Circular No. 10/2003/TT-BYT guiding foreign companies to register their activities related to vaccines and medical products in Vietnam

CIRCULAR

Guidelines for foreign companies to register activities related to vaccines and medical products with Vietnam.

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Pursuant to the Law on Health Care for the People dated June 30, 1989

Pursuant to the Pharmaceutical Products Regulation issued pursuant to the Decree of the Council of Ministers of the Socialist Republic of Vietnam No. 23-HĐBT dated January 24, 1991

Pursuant to Decree No. 11/1999/NĐ-CP dated March 3, 1999 of the Government regarding prohibited goods and services, restricted goods and services, and goods and services subject to conditions for business

Pursuant to Decision No. 4012/2003/QĐ-BYT dated July 30, 2003 of the Minister of Health on the issuance of the "Regulations on Registration of Vaccines and Medical Products"

To manage and facilitate the development of vaccine and medical product imports, ensuring quality and safety for users, the Ministry of Health of the Socialist Republic of Vietnam guides foreign companies (hereinafter referred to as the foreign party) permitted to trade and import finished and semi-finished vaccines and medical products, and raw materials for vaccine and medical product production through Vietnamese companies (hereinafter referred to as the Vietnamese party).

I. OBJECTS AND CONDITIONS FOR REGISTRATION

1. Objectives:

Foreign organizations and companies wishing to operate under import contracts with Vietnamese enterprises engaged in the sale of finished and semi-finished vaccines and medical products, and raw materials for vaccine and medical product production.

2. Conditions for registration:

2.1. For new registrants:

a. Must be a company engaged in the production and trade of vaccines, medical products, and raw materials for vaccine and medical product production established in accordance with the laws of the home country.

b. Only supply vaccines, medical products, and raw materials for vaccine and medical product production to Vietnam through Vietnamese enterprises with relevant functions via import contracts.

c. Complete and valid registration documents

d. If it is a manufacturing company, the production facility must meet Good Manufacturing Practice (GMP) standards; if it is a distribution company, it must have permission to trade, export, import, and store vaccines, medical products, and raw materials for vaccine and medical product production from the competent authority of the home country.

e. Business experience and financial capability: The company must have at least three years of experience in production and trade.

g. Commitment to strictly comply with Vietnamese laws and regulations on vaccine and medical product management by the Ministry of Health of Vietnam.

After obtaining the permit, the foreign party may enter into sales contracts for finished and semi-finished vaccines and medical products, and raw materials for vaccine and medical product production with Vietnamese enterprises with relevant functions according to the regulations of the Ministry of Health and Vietnamese laws.

2.2. For re-registration applicants: When the permit expires, the enterprise must submit a new registration application and meet the following conditions:

- No violations during the period of operation

- Complete and valid registration documents

II. REGISTRATION PROCEDURES

1. New registration documents include:

1.1. Application form for registration in the field of vaccines, finished and semi-finished medical products, and raw materials for vaccine and medical product production (Form 1).

1.2. Company profile (Form 2).

1.3. Trade, export, and import permits for vaccines and medical products issued by the competent authority of the home country for trading companies, and production permits for vaccines and medical products and GMP certificates issued by the competent authority of the home country for manufacturing companies (Original or certified copy).

These documents must remain valid at the time of application. During the period of operation, if these documents expire, the company must provide updated ones.

1.4. Bank account confirmation of the company in the home country (confirmed by the bank) (Original).

The registration documents consist of two sets: one original set (in English) and one set in Vietnamese with notarized copies of the documents mentioned in Clause 1.3 of this section.

2. Re-registration documents include:

2.1. Application form for re-registration (Form 3).

2.2. Trade, export, and import permits for vaccines and medical products issued by the competent authority of the home country for trading companies, and production permits for vaccines and medical products and GMP certificates issued by the competent authority of the home country for manufacturing companies (Original or certified copy).

These documents must remain valid at the time of application. During the period of operation, if these documents expire, the company must provide updated ones.

2.3. Bank account confirmation of the company in the home country (confirmed by the bank) (Original)

2.4. Activity report (Form 4)

The re-registration documents consist of two sets: one original set (in English) and one set in Vietnamese with notarized copies of the documents mentioned in Clause 2.2 of this section.

3. Within three months from the date of receipt of complete and valid documents, the Ministry of Health will consider issuing the permit. In case of non-issuance, the Ministry of Health will notify in writing with specific reasons.

4. The permit is valid for two years from the date of signature. Three months before expiration, if the company wishes to continue operations, it must follow the procedures for re-registration as stipulated in Section II.2 of this Circular. The re-registration documents must remain valid at the time of submission of the application.

5. In cases of name change, address change, division, or merger of the company during the validity period of the permit, the company must notify the Ministry of Health (Preventive Medicine Department and HIV/AIDS Prevention and Control Department) along with relevant legal documents from the home country (original or certified copy). The Ministry of Health will review and respond in writing.

6. When registering anew or re-registering, the company must pay fees as prescribed and complete the fee payment and permit collection procedures within six months from the date of signing the permit. Beyond this period, the permit will automatically become invalid.

III. RIGHTS AND OBLIGATIONS OF FOREIGN COMPANIES REGISTERING ACTIVITIES RELATED TO VACCINES, MEDICAL PRODUCTS, AND RAW MATERIALS FOR VACCINE AND MEDICAL PRODUCT PRODUCTION WITH VIETNAM

1. Rights of foreign companies:

- To be listed as the foreign registrant when registering the circulation of products such as finished and semi-finished vaccines and medical products in Vietnam.

- Supply vaccines, medical products, and raw materials for vaccine and medical product production to Vietnam through import contracts signed with Vietnamese enterprises with relevant functions for vaccine and medical product import and export.

- Organizing scientific seminars, exchanging professional experiences, and disseminating information and advertising vaccines and medical products in accordance with the regulations of the Ministry of Health.

2. Foreign enterprises shall be responsible for:

- Strictly complying with the laws of Vietnam and the regulations of the Ministry of Health on vaccine and medical product management.

- Not importing into Vietnam vaccines and medical products that are not legally permitted to circulate, substandard vaccines and medical products...

- Not directly distributing vaccines and medical products into Vietnam under any form.

- Bearing full responsibility before Vietnamese law, the Vietnamese Ministry of Health, and consumers regarding the quality of vaccines and medical products supplied into Vietnam. Compensating consumers and Vietnamese partners in cases of damage caused by the supplier's fault according to the provisions of the law.

- Reporting annually to the Vietnamese Ministry of Health (Preventive Medicine Department and AIDS Control Department) on activities in the field of vaccines and medical products in Vietnam.

- Reporting to the Vietnamese Ministry of Health (Preventive Medicine Department and AIDS Control Department) and submitting relevant legal documents in the following cases:

+ Changing the General Director or the person primarily responsible for vaccine and medical product activities and raw materials for vaccine and medical product production.

+ Ceasing operations in the field of vaccines and medical products in Vietnam.

Foreign enterprises shall be responsible for reporting immediately in the following cases:

+ When requested by competent authorities.

+ When discovering that products supplied into Vietnam do not meet quality standards or violate other professional regulations.

+ When discovering serious adverse events caused by the use of vaccines and medical products supplied by the enterprise.

IV. INSPECTION, AUDIT AND VIOLATION HANDLING

1. Inspection and Audit: Foreign enterprises granted licenses for vaccine, medical product, and raw material production activities in Vietnam shall be subject to inspection and supervision in accordance with the provisions of the law.

2. Violation Handling: If foreign enterprises granted licenses for vaccine, medical product, and raw material production activities in Vietnam violate the provisions of this Circular, they will be dealt with according to the provisions of the law depending on the level and nature of the violation. If damage is caused, compensation must be provided according to the provisions of the law.

V. IMPLEMENTATION PROVISIONS

The Ministry of Health assigns the Preventive Medicine Department and AIDS Control Department to be responsible for reviewing registration applications and directly monitoring the activities of foreign enterprises in the field of vaccines and medical products in Vietnam.

This Circular takes effect fifteen days from the date of publication in the Official Gazette and replaces Circular No. 01/BYT-TT dated January 29, 1997, issued by the Ministry of Health guiding the registration of foreign companies permitted to import vaccines and immunological medical products for organizations and companies in the Socialist Republic of Vietnam.