Circular No. 08/2006/TT-BYT guiding the importation of vaccines, medical biological products; chemicals, insecticides, bactericides for household and medical use, and medical equipment.

CIRCULAR

Guidelines for importing vaccines, medical biological products; chemicals, insecticides, bactericides for household and medical use, and medical equipment

Pursuant to the Medicine Law No. 34/2005-QH11 dated June 14, 2005.

Pursuant to the Government Decree No. 49/2003/NĐ-CP dated May 15, 2003 on the functions, tasks, powers, and organizational structure of the Ministry of Health.

Pursuant to the Prime Minister's Decree No. 12/2006/NĐ-CP dated January 23, 2006 detailing the implementation of the Trade Law regarding international trade activities and agency buying, selling, processing, and transiting goods with foreign countries, the Ministry of Health issues guidelines for importing vaccines, medical biological products; chemicals, insecticides, bactericides for household and medical use, and medical equipment as follows:

I. GENERAL PROVISIONS

Thông tư này quy định chi tiết khoản 4 Điều 38 Luật Thủy sản số 18/2017/QH14 đã được sửa đổi, bổ sung tại điểm c khoản 21 Điều 14 Luật số 146/2025/QH15.

These Circular regulates the import activities of:

1.1. Finished, semi-finished products, raw materials, packaging, and auxiliary materials for the use, production, and research of vaccines and medical biological products.

1.2. Chemicals, insecticides, bactericides for household and medical use.

1.3. Medical equipment including various types of equipment, tools, supplies, and specialized transportation means serving medical activities.

Thông tư này áp dụng đối với tổ chức, cá nhân có liên quan đến hoạt động kinh doanh đối tượng thủy sản nuôi chủ lực trên lãnh thổ Việt Nam.

These Circular applies to traders and organizations operating in fields related to the import of vaccines, medical biological products; chemicals, insecticides, bactericides for household and medical use, and medical equipment.

3. List of vaccines, medical biological products; chemicals, insecticides, bactericides for household and medical use, and medical equipment

3.1. The list of vaccines, medical biological products, and chemicals, insecticides, bactericides for household and medical use imported based on demand includes vaccines, medical biological products, and chemicals, insecticides, bactericides for household and medical use that have been granted valid registration certificates by the Ministry of Health (for vaccines and medical biological products) and certificates of registration for circulation (for chemicals, insecticides, bactericides for household and medical use).

3.2. Medical equipment not subject to the provisions of Part IV of this Circular and not included in the list of prohibited imports under the Prime Minister's Decree No. 12/2006/NĐ-CP dated January 23, 2006 detailing the implementation of the Trade Law regarding international trade activities and agency buying, selling, processing, and transiting goods with foreign countries may be imported based on demand.

4. Customs procedures

4.1. For vaccines, medical biological products, chemicals, insecticides, bactericides for household and medical use within the list of items imported based on demand: traders and organizations importing these items must submit to Customs a copy of the valid registration certificate (for vaccines and medical biological products) or certificate of registration for circulation (for chemicals, insecticides, bactericides for household and medical use) of the imported product signed and stamped by the head of the enterprise, who bears full responsibility under the law.

4.2. For vaccines, medical biological products, and chemicals, insecticides, bactericides for household and medical use not within the list of items imported based on demand: traders and organizations importing these items must submit to Customs the original import permit issued by the Preventive Medicine Department of the Ministry of Health if importing once or a copy when importing multiple times, and must present the original for verification.

4.3. For medical equipment requiring an import permit from the Ministry of Health: traders importing such equipment must submit to Customs the original import permit issued by the Ministry of Health if importing once or a copy when importing multiple times, and must present the original for verification.

II. PROVISIONS ON IMPORTING VACCINES AND MEDICAL BIOLOGICAL PRODUCTS

1. VACCINES AND MEDICAL BIOLOGICAL PRODUCTS IMPORTED WITHOUT A PERMIT

1.1. Conditions

1.1.1. Traders and organizations engaged in the business of vaccines and medical biological products must hold a Business Registration Certificate issued by the competent authority. Enterprises currently importing vaccines and medical biological products but lacking a Business Registration Certificate must complete the necessary procedures according to the law.

1.1.2. Foreign enterprises with permits to operate in the field of vaccines, medical biological products, and vaccine production raw materials in Vietnam may supply vaccines and medical biological products to Vietnamese enterprises importing vaccines and medical biological products within the scope specified in their permits.

1.1.3. Importing enterprises, using units, and research units bear full legal responsibility for the quality and safety of imported products and their activities.

1.1.4. Vaccines and medical biological products within the list of items imported based on demand must still have at least two-thirds of their shelf life remaining from the date of arrival in Vietnam. In special cases, the Ministry of Health may consider allowing the importation of vaccines and medical biological products with shorter remaining shelf lives.

1.1.5. Semi-finished vaccines and medical biological products imported can only be supplied to facilities with the function and conditions to produce vaccines and medical biological products for production purposes.

1.1.6. After being formulated, packaged, etc., into finished products, semi-finished vaccines and medical biological products must obtain a registration certificate from the Ministry of Health before being marketed and must undergo the same dispatch procedures as domestically produced products.

1.2. Procedures for submitting export documentation and samples for testing

1.2.1. Import enterprises must submit export documentation and samples of the imported batch to the National Institute for Testing of Vaccines and Medical Biological Products, including:

1.2.1.1. Test samples (quantity according to regulations for each type of vaccine and medical biological product).

1.2.1.2. Sample submission form.

1.2.1.3. Summary production and testing documentation of the imported batch of vaccines and medical biological products (copy stamped with confirmation by the manufacturer).

1.2.1.4. Export permit of the competent authority of the country of origin or equivalent authority attached to each imported batch (copy stamped with confirmation by the importer's enterprise director).

1.2.1.5. Evidence ensuring cold chain during the transportation of the imported batch.

1.2.2. After customs clearance, vaccines and medical biological products shall be stored in the warehouse of the enterprise in accordance with regulations and may only be released for use upon receipt of a document from the National Institute of Vaccines and Medical Biological Products confirming that the imported batch of vaccines and medical biological products meets safety standards on animal testing (for finished vaccines and medical biological products used for treatment) or a document confirming receipt of samples and files (for finished medical biological products used for diagnosis and semi-finished products).

1.2.3. For finished vaccines and medical biological products used for treatment, within seven working days from the date of receiving samples and files as stipulated in Section 1.2.1 above, the National Institute of Vaccines and Medical Biological Products must issue a document regarding the safety of vaccines and medical biological products on animal testing to the enterprise. For finished medical biological products used for diagnosis and semi-finished products, within three working days from the date of receiving samples and files as stipulated, the National Institute of Vaccines and Medical Biological Products must issue a document confirming receipt of samples and files to the enterprise.

1.2.4. Within ten days from the date of importation, the importing enterprise shall submit a report on imports to the Ministry of Health (Vietnam Preventive Medicine Department), including the type and quantity of imported vaccines and medical biological products for each imported consignment.

2. IMPORTED VACCINES AND MEDICAL BIOLOGICAL PRODUCTS MUST OBTAIN A LICENSE

2.1. Conditions

2.1.1. Merchants and organizations engaged in the business of vaccines and medical biological products must have a Certificate of Business Registration. Enterprises currently importing vaccines and medical biological products but not yet holding such a certificate must complete these procedures in accordance with the law.

2.1.2. Organizations with functions to research vaccines and medical biological products may import vaccines and medical biological products for their research work.

2.1.3. Representative offices and branches of foreign enterprises in Vietnam are only permitted to import samples of vaccines and medical biological products for registration purposes.

2.1.4. Merchants and organizations bear full responsibility under the law for the quality and safety of imported products and their activities.

2.2. Application Documents and Licensing Procedures

2.2.1. Imported vaccines and medical biological products for special cases (to serve disease prevention and treatment and for specific groups, foreigners living and working in Vietnam, Vietnamese traveling, studying, and working in countries where these diseases are prevalent)

2.2.1.1. Documents:

- Application for permission to import vaccines and medical biological products

- Quantity and type requirements of vaccines and medical biological products and vaccination targets of the vaccination facility.

- Commitment of the vaccination facility to use, store, and vaccinate with vaccines and medical biological products according to purpose, target group, and indications, and to take responsibility for the use of these vaccines and medical biological products (Annex 1).

- Commitment of the distribution company and manufacturer to ensure the quality of vaccines and medical biological products supplied to Vietnam (Annex 2).

- Commitment of the importing company to import, store, and transport vaccines and medical biological products in compliance with regulations (Annex 3).

- Additional documents (if any) include: Certificate of Good Manufacturing Practice (GMP) of the production facility in the country of origin, License for circulation of vaccines and medical biological products in the country of origin, License for circulation in other countries where these vaccines and medical biological products have been registered and circulated.

2.2.1.2. Procedure:

- The merchant or organization applying for import permission shall submit the application documents to the Ministry of Health (Vietnam Preventive Medicine Department).

- Within fifteen working days from the date of receipt of complete and valid documents, the Ministry of Health (Vietnam Preventive Medicine Department) will review and respond in writing regarding approval or disapproval of the import license and any requests for submission of samples and documents to the National Institute of Vaccines and Medical Biological Products as necessary in accordance with Clause II.1.2 of this Circular.

2.2.2. Imported vaccines and medical biological products for testing, field trials, and sample registration (only for registration purposes, not for other uses)

2.2.2.1. Documents:

- Official letter requesting import of test samples, field trial samples, and storage samples

- Written requirements of the testing and field trial agency

2.2.2.2. Procedure:

- The merchant or organization applying for import permission shall submit the application documents to the Ministry of Health (Vietnam Preventive Medicine Department).

- Within fifteen working days from the date of receipt of complete and valid documents, the Ministry of Health (Vietnam Preventive Medicine Department) will review and respond in writing regarding approval or disapproval of the import license.

2.2.3. Imported vaccines and medical biological products for research and project use (only for research purposes at research facilities and project implementation units, not for other uses)

2.2.3.1. Documents:

- Official letter requesting import

- Approval document from the competent authority allowing the implementation of the research project and approved research outline (for projects with approvals)

2.2.3.2. Procedure:

- The merchant or organization applying for import permission shall submit the application documents to the Ministry of Health (Vietnam Preventive Medicine Department).

- Within fifteen working days from the date of receipt of complete and valid documents, the Ministry of Health (Vietnam Preventive Medicine Department) will review and respond in writing regarding approval or disapproval of the import license.

2.2.4. Imported vaccines and medical biological products for national programs or aid (must be included in the list recommended for use by the World Health Organization)

2.2.4.1. Documents:

- Certificate from the competent authority of the country of origin allowing circulation or export of vaccines and medical biological products.

- Certificate of Good Manufacturing Practice (GMP) of the production facility in the country of origin.

- Test report meeting quality standards of vaccines and medical biological products issued by the national testing agency of the country of origin or another authorized agency for the imported consignment (with confirmation of true copy by the importing enterprise).

2.2.4.2. Procedure:

- The documents shall be submitted to the National Institute of Vaccines and Medical Biological Products.

- Upon receipt of the required documents, the National Institute of Vaccines and Medical Biological Products will conduct cold chain checks, collect samples for storage, and evaluate vaccines and medical biological products according to the following requirements:

a. Laboratory safety tests with conclusions meeting the prescribed standards.

b. Field safety tests on humans with conclusions meeting the prescribed standards.

As for vaccines and medical products without circulation registration numbers provided by international organizations that have regularly cooperated with Vietnam in the health sector such as WHO, UNICEF, etc., in emergency cases, the National Institute of Vaccines and Medical Products shall conduct cold chain checks and take samples for storage and laboratory safety testing on a case-by-case basis.

- After reviewing the above documents and with satisfactory inspection and testing results meeting the prescribed standards, the National Institute of Vaccines and Medical Products shall issue a letter to the Ministry of Health (Department of Preventive Medicine) requesting permission for the recipient organization to import and use the donated vaccines and medical products.

- Within fifteen working days from the date of receipt of the request from the National Institute of Vaccines and Medical Products, the Ministry of Health (Department of Preventive Medicine) shall issue a document agreeing or disagreeing to grant the permit.

- After importation, the importer must print or affix the phrase "donated vaccine (medical product), not for sale" or "vaccine (medical product) under national program, not for sale" on the outer packaging of the product.

2.2.5. Raw materials, packaging materials, and auxiliary materials for producing vaccines and medical products (only allowed to be imported to supply to production facilities that meet the conditions for producing vaccines and medical products).

2.2.5.1. Documentation:

- Official letter requesting import

- Written requirements from the production facility.

2.2.5.2. Procedures:

- The trader or organization applying for import permission shall submit the documentation to the Ministry of Health (Department of Preventive Medicine).

- Within fifteen working days from the date of receipt of complete and valid documents, the Ministry of Health (Vietnam Preventive Medicine Department) will review and respond in writing regarding approval or disapproval of the import license.

III. REGULATIONS ON IMPORT OF CHEMICALS AND PESTICIDES, DISINFECTANTS USED IN DOMESTIC AND HEALTH SECTORS (hereinafter referred to as chemicals and formulations)

1. CHEMICALS AND FORMULATIONS THAT DO NOT REQUIRE A PERMIT FOR IMPORTATION

Chemicals and formulations with a valid registration certificate issued by the Department of Preventive Medicine - Ministry of Health can be imported according to demand without quantity or value restrictions, with customs procedures only, and without approval from the Ministry of Health. The importing enterprise bears full responsibility under the law for its activities.

Chemicals and formulations for pest control and disinfection in domestic and health sectors listed for importation based on demand must still have at least two-thirds of their shelf life remaining from the date of arrival in Vietnam. In special cases, the Ministry of Health may consider allowing the importation of chemicals and formulations for pest control and disinfection in domestic and health sectors with shorter remaining shelf lives than specified.

2. CHEMICALS AND FORMULATIONS THAT REQUIRE A PERMIT FOR IMPORTATION

2.1. Chemicals and formulations not yet registered for circulation that are imported as raw materials for production

2.1.1. Documentation:

- Import application form (Annex 4)

- Certified copy of business registration certificate.

- Quality, safety, and efficacy commitment for chemicals (Annex 5).

- Certified copy of registration certificate for chemicals and formulations produced using the imported chemicals.

- Plan for using the imported chemicals and formulations.

2.1.2. Procedures:

- The trader or organization applying for importation shall submit the documentation to the Ministry of Health (Department of Preventive Medicine).

- Within fifteen working days from the date of receiving complete and valid documentation, the Ministry of Health (Department of Preventive Medicine) shall issue a document granting or denying permission to import.

2.2. Chemicals and formulations imported for testing and quality control (after being approved for testing in Vietnam by the Ministry of Health)

2.2.1. Documentation:

- Import application form (Annex 6)

2.2.2. Procedures:

- The trader or organization applying for importation shall submit the documentation to the Ministry of Health (Department of Preventive Medicine).

- Within fifteen working days from the date of receiving complete and valid documentation, the Ministry of Health (Department of Preventive Medicine) shall issue a document granting or denying permission to import.

2.3. Chemicals and formulations without registration numbers imported for research, donation, or other specific purposes

2.3.1. Documentation:

- Application for import permit (Annex 6)

- Certified copy of business registration certificate or other documents proving the legal status of the importing entity.

- Quality, safety, and efficacy commitment for chemicals and formulations (Annex 5).

- Technical documentation for chemicals and formulations

- Research outline (for chemicals and formulations imported for research) or documentation explaining the purpose of using the imported chemicals and formulations (for chemicals and formulations imported for specific purposes).

- Additional documents (if any) including: GMP, ISO certificates of the manufacturing plant, registration permits for chemicals and formulations in the country of origin, and registration permits in other countries where these chemicals and formulations have been sold.

2.3.2. Procedures:

- The trader or organization applying for importation shall submit the documentation to the Ministry of Health (Department of Preventive Medicine).

- Within fifteen working days from the date of receiving complete and valid documentation, the Department of Preventive Medicine shall issue a document granting or denying permission to import.

1. Medical devices listed in Appendix 7 of this Circular

1.1. Conditions:

Traders wishing to import medical devices listed in Appendix 7 must ensure the following conditions:

1.1.1. Complete legal documentation of the trader in accordance with the Enterprise Law or the Cooperative Law, or the Investment Law in Vietnam.

1.1.2. Have a technical staff team and infrastructure meeting the requirements:

- The person primarily responsible for technology must hold one of the following degrees: a bachelor's degree in biomedical engineering; a bachelor's degree in engineering; a bachelor's degree in medicine or pharmacy and a training certificate in medical device technology from a legitimate training institution for medical device technology or an equivalent certificate from abroad, with a minimum duration of one month.

- For those holding the aforementioned degrees and having worked directly in medical equipment technology or management in healthcare facilities for three years or more, confirmed by the head of the workplace, they do not need to have a specialized training certificate in medical device technology.

- Have technical staff capable of guiding installation, warranty, and maintenance of medical devices sold by the trader (trained annually by the equipment manufacturer).

- Regarding technical infrastructure:

Having a suitable headquarters and warehouse that meet the conditions for properly storing medical equipment, possessing all necessary tools and technical equipment to carry out installation, warranty, and maintenance work on medical equipment; having sufficient fire prevention and explosion protection facilities and ensuring environmental safety in accordance with the provisions of the law.

- Application for importing medical equipment (Annex 8)

- Relevant documents as specified in Point 1.1, Clause 1, Section IV

- Accompanying documents include: Catalogues (originals) of each type of equipment; Quality Management Certificates of the manufacturer ISO-9001, ISO 14.000 or equivalent; Product registration certificates at the country of manufacture (Annex 9).

1.3. Procedures:

- The application for importing medical equipment shall be submitted to the Ministry of Health (Medical Equipment and Construction Department - the permanent unit) for consolidation, presentation to the council for review and issuance of import permits within fifteen working days from the date of receipt of complete and valid applications.

- Importers granted permits must pay the import fee as stipulated in Decision No. 44/2005/QD-BTC dated July 12, 2005 issued by the Ministry of Finance.

Medical equipment not listed in Annex 7 but which applies new diagnostic and treatment methods and is being imported into Vietnam for the first time must obtain an import permit from the Ministry of Health. In addition to the conditions, application materials, and procedures for obtaining an import permit as prescribed in Clause 1, Section IV of this Circular, the medical equipment seeking importation must have results of clinical trial evaluations and be reviewed and approved by the Scientific and Technological Council of the Ministry of Health before being permitted to import.

V. IMPLEMENTATION

1. The Ministry of Health announces the list of vaccines, medical products, and insecticides, disinfectants for household and medical use that can be imported based on demand. Annually, the Ministry of Health reviews, supplements, and adjusts the list of medical equipment in Annex 7 to suit current circumstances.

2. The National Center for Preventive Medicine within its jurisdiction receives applications and issues import permits for vaccines, medical products, and insecticides, disinfectants for household and medical use. The Medical Equipment and Construction Department, a permanent unit of the Ministry of Health, is responsible for consolidating, presenting to the council for review, and issuing import permits for medical equipment.

3. The Health Inspection Department of the Ministry of Health collaborates with relevant departments and agencies under the Ministry of Health to conduct inspections and audits nationwide on activities related to the business and importation of vaccines, medical products, insecticides, and disinfectants for household and medical use, and medical equipment.

4. Provincial Health Departments implement inspections and audits of activities related to the business and importation of vaccines, medical products, insecticides, and disinfectants for household and medical use, and medical equipment in their respective localities.

5. The National Institute for Vaccine and Biomedicine Quality Control - Ministry of Health bases on accompanying documents sent with the imported consignment, retained samples, and registered quality standards to perform functions of inspecting and monitoring the quality of circulating vaccines and medical products.

6. Entities using vaccines and medical products are responsible for the use of these vaccines and products and report periodically and urgently on vaccine usage: side effects, adverse events due to vaccine use, and other unusual situations during use.

7. Importers, organizations engaged in the import, sale, and research of vaccines, medical products, insecticides, and disinfectants for household and medical use are responsible for strictly implementing the provisions of the law and bearing responsibility for their own activities.

8. Quarterly, importers and organizations report to the Ministry of Health (National Center for Preventive Medicine) on the situation of importing vaccines, medical products, insecticides, and disinfectants for household and medical use; report to the Medical Equipment and Construction Department on the situation of importing medical equipment.

VI. IMPLEMENTATION PROVISIONS

1. This Circular takes effect fifteen days after its publication in the Official Gazette. It abolishes Circular No. 09/2001/TT-BYT dated May 21, 2001 of the Ministry of Health guiding the implementation of vaccine and immunological product export and import for the period 2001-2005; Circular No. 06/2003/TT-BYT dated May 15, 2003 of the Ministry of Health guiding the management and use of vaccines and medical products without circulation registration numbers provided as aid in emergency cases or imported into Vietnam for special purposes; Circular No. 13/2001/TT-BYT dated June 18, 2001 of the Ministry of Health guiding the export and import of insecticides and disinfectants for household and medical use for the period 2001-2005; and Circular No. 06/2002/TT-BYT dated May 30, 2002 of the Ministry of Health "Guidelines for Export and Import of Medical Equipment Under Specialized Sector Management for the Period 2002-2005."

2. The National Center for Preventive Medicine, the Medical Equipment and Construction Department, the Health Inspection Department, the National Institute for Vaccine and Biomedicine Quality Control, provincial health departments, entities using vaccines and medical products, importers and organizations engaged in the importation of vaccines, medical products, insecticides, and disinfectants for household and medical use, and medical equipment are responsible for strictly implementing the provisions of this Circular.

3. During implementation, if there are difficulties or obstacles, please contact relevant departments and agencies under the Ministry of Health for consideration and resolution./.