Decision No. 3486/2001/QĐ-BYT on the issuance of regulations for the management of chemicals and insecticides for pest control and disinfection in the medical field.

DECISION OF THE MINISTER OF HEALTH

Regarding the issuance of regulations on the management of chemicals and insecticides in the field of pest control and bactericidal agents used in healthcare

Citing the Law on Health Protection for the People dated July 11, 1989;

 

THE MINISTER OF HEALTH

Citing Decree No. 68/

dated October 11, 1993 of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry dated October 20, 2015 of Citing Decision No. 197/1998/QĐ-TTg dated October 10, 1998 of the Prime Minister entrusting the Ministry Y the proposal of the Minister of Planning and Investment;

of Health with the responsibility to manage state affairs regarding chemicals, insecticides, and bactericidal agents used in household and healthcare sectors; Y Citing the Enterprise Law and guiding legal documents implementing the Enterprise Law;

Citing the State Enterprise Law and guiding legal documents implementing the State Enterprise Law;

After receiving the agreement from the Office of the Government at Official Letter No. 1 VPCP-VX dated June 29, 2001, and the concurrence of the Ministry of Trade at Official Letters No. 2319/TM-CSTNTN dated May 23, 2000, and No. 4706/TM-CSTNTN dated October 24, 2000; the Ministry

of Agriculture and Rural Development at Official Letter No. 1467/BNN-BVTV dated May 5, 2000; the Ministry of Science, Technology, and Environment at Official Letter No. 1146/BKHCNMT-NN; of Preventive Medicine - Ministry

At the proposal of the Head of the Y of Health, Y herein,

 

DECISION:

Article 1. Issued along with this Decision are the Regulations on Management of Chemicals, Insecticides, and Bactericidal Agents Used in Household and Healthcare Sectors:

Article 2. This Decision shall take effect fifteen days after its date of issuance and shall replace Decision No. 1654/1999/QĐ-BYT dated May 29, 1999 of the Minister of Health on the issuance of the Regulations on Management of Chemicals, Insecticides, and Bactericidal Agents Used in Household and Healthcare Sectors, Circular No. 18/1999/TT-BYT dated September 20, 1999 of the Ministry of Health guiding the implementation of organization and issuance of Registration Certificates for Circulation, Certificates of Compliance with Standards and Conditions for Production and Business of Chemicals, Insecticides, and Bactericidal Agents Used in Household and Healthcare Sectors.

Article 3. The Heads of the Office, the Inspectorate, the Department of Preventive Medicine, and other Departments under the Ministry of Health, the Director of the Vietnam National Pharmaceutical Administration, the Director of the Quality Control, Sanitation, and Food Safety Bureau; the Heads of units directly under the Ministry; the Directors of Provincial Health Services; and the Heads of establishments producing, trading in chemicals, insecticides, and bactericidal agents used in household and healthcare sectors are responsible for enforcing this Decision.

 

REGULATIONS ON MANAGEMENT OF CHEMICALS, INSECTICIDES, AND BACTERICIDAL AGENTS USED IN HOUSEHOLD AND HEALTHCARE SECTORS

(Issued along with Decision No. 3486/2001/TTg dated November 7, 2002 of the Prime Minister).BYT dated August 13, 2001

of the Minister of Health)

 PART I

GENERAL PROVISIONS

Article 1These Regulations specify conditions for production, trade; testing; registration for circulation; storage; destruction; advertising; labeling, packaging, and importation of chemicals, insecticides, and bactericidal agents; chemicals and products with cleaning, sanitizing, and deodorizing effects used in household and healthcare sectors (hereinafter referred to as chemicals, insecticides, and bactericidal agents).

Article 2. Establishments producing, trading, importing, and organizations registering for circulation, storage, and advertising of chemicals, insecticides, and bactericidal agents within the territory of Vietnam must comply with these Regulations. In cases where international treaties to which Vietnam is a party provide different provisions, such treaties shall be applied.

Article 3: Chemicals, insecticides, and bactericidal agents regulated under these Regulations include:

1. Chemicals and products with effects of killing, limiting, repelling, or attracting various types of medical pests used in household and healthcare sectors.

2. Chemicals and products with bactericidal effects used in household and healthcare sectors.

3. Chemicals and products primarily used for cleaning, sanitizing, and deodorizing in household and healthcare sectors.

Article 4. Annually, the Minister of Health shall issue a list of chemicals and products for insecticides and bactericidal agents permitted for registration and use, those permitted but restricted in use, and those prohibited for use in household and healthcare sectors within the territory of Vietnam.

Chemicals and products for insecticides and bactericidal agents not included in the annual list will be reviewed individually by the Ministry of Health.

Article 5. In this Regulation, the following terms are understood as follows:

1. Active substance is a chemical substance with activity in chemicals and products for insecticides and bactericidal agents:

2. Chemicals is a chemical substance containing active substance concentration used for processing and manufacturing products or used directly.

3. Product is a product produced according to a technological process recognized by competent state authorities, meeting quality standards, and having a brand name as prescribed.

4. Testing Testing issued.

5. is a biological evaluation process to assess efficacy and safety of chemicals and products for insecticides and bactericidal agents according to a specified procedure by the Ministry ADJUSTMENT of Health.

6. Registration for circulation is the process of evaluating efficacy and safety of chemicals and products for insecticides and bactericidal agents and the legality of registration files to allow circulation through issuing a Registration Certificate for Circulation.

Article 6. Accounting Y of Preventive Medicine - Ministry of Health is responsible for advising the Ministry 2.The Project Management Board shall provide comments on the adjustmentrequest of the project owner and submit to the Planning Department for thePlanning Department to review or organize an assessment. of Health on managing state affairs concerning chemicals and products for insecticides and bactericidal agents nationwide.

Foreign-invested traditional medicine healthcare facilities and foreigners practicing traditional medicine in Vietnam must fully comply with the provisions of this Circular and other relevant legal provisions; if they violate, they will be handled according to current regulations; if they cause damage to patients, they must compensate for the damage according to Vietnamese law: of Health of provinces directly under the Central Government (hereinafter collectively referred to as provinces) is responsible for advising provincial People's Committees on managing state affairs concerning chemicals and products for insecticides and bactericidal agents locally.

Article 7. Fees for the examination and approval of testing, granting registration certificates for circulation of chemicals and products for insecticides and bactericidal agents shall be collected in accordance with laws on fees and charges.

 PART II

PROVISIONS ON CONDITIONS FOR PRODUCTION AND TRADE OF CHEMICALS,

PRODUCTS FOR INSECTICIDES, AND BACTERICIDAL AGENTS

Article 8. Establishments producing and trading in chemicals and products for insecticides and bactericidal agents may only produce and trade in chemicals and products for insecticides and bactericidal agents that have been issued a Registration Certificate for Circulation by the Ministry of Health in Vietnam.

Article 9. Cơ A chemical production establishment must meet the following conditions:

1. The person in charge of production must have a university degree related to the field of chemicals and products for insecticides and bactericidal agents being produced.

2. A technical staff with appropriate qualifications and capabilities to meet production requirements.

3. Individuals directly involved in production must have a Health Certificate issued by a health authority at the district level or higher.

4. The production technology process must be appropriate and ensure product quality.

5. Commit to complying with environmental laws and bear legal responsibility if violated.

6. Develop contingency plans and equip necessary means to handle emergencies such as fire, explosion, natural disasters, typhoons, floods, work accidents, poisoning... and long-term impacts on people and the surrounding environment.

7. Provide all necessary protective equipment for individuals directly involved in production according to legal regulations.

8. Ensure full compliance with labor hygiene standards stipulated in Certain Temporary Standards on Hygiene issued together with Decision No. 505/BYT-QĐ dated April 13, 1992 of the Minister of Health, and hygiene regulations under the Law on Protecting Public Health and the Sanitation Regulations issued together with Decree No. 23-HĐBT dated January 24, 1991 of the Council of Ministers. Production facilities for chemicals, insecticides, and bactericides may only commence production when they meet the conditions specified in Article 9 of this Regulation and the facility owner has submitted a commitment to the Ministry of Health. An Inspector is a person assigned to perform inspection duties at theeducation inspection organization, appointed in accordance with the InspectorRegulation issued pursuant to Decree No. 191/HĐBT dated June 18, 1991 of theCouncil of Ministers

Article 10. Cơ For chemicals and products primarily used for cleaning, deodorizing, and disinfecting, production facilities must self-declare their quality standards in accordance with legal provisions on product quality, ensuring effectiveness and safety for users and the environment, and submit a commitment to the Ministry of Health. Health.

Article 11. 1. Business entities must have managers with secondary education or higher in fields related to chemicals, insecticides, and bactericides being traded. For individual traders, the business owners must hold certificates from training courses related to chemicals, insecticides, and bactericides conducted by units designated by the Ministry of Health.

Article 12. Cơ 2. Individuals directly involved in trading chemicals, insecticides, and bactericides must have a Health Certificate issued by a health authority at the district level or higher.

3. Those selling common insecticides and bactericides (mosquito repellents, insect spray bottles, repellent creams, electric mosquito repellent pads, ant and fly killers) do not need to obtain the certificate required under Clause 1 and 2 of this Article. 4. Stores and warehouses must be equipped with necessary fire prevention, explosion protection, occupational safety, and environmental sanitation facilities.

5. Transportation of chemicals, insecticides, and bactericides must comply with safety requirements for each type of chemical and product as stipulated by current regulations.

6. Chemicals, insecticides, and bactericides shall not be sold alongside pharmaceuticals, foodstuffs, beverages, and other consumer goods in the same store. However, stores selling common insecticides and bactericides as specified in Clause 3 of this Article may sell them in the same store but must keep them in separate counters.

Trading facilities for chemicals, insecticides, and bactericides may only commence trading after meeting the conditions specified in Article 2 of this Regulation and submitting a commitment to the Provincial Health Department where the facility is located.

TESTING OF CHEMICALS,

All chemicals, insecticides, and bactericides must undergo testing before applying for registration for circulation in Vietnam.

Article 13. The Ministry of Health designates Institutes and Branch Institutes to conduct testing of chemicals, insecticides, and bactericides as follows: 1. Units responsible for testing the safety and efficacy of insecticides:

 CHAPTER III

- Central Institute of Hygiene and Epidemiology.

PRODUCTS FOR INSECTICIDES, AND BACTERICIDAL AGENTS

Article 14. - Ho Chi Minh City Pasteur Institute.

Article 15. - Nha Trang Pasteur Institute. - West Central Institute of Hygiene and Epidemiology.

- Central Institute of Malariology, Parasitology and Entomology.

- Qui Nhon Institute of Malariology, Parasitology and Entomology.

- Ho Chi Minh City Branch Institute of Malariology, Parasitology and Entomology. Ho Chi Minh.

2. Units responsible for testing bactericides:

- Ho Chi Minh City Pasteur Institute.

- Institute of Occupational Medicine and Environmental Health.

- Ho Chi Minh City Institute of Public Health.

Testing units for chemicals, insecticides, and bactericides must adhere to testing procedures established by the Ministry of Health and bear legal responsibility for testing results.

The testing procedure is carried out as follows:

- Qui Nhon Institute of Malariology, Parasitology and Entomology.

1. A testing application is submitted to the Ministry of Health.

2. Units responsible for testing bactericides:

- Ho Chi Minh City Pasteur Institute.

2. For chemicals listed in the annual publication, within ten days of receiving the testing application, the Ministry of Health will issue a permit for testing and designate the unit to conduct the testing. 3. For chemicals not listed in the annual publication, the Ministry of Health will consider each case individually to grant permission for testing and designate the unit to conduct the testing. If permission is denied, a written response detailing the reasons will be provided.

4. The entity requesting testing must pay the testing fee to the Ministry of Health and receive the permit for testing. Ho Chi Minh.

Article 16. 5. The entity must contact the testing unit to complete the procedures for conducting the testing.

Article 17. 6. After obtaining the testing results, the entity must complete the registration application and submit it to the Ministry of Health for review and approval of circulation registration in accordance with Chapter IV of this Regulation.

REGISTRATION OF CHEMICALS, Health.

Chemicals, insecticides, and bactericides may only circulate in Vietnam upon obtaining a Registration Permit from the Ministry of Health. Chemicals, insecticides, and bactericides circulating in Vietnam must register for circulation:

1. Chemicals, insecticides, and bactericides listed in the annual publication but without a registration number. 2. Chemicals, insecticides, and bactericides that have been granted a Registration Permit but have changed their product form, active ingredient concentration, solvent, additives, or mixed to form new chemicals, insecticides, and bactericides.

If chemicals, insecticides, and bactericides do not fall under the scope of Clauses 1 and 2 of this Article, the Ministry of Health will consider each case individually. the entity requesting the examination must pay the examination fee to the Ministry of Health and receive the permit for the examination. The entity requesting the examination shall contact the examination unit to complete the procedures for conducting the examination.

5. The entity shall contact the examination unit to complete the procedures for conducting the examination.

6. After receiving the examination results, the entity requesting the examination shall complete the registration dossier and submit it to the Ministry of Health for review and approval of the registration according to Chapter IV of this Regulation. REGISTRATION OF CHEMICALS, Chemicals and insecticides, bactericides may only be circulated in Vietnam if they have been granted a Registration Certificate by the Ministry of Health.

PART IV

Chemicals and insecticides, bactericides circulating in Vietnam must be registered for circulation:

PRODUCTS FOR INSECTICIDES, AND BACTERICIDAL AGENTS

Article 18. 1. Chemicals and insecticides, bactericides listed in the annual announcement but without a registration number.

Article 19. 2. Chemicals and insecticides, bactericides that have been granted a Registration Certificate but have changed their product form, active ingredient concentration, solvent, additive, or mixed with other chemicals and insecticides, bactericides to become new products.

If the chemicals and insecticides, bactericides do not fall within the scope of regulation under Clause 1 and 2 of this Article, then depending on specific circumstances, the Ministry of Health

INSECTICIDES AND BACTERICIDES

3. will issue a registration certificate for the circulation of these chemicals and insecticides, bactericides in Vietnam. The competent authority will consider granting registration for circulation provided that all scientific documents required by the competent authority are complete.

Article 20. Each chemical, insecticide, bactericide produced by a production facility shall only be permitted to register one trade name.

Article 21. Facilities eligible to register for circulation of chemicals, insecticides, bactericides in Vietnam include:

1. Production facilities in Vietnam with the function of producing chemicals, insecticides, bactericides.

2. Production facilities in Vietnam authorized by foreign enterprises with the function of producing chemicals, insecticides, bactericides.

3. Representative offices of foreign enterprises with the function of producing and trading in chemicals, insecticides, bactericides.

Article 22. Forms of registration:

1. Official registration for circulation.

Official registration for circulation applies to chemicals, insecticides, bactericides as specified in Article 19 of this Regulation.

2. Re-registration for circulation.

Re-registration for circulation applies to chemicals, insecticides, bactericides that have been registered for circulation in Vietnam but whose Registration Certificate has expired. The application for re-registration must be submitted six months before the expiration date of the Registration Certificate.

3. Supplementary registration.

1. Supplementary registration applies to:

Chemicals, insecticides, bactericides that have been granted a Registration Certificate for circulation in Vietnam within their validity period but require additional scope of use.

2. Chemicals, insecticides, bactericides that have been granted a Registration Certificate for circulation in Vietnam within their validity period but require a change in trade name for export purposes without altering the product form, active ingredient content, solvent, additives, or mixture of chemicals, insecticides, bactericides to form new products.

Supplementary registration does not require a change in the registration number for circulation.

Article 23. 5. Certificate of archival business inspection results The application for registration of chemicals, insecticides, bactericides must be made in two sets, one set being original copies and the other set being copies. Documents in foreign languages must be translated into Vietnamese, and legal documents must be originals or certified copies. The application must be bound and accompanied by a list of documents.

Within sixty days from the date of receipt of a complete and valid application, the Ministry of Health will issue a Registration Certificate for circulation, if not issued, a written response explaining the reasons for non-issuance will be provided.

The validity period of the Registration Certificate for circulation is five years.

Article 24. 5. Certificate of archival business inspection results Application for registration:

1. Official registration for circulation.

1.1 The application for registration submitted to the Ministry of Health includes the following contents:

1.1.1 Application for registration.

1.1.2 Business registration certificate or other valid documents proving the facility's functions of producing and trading in chemicals, insecticides, bactericides.

1.1.3 Test results on the composition and concentration of chemicals, insecticides, bactericides issued by authorized agencies in Vietnam. In cases where authorized agencies in Vietnam cannot test the composition and concentration, results from reputable manufacturers worldwide or countries with agreements on product quality with Vietnam may be used. In case of doubt, the Ministry of Health will send samples abroad for testing, and the applicant must bear all costs associated with the testing.

1.1.4 Responses from testing units designated by the Ministry of Health.

1.1.5 Certificates or confirmation documents from authorized agencies regarding the product's permission for circulation or free sale certificates from the country of origin or at least one country allowing its use (for imported chemicals, insecticides, bactericides).

1.1.6 Technical documentation on the following issues:

a) Composition and structure;

b) Effectiveness and usage instructions;

c) Side effects and handling methods;

d) Stability and storage conditions;

e) Production process.

1.1.7 Label content of the chemicals, insecticides, bactericides for registration.

1.2 For the following chemicals, insecticides, bactericides, in addition to the documents mentioned in Section 1.1, the following additional documents must be supplemented:

1.2.1 For chemicals, insecticides, bactericides first researched and produced in Vietnam, research results recognized by the Ministry of Health according to current regulations must be provided.

1.2.2 For chemicals, insecticides, bactericides produced in Vietnam using technology processes from foreign manufacturers, authorization letters (original or certified copies) permitting the use of technology processes and trademarks must be provided.

1.2.3 For chemicals, products produced in Vietnam applying published technology processes, manufacturers must provide documentation on formulas and published production processes in original or certified copies.

1.2.4 For chemicals, products produced in Vietnam using simple, common, and manual production processes such as dilution and packaging, manufacturers only need to describe the production process but must provide a commitment ensuring efficacy and safety for users and the environment.

1.3 The Ministry of Health will not accept registration applications for chemicals, products without clear origins and not in compliance with current regulations.

2. Re-registration for circulation:

2.1 Application for re-registration.

2.2 Business registration certificate or other valid documents proving the facility's functions of trading in chemicals, insecticides, bactericides.

2.3 Report on business operations in Vietnam, clearly stating whether there were any violations of the Regulations and how they were addressed.

3. Supplementary registration:

3.1. - Enact regulations on the quality assessment of training in public and private schools; on inspections, evaluations, financial management, self-financial audits, accounting, and auditing. supplementary scope of use:

3.1.1 Letter requesting supplementary scope of use for chemicals, products.

3.1.2 Test results on the object for supplementary scope of use.

3.1.3 Sample label of chemicals, insecticides, bactericides after supplementary scope of use.

3.2 Change of trade name:

3.2.1 Letter requesting change of trade name for chemicals, products.

3.2.2 New trade name of chemicals, products.

3.2.3 Names of countries or companies in those countries importing these chemicals, products.

3.2.4 Content of the sample label of chemicals, insecticides, bactericides after changing the trade name.

Article 25. In the case where a product has been granted a Registration Certificate for Circulation that is still valid but the organization, enterprise, or trading entity named on the registration of such product undergoes organizational changes such as division or merger, the organization or enterprise receiving the product must report to the Ministry of Health and must obtain the Ministry of Health's written consent.

 CHAPTER V

REGULATIONS ON STORAGE, DISPOSAL, ADVERTISING,

LABELING, PACKAGING, IMPORT OF PESTICIDES AND DISINFECTANTS

at the bottom of the label and have a length equal to the length of the label, with a height equivalent to 10% of the label's height.

Article 26. The storage and disposal of pesticides and disinfectants shall be carried out in accordance with the regulations set forth in the Hazardous Waste Management Regulation issued together with Decision No. 155/1999/QĐ-TTg dated July 16, 1999 of the Prime Minister and other relevant laws.

Article 27.

1. Advertising of pesticides and disinfectants must comply with the provisions of the law on advertising.

2. Only pesticides and disinfectants that have been granted a Registration Certificate for Circulation by the Ministry of Health may be advertised; the content of the advertisement and information must accurately reflect the features and effects of the pesticides and disinfectants as registered.

3. Any entities wishing to organize seminars for advertising or introducing new products for circulation registration purposes must obtain permission from the Ministry of Health and can only organize such seminars upon obtaining the Ministry of Health's written consent.

Article 28. Labels for pesticides and disinfectants shall be implemented in accordance with current laws regarding labeling of goods circulating domestically and imported/exported goods.

Additionally, the mandatory content of labels for pesticides and disinfectants must include:

1. The registration number granted by the Ministry of Health for the circulation of pesticides and disinfectants in Vietnam. INSPECTION

2. Safety warnings:

Provide some information for users to know how to prevent adverse effects of pesticides and disinfectants (for example: avoid contact with eyes, skin...; wash hands and feet or take a shower after use...).

3. First aid instructions for pesticide and disinfectant poisoning:

Clearly state the initial treatment methods when poisoned by pesticides and disinfectants; if symptoms of poisoning appear during or after use, specify what actions should be taken, what symptoms of poisoning look like, and antidotes.

4. For highly toxic pesticides and disinfectants (Groups I and II according to WHO classification), the following must also be included:

4.1. Toxicity level color coding:

4.1.1. For Group I pesticides and disinfectants: red stripe.

4.1.2. For Group II pesticides and disinfectants: yellow stripe.

4.1.3. This stripe must be placed at the bottom of the label and its length must equal the width of the label, with a height equivalent to 10% of the label's height. notify in writing the reasons, developments, and results of the handling.

4.1.4. The background color of the label must not match the toxicity level color of the pesticide or disinfectant.

4.2. Information about toxicity: phrases such as "Extremely Toxic," "Highly Toxic," "Danger," "Caution" and corresponding toxicity symbols must be placed above the main column on the label.

Article 29.

1. Packaging for pesticides and disinfectants must ensure:

a) Durability during storage, circulation, and use;

b) Not affecting the composition and efficacy of pesticides and disinfectants;

c) Preventing environmental factors from impacting the quality of pesticides and disinfectants;

d) Not being prone to explosion, breakage, or decay during storage and use.

2. Pesticides and disinfectants must be contained in separate packaging and cannot be stored in packaging specifically designed for food, beverages, or other consumer goods.

Article 30. Enterprises authorized to import pesticides and disinfectants may only import:

1. Pesticides and disinfectants that have been granted a Registration Certificate for Circulation in Vietnam and are still valid.

2. Active ingredients and raw materials for producing pesticides and disinfectants that have been granted a Registration Certificate for Circulation in Vietnam and are still valid.

3. Pesticides and disinfectants not covered under items 1 and 2 of this Article, if imported for research, testing, or special purposes without commercial sale, sample making, exhibition, or trade fair participation, must obtain the written consent of the Ministry of Health. Specifically, pesticides and disinfectants participating in exhibitions or trade fairs must be re-exported after the event concludes.

4. Pesticides and disinfectants used in household and medical fields must have at least two-thirds of their shelf life remaining when imported into Vietnam.

 Chapter VI

DOCUMENTARILY RESTATE THE REASONS, COURSE OF EVENTS, AND OUTCOMES OF THE HANDLING. During implementation, if there are difficulties or obstacles, units and localities should report to the Ministry of Health (Department of Traditional Medicine) for guidance and resolution./. INSPECTION AND VIOLATION HANDLING

Article 31. AND Y The Ministry of Health and provincial health departments will coordinate with competent authorities to regularly or突击检查生产、销售农药和消毒剂的情况，以及生产、销售农药和消毒剂的单位的条件。

Article 32. AND Y 如果农药或消毒剂已经注册但不符合质量要求或与注册文件不符，卫生部将作出决定收回注册证书。

Article 33.

1 ||| When receiving the decision to revoke the Registration Certificate for Circulation from the Ministry of Health, the production and sales units of pesticides and disinfectants must implement the following regulations:

a) Promptly cease production and sales and inform customers.

b) Carry out the recovery of pesticides and disinfectants.

c) Seek the opinion of the competent authority on handling measures and proceed to handle recovered pesticides and disinfectants according to current regulations.

d) Report in writing to the Ministry of Health on the cause, development, and results of the handling. DOCUMENTARILY STATE THE REASONS, DEVELOPMENT, AND RESULTS OF THE PROCESSING.

2 ||| Entities with recovered pesticides and disinfectants must bear all costs and compensate for losses in accordance with the law.

Article 34. Organizations and individuals who violate the provisions of this Regulation and other relevant laws shall be subject to administrative penalties or criminal liability pursued depending on the extent of the violation, and if damage is caused, they must compensate according to the provisions of the law.

 Chapter VII

IMPLEMENTATION

Article 35.

1. The Preventive Medicine Department shall cooperate with relevant functional departments and the Inspectorate of the Ministry of Health to be responsible for guiding, organizing, inspecting, and auditing the implementation of the Chemicals Management Regulation and insecticides, bactericides throughout the country. 2. The Provincial Health Department shall be responsible for organizing and implementing the Chemicals Management Regulation and insecticides, bactericides at the local level, informing the provisions of this Regulation to production and trading establishments of chemicals and insecticides, bactericides so that they are aware and comply with it, and inspecting and auditing the implementation of this Regulation within the scope of its management.

2. The Provincial Health Department shall be responsible for organizing and implementing the Chemicals Management Regulation and insecticides, bactericides at the local level, informing the provisions of this Regulation to production and trading establishments of chemicals and insecticides, bactericides so that they are aware and comply with it, and inspecting and auditing the implementation of this Regulation within the scope of its management.

Article 36. Every six months and annually, the Provincial Health Department shall compile and report the situation of inspecting the implementation of the Chemicals Management Regulation and insecticides, bactericides in its province to the Ministry of Health (Preventive Medicine Department)./