|
THE MINISTRY
OF HEALTH
--------
|
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
|
|
No. 37/2013/TT-BYT
|
Hanoi,
November 11, 2013
|
CIRCULAR
GUIDING THE ELABORATION OF BIDDING DOSSIER FOR MEDICINE
PURCHASE IN MEDICAL ESTABLISHMENTS
Pursuant to the Pharmacy Law No. 34/2005/QH11
dated June 14, 2005;
Pursuant to the Law on tendering No.
61/2005/QH11 dated November 29, 2005; Law amending and supplementing a number of
articles of the laws concerning capital construction investment No.
38/2009/QH12 dated June 19, 2009;
Pursuant to the Government’s Decree No.
79/2006/ND-CP dated August 09, 2006, detailing implementation of a number of
Articles of the Pharmacy Law; Government’s Decree No. 89/2012/ND-CP dated
October 24, 2012, amending and supplementing a number of Articles of
Government’s Decree No. 79/2006/ND-CP dated August 09, 2006, detailing
implementation of a number of Articles of the Pharmacy Law;
Pursuant to the Government’s Decree No.
85/2009/ND-CP dated October 15, 2009, guiding implementation of Law on
tendering and selection of the building contractors under construction law;
Pursuant to Government’s Decree No.
63/2012/ND-CP dated August 31, 2012, defining the functions, tasks, powers and
organizational structure of the Ministry of Health;
Pursuant to the Joint Circular No.
01/2012/TTLT-BYT-BTC dated January 19, 2012, of the Minister of Health and the
Minister of Finance guiding the bidding for medicine purchase by medical
establishments; the Joint Circular No. 36/2013/TTLT-BYT-BTC dated November 12,
2013, of the Minister of Health and the Minister of Finance amending and
supplementing a numbers of Articles of the Joint Circular No.
01/2012/TTLT-BYT-BTC dated January 19, 2012, of the Minister of Health and the
Minister of Finance guiding the bidding for medicine purchase by medical
establishments;
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
The Minister of Health promulgates Circular
guiding the elaboration of bidding dossier for medicine purchase in medical
establishments as follows:
Chapter I
GENERAL PROVISIONS
Article 1. Scope of
regulation
1. This Circular guiding the elaboration of
bidding dossier when conduct the domestic open bidding, limited bidding for
medicine purchase in serve of prevention of disease, medical examination and
treatment from state budget, fund of medical insurance and other lawful
revenues in medical establishments (hereinafter collectively referred to as
units).
2. For bidding packages for medicine purchase of
projected used ODA funding, if donors agree, this Circular may be applied or
some content may be amended and supplemented under regulations on bidding in
International treaties in which the Socialist Republic of Vietnam is a
contracting party or international agreement which competent agencies or
organizations of the Socialist Republic of Vietnam have been concluded in.
3. This Circular does not apply in the following
cases:
a) Medicines under orders of state and paid with
the state budget source;
b) materia medica and traditional medicines;
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) Medical oxygen.
Article 2. Subjects of
application
This Circular applies to organizations and
individuals responsible for the elaboration of bidding dossier for medicine
purchase in units using funding source from state budget, fund of medical
insurance and other lawful revenues in order to purchase medicines in serve of
prevention of disease, medical examination and treatment.
Article 3. Principles in
elaboration of bidding dossier for medicine purchase
The elaboration of bidding dossier for medicine
purchase in units shall comply with the Circular No. 05/2010/TT-BKH dated
February 10, 2010 of the Minister of Planning and Investment detailing the
elaboration of bidding dossier for goods procurement (hereinafter abbreviated
to Circular No. 05/2010/TT-BKH), the detailed guides in this Circular and other
relevant legal documents.
Chapter II
DETAILING SOME CONTENTS
IN THE ELABORATION OF BIDDING DOSSIER FOR MEDICINE PURCHASE
Article 4. Conditions for
participation in bidding of contractors
Apart from the satisfaction of provisions in
section 2 Chapter I the first part of model bidding dossier for goods
procurement promulgated together with Circular No. 05/2010/TT-BKH, contractors
must satisfy the following conditions:
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2. For bidding packages for medicines under
generic name, contractors may participate in one or many medicine group if they
satisfy criteria of such medicine group as defined in article 3 of the Joint
Circular No. 36/2013/TTLT-BYT-BTC, specified as follows:
a) Contractors that have medicines satisfying
criteria at Group 1 are entitled to participate in bidding of Group 1, Group 2
and Group 5;
b) Contractors that have medicines satisfying criteria
at Group 2 are entitled to participate in bidding of Group 2 and Group 5;
c) Contractors that have medicines satisfying
criteria at Group 3 are entitled to participate in bidding of Group 3 and Group
5;
d) Contractors that have medicines satisfying
criteria at Group 4 are entitled to participate in bidding of Group 4 and/or
other Group if they also meet criteria of such group;
dd) Contractors that have medicines failing to
meet criteria of Groups 1, 2, 3, 4 are entitled to participate in bidding of
Group 5.
3. For bidding package of oriental medicines,
medicines from materia medica”
a) Contractors that have medicines satisfying
criteria at Group 1 are entitled to participate in bidding of Group 1, Group 2;
b) Contractors that have medicines satisfying
criteria at Group 2 are entitled to participate in bidding of Group 2 only.
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 5. Provisions on
content of bid dossier
Apart from implementation under provisions in
section 8 Chapter I the first part of model bidding dossier for goods
procurement promulgated together with Circular No. 05/2010/TT-BKH, bid dossier
must implement some contents specified as follows:
1. Documents, information to prove eligibility,
capability and experiences of contractor:
a) Certificate of eligibility for medicine
business:
In the business scope must clearly state
medicine manufacture or medicine wholesale.
b) Good practice certificate depending on each
business form:
- GSP (Good storage practices): For
establishments directly importing medicines.
- GDP (Good distribution practices): For
establishments of medicine wholesale.
- GACP (Good agricultural and collection
practices): For materia medica agricultural establishments.
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) Documents to prove capability and experiences
of contractor (contracts in performance course and similar contracts performed
by contractor; capability and experiences of contractor in domain of
manufacture, business; financial capability of contractor):
To comply with provisions in forms No. 8, 9, 10
and 12 Chapter IV of model bidding dossier for goods procurement promulgated
together with the Circular No. 05/2010/TT-BKH.
2. Documents, information to prove the legality
and eligibility of item of drug used in bidding participation:
a) Information of name of medicines user in
bidding participation, circulation registration number or number of import
permit for medicines which have not yet had registration number granted by the
Drug Administration of Vietnam and other relevant information:
Contractor writes fully information as
prescribed at Annex 1 promulgated together with this Circular. Information must
be appropriate with information of medicines granted registration number or
import permit as announced by the Drug Administration of Vietnam on its website
(address: http://www.dav.gov.vn);
b) Written commitment on satisfying requirements
made by unit involving the progress and supply scope for evaluation as
prescribed at section 4 Annex 2 promulgated together with this Circular.
c) Written commitment of contractor for the
remaining use time limit of medicines selected to win bidding as from supplying
medicine to medical establishments, which is not less than 06 months for
medicines with use time limit of 02 years or more; 03 months for medicines with
use time limit of 01-02 years; ¼ of use time limit for medicines with use time
limit of less than 01 year.
3. Other contents:
Contractor need supply the following documents
(if any):
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Certificate of dossier of announcing on organization
of GPP medicine store chains by enterprise, certificate of medicine
distribution center for evaluation as prescribed at sections 13 and 14 Annex 3
promulgated together with this Circular;
c) Documents clearly state the origin of materia
medica for oriental medicines, medicines from materia medica (valid invoices,
vouchers of purchasing materia medica from providers that have been granted
certificate of manufacture and business in medicines from materia medica by the
Ministry of Health or the provincial Services of Health; the receipt of
announcement on materia medica produced under WHO-GACP of manufacturers of
materia medica) for evaluation as prescribed at section 8 Annex 3 promulgated
together with this Circular;
d) Valid invoices and vouchers of purchasing
antibiotics, raw materials produced domestically for manufacture of medicines
used in bid participation for evaluation as prescribed at section 7 Annex 3
promulgated together with this Circular.
4. Documents supplied by contractor when participating
in bid are copies with seal for confirmation of contractor. Especially for
certificate of satisfying GMP standard, contractor is required only write its
information as prescribed at section 1 Annex 3 promulgated together with this
Circular (information of certificate of satisfying GMP standard must be
appropriate with information announced by the Drug Administration of Vietnam on
its website (address: http://www.dav.gov.vn).
Article 6. Prerequisites to
remove bidding dossiers
Apart from implementation under provisions at
Clause 2 section 24 Chapter I and Clause 2 section 24 Chapter II the first part
of model bidding dossier for goods procurement promulgated together with
Circular No. 05/2010/TT-BKH, prerequisites to remove bid dossier are specified
as follows:
1. Bid dossier of a contractor is removed in
cases:
a) Contractor fails to have certificate of
eligibility for medicine business granted by competent agencies (in case of
lack of such certificate in bid dossier, the bid solicitor may require
contractor for supplementation under regulations).
b) Certificate of eligibility for medicine
business has no content of medicine manufacture or medicine wholesale in its
business scope.
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Item of drug used in bid participation or
medicine group is not appropriate with article 4 of this Circular.
b) Item of drug used in bid participation is not
permitted to circulate legally in Vietnam (banned producing for medicines
produced domestically or banned import for foreign medicines in the effective
time limit of the circulation registration number or import permit).
c) Item of drug used in bid participation is
withdrawn registration number in the effective time limit of registration
number as prescribed in Article 33 Chapter IV of Circular No. 22/2009/TT-BYT
dated November 24, 2009 of Minister of Health providing for the medicine
registration.
a) All products of item of drug used in bid
participation are suspended for circulation, recalled as prescribed in Clause 1
Article 13 Chapter IV of Circular No. 09/2010/TT-BYT dated April 28, 2010 of
Minister of Health guiding management of medicine quality.
dd) In bid dossier, item of drug has unfixed
price, is offered at various prices (unless contractor participate in bid with
many items of drug with the same name of active ingredient, concentration,
content, dosage form of different manufacturers).
e) Contractor supplies information and enclosed
documents of items of drug used in bid participation dishonestly (supply of
wrong information in comparison with dossier of medicine registration, dossier
of declaring medicine price, certificates granted by the provincial Services of
Health, the Ministry of Health falsifying result of contractor selection).
Article 7. Criteria for
evaluation and content to define the evaluation price
To comply with Chapter III the first part of
model bidding dossier for goods procurement promulgated together with Circular
No. 05/2010/TT-BKH, and some specific contents are implemented as follows:
1. Criteria for evaluation on capability and
experiences of contractor:
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Method of evaluation: Under criterion of
"pass", “fail”, specified:
- Contractor passing all criteria specified in
Annex 2 promulgated together with this Circular is evaluated as satisfying
requirements on capability and experiences.
- Criteria specified in Annex 2 promulgated
together with this Circular are evaluated as “pass” if all detailed criteria in
each criterion of requirement are evaluated as “pass”.
2. Criteria for technical evaluation:
a) Criteria for technical evaluation include
criteria specified in Annex 3 promulgated together with this Circular.
b) Method of evaluation: Under method of scoring
points (point scale of 100), specified:
- In each item specified in Annex 3 promulgated
together with this Circular, a contractor passing concurrently two criteria or
more only is calculated for point of criterion having highest point.
- The required minimum point level in technical
aspect is defined under nature of each bidding package or item of goods in
bidding plan already been approved by competent persons but must not be lower
than 70 point.
- Bid dossier with total passing points equal to
or exceeding the required minimum point level in technical aspect will be
evaluated as satisfying technical requirements.
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
To apply evaluation under criterion of “pass” or
“fail” based on contents of evaluation specified in pl 3 promulgated together
with this Circular and comply with provisions at Clause 2.2 item 2 Chapter III
the first part of model bidding dossier for goods procurement promulgated together
with the Circular No. 05/2010/TT-BKH.
3. Content of determining the evaluation price:
a) Bid dossiers satisfying requirements on
criteria for evaluation, capability, experiences of contractors and criteria
for technical evaluation are further considered to determine the evaluation
price.
b) Bid dossiers satisfying requirements are
determined the evaluation price in accordance with section 26 Chapter I and
section 3 Chapter III the first part of model bidding dossier for goods
procurement promulgated together with the Circular No. 05/2010/TT-BKH.
Article 8. Conditions to be
considered for proposal for winning bid
To comply with provisions in section 31 Chapter
I the first part of model bidding dossier for goods procurement promulgated
together with Circular No. 05/2010/TT-BKH, and items of drug selected for bid
winning must satisfy the following conditions:
1. The selected item of drug must satisfy the
current provisions on management of medicine price:
a) Price proposed for bid winning of each item
of drug is not higher than price in bidding plan already been approved by
competent person and not higher than the wholesale price as declared or
re-declared which are still valid and made by establishments of medicine
manufacture and business to state management agencies.
If item of drug having bid price of all
contractors is higher than price in bid plan already been approved by competent
authorities, investor may consider and decide drug selected for bid winning as
prescribed at Clause 2 Article 20 of the Joint Circular No.
01/2012/TTLT-BYT-BTC;
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2. Item of drug selected for bid winning has the
lowest evaluation price under regulations, specified:
a) Item of drug of contractor having the lowest
evaluation price in bidding package for medicines under proprietary name or in
each medicine group for bidding package for medicines under generic medicine
and bidding package for oriental medicines, medicine from materia medica are
considered to propose for bid winning.
b) If the evaluation prices is equal each other,
selection of item of drug for consideration to propose for bid winning under
the priority order as follows:
- Item of drug having high technical point or
item of drug produced domestically with equivalent quality;
- To select item of drug with quality,
efficiency and used at medical establishments: Based on the expiry date of
medicines, violation of medicine quality, duration of using medicines at
medical establishments;
- To select item of drug of contractor having
experiences, prestige in medicine supply to medical establishment: Base on
experiences in supply of contractor, prestige of contractor on medicine supply
in medical establishment such as the assurance of supply, implementation of
medicine recall, possessing distribution system in geographical area,
organizing GPP medicine store chains.
Article 9. Provisions on
contract
To comply with the first part of model bidding
dossier for goods procurement promulgated together with Circular No.
05/2010/TT-BKH, and in contract, compulsorily, it must clearly stipulate the
following contents:
1. Obligations and duties of parties in medicine
supply, payment and assurance of supply of sufficient medicines according to
the result of bid winning in serve of medical examination and treatment of
medical establishments.
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Chapter III
IMPLEMENTATION PRVISIONS
Article 10. Organization of
implementation:
1. When submitting for approving the bidding
plan, hospitals, institutions having hospital begs affiliated the Ministry of
Health; the provincial/municipal Services of Health shall sum up and send
report on violations of contractors during bid, medicine supply in previous
period of medical establishments in their localities according to Annex 4
promulgated together with this Circular to the Ministry of Health ( the Drug
Administration of Vietnam) so as to sum up and announce, do as basis for units
to consider, evaluate and select contractors in the next period.
2. The Drug Administration of Vietnam shall sum
up and announce information on its website as basis for units to organize,
implement the work of bidding for medicine purchase:
a) List of medicines granted registration number
or import permit;
b) List of medicines, medicine manufacture
establishments violating medicine quality;
c) List of countries participating in EMA, ICH,
and PIC/s;
d) List of medicine manufacture establishments
which satisfy WHO-GMP standard and granted certificate by Vietnam Ministry of
Health (the Drug Administration of Vietnam);
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
e) List of data on the declared medicine price,
the selected bid medicine price at medical establishments;
g) List of the infringing contractors during bid
and medicine supply to medical establishments;
h) List of drugs produced at establishments
producing medicines which are granted certificate or satisfying WHO-GMP
standard by Vietnam Ministry of Health (the Drug Administration of Vietnam) and
licensed for circulation by competent management agencies of countries
participating in ICH;
i) List of medicines produced from raw materials
(active ingredients) produced in countries participating in ICH; raw materials
(active ingredients) which are granted certificate of satisfying CEP;
k) List of drugs franchised by production
establishments satisfying EU-GMP or PIC/s-GMP standard of countries
participating in ICH and produced at medicine production establishments subject
to grant of certificate of satisfying WHO-GMP standard by Vietnam Ministry of
Health (the Drug Administration of Vietnam);
l) List of enterprises organizing the GPP
medicine store chains;
m) List of enterprises organizing the medicine
distribution center.
Article 11. Effect
1. This Circular takes effect on January 01,
2014.
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. For bidding packages already been approved
before the effective day of this Circular, further complying with the Joint
Circular No. 01/2012/TTLT dated June 28, 2012, of the Minister of Health
guiding the elaboration of bidding dossier for medicine purchase by medical
establishments.
4. Chairpersons of provincial/municipal People’s
Committees; Directors of provincial/municipal Services of Health; Directors of
medical establishments and heads of relevant units shall implement this
Circular.
In the course of implementation, any arising
problems should be reported to the Ministry of Health (the Drug Administration
of Vietnam, Department of Planning and Finance) for consideration and
settlement.
FOR THE
MINISTER OF HEALTH
DEPUTY MINISTER
Nguyen Thi Xuyen
ANNEX 3
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
THE CRITERIA TABLE FOR TECHNICAL EVALUATION
No.
Content
Score
I
Criteria for medicine
quality evaluation: 70 points
1
Medicine item for bid participation
is produced by establishments
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Of country participating in
ICH
23
b) Not being countries
participating in ICH, having been granted WHO-GMP certificate by Vietnam's Ministry
of Health (the Drug Administration of Vietnam)
21
c) Not being countries
participating in ICH, not yet been granted WHO-GMP certificate by Vietnam's
Ministry of Health (the Drug Administration of Vietnam)
19
1.2. To satisfy WHO-GMP standard:
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
22
b) Being granted WHO-GMP certificate
by Vietnam's Ministry of Health (the Drug Administration of Vietnam) and
franchised the production from establishments satisfying PIC/s-GMP, EU-GMP
standard of countries participating in ICH.
20
c) Being granted WHO-GMP certificate
by Vietnam's Ministry of Health (the Drug Administration of Vietnam).
18
d) Not being granted WHO-GMP
certificate by Vietnam's Ministry of Health (the Drug Administration of
Vietnam).
17
1.3. Oriental medicines, medicines
from materia medica produced by establishments:
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
23
b) Not yet been checked and
granted certificate of satisfying WHO-GMP standard by Vietnam's Ministry of
Health (the Drug Administration of Vietnam).
18
2
Situation of quality
violation of medicines used for bid participation(1)
2.1. Not yet detected violations
of quality within 1 year recently.
15
2.2. Having notification of
quality violations within 1 year recently:
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Quality violation at level
2.
5
0
3
Situation of quality violation
of establishments producing medicines used for bid participation(2)
3.1. No medicine violating
quality within 1 year recently.
10
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3.1. Having 01 item of
medicine violating quality within 1 year recently.
8
3.3. Having 02 items of
medicine violating quality within 1 year recently.
4
3.4. Having 03 items of
medicine violating quality within 1 year recently.
0
4
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
4.1. Medicines used for bid participation
have shelf life of 3 years or longer.
10
4.1. Medicines used for bid
participation have shelf life of between 2 and less than 3 years.
8
4.3. Medicines used for bid
participation have shelf life of less than 2 years.
6
5
Criteria for evaluation
involving raw materials (active ingredient) used for production of medicines
in bid participation(4)
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
5.1. Raw materials (active
ingredient) are produced in countries participating in ICH.
4
5.2. Raw materials (active
ingredient) are produced in other countries not in ICH, granted CEP
certificate.
2
5.3. Other cases.
1
6
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
6.1. Medicines used for bid participation
has documents proving bioequivalence announced by the Ministry of Health.
4
6.2. Medicines used for bid
participation has no documents proving bioequivalence announced by the
Ministry of Health.
2
7*
Medicines produced from antibiotic
raw materials produced domestically (* not used for evaluation of oriental
medicines, medicines from material medica)
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
4
7.2. Medicines used for bid
participation produced from raw materials not being antibiotics produced
domestically.
2
8*
Medicines used for bid
participation are oriental medicines, medicines from materia medica (* only applying
evaluation for oriental medicines, medicines from materia medica)
8.1. Medicines used for bid
participation are produced from materia medica having certificate of
satisfying GACP.
4
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
8.2. Medicines used for bid participation
are produced from materia medica having clear origin.
2
8.3. Medicines used for bid
participation are produced from materia medica which is impossible to prove
origin clearly.
0
II
Criteria for service
quality evaluation: 30 points
9
Medicines are supplied
by establishments:
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
9.1. Being enterprises
producing medicines used bid participation.
6
9.2. Being enterprises
importing directly medicines used bid participation. (6)
4
9.3. Not being enterprises
producing or importing directly medicines used bid participation.
2
10
Medicines are supplied
by establishments which have experiences in medicine provision (7)
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
6
10.2. Having supplied
medicines to health establishments for less than 3 years.
4
10.3. Not yet supplied
medicines to health establishments.
2
11
Ability of contractor to
satisfy requirement on delivery condition (8)
11.1. Satisfying requirement
on delivery condition at bidding dossier.
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
11.2. Failing to satisfy
requirement on delivery condition at bidding dossier.
0
12
Medicines are supplied by
establishments which have prestige in contract performance(9)
12.1. Not yet had violation in
bid for medicine provision to health establishments.
a) Having been selected for
winning bid at unit, ensuring provision in accordance with progress under
contract.
b) Having been selected for
winning bid at unit, ensuring provision but not in accordance with progress
under contract.
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
7
5
4
12.2. Having violation in bid for
medicine provision to health establishments.
0
13
Medicines used for bid
participation by contractors organizing GPP medicine store chains
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
13.1. Contractor is an
enterprise organizing GPP medicine store chain.
2
13.2. Contractor is not
enterprise organizing GPP medicine store chain.
1
14
Medicines used for bid
participation by contractors organizing medicine distribution center
14.1. Contractor is an enterprise
organizing medicine distribution center.
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
14.2. Contractor is not
enterprise organizing medicine distribution center.
1
15
Medicines used for bid
participation by contractors which have a widespread system of distribution and
provision at mountainous and difficulty-stricken areas
15.1. Contractor has a
widespread system of distribution and provision in provinces (only apply to
Ha Giang, Cao Bang, Bac Kan, Lao Cai, Yen Bai, Bac Giang, Phu Tho, Dien Bien,
Lai Chau, Son La, Thanh Hoa, Nghe An, Quang Binh, Quang Tri, Quang Nam, Quang
Ngai, Binh Dinh, Ninh Thuan, Kon Tum, Lam Dong, Quang Ninh, Ha Tinh, Gia Lai,
Phu Yen, Hoa Binh, Tuyen Quang provinces).
2
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
0
Note:
(1), (2): Base on information
of medicines and establishments producing medicines with quality violation
under decisions on withdrawal issued by the Drug Administration of Vietnam and
announced on its website (address: http://www.dav.gov.vn).The seriousness of
medicine quality violation is defined at clause 3 Article 13 Chapter IV
Circular No. 09/2010/TT-BYT dated 28/4/2010 of the Ministry of Health, guiding
management of medicine quality.
(3) “Shelf life of medicine
is duration of usage fixed for a patch of medicines and passing this duration,
medicines are not permitted using” (according to Clause 21 Article 2 of the
Pharmacy Law). Example: Descriptions of medicine on label: Production date:
11/02/2006; expiry date 11/02/2011, shelf life of medicine is 5 years.
(4): Base on list of
medicines produced from raw materials produced at countries participating in
ICH, raw materials granted CEP certificate as announced on website of the
Drug Administration of Vietnam (address: http://www.dav.gov.vn). (5): Base on
list of medicines which have documents proving bioequivalence with original
proprietary as announced on website of the Drug Administration of Vietnam
(address: http://www.dav.gov.vn).
(6) Base on import goods
declaration of commodities used for bid participation.
(7) Base on notification of
winning bid, contract of medicine purchase and sale, invoice of medicine sale
for medical examination and treatment establishments which contractor is
participating in bid or other medical examination and treatment establishments
which contractor has supplied medicines.
(8) Contractor should
state clearly in bid dossier about it can satisfy or cannot satisfy requirement
of investor/unit (unit organizing bid) about delivery conditions in the biding
dossier (at table of provision progress (Chapter VI) and requirement on goods
transport (Article 27 Chapter VIII) in the Model Bidding Dossier of goods
purchase promulgated together with the Circular No. 05/2010/TT-BKH.
(9) To evaluate this content,
base on contract performance involving medicine provision between contractor
and investor/unit (unit organizing bid) in case of contractor selected for
winning bid in previous year; base on information of violation during bid,
medicine provision of contractors at health establishments announced on website
of the Drug Administration of Vietnam (address: http://www.dav.gov.vn).
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66