Circular No. 04/2000/TT-BYT guides the implementation of Decree No. 11/1999/NĐ-CP dated March 3, 1999 of the Government on goods prohibited from circulation, commercial services prohibited from performance; goods and commercial services restricted for business, conditional business in the field of vaccines and biological products.

CIRCULAR

Guidelines for implementing Decree No. 11/1999/NĐ-CP dated March 3, 1999 of the Government on goods prohibited from circulation, services prohibited from conducting; goods and services with restricted business operations, conditional business operations in the field of vaccines and biological products.

services prohibited from conducting; goods and services with restricted business operations, conditional business operations.

Conditional business operations in the field of vaccines and biological products.

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Pursuant to Decree No. 11/1999/NĐ-CP dated March 3, 1999 of the Prime Minister on goods prohibited from circulation, services prohibited from conducting; goods and services with restricted business operations, conditional business operations, this Circular provides detailed guidance on the conditions for operating vaccines and biological products as specified in Section I, List 3 issued together with Decree No. 11/1999/NĐ-CP dated March 3, 1999 as follows:

PART I

GENERAL PROVISIONS

Article 1.

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1. Vaccine is a preparation containing antigens of natural or synthetic origin, used to induce active immunization for prevention.

2. Immunological biological products (referred to as biological products) are biological products derived from living organisms used for disease prevention, treatment, and diagnosis of infectious diseases in humans.

3. Legally circulating vaccines and biological products are those vaccines and biological products that have been registered or officially imported according to specific disease prevention, treatment, or diagnostic needs by the Ministry of Health.

4. Operating vaccines and biological products involves selling these products on the market for profit.

5. A business entity operating vaccines and biological products is an enterprise with the function of buying and selling vaccines and biological products.

Article 2. This Circular applies to the following types of businesses:

1. State-owned enterprises engaged in pharmaceuticals that operate vaccines and biological products.

2. Enterprises established under the Enterprise Law to operate vaccines and biological products or pharmaceutical enterprises that operate vaccines and biological products.

3. Foreign-invested enterprises with production facilities for vaccines and biological products may only operate vaccines and biological products produced in Vietnam.

Article 3. Strictly prohibit private pharmacies, drug agents, or other entities not listed in Article 2 of this Circular from operating vaccines and biological products.

Article 4. Those officials and civil servants holding the following positions or performing the following tasks shall not participate in vaccine and biological product business operations:

1. Civil servants of the Department of Drug Management and the Preventive Medicine Department.

2. Director and Deputy Director of the National Institute of Biological Product Quality Control.

3. Director and Deputy Director of Provincial Health Departments (commonly referred to as provinces).

4. Director and Deputy Director of Provincial Preventive Health Centers.

5. Chief Inspector, Deputy Chief Inspector, and specialized health inspection officers of the Ministry of Health and Provincial Health Departments.

6. Staff managing vaccines and immunological biological products at provincial health departments.

Article 5. Individuals prohibited from establishing or participating in management of enterprises under the provisions of the law shall not be allowed to establish or participate in management of enterprises established under the Enterprise Law to operate vaccines and biological products.

Chapter II

STANDARDS AND CONDITIONS FOR OPERATING VACCINES AND BIOLOGICAL PRODUCTS

Article 6. Business operators must have a Business Registration Certificate for Pharmaceuticals and a Certificate of Compliance with Pharmaceutical Practice Standards.

Article 7. Physical facilities, technical equipment, and tools

- Business office:

+ Separate, stable, if rented, must have a legal lease agreement for at least one year.

+ Must have sufficient office equipment to support the management activities of the business.

+ Must have a signboard as prescribed (fully displaying the name in Vietnamese according to the permit, can include a foreign language trade name but it must be smaller than the Vietnamese name).

- Vaccine and biological product warehouse:

+ The warehouse must be sturdy, dry, clean, and well-ventilated.

+ The warehouse must have ventilation systems, temperature control, cold storage equipment, and daily temperature monitoring devices meeting the requirements for vaccine and biological product preservation.

- Inventory records:

+ Each type of vaccine and biological product must have a warehouse card indicating storage conditions and expiration dates.

+ Must have an import and export record book.

+ Must have all invoices and certificates for imports and exports of vaccines and biological products.

+ Must maintain an up-to-date import and export record book.

- Must have cold storage equipment and temperature monitoring devices suitable for transporting vaccines and biological products.

Article 8. Managers and technical staff must meet the following conditions:

- Managers and personnel responsible for business operations:

+ A bachelor's degree in pharmacy or medicine with at least five years of experience working in a legally operating pharmaceutical, vaccine, or biological product business.

+ Not currently subject to disciplinary action in pharmaceutical, vaccine, or biological product practice, and not currently under criminal investigation.

- Warehouse manager:

+ Must have a minimum of a college-level education in medical or pharmaceutical sciences.

+ Not currently subject to disciplinary action in vaccine or biological product practice, and not currently under criminal investigation.

- Warehouse staff:

Staff responsible for distribution must have a minimum of a basic-level education in medical or pharmaceutical sciences and be knowledgeable about vaccines and biological products.

- Staff responsible for transporting vaccines and biological products must have a secondary-level education in pharmacy.

Article 9Direct business personnel must have a health certificate from a district or county health authority, and must not be suffering from communicable diseases.

Article 10. Must have necessary equipment to ensure fire prevention, occupational safety, and environmental hygiene standards.

Article 11. Ensuring quality of vaccines and biological products:

- Must maintain a quality management logbook for vaccines and biological products, keeping copies of original test reports for each batch received (with an import company stamp confirming receipt).

- Quality monitoring staff must regularly and periodically check the quality of vaccines and biological products in the warehouse (at least once a month). After each inspection, they must record in the logbook or report for tracking purposes.

- Private enterprises operating vaccines and biological products may enter into contracts with recognized quality testing facilities to ensure the quality of their vaccines and biological products.

Chapter III

SCOPE OF BUSINESS AND RESPONSIBILITIES OF VACCINE AND BIOLOGICAL PRODUCT BUSINESS ENTITIES

Article 12. Scope of business:

- Businesses engaged in vaccine and medical product trading are only permitted to sell vaccines and medical products that have been legally authorized for circulation. Treatment vaccines and medical products must be accompanied by a certificate of quality standards issued by the National Institute of Hygiene and Epidemiology (or an authorized entity).

- Businesses engaged in vaccine and medical product trading are not allowed to purchase or sell vaccines and medical products of unknown origin, past their expiration date, substandard, or those which have not been granted a legal circulation permit by the Ministry of Health.

- Businesses engaged in vaccine and medical product trading are only permitted to sell vaccines and medical products to Preventive Medical Centers and healthcare facilities authorized to use immunization vaccines and medical products.

Article 13. In addition to complying with the provisions of the Enterprise Law, the Trade Law, and related laws of the Socialist Republic of Vietnam, business entities engaged in vaccine and medical product trading must also adhere to the following regulations:

- Strictly comply with health policies, legal documents concerning vaccines and medical products in Vietnam, and be subject to professional and technical management by the Ministry of Health and Provincial Health Departments.

- Bear legal responsibility and accountability to consumers regarding the quality of vaccines and medical products they trade.

- Compensate for damages caused by circulating vaccines and medical products that do not meet quality standards according to the law.

- Have the responsibility to report to the Ministry of Health (Preventive Medicine Department) and Provincial Health Departments about issues related to the quality of vaccines and medical products, adverse events, and side effects of vaccines and medical products when reported by physicians or consumers.

- Participate in serving urgent health needs.

- Study, understand, and implement relevant legal regulations on professional and technical medical matters within their scope of business operations.

Chapter IV

AUTHORITY AND PROCEDURES FOR ISSUING LICENSES TO OPERATE VACCINE AND MEDICAL PRODUCT TRADING

Article 14. Authority to examine and issue licenses for operating vaccine and medical product trading in Vietnam;

The Director of the Provincial Health Department shall review and issue licenses for domestic businesses engaged in vaccine and medical product trading within their jurisdictional area.

The Provincial Health Department shall establish an advisory board to assist the Director in assessing standards and conditions for issuing licenses.

Article 15. The application package for operating vaccine and medical product trading in Vietnam includes:

1. Application for a Certificate of Eligibility to Operate Vaccine and Medical Product Trading.

2. Business Registration Certificate, Pharmaceutical Trading License, and Certificate of Compliance with Professional Standards and Conditions issued by the Ministry of Health.

3. Documentation on professional expertise, technical capabilities, and organizational structure of the business.

4. Lease agreement or ownership certificate for the business premises and warehouse.

5. Application materials for the business director, board of directors, and person in charge of business activities include:

- A copy of valid professional certification.

- A detailed resume confirmed by the managing authority or local government.

- A health examination report from a district or county-level health authority.

- Certificate of having practiced for at least five years at a legally established vaccine and medical product trading facility.

6. Commitment to assume responsibility for the quality of vaccines and medical products sold.

7. Commitment to assume responsibility for compensating losses if vaccines and medical products affect the health or life of users.

The business application package consists of three sets, one original and two certified copies, to be submitted to the Provincial Health Department where the business is headquartered for review.

Within fifteen days from the date of receiving complete and valid applications, the Provincial Health Department will respond in writing to the business based on the assessment results according to the standards set forth in this Circular.

Article 16

The Certificate of Eligibility to Operate Vaccine and Medical Product Trading shall be made in four copies: one sent to the Ministry of Commerce or People's Committee (where the Business Registration Certificate was issued), one given to the business, one reported to the Ministry of Health (filed in the Preventive Medicine Department), and one retained by the Provincial Health Department (where the business is headquartered).

Any changes in actual circumstances compared to the approved application (changes in vaccine and medical product types, headquarters location, personnel changes, etc.) must be reported in writing to the Provincial Health Department that issued the license for review and confirmation.

The Certificate of Eligibility to Operate Vaccine and Medical Product Trading issued to a business is valid for five years from the date of issuance. Three months before the expiration date, businesses must submit an application to the Provincial Health Department to renew the certificate.

After obtaining the Certificate, the business may conduct trading activities in accordance with legal regulations.

Article 17. Businesses granted a Certificate of Eligibility to Operate Vaccine and Medical Product Trading must pay fees as stipulated by current laws on fees and charges.

Chapter V

INSPECTION, AUDIT AND VIOLATION HANDLING

Article 18. Inspection and supervision

- The Ministry of Health's Inspectorate, in collaboration with the Preventive Medicine Department and other relevant departments, will organize inspections and audits of all businesses engaged in vaccine and medical product trading nationwide to ensure compliance with legal regulations.

- The Provincial Health Department's Inspectorate, in collaboration with the pharmaceutical affairs department of the Provincial Health Department, will organize inspections and audits of all businesses engaged in vaccine and medical product trading within their jurisdiction to ensure compliance with legal regulations.

Inspections and audits will be conducted regularly or at random.

Businesses engaged in vaccine and medical product trading must comply and facilitate inspections and audits at their facilities.

Article 19. Handling Violations

Organizations and individuals engaging in vaccine and medical product trading who violate the provisions of this Circular and related laws will be subject to administrative penalties or criminal liability as provided by law, and must compensate for damages according to the law if such violations cause harm.

Chapter VI

IMPLEMENTING PROVISIONS

Article 20

During the implementation process, if there are any issues that are not appropriate or problematic, localities and units must promptly report to the Ministry of Fisheries for research, guidance, supplementation, and amendment./.

During implementation, if difficulties arise, units and localities should report to the Ministry of Health (Preventive Medicine Department) and Provincial Health Departments for research and resolution.