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MINISTRY OF HEALTH
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SOCIAL REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.
15/2019/TT-BYT
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Hanoi,
July 11, 2019
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CIRCULAR
ON BIDDING FOR SUPPLY OF DRUGS FOR PUBLIC HEALTH FACILITIES
Pursuant to Law on Bidding dated
November 26, 2013;
Pursuant to Law on Pharmacy
dated April 06, 2016;
Pursuant to Decree No.
63/2014/ND-CP dated June 26, 2014 on guidelines for some articles on contractor
selection of Law on Bidding;
Pursuant to Decree No.
54/2017/ND-CP dated May 8, 2017 on guidelines for some articles and
implementation of Law on Pharmacy;
Pursuant to Decree No.
75/2017/ND-CP dated June 20, 2017 on functions, tasks, powers and
organizational structure of the Ministry of Health;
At the request of Director of
the Drug Administration, Director of the Planning and Finance Department;
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Chapter I
GENERAL
PROVISIONS
Article 1.
Scope
1. This
Circular provides guidance on bidding for supply of drugs (modern medicines,
herbal medicines, traditional medicines, vaccines and biological medical
products) and herbal ingredients for public health facilities, including: the
division of contract packages and drug groups; prepares plans, forms, methods
and organizes selection of drug suppliers; provides guidance on centralized
procurement and price negotiation using state capital, health insurance fund,
proceeds from medical examination and treatment services and other lawful
sources of income of public health facilities.
2. The
procurement of drugs by drug retailers within the premises of public health
facilities shall comply with the provisions specified in Clause 76, Article 5
of Decree No. 155/2018/ND-CP dated November 12, 2018 amending a number of
provisions on business investment conditions under the state management scope
of the Ministry of Health. In case the health facility organizes the bidding
for supply of drugs for the drug retailers within their premises, the guidance
in this Circular shall be applied.
3. The
procurement of medicines under orders and plans of the State shall follow the
Decree No. 32/2019/ND-CP dated April 10, 2019 on task assignment, ordering or
bidding for supplying products and public services using state budget sources.
4. The
procurement of medicines for use in military health facilities shall comply
with the guidance of the Ministry of Defense and the Ministry of Public
Security.
5. The
procurement of medical oxygen, nitrite oxide (NO) and in vitro diagnostic
reagents shall comply with the Circular No. 58/2016/TT-BTC dated March 29, 2016
of the Minister of Finance on using state capital to procure and maintain
regular operation of regulatory authorities, units of the people's armed forces,
public service providers, political organizations, socio-political
organizations, socio-political-professional organizations, social
organizations, socio-professional organizations.
6. The
procurement of whole blood, qualified blood preparations shall comply with
Circular No. 05/2017/TT-BYT of April 14, 2017 of the Minister of Health on
maximum prices and cost of pricing a unit of whole blood or blood qualified
preparation, and Circular No. 20/2018/TT-BYT dated August 30, 2018 of the
Minister of Health amending some articles of the Ministry's Circular No.
05/2017/TT-BYT dated April 14, 2017 on maximum prices and cost of pricing a
unit of whole blood or blood qualified preparation.
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Other contents relating to preparation
of demand plans; signing contract with suppliers; management of use, advance,
payment for ARVs; regulations, funding sources and methods of cost support as
well as payment for ARVs to HIV-infected people with health insurance cards
shall comply with Circular No. 28/2017/TT-BYT dated June 28, 2017 of the
Ministry of Health on management of ARVs funded by health insurance fund and
cost support as well as payment for ARVs to HIV-infected people with health
insurance cards and Circular No. 08/2018/TT-BYT dated April 18, 2018 amending a
number of articles of Circular No. 28/2017/TT-BYT dated June 28, 2017 on
management of ARVs funded by health insurance fund and cost support as well as
payment for ARVs to HIV-infected people with health insurance cards.
Article 2.
Regulated entities
1. This
Circular applies to organizations and individuals participating or involved in
bidding for supply of drugs.
2. State-invested
health facilities operated under Law on Enterprises shall follow the provisions
of this Circular.
3. Private
health facilities participating in provision of medical examination and
treatment services covered by health insurance shall follow Article 52 of Law
on Bidding and the provisions of Clause 7, Article 50 of this Circular.
Article 3.
Definitions
For the purposes of this Circular;
the terms below shall be construed as follows:
1. SRA
(Stringent Regulatory Authorities) refers to drug administration specified in
Clause 10 Article 2 of Circular No. 32/2018/TT-BYT dated November 12, 2018 on
marketing authorization of drugs and medicinal ingredients.
2. Reference
authority refers to drug administration specified in Clause 9 Article 2 of
Circular No. 32/2018/TT-BYT dated November 12, 2018 on marketing authorization
of drugs and medicinal ingredients.
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4. PIC/s
(Pharmaceutical Inspection Co-operation Scheme) stands for Pharmaceutical
Inspection Co-operation Scheme.
5. GMP
requirements refer to good manufacturing practices for pharmaceutical products.
6. GACP requirements
refer to good agricultural and collection practices for herbal ingredients.
7. A drug
manufacturing line fulfilling EU-GMP requirements refers to a drug
manufacturing line granted EU-GMP certificate by a competent authority of a
country that is a member state of EMA (European Medicines Agency).
8. A drug
manufacturing line fulfilling the requirements equivalent to EU-GMP refers to a
drug manufacturing line granted GMP certificate by a competent authority of a
country that is considered SRA.
9. A drug
manufacturing line satisfying PIC/s-GMP requirements refers to a drug
manufacturing line granted PIC/s-GMP certificate by a competent authority of a
country that is a participant in PIC/s.
10. CIF price
is an import price that includes the cost, insurance and freight from the
exporting country to the Vietnamese port.
11. Reference
biological means a biological granted certificates of marketing authorization
in Vietnam on the basis of sufficient data about its quality, safety and
efficacy.
12. Pharmaceutical
equivalence means drugs containing the same active ingredient and concentration
in the same dosage form, having the same route of administration and reaching
the same quality standards.
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Article 4.
Responsibility for planning and organizing selection of drug supplier (hereinafter
referred to as “contractor”)
1. Heads of
health facilities shall organize and develop the contractor selection plan
specified in Article 14 of this Circular and the following provisions:
a) For drugs on the national list
of drugs for centralized bidding procurement, list of drugs for procurement by
price negotiation: National centralized drug procurement center shall develop
the contractor selection plan.
The plan shall be based on the
demand for drugs of health facilities according to the notification of the
national centralized drug procurement center. The implementation time is up to
36 months, categorized by drug category and supply interval (quarterly,
annually);
a) For drugs on the local lists of
drugs for centralized bidding procurement: the local centralized drug
procurement units shall develop the contractor selection plan. The plan is
based on the demand for drugs of health facilities according to the
notification of the local centralized drug procurement units. The
implementation time is up to 36 months, categorized by drug category and supply
interval (quarterly, annually);
c) For contractor selection
carried out by health facilities, the health facilities shall develop their own
contractor selection plans. The plan is made periodically or on request. The
implementation time is up to 12 months or on request, categorized by drug
category.
2. Heads of
health facilities shall organize the contractor selection plan and ensure the
following regulations:
a) For drugs on the national list
of drugs for centralized bidding procurement, list of drugs for procurement by
price negotiation: national centralized drug procurement center shall organize
the contractor selection plan specified in Chapter IV and Chapter V of this
Circular;
a) For drugs on the Local lists of
drugs for centralized bidding procurement: the local centralized drug
procurement units shall organize the contractor selection plan specified in
Chapter IV of this Circular;
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Article 5.
Reporting bidding results
1. Within 10
days from the day on which the contractor selection result is approved, Heads
of health facilities shall report the contractor selection result as below:
a) Hospitals and institutions
providing inpatient treatment affiliated to the Ministry of Health shall send
their contractor selection results to the Ministry of Health.
b) Local centralized drug
procurement units, health facilities offering bidding for supply of drugs under
management of People's Committees of provinces and central-affiliated cities
(hereinafter refer to as “provinces”) shall send contractor selection results
to Provincial Departments of Health of provinces.
c) Health facilities of other
sectors and other health facilities shall send contractor selection results to
competent authorities for approval.
2. Within up
to 10 days from the day on which the contractor selection results are received
from the units specified in Point b Clause 1 of this Article, Provincial
Departments of Health of provinces shall send a consolidated report to the
Ministry of Health.
3. Forms of
report submission:
a) Report forms shall comply with
Appendix 1 and Appendix 2 enclosed herewith;
b) Reports shall be sent by post
and email to the Ministry of Health as follows:
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- 01 copy
shall be sent to Drug Administration (Ministry of Health) at: qlgiathuoc.qld@moh.gov.vn
for procurements of generic drugs, proprietary drugs or equivalent drugs.
- 01 copy
shall be sent to Traditional Medicine Administration (Ministry of Health) at:
quanlyduoclieu@moh.gov.vn for procurements of traditional drugs, herbal drugs,
herbal ingredients and traditional ingredients.
4. Before the
31st of October every year, health authorities, hospitals and
institutions providing inpatient treatment affiliated to the Ministry of Health
and; Provincial Departments of Health of provinces and central-affiliated
cities shall prepare and send reports on violations committed by contractors
during bidding for supply of drugs by local health facilities in the previous
period as specified in Appendix 3 enclosed herewith to the Ministry of Health
(Department of Planning - Finance for all contract packages; Drug
Administration for contract packages of generic drugs, proprietary drugs or
equivalent drugs; Traditional Medicine Administration for contract packages of
herbal drugs, traditional drugs, herbal ingredients and traditional
ingredients). The reports shall be the basis for contractor evaluation in the
next period.
Article 6.
Expenses and document retention during contractor selection
1. Expenses
incurred during the process of contractor selection shall comply with Article 9
of Decree No. 63/2014/ND-CP dated June 26, 2014 on detailed guidelines for some
articles on contractor selection of Law on Bidding (hereinafter referred to as
Decree No. 63/2014/ND-CP).
2. Retention
of documents during the process of contractor selection shall comply with
Article 10 of Decree No. 63/2014/ND-CP.
Chapter II
DIVISION OF
CONTRACT PACKAGES AND DRUGS
Article 7.
Generic drug contract package
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1. Category 1
includes drugs satisfying one of the three following criteria:
a) Drugs manufactured entirely by
a manufacturing line satisfying EU-GMP requirements or equivalent requirements
in a country that is considered SRA;
b) Drugs on the list of
proprietary drugs or reference biological announced by Ministry of Health,
except for proprietary drugs on the list of drugs eligible for price
negotiation issued by Ministry of Health and with announced price negotiation
results;
c) Drugs manufactured entirely in
Vietnam and satisfy all following requirements:
- Drugs
manufactured by a manufacturing line satisfying EU-GMP requirements or
equivalent requirements and certified by drug authority of Vietnam to satisfy
EU-GMP requirements or equivalent requirements;
- Drugs
granted certificates of free sale by the national drug authority of a country
that is considered SRA as specified in Clause 8 Article 50 of this Circular;
- Drugs sold
in Vietnam and drugs granted certificates of free sale by a country that is
considered SRA shall have the same dosage form, production process, quality
criterion, verification method; active ingredients, excipients shall have the
same quality criterion, production facility and production place as specified in
Clause 8 Article 50 of this Circular.
2. Category 2
includes drugs satisfying one of the two following criteria:
a) Drugs manufactured entirely by
a manufacturing line satisfying EU-GMP requirements or equivalent requirements
and granted certificates by the drug authority of Vietnam.
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3. Category 3
includes drugs manufactured by a manufacturing line satisfying GMP requirements
and granted certificates by the drug authority of Vietnam and having evidence
of bioequivalence announced by the drug authority of Vietnam.
4. Category 4
includes drugs manufactured entirely by a manufacturing line in Vietnam
satisfying WHO-GMP requirements and granted certificates by the drug authority
of Vietnam.
5. Category 5
includes drugs manufactured by a manufacturing line satisfying WHO-GMP
requirements and granted certificates by the drug authority of Vietnam and not
included in provisions specified in Clauses 1, 2, 3 and 4 of this Article.
Article 8.
Contract package of proprietary drugs or equivalent drugs
1. Heads of
health facilities shall make decision on procurement of proprietary drugs or
equivalent drugs or reference biological on the basis of suggestions of Drug
and Treatment Council.
2. A contract
package of proprietary drugs or equivalent drugs may contain one or several proprietary
drugs or equivalent drugs or reference biological, each drug is one part of the
contract package. Drugs bidding for a contract package of proprietary drugs or
equivalent drugs shall include drugs satisfying the two following criteria:
a) Drugs on the list of
proprietary drugs or equivalent drugs and reference biological announced by
Ministry of Health, except for proprietary drugs on the list of drugs eligible
for price negotiation issued by Ministry of Health and with announced price
negotiation results;
b) Drugs manufactured entirely in
countries considered SRA, unless the health facility requests for evidence of
proprietary drugs or reference biological marketing for the first time in
countries not considered SRA or having at least one manufacturing stage in
Vietnam
Article 9.
Contract package of herbal drugs and traditional drugs (excluding traditional
ingredients)
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1. Category 1
includes drugs satisfying the two following criteria:
a) Drugs manufactured entirely
from herbal ingredients planted and collected or naturally farmed satisfying
GACP requirements and granted certificates by Ministry of Health of Vietnam;
b) Drugs manufactured entirely by
a manufacturing line in Vietnam satisfying GMP requirements of herbal drugs and
traditional drugs and granted certificates by Ministry of Health of Vietnam.
2. Category 2
includes herbal drugs and traditional drugs manufactured entirely by a
manufacturing line in Vietnam satisfying GMP requirements of herbal drugs and
traditional drugs and granted certificates by Ministry of Health of Vietnam.
3. Category 3
includes herbal drugs and traditional drugs not satisfying criteria specified
in Clauses 1 and 2 of this Article.
Article 10.
Contract package of traditional ingredients
A contract package of traditional
ingredients may contain one or several traditional ingredients; each list of
ingredient must be sorted by category; each ingredient in each category is one
part of the contract package. The contract package of traditional ingredients
is divided into 3 categories and based on technical criteria as follows:
1. Category 1
includes traditional ingredients satisfying the following two criteria:
a) Drugs manufactured from herbal
ingredients planted and collected or naturally farmed satisfying GACP
requirements and granted certificates by Ministry of Health of Vietnam;
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2. Category 2
includes traditional ingredients manufactured entirely by a manufacturing line
in Vietnam satisfying GMP requirements of traditional ingredients (including
glue, granule, extract, essential oil, resin, gum, jelly) and granted
certificates by Ministry of Health of Vietnam.
3. Category 3
includes traditional ingredients not satisfying criteria specified in Clauses 1
and 2 of this Article.
Article 11.
Contract package of herbal ingredients
A contract package of herbal
ingredients may contain one or several herbal ingredients, each list of herbal
ingredients shall be sorted by category; each ingredient in each category is
one part of the contract package. The contract package of herbal ingredients is
divided into 3 categories and based on technical criteria as follows:
1. Category 1
includes herbal ingredients planted and collected or naturally farmed
satisfying GACP requirements and granted certificates by Ministry of Health of
Vietnam.
2. Category 2
includes semi-finished herbal ingredients: glue, granule, extract, essential
oil, resin, gum, jelly manufactured by a manufacturing line in Vietnam
satisfying GMP requirements of herbal ingredients and granted certificates by
Ministry of Health of Vietnam.
3. Category 3
includes herbal ingredients not satisfying criteria specified in Clauses 1 and
2 of this Article.
Article 12.
Provisions on submission of bids of drug categories
1. Bidding
principles of drug categories in a contract package.
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b) If an offered drug manufactured
by several facilities, these facilities participated in production process
shall satisfy technical criteria of the offered drug category.
2. Contract
package of generic:
a) Drugs satisfying criteria of
Category 1 may be sorted into Category 1, Category 2, Category 5;
b) Drugs satisfying criteria of
Category 2 may be sorted into Category 2, Category 5;
c) Drugs satisfying criteria of
Category 3 may be sorted into Category 3, Category 5;
d) Drugs satisfying criteria of
Category 4 may be sorted into Category 4, Category 5;
dd) Drugs not satisfying criteria
of Category 1, Category 2, Category 3 and Category 4 shall only be sorted into
Category 5.
3. Contract
package of herbal drugs and traditional drugs:
a) Drugs satisfying criteria of
Category 1 may be sorted into Category 1, Category 2 and Category 3;
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c) Drugs not satisfying criteria
of Category 1, Category 2 shall only be sorted into Category 3.
4. Contract
package of traditional ingredients:
a) Traditional ingredients
satisfying criteria of Category 1 may be sorted into Category 1, Category 2,
Category 3;
b) Traditional ingredients
satisfying criteria of Category 2 may be sorted into Category 2, Category 3;
c) Traditional ingredients not
satisfying criteria of Category 1, Category 2 shall only be sorted into
Category 3.
5. Contract
package of herbal ingredients:
a) Herbal ingredients satisfying
criteria of Category 1 may be sorted into Category 1 and Category 3;
b) Herbal ingredients satisfying
criteria of Category 2 shall only be sorted into Category 2;
c) Herbal ingredients not
satisfying criteria of Category 1, Category 2 shall only be sorted into
Category 3.
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a) Foreign drugs manufactured
under a processing contract or technology transfer contract in Vietnam may be
sorted into the drug categories specified in Point b of this Clause if
satisfying the following criteria:
- There's a
technology transfer contract with specific comprehensive technology transfer
roadmap for the processor or technology transferee to prepare to manufacture
finished drugs in Vietnam within 5 years from the date of certificate of
marketing authorization is granted.
- Drugs
manufactured under a processing contract or technology transfer contract and
drugs manufactured without under a processing contract or technology transfer
contract shall have the same dosage form, production process, quality criteria
of ingredients and finished drugs;
- Drugs not
on the List of domestically-manufactured drugs satisfying treatment, pricing
and supply requirements issued by the Ministry of Health according to technique
criteria (except for all manufacturing stages in Vietnam when the certificate
of marketing authorization is granted in Vietnam).
b) The submission of bids for
foreign drugs manufactured under a processing contract or technology transfer
contract in Vietnam satisfying the provisions specified in Point a of this
Clause if:
- Foreign
drugs manufactured under a processing contract or technology transfer contract
in Vietnam on the List of proprietary drugs or the List of reference
bioequivalence and satisfying the provisions specified in Point b Clause 2
Article 8 of this Circular may be sorted into the contract package of
proprietary drugs or equivalent drugs. Drugs on the List of drugs for
procurement through price negotiation issued by Ministry of Health, procurement
of these drugs shall be under price negotiation form;
- Foreign
drugs specified in Point a Clause 1 Article 7 of this Circular manufactured
under a processing contract or technology transfer contract in Vietnam by a
manufacturing line satisfying EU-GMP requirements or equivalent requirements
and granted certificates by the drug authority of Vietnam may be sorted into
Category 1, Category 2, Category 4 and Category 5;
- Foreign
drugs specified in Clause 2 Article7 of this Circular manufactured under a
processing contract or technology transfer contract in Vietnam by a manufacturing
line satisfying EU-GMP requirements or equivalent requirements and granted
certificates by the drug authority of Vietnam may be sorted into Category 2,
Category 4 and Category 5;
- Other drugs
manufactured under a processing contract or technology transfer contract in
Vietnam may be sorted into Category 4 and Category 5.
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Chapter III
DRUG
PROCUREMENT FOR PUBLIC HEALTH FACILITIES
Section 1.
MAKING CONTRACTOR SELECTION PLAN
Article 13.
Basis for making contractor selection plan
1. The
contractor selection plan is made annually or whenever necessary on the
following bases:
a) State budget:
Funding of drug procurement from
state budget shall be annually provided by a competent authority. If funding
has not been provided, the plan shall be made according to the procurement and
use of drugs funded by state budget in the preceding year and the anticipated
demand for drugs in the current year;
b) Proceeds from provision of
medical examination and treatment services and payments from social insurance
agencies:
- Contract
for medical examination and treatment covered by health insurance between the
health facility and the social insurance agency;
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c) For drugs covered by other
sources of income of the health facility: the plan shall be made according to
the procurement and use of drugs covered by other sources of income in the
preceding year and anticipated demand for drugs in the planning year of the
health facility.
2. If the
health facility has selected a contractor and signed a contract but the demand
for a drug exceeds the contractual quantity by 20%, such health facility shall
make a plan for selection of additional contractor to satisfy its demand.
Article 14.
Contents of contractor selection plan
1. Name of
contract package:
Categorization of contract
packages and drug categories shall follow the provisions from Article 7 to
Article 12 of this Circular.
If a contract package is
categorized into several parts, each of them shall have a suitable name.
Specific information in contractor selection plan are as follows:
a) Each part in a contract package
of generic drugs shall include: name of the active ingredient;
content/concentration; route of administration, dosage form; category;
measuring unit, quantity; unit price and total value;
b) Each part in a contract package
of original branded name drugs or equivalent drugs shall include: name of the
drug and the phrase “or equivalent drugs”; content/concentration; route of
administration, dosage form; category; measuring unit, quantity; unit price and
total value. If an active ingredient has several names of proprietary drug or
equivalent drug or reference bioequivalence on the List of proprietary drug or
equivalent drug or reference bioequivalence published by Ministry of Health,
name of the drug shall include names of proprietary drug or equivalent drug or
reference bioequivalence;
c) Each part in a contract package
of herbal drugs or traditional drugs shall include: name of the drug; route of
administration, dosage form; measuring unit; category; quantity; unit price and
total value; Names of drugs shall be written complying with the provisions in
Article 3 of this Decree.
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2. Dosage
form of a contract package of generic drugs/herbal drugs/traditional drugs
under contractor selection plan shall be written complying with the provisions
in Appendix 4 enclosed herewith. The dosage forms (with asterisks) shall be
written separately under the condition that:
a) Having the same dosage form as
proprietary drugs or reference bioequivalence with the same active ingredients,
route of administration, or drugs with the same active ingredients, route of
administration granted certificates of free sale in SRA countries.
b) If the drug is not specified in
Point a Clause 2 of this Article, the health facility shall state clearly the
demand for using this dosage form in terms of necessity, estimated quantity and
it’s only used in case use of another dosage form is impossible;
3. Names in a
contract package of herbal drugs or traditional drugs shall be written as
follows:
a) Only specify the drug
ingredients; do not write trade names;
b) For drugs having the same
ingredients or dosage form: only specify the concentrations of the ingredients
if the difference in concentrations leads to difference in dose and indications
of treatment according to opinions of Drug and Treatment Council.
4. Value of
contract package:
a) Value of a contract package
means total value of the contract package, including all expenses;
b) If a contract package is
divided into smaller parts, each part shall specify unit price and total value
of that part as prescribed in Clause 1 of this Article, except for total value
of the contract package. The unit price in the contractor selection plan shall
be proposed by the planning health facility, which is responsible for such proposed
price;
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- The
estimated price of each drug/ingredient shall not exceed the highest successful
bid for that drug/ingredient in each published technical category;
- For drugs/ingredients whose
successful bids are unpublished or estimated prices are higher than successful
bids published by the Ministry of Health (Drug Administration of Vietnam,
Traditional Medicine Administration of Vietnam) within the previous 12 months,
the health facility shall check quotations or invoices of at least 03 suppliers
during the contractor selection plan and ensure that the price estimated by the
health facility shall not exceed the effective wholesale price of such drugs
(except for herbal ingredients and traditional ingredients).
For drugs having fewer than 03
suppliers (fewer than 03 quotations or invoices), the head of the health
facility shall propose the price according to such quotations and invoices,
provide explanation, and take responsibility for the appropriateness of the estimated
price when the contractor selection plan is made.
d) Estimated price of items with
the same active ingredients, concentrations/contents, dosage form in the
contract package of generic drugs shall comply with the following principles:
- The
estimated price of Category 1 shall not be higher than that of proprietary
drugs or reference bioequivalence;
- The
estimated price of Category 2 and Category 3 shall not be higher than that of proprietary
drugs or reference bioequivalence and Category 1;
- The
estimated price of Category 4 shall not be higher than the that of proprietary
drugs or reference bioequivalence; Category 1 and Category 2 manufactured in
Vietnam and Category 3;
- The estimated
price of Category 5 shall not be higher than that of proprietary drugs or
reference bioequivalence; Category 1; Category 2; Category 3 and Category 4.
5. Funding
sources: the health facility must specify the sources of funding for drug
procurement; if the funding source is ODA or concessional loan, the name of
sponsor and fund composition must be specified, including the aid and
counterpart fund (if any).
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a) Contractor selection methods:
Depending on the value and nature
of each contract package, the health facility shall select one of the methods
specified in Article 20 through 25 of the Law on Bidding and detailed guidance
in this Circular.
b) Contractor selection
procedures:
Depending on the contractor
selection method and value of the contract package, the health facility shall
propose contractor selection procedures as prescribed in Article 28 and Article
29 of the Law on Bidding and Decree No. 63/2014/ND-CP, and guidance in this
Circular. For a small contract package requiring quality and good prices, the
single-stage two-envelop bidding procedures shall be applied.
7. Starting
time of contractor selection:
The month or quarter in which
bidding documents or request for proposals are issued shall be specified.
8. Type of
contract shall depend on the value and nature of the contract package and
supply method as prescribed in Article 62 of the Law on Bidding.
9. Time limit
for contract execution shall be specified in the contractor selection plan
which must not exceed 12 months from the effective date of the contract.
Article 15.
Submission of contractor selection plan for approval
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2. A proposal
of contractor selection plan shall contain:
a) Basis for making the contractor
selection plan as specified in Article 13 of this Circular;
b) Contents of the contractor
selection plan as specified in Article 14 of this Circular to be specific:
- Names of
contract packages, value of each part and total value of contract packages in
the contractor selection plan and the basis for dividing the contract packages.
If the contract package of drug is funded by state budget, the total value of
contract packages in the contractor selection plan must not exceed the approved
cost estimate;
- The
contractor selection method and procedures applied to each contract package
shall be one of those specified in Articles 19, 20, 21, 22, 23, 24, 25, 26 of
this Circular. If competitive bidding is not applied, the proposal shall
explain the reason for choosing other methods.
- Explanation
for increase in using drugs manufactured in Vietnam in accordance with guidance
of Ministry of Health.
3. Documents
enclosed with the proposal:
a) Summary of the result of
contractor selection and drug use of the preceding year and explanation for the
proposed contractor selection plan;
b) Documents as the basis for
making the contractor selection plan as specified in Article 13 of this
Circular;
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d) Investors shall make decision
on approval for funding source, list, quantity and estimated price in the
contractor selection plan.
4. The
proposal of the contractor selection plan shall be sent by post or directly or
electronically to the unit appointed to appraise contractor selection plans.
The proposal of contractor selection plan shall comply with Form No. 5 in
Appendix enclosed herewith.
Article 16.
Appraisal of contractor selection plan
The contractor selection plan shall
be appraised before it is submitted to the competent person for approval as
specified in Clause 1 Article 17 of this Circular.
1. Organization
of appraisal:
a) For public health facilities
under the management of Ministries, ministerial authorities, Governmental
authorities: Ministers, Heads of ministerial authorities and Governmental
authorities shall decide the unit in charge of appraising their contractor
selection plans (hereinafter referred to as appraising unit);
b) For public health facilities under
the management of local governments:
- If
Chairperson of People's Committee of province is the competent person to
approve the contractor selection plan of the contract package, Department of
Health shall organize appraisal of the contractor selection plan.
- The person
authorized by the Chairperson of People's Committee of province (if any) to
approve the contractor selection plan shall appoint a qualified unit to
appraise the plan before approving it.
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2. Duties of
appraising unit:
a) Appraise the contents specified
in Articles 7, 8, 9, 10, 11, 12, 13, 14, 15 of this Circular within 20 days
from the day on which adequate documents are received. If documents are
inadequate, the appraising unit shall request addition of documents or return the
documents to the health facility within 05 working days from the receipt of
such documents;
b) Make an appraisal report
according to Form No. 6 enclosed herewith. The report shall be enclosed with one
set of the application for approval for appraised contractor selection plan
(original) and submitted to the competent person specified in Clause 1 Article
17 of this Circular for approval.
Article 17.
Approval for contractor selection plan
1. The power
to approve contractor selection plans:
a) Ministers, Heads of ministerial
authorities and Governmental authorities shall consider approving contractor
selection plans for health facilities under their management; Ministers, Heads
of ministerial authorities and Governmental authorities shall appoint a unit to
approve contractor selection plans for heads of health facilities under their
management In this case, the authorized person shall appoint a qualified unit
to appraise the plan before approving it.
b) Chairpersons of People's
Committee of province shall consider approving contractor selection plans of
health facilities under their management. Chairpersons of People's Committee of
province may appoint a unit to approve contractor selection plans for heads of
health facilities within their management. In this case, the authorized person
shall appoint a qualified unit to appraise the plan before approving it.
c) The legally responsible person
or the person authorized by the legally responsible person of health facilities
shall consider approving the contractor selection plan for the health
facilities not specified in Points a and b Clause 1 of this Article.
d) Task assignment of approval for
contractor selection plans of military health facilities shall comply with the
guidance of the Ministry of Defense and the Ministry of Public Security.
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3. The
contractor selection plan shall be posted on national bidding network as
prescribed in Article 8 of the Law on Bidding and its instructional documents.
Article 18.
Regulations on contractor selection self-organization for drugs on the list of
drugs for centralized bidding procurement and the list of drugs for procurement
by price negotiation
1. Health
facilities may carry out contractor selection themselves for drugs on the list
of drugs for centralized bidding procurement and the list of drugs for
procurement by price negotiation, ensure that time limit and quantity must not
exceed demand for use within 12 months (from the receipt of written
notification from centralized drug procurement units) if:
a) The health facility needs to
use a drug on the List of drugs for centralized bidding procurement or the list
of drugs for procurement by price negotiation but the results of centralized
contractor selection or price negotiation have not been published;
b) The health facility needs to
use a drug on the list of drugs for centralized bidding procurement or the list
of drugs for procurement through price negotiation with a concluded supply
contract but the selected contractor is unable to supply drugs and the receipt
of notification from the centralized drug procurement unit of contractor
selection self-organization.
c) The health facility has used up
the quantity of drugs specified in the framework agreement and exceeds the
capacity specified in Clause 5 Article 37, Clause 13 Article 40 and Clause 12
Article 41 of this Circular;
d) The health facility is
established after the demand for drugs has been determined, and the increased
demand exceeds the capability of the national centralized drug procurement
center and the local centralized drug procurement unit.
2. A health
facility shall not carry out contractor selection for supply of drugs on the
national list of drugs for centralized bidding procurement or local lists of
drugs for centralized bidding procurement or list of price negotiation if the
contractor selection result is available on the date of issuance of the bidding
documents and a framework agreement has been published, except for the cases
specified in Points b, c and d Clause 1 of this Article. If such health
facility still carries out contractor selection and signs a contract with
another contractor, the contract shall not be paid for.
Section 2.
CONTRACTOR SELECTION METHODS
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Competitive bidding shall be
applied to every contract package regulated by this Circular, except for the
cases in Article 20 through 24 hereof.
Article 20.
Selective bidding
1. Selective
bidding shall be applied to any procurement under special control of the
Ministry of Health or any procurement of special drugs that can be supplied by
few suppliers.
2. Drug
manufacturers and drug suppliers included by the Ministry of Health on the list
of capable, experienced, reputable manufacturers specified in Point dd Clause 1
Article 77 of Decree No. 63/2014/ND-CP shall be invited to participate in
selective bidding if their drugs are suitable for the procurements.
Article 21.
Direct contracting
1. Usual
direct contracting and simplified direct contracting:
a) Usual direct contracting
applies to contract packages worth VND1 billion at most specified in Point e,
Clause 1, Article 22 of Law on Bidding;
a) Simplified direct contracting
applies to contract packages specified in Point a Clause 1 Article 22 of Law on
Bidding and Article 79 of the Decree 63/2014/ND-CP.
2. Procedures
of usual direct contracting and simplified direct contracting:
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b) The simplified direct
contracting procedures are specified in Article 56 of Decree No. 63/2014/ND-CP
after the contractor selection plan is approved.
In case of direct contracting
specified in Point a Clause 1 Article 22 of Law on Bidding (except for contract
packages that are state secrets), the provisions specified in Clause 8 Article
6 of Circular No. 10/2015/TT-BKHDT dated October 26, 2015 of Minister of
Planning and Investment on contractor selection plans.
Article 22.
Competitive offering
1. Competitive
offering shall be applied when all of the conditions below are satisfied:
a) The contract package value does
not exceed VND5 billion;
b) The drug on the list of
essential medicines promulgated by the Ministry of Health or a commonly
available drug whose technical characteristics and quality have been
standardized and equivalent;
c) There is a contractor selection
plan approved by the competent person;
d) If the contract package is
funded by state budget, it is required to have an approved cost estimate. If
the contract package is funded by another funding source, it must be sufficient
to pay for the contract package on schedule.
2. The
competitive offering procedures are specified in Article 58 and Article 59 of
Decree No. 63/2014/ND-CP.
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1. Direct
procurement shall be applied when all of the conditions below are satisfied:
a) The contractor has won the
contract through competitive bidding or selective bidding and has signed a
contract earlier;
b) The current procurement
includes similar drugs and the value is smaller than 130% of the earlier
contract. If the drug of the direct procurement is one of the drugs of a
similar contract signed earlier, the value of the direct procurement must be
smaller than 130% of that of the same kind of drug of the earlier contract;
c) Unit prices of drugs of the
direct procurement do not exceed those of corresponding drugs in the earlier
contract and suitable for the successful bids announced at the time of approval
for contractor selection plan;
d) The period of time from the
signing date of the earlier contract to the date on which the direct
procurement result is approved must not exceed 12 months. In a 12-month period,
a health facility may make only one procurement of each product in the earlier
contract. In special cases, the health facility shall submit a document to the
competent person specified in Clause 1 Article 17 of this Circular for
consideration.
2. If the
previous contractor is no longer capable of executing the direct procurement
contract, another contractor who satisfies the requirements (in terms of capacity,
experience, technology and prices) in the bidding documents and the previous
contractor selection result may be selected.
3. The direct
procurement procedures are specified in Article 60 of Decree No. 63/2014/ND-CP.
Article 24.
Self-supply
1. Self-supply
shall be applied to the procurements specified in Article 25 of Law on Bidding
after all provisions specified in Article 61 of Decree No. 63/2014/ND-CP are
satisfied.
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Section 3.
CONTRACTOR SELECTION PROCEDURES
Article 25.
Single-stage one-envelop procedures
Single-stage one-envelop
procedures shall be applied to:
1. Small-value
contract packages through competitive bidding or selective bidding specified in
Article 63 Decree No. 63/2014/ND-CP;
2. Contract
packages through competitive offering;
3. Contract
packages through direct procurement;
4. Contract
packages through usual direct contracting.
Article 26.
Single-stage two-envelop procedures
Single-stage two-envelop
procedures shall be applied to:
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2. Contract
packages worth less than VND10 billion through competitive bidding or selective
bidding but both quality and prices have to be taken into account.
Section 4.
BIDDING DOCUMENTS AND REQUEST FOR PROPOSALS
Section 27.
Preparing bidding documents amd request for proposals
1. Bidding
documents or request for drug procurement shall be prepared in accordance with Law
on Bidding and the following instructional documents and provisions:
a) The bidding documents and
request for drug procurements of proprietary drugs or equivalent drugs, generic
drugs, herbal drugs and traditional drugs shall comply with the bidding documents
applying one-stage one-envelop procedures specified in Appendix 7 or bidding
documents applying one-stage two-envelop procedures specified in Appendix 8
enclosed herewith.
b) The bidding documents and
request for contract packages of traditional ingredients and herbal ingredients
shall comply with the guidance of Ministry of Health on detailed bidding
documents for procurement of herbal and traditional ingredients for health
facilities.
2. According
to the contractor selection plan approved by a competent authority, the
procuring entity shall prepare the bidding documents or request for drug
procurement and submit an application for approval to the appraising unit.
3. The
bidding documents or request for drug procurement must specify that contractors
shall not offer imported drugs in the same categories as drugs on the list of
domestically manufactured drugs satisfying treatment, pricing and supply
requirements published by the Ministry of Health (hereinafter referred to as
Circular No. 03/2019/TT-BYT), to be specific:
a) Drugs on the list enclosed with
Circular No. 03/2019/TT-BYT satisfying WHO-GMP technical criteria may not offer
imported drugs satisfying technical criteria of category 5 specified in Clause
5 Article 7 of this Circular.
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4. The
bidding documents or request for herbs procurement must specify that
contractors shall not offer imported herbs in the same categories as herbs on
the list of domestically planted and collected herbs satisfying treatment,
pricing and supply requirements published by the Ministry of Health.
5. Due to
unexpected increase in demand, drugs on the list of domestically manufactured
drugs satisfying treatment, pricing and supply capacity or herbs on the list of
domestically planted and collected drugs satisfying treatment, pricing and
supply capacity exceed supply capacity of domestic manufacturing facilities or
health facilities, Ministry of Health shall decide the imported drug/herbs
offering in the same technical criteria categories as drugs/herbs on the list
of domestically manufactured drugs/domestically planted and collected herbs
satisfying treatment, pricing and supply requirements in a certain time to
ensure sufficient supply of drugs/herbs.
Section 28.
Appraising bidding documents and request for proposals
1. Bidding
documents and request for proposals shall be appraised before it is submitted
to heads of health facilities for approval.
2. Appraising
units shall be decided by heads of health facilities.
3. Duties of
appraising unit:
Inspect the contents of bidding
documents or request for proposals in accordance with Law on Bidding as well as
its instructional documents and provisions of this Circular;
b) Make an appraisal report and
send it together with one set of the bidding documents or request for proposals
to the head of the health facility for approval within 20 days from the day on
which sufficient documents are received.
Article 29.
Approving bidding documents, request for proposals
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Section 5.
CONTRACTOR SELECTION ORGANIZATION
Article 30.
Bid security, submission of bids/proposals
1. The head
of the health facility (or the procuring entity) shall specify the value of bid
security in the bidding documents/request for proposals in accordance with the
following principles:
a) The bid security value shall
equal 1% - 3% of the contract package value (1% - 1.5% for small contract
packages).
b) If the contract package is
divided into smaller parts, the bid security value for each part shall equal 1%
- 3% of the value of such part (1% - 1.5% for small contract packages).
2. A
contractor may participate in one, some, or all parts of a procurement. If the
contractor participates in more than one part, the bid security value shall be
the total value of bid security for each part.
3. A
contractor may choose one of the following bid security methods:
a) Pay a deposit;
b) Pay security;
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Investors shall not request
contractors to follow any specific method of the three above methods.
4. The
procuring entity shall specify the validity period of request for proposals or
bids which shall not exceed 180 days from the bid closing time.
Where
necessary, the validity period of bids/proposals may be extended as long as the
drug supply schedule is met. Each contractor shall submit 02 sets of the
bid/proposal (01 original and 01 copy) to the procuring entity before the bid
closing time.
Article 31.
Evaluating bids/request for proposals
1. Depending
on the nature and value of the contract package, the method and procedure for
contractor selection, the head of the health facility shall select one of the
method for evaluating bids/proposals specified in Article 39 and Article 41 of
Law on Bidding. The evaluation method must be specified in bids/request for
proposals.
2. The
procuring entity shall evaluate bids/proposals for each part of the procurement
in accordance with the Law on Bidding and regulations of the Ministry of Health
on preparing bids/proposals for supply of drugs.
The evaluation of ability and
experience of contractors shall be based on the total parts of the contract
package that the contractors participated.
3. The standards for evaluating
bids/proposals shall comply with provisions in the bidding documents specified
in Appendix 7 or Appendix 8 enclosed herewith and shall be specified in the
bidding documents/request for proposals. Procuring units shall follow
regulations on incentives in Article 3 through 6 of Decree No. 63/2014/ND-CP.
4. Procedures
for evaluating bids/proposals shall depend on the contractor selection procedures
approved by a competent authority, to be specific:
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Single-stage two-envelop
procedure: Article 27 through 30 of Decree No. 63/2014/ND-CP shall be applied ;
5. Time limit
for evaluating proposals is up to 30 days; time limit for evaluating bids is 45
days (25 days for small procurements) from the bid closing to the day on which
the procuring entity submits the contractor selection result to the head of the
health facility for approval. In case of competitive bidding and selective
bidding under single-stage two-envelop procedures, the time limit for
evaluating bids shall be the total time for evaluating technical proposals
(from the bid closing date to the day on which the head of the health facility
approves the list of bidders satisfying technical requirements) plus (+) the
time for evaluating financial proposals (from the day on which financial
proposals are opened to the day on which the procuring entity submits the
contractor selection result to the head of the health facility for approval).
Where necessary, the time limit for evaluating bids/proposals may be extended
for up to 20 more days as long as the drug supply schedule is met.
Article 32.
Contract negotiation and proposal for successful contractor
1. Contract
negotiation shall comply with the provisions specified in Article 19 of Decree
No. 63/2014/ND-CP and shall be implemented before the procuring entity proposes
successful contractor.
The contractor whose bid after
correction of errors and adjustment of deviation minus (-) discount is lowest
(if lowest price method is applied); whose evaluated price is lowest (if
evaluated price method is applied); or whose total score is highest (if combined
method is applied) shall be ranked first and invited to contract negotiation.
If the selected contractor is
invited to contract negotiation but he/she is absent, such contractor shall not
receive bid security.
2. Conditions
for being proposed for successful contractors are specified in Article 43 of
Law on Bidding and the bidding documents specified in Appendix 7 or Appendix 8
enclosed herewith.
The procuring entity shall propose
the successful contractor for each part of the approved contractor selection
plan in accordance with Law on Bidding as well as this Circular and its
instructional documents on management of drug quality and prices. Only one
drug/ingredient in a category (which is a part of the contract package)
satisfying technical and quality requirements specified in the bidding
documents/request for proposals and whose bid after correction of errors and
adjustment of deviation minus (-) discount is lowest (if lowest price method is
applied); whose evaluated price is lowest (if evaluated price method is
applied); or whose total score is highest (if combined method is applied) shall
be proposed.
3. If the bid
after correction of errors and adjustment of deviation minus (-) discount (if
any) of every contractor satisfying technical requirements and on the list of
ranked contractors exceeds the price for the approved part in the contract
package, there are the following options:
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b) If the drug price is not
reasonable, the procuring entity shall prepare a report and propose adjustment
to the contract package value and send it to the competent person for
consideration;
c) If sufficient supply of drugs
is necessary to serve demand for medical examination and treatment, the
procuring entity may consider deciding to select the drug according to
contractors’ rankings when all of the following conditions are satisfied:
- The
successful bid shall not exceed the effective declared or re-declared wholesale
price of the drug;
- The total
value of proposed drugs offered by bidders shall not exceed the total value of
those parts in the contractor selection plan approved by a competent authority.
Article 33.
Reporting on submission of contractor selection result appraisal
1. The
procuring entity shall send 01 set of the contractor selection result appraisal
to the appraising unit, including:
a) 01 original of the report on
evaluation of bids/request for proposals
b) 01 set of the application for
bidding documents/request for proposals (copies) appraised and approved as
specified in Article 27, 28 and Article 29 of this Circular and other provisions
of Law on Bidding.
2. Procedures
for reporting, appraising, approving, and publishing contractor selection
results are specified in Article 20 of Decree No. 63/2014/ND-CP.
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1. The head
of the health facility shall appoint a unit to appraise the contractor
selection result.
2. Duties of
appraising unit:
a) Within 20 days (10 days for
small contract packages) from the date on which sufficient documents are
received, the appraising unit shall inspect and evaluate the contractor
selection procedures specified in Article 30, 31 and Article 32 of this
Circular;
b) Prepare an appraisal report and
submit it to the head of the health facility for consideration for approval in
accordance with provisions of this Circular and regulations of law on bidding.
3. An
application for approval for contractor selection result shall include:
a) 01 original of the report on
contractor selection result appraisal;
b) A set of the application for
approval for contractor selection result (original) of the procuring entity.
Article 35.
Approving and notifying contractor selection result
1. Within 10
working days (up to 05 working days for small contract packages) from the
receipt of the sufficient application for approval for contractor selection
result of the appraising unit specified in Clause 3 Article 34 of this
Circular, the head of the health facility shall consider approving the result.
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3. The
notifications sent to unsuccessful contractors shall provide explanation for
their failure.
4. If the contract
package is divided into smaller parts and the time for bid evaluation might
affect the drug supply schedule of the health facility, the head of the health
facility may consider approving the contractor selection result of one or some
parts in several stages to keep the drug supply schedule unchanged.
5. If any
drug in a contract package does not receive any bids or no bidders for which
are successful or none of the options specified in Clause 1 of this Article is
viable, the head of the health facility or the procuring entity shall cancel
the procurement and submit an adjusted contractor selection plan to a competent
authority for approval. The time for appraisal and approval for adjusted plan
shall comply with Article 16 and Article 17 of this Circular. If drug
information of the contract package including name of the active ingredient;
contents/concentrations; route of administration, dosage form; category;
measuring unit; quantity; unit price and total value of those drugs are
unchanged comparing to the approved plan, the competent authority shall select
the qualified contractor without reappraisal of the contractor selection plan.
Article 36.
Successful bids
The successful bid for each drug
shall not exceed its price in the contractor selection plan approved by the
competent person and shall not exceed the effective wholesale price of such
drug, except for the cases specified in Clause 3 Article 32 of this Circular.
Article 37.
Contract conclusion and guarantee for contract execution and use of drugs
1. Before
signing the contract, the procuring entity may increase or decrease the maximum
quantity of drugs by less than 10% comparing to the quantity of drugs in the
bidding plan under the condition that there is no change on unit price or other
provisions of bids and bidding documents.
2. The
selected contractor shall provide guarantee for contract execution before the
effective time of the contract. The bid security value shall equal 2% - 10% of
the contract value in the bidding documents and request for proposals. For
smaller contract package, the bid security value shall equal 2% - 3% of the
contract value in the bidding documents and request for proposals.
3. The head
of the health facility and the successful contractor shall implement the drug supply
contract in accordance with law on business contracts and ensure that at least
80% of the value of each part in the concluded contract shall be implemented.
For emergency treatment, antidotes, and rare drugs, specially controlled drugs,
fluids for intravenous infusion and other cases after reporting to the
competent authority, the health facility shall ensure that at least 50% of the
value of each part in the concluded contract shall be implemented.
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4. The health
facility must not buy more drug in a category than the quantity specified in
the contractor selection result if the quantity of drugs in other categories of
the same selected active ingredient is not completely bought under concluded
contracts.
5. In the
following cases, it is allowed to buy in excess to the limit by up to 20% of
the quantity of drug in such category specified in the concluded contract
without having to submit the additional contractor selection plan:
a) Drugs of other categories with
the same active ingredient or concentration or content are depleted and only
drugs of a contract package of proprietary drugs or equivalent drugs remain;
b) Other drug categories with the
same selected active ingredient or concentration or content has to be suspended
from supply or suspended from sale or removed from the list of drugs having
evidence of bioequivalence after they are selected;
c) The contractor is unable to
supply a sufficient quantity of drugs in a category as specified in the
concluded contract due to force majeure events. In this case, a written
notification and relevant documents shall be presented.
6. If an
offered drug is changed during the contractor selection process, or the drug is
supplied but the substitute drug is not offered in the bid, the investor may
consider allowing the contractor to supply the substitute drug, to be specific:
a) The name of the drug or the
factory or package content is changed during its sale but the number of
marketing authorization certificate or number of import license remains
unchanged;
b) The number of marketing
authorization certificate is changed or new import license is issued but other
information remains unchanged (name of drug, manufacturer, quality standards,
shelf life, category); quality standards can be changed but the standard level
and quality criteria shall not be lower than that of the selected drug (or offered
in the bid or updated on Pharmacopoeia);
When using the substitute drug,
the contractor must provide every information necessary for the procuring
entity to evaluate the replacement, including: copies (certified by the
contractor) of the marketing authorization or certificate of pharmaceutical
product, written permissions from regulatory authorities (if any) and
explanation for the unchanged quality standards of the offered drug and
substitute drug.
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d) Changes in name specification
of herbal ingredients do not change components of the drug and allowed by the
competent authority.
Chapter IV
CENTRALIZED
DRUG PROCUREMENT
Article 38.
General provisions on centralized drug procurement
1. Centralized
drug procurement units shall:
a) Survey demand for drugs,
prepare and submit a contractor selection plan, organize the contractor
selection, complete and conclude contracts or framework agreements with
selected contractors, publish contractor selection results and framework
agreements on the websites of the Ministry of Health and Provincial Departments
of Health as the basis for them to complete and sign contracts with selected
contractors.
b) Supervise the progress of
execution of framework agreements and contracts with selected contractors.
2. Local
centralized drug procurement units shall not carry out contractor selection for
supply of drugs on the national list of drugs for centralized bidding
procurement or the list of drugs for procurement by price negotiation if the
contractor selection result is available on the date of issuance of the bidding
documents and a framework agreement has been posted on the website of Ministry
of Health.
3. When
surveying demand for drugs on the national list of drugs for centralized bidding
procurement list or the price negotiation list, the health facility shall
exclude the remaining quantity of drugs under contracts with selected
contractors according to previous contractor selection results.
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5. Contractor
selection procedure: single-stage two-envelop;
6. Bid
evaluation shall be carried out according to the method that evaluates both
quality and price of each drug, which is one part of the contract package
(combined method).
7. The
centralized drug procurement shall be carried out by signing a framework
agreement, except for the following cases in which a contract shall be signed
directly:
a) Procurement of medicines and
vaccines serving open vaccination programs/projects funded by state budget
under decisions of the Minister of Health or Presidents of the People’s
Committees of provinces;
b) Procurement of drugs of
programs and projects funded by ODA, aid, sponsorship from domestic and
overseas sponsors who require direct contract conclusion;
8. Organizing
appraisal of contractor selection plan:
a) Planning – Finance Department
shall organize appraisal of national centralized drug procurement plans.
b) Provincial Provincial Departments
of Health shall organize appraisal of local centralized drug procurement plans.
c) Centralized drug procurement
plans shall be appraised in accordance with Clause 1 Article 37 of Law on
Bidding and Article 16 of this Circular.
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Contract negotiation shall be in
accordance with Clause 1 Article 32 of this Circular, During centralized
contractor selection, contract negotiation shall comply with the provisions of
Clause 3 Article 19 of Decree 63/2014/ND-CP and these following cases shall be
considered:
a) If a large quantity of a drug
is divided into smaller contract packages specified in point a Clause 4 Article
40 of this Circular and has the same item proposed for contract
awarding in several contract packages with the price
difference, the contractor may be requested to analyse components of the bid
price and explain about the price difference of the same item supplied at
different places. These analyses shall be used as a basis for contract
negotiation towards the price of the drug under the contract package whose the
proposed successful bid is low in order to bring economic efficiency of the
contract package.
b) If a drug in a category only
has 01 certificate of marketing authorization, 01 contractor and the proposed
successful bid in this drug category is higher than that of the drug having the
same active ingredient, content/concentration, route of administration and
dosage form in another category with more advanced technical standards and
competitive price thanks to the participation of many contractors, the contract
negotiation on the proposed successful bid shall follow these principles:
- The
successful bid of Category 1 shall not be higher than the successful bid of
proprietary drugs or reference bioequivalence;
- The
successful bid of Category 2 or Category 3 shall not be higher than the
successful bid of proprietary drugs or reference bioequivalence and Category 1;
- The
successful bid of Category 4 shall not be higher than the successful bid of
proprietary drugs or reference bioequivalence; Category 1 and Category 2
manufactured in Vietnam and Category 3;
- The
successful bid of Category 5 shall not be higher than the successful bid of
proprietary drugs or reference bioequivalence; Category 1; Category 2; Category
3 and Category 4.
10. If an
offered drug is changed during the contractor selection process, or the drug is
supplied but the substitute drug is not offered in the bid, the drug
substitution shall comply with the provisions of Clause 6 Article 37 of this Circular.
11. Duties,
functions, organization and operation of the national centralized drug
procurement center shall be decided by Minister of Health. Duties, functions,
organization and operation of the local centralized drug procurement units
shall be decided by Presidents of the People’s Committees of provinces at the
request of Ministry of Health.
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1. A health
facility wishing to purchase drugs on the list of drugs for centralized drug
procurement shall prepare and sign a contract with the selected contractor
according to the contractor selection result and the contractual unit price
does not exceed the framework agreement published. The contractor shall provide
guarantee for contract execution in accordance with Article 66 of Law on
Bidding and Clause 2 Article 37 of this Circular with the health facility
before the effective time of the contract.
2. The unit
specified in Clause 1 Article 40 and Clause 2 Article 41 of this Circular shall
survey demand for drugs on the lists of each health facility under its
management and regulate the plan procedures to ensure that at least 80% of the
quantity of drugs reported are used. For emergency treatment, antidotes, and
rare drugs, specially controlled drugs, fluids for intravenous infusion and
drugs used in other emergency cases after reporting to the competent authority,
the health facility shall ensure that at least 50% of the value of each part in
the concluded contract shall be implemented.
3. The
contractor selected by centralized procurement shall supply drugs with the
quantity and schedule agreed in the contract with each health facility. During
the contract implementation, the health facility and the contractor may
negotiate changes to the quantity according to stipulations of the bidding
documents issued by the unit in charge of centralized drug procurement. The
centralized drug procurement unit shall cooperate with units in charge and
selected contractors in regulating plan implementation to ensure adequate
supply of drugs for the health facility.
4. Time limit
for the centralized drug procurement contract (national and local) shall comply
with provisions of the contractor selection plan approved by the competent
authority but shall not exceed 36 months from the effective date of the
centralized drug procurement results and framework agreements.
Article 40.
Organizing national-level centralized drug procurement
1. The survey
on demand for drug use shall follow these principles:
a) The health facilities
affiliated to Ministry of Health shall survey the demand for drugs with
specified names, detailed quantities, categories, supply schedules and submit
the result enclosed with the documents specified in Clause 2 of this Article to
the national centralized drug procurement center.
a) The health facilities under the
management of ministries and regulatory authorities shall survey the demand for
drugs with specified names, detailed quantities, categories, supply schedules
and submit the results to the local centralized drug procurement units.
d) The local centralized drug
procurement units surveys demand for drug use, reports to Provincial
Departments of Health and send the drug use plan enclosed with the documents
specified in Clause 2 of this Article to the national centralized drug
procurement center.
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2. Documents
enclosed with the application for centralized drug procurement demand:
a) Summary of the result of
contractor selection and drug use of the preceding year, the drug inventory and
the quantity of drugs that are planned but have not been used at the time of
making summary of the health facilities;
b) A brief explanation for the
proposed drug procurement plan shall be given, and a detailed explanation shall
also be given in case of fluctuations in 30% of the quantity of the used drugs
of the preceding year.
b) Documents as the basis for
making the drug procurement plan specified in Article 13 of this Circular;
d) The minutes of the meeting with
Drug and Treatment Council of the health facility affiliated to Ministry of
Health or the minutes of review of Provincial Departments of Health and its
comments on the list, quantity of drugs and demand for drugs of the health
facilities under the management of ministries and regulatory authorities and
local health authorities.
3. The national
centralized drug procurement center shall review the demand for list and
quantity of drugs of each health facility under the management of Ministry of
Health and survey the demand for list, quantity, supply schedule of each drug
in order to develop contractor selection plan.
4. Contractor
selection plan shall be developed as follows:
a) If the demand for the drug is
high and a single supplier is unable to supply an adequate quantity for the
whole contract package, it may be divided into smaller packages by regions or
socio-economic areas or package values;
Example: Drug A is on the national
list of drugs for centralized bidding procurement and the demand for drug A is
100 million tablets per year. No supplier is able to supply this drug with such
quantity so it may be divided into smaller contract packages:
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- + It may be
divided into several smaller contract packages for 07 socio-economic areas: Red
River Delta, the Northeast, the Northwest; the North Central Coast, the South
Central Coast, the Southeast and Mekong Delta.
b) Drug category division in
contract packages and contents of contractor selection plans shall comply with
Article 7 through Article 14 of this Circular. Time limit for contract
execution shall comply with Clause 4 Article 39 of this Circular.
5. Organizing
appraisal of contractor selection plan:
a) The national centralized drug
procurement center shall submit the proposal of the contractor selection plan
to Department of Planning - Finance, Ministry of Health.
b) The appraisal of contractor
selection plan under the national list of drugs for centralized bidding
procurement shall comply with Clause 2 Article 16 of this Circular. Planning –
Finance Department shall organize the appraisal of lists, quantity of contract
packages, estimated unit prices and quantity of drugs as well as contractor
selection plans. In case of necessity, Planning – Finance Department shall ask
for advice from Drug Procurement Consultancy Council before submitting the
contractor selection plan to Minister of Health for approval.
6. Approving
contractor selection plan:
Minister of Health shall consider
approving contractor selection plans at the request of Planning – Finance
Department.
7. Preparation
for contractor selection:
According to the contractor
selection plan approved by Minister of Health, the national centralized drug
procurement center shall prepare the bidding documents and organize bid
evaluation in accordance with Article 27 through 29 of this Circular.
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The national centralized drug
procurement center shall organize the contractor selection, bid evaluation,
negotiation of contracts, propose successful contractors; and report the
contractor selection result in accordance with Article 30 through 33 of this
Circular.
9. Appraising,
approving and publishing contractor selection result:
The national centralized drug
procurement center shall organize the contractor selection, bid evaluation,
negotiation of contracts, propose successful contractors and report the
contractor selection result in accordance with Article 30 through 33 of this
Circular. It may be necessary to consult with Drug Procurement Consultancy
Council before approving the contractor selection result;
b) The national centralized drug
procurement center shall announce and publish contractor selection result
according to Law on bidding.
10. Completing
and concluding contracts or framework agreements:
a) The national centralized drug
procurement center shall complete and conclude contracts or framework
agreements with selected contractors in accordance with Law on bidding; publish
framework agreements on the Ministry of Health's website and send written
notifications to health facilities under the management of the Ministry of
Health, other regulatory authorities, and Provincial Provincial Departments of
Health;
b) The units surveying and
proposing demand for drugs specified in Clause 1 of this Article shall notify
the contractor selection result and the framework agreement to the health
facilities regulated by the framework agreement.
11. Completing
and concluding drug supply contracts:
In consideration of the contractor
selection result, the framework agreement, the demand for drug and drug use
plans of health facilities, the national centralized drug procurement center
(for direct contract conclusion) and health facilities shall complete and
conclude contracts with contractors ensuring:
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b) The price of each drug in the
contract does not exceed the successful bid announced by the national
centralized drug procurement center.
c) Time limit for contract
execution shall be specified in the contractor selection plan approved by
competent authority but may not exceed 36 months from the effective date of the
centralized procurement results and framework agreements until the date parties
fulfill obligations in accordance with the provisions of the contract.
12. Report on
contractor selection results of national centralized drug procurement:
a) Before 10th of each month and
the first 10th of each quarter or on request, contractors shall submit reports
on supply of drugs on the national list of drugs for centralized drug
procurement to the national centralized drug procurement center in accordance
with Appendix 9 and Appendix 10 enclosed herewith.
b) Before the first 10th of each
quarter or on request, the health facilities under the management of local governments
and the health facilities under the management of ministries and branches shall
submit reports on supply of drugs to the local centralized drug procurement
units in accordance with Appendix 11 enclosed herewith.
c) Before the first 15th of each
quarter or on request, the local centralized drug procurement units and the
health facilities affiliated to Ministry of Health shall submit reports on
supply of drugs on the national list of drugs for centralized drug procurement
to the national centralized drug procurement center in accordance with Appendix
11 enclosed herewith.
13. Supervising
the progress of execution of framework agreements:
The national centralized drug
procurement center and the local centralized drug procurement units shall
supervise and regulate drug supply for the health facilities regulated by the
framework agreement in accordance with the instructions of the national
centralized drug procurement center on the basis of these principles:
a) If the demand for drugs of a
health facility under the management of local governments or a health facility
under the management of ministries and branches exceeds the quantity of drugs
specified in the framework agreement by 20%, the local centralized drug
procurement unit shall be notified to regulate drug quantities between local
health facilities.
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b) If the demand for drugs of the
health facility affiliated to Ministry of Health exceeds the quantity of drugs
specified in the framework agreement; or the demand for drugs of health
facilities under the management of local governments or ministries and branches
exceeds the capacity of the local centralized drug procurement unit; or the
health facility's unexpected demand for a drug has not been mentioned in the
contractor selection plan, the national centralized drug procurement center
shall be notified to regulate drug quantities between health facilities. Within
05 days from the receipt of the request for regulation of the local health
facility, the local centralized drug procurement unit shall submit a report to
the national centralized drug procurement center in accordance with Appendix 12
enclosed herewith.
Within 10 days from the receipt of
the written request for regulation of the health facility, the national
centralized drug procurement center shall send a written reply to the health
facility.
The regulated drug quantities of
the national centralized drug procurement center shall not exceed the quantity
of drugs approved in the contractor selection plan and on the national list of
drugs for centralized bidding procurement. The regulation shall comply with the
regulation process of drugs on the national list of drugs for centralized
bidding procurement published by the national centralized drug procurement
center.
14. Payments
for drug supply contracts:
The national centralized drug procurement
center (for direct contract conclusion); health facilities (for framework
agreement conclusion) shall pay the contractors in accordance with regulations
of law and terms of the concluded contracts.
The written approval for drug
regulation between centralized drug procurement units is a part of Drug
Purchase Contract and also a basis for the health facility and the contractor
to sign appendix of contract (for regulated items in the framework agreement)
or sign contract (for regulated items not in the framework agreement).
Article 41.
Organizing local centralized drug procurement
1. Surveying
demands for drug use:
a) The local lists of drugs for
centralized bidding procurement apply to the health facilities located in
localities including local health facilities, central health facilities, health
facilities under the management of ministries and branches and health
authorities in localities. Central health facilities, health facilities under
the management of ministries and branches and internal health departments shall
have the same responsibility as health facilities under the management of local
authorities for preparing drug use plans in accordance with regulations on the
local centralized contractor selection in their provinces.
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b) According to the local lists of
drugs for centralized bidding procurement, health facilities of provincial
governments (including local health facilities, central health facilities,
health facilities under the management of ministries and branches and internal
health departments) shall survey demand for drugs and submit it to the local
centralized drug procurement units.
c) The lists and quantities of
drugs shall be sent to the local centralized drug procurement units before July
15th or another deadline specified by the local centralized drug
procurement units;
2. The local
centralized drug procurement center shall review the demand for list and
quantity of drugs of local health facilities and survey the demand for list,
quantity, supply schedule of each drug in order to develop contractor selection
plan.
3. Making
contractor selection plan: Local centralized drug procurement units shall be
responsible for division of drug categories in contract packages and contents
of contractor selection plans shall comply with Article 7 through Article 14 of
this Circular. Time limit for contract execution shall comply with Clause 4
Article 39 of this Circular.
4. Organizing
appraisal of contractor selection plan:
a) Local centralized drug
procurement units shall submit proposals of contractor selection plans to
Provincial Departments of Health.
b) The appraisal of contractor
selection plan for drugs on the local lists of drugs for centralized bidding
procurement shall comply with Clause 2 Article 16 of this Circular. Provincial
Departments of Health shall organize the appraisal of contractor selection
plans and submit them to Chairpersons of the People’s Committees of provinces
for approval;
5. Approving
contractor selection plans:
Chairpersons of the People’s
Committees of provinces shall consider approving the local contractor selection
plans at the request of Provincial Departments of Health.
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According to the contractor
selection plans approved by Minister of Health, the local centralized drug
procurement units shall prepare the bidding documents and submit them to
Provincial Departments of Health for approval in accordance with Article 27
through 29 of this Circular.
7. Organizing
contractor selection:
The local centralized drug
procurement units shall implement the contractor selection, bid evaluation,
negotiation of contracts; propose successful contractors and report on appraisal
submission in accordance with Article 30 through 33 of this Circular.
8. Appraising,
approving and publishing contractor selection results:
a) The local centralized drug
procurement units shall prepare and submit the contractor selection results to Provincial
Departments of Health for appraisal and approval;
b) Provincial Departments of
Health shall appraise and approve the contractor selection results in
accordance with Article 34 and Article 35 of this Circular;
c) The local centralized drug
procurement units shall announce and publish the contractor selection results
in accordance with Law on bidding.
9. Completing
and concluding contracts or framework agreements:
a) According to the approved
contractor selection results, the local centralized drug procurement units
shall complete and conclude framework agreements with contractors in accordance
with Law on Bidding;
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10. Completing
and concluding drug supply contracts:
According to the contractor selection
results, the framework agreement, the demand for drug and drug use plans of
health facilities, the local centralized drug procurement units (for direct
contract conclusion) and health facilities shall complete and conclude
contracts with contractors ensuring:
a) Conformity with conditions in
framework agreements;
b) The price of each drug in the
contract does not exceed the successful bid announced by the local centralized
drug procurement units.
c) Time limit for contract
execution shall be specified in the contractor selection plans approved by
competent authorities but may not exceed 36 months from the effective date of
the centralized procurement results and framework agreements until the parties
fulfill obligations in accordance with the provisions of the contract.
11. Reporting
local centralized contractor selection results:
c) Before the first 10th of each
quarter or on request, contractors shall submit reports on supply contract of
drugs on the local lists of drugs for centralized bidding procurement to the
local centralized drug procurement units in accordance with Appendix 10
enclosed herewith.
b) Before the first 10th of each
quarter or on request, health facilities under the management of Ministry of
Health, local governments, ministries and branches shall submit reports on drug
supply results to the local centralized drug procurement units in accordance
with Appendix 11 enclosed herewith.
12. Supervising
progress of execution of framework agreements:
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a) If the demand for drugs of a
health facility exceeds the quantity of drugs specified in the framework agreement
by 20%; or the health facility's unexpected demand for a drug has not been
mentioned in the contractor selection plan, the local centralized drug
procurement unit shall be notified in accordance with Appendix 12 enclosed
herewith to regulate drug quantities between local health facilities. Within 10
days from the receipt of the written request for regulation of the health
facility, the local centralized drug procurement unit shall send a written
reply to the health facility.
The regulated drug quantities of
the local centralized drug procurement units shall not exceed the quantity of
drugs approved in the contractor selection plan for supply of drugs on the
local lists of drugs for centralized bidding procurement by 30%. The regulation
shall comply with the regulation process of drugs on the local lists of drugs
for centralized bidding procurement published by the local centralized drug
procurement units.
13. Payment:
Health facilities shall pay contractors in accordance with regulations of law
and terms of the concluded contracts. The written approval for drug regulation
between centralized drug procurement units is a part of Drug Purchase Contract
and also a basis for health facilities and contractors to sign appendix of contract
(for regulated items in framework agreements) or sign contract (for regulated
items not in framework agreements).
Chapter V
PRICE
NEGOTIATION
Article 42.
General provisions on price negotiation
1. Drug Price
Negotiation Council (hereinafter referred to as Council):
a) Council formed by Minister of
Health. Minister of Health shall provide guidance on duties and entitlements,
organizational structure and operation of Council. Council shall be funded by
state budget from the national centralized drug procurement center and other
legal fundings.
b) Council shall include:
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- 02 Deputy
Chairpersons is Head of Social Insurance of Vietnam and Director of National
Centralized Drug Procurement Center.
- Members who
are representatives of relevant agencies affiliated to Ministry of Health,
Ministry of Finance, Social Insurance Office, and independent experts in
relevant fields.
c) Council shall:
- Consider
price negotiation plans developed by the national centralized drug procurement
center.
- Implement
drug price negotiation under the approved plans;
2. The
national centralized drug procurement center, a standing unit of Council,
shall:
a) Develop detailed price
negotiation plans;
b) Develop, appraise and approve
proposals;
c) Evaluate proposals;
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dd) Publish price negotiation
results;
e) Supervise and regulate the
supply and use of drugs selected by price negotiation;
g) Participate in all stages of
drug price negotiation process; aggregate and provide relevant information
during price negotiation process;
h) Carry out other tasks at the
request of Chairperson of Council.
3. Drug
Procurement Consultancy Council shall advise the Minister of Health in all
stages of the drug price negotiation process on request.
4. If an
offered drug is changed during the contractor selection process, or the drug is
supplied but the substitute drug is not offered in the bid, the unit in charge
specified in Clause 1 Article 37 of this Circular shall consider approving for
drug substitution specified in Clause 6 Article 37 of this Circular.
Article 43.
Prepare, appraise and approve price negotiation plans
1. Aggregating demand for using
drugs on the list of drugs for procurement through price negotiation:
The national centralized drug
procurement center shall aggregate demand for drug use specified in Clause 1
Article 40 of this Circular.
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The national centralized drug
procurement center shall prepare drug price negotiation plans. Contents of drug
price negotiation plan shall be specified in Article 14 of this Circular with
the following information:
a) Names and prices of contract
packages, total value of contract packages and value of each part of contract
packages in contractor selection plans;
b) The estimated price of each
drug through price negotiation shall be specified in Clause 4 Article 14 of
this Circular;
c) Requirements in terms of
quality standards and delivery time, specific purchase conditions of each drug
under price negotiation;
d) The expected time for price
negotiation for each drug on the list of drugs under price negotiation;
dd) In case of necessity, the
national centralized drug procurement center shall consult with Council on the
price negotiation plan before submitting to the appraising unit.
3. Appraising
drug price negotiation plan:
a) The national centralized drug
procurement center shall submit the proposal of contractor selection plan to
Planning – Finance Department for appraisal organization;
Planning – Finance Department
shall appraise the lists, contract package quantities, estimated unit prices
and drug quantities. The appraisal of price negotiation plan shall comply with
Clause 2 and Article 16 of this Circular.
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Article 44.
Prepare, appraise and approve proposals
According to the contractor
selection through price negotiation plan approved by Minister of Health, the
national centralized drug procurement center shall prepare the bidding
documents, appraise and approve the proposals.
1. Preparing
the request for proposals:
a) The request for proposals for
drugs through price negotiation shall comply with Law on bidding, detailed
documents on Law on bidding and the national centralized drug procurement
center;
b) A proposal shall contain
sufficient information about the contract package; instructions on preparation
and submission of approvals; required capacity and experience of contractors;
criteria for technical and financial evaluation. Capacity, experience and
technical criteria shall be marked by “pass” or “fail”;
c) A proposal for instructions
shall contain information about prices, specific economic-technical criteria to
be applied during the price negotiation process that has to be provided by contractors
in their quotations, such as:
- EX works,
CIF, selling prices for health facilities in manufacturing countries and ASEAN
countries provided by contractors;
- EX works,
CIF, selling prices for health facilities in Vietnamese market.
- Indications
and clinical effectiveness evaluation of drugs in treatment; The report on
clinical effectiveness evaluation in treatment in comparison with other
standard drugs (if any);
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- The
contractor’s commitments to quantity and quality of drugs supplied as well as
supply schedule if awarded the contract;
2. Appraising
request for proposals:
a) The request for proposals under
price negotiation shall be appraised before submitting to Director of the
National Centralized Drug Procurement Center for approval.
b) The appraising unit shall be
decided by the Director of the National Centralized Drug Procurement Center.
3. Approving
request for proposals:
The Director of the National
Centralized Drug Procurement Center shall approve the request for proposals
according to the appraising unit’s report.
Article 45.
Organizing drug price negotiation
1. Notification
of bidding for drug supply under price negotiation and request for proposals
shall be publicly issued.
2. Contractors
prepare and submit proposals according to request for proposals.
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b) According to the notification
of bidding for drug supply and request for proposals under price negotiation in
order to prepare and submit the proposal by post or directly to the national
centralized drug procurement center.
3. Evaluating
proposals and preparing price negotiation plans
a) The national centralized drug
procurement center shall evaluate proposals in accordance with regulations of
request for proposals. Proposals shall be publicly opened. In the process of
evaluation, the procuring entity may invite the contractor to negotiation and
amendments to some necessary information of proposals in order to prove the
contractor's qualification in terms of capacity, experience, schedule,
quantity, quality, technical solutions and measures of implementing the
contract package.
b) According to the contractor’s
proposal and the experts’ proposal evaluation report, the national centralized
drug procurement center shall prepare price negotiation plans. In case of
necessity, the center shall invite clinical and pharmaceutical economic experts
to participate in developing price negotiation plan for each drug.
The price negotiation plan shall
summarize the information on pharmacological effect, the estimated price and
successful bid of the drug under price negotiation; drugs having the same
active ingredient, content/concentration, dosage form but not in the same group
of offered drugs; drugs in the same group of replaceable pharmacological effect
(if any), the factors relating to the price negotiation plan and terms of the
framework agreement that will be negotiated.
c) Chairperson of Council shall
approve the price negotiation plan before price negotiation.
4. Price
negotiation and decision:
a) The national centralized drug
procurement center shall invite qualified contractors to price negotiation. In
case of necessity, the national centralized drug procurement center may invite
representative of the drug manufacturing facility or representative of the
license holder in Vietnam (including representative office) to make clear the
contents relating to the drug under price nogotiation;
b) A contractor shall be invited
to price negotiation if having lawful qualification, satisfying requirements of
capacity, experience and technical proposal of the request for proposals and
providing the estimated price that does not exceed the estimate for the
approved contract package;
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d) If more than one contractors
participate in the price negotiation of the drugs having the same active
ingredient, content/concentration, dosage form, the Council shall request them
to submit new quotations which specify the time and location for receiving such
quotations and time for opening them, and invite them to attend the opening
session. The prices in the new quotations must not exceed the negotiated
prices. The contractor whose new bid is lowest shall be awarded the contract.
dd) If the first price negotiation
is unsuccessful, the Council shall decide to invite or not to invite the
contractor to the second negotiation. The national centralized drug procurement
center shall notify the Council's official conclusion to each contractor after
the first negotiation;
e) If the contractor is invited to
the second price negotiation, the contractor shall submit the new proposal and
quotation in accordance with the negotiation letter of the national centralized
drug procurement center.
g) Successful bids through price
negotiation shall be decided by the Council and contractors. The Council and
the contractor shall conclude a framework agreement and other conditions after
reaching agreement on price;
h) After the Council and the
contractor’s representative conclude price nogotiation contracts, the national
centralized drug procurement center shall send a written request for concluded
price confirmation within 7 days to the contractor.
Article 46.
Appraising, approving and implementing drug price negotiation results
1. Appraising
and approving drug price negotiation results:
The national centralized drug procurement
center shall aggregate price negotiation results and submit to Planning –
Finance Department for appraisal. Time for appraisal is up to 20 days from the
receipt of sufficient documents. Minister of Health shall consider approving
price negotiation results on the basis of Planning – Finance Department.
- If the
Council and the contractor are unable to reach agreement on price after
negotiation sessions, the national centralized drug procurement center shall
submit a report to Planning – Finance Department and notify the result to the
contractor and health facilities nationwide.
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a) The national centralized drug
procurement center shall publish contractor selection results through price
negotiation and provide guidance on implementation of price negotiation results
to health facilities in accordance with law.
b) For drugs on the unsuccessful
list of drugs for procurement by price negotiation, according to the Council's
opinions, the national centralized drug procurement center shall propose
alternative procurement plans and submit them to Minister of Health for
consideration and approval. For the proprietary drugs granted many certificates
of marketing authorization of Category 1 specified in Article 7 of this
Circular promulgated by Ministry of Health, health facilities may carry out
contractor selection by themselves through competitive bidding of generic
contract packages according to the Ministry of Health’s notice.
3. Payments
for drug supply contracts:
a) The national centralized drug
procurement center shall complete and conclude framework agreements with
successful contractors; publish price negotiation results and framework
agreements on the Ministry of Health's website. Responsibility of relevant
parties and effect of framework agreements shall comply with Article 39 of this
Circular. Selected contractors shall provide guarantee for contract execution
specified in Clause 1 Article 39 of this Circular;
b) According to price negotiation
results, framework agreements, distributed drug quantities and plan of drug use
budget approved by the competent authority, health facilities shall conclude
contracts with contractors under the condition that prices in contracts do not
exceed successful bids and framework agreements published by the national
centralized drug procurement center;
For effective drug supply
contracts, health facilities shall regulate drug prices to ensure that they do
not exceed published negotiation prices or the effective time of framework
agreements.
c) The contractor selected through
price negotiation shall supply drugs with the quantity, schedule and other
conditions agreed in the framework agreement and the concluded contract with
each health facility;
d) Time limit for contract
execution shall be specified in the price negotiation plan approved by the
competent authority but may not exceed 36 months from the effective date of the
price negotiation result and framework agreement until the parties fulfill
obligations in accordance with the provisions of the contract.
e) The health insurance authority
shall make unanimous payment for all public health facilities according to
price negotiation results published by the national centralized drug
procurement center.
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Contractors through price
negotiation and health facilities shall submit reports on drug supply results
through price negotiation to the national centralized drug procurement center
specified in Clause 12 Article 40 of this Circular.
5. Supervising
progress of execution of framework agreements:
The national centralized drug
procurement center shall supervise and regulate the supply and use of drugs
selected by price negotiation in the concluded framework agreement specified in
Clause 13 Article 40 of this Circular.
Chapter VI
IMPLEMENTATION
Article 47.
Effect
1. This
Circular comes into force from October 1, 2019.
2. Circular
No. 11/2016/TT-BYT dated May 11, 2016 of Minister of Health providing guidance
on bidding for supply of drugs for public health facilities shall be annulled
from the effective date of this Circular.
Article 48.
Transitional provisions
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2. For drug
manufacturing facilities satisfying EU-GMP requirements or equivalent
requirements and manufacturing facilities satisfying PIC/s-GMP requirements of
the national drug authority of the country considered a member of PIC/s and ICH
published by Drug Administration of Vietnam on its website before the effective
date of this Circular; these manufacturing facilities shall not need to undergo
evaluation of satisfying EU-GMP requirements or equivalent requirements or
PIC/s-GMP requirements organized by the drug authority of Vietnam within months
from the effective date of this Circular.
Article 49.
Reference clause
In case any of the documents
referred to in this Circular is replaced or amended, the newest document shall
be applied.
Article 50.
Organization and implementation
1. Heads of
central authorities shall instruct affiliated health facilities to select
contractors in accordance with this Circular and regulations of law on contractor
selection.
2. Ministers,
Heads of ministrial authorities shall assign tasks and inspect the assignment
applied to some contract packages of health facilities under their management.
3. Chairperson
of People’s Committee of each province shall:
a) Appoint a local centralized
drug procurement unit to procure drugs on the local lists of drugs for
centralized bidding procurement for health facilities participating in
centralized procurement locally in accordance with this Circular;
a) Instruct health facilities to
organize selection of suppliers of drugs on such list in accordance with this
Circular;
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If central health facilities,
internal health departments and health facilities under the management of
ministries and branches use the local lists of additional drugs (except for the
local lists of drugs for centralized bidding procurement issued by Ministry of
Health), health authorities of other sectors and internal health departments
and supervisory authorities of health facilities under the management of
ministries and branches shall sign agreement with Provincial Departments of
Health to submit reports to People's Committees of provinces for contractor
selection organization.
d) Decide and inspect task
assignments to some contract packages of health facilities under their
management at the request of the Director of the Provincial Department of
Health.
4. Drug
administration of Vietnam, Traditional Medicine Administration of Vietnam shall
update the following information on their websites:
a) Lists serving contractor
selection, including:
- The list of
reference authorities;
- The list of
drug authorities of SRA countries;
- The list of
drug authorities of countries that are state members of PIC/s and ICH;
- The list of
drug manufacturing facilities in Vietnam satisfying WHO-GMP requirements
granted certificates by drug authority of Vietnam;
- The list of
drug manufacturing facilities satisfying EU-GMP requirements or equivalent
requirements ;
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- The list of
drug manufacturing facilities that have herbal and traditional drugs satisfying
GMP requirements granted certificates by Ministry of Health of Vietnam;
- The list of
drug manufacturing facilities in Vietnam that have traditional ingredients
satisfying GMP requirements granted certificates by Ministry of Health of
Vietnam;
- The list of
drug manufacturing facilities in Vietnam that have herbal ingredients
satisfying GMP requirements granted certificates by Ministry of Health of
Vietnam;
b) Lists of drugs serving
contractor selection, including:
- List of
drugs granted certificates of marketing authorization or import licences;
- List of
proprietary drugs;
- List of
reference bioequivalence;
- List of
drugs whose therapeutic effects equivalent to those of proprietary drugs;
- List of
drugs manufactured under a processing contract or technology transfer contract
in Vietnam;
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- List of
drugs having documents proving bioequivalence;
- List of
drugs granted certificates of marketing authorization by one of reference
authority;
- List of
drugs granted certificates of marketing authorization by one of drug authority
of SRA countries;
- List of
drugs manufactured entirely in Vietnam satisfying criteria of Category 1
specified in point c Clause 1 Article 7 of this Circular;
- List of
ingredients in dosage form of glue, granule, extract, essential oil, resin,
gum, jelly in accordance with regulations of Ministry of Health on quality
management of herbal ingredients and traditional drugs;
- List of
semi-finished herbal ingredients: glue, granule, extract, essential oil, resin,
gum, jelly in accordance with regulations of Ministry of Health on quality
management of medicinal ingredients;
- List of
drugs on the list of national products;
- List of
drugs awarded the Ministry of Health's prize of “Star of Vietnamese
medicines"
- List of herbal
ingredients planted and collected or naturally farmed satisfying GACP
requirements and granted certificates by Ministry of of Health of Vietnam;
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- List of
herbal ingredients domestically planted and collected satisfying requirements
for treatment, price and supply capacity;
- List of
drugs manufactured from active ingredients in SRA countries or active
ingredients granted CEP certificates;
- List of
drugs and manufacturing facilities, suppliers failing to satisfy quality
requirements or complying with regulations on bidding and drug supply;
c) Information on
declared/re-declared drug price;
d) Information on drug price and
successful bids of herbal ingredients for health facilities;
dd) List of capable, experienced
and reputable drug manufacturers and suppliers to be invited to selective
bidding.
5. When
purchasing drugs funded by health insurance, the social insurance shall send
officials to participate in:
a) Making, appraising the
contractor selection plan;
b) Making, appraising the bidding
documents;
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6. During the
contractor selection process, the health facility or organizing unit shall send
documents (except for confidential documents in accordance with Law on bidding)
to members participating in the Council or Expert group specified in points a b
c Clause 5 of this Article before meeting within 5 days (except for urgent drug
procurement for treatment). After the above deadline, the health facility or
organizing unit shall follow the steps in the process of contractor selection
to hold meeting of Council or Expert Group. The members participating in the
above-mentioned Councils or Expert Groups shall comply with regulations of
these Councils or Expert Groups according to the Heads of Councils or Expert
Groups.
Participants’ opinions shall be
raised at the meeting. Any participant's opinion that is different from that of
the others shall be specified in the report.
7. Procurement
of health insurance drugs of private health facilities shall be based on the
following principles:
a) Private health facilities may
participate in centralized drug procurements (national procurements, local
procurements, price negotiations) in their provinces. Such private health
facilities shall formulate drug use plans and comply with regulations on local
centralized bidding as if they are health facilities under the management of
local authorities. Provincial Departments of Health and local centralized drug
procurement units shall organize biddings for supply of drugs for private
health facilities as if they are health facilities under the management of
local authorities.
b) Private health facilities not
participating in centralized drug procurements (national procurements, local
procurements, price negotiations) may carry out contractor selection themselves
in accordance with law on bidding, instructional documents and this Circular.
c) If a private health facility
does not organize contractor selection as prescribed in points a and b of this
Circular, the social insurance authority shall only pay according to the
published result of local or national contractor selection or price negotiation
result if the information such as trade name, number of marketing authorization
certificate or number of import license, dosage form, content/concentration,
route of administration, package contents, manufacturer, manufacturing country
are correct.
If the drug is not included in the
local or national-level concentrated procurement plan or price negotiation
plan, it shall be paid for according to successful bids of public health
facilities of the same districts which are published by Social Insurance Office
in accordance with Point b Clause 3 Article 77 of Decree No. 63/2014/ND-CP.
8. Health
facilities requesting for announcement of information specified in Clause 1
Article 7 of this Circular shall provide the following documents and be legally
responsible for their precision:
a) Certificates of free sale
granted by drug authority of SRA countries and consular legalization (original
copies or certified true copies).
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9. Health
facilities requesting for evidence of proprietary drugs or reference
bioequivalence sold for the first time in countries not on the SRA list
specified in point b Clause 2 Article 8 of this Circular shall provide the
following documents and be legally responsible for their precision:
a) Patents for modern medicines
granted by one of competent intellectual property authority. A patent for the
active ingredient (if the drug has only one active ingredient) or the mixture
of active ingredients (if the drug has more than one active ingredients)
enclosed with the request for protection of the corresponding drug (original
copy or certified true copy).
b) International birth date of
drugs shall be expressed in periodic safety update reports;
c) Other evidence (if any).
Article 51.
Responsibility for implementation
Director of Drug administration of
Vietnam, Director of Traditional Medicine Administration of Vietnam, Director
of Planning – Finance Department, Chief of the Ministry Office, Ministrial
Chief Inspector, Director of the National Centralized Drug Procurement Center,
Heads of units affiliated to Ministry of Health, Director of Departments of
Health of provinces, drug business facilities and other relevant
organizations/individuals/authorities shall implement this Circular.
Difficulties that arise during the
implementation of this Circular should be reported to the Ministry of Health
for consideration./.
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