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MINISTRY OF
HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
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No.: 14/VBHN-BYT
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Hanoi, November
26, 2021
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CIRCULAR
PRESCRIBING BIDDING FOR SUPPLY OF DRUGS FOR PUBLIC HEALTH
FACILITIES
The Circular No. 15/2019/TT-BYT
dated July 11, 2019 of the Minister of Health prescribing bidding for supply of
drugs for public health facilities, coming into force from October 01, 2019, is
amended by:
The Circular No. 15/2021/TT-BYT
dated September 24, 2021 of the Minister of Health providing amendments to the
Circular No. 15/2019/TT-BYT dated July 11, 2019 of the Minister of Health
prescribing bidding for supply of drugs for public health facilities.
Pursuant to the Law on
Bidding dated November 26, 2013;
Pursuant to the Law on
Pharmacy dated April 06, 2016;
Pursuant to the Government’s
Decree No. 63/2014/ND-CP dated June 26, 2014 providing guidelines for the Law
on bidding regarding contractor selection;
Pursuant to the Government’s
Decree No. 54/2017/ND-CP dated May 08, 2017 providing guidelines for
implementation of the Law on Pharmacy;
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At the request of the
Director of the Drug Administration of Vietnam and the Director of the
Department of Planning and Finance;
The Minister of Health
promulgates a Circular prescribing bidding for supply of drugs for public
health facilities. 1
Chapter I
GENERAL PROVISIONS
Article 1.
Scope
1. This Circular provides
guidelines on bidding for supply of drugs (including modern drugs, herbal
drugs, traditional drugs, vaccines and biologicals) and herbal ingredients for
public health facilities, including: the division of contract packages and drug
categories; planning, forms, methods and organization of selection of drug
suppliers; centralized drug procurement and procurement of drugs by price
negotiation using funding from state budget, health insurance fund, revenues
from medical examination and treatment services and other lawful funding
sources of public health facilities.
2. Procurement of drugs by drug
retailers located within the precincts of a public health facility shall comply
with the provisions of Clause 76 Article 5 of Decree No. 155/2018/ND-CP dated
November 12, 2018 providing amendments to regulations on business and
investment conditions under the management of the Ministry of Health. In case
the health facility organizes the bidding for supply of drugs for the drug
retailers located within its precincts, it must comply with the guidelines
herein.
3. Procurement of drugs
according to orders or plans of the State shall comply with the Government’s
Decree No. 32/2019/ND-CP dated April 10, 2019 prescribing task assignment,
ordering or bidding for supply of public products and services funded by state
budget for recurrent expenditures.
4. Procurement of drugs for use
in health facilities or infirmaries of armed forces shall comply with the
guidelines given by the Ministry of National Defence and the Ministry of Public
Security.
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6. Procurement of qualified
whole blood and blood products shall comply with the Circular No.
05/2017/TT-BYT of April 14, 2017 of the Minister of Health and the Circular No.
20/2018/TT-BYT dated August 30, 2018 of the Minister of Health.
72.
With regard to antiretroviral drugs (ARVs) funded by health insurance fund, the
formulation, appraisal, approval and implementation of the drug supplier
selection plan as well as the conclusion of framework agreements with selected
drug suppliers shall comply with the provisions of this Circular. Other
contents relating to planning for drug demands, conclusion of contracts with
suppliers, management of use, advance payment, payment and statement of costs
of ARVs, regulations, funding sources and methods of support for co-payments of
costs of ARVs for HIV-infected people who have valid health insurance cards
shall comply with the Circular No. 28/2017/TT-BYT dated June 28, 2017 of the Minister
of Health and the Circular No. 08/2018/TT-BYT dated April 18, 2018 of the
Minister of Health.
Article 2.
Regulated entities
1. This Circular applies to
regulatory authorities, organizations and individuals participating or involved
in bidding for supply of drugs.
2. State-invested health
facilities operated under the Law on Enterprises shall follow the provisions of
this Circular.
3. Private health facilities
providing medical services covered by health insurance fund shall comply with
the provisions of Article 52 of the 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” stands for
Stringent Regulatory Authorities that include the drug regulatory authorities
defined in Clause 10 Article 2 of the Circular No. 32/2018/TT-BYT dated
November 12, 2018 of the Minister of Health.
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3. “ICH” stands for the
International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use.
4. “PIC/s” stands for
Pharmaceutical Inspection Co-operation Scheme.
5. “GMP" means Good
Manufacturing Practices for drug products.
6. “GACP” means Good
Agricultural and Collection Practices for herbal ingredients.
7. “production line fulfilling
EU-GMP requirements” means a drug production line that is certified to
comply with EU-GMP requirements by a competent authority of the Member State of
EMA (European Medicines Agency).
8. “production line
fulfilling EU-GMP-equivalent requirements” means a drug production line
that is certified to comply with GMP requirements by a competent authority of a
country included in the list of countries considered as SRA.
9. “production line
fulfilling PIC/s-GMP requirements” means a drug production line that is
certified to comply with PIC/s-GMP requirements by a competent authority of a
country included in the list of PIC/s-GMP participating authorities.
10. “CIF price” means
the import price that includes the costs, insurance, and freight of drugs from
the exporting country to the port of Vietnam.
11. “reference biological” means
a biological granted the certificate of marketing authorization in Vietnam on
the basis of sufficient data about its quality, safety and efficacy.
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13. “therapeutic
equivalence” means drugs of pharmaceutical equivalence that are approved as
bioequivalent, and have the same safety and clinical effect on patients when
they are used under specific conditions on their package inserts.
Article 4.
Responsibility to develop and implement drug supplier selection plans
1. Heads of health facilities
shall develop their own plans for selection of drug suppliers according to
Article 14 of this Circular and the following provisions:
a) With regard to drugs
included in the list of drugs procured through national centralized bidding or
the list of drugs procured through price negotiation: The National centralized
drug procurement center shall develop the drug supplier 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
maximum period of a contract is 36 months and divided by drug category and
supply interval (quarterly and annually);
b) With regard to drugs
included in the list of drugs procured through provincial-level centralized bidding:
The provincial-level centralized drug procurement units shall develop drug
supplier selection plans. The plan shall be based on the demand for drugs of
health facilities according to the notification of the provincial-level
centralized drug procurement unit. The maximum period of a contract is 36
months and divided by drug category and supply interval (quarterly and
annually);
c) With regard to drugs of
which suppliers are selected by health facilities themselves: Health facilities
shall develop their own plans for selection of drug suppliers. The plan
shall be made periodically or on request. The maximum period of a
contract is 12 months and divided by drug category.
2. Heads of health facilities
shall organize selection of drug suppliers and ensure their compliance with the
following provisions:
a) With regard to drugs
included in the list of drugs procured through national centralized bidding or
the list of drugs procured through price negotiation: The National centralized
drug procurement center shall organize the selection of drug suppliers in
accordance with regulations in Chapter IV and Chapter V of this Circular;
b) With regard to drugs
included in the list of drugs procured through provincial-level centralized
bidding: Provincial-level centralized drug procurement units shall organize the
selection of drug suppliers in accordance with regulations 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 drug supplier selection result is approved, the head of the health
facility shall submit report on drug supplier selection result as follows:
a) Hospitals and institutions
providing inpatient treatment affiliated to the Ministry of Health shall submit
reports on drug supplier selection results to the Ministry of Health.
b) Provincial-level centralized
drug procurement units and health facilities organizing bidding for supply of drugs
under the management of People's Committees of central-affiliated cities and
provinces (hereinafter referred to as “Provincial-level People's Committees”)
shall submit reports on drug supplier selection results to relevant Provincial
Departments of Health.
c) Health facilities affiliated
to regulatory authorities and other health facilities shall submit reports on
drug supplier selection results to competent authorities that have given
approval for their drug supplier selection plans.
2. Within 10 days from the date
of receipt of reports on drug supplier selection results as prescribed in Point
b Clause 1 of this Article, Provincial Departments of Health shall repaper and
submit consolidated reports to the Ministry of Health.
3. Methods of report submission:
a) Reports shall be made using
forms in Appendix 1 and Appendix 2 enclosed herewith;
b) Reports shall be submitted
in physical form and by email to the Ministry of Health as follows:
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- 01 copy shall be sent to the
Drug Administration of Vietnam affiliated to the Ministry of Health through
email: [email protected], in respect of contract packages of original
brand-name drugs or drugs of therapeutic equivalence or generic drugs.
- 01 copy shall be sent to the
Traditional Medicine Administration of Vietnam affiliated to the Ministry of
Health through email: [email protected], in respect of
contract packages of herbal drugs, traditional drugs, herbal ingredients or
traditional ingredients.
4. Before the 31st of
October every year, health authorities of Ministries, hospitals and
institutions providing inpatient treatment affiliated to the Ministry of
Health, Provincial Departments of Health shall prepare and send reports on
violations committed by bidders during bidding for supply of drugs for health
facilities in the previous period (using the form in Appendix 3 enclosed
herewith) to the Ministry of Health (via the Department of Planning and
Finance, in respect of all contract packages; the Drug Administration of
Vietnam, in respect of contract packages of generic drugs, original brand-name
drugs or drugs of therapeutic equivalence; or Traditional Medicine
Administration of Vietnam, in respect of contract packages of herbal drugs,
traditional drugs, herbal ingredients or traditional ingredients) for
consolidation and announcement for use as the basis for bidder evaluation in
the next period.
Article 6.
Expenses and document retention
1. Expenses incurred during the
process of drug supplier selection shall comply with Article 9 of the
Government’s Decree No. 63/2014/ND-CP dated June 26, 2014 providing guidelines
for implementation of the Law on bidding regarding contractor selection
(hereinafter referred to as “Decree No. 63/2014/ND-CP”).
2. Retention of documents during
the process of drug supplier 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 01 (one) of the 03 (three) following criteria:
a) The drug is wholly
manufactured on the production line fulfilling EU-GMP requirements or the
production line fulfilling EU-GMP-equivalent requirements in a country included
in the list of countries considered as SRA;
b) The drug is included in the
list of original brand-name drugs or reference biologicals announced by the
Ministry of Health, except original brand-name drugs which are included in the
list of drugs procured through price negotiation announced by the Ministry of
Health and for which price negotiation results have been announced;
c) The drug is wholly
manufactured in Vietnam and meets all of the following criteria:
- The drug is wholly
manufactured on the production line fulfilling EU-GMP requirements or the
production line fulfilling EU-GMP-equivalent requirements and certified by a
drug authority of Vietnam to fulfill EU-GMP requirements or EU-GMP-equivalent
requirements;
- The drug is granted
certificate of marketing authorization by a drug authority of a country
included in the list of countries considered as SRA according to Clause 8
Article 50 of this Circular;
- The drug sold in Vietnam and
the drug granted certificate of marketing authorization a drug authority of a
country included in the list of countries considered as SRA must have the same
dosage form, production process, quality and testing methods; active
ingredients and excipients must have the same quality, manufacturing facility
or site as prescribed in Clause 8 Article 50 of this Circular.
2. Category 2 includes drugs
satisfying 01 (one) of the 02 (two) following criteria:
a) The drug is wholly
manufactured on the production line fulfilling EU-GMP requirements or the
production line fulfilling EU-GMP-equivalent requirements and certified by a
drug authority of Vietnam to fulfill EU-GMP requirements or EU-GMP-equivalent
requirements.
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3. Category 3 includes drugs
which are manufactured on production lines fulfilling GMP requirements as
certified by drug authorities of Vietnam and of which bioequivalence study
results have been announced by drug authorities of Vietnam.
4. Category 4 includes drugs
which are wholly manufactured in Vietnam on production lines fulfilling WHO-GMP
requirements as certified by drug authorities of Vietnam.
5. Category 5 includes drugs
which are manufactured on production lines fulfilling WHO-GMP requirements as
certified by drug authorities of Vietnam and not classified in categories
specified in Clauses 1, 2, 3 and 4 of this Article.
Article 8.
Contract packages of original brand-name drugs or drugs of therapeutic
equivalence
1. Heads of health facilities
shall make decision on procurement of original brand-name drugs or drugs of
therapeutic equivalence to original brand-name drugs or reference biologicals
on the basis of opinions given by their Drug and Treatment Councils.
2. A contract package of
original brand-name drugs or drugs of therapeutic equivalence may contain one
or several original brand-name drugs or drugs of therapeutic equivalence or
reference biological. Each drug is a part of the contract package. A drug
included in the contract package of original brand-name drugs or drugs of
therapeutic equivalence is required to satisfy 02 (two) following criteria:
b) The drug is included in the
list of original brand-name drugs, drugs of therapeutic equivalence with
original brand-name drugs and reference biologicals announced by the Ministry
of Health, except original brand-name drugs which are included in the list of
drugs procured through price negotiation announced by the Ministry of Health
and for which price negotiation results have been announced.
b) The drug is wholly
manufactured in a country included in the list of countries considered as SRA,
unless the health facility proves that the original brand-name drug or
reference biological is initially manufactured in a country which is not
included in the list of countries considered as SRA or undergoes one or several
manufacturing stages in Vietnam.
Article 9.
Contract packages of herbal drugs and traditional drugs (excluding traditional
ingredients)
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1. Category 1 includes drugs
satisfying 02 (two) following criteria:
a) The drug is wholly
manufactured from herbal ingredients which are planted, collected or obtained
naturally and certified to fulfill GACP requirements by the Ministry of Health
of Vietnam;
b) The drug is wholly
manufactured in Vietnam on the production line which is certified to fulfill
GMP requirements for herbal drugs or traditional drugs by the Ministry of
Health of Vietnam.
2. Category 2 includes herbal
drugs and traditional drugs wholly manufactured in Vietnam on the production
lines which are certified to fulfill GMP requirements for herbal drugs or
traditional drugs by the Ministry of Health of Vietnam.
3. Category 3 includes herbal
drugs and traditional drugs which do not satisfy the criteria specified in
Clauses 1 and 2 of this Article.
Article
10. Contract packages of traditional ingredients
A contract package of
traditional ingredients may contain one or several herbal ingredients. Each
list of herbal ingredients must be sorted by category. Each herbal ingredient
in a category is a part of the contract package. A contract package of herbal
ingredients is divided into 03 (three) categories based on technical criteria
as follows:
1. Category 1 includes
traditional ingredients satisfying 02 (two) following criteria:
a) The traditional ingredient
is wholly manufactured from herbal ingredients which are planted, collected or
obtained naturally and certified to fulfill GACP requirements by the Ministry
of Health of Vietnam;
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2. Category 2 includes
traditional ingredients wholly manufactured in Vietnam on the production lines
which are certified to fulfill GMP requirements for traditional ingredients by
the Ministry of Health of Vietnam (including traditional ingredients in the
following dosage forms: glue, granule, powder, extract, essential oil, resin,
gum or jelly).
3. Category 3 includes
traditional ingredients which do not satisfy the criteria specified in Clauses
1 and 2 of this Article.
Article
11. Contract packages of herbal ingredients
A contract package of herbal
ingredients may contain one or several herbal ingredients. Each list of herbal
ingredients must be sorted by category. Each herbal ingredient in a category is
a part of the contract package. A contract package of herbal ingredients is
divided into 03 (three) categories based on technical criteria as follows:
1. Category 1 includes herbal
ingredients which are planted, collected or obtained naturally, and certified
to fulfill GACP requirements by the Ministry of Health of Vietnam.
2. Category 2 includes
semi-finished herbal ingredients, including glue, granule, powder, extract,
essential oil, resin, gum and jelly, which are manufactured in Vietnam on the
production lines certified by the Ministry of Health of Vietnam to fulfill GMP
requirements for medicinal materials being herbal ingredients.
3. Category 3 includes herbal
ingredients which do not satisfy the criteria specified in Clauses 1 and 2 of
this Article.
Article
12. Provisions on bidding for drug categories
1. Principles for bidding for
drug categories in a contract package
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b) If a drug bid for is
manufactured by several facilities, all of them have to satisfy the technical
criteria of the category into which they are sorted.
2. Generic drug contract
package:
a) A bidder whose drug
satisfies the criteria of category 1 shall be sorted into category 1, category
2, and category 5;
b) A bidder whose drug
satisfies the criteria of category 2 shall be sorted into category 2 and
category 5;
c) A bidder whose drug
satisfies the criteria of category 3 shall be sorted into category 3 or
category 5;
d) A bidder whose drug
satisfies the criteria of category 4 shall be sorted into category 4 and
category 5;
dd) A bidder whose drug
satisfies the criteria of neither of category 1, category 2, category 3, and
category 4 shall be sorted into category 5.
3. Contract packages of herbal
drugs and traditional drugs:
a) A bidder whose drug
satisfies the criteria of category 1 shall be sorted into category 1, category
2 and category 3;
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c) A bidder whose drug
satisfies the criteria of neither of category 1 and category 2 shall be sorted
into category 3.
4. Contract packages of traditional
ingredients:
a) A bidder whose traditional
ingredient satisfies the criteria of category 1 shall be sorted into category
1, category 2 and category 3;
b) A bidder whose traditional
ingredient satisfies the criteria of category 2 shall be sorted into category 2
and category 3;
c) A bidder whose traditional
ingredient satisfies the criteria of neither of category 1 and category 2 shall
be sorted into category 3.
5. Contract packages of herbal
ingredients:
a) A bidder whose herbal
ingredient satisfies the criteria of category 1 shall be sorted into category 1
and category 3;
b) A bidder whose herbal
ingredient satisfies the criteria of category 2 shall be sorted into category
2;
c) A bidder whose herbal
ingredient satisfies the criteria of neither of category 1 and category 2 shall
be sorted into category 3.
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a) A foreign drug manufactured
under a processing contract or technology transfer contract in Vietnam shall be
sorted into the drug categories prescribed in Point b of this Clause when it
satisfies the following criteria:
- There is a technology
transfer contract which contains a schedule for fully transferring technology
to the processor or technology transfer receiver to manufacture all finished
drugs in Vietnam within a maximum duration of 5 years from the issue date of
the registration certificate in Vietnam;
- The drugs manufactured under
a processing contract or technology transfer contract in Vietnam and those
before processing or technology transfer must have the same dosage form,
production process, and quality standards in terms of ingredients and finished
products;
- The drug is not included in
the List of domestically manufactured drugs satisfying treatment, pricing and
supply requirements published by the Ministry of Health according to technical
criteria (unless the drug is wholly manufactured in Vietnam when it is granted
registration certificate in Vietnam).
b) Inclusion of foreign drugs
which are manufactured under processing contracts or technology transfer
contracts in Vietnam and satisfy the requirements set out in Point a of this
Clause shall be made as follows:
- Foreign drugs manufactured
under processing contracts or technology transfer contracts in Vietnam,
included in the list of original brand-name drugs or the list of reference
biologicals as announced by the Ministry of Health, and satisfying the
requirements set out in Point b Clause 2 Article 8 of this Circular shall be
included in contract packages of original brand-name drugs or drugs of
therapeutic equivalence. If a drug is included in the list of drugs procured
through price negotiation announced by the Ministry of Health, this drug shall
be procured through price negotiation;
- If foreign drugs specified in
Point a Clause 1 Article 7 of this Circular are manufactured under processing
contracts or technology transfer contracts in Vietnam on the production line
fulfilling EU-GMP requirements or the production line fulfilling
EU-GMP-equivalent requirements and certified by a drug authority of Vietnam to
fulfill EU-GMP requirements or EU-GMP-equivalent requirements, they shall be
sorted into category 1, category 2, category 4 and category 5;
- If foreign drugs specified in
Clause 2 Article 7 of this Circular are manufactured under processing contracts
or technology transfer contracts in Vietnam on the production line fulfilling
EU-GMP requirements or the production line fulfilling EU-GMP-equivalent
requirements and certified by a drug authority of Vietnam to fulfill EU-GMP
requirements or EU-GMP-equivalent requirements, they shall be sorted into
category 2, category 4 and category 5;
- Other drugs manufactured
under processing contracts or technology transfer contracts in Vietnam shall be
sorted into category 4 and category 5.
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Chapter
III
PROCUREMENT OF DRUGS FOR
HEALTH FACILITIES
Section 1.
DRUG SUPPLIER SELECTION PLAN
Article
13. Grounds for drug supplier selection plan
1. The drug supplier selection
plan shall be made annually or whenever necessary on the following grounds:
a) Funding from state budget:
Funding for procurement of
drugs from state budget shall be annually allocated 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 of the previous year and
the anticipated demand for drugs in the current year;
b) Revenues from medical
examination and treatment services and payments from social insurance agencies:
- Contract for provision of
covered medical services signed between the heath facility and the social
insurance agency;
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c) For drugs covered by other
funding sources of the health facility: the plan shall be made according to the
procurement and use of drugs covered by such funding sources in the preceding
year and anticipated demand for drugs in the current year of the health
facility.
2. If the health facility has
selected a drug supplier and signed a contract but the demand for a drug
exceeds the contractual quantity by more than 20%, such health facility shall
make a plan for selection of additional drug suppliers.
Article
14. Contents of drug supplier selection plan
1. Name of the contract
package:
The division of contract
package and drug categories shall comply with the provisions of Articles 7
through 12 of this Circular. If a contract package is divided into smaller
parts, each of them must have a suitable name. Specific information in a drug
supplier selection plan:
a) Each part of a contract
package of generic drugs shall contain: name of active ingredient; content or
concentration; route of administration, dosage form; drug category; measuring
unit; quantity; unit price and total value;
b) Each part of a contract
package of original brand-name drugs or drugs of therapeutic equivalence shall
contain: the name of drug and the phrase “hoặc tương đương điều trị) (“or drugs
of therapeutic equivalence”); name of active ingredient; content or
concentration; route of administration, dosage form; measuring unit; quantity;
unit price and total value. If a single active ingredient has several names of
the original brand-name drug or drug of therapeutic equivalence or reference biological
on the list of original brand-name drugs or the list of drugs of therapeutic
equivalence or the list of reference biologicals published by the Ministry of
Health, all names must be specified;
c) Each part of a contract
package of herbal drugs or traditional drugs shall contain: name of drug; route
of administration, dosage form; measuring unit; quantity; drug category; unit
price and total value. Names of drugs shall be specified according to Clause 3
of this Article.
d) Each part of a contract package
of herbal ingredients or traditional ingredients shall contain: name of herbal
ingredient or traditional ingredient; scientific name; quality standards; raw
form or processing method; category; measuring unit, quantity; unit price and
total value.
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a) It has the same dosage form
as the original brand-name drug or reference biological which has the same
active ingredient and route of administration or the drug which has the same
active ingredient and route of administration, and granted certificate of
marketing authorization in a country included in the list of countries
considered as SRA;
b) If a drug is not specified
in Point a Clause 2 of this Article, the health facility shall clearly state its
demand for this dosage form in terms of necessity and estimated quantity, and
shall only use it in case another dosage form cannot be used or does not
respond to treatment;
3. Names
of herbal drugs or traditional drugs shall be written as follows:
a) Only the drug ingredients
are specified; their trade names shall not be specified;
b) For drugs having the same
ingredients or dosage form: only contents or concentrations of the ingredients
are specified if the difference in contents or concentrations leads to
difference in dose and indications of the drug according to opinions of the
Drug and Treatment Council.
4. Value
of contract package:
a) The value of the contract
package is total value of the contract package, including all expenses;
b) If a contract package is
divided into smaller parts, the unit price and value of each part must be
specified in accordance with Clause 1 of this Article.
The health facility shall propose the unit price in the drug supplier
selection plan and assume responsibility for its proposal;
c) When making the drug
supplier selection plan, the procuring entity shall check the successful bids
of drugs and herbal ingredients over the previous 12 months of health
facilities published by the Ministry of Health (Drug Administration of Vietnam,
Traditional Medicine Administration of Vietnam) on their website. To be
specific:
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- For
a drug or herbal ingredient whose successful bid is unpublished or proposed
price is higher than successful bids published by the Ministry of Health (Drug
Administration of Vietnam, Traditional Medicine Administration of Vietnam) in
the previous 12 months, the health facility shall check quotations or sales
invoices of at least 03 drug suppliers on the market at the time of preparation
of the drug supplier selection plan and ensure that the proposed price shall
not exceed the effective wholesale price it refers to (except for herbal
ingredients and traditional ingredients). For
a drug or herbal ingredient 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 explanations, and take
responsibility for the appropriateness of the proposed price when the drug
supplier selection plan is made.
d) The proposed price of items
with the same active ingredient, concentration or content, and dosage form in
the generic drug contract package must comply with the following rules:
- The
proposed price of category 1 shall not be higher than that of the original
brand-name drug or reference biological;
- The
proposed price of category 2 or category 3 shall not be higher than that of the
original brand-name drug or reference biological and that of category 1;
- The
proposed price of category 4 shall not be higher than the proposed prices of
the original brand-name drugs or reference biologicals, and drugs of category
1, drugs of category 2 manufactured in Vietnam, and drugs of category 3;
- The
proposed price of category 5 shall not be higher than the proposed prices of
the original brand-name drugs or reference biologicals, and drugs of category
1, category 2, category 3 and category 4.
5. Funding
sources: 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).
6. Drug
supplier selection methods and procedures:
a) Drug supplier selection
methods:
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b) Drug supplier selection
procedures:
Based on the drug supplier
selection method and value of the contract package, the health facility shall
propose drug supplier selection procedures in accordance with the provisions of
Articles 28 and 29 of the Law on bidding, Decree No. 63/2014/ND-CP and
guidelines in this Circular. For a small
contract package requiring quality and good prices, the single-stage
two-envelope bidding procedures shall be applied.
7. Starting
time of drug supplier selection:
The month or quarter in which
bidding documents or request for proposals are issued shall be specified.
8. Type
of contract:
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:
The time limit for contract execution
is specified in the drug supplier selection plan but shall not exceed 12 months
from the effective date of the contract.
Article
15. Submission of drug supplier selection plan for approval
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a) The head of the health
facility shall assume responsibility to prepare the drug supplier selection
plan to ensure that the supply of drugs can meet its medical treatment
requirements.
b) At least 03 months before
the expiry of the previous drug supply contract, the head of the health
facility shall submit the drug supplier selection plan to the person who is
competent or assigned to consider giving approval for the drug supplier
selection plan as prescribed in Clause 1 Article 17 of this Circular.
2. A
request for approval for the drug supplier selection plan shall contain:
a) Grounds for the drug
supplier selection plan as prescribed in Article 13 of this Circular;
b) Contents of the drug
supplier selection plan as prescribed in Article 14 of this Circular, which
must be specified as follows:
- Names
of contract packages, value of each part and value of the contract package, and
total value of contract packages specified in the drug supplier selection plan,
and grounds for division of contract packages. If
drugs are procured with funding from state budget, total value of contract
packages in the drug supplier selection plan shall not exceed the approved cost
estimate;
- The
drug supplier selection method and procedures applied to each contract package
shall be one of those specified in Articles 19 through 26 of this Circular. If the competitive bidding is not applied, the
request shall specify reasons for choosing other methods;
- Explanation
for increase in quantity of drugs manufactured in Vietnam according to
guidelines given by the Ministry of Health.
3. Documents
enclosed with the request include:
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b) Documents used as the basis
for the drug supplier selection plan as prescribed in Article 13 of this
Circular;
c) Minutes of the meeting of
the Drug and Treatment Council of the health facility on the list, quantity,
demand for original brand-name drugs or drugs of therapeutic equivalence or
reference biologicals, demand for drugs of the dosage form separately written
in the drug supplier selection plan as prescribed in Clause 2 Article 14 of
this Circular, the expression of names and contents or concentrations in the
contract package of herbal drugs or traditional drugs;
d) The investor’s decision on
approval for funding sources, list, quantity and proposed prices of drug items
specified in the drug supplier selection plan.
4. The
request for approval for the drug supplier selection plan shall be sent by post
or directly or electronically, according to guidelines given by competent
authorities, to the unit assigned to appraise drug supplier selection plans. The request for approval for the drug supplier
selection plan shall be made using the form in Appendix 5 enclosed herewith.
Article
16. Appraisal of drug supplier selection plan
The drug supplier selection plan
shall be appraised before it is submitted to the competent person for approval
as prescribed in Clause 1 Article 17 of this Circular.
1. Organization
of appraisal:
a) For public health facilities
affiliated to ministries, ministerial agencies and governmental agencies:
Competent persons specified in Point a Clause 1 Article 17 of this Circular
shall decide to choose the agencies in charge of appraising drug supplier
selection plans;
b) For public health facilities
under the management of provincial governments:
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- If
the Chairperson of the Provincial People’s Committee authorizes another person
to consider giving approval for the drug supplier selection plan, the
authorized person shall assign a unit whose functions and duties are
appropriate for the nature of the contract package to perform plan appraisal
tasks.
c) For health facilities other
than those specified in Points a and b Clause 1 of this Article, the legal
representative of the health facility or his/her authorized person shall choose
a unit in charge of appraising the drug supplier selection plan.
2. Duties
of an appraising unit:
a) Examine and appraise the
contents specified in Articles 7 through 15 of this Circular within 20 days
from the receipt of adequate relevant documents. If
required documents are inadequate, the appraising unit shall request submission
of additional documents or return the received documents to the health facility
within 05 working days from the receipt of such documents;
b) Make a report on appraisal
of the drug supplier selection plan using the form in Appendix 6 enclosed herewith. The appraisal report shall be enclosed with a set
of original documents of the health facility’s request for approval for the
drug supplier selection plan, which has been appraised, and submitted to the
competent person specified in Clause 1 Article 17 of this Circular for
approval.
Article
17. Approval for drug supplier selection plan
1. Power
to approve drug supplier selection plans:
a) Ministers, heads of
ministerial agencies, and heads of governmental agencies shall have the power
to approve drug supplier selection plans of health facilities under their
management. a) Ministers, heads of ministerial
agencies, and heads of governmental agencies may authorize heads of health
facilities under their management to consider giving approval for drug supplier
selection plans of some contract packages. In this case, the authorized person
shall appoint a unit whose functions and duties are appropriate for the nature
of the contract package to appraise the drug supplier selection plan before
approving.
b) Chairpersons of Provincial
People's Committees shall consider approving drug supplier selection plans of
health facilities under their management. Chairpersons
of Provincial People's Committees may authorize heads of health facilities
under their management to consider giving approval for drug supplier selection
plans of some contract packages. In this case,
the authorized person shall appoint a unit whose functions and duties are
appropriate for the nature of the contract package to appraise the drug supplier
selection plan before approving.
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d) Authorization to approve
drug supplier selection plans of health facilities of armed forces shall comply
with guidelines given by the Ministry of National Defence or the Ministry of
Public Security.
2. Within
05 working days from the receipt of the appraisal report and the request for
approval for the drug supplier selection plan, the competent person specified
in Clause 1 of this Article shall consider approving the plan.
3. The
approved drug supplier selection plan shall be published on the national
bidding system in accordance with the provisions of Article 8 of the Law on
Bidding and its guiding documents.
Article
18. Selection of suppliers of drugs included in list of drugs procured through
centralized bidding or list of drugs procured through price negotiation by
health facilities
1. A
health facility may itself carry out selection of suppliers of drugs included
in the List of drugs procured through centralized bidding or the List of drugs
procured through price negotiation, provided the drug quantity does not exceed
the demand for drugs for 12 months (from the date of receipt of written
notification from the centralized drug procurement unit), in one of the
following cases:
a) The health facility needs to
use a drug included in the List of drugs procured through centralized bidding
or the List of drugs procured through price negotiation but results of
centralized bidding or price negotiation have not been published;
b) The health facility needs to
use a drug included in the List of drugs procured through centralized bidding
or the List of drugs procured through price negotiation for which a drug supply
contract has been concluded but the selected supplier is unable to supply drugs
and the health facility has been notified in writing by the centralized drug
procurement unit of self-selection of drug suppliers to meet its medical
treatment requirements;
c) The health facility has used
up the quantity of drugs specified in the framework agreement and its demand
for drugs exceeds the regulating 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 regulating capacity of the national centralized drug
procurement center and relevant provincial-level centralized drug procurement
unit.
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Section 2.
DRUG SUPPLIER SELECTION METHODS
Article
19. Competitive bidding
Competitive bidding shall be
applied to every contract package regulated by this Circular, except for the
cases in Articles 20 through 24 of this Circular.
Article
20. Selective bidding
1. Selective
bidding shall be applied to the contract packages of controlled drugs included
in the list of controlled drugs published by the Ministry of Health or special
drugs that can be supplied by few suppliers.
2. Drug
manufacturers and drug suppliers included in the Ministry of Health’s the list
of capable, experienced and reputable manufacturers and suppliers as prescribed
in Point dd Clause 1 Article 77 of the Decree No. 63/2014/ND-CP shall be
invited to participate in the selective bidding if their drugs are suitable for
contract packages.
Article
21. Direct contracting
1. Cases
of standard direct contracting and shortened direct contracting:
a) Standard direct contracting
applies to contract packages whose value does not exceed VND 01 billion as
prescribed in Point e Clause 1 Article 22 of the Law on bidding;
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2. Standard
direct contracting and shortened direct contracting procedures:
a) Standard direct contracting
procedures shall be carried out in accordance with Article 55 of the Decree No.
63/2014/ND-CP.
b) Shortened direct contracting
procedures shall be carried out in accordance with Article 56 of the Decree No.
63/2014/ND-CP after the drug supplier selection plan is approved.
In case of direct contracting
specified in Point a Clause 1 Article 22 of the Law on bidding (except for
contract packages that are state secrets), the provisions of Clause 8 Article 6
of the Circular No. 10/2015/TT-BKHDT dated October 26, 2015 of the Minister of
Planning and Investment prescribing contractor selection plans.
Article
22. Competitive offering
1. Competitive
offering shall be applied when all of the following conditions are satisfied:
a) The value of the contract
package does not exceed VND 05 billion;
b) The drug to be procured is
included in the list of essential drugs announced by the Ministry of Health or
is a commonly available drug whose technical characteristics and quality have
been standardized and equivalent;
c) There is a drug supplier
selection plan approved by a competent person;
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2. Competitive
offering procedures shall be carried out in accordance with Article 58 and
Article 59 of Decree No. 63/2014/ND-CP.
Article
23. Direct procurement
1. Direct
procurement shall be applied when all of the following conditions are
satisfied:
a) The drug supplier has won
the contract through competitive bidding or selective bidding and has signed a
contract earlier;
b) The current contract package
includes similar contents and characteristics, and has a scale 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 scale 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 date of approval
of the drug supplier selection plan;
d) The period of time from the
conclusion 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 only
make a direct 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 drug supplier is no longer capable of executing the direct
procurement contract, another drug supplier whose capacity, experience,
technology, and prices satisfy the requirements set out in the bidding
documents and the previous drug supplier selection result may be selected.
3. Direct
procurement procedures shall be carried out in accordance with Article 60 of
the Decree No. 63/2014/ND-CP.
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1. Self-supply
shall be applied to the contract packages prescribed in Article 25 of the Law
on bidding after all requirements set out in Article 61 of the Decree No.
63/2014/ND-CP are satisfied.
2. Self-supply
procedures shall be carried out in accordance with Article 62 of the Decree No.
63/2014/ND-CP.
Section 3.
DRUG SUPPLIER SELECTION PROCEDURES
Article
25. Single-stage one-envelope procedures
Single-stage one-envelope
procedures shall be applied to:
1. Small-scale
contract packages through competitive bidding or selective bidding as
prescribed in Article 63 of the Decree No. 63/2014/ND-CP;
2. Contract
packages through competitive offering;
3. Contract
packages through direct procurement;
4. Contract
packages through standard direct contracting.
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Single-stage two-envelope
procedures shall be applied to:
1. Contract
packages worth more than VND 10 billion through competitive bidding or
selective bidding.
2. Contract
packages worth less than VND 10 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
Article
27. Preparing bidding documents and request for proposals
1. Bidding
documents or request for proposals shall be prepared in accordance with the Law
on bidding, its guiding documents and the following provisions:
a) Bidding documents or
requests for proposals for contract packages of original brand-name drugs or
drugs of therapeutic equivalence, generic drugs, herbal drugs and traditional
drugs shall be prepared using forms of the bidding documents applying one-stage
one-envelope procedures specified in Appendix 7 or forms of bidding documents
applying one-stage two-envelope procedures specified in Appendix 8 enclosed
herewith.
b) Bidding documents or
requests for proposals for contract packages of traditional ingredients and
herbal ingredients shall be prepared according to the Ministry of Health’s
guidelines for bidding documents for procurement of herbal ingredients and
traditional ingredients at health facilities.
2. Based
on the drug supplier selection plan approved by a competent authority, the
procuring entity shall prepare the bidding documents or request for proposals
and submit them to the responsible appraising unit.
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a) With regard to drugs
satisfying WHO-GMP technical criteria included in the List enclosed with the
Circular No. 03/2019/TT-BYT, bidders shall not offer imported drugs satisfying
technical criteria of category 5 specified in Clause 5 Article 7 of this
Circular.
b) With regard to drugs
satisfying EU-GMP technical criteria included in the List enclosed with the
Circular No. 03/2019/TT-BYT, bidders shall not offer imported drugs satisfying
technical criteria of category 2 specified in Clause 2 Article 7 of this
Circular.
4. The
bidding documents or request for proposals must specify that bidders shall not
offer imported herbal ingredients in the same categories as herbal ingredients
included in the Ministry of Health's List of domestically cultivated and
harvested herbal ingredients satisfying treatment, pricing and supply
requirements.
5. In
case there is a sudden increase in demand for drugs included in the List of
domestically manufactured drugs satisfying treatment, pricing and supply
requirements or herbal ingredients included in the List of domestically
cultivated and harvested herbal ingredients satisfying treatment, pricing and
supply requirements beyond the supply capacity of domestic manufacturers, and
health facilities need to use imported drugs or herbal ingredients to meet
their medical treatment requirements, the Minister of Health shall, based on
reports of relevant health facilities and current drug supply situations,
decide to accept bids for imported drugs or herbal ingredients in the same
categories as the required drugs or herbal ingredients for a given period of
time to ensure the supply of adequate drugs or herbal ingredients serving
medical treatment of health facilities.
Article
28. Appraisal of bidding documents and request for proposals
1. Bidding
documents and request for proposals shall be appraised before they are
submitted to heads of health facilities for approval.
2. Heads
of health facilities shall decide agencies in charge of appraising bidding
documents and request for proposals.
3. Duties
of an appraising unit:
a) Examine to ensure that the
contents of bidding documents or request for proposals comply with the Law on
bidding, its guiding documents regarding contractor selection and the
provisions of this Circular;
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Article
29. Approval for bidding documents and request for proposals
The head of the health facility
shall consider approving the bidding documents or request for proposals within
10 days from the receipt of adequate documents and appraisal report from the
appraising unit.
Section
5. ORGANIZATION OF DRUG SUPPLIER SELECTION
Article
30. Bid security, submission of bids or proposals
1. The
head of the health facility (or the procuring entity) shall specify the value
of bid security in the bidding documents or 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
drug supplier may participate in one, some, or all parts of a contract package. If a drug supplier participates in more than one
part, the bid security value shall be the sum of values of bid security for
such parts.
3. A
drug supplier may choose one of the following bid security methods:
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b) Pay security;
c) Provide a letter of
guarantee issued by a credit institution or foreign bank branch lawfully
established under the law of Vietnam.
The investor shall not request
drug suppliers to follow any of the three methods mentioned above.
4. The
procuring entity shall specify the validity period of bidding documents or
request for proposals which shall not exceed 180 days from the bid closing
time. Where necessary, the validity period of bids or proposals may be extended
as long as the drug supply schedule is met. Each
drug supplier shall submit 02 sets of the bid or proposal (01 original and 01
copy) to the procuring entity before the bid closing time.
Article
31. Evaluation of bids or proposals
1. Depending
on the nature and scale of the contract package, drug supplier selection method
and procedures, the head of the health facility shall select a method for
evaluating bids or proposals specified in Article 39 and Article 41 of the Law
on Bidding. The method for evaluating bids or
proposals must be specified in the bidding documents or request for proposals.
2. The
procuring entity shall evaluate bids or proposals for each part of the contract
package which comprises multiple parts in accordance with the Law on Bidding
and regulations of the Ministry of Health on preparation of bidding documents
and request for proposals for supply of drugs to health facilities. The evaluation of ability and experience of a drug
supplier shall be based on the total parts of the contract package in which it
participates.
3. The
standards for evaluating bids or proposals shall comply with the provisions in
Appendix 7 or Appendix 8 enclosed herewith and shall be specified in the
bidding documents or request for proposals. The
procuring unit shall comply with regulations on contractor selection incentives
in Articles 3, 5 and 6 of the Decree No. 63/2014/ND-CP.
4. Procedures
for evaluation of bids or proposals shall depend on the drug supplier selection
procedures approved by a competent authority. To be specific:
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b) Single-stage two-envelope
procedure: Articles 27 through 30 of the
Decree No. 63/2014/ND-CP shall be applied.
5. The
maximum time limit for evaluating proposals is 30 days; the maximum time limit
for evaluating bids is 45 days (or 25 days for small contract packages) from
the bid closing date to the day on which the procuring entity submits the drug
supplier selection result to the head of the health facility for approval. In case of competitive bidding or selective bidding
under single-stage two-envelope procedures, the time limit for evaluating bids
shall be the total length for evaluating technical proposals (from the bid
closing date to the day on which the procuring entity requests the head of the
health facility to consider giving approval for the list of bidders satisfying
technical requirements) plus (+) the length of time for evaluating financial
proposals (from the day on which financial proposals are opened to the day on
which the procuring entity submits the drug supplier selection result to the
head of the health facility for approval). Where
necessary, the time limit for evaluating bids or 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 drug supplier
1. The
contract negotiation shall be carried out in accordance with the provisions of
Article 19 of the Decree No. 63/2014/ND-CP before the procuring entity proposes
successful drug supplier.
The drug supplier whose bid
after correction of errors and adjustment of deviation minus (-) discount is
the lowest bid (if the least-cost selection method is applied), or whose
evaluated bid is the lowest bid (if the lowest evaluated bid selection method
is applied), or whose total score is the highest score (if the quality- and
cost-based selection method is applied) shall be ranked first and invited to
the contract negotiation session.
If the drug supplier who is
invited to the contract negotiation session fails to be present or refuses the
contract negotiation, the bid security provided by that drug supplier shall not
be refunded.
2. Conditions
to be satisfied by a proposed successful drug supplier are specified in Article
43 of the Law on Bidding and the bidding documents specified in Appendix 7 or
Appendix 8 enclosed herewith.
The procuring entity shall
propose the successful drug supplier for each part of the approved drug
supplier selection plan in accordance with the Law on Bidding, provisions of
this Circular and specific guidelines on management of drug quality and prices. Only a drug or herbal ingredient in a category
(which is a part of the contract package) satisfying technical and quality
requirements specified in the bidding documents or request for proposals and
for which the bid after correction of errors and adjustment of deviation minus
(-) discount is the lowest bid (if the least-cost selection method is applied),
or the evaluated bid is the lowest bid (if the lowest evaluated bid selection
method is applied), or the total score is the highest score (if the quality-
and cost-based selection method is applied) shall be proposed.
3. If
the bid after correction of errors and adjustment of deviation minus (-)
discount (if any) of every drug supplier satisfying technical requirements and
included in the list of ranked drug suppliers exceeds the approved value of a
part of the contract package, there are the following options:
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b) If the value of that part in
the approved drug supplier selection plan is not reasonable, the procuring
entity shall provide explanations thereof and propose modification of the value
of that part as well as the value of the contract package to a competent person
for consideration;
c) Where it is necessary to
ensure the sufficient supply of drugs so as to serve medical examination and
treatment requirements, the procuring entity may consider deciding to select
the drug supplier according to drug suppliers’ ranking when all of the
following conditions are satisfied:
- The
successful bid shall not exceed the drug’s declared or re-declared wholesale
price which is still valid;
- Total
value of proposed drugs offered by drug suppliers shall not exceed the total
value of those parts in the drug supplier selection plan approved by a
competent authority.
Article
33. Reporting and submission of drug supplier selection result for appraisal
1. The
procuring entity shall send 01 set of documents to the unit in charge of
appraising the drug supplier selection result, including:
a) 01 original of the report on
evaluation of bids or proposals;
b) 01 set of bidding documents
or request for proposals (copies) appraised and approved as prescribed in
Articles 27, 28 and 29 of this Circular and other provisions of the Law on
Bidding.
2. Procedures
for reporting, appraisal, approval, and publishing of information about the
drug supplier selection result shall be carried out according to Article 20 of
the Decree No. 63/2014/ND-CP.
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1. The
head of the health facility shall establish or appoint a unit to appraise the
drug supplier selection result.
2. Duties
of an appraising unit:
a) Within 20 days (or 10 days
for small contract packages) from the date of receipt of adequate documents,
the appraising unit shall inspect and evaluate the drug supplier selection
procedures specified in Articles 30, 31 and 32 of this Circular;
b) Prepare and submit the
report on appraisal of the drug supplier selection result to the head of the
health facility for consideration and approval in accordance with the
provisions of this Circular and the Law on Bidding.
3. Documents
submitted for approval for drug supplier selection result include:
a) 01 original of the report on
appraisal of the drug supplier selection result;
b) 01 set of documents
submitted for appraisal of the drug supplier selection result (originals).
Article
35. Approval and notification of drug supplier selection result
1. Within
a maximum duration of 10 working days (or 05 working days for small contract
packages) from the receipt of adequate documents submitted for approval for
drug supplier selection result from the appraising unit specified in Clause 3
Article 34 of this Circular, the head of the health facility shall consider
approving the drug supplier selection result.
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3. The
notification sent to unsuccessful drug suppliers shall provide explanation for
their failure.
4. If
the contract package is divided into smaller parts and the time limit for bid
evaluation might affect the drug supply schedule, the head of the procuring
entity may consider approving the drug supplier 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 there is no
successful drug supplier or none of the options specified in Clause 3 Article
32 of this Circular is viable, the procuring entity is entitled to cancel the
contract package and submit an adjusted drug supplier selection plan to a
competent authority for approval. The time
limit for appraisal and approval for the adjusted plan shall comply with
Article 16 and Article 17 of this Circular. If
information about a drug included in the contract package, including name of
the active ingredient, content or concentration, route of administration,
dosage form, category, measuring unit, quantity, unit price and total value of
the drug is unchanged in comparison to the approved plan, the competent
authority shall consider approving the adjusted plan without reappraisal of the
drug supplier selection plan.
Article
36. Successful bids
The successful bid for each drug
shall not exceed the price of that drug in the drug supplier selection plan
approved by a competent person and shall not exceed the declared or redeclared
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% compared to the quantity of drugs in the
bidding plan provided that there is no change in the unit price or other
provisions of bids and bidding documents.
2. The
selected drug supplier shall provide guarantee for contract execution before
the effective date of the contract. The value
of the bid security in the bidding documents or request for proposals shall
equal 2% - 10% of the contract value. For
small contract packages, the value of the bid security in the bidding documents
or request for proposals shall equal 2% - 3% of the contract value.
3. The
head of the health facility and the successful drug supplier shall execute the
drug supply contract in accordance with relevant laws on business contracts,
and ensure that at least 80% of the value of each part in the concluded
contract shall be executed. For emergency
treatment drugs, antidotes, rare drugs, specially controlled drugs, intravenous
fluids and other cases, after reporting to a competent authority, the health
facility shall ensure that at least 50% of the value of each part in the concluded
contract shall be executed.
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4. The
quantity of drug in a category purchased by the health facility shall not
exceed the quantity of that drug specified in the drug supplier selection
result if the quantity of drugs in other categories of the same active
ingredient, content or concentration, and dosage form is not completely bought
under the concluded contracts.
5. The
quantity of purchased drug may exceed by up to 20% of the quantity of drug in
such category specified in the concluded contract without having to submit the
additional drug supplier selection plan in the following cases:
a) Drugs of other categories of
the same active ingredient, concentration or content are used up and only drugs
of a contract package of original brand-name drugs or drugs of therapeutic
equivalence are available;
b) Selected drugs of other
categories of the same active ingredient, concentration or content have to be
suspended from supply or marketing or removed from the list of drugs of
evidenced bioequivalence after they are selected;
c) The drug supplier 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 enclosed with relevant supporting documents shall be provided.
6. If
there are changes in a drug bid for during the drug supplier selection, or the
drug is supplied but the substitute drug is not offered in the bids, the
investor may consider allowing the drug supplier to supply the substitute drug.
To be specific:
a) There are changes in the
name of the drug or the factory or packaging specifications during the
marketing of the drug but the registration number or import license number
remains unchanged;
b) There are changes in the
registration number or a new import license is issued but other information
(name of drug, manufacturer, quality standards, shelf life, category) remains
unchanged (quality standards may be changed but the standard level and quality
criteria shall not be lower than those of the selected drug (or offered in the
bid) or updated on the Pharmacopoeia);
When using the substitute drug,
the drug supplier must sufficiently provide information necessary for the
procuring entity to evaluate the substitute drug, including: copies (bearing
certification of the drug supplier) of the Marketing Authorization (MA) or
Certificate of Pharmaceutical Product (CPP), 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) There are changes in method
for naming of herbal ingredients which do not influence their formula and are
permitted by a competent authority.
Chapter
IV
CENTRALIZED DRUG
PROCUREMENT
Article
38. General provisions on centralized drug procurement
1. The
unit in charge of centralized drug procurement shall:
a) Survey demand for drugs,
prepare and submit a drug supplier selection plan, organize the drug supplier
selection, complete and conclude contracts or framework agreements with
selected drug suppliers, publish drug supplier selection results and framework
agreements on the websites of the Ministry of Health and Provincial Departments
of Health as the basis for health facilities to complete and sign contracts
with selected drug suppliers.
b) Supervise the execution of
framework agreements and contracts signed with selected drug suppliers.
2. Provincial-level
centralized drug procurement units shall not carry out drug supplier selection
for drugs on the list of drugs procured through national centralized bidding,
the list of drugs procured through provincial-level centralized bidding or the
list of drugs procured through price negotiation if, on the date of issuance of
bidding documents, the drug supplier selection result is available and a
framework agreement has been published on the website of Ministry of Health.
3. When
surveying demand for drugs on the list of drugs procured through national
centralized bidding and the list of drugs procured through price negotiation,
the health facility shall exclude the remaining quantity of drugs to be
supplied under contracts signed with selected drug suppliers according to
previous drug supplier selection results.
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5. Drug
supplier selection procedure: single-stage two-envelope procedure;
6. Bid
evaluation: the quality- and cost-based selection method shall be employed to
evaluate each part of the contract package.
7. Implementation:
the centralized drug procurement shall be carried out by signing the framework
agreement, except for the following cases where a contract may be signed
directly:
a) Procurement of drugs and
vaccines serving open vaccination programs/projects funded by state budget
under decisions of the Minister of Health or Chairpersons of Provincial
People’s Committees;
b) Procurement of drugs of
programs and projects funded by ODA, aid, sponsorship from domestic and
overseas sponsors who require direct contract conclusion;
8. Appraisal
of drug supplier selection plan:
a) Planning – Finance
Department shall take charge of appraising national centralized drug
procurement plan.
b) Provincial Departments of
Health shall take charge of appraising provincial-level centralized drug
procurement plans.
c) Centralized drug procurement
plans shall be appraised in accordance with Clause 1 Article 37 of the Law on
Bidding and Article 16 of this Circular.
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Contract negotiation shall be
carried out in accordance with Clause 1 Article 32 of this Circular. During centralized drug supplier selection, in
order to ensure economic efficiency of the contract package, the contract
negotiation shall comply with Clause 3 Article 19 of the Decree 63/2014/ND-CP
and the following provisions:
a) If a large quantity of a
drug is divided into smaller contract packages as prescribed 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 drug
supplier may be requested to analyze components of the bid and explain about
the bid 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 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 registration certificate, 01 drug supplier and the proposed successful
bid in this drug category is higher than that of the drug having the same
active ingredient, concentration or content, dosage form, and route of
administration in another category with more advanced technical standards and
competitive price thanks to the participation of many drug suppliers, the
contract negotiation on the adjusted bid shall follow these principles:
- The
successful bid of category 1 shall not be higher than that of the original
brand-name drug or reference biological;
- The
successful bid of category 2 or category 3 shall not be higher than that of the
original brand-name drug or reference biological and category 1;
- The
successful bid of category 4 shall not be higher than that of the original
brand-name drug or reference biological, and drugs of category 1, drugs of
category 2 manufactured in Vietnam, and drugs of category 3;
- The
successful bid of category 5 shall not be higher than that of the original
brand-name drug or reference biological, and drugs of category 1, drugs of
category 2, drugs of category 3 and drugs of category 4.
10. If
a drug bid for is changed during the drug supplier selection, or the drug is
supplied but the substitute drug is not offered in the bids, the drug
substitution may be carried out according to Clause 6 Article 37 of this Circular
so as to ensure the sufficient supply of drugs serving medical examination and
treatment requirements.
11. Duties,
functions, organizational structure and operation of the National centralized
drug procurement center shall be decided by the Minister of Health. Duties,
functions, organizational structure and operation of Provincial-level
centralized drug procurement units shall be decided by Chairpersons of
Provincial People’s Committees at the request of Provincial Departments of
Health.
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1. A
health facility wishing to purchase drugs on the list of drugs to be procured
through centralized bidding shall prepare and sign a contract with the selected
drug supplier according to the drug supplier selection result or the signed
framework agreement, provided the contractual unit price does not exceed that
specified in the published framework agreement. The
drug supplier shall provide contract performance security as prescribed in
Article 66 of the Law on Bidding and Clause 2 Article 37 of this Circular for
the health facility before the effective date of the contract.
2. The
contact points specified in Clause 1 Article 40 and Clause 2 Article 41 of this
Circular shall survey demand for drugs (items and quantity of drugs) of each
health facility under their management and regulate the plan implementation to
ensure that at least 80% of the quantity of drugs reported are used. For emergency treatment drugs, antidotes, rare
drugs, specially controlled drugs, intravenous fluids and drugs used in other
emergency cases, after reporting to a competent authority, the health facility
shall ensure that at least 50% of the value of each part in the concluded
contract shall be executed.
3. The
drug supplier selected by centralized drug procurement shall supply drugs with
the agreed quantity and schedule specified in the contract signed with each
health facility During the contract execution,
the health facility and the drug supplier may negotiate changes to the quantity
specified in the concluded contract according to bidding documents issued by
the centralized drug procurement unit. The
centralized drug procurement unit shall cooperate with the contact points and
successful drug suppliers in regulating the plan implementation in a manner
that ensures sufficient supply of drugs for the health facility.
4. Time
limit for executing a centralized drug procurement contract (either national or
provincial-level) shall comply with provisions of the drug supplier selection
plan approved by a competent authority but shall not exceed 36 months from the
effective date of the centralized drug procurement results and framework
agreements.
Article
40. Organization of national centralized drug procurement
1. The
survey on demand for drug use shall follow these principles:
a) The health facilities
affiliated to the Ministry of Health shall survey the demand for drugs with
specified names, detailed quantities, categories, and supply schedules, and
submit the survey result enclosed with the documents specified in Clause 2 of
this Article to the National centralized drug procurement center.
b) Health facilities under the
management of Ministries or regulatory authorities and infirmaries shall survey
the demand for drugs with specified names, detailed quantities, categories, and
supply schedules, and submit the survey results to the provincial-level
centralized drug procurement units.
Provincial-level centralized
drug procurement units shall survey demand for drug use, submit reports to
Provincial Departments of Health for appraisal, and send the drug use plans
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 registration of centralized drug procurement
demand:
a) Summary report on
implementation of drug supplier selection result and drug use in the preceding
year, the drug inventory and the planned quantity of drugs that have not been
used at the planning date of the health facilities;
b) A brief explanation for the
proposed drug procurement plan; detailed explanations about any change in the
quantity of drugs by more than 30% of the quantity of drugs used in the
preceding year;
c) Documents used as the basis
for the drug procurement plan as prescribed in Article 13 of this Circular;
d) The minutes of the meeting
of the Drug and Treatment Council of the health facility affiliated to the
Ministry of Health or the minutes of review meeting of Provincial Department of
Health on the list, quantity of drugs and demand for drugs of the health
facilities under the management of the provincial government, Ministry or
regulatory authority and infirmaries located in province.
3. The
National centralized drug procurement center shall review the demand for drugs
regarding the list and quantity of drugs of each health facility under the
management of the Ministry of Health; consolidate list, quantity, and supply
schedule of each drug in order to develop a drug supplier selection plan.
4. A
drug supplier 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 contract packages by
regions or socio-economic areas or package scales;
E.g.: Drug A is included in the
list of drugs procured through centralized bidding and total 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 as follows:
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- It
may be divided into 06 smaller contract packages for 7 socio-economic areas:
Northeast, Northwest, Red River Delta, North Central Coast, South Central
Coast, Southeast, and Mekong Delta.
b) Drug category division in contract
packages and contents of drug supplier selection plans shall comply with
Articles 7 through 14 of this Circular. Time
limit for contract execution shall comply with Clause 4 Article 39 of this
Circular.
5. Appraisal
of drug supplier selection plan:
a) The National centralized
drug procurement center shall submit required documents for approval for the
drug supplier selection plan to the Planning - Finance Department of the
Ministry of Health.
b) The appraisal of the drug
supplier selection plan for a drug included in the list of drugs procured
through national centralized bidding shall comply with Clause 2 Article 16 of
this Circular. The Planning – Finance
Department shall act as the contact point in charge of appraising the list,
quantity of contract packages, unit prices and quantity of drugs as well as
drug supplier selection plans. Where
necessary, the Planning – Finance Department shall obtain opinions given by the
Drug Procurement Consultancy Council before submitting the drug supplier
selection plan to the Minister of Health for approval.
6. Approval
for drug supplier selection plan
The Minister of Health shall
consider approving the drug supplier selection plan at the request of the
Planning – Finance Department.
7. Preparation
for drug supplier selection:
Based on the drug supplier selection plan
approved by the Minister of Health, the National centralized drug procurement
center shall prepare the bidding documents, and organize appraisal and approval
for bidding documents in accordance with Articles 27 through 29 of this
Circular.
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The National centralized drug
procurement center shall organize the drug supplier selection, bid evaluation,
contract negotiation, propose successful drug suppliers, and submit drug
supplier selection result for appraisal in accordance with Articles 30 through
33 of this Circular.
9. Appraisal,
approval and publishing of drug supplier selection results:
a) Based on the bid evaluation
results and negotiation of contracts or framework agreements with drug
suppliers, the National centralized drug procurement center shall organize
appraisal and approval for drug supplier selection result in accordance with
Article 34 and Article 35 of this Circular. Where
necessary, opinions from the Drug Procurement Consultancy Council are required
before giving approval for the drug supplier selection result;
b) The National centralized
drug procurement center shall notify and publish the drug supplier selection
result according to the 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 successful drug suppliers in accordance with the 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, health agencies of regulatory authorities and Provincial Departments
of Health;
b) The contact points in charge
of surveying and proposing demand for drugs specified in Clause 1 of this
Article shall notify the drug supplier selection result and the framework
agreement to the health facilities under the scope of the framework agreement.
11. Completing
and concluding drug supply contracts:
Based on the drug supplier
selection result, the framework agreement, the demand for drug and drug use
plans of health facilities as registered with the contact points, the National
centralized drug procurement center (for direct contract conclusion) and health
facilities shall complete and conclude contracts with drug suppliers according
to the following principles:
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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 comply with provisions of the drug supplier selection plan
approved by a competent authority but shall not exceed 36 months from the
effective date of the centralized drug procurement results and framework
agreements until the day on which the parties fulfill their obligations under
terms and conditions of the concluded contract.
12. Reporting
on drug supplier selection results for drugs procured through provincial-level
centralized bidding:
a) Before the 10th
of each month and the 10th of the first month of each quarter or on
request, drug suppliers shall submit reports on supply of drugs on the list of
drugs procured through national centralized bidding using the form in Appendix
9 and Appendix 10 enclosed herewith to the National centralized drug
procurement center.
b) Before the 10th
of the first month of each quarter or on request, the health facilities under
the management of provincial governments and the health facilities located in
provinces under the management of ministries or regulatory authorities shall
submit reports on supply of drugs using the form in Appendix 11 enclosed
herewith to provincial-level centralized drug procurement units.
ca) Before 15th of
the first month of each quarter or on request, provincial-level centralized
drug procurement units and health facilities affiliated to the Ministry of
Health shall submit reports on supply of drugs on the list of drugs procured
through national centralized bidding using the form in Appendix 11 enclosed
herewith to the National centralized drug procurement center.
13. Supervising
and regulating execution of framework agreements:
The National centralized drug
procurement center and provincial-level centralized drug procurement units
shall supervise and regulate the supply of drugs for health facilities
executing the concluded framework agreement in accordance with guidelines given
by the National centralized drug procurement center and the following
principles:
a) If the demand for drugs of a
health facility under the management of a provincial government or ministry or
regulatory authority exceeds the quantity of drugs specified in the framework
agreement by more than 20%, the provincial-level centralized drug procurement
unit shall be notified to regulate drug quantities between provincial health
facilities, provided the quantity of drugs to be supplied to health facilities
under the management of the provincial government under the framework agreement
is not exceeded by more than 20%. Within 10
days from the receipt of the written request for regulation from a health
facility, the provincial-level centralized drug procurement unit shall send a
written response to the health facility.
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Within 10 days from the receipt
of the written request for regulation from a health facility, the National
centralized drug procurement unit shall send a written response to the health
facility.
The quantity of drugs regulated
by the National centralized drug procurement center shall not exceed the quantity
of drugs approved in the plan for selection of suppliers of drugs included in
the list of drugs procured through national centralized bidding by more than
30%. The regulation of drugs shall comply with
the procedures for regulations of drugs included in the list of drugs procured
through national centralized bidding issued by the National centralized drug
procurement center.
14. Payment
for drug supply contracts:
The National centralized drug
procurement center (for direct contract conclusion) and health facilities (for
framework agreement conclusion) shall make payments for drug suppliers in
accordance with regulations of law and under terms and conditions of the
concluded contracts.
The written approval for drug
regulation between centralized drug procurement units is a part of the drug
purchase contract and also a basis for the health facility and the drug
supplier to sign appendix of contract (for regulated items specified in the
framework agreement) or sign contract (for regulated items which are not
specified in the framework agreement).
Article
41. Organization of provincial-level centralized drug procurement
1. Surveying
demands for drug use:
a) The list of drugs procured
through provincial-level centralized bidding shall apply to the health facilities
located in a province, including provincial health facilities, health
facilities under the management of central authorities or ministries or other
regulatory authorities, and infirmaries located in that province. Health
facilities under the management of central authorities or ministries or other
regulatory authorities and infirmaries shall develop their own drug use plans
and comply with the same regulations on provincial-level centralized drug
supplier selection plans as provincial health facilities. The provincial-level centralized drug procurement
unit shall survey demands for drugs and organize selection of suppliers of
drugs for provincial health facilities, and health facilities under the
management of central authorities or ministries or other regulatory authorities
and infirmaries located in the province, which must be treated in the same
manner as provincial health facilities.
b) Based on the list of drugs
procured through provincial-level centralized bidding, health facilities in the
province or central-affiliated city (including provincial health facilities,
and health facilities under the management of central authorities or ministries
or other regulatory authorities and infirmaries located in the province) shall
develop their own drug use plans and send them to the provincial-level
centralized drug procurement unit;
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2. The
provincial-level centralized drug procurement unit shall review the list and
quantity of drugs to be procured through provincial-level centralized bidding
of each health facility; consolidate list, quantity, and supply schedule of
each drug in order to develop a drug supplier selection plan.
3. Developing
drug supplier selection plan: The
provincial-level centralized drug procurement unit shall carry out division of
drug categories in contract packages and contents of drug supplier selection
plan in accordance with Articles 7 through 14 of this Circular. Time limit for contract execution shall comply with
Clause 4 Article 39 of this Circular.
4. Appraisal
of drug supplier selection plan:
a) The provincial-level
centralized drug procurement unit shall a request for approval for the drug
supplier plan to the Provincial Department of Health.
b) The appraisal of the drug
supplier selection plan for a drug included in the list of drugs procured
through provincial-level centralized bidding shall comply with Clause 2 Article
16 of this Circular. The Provincial Department
of Health shall organize appraisal of the drug supplier selection plan, and
request the Chairperson of the Provincial People’s Committee to consider giving
approval for the drug supplier selection plan;
5. Approval
for drug supplier selection plan:
Chairperson of the Provincial
People’s Committee shall consider giving approval for the drug supplier selection
plan at the request of the Provincial Department of Health.
6. Preparation
for drug supplier selection:
Based on the approved drug
supplier selection plan, the provincial-level centralized drug procurement unit
shall prepare and submit the bidding documents to the Provincial Department of
Health for appraisal and approval in accordance with Articles 27 through 29 of
this Circular.
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The provincial-level
centralized drug procurement unit shall organize the drug supplier selection,
bid evaluation, contract negotiation, propose successful drug suppliers, and
submit drug supplier selection result for appraisal in accordance with Articles
30 through 33 of this Circular.
8. Appraisal,
approval and publishing of drug supplier selection result:
a) The provincial-level
centralized drug procurement unit shall prepare and submit report on the drug
supplier selection result to the Provincial Department of Health for appraisal
and approval;
b) The Provincial Department of
Health shall appraise and give approval for the drug supplier selection result
in accordance with Article 34 and Article 35 of this Circular;
c) The provincial-level
centralized drug procurement unit shall notify and publish the drug supplier
selection result according to the Law on Bidding.
9. Completing
and concluding contracts or framework agreements:
a) Based on the approved drug
supplier selection result, the provincial-level centralized drug procurement
unit shall complete and conclude contracts or framework agreements with
successful drug suppliers in accordance with the Law on Bidding;
b) The provincial-level
centralized drug procurement unit shall publish the framework agreement signed
according to the Law on Bidding on the portal of the Provincial People’s
Committee and the website of the Provincial Department of Health, and notify
health facilities under the scope of the signed framework agreement.
10. Completing
and concluding drug supply contracts:
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a) Conformity with the
framework agreement;
b) The price of each drug in
the contract does not exceed the successful bid announced by the provincial-level
centralized drug procurement unit.
c) Time limit for contract
execution shall comply with provisions of the drug supplier selection plan
approved by a competent authority but shall not exceed 36 months from the
effective date of the centralized drug procurement results and framework
agreement until the day on which the parties fulfill their obligations under
terms and conditions of the concluded contract.
11. Reporting
on drug supplier selection results for drugs procured through provincial-level
centralized bidding
a) Before the 10th
of the first month of each quarter or on request, drug suppliers shall submit
reports on supply of drugs on the list of drugs procured through
provincial-level centralized bidding using the form in Appendix 10 enclosed
herewith to the provincial-level centralized drug procurement unit.
b) Before the 10th
of the first month of each quarter or on request, the health facilities under
the management of provincial government and the health facilities located in
the province under the management of the Ministry of Health, ministries or
regulatory authorities shall submit reports on supply of drugs using the form
in Appendix 11 enclosed herewith to provincial-level centralized drug
procurement unit.
12. Supervising
and regulating execution of framework agreement:
The provincial-level
centralized drug procurement unit shall supervise and regulate the supply of
drugs for health facilities executing the concluded framework agreement
according to the following principles:
a) If the demand for drugs of
health facilities exceeds the quantity of drugs specified in the framework
agreement by more than 20% or a health facility's unexpected demand for a drug
has not been included in the drug supplier selection plan, a report shall be made
using the form in Appendix 12 enclosed herewith and submitted to the
provincial-level centralized drug procurement unit for consolidating and
regulating drug quantities between health facilities in the province. Within 10 days from the receipt of the written
request for regulation from a health facility, the provincial-level centralized
drug procurement unit shall send a written response to the health facility.
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13. Payment
for drug supply contracts: Health facilities
shall make payments for drug suppliers in accordance with regulations of law in
force and under terms and conditions of the signed contracts. The written approval for drug regulation between
centralized drug procurement units is a part of the drug purchase contract and
also a basis for the health facility and the drug supplier to sign appendix of
contract (for regulated items specified in the framework agreement) or sign
contract (for regulated items which are not specified in the framework
agreement).
Chapter V
PRICE NEGOTIATION
Article
42. General provisions on price negotiation
1. Drug
Price Negotiation Council:
a) The Drug Price Negotiation
Council is established by the Minister of Health. The
Minister of Health shall stipulate functions, tasks, powers and operating
mechanism of the Drug Price Negotiation Council. Operating
costs of the Drug Price Negotiation Council shall be covered by funding derived
from state budget, which is allocated to the National centralized drug
procurement center and other lawful funding sources in accordance with
regulations of law.
b) The Drug Price Negotiation
Council is composed of:
- A
Chairperson who is a senior representative of the Ministry of Health;
- 02
Deputy Chairpersons who are a senior representative of Vietnam Social Security
and Director of the National centralized drug procurement center.
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c) Tasks of the Drug Price
Negotiation Council:
- Consider
and decide price negotiation plans developed by the National centralized drug
procurement center;
- Carry
out drug price negotiation under the approved plans;
2. The
National centralized drug procurement center is the standing unit of the Drug
Price Negotiation Council and shall fulfill the following tasks:
a) Develop price negotiation
plan and roadmap;
b) Organize formulation,
appraisal and approval for request for proposals;
c) Organize evaluation of
proposals;
d) Develop estimated price
negotiation plans;
dd) Publish price negotiation
results;
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g) Participate in all stages of
drug price negotiation process, and consolidate and provide relevant
information during price negotiation;
h) Perform other tasks assigned
by the Council’s Chairperson.
3. The
Drug Procurement Consultancy Council shall advise the Minister of Health in all
stages of the drug price negotiation process as requested.
4. If
a drug bid for is changed during the drug supplier selection, or the drug is
supplied but the substitute drug is not offered in the bids, the contact point
mentioned in Clause 1 Article 40 of this Circular shall consider allowing the
drug supplier to provide substitute drugs according to Clause 6 Article 37 of
this Circular.
Article
43. Formulation, appraisal and approval for price negotiation plan
1. 3 Aggregating
demands for use of drugs included in the list of drugs procured through price
negotiation:
The National centralized drug
procurement center shall aggregate demands for use of drugs according to Clause
1 Article 40 of this Circular
2. Develop
price negotiation plan:
The National centralized drug
procurement center shall develop the drug price negotiation plan. The drug
price negotiation plan shall include the contents prescribed in Article 14 of
this Circular and the following information:
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b) The proposed price of each drug
to be procured through price negotiation which is determined according to
Clause 4 Article 14 of this Circular;
c) Quality standards, delivery
time, and specific conditions of each drug procured through price negotiation;
d) The expected time for price
negotiation for each drug included in the list of drugs procured through price
negotiation;
dd) Where necessary, the
National centralized drug procurement center may seek opinions from the Drug
Price Negotiation Council about the drug price negotiation plan before it is
submitted for appraisal.
3. Appraisal
of drug price negotiation plan:
a) The National centralized
drug procurement center shall submit required documents for approval for the
drug supplier selection plan to the Planning - Finance Department for
appraisal;
b) The Planning - Finance
Department shall appraise the lists, number of contract packages, proposed unit
price and drug quantity. The drug price
negotiation plan shall be appraised according to Clause 2 Article 16 of this
Circular.
4. Approval
for the drug price negotiation plan: The
Minister of Health shall consider approving the drug price negotiation plan on
the basis of the report submitted by the Planning – Finance Department. Where necessary, the Minister of Health may seek
opinions from the Drug Procurement Consultancy Council before giving approval.
Article
44. Preparation, appraisal and approval for request for proposals
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1. Preparation
of request for proposals:
a) The request for proposals
for drugs procured through price negotiation shall comply with regulations of
the Law on Bidding, its guiding documents and regulations adopted by the
National centralized drug procurement center;
b) The request for proposals
shall include brief information about the contract package; instructions on
preparation and submission of proposals; capacity and experience requirements
satisfied by drug suppliers; criteria for technical evaluation and
determination of the contract package value. Capacity,
experience and technical requirements shall be assessed as “pass” or “failed”;
c) The request for proposals
shall provide instructions for drug suppliers to provide information about
prices and specific economic-technical criteria to be employed during price
negotiation process in their quotations. To be specific:
- Ex-works
price, CIF price, and selling prices for health facilities in manufacturing
countries and ASEAN countries provided by drug suppliers;
- Ex-works
price, CIF price, and selling prices for health facilities in Vietnam;
- Indications
and clinical effectiveness evaluation of drugs in treatment; reports on
clinical effectiveness evaluation in treatment in comparison with other
standard drugs (if any);
- Data
on pharmaceutical economic analysis of drugs including: cost – efficacy, cost –
benefits and cost – effects provided by drug suppliers (if any);
- The
drug supplier’s commitments and plan on quantity and quality of drugs supplied,
and supply schedule, if awarded the contract.
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a) The request for proposals
for drugs procured through price negotiation shall be appraised before it is
submitted to the Director of the National centralized drug procurement center
for approval.
b) The Director of the National
centralized drug procurement center shall decide the composition of the unit in
charge of appraising the request for proposals.
3. Approval
for request for proposals
Based on the report on
appraisal of the request for proposals, the Director of the National
centralized drug procurement center shall consider giving approval for the
request for proposals as prescribed.
Article
45. Organization of drug price negotiation
1. Notification
of selection of drug suppliers through price negotiation and request for
proposals shall be made publicly available.
2. Drug
suppliers shall prepare and submit proposals according to the request for
proposals.
a) Provision of bid security
and submission of proposals shall comply with Article 30 of this Circular;
b) Based on the notification of
selection of drug suppliers through price negotiation and the request for
proposals, drug suppliers shall prepare and send their proposals directly or by
post to the National centralized drug procurement center.
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a) The National centralized
drug procurement center shall organize evaluation of proposals according to the
requirements set out in the request for proposals. These
proposals shall be publicly opened. During
evaluation, the procuring entity may invite drug suppliers to negotiate,
clarify, modify or provide additional information about their proposals in
order to prove the drug supplier’s satisfaction of requirements regarding their
capacity, experience, schedule, quantity, quality, technical solutions and
measures for implementing the contract package.
b) Based on the received
proposals and report on evaluation of proposals given by the expert team, the
National centralized drug procurement center shall develop price negotiation
plans. Where necessary, the National
centralized drug procurement center may invite clinical and pharmaceutical
economic experts to participate in development of the price negotiation plan
for each drug category. The price negotiation
plan should indicate brief information about pharmacological effects, the
proposed price and successful bid of the drug procured under price negotiation,
drugs which have the same active ingredient, content or concentration, and
dosage form but are not classified in the same drug category, and substitute
drugs which have the same pharmacological effects (if any), the factors
relating to the price negotiation plan and terms and conditions of the
framework agreement to be negotiated.
c) Chairperson of the Drug
Price Negotiation Council shall consider giving approval for the price
negotiation plan before carrying out the price negotiation session.
4. Price
negotiation and decision:
a) The National centralized
drug procurement center shall send invitations to negotiate to drug suppliers
that meet the requirements set out in the request for proposals. Where necessary, the National centralized drug
procurement center may invite representatives of drug manufacturers or license
holders in Vietnam (including their representative offices) to clarify
information about drugs to be procured through price negotiation;
b) A drug supplier shall be
invited to negotiate if having lawful qualification, satisfying requirements
regarding capacity, experience and technical proposals set out in the request
for proposals, and proposing the price which does not exceed the approved cost
estimate of the contract package;
c) The Drug Price Negotiation
Council shall decide whether or not to carry out the negotiation directly or by
correspondence as the case may be. The Drug
Price Negotiation Council shall carry out the price negotiation according to
the drug supplier’s proposal, the proposal evaluation report, relevant
information and the approved price negotiation plan;
d) Where more than one drug
supplier participates in the price negotiation for supply of drugs having the
same active ingredient, content or concentration, and dosage form, the Drug
Price Negotiation Council shall, based on the negotiation results, send written
request to them to submit new quotations which must indicate the time and
location for receiving such quotations, and time for opening such quotations,
and invite them to the quotation opening session. The
price specified in a new quotation must not exceed the negotiated price. The supplier that gives the lowest quotation price
shall be awarded the contract;
dd) If the first price
negotiation is unsuccessful, the Drug Price Negotiation Council shall decide
whether or not to invite a drug supplier to the second negotiation as the case
may be. The National centralized drug
procurement center shall notify each drug supplier of the official conclusion
given by the Drug Price Negotiation Council after the first negotiation;
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g) The successful bid shall be agreed by the
Drug Price Negotiation Council and the drug supplier.
After reaching the agreement on the drug price, the Drug Price
Negotiation Council and the drug supplier shall conclude the framework
agreement and relevant terms and conditions;
h) After the Drug Price
Negotiation Council and the drug supplier’s representative sign the price
negotiation record, the National centralized drug procurement center shall send
a written request to the drug supplier to confirm the agreed price within 7
days.
Article
46. Appraisal, approval for and implementation of price negotiation result
1. Appraisal
and approval for price negotiation result:
The National centralized drug
procurement center shall consolidate and send the price negotiation result to
the Planning – Finance Department for appraisal. The
appraisal must be completed within 20 days from the receipt of adequate
documents. The Minister of Health shall
consider approving the drug price negotiation result on the basis of the report
provided by the Planning – Finance Department.
If the Drug Price Negotiation
Council and the drug supplier fail to reach agreement on the drug price after
negotiation, the National centralized drug procurement center shall submit a
report to the Planning – Finance Department and notify the negotiation result
to the drug supplier and health facilities nationwide.
2. Publishing
price negotiation result:
a) The National centralized
drug procurement center shall publish the drug supplier selection result
through price negotiation and provide guidelines for implementation of the
price negotiation result for health facilities in accordance with regulations
of law.
b) With regard to the drugs
included in the List of drugs procured through price negotiation for which the
price negotiation is unsuccessful, based on the opinions given by the Drug
Price Negotiation Council, the National centralized drug procurement center
shall propose an alternative procurement plan or solution to the Minister of
Health for consideration. With regard to an
original brand-name drug granted by the Ministry of Health multiple registration
certificates of Category 1 as prescribed in Article 7 of this Circular, health
facilities may themselves organize drug supplier selection through competitive
bidding for generic contract packages according to the Ministry of Health’s
notification.
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a) The National centralized
drug procurement center shall complete and conclude framework agreements with
successful drug suppliers, publish price negotiation results and framework
agreements on the Ministry of Health's website. Responsibilities
of relevant parties and effect of framework agreement shall comply with Article
39 of this Circular. Selected drug suppliers
shall provide contract performance security according to Clause 1 Article 39 of
this Circular;
b) Based on price negotiation
result, framework agreement, distributed drug quantity and the drug use budget
plan approved by a competent authority, health facilities shall conclude
contracts with drug suppliers under the condition that the contractual price
shall not exceed the price of drug agreed through price negotiation and
specified in the framework agreement published by the National centralized drug
procurement center;
For effective drug supply
contracts, health facilities shall modify the contractual prices of drugs to
ensure that they do not exceed the published negotiation price and the
effective time of such prices shall comply with the effective date of the
framework agreement.
c) The drug supplier selected
through price negotiation shall supply drugs according to the agreed quantity
and schedule, and terms and conditions of the framework agreement and the
contract signed with each health facility;
d) Time limit for contract
execution shall comply with provisions of the price negotiation plan approved
by a competent authority but shall not exceed 36 months from the effective date
of the price negotiation results and framework agreement until the day on which
the parties fulfill their obligations under terms and conditions of the
concluded contract.
e) The health insurance
authority shall consistently make payments for all public health facilities
according to price negotiation results published by the National centralized
drug procurement center.
4. Reporting
on implementation of drug price negotiation results:
Drug suppliers selected through
price negotiation and health facilities shall submit reports on execution of
drug supply results signed through price negotiation to the National
centralized drug procurement center as prescribed in Clause 12 Article 40 of
this Circular.
5.
4 Supervising and regulating
the performance of framework agreement:
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Chapter
VI
IMPLEMENTATION
Article
47. Effect5
1. This
Circular comes into force from October 01, 2019.
2. The
Circular No. 11/2016/TT-BYT dated May 11, 2016 of the Minister of Health
prescribing bidding for supply of drugs for public health facilities shall be
null and void from the effective date of this Circular.
Article
48. Transition
1. The
contract packages for which drug supplier selection plans have been approved
before the effective date of this Circular shall be executed in accordance with
regulations in the Circular No. 11/2016/TT-BYT dated May 11, 2016 of the
Minister of Health, unless the facilities mentioned in Article 2 of this
Circular volunteer to follow regulations of this Circular after it is
promulgated.
2. The
drug manufacturers fulfilling EU-GMP requirements or EU-GMP-equivalent requirements
and those fulfilling PIC/s-GMP requirements as certified by the drug authority
of the country that is concurrently a member state of PIC/s and of ICH, and
published by Drug Administration of Vietnam on its website before the effective
date of this Circular are not required to undergo assessment of compliance with
EU-GMP requirements or EU-GMP-equivalent requirements or PIC/s-GMP
requirements by a drug authority of Vietnam within 6 months from the effective
date of this Circular.
Article
49. Reference
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Article
50. Implementation organization
1. Heads
of central authorities shall instruct their affiliated health facilities to
select drug suppliers in accordance with this Circular and regulations of the
law on contractor selection.
2. Ministers
and heads of ministerial agencies shall decide and inspect the delegation of
powers to perform some contract packages for drug procurement of health facilities
under their management in accordance with regulations of law.
3. Chairpersons
of Provincial People’s Committees shall:
a) Assign a unit in charge of
provincial-level centralized drug procurement to procure drugs included in the
list of drugs procured through provincial-level centralized bidding for health
facilities participating in provincial-level centralized bidding in accordance
with this Circular;
b) Instruct health facilities
to organize selection of suppliers of drugs included in the list of drugs
procured through bidding organized by health facilities in accordance with this
Circular;
c) Based on actual conditions
of each province, decide addition of other drugs to the list of drugs procured
through provincial-level centralized bidding (except for drugs included in the
list of drugs procured through price negotiation or the list of drugs procured
through national centralized bidding) for use by provincial health facilities
at the request of the Director of the Provincial Department of Health. Time limit for contract execution shall comply with
Clause 4 Article 39 of this Circular.
In such cases, if health
facilities under the management of central authorities or ministries, and
infirmaries located in the province use the list of additional drugs procured
through provincial-level centralized bidding (apart from the list of drugs
procured through provincial-level centralized bidding issued by Ministry of
Health), drug authorities of Ministries, ministerial agencies or governmental
agencies (sectoral health authorities) and supervisory authorities of health
facilities under the management of Ministries and infirmaries shall reach
agreements with the relevant Provincial Department of Health for reporting to
Provincial People's Committee to organize drug supplier selection as
prescribed.
d) Based on actual conditions
of each province, decide and inspect the delegation of powers to perform some
contract packages for drug procurement of health facilities under their
management at the request of the Director of the Provincial Department of
Health.
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a) Lists serving drug supplier
selection, including:
- List
of reference authorities;
- List
of drug authorities of countries considered as SRA;
- List
of drug authorities of countries that are members of PIC/s and ICH;
- List
of drug manufacturers in Vietnam fulfilling WHO-GMP requirements as certified by
drug authorities of Vietnam;
- List
of drug manufacturers fulfilling EU-GMP requirements or EU-GMP-equivalent
requirements;
- List
of drug manufacturers fulfilling PIC/s-GMP requirements as certified by a
competent authority of a country that is concurrently a member state of PIC/s
and of ICH, and also certified by a drug authority of Vietnam;
- List
of drug manufacturers fulfilling GMP requirements for herbal drugs or
traditional drugs as certified by the Ministry of Health of Vietnam;
- List
of drug manufacturers in Vietnam fulfilling GMP requirements for traditional
ingredients as certified by the Ministry of Health of Vietnam;
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b) Lists of drugs serving drug
supplier selection, including:
- List
of drugs granted registration certificate or import license;
- List
of original brand-name drugs;
- List
of reference biologicals;
- List
of drugs of therapeutic equivalence with original brand-name drugs;
- List
of drugs manufactured under a processing contract or technology transfer
contract in Vietnam;
- List
of original brand-name drugs and reference biologicals manufactured under a
processing contract or technology transfer contract in Vietnam;
- List
of drugs of bioequivalence proved by documentary evidences;
- List
of drugs granted certificate of marketing authorization by a reference
authority;
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- List
of drugs wholly manufactured in Vietnam on production lines fulfilling
category-1 drug category criteria as prescribed in Point c Clause 1 Article 7
of this Circular;
- List
of traditional ingredients in the following dosage forms: glue, granule,
powder, extract, essential oil, resin, gum or jelly meeting quality standards
according to the Ministry of Health’s regulations on management of quality of herbal
ingredients and traditional drugs;
- List
of semi-finished herbal ingredient products in the following dosage forms:
glue, granule, powder, extract, essential oil, resin, gum or jelly meeting
quality standards according to the Ministry of Health’s regulations on
management of quality of medicinal ingredients;
- List
of drugs included in the List of natural products;
- List
of drugs awarded the "Ngôi sao thuốc Việt” (“Star of Vietnamese
medicines”) by the Ministry of Health;
- List
of herbal ingredients which are planted, collected or obtained naturally and
certified to fulfill GACP requirements by the Ministry of Health of Vietnam;
- List
of drugs manufactured in Vietnam and satisfying treatment, pricing and supply
requirements;
- List
of domestically cultivated and harvested herbal ingredients satisfying
treatment, pricing and supply requirements;
- List
of drugs manufactured from materials (active ingredients) originating from
countries included in the list of countries considered as SRA or granted CEP
certificate;
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c) Information on
declared/re-declared drug prices;
d) Information on drug prices 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. In
case of procurement of drugs funded by health insurance fund, the social
insurance agencies shall send their officials to participate in:
a) Preparation and appraisal of
the drug supplier selection plan;
b) Preparation and appraisal of
bidding documents;
c) Bid evaluation and appraisal
of drug supplier selection result.
6. Health
facilities or in-charge units of steps of the drug supplier selection shall
send documents (except those which cannot be published in accordance with
regulations of the Law on bidding) to members of the Council or expert team in
charge of bidding stages specified in Points a, b and c Clause 5 of this
Article before holding meetings within 5 days (except for urgent procurement of
drugs to serve treatment). After this
deadline, health facilities or in-charge units of steps of the drug supplier
selection shall hold meetings of Council or expert team. Members of the Council or expert team mentioned above must
comply with operating regulations of the Council or expert team according to
regulations and assignment by the Council’s Chairperson or expert team’s head.
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.
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a) Private health facilities
may participate in centralized drug procurements (national procurements,
provincial-level procurements, or price negotiations) in their provinces. Such private health facilities shall formulate drug
use plans and comply with the same regulations on provincial-level centralized
bidding as health facilities under the management of provincial governments;
Provincial Departments of Health and provincial-level centralized drug
procurement units shall organize procurement of drugs for private health
facilities in the same manner as health facilities under the management of
provincial governments.
b) Private health facilities
that do not participate in centralized drug procurements (national procurements,
provincial-level procurements, or price negotiations) may carry out drug
supplier selection themselves in accordance with the Law on bidding, its
guiding documents and this Circular.
c) If a private health facility
does not organize drug supplier selection as prescribed in Points a and b of
this Circular, the social insurance agency shall only make payments for drugs
according to the published results of provincial-level or national drug
supplier selection or price negotiation results if the information such as
trade name, registration number or import license number, content or
concentration, route of administration, dosage form, packing specifications,
manufacturer, and manufacturing country is correct.
If the drug is not included in
the provincial-level or national centralized procurement result or price
negotiation result, it shall be paid for according to successful bids of
provincial-level public health facilities located in the same provinces as
published by social insurance agencies in accordance with Point b Clause 3
Article 77 of the Decree No. 63/2014/ND-CP.
8. Health
facilities requesting for information disclosure specified in Point c Clause 1
Article 7 of this Circular shall provide the following documents and be legally
responsible for the accuracy of the provided documents:
a) Certificates of marketing
authorization for drugs which have been granted by drug authorities of
countries included in the list of countries considered as SRA and bear consular
legalization (originals or certified true copies).
b) Statements proving that the
drug sold in Vietnam and the drug granted certificate of marketing
authorization by a drug authority of a country included in the list of
countries considered as SRA have the same dosage form, production process,
quality and testing methods; active ingredients and excipients have the same
quality, manufacturing facility or site as prescribed in Appendix 13 enclosed
herewith.
9. Health
facilities proving that the original brand-name drug or reference biological is
initially manufactured in a country which is not included in the list of
countries considered as SRA as prescribed in Point b Clause 2 Article 8 of this
Circular shall provide the following documents and be legally responsible for
the accuracy of the provided documents:
a) The patent for a modern drug
granted by a competent intellectual property authority 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 ingredient) enclosed
with corresponding reference to the request for protection of the drug
(original copy or certified true copy);
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c) Other documentary evidences
(if any).
Article
51. Responsibility for implementation
The Director of Drug
Administration of Vietnam, the Director of the Traditional Medicine
Administration of Vietnam, the Director of the Planning - Finance Department,
Chief of the Ministry’s Office, the Ministry’s Chief Inspector, Director of the
National centralized drug procurement center, heads of departments of and
affiliated to the Ministry of Health, Directors of Provincial Departments of
Health, pharmacy business establishments and other relevant authorities,
organizations and individuals shall implement this Circular.
Difficulties that arise during
the implementation of this Circular should be promptly reported to the Ministry
of Health (via the Drug Administration of Vietnam, the Traditional Medicine
Administration and the Planning - Finance Department) for consideration./.
CERTIFIED BY
PP. MINISTER
DEPUTY MINISTER
Nguyen Truong Son
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“ The Law on Bidding dated
November 26, 2013;
The Law on Pharmacy dated
April 06, 2016;
The Government’s Decree No.
63/2014/ND-CP dated June 26, 2014 providing guidelines for the Law on bidding
regarding contractor selection;
The Government’s Decree No.
54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on
Pharmacy;
The Government’s Decree No.
75/2017/ND-CP dated June 20, 2017 defining functions, tasks, powers and
organizational structure of the Ministry of Health;
And at the request of
Director of Vietnam Administration of HIV/AIDS Control and Director of Legal Department,”
2 This Clause is
abrogated according to Clause 1 Article 1 of the Circular No. 15/2021/TT-BYT,
coming into force from November 15, 2021.
3 This Clause is
amended according to Clause 2 Article 1 of the Circular No. 15/2021/TT-BYT,
coming into force from November 15, 2021.
4This Clause is
amended according to Clause 3 Article 1 of the Circular No. 15/2021/TT-BYT,
coming into force from November 15, 2021.
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“Article 2. Effect
This Circular comes into
force from November 15, 2021.
Article 3. Responsibility
for implementation
Director of Vietnam Administration of HIV/AIDS
Control, Director of Legal Department, Chief of the Ministry's Office, the
Ministry’s Chief Inspector, General Directors/ Directors of Departments/
General Departments affiliated to the Ministry of Health, and relevant
authorities, organizations and individuals shall implement this Circular./.”