Thông tư 10/2003/TT-BYT

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

1. Entities:

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;

After the permit is granted, the foreign side can contract with Vietnamese side to supply vaccines and biologicals (finished and semi-finished products), raw materials for production of vaccines and biologicals as regulated by the Ministry of Health and Vietnam’s law.

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.

1.4. Enterprise’ confirmation of current accounts at the host country's bank (with confirmations by the bank) (Original).

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.

4. The permit shall be valid for two years since the date of signing. Three months prior to the expiration date, if an enterprise wishes to continue its operation, it must carry out re-registration procedures as prescribed in Section II.2 hereof. All the papers for re-registration must be valid at the time of registration.

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;

- Do not import into Vietnam vaccines and biologicals of poor quality or ineligible for circulation...

- 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

+ Upon finding serious accidents due to use of vaccines and biologicals;

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.

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:

Fax:

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. 

FORM 2

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

- Raw materials for production of vaccines, biologicals

- 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

12. Enterprise’s director

- 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. 

FORM 3

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:

Exportation , importation , production ;

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. 

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:

Content

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)

4. Other activities (if any)

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.