Circular No. 18/1999/TT-BYT guides the implementation of organizing the issuance of Circulation Registration Certificates, Production Standards Certificates, and Business Conditions Certificates for chemicals, insecticides, and bactericides used in household and medical fields.

CIRCULAR

Guidelines for Implementing the Issuance of Certificates of Registration for Circulation, Certificates of Compliance with Standards and Conditions for Production and Business of Chemicals, Insecticides, and Disinfectants Used in Household and Medical Fields

To implement the Regulation on Management of Chemicals, Insecticides, and Disinfectants Used in Household and Medical Fields issued together with Decision No. 1654/1999/QĐ-BYT dated May 29, 1999 of the Minister of Health, the Ministry of Health provides guidelines for implementing the organization of issuing Certificates of Registration for Circulation, Certificates of Compliance with Standards and Conditions for Production, Business, and Import-Export of Chemicals, Insecticides, and Disinfectants Used in Household and Medical Fields as follows:

I. ORGANIZATION OF ISSUING CERTIFICATES OF REGISTRATION FOR CIRCULATION OF CHEMICALS, INSECTICIDES, AND DISINFECTANTS USED IN HOUSEHOLD AND MEDICAL FIELDS (HEREINAFTER REFERRED TO AS CHEMICALS, INSECTICIDES, AND DISINFECTANTS FOR HOUSEHOLD AND MEDICAL USE)

A. DOCUMENTATION:

1. Documentation for registration of trials:

As stipulated in Article 24, Section 2 of the Regulation on Management of Chemicals, Insecticides, and Disinfectants for Household and Medical Use.

2. Documentation for registration of circulation:

The documentation specified in this section applies to formal registration, re-registration, and supplementary registration, including:

a. According to Form No. 4 in the Appendix accompanying the Regulation on Management of Chemicals, Insecticides, and Disinfectants for Household and Medical Use.

b. For domestically produced chemicals, insecticides, and disinfectants for household and medical use, additional copies of certified true copies of industrial property rights certificates (if any) issued by the National Office of Intellectual Property, transfer agreements, and other certificates protecting industrial property rights in Vietnam (if any) must be provided.

c. For imported chemicals, insecticides, and disinfectants for household and medical use, additional documents confirming that the chemicals, insecticides, and disinfectants for household and medical use being registered have been registered for use in another country must be provided.

B. PROCEDURES:

1. Businesses and trading establishments wishing to register trials or circulation of chemicals, insecticides, and disinfectants for household and medical use must submit the registration documentation to the Ministry of Health (Preventive Medicine Department).

2. Chemicals, insecticides, and disinfectants for household and medical use with valid registration numbers not issued by the Ministry of Health must submit documentation requesting a change of registration number to the Ministry of Health (Preventive Medicine Department).

3. The Preventive Medicine Department of the Ministry of Health will organize the receipt of documentation and present it to the Review and Approval Council for Chemicals, Insecticides, and Disinfectants for Household and Medical Use.

4. Within sixty days from the date of receiving complete documentation as prescribed, the Ministry of Health will issue a Certificate of Registration for Circulation of Chemicals, Insecticides, and Disinfectants for Household and Medical Use or refuse issuance, providing reasons if refusal occurs.

C. AUTHORITY TO ISSUE CERTIFICATES OF REGISTRATION FOR CIRCULATION:

1. The Minister of Health delegates authority to the Director of the Preventive Medicine Department to examine and issue Certificates of Registration for Circulation of Chemicals, Insecticides, and Disinfectants for Household and Medical Use based on the recommendation of the Review and Approval Council for Chemicals, Insecticides, and Disinfectants for Household and Medical Use.

2. The Certificate of Registration for Circulation will be suspended or revoked in the following cases:

a. Chemicals, insecticides, and disinfectants for household and medical use circulating in the market do not conform to the registration documentation.

b. Chemicals, insecticides, and disinfectants for household and medical use circulating in the market are substandard and do not meet the standards and quality as registered.

3. The Certificate of Registration for Circulation of Chemicals, Insecticides, and Disinfectants for Household and Medical Use is valid for five years from the date of issuance. Thirty days before expiration, businesses and trading establishments must resubmit the application for issuance of the Certificate of Registration for Circulation according to current regulations.

II. ORGANIZATION OF ISSUING CERTIFICATES OF COMPLIANCE WITH STANDARDS AND CONDITIONS FOR PRODUCTION OF INSECTICIDES AND DISINFECTANTS FOR HOUSEHOLD AND MEDICAL USE

A. DOCUMENTATION:

As stipulated in Article 12 of the Regulation on Management of Chemicals, Insecticides, and Disinfectants for Household and Medical Use.

B. PROCEDURES:

1. Businesses wishing to obtain a Certificate of Compliance with Standards and Conditions for Production of Insecticides and Disinfectants for Household and Medical Use must submit two sets of documentation: one set submitted to the Ministry of Health (Preventive Medicine Department), and one set submitted to the Provincial Health Department where the business's production facility is located.

2. Within fifteen days from the date of receiving complete documentation as prescribed, the Ministry of Health will issue a letter assigning the Provincial Health Department (where the business's production facility is located) to assess the conditions for production and processing of chemicals, insecticides, and disinfectants for household and medical use.

3. Within forty days from the date of receiving the request for assessment from the Ministry of Health, the Provincial Health Department must organize the assessment and send the results along with a letter recommending issuance of the Certificate of Compliance with Standards and Conditions for Production and Processing of Chemicals, Insecticides, and Disinfectants for Household and Medical Use to the Ministry of Health (Preventive Medicine Department).

4. The Preventive Medicine Department of the Ministry of Health will organize the receipt of documentation (if necessary, may conduct reassessment) and present it to the Review and Approval Council for Chemicals, Insecticides, and Disinfectants for Household and Medical Use.

5. Within four months from the date of receiving complete documentation as prescribed, the Ministry of Health will issue a Certificate of Compliance with Standards and Conditions for Production and Processing of Chemicals, Insecticides, and Disinfectants for Household and Medical Use, or refuse issuance, providing reasons if refusal occurs.

6. Production facilities that have obtained a Certificate of Compliance with Standards and Conditions for Production and Processing of Chemicals, Insecticides, and Disinfectants for Household and Medical Use with remaining validity but not issued by the Ministry of Health must submit documentation requesting a change of certificate to the Ministry of Health (Preventive Medicine Department).

C. AUTHORITY TO ISSUE CERTIFICATES:

1. The Minister of Health delegates authority to the Director of the Preventive Medicine Department of the Ministry of Health to examine and issue Certificates of Compliance with Standards and Conditions for Production of Insecticides and Disinfectants for Household and Medical Use based on the recommendation of the Review and Approval Council for Chemicals, Insecticides, and Disinfectants for Household and Medical Use.

2. The Certificate of Compliance with Standards and Conditions for Production and Processing of Chemicals, Insecticides, and Disinfectants for Household and Medical Use will be suspended or revoked when the enterprise violates any of the following circumstances:

a. Producing chemicals, insecticides, disinfectants for household and medical use that are substandard and fail to meet quality standards.

b. Producing chemicals, insecticides, disinfectants for household and medical use using raw materials that have not been tested.

c. Producing chemicals, insecticides, disinfectants for household and medical use without registration numbers (Registration Certificate).

3. The certificate of compliance with production and processing standards for chemicals, insecticides, disinfectants for household and medical use shall be issued once.

III. ORGANIZATION ISSUING THE CERTIFICATE OF COMPLIANCE WITH BUSINESS CONDITIONS (TRADE) FOR CHEMICALS, INSECTICIDES, DISINFECTANTS FOR HOUSEHOLD AND MEDICAL USE

This certificate applies to the business (trade) of chemicals, insecticides, disinfectants for household and medical use.

A. REGISTRATION REQUIREMENTS:

1. For businesses trading (selling) insecticides, disinfectants for household and medical use:

a. Must be a trader.

b. Management and technical staff must meet one of the following conditions:

- Bachelor's degree in preventive medicine, medical entomology, plant protection.

- Certificate of having participated in training courses on chemical products, insecticides, disinfectants for household and medical use for at least three months, issued by universities, institutes of hygiene and epidemiology, Pasteur Institutes.

c. Must have retail stores, warehouses, and specialized transportation means for transporting chemicals, insecticides, disinfectants for household and medical use.

d. Direct business personnel must have a health certificate issued by a district or higher-level health authority.

e. Must have necessary equipment to ensure fire prevention, explosion prevention, occupational safety, and environmental sanitation requirements.

2. For business establishments (individuals and groups registered to conduct business under current laws):

a. Must be a trader.

b. The owner of the business establishment or the person directly responsible for business operations must meet one of the following conditions:

- Certificate of having participated in training courses on chemical products, insecticides, disinfectants for household and medical use for at least one month, issued by preventive medicine centers, provincial plant protection agencies.

- High school or bachelor's degree in preventive medicine, medical entomology, plant protection.

c. Must have retail stores and equipment to ensure the operation of trading chemicals, insecticides, disinfectants for household and medical use.

d. Must have a health certificate issued by a district or higher-level health authority.

e. Must have necessary equipment to ensure fire prevention, explosion prevention, occupational safety, and environmental sanitation requirements.

B. DOCUMENTATION:

1. For Enterprises:

a. Application for issuance of the Certificate of Compliance with Business Conditions for Chemicals, Insecticides, Disinfectants for Household and Medical Use.

b. Business Registration Certificate.

c. Certificate of having participated in training courses on chemical products, insecticides, disinfectants for household and medical use for at least three months or bachelor's degree in preventive medicine, medical entomology, plant protection.

d. Health certificate issued by the competent health authority.

e. Environmental impact assessment certificate issued by the Department of Science and Industry and Environment.

2. For business establishments:

a. Application for issuance of the Certificate of Compliance with Business Conditions for Chemicals, Insecticides, Disinfectants for Household and Medical Use.

b. Business registration certificate.

c. Certificate of having participated in training courses on chemical products, insecticides, disinfectants for household and medical use for at least one month or high school or bachelor's degree in preventive medicine, medical entomology, plant protection.

d. Health certificate issued by the competent health authority.

c. PROCEDURE:

1. Businesses wishing to engage in the trade of chemicals, insecticides, disinfectants for household and medical use must submit an application for the Certificate of Compliance with Business Conditions for Chemicals, Insecticides, Disinfectants for Household and Medical Use to the Provincial Health Department where the business location or headquarters is located.

2. The Provincial Health Department will organize the receipt, review, and issue the Certificate of Compliance with Business Conditions for Chemicals, Insecticides, Disinfectants for Household and Medical Use within sixty days from the date of receiving complete and valid documentation. If the application is denied, the reasons must be stated in writing and sent to the applicant.

D. AUTHORITY TO ISSUE THE CERTIFICATE:

1. The Provincial Health Department issues the Certificate of Compliance with Business Conditions for Chemicals, Insecticides, Disinfectants for Household and Medical Use to businesses within its jurisdiction. The validity period of the Certificate of Compliance with Business Conditions for Chemicals, Insecticides, Disinfectants for Household and Medical Use is five years for businesses and three years for business establishments from the date of issuance. If the certificate expires without renewal, the Provincial Health Department may extend it (as detailed on page 3 of the extension certificate). The extension period shall not exceed sixty days.

2. The Certificate of Compliance with Business Conditions for Chemicals, Insecticides, Disinfectants for Household and Medical Use will be suspended or revoked if the business establishment or enterprise violates any of the following cases:

a. Trading chemicals, insecticides, disinfectants for household and medical use that are not included in the list of chemicals, insecticides, disinfectants for household and medical use approved for circulation by the Ministry of Health...

b. Trading chemicals, insecticides, disinfectants for household and medical use without registration numbers issued by the Ministry of Health.

In special cases not covered by the Management Regulations for Chemicals, Insecticides, Disinfectants for Household and Medical Use and this Circular, the Provincial Health Department must report in writing to the Ministry of Health and can only issue the Certificate of Compliance with Business Conditions when approved in writing by the Ministry of Health.

Enterprises already holding a Certificate of Compliance with Business Conditions for Chemicals, Insecticides, Disinfectants for Household and Medical Use that are still valid but not issued by the Ministry of Health must submit an application for replacement at the Ministry of Health (Preventive Medicine Department).

IV. PROVISIONS ON FEES AND CHARGES

Collection, management, and use of fees and charges for issuing the Registration Certificate, Certificate of Compliance with Production and Processing Standards, Certificate of Compliance with Business Conditions, and Import-Export Certificates shall be carried out according to current regulations.

V. INSPECTION AND AUDIT

1. The Ministry of Health assigns the Preventive Medicine Department to coordinate with the specialized inspection agency of the Ministry of Health (Sanitation Inspection) to organize inspections and audits of the implementation of this Circular throughout the country. The Health Departments are responsible for organizing inspections and audits of the implementation of this Circular within their jurisdictional areas. The Ministry of Health’s Inspection Agency and the Health Departments’ Inspection Agencies have the authority to impose administrative penalties according to the provisions of the Law.

2. The Health Departments are tasked with reporting in writing to the Ministry of Health when they discover establishments or enterprises producing, processing, or trading chemicals, insecticides, and disinfectants for household and medical use that violate any of the following situations:

a. Chemicals, insecticides, and disinfectants for household and medical use circulating in the market without registration numbers (Registration Certificate).

b. Chemicals, insecticides, and disinfectants for household and medical use circulating in the market being substandard and failing to meet quality standards as registered.

VII. IMPLEMENTATION PROVISIONS

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./.

The Preventive Medicine Department is responsible for coordinating with relevant departments, the Ministry of Health’s Inspection Agency to implement, guide, inspect, evaluate, and compile information on the implementation of this Circular to report to the Minister of Health.

Provincial and centrally-administered city Health Departments are responsible for coordinating with related agencies at the local level to organize the implementation of this Circular within their jurisdictional areas and report the results of its implementation to the Ministry of Health (Preventive Medicine Department) as prescribed.

Organizations and individuals producing or trading chemicals, insecticides, and disinfectants for household and medical use that violate the provisions of this Circular may be subject to legal action depending on the severity of the violation.

During the implementation process, if there are difficulties or obstacles, they must be reported to the Ministry of Health (Preventive Medicine Department) for research and timely resolution.