division of contract packages and drug
categories;
b) Procedures for selection of drug suppliers;
c) Centralized drug procurement.
2. This Circular applies to the bidding for supply of
modern drugs, radioactive drugs, tracers, vaccines, biologicals, herbal drugs,
traditional drugs, herbal materials, traditional medicinal materials and
various types of gases which are granted marketing authorization number as
drugs to serve medical examination and treatment.
3. Procurement of drugs according to orders or task
assignment of the State shall comply with the Government’s Decree No.
32/2019/ND-CP dated April 10, 2019 prescribing task assignment, ordering or
bidding for supply of public products and services funded by state budget for
recurrent expenditures.
4. Procurement of drugs for use in health offices
of authorities and detention facilities of the armed forces shall comply with
the guidelines given by the Ministry of National Defence of Vietnam and the
Ministry of Public Security of Vietnam.
5. Procurement of qualified whole blood and blood
products shall comply with provisions of the Circular No. 15/2023/TT-BYT dated
July 20, 2023 of the Minister of Health of Vietnam prescribing maximum prices
and costs of determination of prices of qualified whole blood units and blood
products.
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For the purposes of this Circular, the terms below
shall be construed as follows:
1. “national centralized procurement unit” is
an unit assigned by the Ministry of Health of Vietnam to organize the national
centralized procurement of drugs.
2. “provincial centralized procurement unit” is
an unit assigned by a provincial People's Committee to organize the centralized
procurement of drugs in the province.
Article 3. Responsibility to
formulate drug supplier selection plan and organize drug supplier selection
1. The national centralized procurement unit shall
develop and organize the implementation of drug supplier selection plans in
accordance with Chapter IV of this Circular under which the time for
implementation of a framework agreement and time for execution of a contract
package must not exceed 36 months, divided by drug category and supply interval
(quarterly and annually), in respect of the following drugs:
a) Drugs which are included in the list of drugs
procured through national centralized procurement promulgated by the Minister
of Health of Vietnam, and meet category-1 or category-2 technical criteria set
out in Article 4 of this Circular;
b) Drugs included in the list of rare drugs
promulgated by the Minister of Health of Vietnam;
c) Drugs for which only a small quantity needs to
be procured to meet medical examination and treatment as prescribed in Clause 1
Article 53 of the Law on Bidding.
2. Provincial centralized procurement units shall
develop and organize the implementation of drug supplier selection plans in
accordance with Chapter IV of this Circular under which the time for
implementation of a framework agreement and time for execution of a contract
package must not exceed 36 months, divided by drug category and supply interval
(quarterly and annually), in respect of the following drugs:
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b) Drugs included in the list of rare drugs
promulgated by the Minister of Health of Vietnam;
c) Drugs for which only a small quantity needs to
be procured to meet medical examination and treatment as prescribed in Clause 1
Article 53 of the Law on Bidding.
3. Procurement of drugs as prescribed in clause 5
Article 53 of the Law on Bidding shall be subject to the following provisions:
a) If regulatory authorities, organizations and
units (hereinafter referred to as “units”) have reach an agreement to appoint a
unit to take charge of the procurement, the appointed unit shall consolidate
demands of other units that have entered into the agreement and organize the
procurement in accordance with regulations of the Law on Bidding.
Such an agreement must be made in writing and
clearly indicate responsibility to consolidate and send procurement demands,
and responsibility to pay costs.
b) If units do not reach any agreement and cannot
organize the drug supplier selection themselves or have themselves organized
the drug supplier selection which is unsuccessful, they shall send their
procurement demands to:
- The Ministry of Health of Vietnam, for units
under the management of this Ministry or in case a drug is requested by 02
provinces or more;
- The Ministry of National Defence of Vietnam, for
units under the management of this Ministry.
- The Ministry of Public Security of Vietnam, for
units under the management of this Ministry;
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Within 10 from the receipt of the written request
from units, the relevant supervisory authority shall appoint a unit to take
charge of the procurement. If a request is refused, a written response
indicating reasons for such refusal shall be provided.
4. Public health facilities shall themselves
develop and organize the implementation of drug supplier selection plans in
respect of the drugs which are not covered by the drug supplier selection plans
of either the national centralized procurement unit or the provincial
centralized procurement units. Formulation of drug supplier selection plans and
organization of drug supplier selection by public health facilities shall
comply with provisions of Chapter III of this Circular; the maximum duration of
execution of a contract package is 36 months and is divided into smaller parts
and by the drug category.
Chapter II
DIVISION OF CONTRACT
PACKAGES AND DRUG CATEGORIES
Article 4. Generic drug
contract package
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 categories based on
technical criteria as follows:
1. Category 1 consists of drugs which have been granted
certificate of marketing authorization or import license for sale in Vietnam
and satisfy one of the following criteria:
a) The drug is 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;
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- The drug is 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;
- The drug has been granted certificate of
marketing authorization by a drug authority of a SRA or EMA country according
to Clause 4 Article 40 of this Circular;
- 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 been manufactured at the same manufacturing facility or site
as prescribed in Clause 4 Article 40 of this Circular.
2. Category 2 consists of drugs which have been
granted certificate of marketing authorization or import license for sale in
Vietnam and satisfy one of the 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
granted certificate of marketing authorization in Vietnam and 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.
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1. Heads of public health facilities shall make
decision on procurement of original brand-name drugs or reference biologicals
on the basis of opinions given by the Drug and Treatment Councils, for
hospitals, or the Expert Councils, for other public health facilities
(hereinafter referred to as “Councils”).
2. An original brand-name drug contract package may
contain one or several original brand-name drugs or reference biologicals. Each
drug is a part of the contract package. A drug included in the original
brand-name drug contract package must be included in the list of original
brand-name drugs or reference biologicals announced by the Ministry of Health
of Vietnam, except original brand-name drugs or reference biologicals which are
manufactured in countries other than SRA or EMA countries and announced by
competent authorities before the effective date of the Circular No.
08/2022/TT-BYT dated September 05, 2022 of the Minister of Health of Vietnam.
Article 6. Contract packages of
herbal drugs, drugs containing active ingredients combined with herbal
materials, and traditional drugs
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 drugs which have been
granted certificate of marketing authorization or import license for sale in
Vietnam.
Article 7. Contract packages of
traditional medicinal materials
A contract package of traditional medicinal
materials may contain one or several traditional medicinal materials (except contract
packages of traditional medicinal materials in the form of glue, granule,
powder, extract, essential oil, resin, gum or jelly). 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 categories based on technical criteria as follows:
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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.
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 or import
license for sale in Vietnam.
Article 8. 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 categories based on technical
criteria as follows:
1. Category 1 consists of traditional medicinal
materials in the form of glue, granule, powder, extract, essential oil, resin,
gum or jelly 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 in the form of glue, granule, powder, extract, essential oil, resin,
gum or jelly which have been wholly manufactured in Vietnam on production lines
fulfilling GMP requirements as certified by drug authorities of Vietnam.
3. Category 3 consists of traditional medicinal
materials in the form of glue, granule, powder, extract, essential oil, resin,
gum or jelly which fail to meet the criteria in Clause 1 and Clause 2 of this
Article but have been granted certificate of marketing authorization or import
license for sale in Vietnam.
Article 9. Contract packages of
herbal materials
A contract package of herbal materials may contain
one or several herbal materials (except semi-finished herbal materials in the
form of glue, granule, powder, extract, essential oil, resin, gum or jelly).
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 categories based on technical criteria as follows:
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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.
Article 10. 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
categories based on technical criteria as follows:
1. Category 1 consists of semi-finished herbal
materials in the form of glue, granule, powder, extract, essential oil, resin,
gum or jelly which have been wholly manufactured in Vietnam on production lines
fulfilling GMP requirements for medicinal materials of herbal origin 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 semi-finished herbal
materials in the form of glue, granule, powder, extract, essential oil, resin,
gum or jelly which have been wholly manufactured in Vietnam on production lines
fulfilling GMP requirements for medicinal materials of herbal origin as
certified by drug authorities of Vietnam.
3. Category 3 consists of semi-finished herbal
materials in the form of glue, granule, powder, extract, essential oil, resin,
gum or jelly which fail to meet the criteria in Clause 1 and Clause 2 of this
Article but have been granted certificate of marketing authorization or import
license for sale in Vietnam.
Article 11. Provisions on
bidding for drug categories
1. Principles for bidding for drug categories in a
contract package:
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b) If a drug bidded for is manufactured by several
facilities, all of them have to satisfy the technical criteria of the category
into which they are sorted.
2. Generic drug contract package:
a) A bidder whose drug satisfies the criteria of
category 1 shall be sorted into category 1, category 2 and category 5;
b) A bidder whose drug satisfies the criteria of
category 2 shall be sorted into category 2 and category 5;
c) A bidder whose drug satisfies the criteria of
category 3 shall be sorted into category 3 and category 5;
d) A bidder whose drug satisfies the criteria of
category 4 shall be sorted into category 4 or category 5;
dd) A bidder whose drug satisfies the criteria of
neither of category 1, category 2, category 3, and category 4 shall be sorted
into category 5.
A bidder whose drug satisfies technical criteria of
more than one category may be sorted into the categories as prescribed above.
E.g.: A bidder whose drug concurrently satisfies
the criteria of category 3 and the criteria of category 4 shall be sorted into
category 3, category 4 and category 5. A bidder whose drug concurrently
satisfies the criteria of category 2 and the criteria of category 3 shall be
sorted into category 2, category 3 and category 5.
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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.
4. Contract packages of traditional medicinal
materials:
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.
5. Contract packages of traditional medicinal
materials in the form of glue, granule, powder, extract, essential oil, resin,
gum or jelly:
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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.
6. Contract packages of herbal materials:
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.
7. 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;
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8. The inclusion of foreign drugs manufactured
under a processing contract or technology transfer contract in Vietnam in the
contract packages of generic drugs and original brand-name drugs shall be made
as follows:
a) A foreign drug manufactured under a processing
contract or technology transfer contract in Vietnam shall be sorted into the
drug categories prescribed in Point b of this Clause when it satisfies all of
the following criteria:
- The drug is included in the list of drugs
manufactured under processing contracts (with transfer of manufacturing
technology) as certified by the Ministry of Health of Vietnam, and has a
certificate of marketing authorization issued or renewed as prescribed in point
a clause 1 Article 6 of the Circular No. 16/2023/TT-BYT dated August 15, 2023
of the Minister of Health prescribing marketing authorization for drugs
manufactured in Vietnam under processing contracts or technology transfer
contracts (hereinafter referred to as “Circular No. 16/2023/TT-BYT”) or is
included in the list of drugs manufactured under technology transfer contracts
and has a certificate of marketing authorization issued or renewed as
prescribed in point a clause 1 Article 10 of the Circular No. 16/2023/TT-BYT;
- The drug is not included in the list of drugs
announced by the Ministry of Health of Vietnam as prescribed in clause 2
Article 56 of the Law on Bidding (unless the drug is wholly manufactured in
Vietnam when it is granted certificate of marketing authorization in Vietnam);
b) Inclusion of foreign drugs which are
manufactured under processing contracts or technology transfer contracts in
Vietnam and satisfy the requirements set out in Point a of this Clause shall be
made as follows:
- A drug that is manufactured under a processing
contract or technology transfer contract may be included in contract packages
of original brand-name drugs if it is included in the list of original
brand-name drugs or reference biologicals announced by the Ministry of Health
of Vietnam, and satisfies the requirements in clause 2 Article 5 of this
Circular. If a drug is included in the list of drugs procured through price
negotiation announced by the Ministry of Health of Vietnam, it shall be
procured through price negotiation;
- A drug shall be sorted into category 1, category
2, category 4 and category 5 if it meets all of the following criteria: The
drug for which manufacturing technology is to be transferred or which will be
manufactured under a processing contract meets the requirements in point a
clause 1 Article 4 of this Circular; the drug is manufactured in Vietnam under
a processing contract or technology transfer contract on the production line
fulfilling EU-GMP requirements or the production line fulfilling EU-GMP-equivalent
requirements and certified by a drug authority of Vietnam to fulfill EU-GMP
requirements or EU-GMP-equivalent requirements.
- A drug shall be sorted into category 2, category
4 and category 5 if it meets all of the following criteria: The drug for which
manufacturing technology is to be transferred or which will be manufactured
under a processing contract meets the requirements in clause 2 Article 4 of
this Circular; the drug is manufactured in Vietnam under a processing contract
or technology transfer contract on the production line fulfilling EU-GMP
requirements or the production line fulfilling EU-GMP-equivalent requirements
and certified by a drug authority of Vietnam to fulfill EU-GMP requirements or
EU-GMP-equivalent requirements.
- Other drugs shall be sorted in category 4 and
category 5.
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Chapter III
PROCEDURES FOR SELECTION
OF DRUG SUPPLIERS
Article 12. Drug supplier
selection plans
Contents of a drug supplier selection plan shall
comply with provisions of Article 39 of the Law on Bidding. To be specific:
1. Name of the contract package:
The contract package shall be named according to
the division of contract package and drug categories in conformity with the
provisions of Articles 4 through 10 of this Circular. If a contract package is
divided into smaller parts, each of them must have a suitable name. Mandatory
information on the contract package included in the drug supplier selection
plan:
a) Each part of a contract package of generic drugs
shall contain: name of active ingredient; content or concentration; route of
administration, dosage form; drug category; measuring unit; quantity; unit
price and total value;
b) Each part of a contract package of original
brand-name drugs shall contain: name of the drug and the phrase “hoặc tương
đương” (“or equivalent”) as prescribed in point c clause 9 Article 24 of the
Government’s Decree No. 24/2024/ND-CP dated February 27, 2024 elaborating and
providing measures for implementation of the Law on Bidding regarding
contractor selection (hereinafter referred to as “Decree No. 24/2024/ND-CP”);
name of active ingredient; content or concentration; route of administration,
dosage form; measuring unit; quantity; unit price and total value. If a single
active ingredient has several names of the original brand-name drug or
reference biological on the list of original brand-name drugs and reference
biologicals announced by the Ministry of Health of Vietnam, all names shall be
specified;
c) Each part of a contract package of herbal drugs,
drugs containing active ingredients combined with herbal materials, traditional
drugs, semi-finished herbal materials, or traditional medicinal materials in
the form of glue, granule, powder, extract, essential oil, resin, gum or jelly
shall contain: name of the drug or semi-finished herbal material or traditional
medicinal material in the form of glue, granule, powder, extract, essential
oil, resin, gum or jelly; route of administration, dosage form; measuring unit;
quantity; drug category; unit price. Names of herbal drugs, drugs containing active
ingredients combined with herbal materials, traditional drugs, semi-finished
herbal materials, or traditional medicinal materials in the form of glue,
granule, powder, extract, essential oil, resin, gum or jelly in the contract
package shall be specified according to clause 3 of this Article;
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If a public health facility provides any additional
information on a contract package specified in this Clause, it shall assume
responsibility to provide explanation about such additional information.
2. Information about the dosage form of a drug in a
contract package of generic drugs, herbal drugs, drugs containing active
ingredients combined with herbal materials or traditional drugs in the drug
supplier selection plan shall be provided in accordance with Appendix I
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 has been granted certificate of marketing
authorization in a SRA or EMA country;
b) If a drug is not subject to the provisions of
Point a of this Clause, the health facility shall clearly state the necessity
and its demand for this dosage, and shall only use it in case another dosage
form cannot be used or does not respond to treatment.
3. Names of herbal drugs, drugs containing active
ingredients combined with herbal materials, traditional drugs, semi-finished
herbal materials, or traditional medicinal materials in the form of glue,
granule, powder, extract, essential oil, resin, gum or jelly in the contract
package shall be specified according to the following provisions:
a) Only ingredients of herbal drugs, drugs
containing active ingredients combined with herbal materials, traditional
drugs, semi-finished herbal materials, or traditional medicinal materials in
the form of glue, granule, powder, extract, essential oil, resin, gum or jelly
are specified; their trade names shall not be specified;
b) For herbal drugs, drugs containing active
ingredients combined with herbal materials, traditional drugs, semi-finished
herbal materials, or traditional medicinal materials in the form of glue,
granule, powder, extract, essential oil, resin, gum or jelly that have the same
ingredients or dosage form: only contents or concentrations of the ingredients
are specified if the difference in contents or concentrations leads to the
difference in dose and indications according to opinions given by the Council.
4. Price of the contract package:
a) The price of the contract package shall comply
with the provisions of Clause 1 Article 16 of the Decree No. 24/2024/ND-CP;
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c) Grounds for determination of the price of the
contract package shall comply with provisions of Clause 2 Article 16 of the
Decree No. 24/2024/ND-CP. Additionally, the public health facility may refer to
the successful bids of drugs, herbal materials or traditional medicinal
materials in the same technical criteria category of public health facilities
or through provincial centralized bidding sessions conducted within the 12
months prior to the date of submission of the drug supplier selection plan for
approval or through the national centralized bidding sessions or their
effective negotiated prices under framework agreements published on the web
portal of the Ministry of Health of Vietnam; or the website of the national
centralized procurement unit; or obtained from the Vietnam E-Procurement System
(VNEPS) or collected by the public health facility itself;
d) The proposed price of items with the same active
ingredient, concentration or content, route of administration and dosage form
in the generic drug contract package must comply with the following rules:
- The proposed price of category 1 shall not be
higher than that of the original brand-name drug or reference biological;
- The proposed price of category 2 or category 3
shall not be higher than that of the original brand-name drug or reference
biological and that of category 1;
- The proposed price of category 4 shall not be higher
than the proposed prices of the original brand-name drugs or reference
biologicals, and drugs of category 1, drugs of category 2 manufactured in
Vietnam, and drugs of category 3;
- The proposed price of category 5 shall not be
higher than the proposed prices of the original brand-name drugs or reference
biologicals, and drugs of category 1, category 2, category 3 and category 4.
5. Funding sources: Funding sources must be clearly
specified as prescribed in clause 3 Article 39 of the Law on Bidding. Where the
duration of a package exceeds 01 year, the funding sources may be determined on
the basis of the procurement cost estimate of the current budget year and
planned procurement cost estimates of the following budget years.
6. Drug supplier selection method and procedure:
a) Drug supplier selection methods: Based on the
price and nature of each contract package, one of the following drug supplier
selection methods will be adopted: competitive bidding, limited bidding, direct
contracting, shopping method, direct procurement, online quotation and online
procurement;
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7. Drug supplier selection duration: The starting
time and duration of the drug supplier selection must be clearly specified
according to clause 5 Article 39 of the Law on Bidding.
8. Type of contract: The specific type of contract
must be determined according to Article 64 of the Law on Bidding as the basis
for preparation of bidding documents, request for proposals, and signing of the
contract.
9. Duration of the contract package: The duration
for execution of the contract package shall be specified according to clause 7
Article 39 of the Law on Bidding but shall not exceed 36 months.
10. Additional purchase option (if any):
a) If the additional purchase option applies, the
quantity and estimated value of the additional purchase must be specified;
b) The additional purchase option may be applied
if: the bidder has won the bid through the competitive bidding; the quantity of
additional purchase does not exceed 30% of that of the corresponding drug
specified in the contract; there is an approved cost estimate for the
additional purchase; the unit price of the drug additionally purchased shall
not be higher than that of the drug specified in the contract; and the
additional purchase option is exercised during the validity period of the
contract.
11. Supervision of bidding activities (if any).
Article 13. Submission,
appraisal and approval of drug supplier selection plan
1. The request for approval of the drug supplier
selection plan shall be made using the form in Appendix II enclosed herewith.
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2. The drug supplier selection plan shall be
appraised according to Article 128 of the Decree No. 24/2024/ND-CP. The
appraisal report is made using the form in the Appendix III enclosed herewith.
3. The approval of the drug supplier selection plan
shall comply with Articles 40 and 41 of the Law on Bidding.
4. In case of procurement prescribed in clause 3
Article 3 of this Circular, the head of the unit in charge of the procurement
or the unit appointed to take charge of the procurement shall organize
appraisal and approval of the drug supplier selection plan.
Article 14. Preparing bidding
documents and request for proposals (RFP)
1. The bidding documents or RFP shall be prepared
according to the following provisions:
a) Bidding documents for contract packages of
herbal materials and traditional medicinal materials shall be prepared using
the forms in Appendix IV enclosed herewith;
b) Bidding documents for contract packages of
original brand-name drugs; generic drugs; herbal drugs, drugs containing active
ingredients combined with herbal materials or traditional drugs; 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 shall be prepared
using the forms in Appendix V enclosed herewith;
c) Regarding contract packages of drugs, herbal
materials and traditional medicinal materials applying shopping method: health
facilities shall prepare appropriate bidding documents using the forms in
Appendix IV and Appendix V enclosed herewith and in conformity with provisions
of point c clause 1 Article 45 of the Law on Bidding, clause 1 Article 79 of
the Decree No. 24/2024/ND-CP.
d) RFP for contract packages of drugs applying
common direct procurement or direct contracting procedure shall be prepared
with reference to contents and forms of bidding documents and RFP issued by the
Ministry of Health of Vietnam or the Ministry of Planning and Investment of
Vietnam.
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Article 15. Evaluation of
bids/proposals, consideration for contract award and use of drugs
1. Bids/proposals shall be evaluated in accordance
with regulations of law on bidding. During evaluation of the drug-related
information, in addition to the documents provided by the bidder, the procuring
entity may use the drug-related information (certificate of marketing
authorization or import license), information on fulfillment of GMP
requirements of the manufacturer and other information in official dispatches
and/or decisions giving approval of Drug Administration of Vietnam, or
Traditional Medicine Administration of Vietnam, or published on the websites of
these authorities.
2. The award of contract shall be subject to a
bidder’s satisfaction of the prerequisites set out in Article 61 of the Law on
Bidding and the issued bidding documents or RFP, and the following provisions:
a) The procuring entity shall propose the
successful bidder for each part specified in the approved drug supplier
selection plan (except the contract package specified in Point b Clause 2 of
this Article). Only a drug, herbal material or traditional medicinal material
in a category (which is a part of the contract package) which satisfies
technical and quality requirements specified in the bidding documents or RFP
and for which the bid after error correction and deviation adjustment minus (-)
discount (if any) is the lowest bid (if the least-cost method is applied), or
the evaluated bid is the lowest bid (if the lowest evaluated bid method is
applied), shall be proposed;
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 RFP and its submitted bid for each part of the contract package
and total value of the contract package after error correction and deviation
adjustment minus (-) discount (if any) is the lowest bid (if the least-cost
method is applied), or its evaluated bid is the lowest bid (if the lowest
evaluated bid method is applied). In this case, the price of the contract
package includes costs of packaging for the requested quantity of drugs.
3. If there are changes in a drug bidded for during
the drug supplier selection or the drug supply but the substitute drug is not
offered in the bid or proposal, the purchaser may consider allowing the drug
supplier to supply the substitute drug to meet its medical examination and
treatment requirements in the following cases:
a) There are changes in information on an original
brand-name drug or reference biological in comparison with the information in
the decision to grant marketing authorization:
- If the changes do not involve any contents of the
decision to announce the list of original brand-name drugs and reference
biologicals, a drug authority's approval for such changes is required or such
changes must be disclosed following procedures for registration of changes in
the marketing authorization;
- If there are changes in the contents of the
decision to announce the list of original brand-name drugs and reference
biologicals, such changes must be updated and included in the list of original
brand-name drugs and reference biologicals;
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c) There are changes in the marketing authorization
number of a generic drug or a new import license is issued but other
information remains unchanged;
d) There are changes in the marketing authorization
number of a generic drug or a new import license is issued and there is one or
some of the following changes: change in name of the drug; change in name of
the manufacturer or the method for specifying address of the manufacturer (but
the manufacturing factory is unchanged); changes in the manufacturing factory
which do not influence on the manufacturer’s fulfillment of GMP requirements;
increase in shelf life of the drug; changes in packaging specifications but the
content, concentration or volume of the drug specified in the bidding documents
or RFP remains unchanged; changes in quality specifications of the drug as a
result of application of new version of Pharmacopoeia as prescribed; changes in
quality specifications but new qualification specifications shall not be lower
than those of the selected drug or offered in the bid or proposal.
4. When supplying a substitute drug in the cases
prescribed in Clause 3 of this Article, the supplier shall provide all
necessary information for the procuring entity for its evaluation of the
substitute drug, including: decisions and official dispatches on approval of
the changes issued by competent authorities, and explanations and/or
commitments on unchanged quality specifications of the substitute drug.
5. The head of the health facility and the
successful drug supplier shall execute the drug supply contract in accordance
with relevant laws on business contracts, and ensure that at least 80% of the
value of each part in the signed contract shall be executed. For specially
controlled drugs, intravenous fluids and other cases, after reporting to a
competent authority, the health facility ensures that at least 50% of the value
of each part in the signed contract shall be executed. For emergency treatment
drugs, antidotes and rare drugs, public health facilities shall take actions
appropriate for its actual conditions.
If a health facility fails to complete at least 80%
or 50%, for specially controlled drugs and intravenous fluids, of the value of
each part in the signed contract, its head shall be required to provide
explanations to a competent person.
Article 16. Selection of drug
suppliers for retailers located within precinct of public health facilities
Retailers located within the precinct of public
health facilities shall purchase drugs according to the following provisions:
1. For drugs covered by the health insurance fund
as prescribed by the law on health insurance:
a) Public health facilities may develop their own
drug supplier selection plans and carry out the procurement adopting one of the
contractor selection methods specified in clause 1 Article 20 of the Law on
Bidding, documents elaborating this law, and provisions of this Circular;
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2. For cases other than those specified in Clause 1
of this Article, public health facilities shall make their own decision to
purchase drugs in a manner that ensures openness, transparency, economic
efficiency, and accountability.
Chapter IV
CENTRALIZED PROCUREMENT
OF DRUGS
Section 1. GENERAL PROVISIONS
Article 17. Notification of
centralized procurement roadmap/schedule
1. In order to facilitate public health facilities’
organization of drug supplier selection to ensure adequate drugs to serve their
medical examination and treatment, centralized procurement units shall promptly
notify such public health facilities of the drug supplier selection in the
following cases:
a) The drug supplier selection has been carried out
according to the drug supplier selection plan approved by a competent authority
but, at least 03 months before the expiration of the signed framework
agreement, the drug supplier selection result is not available;
b) The drug supplier selection has been carried out
but no bids are received or none of the bidders meets relevant technical
requirements or all bids after error correction and deviation adjustment minus
(-) discount (if any) of the technically-responsive bidders included in list of
bidders to be ranked exceed the price of the contract package, and the
situation cannot be handled according to clause 8 Article 131 of the Decree No.
24/2024/ND-CP.
Within 10 days after the event in this Point is
certified, centralized procurement units shall give notification thereof to
health facilities under their management and relevant units.
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- If the bidding documents or RFP has been issued,
the centralized procurement unit shall continue conducting the drug supplier
selection according to the approved drug supplier selection plan;
- If the bidding documents or RFP is not yet
issued, the centralized procurement unit shall notify such change to public
health facilities whose demands have been consolidated and relevant units
within 05 working days after it receives information on such change.
2. When it is unable to carry out the regulation as
prescribed in Article 33 of this Circular, the national centralized procurement
unit shall give written notification to health facilities and Departments of
Health of provinces or central-affiliated cities (hereinafter referred to as
“provincial Departments of Health”) so that they can proactively determine
their demands and organize the drug supplier selection in the following cases:
- Public health facilities have used up the
quantity of drugs specified in the framework agreement or have unexpected
demands for drugs which are beyond the regulating capacity of the national
centralized procurement unit;
- Public health facilities are established after
demands for drugs have been determined, and the increased demands exceed the
regulating capacity of the national centralized procurement unit;
For antiretroviral drugs, tuberculosis treatment
drugs and vaccines: the national centralized procurement unit shall cooperate
with the units in charge of consolidating demands prescribed in points a, b and
c clause 1 Article 22 of this Circular (hereinafter referred to as “units in
charge of consolidating demands”) in giving notification so that public health
facilities can proactively organize the drug supplier selection to ensure
adequate drugs to serve their medical examination and treatment.
3. When it is unable to carry out the regulation as
prescribed in Article 34 of this Circular, provincial centralized procurement
units shall give written notification of their provincial centralized
procurement status to health facilities in their provinces so that they can
proactively determine their demands and organize the drug supplier selection in
the following cases:
a) Public health facilities have used up the quantity
of drugs specified in the framework agreement or have unexpected demands for
drugs which are beyond the regulating capacity of the relevant provincial
centralized procurement unit;
b) Public health facilities are established after
demands for drugs have been determined, and the increased demands exceed the
regulating capacity of the relevant provincial centralized procurement unit.
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Article 18. Drug supplier
selection method and procedure
1. Drug supplier selection methods:
a) Domestic competitive bidding: applied to all
contract packages;
b) Direct contracting: applied to all contract
packages for drugs which are included in the list of drugs procured through
centralized procurement but must be purchased as prescribed in point c clause 1
Article 23 of the Law on Bidding and clause 1 Article 94 of the Decree No.
24/2024/ND-CP.
2. Drug supplier selection procedure: the
single-stage two-envelope procedure shall be adopted as prescribed in Article
30 of the Law on Bidding, except the cases of contract packages prescribed in
point b clause 1 of this Article where the simplified direct contracting
procedure is applied at the purchaser’s discretion. Centralized procurement
units shall only apply the single-stage two-envelope procedure as the law on
science and technology provides for guidelines thereon.
Article 19. Implementation
methods
The centralized procurement of drugs shall be
carried out by signing a framework agreement, except for the following cases
where a contract may be signed directly:
1. Procurement of drugs and vaccines serving the
implementation of expanded immunization programs and/or projects funded by
state budget under decisions of the Minister of Health of Vietnam or
Chairpersons of Provincial People’s Committees.
2. Procurement of drugs under programs and/or
projects funded by ODA, aid, sponsorship from domestic and overseas sponsors
who require direct contract conclusion.
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2. The drug supplier selected applying centralized
procurement method shall supply drugs with the agreed quantity and schedule
specified in the contract signed with each health facility.
Centralized drug procurement units shall cooperate
with units in charge of consolidating demands and successful drug suppliers in
regulating the contract execution in a manner that ensures sufficient supply of
drugs for health facilities.
3. Duration of a national or provincial centralized
procurement package shall be specified in the drug supplier selection plan
approved by a competent authority but shall not exceed 36 months from the
effective date of the signed contract until the day on which contractual works
are accepted and all contractual obligations are fulfilled.
4. Provincial Departments of Health, health
facilities, units in charge of consolidating demands and provincial centralized
procurement units shall review and consolidate demands in terms of list of
drugs and quantities of each of health facilities under their management, and
regulate the execution of contracts in a manner ensuring that at least 80% of
the quantity of each part in the signed framework agreement or contract shall
be supplied. For specially controlled drugs, intravenous fluids and other
cases, after reporting to a competent authority, the health facility ensures
that at least 50% of the quantity of each part in the signed framework
agreement or contract shall be supplied. For emergency treatment drugs,
antidotes and rare drugs, public health facilities shall take actions
appropriate for its actual conditions.
Article 21. Changes in
information and substitution of drugs during drug supplier selection or
contract execution
If there are changes in a drug bidded for during
the drug supplier selection or the drug supply but the substitute drug is not
offered in the bid or proposal, the centralized procurement unit shall consider
allowing the substitution of drug according to clauses 3 and 4 Article 15 of
this Circular in order to ensure the supply of adequate drugs to serve medical
examination and treatment.
Section 2. PREPARATION,
APPRAISAL AND APPROVAL OF DRUG SUPPLIER SELECTION PLANS, BIDDING DOCUMENTS OR
REQUEST FOR PROPOSALS
Article 22. Determination of
demands for national centralized procurement
1. Units in charge of consolidating demands:
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Vietnam Administration of HIV/AIDS Control plays
the leading role and cooperates with the national centralized procurement unit in
determining and consolidating demands according to the following provisions:
- Public health facilities under management of the
Ministry of Health of Vietnam, public health facilities under management of
Ministries or central-government authorities located in provinces or
central-affiliated cities, and public health facilities under management of
provincial governments shall determine their demands for antiretroviral drugs
in terms of list of antiretroviral drugs, detailed quantities, categories,
additional quantities (if any) and supply schedules, and submit reports on
their demands to HIV/AIDS Control Agencies of province where the public health
facility is headquartered;
- Provincial HIV/AIDS Control Agencies shall
review, consolidate and assume responsibility for demands for antiretroviral
drugs of public health facilities in their provinces or cities, and send
consolidated reports on such demands to provincial Departments of Health for
consideration and decision;
- Provincial Departments of Health shall send their
written proposals indicating demands for antiretroviral drugs, which are
accompanied with the documents in Article 24 of this Circular, to Vietnam
Administration of HIV/AIDS Control;
- Vietnam Administration of HIV/AIDS Control shall
consolidate and assume responsibility for consolidated demands, and send its
proposal for procurement of antiretroviral drugs to the national centralized
procurement unit.
b) For tuberculosis treatment drugs:
The National Lung Hospital plays the leading role
and cooperates with the national centralized procurement unit in giving
instructions for determining and consolidating demands for tuberculosis
treatment drugs, or, based on the quantity of tuberculosis treatment drugs
actually used by health facilities and suppliers’ capacity in the previous
period, the estimated number of patients, determine and assume responsibility
for determined demands for tuberculosis treatment drugs and additional
quantities (if any), and sending a written proposal for procurement of tuberculosis
treatment drugs to the national centralized procurement unit;
c) For vaccines:
The General Department of Preventive Medicine plays
the leading role and cooperates with the National Institute of Hygiene and
Epidemiology and the national centralized procurement unit in giving
instructions for determining and consolidating demands for vaccines, or, based
on the quantity of vaccines actually used by health facilities and suppliers’
capacity in the previous period, and the estimated number of vaccinees,
determine demands for vaccines, and additional quantities (if any). General
Department of Preventive Medicine shall assume responsibility for determined
demands and send a written proposal for procurement of vaccines to the national
centralized procurement unit;
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The national centralized procurement unit shall
give instructions for determining and consolidating demands as follows:
- Public health facilities under management of the
Ministry of Health of Vietnam shall determine their demands in terms of list of
drugs, detailed quantities, including additional quantities (if any), assume responsibility
for their determined demands, and submit reports on their demands to the
national centralized procurement unit;
- Public health facilities under management of
Ministries or central-government authorities, infirmaries of regulatory
authorities, and private health facilities shall determine their demands in
terms of list of drugs, detailed quantities, and additional quantities (if
any), and submit reports on their demands to Departments of Health of provinces
or cities where the health facility is headquartered; provincial Departments of
Health shall consolidate demands and send reports to the national centralized
procurement unit. Health facilities assume responsibility for determined
demands submitted to the national centralized procurement unit;
- Public health facilities under management of
provincial Departments of Health shall determine their demands in terms of list
of drugs, detailed quantities, and additional quantities (if any), and submit
reports on their demands to provincial centralized procurement units.
Provincial centralized procurement units shall consolidate demands and submit
consolidated reports to provincial Departments of Health. Provincial
Departments of Health shall consider and decide demands, and assume
responsibility for their decision, and then send written proposals for
procurement of drugs to the national centralized procurement unit.
2. Consolidation of demands:
a) Provincial Departments of Health, health
facilities, and units in charge of consolidating demands shall consolidate and
send consolidated demands within a time limit which is prescribed by the
national centralized procurement unit but does not exceed 45 days;
b) If Provincial Departments of Health, health
facilities, or units in charge of consolidating demands do not send their
consolidated demands within 45 days from the day on which the national
centralized procurement unit makes initial request for consolidation of
demands, they shall be considered to have no demands for drugs;
c) If a Provincial Department of Health, health
facility, or unit in charge of consolidating demands fails to send adequate
documents as prescribed in Article 24 of this Circular, the national
centralized procurement unit shall send a written request for submission of
additional documents. Within 5 working days from the date of the request sent
by the national centralized procurement unit, if the Provincial Department of
Health, health facility, or unit in charge of consolidating demands still fails
to submit the requested documents or submits inadequate documents, the national
centralized procurement unit shall, based on the quantity of the drug used and
proposals of Provincial Departments of Health, health facilities, and units in
charge of consolidating demands, determine and consolidate demands of health
facilities, provided that the increased quantity does not exceed 30% of the
quantity of that drug used in the previous period or in 12 months prior to the
date of the request for consolidation of demands;
d) Where necessary, in order to ensure the supply
of adequate drugs to serve medical examination and treatment of public health
facilities, the national centralized procurement unit may determine demands,
including additional quantities (if any), based on the quantity of the drug actually
used in the previous period or in 12 months prior to the date of determination
of demands, provided that the increased quantity shall not exceed 30% of the
quantity of that drug actually used in the previous period or in 12 months
prior to the date of determination of demands. Then, the national centralized
procurement unit shall send written request to public health facilities under
management of the Ministry of Health of Vietnam, public health facilities under
management of Ministries or central-government authorities and provincial
centralized procurement units for review of the determined demands. If any
requested unit fails to give its response within 30 days from the date of the
written request for review of demands sent by the national centralized
procurement unit, it shall be considered to have no demand;
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Within 10 days from the date of the written request
for opinions sent by the national centralized procurement unit, Vietnam Social
Security shall give its written response. If Vietnam Social Security fails to
give its response by the abovementioned deadline or gives its response after
the abovementioned deadline, Vietnam Social Security shall be considered to
have agreed with the consolidated demand presented by the national centralized
procurement unit.
Where Vietnam Social Security disagrees with the
consolidated demand presented by the national centralized procurement unit, the
national centralized procurement unit shall receive and clarify opinions given
by Vietnam Social Security. If the national centralized procurement unit
disagrees with any opinion given by Vietnam Social Security, within 05 working
days from the date of receipt of opinions given by Vietnam Social Security, it
shall organize a meeting with Vietnam Social Security to reach an agreement.
Opinions given by the person who attends the meeting as assigned by Vietnam
Social Security shall be considered the official opinions given by Vietnam
Social Security. Any discrepancies which cannot be resolved at the meeting
shall be submitted to the Ministry of Health of Vietnam for consideration and
decision.
Where Vietnam Social Security does not assign its
representative to attend the meeting, it shall be considered to have agreed
with the consolidated demand presented by the national centralized procurement
unit after this unit has received and clarified opinions of Vietnam Social
Security.
Article 23. Determination of
demands for provincial centralized procurement
1. Determination of demands for provincial
centralized procurement:
a) Health facilities under management of provincial
governments shall determine their demands in terms of list of drugs, detailed
quantities, including additional quantities (if any), and submit reports on
their demands to provincial centralized procurement units;
b) Private health facilities engaging in provincial
centralized procurement shall determine their demands in terms of list of
drugs, detailed quantities, including additional quantities (if any), submit
reports on their demands to provincial centralized procurement units, and
assume responsibility for their submitted demands.
2. Consolidation of demands for provincial
centralized procurement:
a) The time limit for submission of demands shall be
decided by provincial centralized procurement units but shall not exceed 30
days. If a health facility does not submit their demands within 30 days from
the day on which the provincial centralized procurement unit makes initial
request for consolidation of demands, it shall be considered to have no
demands;
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c) After consolidating demands, the provincial
centralized procurement unit shall send a written request to the Social
Security Office of province or city (hereinafter referred to as “provincial
Social Security Office”) for its opinions on demands of public health facilities
under its management. To be specific:
- Within 10 days from the date of the written
request for opinions sent by the provincial centralized procurement unit, the
provincial Social Security Office shall give its response to the provincial
centralized procurement unit. If the provincial Social Security Office fails to
give its response by the abovementioned deadline or gives its response after
the abovementioned deadline, the provincial Social Security Office shall be
considered to have agreed with the consolidated demand presented by the
provincial centralized procurement unit.
- Where the provincial Social Security Office
disagrees with the consolidated demand presented by the provincial centralized
procurement unit, the provincial centralized procurement unit shall receive and
clarify opinions given by the provincial Social Security Office. If the
provincial centralized procurement unit disagrees with any opinion given by the
provincial Social Security Office, within 05 working days from the date of receipt
of opinions given by the provincial Social Security Office, it shall organize a
meeting with the provincial Social Security Office to reach an agreement.
Opinions given by the person who attends the meeting as assigned by the
provincial Social Security Office shall be considered the official opinions
given by the provincial Social Security Office. Any discrepancies which cannot
be resolved at the meeting shall be submitted to provincial competent
authorities for consideration and decision.
Where the provincial Social Security Office does
not assign its representative to attend the meeting, it shall be considered to
have agreed with the consolidated demand completed by the provincial
centralized procurement unit after receiving and clarifying opinions given by
the provincial Social Security Office.
Article 24. Required documents
for registration of centralized procurement demands
When submitting its demand for centralized
procurement, a health facility shall be required to submit the following
documents:
1. Summary report on implementation of the drug
supplier selection result and drug use in the previous 12 months and in the
previous period prior to the date of notification of the consolidation of
demands, the drug inventory and the planned quantity of drug of the previous
period that has not been used at the date of determination of the health
facility's demand.
2. A brief explanation for the demand for the
proposed drug. In case there is an increase in the quantity by more than 30% of
the quantity of the drug used in the previous period or in 12 months prior to
the date of determination of demands, detailed explanations must be provided.
3. Documents used as the basis for the drug
supplier selection plan as prescribed.
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- The Drug and Treatment Council in respect of the
list of drugs, quantities thereof and demands of health facilities.
- Provincial Department of Health in respect of
drugs included in the list of drugs procured through centralized procurement of
health facilities under management of the Provincial Department of Health,
including private health facilities and health facilities under management of
Ministries or central-government authorities located in the province (except
health facilities affiliated to the Ministry of Health of Vietnam).
When submitting consolidated reports on demands of
a new health facility or a health facility that first has demands for the drug,
the documents in clause 1 of this Article are not required.
Article 25. Formulation,
appraisal and approval of drug supplier selection plan
1. Formulation of drug supplier selection plan:
A drug supplier selection plan shall be prepared
according to the following provisions:
a) If the demand for a drug is high and a single
supplier is unable to supply total quantity for that drug, it may be divided
into smaller contract packages by regions or socio-economic areas to ensure the
competitiveness in bidding. The selection of more than one supplier to execute
a part of the contract package, where necessary, must be clearly stated in the
drug supplier selection plan;
b) Division of a contract package and contents of a
drug supplier selection plan shall comply with Articles 4 through 12 of this
Circular.
2. Appraisal of drug supplier selection plan:
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b) The appraising agency shall play the leading
role in organizing the appraisal of the drug supplier selection plan for
centralized procurement as prescribed in clause 2 Article 13 of this Circular;
c) Vietnam Social Security shall engage in the
appraisal of the drug supplier selection plan as prescribed in clause 4 Article
94 of the Decree No. 24/2014/ND-CP. To be specific:
Within 10 days from the receipt of the documents
submitted for approval of the drug supplier selection plan, the appraising
agency shall send a written request to Vietnam Social Security (in case of
national centralized procurement) or the provincial Social Security Office (in
case of provincial centralized procurement) (hereinafter referred to as “Social
Security Office”) for its opinions about the drug supplier selection plan,
except the contents of procurement which have been unanimously agreed upon as
prescribed in point dd clause 2 Article 22 and point c clause 2 Article 23 of
this Circular;
Within 10 days from the receipt of the written
request for opinions, the Social Security Office shall clearly give its
opinions on the drug supplier selection plan. If the Social Security Office
fails to give its opinions by the abovementioned deadline or gives its opinions
after the abovementioned deadline, it shall be considered to have agreed with
all contents of the drug supplier selection plan presented by the appraising
agency.
Where the Social Security Office disagrees with any
contents of the drug supplier selection plan presented by the appraising
agency, the appraising agency shall cooperate with the centralized procurement
unit in receiving and clarifying opinions given by the Social Security Office.
If the appraising agency disagrees with any opinion given by the Social
Security Office, within 5 working days from the date of receipt of opinions
given by the Social Security Office, it shall organize a meeting with the
Social Security Office to reach an agreement. Opinions given by the person who
attends the meeting as assigned by the Social Security Office shall be
considered the official opinions given by the Social Security Office. Any
discrepancies which cannot be resolved at the meeting shall be submitted to the
Ministry of Health of Vietnam (in case of national centralized procurement) or
a provincial competent authority (in case of provincial centralized
procurement) for consideration and decision.
Where the Social Security Office does not assign
its representative to attend the meeting, it shall be considered to have agreed
with the drug supplier selection plan completed by the centralized procurement
unit after receiving and clarifying opinions given by the Social Security
Office.
3. Approval of drug supplier selection plan:
a) The Ministry of Health of Vietnam shall consider
approving the drug supplier selection plan for national centralized procurement
on the basis of the documents submitted for approval of the drug supplier
selection plan by the national centralized procurement unit, appraisal report
and request of the appraising agency;
b) The provincial competent person shall consider
approving the drug supplier selection plan for provincial centralized
procurement on the basis of the documents submitted for approval of the drug
supplier selection plan by the provincial centralized procurement unit,
appraisal report and request of the appraising agency.
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1. Based on the approved drug supplier selection
plan, the centralized procurement unit shall organize the preparation,
appraisal and approval of the bidding documents or RFP according to Article 14
of this Circular.
2. Where more than one supplier will be selected to
execute a part of the contract package or an undivided contract package, the
bidding documents or RFP must impose requirements for bid submission, and
methods for evaluation and ranking of bidders, including provisions allowing
bidders to submit bids according to their supply capacity so that bidders can
develop measures for submitting bids according to their supply capacity.
Section 3. ORGANIZATION OF
DRUG SUPPLIER SELECTION
Article 27. Evaluation of bids
or proposals
1. Depending on the nature of the contract package,
drug supplier selection method and procedure, the procuring entity shall adopt
appropriate method for evaluating bids or proposals according to Article 58 of
the Law on Bidding. The method for evaluating bids or proposals must be
specified in the bidding documents or RFP.
2. Evaluation of bids or proposals for each part of
the contract package which is divided into smaller parts shall comply with
provisions of the Law on Bidding, except the cases prescribed in point b clause
2 Article 15 of this Circular. To be specific:
a) The drug-related information shall be evaluated
on the basis of the certificate of marketing authorization or import license,
information on fulfillment of GMP requirements of the manufacturer and other
information in official dispatches and/or decisions giving approval of Drug
Administration of Vietnam, or Traditional Medicine Administration of Vietnam,
or published on the websites of the Drug Administration of Vietnam, the
Traditional Medicine Administration of Vietnam, the national centralized
procurement unit (if any) and provincial centralized procurement units (if
any);
b) The evaluation of capacity and experience of a
bidder shall be based on the total parts of the contract package in which the
bidder participates.
Article 28. Ranking of bidders
and award of contract
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The expert team shall prepare and send a report on
evaluation of bids or proposals to the centralized procurement unit for
consideration and ranking of bidders.
2. Award of contract:
The award of contract shall be subject to a
bidder’s satisfaction of the prerequisites set out in Article 61 of the Law on
Bidding and the issued bidding documents or RFP.
Section 4. APPRAISAL,
APPROVAL, DISCLOSURE AND IMPLEMENTATION OF DRUG SUPPLIER SELECTION RESULT
Article 29. Submission of drug
supplier selection result for appraisal and approval
Based on the report on evaluation of bids or
proposals, the centralized procurement unit shall organize appraisal and
approval of the drug supplier selection result according to Article 13 of this
Circular.
Article 30. Completion,
signing and disclosure of framework agreement
1. The centralized procurement unit and the
selected supplier shall complete contents of the framework agreement according
to point e clause 1 Article 89 of the Decree No. 24/2024/ND-CP as the basis for
signing of the framework agreement.
2. If a supplier wins bids for the same product in
different contract packages, the supplier shall be required to submit a
statement that they have adequate experience and capacity to supply drugs
according to the specified quality and supply schedule; this statement shall be
considered an integral part of the framework agreement.
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a) publish the framework agreement on the web
portal of the Ministry of Health of Vietnam, and on its website, and publish
information on the drug supplier selection result according to point a clause 1
and clause 4 Article 8 of the Law on Bidding;
b) send written notification of the drug supplier
selection result to bidders within 05 working days from the day on which the
drug supplier selection result is approved;
c) send written notification to public health
facilities under management of the Ministry of Health of Vietnam; public health
facilities under management Ministries or central-government authorities;
provincial Departments of Health and units in charge of consolidating demands.
4. Provincial Departments of Health, health
authorities of Ministries or central-government authorities, and units in
charge of consolidating demands shall notify the drug supplier selection result
and the framework agreement to health facilities within the scope of the
framework agreement.
5. Each provincial centralized procurement unit
shall:
a) publish the framework agreement on the web
portal of the provincial People's Committee, the website of the provincial
Department of Health, and on its website (if any), and publish information on
the drug supplier selection result according to point a clause 1 and clause 4
Article 8 of the Law on Bidding;
b) send written notification of the drug supplier
selection result to bidders within 05 working days from the day on which the
drug supplier selection result is approved;
c) send written notification to health facilities
under management of the provincial government.
Article 31. Completion and
signing of drug supply contract
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1. The compliance with supply conditions set out in
the framework agreement must be ensured.
2. The price of each drug in the contract does not
exceed the successful bid announced by the relevant centralized procurement
unit.
3. Duration of the contract package is specified in
the drug supplier selection plan approved by a competent authority but shall
not exceed 36 months from the effective date of the signed contract until the
day on which all contractual obligations are fulfilled.
Article 32. Payment for and
finalization of drug supply contracts
1. Centralized procurement units (in case of direct
conclusion of contract) or health facilities (in case of conclusion of the
framework agreement) shall make payments and carry out finalization of
contracts with drug suppliers in accordance with regulations of law and under
terms and conditions of the signed contracts.
2. The written approval for transfer of drugs
between health facilities given by a centralized procurement unit shall be
considered a part of the drug supply contract, and the basis for the health
facility and the drug supplier to sign an appendix to the contract (if the
quantity of drug to be transferred is included in the framework agreement) or
sign a new contract (if the quantity of drug to be transferred is not included
in the framework agreement).
Article 33. Regulating
implementation of framework agreement for national centralized procurement
1. The units in charge of consolidating demands
prescribed in clause 1 Article 22 of this Circular assume responsibility to
regulate the use of drugs supplied by the supplier that is selected through the
national centralized bidding under the signed framework agreement or contract.
2. A selected drug may be regulated by executing the
additional purchase option and making the drug transfer between health
facilities. Such regulation shall be made following the procedures for
regulating drugs procured through national centralized procurement announced by
the national centralized procurement unit. A health facility is only eligible
for replenishment of a drug procured through national centralized procurement
on the condition that:
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b) Drugs of other categories of the same active
ingredient, concentration or content have to be suspended from supply or
marketing or removed from the list of drugs of evidenced bioequivalence after
they are selected;
c) The selected supplier is unable to fully supply
the quantity of drugs of a category as specified in the signed contract due to
force majeure events. In this case, the supplier’s written notification
enclosed with relevant supporting documents must be provided; or
d) A drug is necessary to meet treatment demands.
In this case, the health facility is required to provide convincing
explanation.
3. If the demand for a drug of a health facility
under management of a Ministry or central-government authority or provincial
government exceeds the quantity of that drug supplied under the framework
agreement, the provincial centralized procurement unit or the provincial unit
in charge of consolidating demands (for antiretroviral drugs, tuberculosis
treatment drugs, or vaccines) shall be notified to consolidate and regulate the
transfer of drug quantities between provincial health facilities, provided that
total quantity of drug to be supplied to all health facilities in that province
or city under the framework agreement must not be exceeded. Within 10 days from
the receipt of a written request for replenishment of drugs from a health
facility, the provincial centralized procurement unit or the provincial unit in
charge of consolidating demands shall give its written response or make regulation.
If demands for drugs of health facilities under
management of Ministries, central-government authorities or provincial
governments exceed the regulating capacity of provincial centralized
procurement units or provincial units in charge of consolidating demands (for
antiretroviral drugs, tuberculosis treatment drugs, or vaccines), or demands
for drugs of health facilities under management of the Ministry of Health of
Vietnam exceed the drug quantities distributed under the framework agreement, or
health facilities’ unexpected demands for drugs have not been included in the
drug supplier selection plan, provincial centralized procurement units or
provincial units in charge of consolidating demands (for antiretroviral drugs,
tuberculosis treatment drugs, or vaccines) or health facilities under
management of the Ministry of Health of Vietnam shall inform such demands to
units in charge of consolidating demands to regulate the transfer of drug
quantities between health facilities.
Within 05 working days from the receipt of the
written request for replenishment of drugs from provincial health facilities,
provincial centralized procurement units or provincial units in charge of
consolidating demands (for antiretroviral drugs, tuberculosis treatment drugs, or
vaccines) shall send reports on such request to units in charge of
consolidating demands.
Within 15 days from the receipt of the written
request from the provincial centralized procurement unit or the provincial unit
in charge of consolidating demands (for antiretroviral drugs, tuberculosis
treatment drugs, or vaccines) or a health facility under management of the
Ministry of Health of Vietnam, units in charge of consolidating demands shall
give their written responses or make regulation. If a request is refused,
reasons for such refusal must be indicated in the written response.
4. After the quantity of drugs procured under the
framework agreement has been fully transferred between health facilities to
meet their demands, the national centralized procurement unit or unit in charge
of consolidating demands shall make regulation by executing the additional
purchase option. The quantity of drugs replenished to health facilities shall
not exceed the quantity specified in the approved drug supplier selection plan,
including additional quantity received by executing the additional purchase
option.
5. Drugs are regulated to meet demands of health
facilities and ensure the execution of signed contracts as prescribed in clause
4 Article 20 of this Circular.
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Article 34. Regulating
implementation of framework agreement for provincial centralized procurement
1. Provincial centralized procurement units assume responsibility
to regulate the use of drugs supplied by the supplier that is selected through
the provincial centralized bidding under the signed framework agreement or
contract.
2. A selected drug may be regulated by executing
the additional purchase option and making the drug transfer between health
facilities. Such regulation shall be made following the procedures for
regulating drugs procured through provincial centralized procurement announced
by the centralized procurement unit (if any).
3. If the demand for a drug of health facilities
exceeds the quantity of that drug supplied under the framework agreement or a
health facility's unexpected demand for a drug has not been included in the
drug supplier selection plan, the provincial centralized procurement unit shall
be notified to consolidate and regulate the transfer of drug quantities between
provincial health facilities, provided that total quantity of drug to be
supplied to all health facilities in that province or city under the framework
agreement must not be exceeded.
Within 10 days from the receipt of a written
request for replenishment of drugs from a health facility, the provincial
centralized procurement unit shall give its written response or make regulation.
If a request is refused, reasons for such refusal must be indicated in the
written response.
4. After the quantity of drugs procured under the
framework agreement has been fully transferred between health facilities, the
provincial centralized procurement unit shall make regulation by executing the
additional purchase option on the condition that total quantity of drugs
replenished to health facilities shall not exceed the quantity specified in the
approved drug supplier selection plan, including additional quantity received
by executing the additional purchase option.
5. Drugs are regulated to meet demands of health
facilities and ensure the proper use of drugs as prescribed in clause 4 Article
20 of this Circular.
6. A written request for replenishment of a drug
shall be made using the form in Appendix VI enclosed herewith.
Article 35. Additional
purchase option in centralized procurement
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1. The centralized procurement unit may purchase an
additional amount of drugs which must not exceed the maximum permissible limit
specified in the approved drug supplier selection plan to additionally supply
them for health facilities.
2. If a health facility wants to use an additional
amount of a drug under the framework agreement which is beyond the regulating
capacity and exceeds the approved quantity, after obtaining a written consent
from the centralized procurement unit, it may purchase an additional amount of
drugs within the scope of the additional purchase option. In this case, the
quantity, value and supply schedule of the drug additionally purchased must be
clearly specified in the contract or its appendix.
3. The centralized procurement unit or health
facility may make multiple additional purchases provided that total amount of
drug additionally purchased must not exceed the maximum permissible limit
specified in the approved drug supplier selection plan.
Article 36. Reporting on
implementation of supplier selection result in national centralized bidding
1. By the 10th of each month and the 10th
of the first month of each quarter or upon request, selected suppliers shall
prepare reports on their execution of contracts for supply of drugs included in
lists of drugs procured through national centralized bidding using the form in
Appendix VII enclosed herewith, and submit them to the national centralized
procurement unit and Vietnam Administration of HIV/AIDS Control (for
antiretroviral drugs).
2. By the 10th of the first month of
each quarter or upon request, health facilities under management of provincial
governments, Ministries or central-government authorities shall prepare reports
on their execution of contracts for supply of drugs included in lists of drugs
procured through national centralized bidding using the form in Appendix VII
enclosed herewith, and send them to provincial centralized procurement units
and provincial HIV/AIDS Control Agencies (for antiretroviral drugs).
3. By the 15th day of the first month of
each quarter or upon request, provincial centralized procurement units and
health facilities under management of the Ministry of Health of Vietnam shall
prepare reports on their execution of contracts for supply of drugs included in
lists of drugs procured through national centralized bidding using the form in
Appendix VII enclosed herewith, and send them to the national centralized
procurement unit and Vietnam Administration of HIV/AIDS Control (for
antiretroviral drugs).
Article 37. Reporting on
implementation of supplier selection result in provincial centralized bidding
1. By the 10th day of the first month of
each quarter or upon request, selected suppliers shall prepare reports on their
execution of contracts for supply of drugs included in lists of drugs procured
through provincial centralized bidding using the form in Appendix VII enclosed
herewith, and submit them to provincial centralized procurement units.
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Chapter V
IMPLEMENTATION
Article 38. Effect
1. This Circular comes into force from May 17, 2024.
2. From the effective date of this Circular, the
following regulations shall cease to have effect:
a) 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;
c) Clause 8 Article 1 of the Circular No.
29/2020/TT-BYT dated December 31, 2020 of the Minister of Health of Vietnam;
d) The Circular No. 15/2021/TT-BYT dated September
24, 2021 of the Minister of Health of Vietnam;
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e) The Circular No. 22/2020/TT-BYT dated December
02, 2020 of the Minister of Health of Vietnam;
g) Chapter III of the Circular No. 36/2021/TT-BYT
dated December 31, 2021 of the Minister of Health of Vietnam;
h) The Circular No. 09/2022/TT-BYT dated September
09, 2022 of the Minister of Health of Vietnam.
Article 39. Terms of reference
If any legislative documents referred to in this Circular
are superseded or amended, the new ones shall apply.
Article 40. Implementation
organization
1. Heads of central-government authorities shall
instruct public health facilities under their management to select qualified
drug suppliers in accordance with this Circular and regulations of the law on
contractor selection.
2. The Minister of Health of Vietnam shall delegate
authority to decide the procurement of drugs to 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.
3. Drug Administration of Vietnam, and Traditional
Medicine Administration of Vietnam shall update and publish the following
information on their websites:
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- 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 being herbal ingredients as certified
by the Ministry of Health of Vietnam.
b) Lists of drugs serving drug supplier selection,
including:
- List of drugs, traditional medicinal materials
and semi-finished herbal materials granted certificate of marketing
authorization or import license;
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- List of original brand-name drugs and reference
biologicals manufactured under processing contracts or technology transfer
contracts in Vietnam;
- List of drugs of evidenced bioequivalence;
- List of drugs wholly manufactured in Vietnam on
production lines fulfilling category-1 drug category criteria as prescribed in
Point c Clause 1 Article 4 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;
- 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 processed drugs (without transfer of drug
manufacturing technology);
- List of processed drugs (with transfer of drug
manufacturing technology); List of drugs which are manufactured under
technology transfer contracts and granted new or renewed certificate of
marketing authorization;
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- List of drugs and manufacturers and suppliers
committing violations against quality standards;
c) List of capable, experienced and reputable drug
manufacturers and suppliers to be invited to limited bidding.
4. Health facilities requesting for information
disclosure specified in Point c Clause 1 Article 4 of this Circular shall provide
the following documents and be legally responsible for the accuracy of the
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 VIII enclosed herewith.
5. Centralized procurement units shall take charge
of supervising and expediting the supply of drugs by selected suppliers, health
facilities’ use of drugs, and performance of regulation tasks under signed
framework agreements.
6. Bidders for contract packages of herbal drugs,
drugs containing active ingredients combined with herbal materials, 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 have fulfilled GACP requirements shall wholly
assume legal responsibility for the following contents:
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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
or RFP.
7. Regarding a drug which is included in the
approved drug supplier selection plan but no longer meets the principles and
criteria for being included in the list of drugs procured through centralized
procurement:
a) If the bidding documents or RFP has been issued,
the centralized drug supplier selection shall continue to be carried out
according to the approved drug supplier selection plan;
b) If the bidding documents or RFP is not yet
issued, the centralized procurement unit shall:
- request competent authorities to consider
permitting application of clause 5 Article 53 of the Law on Bidding; or
- notify the termination of the centralized
procurement, and request health facilities/provincial governments to
proactively organize the procurement of drugs.
8. If a drug which can be manufactured by at least
03 domestic manufacturers on production lines fulfilling EU-GMP requirements or
EU-GMP-equivalent requirements, and meet technical requirements as announced by
the Ministry of Health of Vietnam, and other quality, price and supply capacity
requirements no longer meets principles and criteria as prescribed, the unit in
charge of organizing the drug supplier selection shall consider taking one of
the following actions:
a) If the bidding documents or RFP has been issued,
the drug supplier selection shall continue to be carried out according to the
approved drug supplier selection plan and the issued bidding documents or RFP;
or
b) if the bidding documents or RFP is not yet
issued, the purchase must not grant the incentives as prescribed in point b
clause 1 Article 56 of the Law on Bidding.
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The Director of Drug Administration of Vietnam, the
Director of the Traditional Medicine Administration of Vietnam, the Director of
the Planning - Finance Department, Chief of the Ministry’s Office, the
Ministry’s Chief Inspector, head of the national centralized procurement unit,
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.
Difficulties that arise during the implementation
should be reported to the Ministry of Health of Vietnam for consideration./.
PP. MINISTER
DEPUTY MINISTER
Le Duc Luan