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THE MINISTRY OF
HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom - Happiness
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No.:
10/2003/TT-BYT
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Hanoi, December
16, 2003
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CIRCULAR
PROVIDING
GUIDANCE TO FOREIGN ENTERPRISES ON REGISTRATION FOR OPERATION IN VACCINES AND
BIOLOGICALS WITH VIETNAM
Pursuant to the Law on People’s Health
Protection dated June 30, 1989;
Pursuant to the Statute on preventive healthcare
and cure as prescribed in the Decree No. 23-HĐBT dated January 24, 1991 by the
Council of Ministers of the Socialist Republic of Vietnam;
Pursuant to the Government’s Decision No.
11/1999/NĐ-CP dated March 03, 1999 regulating goods and services being banned
from circulation or practice; commercial goods and services subject to
restriction or conditional business;
Pursuant to the Minister of Health’s Decision
No. 4012/2003/QĐ-BYT dated July 30, 2003 promulgating “Statute on registration
for vaccines and biologicals”;
To manage and create conditions for the
development of sources of importing vaccines and biologicals and to ensure
quality and safety to customers, the Ministry of Health provides guidance to
foreign companies (hereinafter referred to as the foreign side) on registration
for trading and importation of vaccines and biologicals (finished products and
semi-finished products), raw materials for production of vaccines and
biologicals via Vietnamese companies (hereinafter referred to as Vietnamese side).
I. ENTITIES AND CONDITIONS FOR
REGISTRATION
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Foreign organizations, individuals that wish to
operate under import contracts with Vietnamese enterprises trading vaccines and
biologicals (finished products and semi-finished products), raw materials for
production of vaccines and biologicals;
2. Conditions for registration:
2.1. For new enterprises (enterprises that carries
out registration for the first time)
a. Enterprises that are established under the host
country's law for operation in production and trading of vaccines and
biologicals, raw materials for production of vaccines and biologicals;
b. Activity confined to importation of vaccines and
biologicals, raw materials for production of vaccines and biologicals into
Vietnam via Vietnamese relevant enterprises;
c. Registration documents must be adequate and
eligible.
d. If the exporter is a production enterprise, its
production facility must obtain GMP (Good Manufacturing Practice); if the
exporter is a distributor, it must obtain the permit for trading, exportation,
importation and storage of vaccines and biologicals, raw materials for
production of vaccines and biologicals granted by the host country’s competent
agencies.
e. Experience in business and financial resources:
At least three years in production and trading;
g. Committed to complying strictly with Vietnam's
law and the Ministry of Health's regulations on management of vaccines and
biologicals;
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2.2. As for enterprises that carry out
re-registration: When the permit expires, such enterprises must prepare
documents of re-registration that meet the following conditions:
- No violations committed during the operation
- Registration documents must be adequate and
eligible
II. REGISTRATION PROCEDURES:
1. New registration documents include:
1.1. Application form for registration of operation
in vaccines and biologicals (finished and semi-finished products), raw
materials for production of vaccines and biologicals (Form 1);
1.2. Company history (Form 2).
1.3. Permit for trading, exportation and
importation of vaccines and biologicals granted by the host country’s competent
agencies (in case of a trading enterprise) and the permit for production of
vaccines and biologicals and GMP certificate issued by the host country’s
competent agencies (in case of a production enterprise) (Original or notarized
copies).
All aforesaid papers must be valid at the time of
registration. During the operation, enterprises must make supplements if such
papers expire.
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Registration documents include two sets: One
original in English and one copy in Vietnamese (with notarized copies of the
papers as specified in Section 1.3 of this Clause).
2. Re-registration documents include:
2.1. Application form for re-registration (Form 3).
2.2. Permit for trading, exportation and
importation of vaccines and biologicals granted by the host country’s competent
agencies (in case of a trading enterprise) and the permit for production of
vaccines and biologicals and GMP certificate issued by the host country’s
competent agencies (in case of a production enterprise) (Original or notarized
copies).
All aforesaid papers must be valid at the time of
registration. During the operation, enterprises must make supplements if such
papers expire.
2.3. Enterprise’ confirmation of current account at
the host country's bank (with confirmations by the bank) (Original).
2.4. Report on operation (Form 4)
Re-registration documents include two sets: One
original in English and one copy in Vietnamese (with notarized copies of the
papers as specified in Section 2.2 of this Clause)
3. Within three months since receipt of adequate and
eligible documents, the Ministry of Health shall carry out consideration and
grant the permit. In case the permit is not granted, the Ministry of Health
shall make a written notice and specify the reasons.
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
5. In case an enterprise changes its name or
address, carries out separation or merger while the permit remains unexpired, a
written notice must be made to the Ministry of Health (Department of Preventive
Medicine and HIV/AIDS control), accompanied by relevant documents issued in the
host country (original or copies). The Ministry of Health shall carry out
consideration and issue a written reply.
6. When carrying out new registration or
re-registration, an enterprise must pay a fee as prescribed in applicable
regulations and complete procedures for payment of fees, and shall receive the
permit within six months since the permit is signed. Beyond such period, the
permit is no longer effective by default.
III. RIGHTS AND RESPONSIBILITIES
OF FOREIGN ENTERPRISES FOR REGISTERING OPERATION IN VACCINES, BIOLOGICALS AND
RAW MATERIALS FOR PRODUCTION OF VACCINES AND BIOLOGICALS
1. Rights of foreign enterprises:
- Apply for registration for circulation of
vaccines, biologicals (finished and semi-finished products) in Vietnam under
the name of a foreign entity;
- Supply vaccines, biologicals, raw materials for
production of vaccines and biological into Vietnam under an import contract
with Vietnamese enterprises;
- Organize symposiums, exchange of professional
experience, information and advertisement of vaccines and biologicals as
prescribed by the Ministry of Health;
2. Responsibilities of foreign enterprises:
- Comply strictly with Vietnam and the Ministry of
Health’s regulations on management of vaccines and biologicals;
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- Do not carry out direct distribution of vaccines
or biologicals in Vietnam in any form;
- Take responsibility to the Law, the Ministry of
Health and consumers for quality of vaccines, biologicals supplied to Vietnam;
Make compensation to consumers and Vietnamese partners for any damage caused by
suppliers of vaccines and biologicals as prescribed by the law;
- Make annual reports to the Ministry of Health
(Department of Preventive Medicine and HIV/AIDS control) on operation of
vaccines and biologicals in Vietnam;
- Make the report to the Ministry of Health
(Department of Preventive Medicine and HIV/AIDS control) and enclose relevant
documents in the following cases:
+ Change the director who takes main responsibility
for operation of vaccines, biologicals and raw materials for production of
vaccines and biologicals;
+ Terminate operation in vaccines and biologicals
with Vietnam;
- Make irregular report in the following cases:
+ As requested by functional agencies;
+ Upon finding any product imported into Vietnam
does not meet quality standards or commits other violations
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
IV. INSPECTION, INVESTIGATION
AND HANDLING OF VIOLATIONS:
1. Inspection and investigation: Foreign
enterprises granted permit for operation in vaccines and biologicals, raw
materials for production of vaccines and biologicals with Vietnam shall be
subject to inspection and monitoring as prescribed by the law.
2. Handling of violations: If any foreign
enterprise granted permit for cooperation in vaccines and biologicals, raw
materials for production of vaccines and biologicals with Vietnam violates the
provisions set out hereof, depending on severity and nature of the violation,
such enterprise shall be subject to handling or make compensations for any loss
caused according to the law provisions.
V. IMPLEMENTATION
The Ministry of Health shall assign Department of
Preventive Medicine and HIV/AIDS control to play a role as a standing unit in
the examination of registration and monitoring of activities in vaccines and
biologicals conducted by foreign side with Vietnamese side.
This Circular takes effect after 15 days since the
release of official gazette and replaces the Ministry of Health’s Circular No.
01/BYT-TT dated January 29, 1997 providing guidance to foreign enterprises
granted permit for importation of vaccines and biologicals of immunity on
registration with Vietnamese organizations, enterprises.
PP THE MINISTER
OF HEALTH
DEPUTY MINISTER
Tran Chi Liem
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
FORM 1
APPLICATION
FORM FOR ISSUANCE OF PERMIT FOR OPERATION OF VACCINES AND BIOLOGICALS, RAW
MATERIALS FOR PRODUCTION OF VACCINES AND BIOLOGICALS WITH VIETNAM (New
registration)
Respectfully to: The Ministry of
Health
Department of Preventive
Medicine and HIV/AIDS control
Name of enterprise:
Address:
Phone:
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Activities of vaccines and
biologicals to be registered:
Exportation, importation,
production;
We hereby submit this form to apply for the permit
for operation in vaccines and biologicals, raw materials for production of
vaccines and biologicals with Vietnam. If granted the permit, we are committed
to complying strictly with the law provisions, the provisions prescribed by the
Ministry of Health and being placed under the inspection and investigation by
Vietnam’s competent agencies.
Date......
DIRECTOR
(Signature,
full name and stamp)
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
ENTERPRISE
HISTORY
1. Name of
enterprise/nationality
2. Address:
Phone:
Fax:
3. Permissible activities of
production and trading in the host country
Production
Trading
- Vaccines
- Biologicals
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- Other activities (if any)
4. Year of establishment
5. Legal capital
6. Bank account number
7. Number of permit issued by
the host country, expiration date:
8. Name, address of the host
country’s competent agencies that grant the permit:
9. Revenues in vaccines and
biologicals in three recent years
10. Total number of staff
11. Total number of staff
specializing in vaccines and biologicals
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- Full name:
- Professional level
I hereby guarantee that all the
aforesaid information is true and shall take full responsibility for any untrue
and wrong statement.
Date......
DIRECTOR
(Signature,
full name and stamp)
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
REGISTRATION
FORM FOR OPERATION IN VACCINES AND BIOLOGICALS, RAW MATERIALS FOR PRODUCTION OF
VACCINES AND BIOLOGICALS WITH VIETNAM BY FOREIGN ENTERPRISES
(Re-registration)
Respectfully
to: The Ministry of Health
Department of
Preventive Medicine and HIV/AIDS control
Name of enterprise:
Address:
Phone:
Fax:
Activities of vaccines and
biologicals to be registered:
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Has been granted the permit for foreign
enterprises to operate in vaccines and biologicals, raw materials for
production of vaccines and biologicals with Vietnam.
Number of permit issued for the
first time, date of issuance
Number of
permit unexpired, expiration date:
We hereby submit this form to
apply for re-issuance of the permit for operation in vaccines and biologicals,
raw materials for production of vaccines and biologicals with Vietnam. If
granted the permit, we are committed to complying strictly with the law
provisions, the provisions prescribed by the Ministry of Health and being
placed under the inspection and investigation by Vietnam’s competent
agencies.
Date......
DIRECTOR
(Signature,
full name and stamp)
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
FORM 4
REPORT
ON OPERATION IN VACCINES AND BIOLOGICALS, RAW MATERIALS FOR PRODUCTION OF
VACCINES AND BIOLOGICALS WITH VIETNAM BY FOREIGN ENTERPRISES
(Two-year period)
Respectfully to: The
Ministry of Health
Department of Preventive
Medicine and HIV/AIDS control
Name of enterprise:
Address:
Phone:
Fax:
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. Representative office (if
any):
- Representative office permit,
date of issuance
- Address:
- Charge of representative
office
2. Relationship and cooperation in business with
Vietnamese enterprises as follows:
3. Revenues in vaccines and
biologicals, raw materials for production of vaccines and biologicals in
Vietnam (converted into USD)
Year
Year
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Biologicals
Raw materials
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5. Reports on violations (if
any)
We hereby guarantee that all the
aforesaid information is true and shall take full responsibility for any untrue
and wrong statement.
Date......
DIRECTOR
(Signature, full
name and stamp)