Consolidated Document number 10/VBHN-BYT on the management of chemicals, insecticides, and bactericides for household and medical use.

DECREE

On the management of chemicals, insecticides, and bactericides for household and medical use
for household and medical use

Government Decree No. Decision No. 91/2016/NĐ-CP dated July 1, 2016, of the Government on the management of chemicals, insecticides, and bactericides for household and medical use, which took effect from July 1, 2016, amended and supplemented by;

Government Decree No. Decision No. 155/2018/NĐ-CP dated November 12, 2018, of the Government amending and supplementing certain provisions related to business conditions under the Ministry of Health's jurisdiction, which took effect from November 12, 2018

Pursuant to the Law on Organization Government September 19 the 2015;

Pursuant to the Chemicals Law dated November 21, 2007;

Pursuant to the Investment Law dated November 26, 2014;

Pursuant to the Product Quality Law dated November 21, 2007;

Pursuant to the Enterprise Law dated June 26 the 2014;

Pursuant to the Trade Law dated June 14, 2005;

Pursuant to the Standards and Technical Regulations Law dated June 29, 2006;

At the proposal of the Minister of Health;

Government Issuing this Decree on the management reason of chemicals, insecticides, and bactericides for household and medical use.[1]

Chapter I. GENERAL PROVISIONS

Article 1. Scope of Regulation

This Decree stipulates the production, bottling and packaging (hereinafter referred to as production), testing, trial use, circulation, purchase and sale, transportation, and export and import of chemicals, insecticides, and bactericides for household and medical use.

Chemicals and bactericides for food and chemicals and products used solely are for sterilizing medical equipment are not within the scope of regulation of this Decree.

Article 2. Interpretation of Terms

In this Decree, the following terms are understood as follows:

1. Active substance is a substance with insecticidal or bactericidal activity.

2. Insecticide and bactericide chemical is a chemical containing an active insecticidal or bactericidal substance in technical form used to process and manufacture insecticides and bactericides for household and medical use (hereinafter referred to as chemical).

3. Insecticide and bactericide product is a product containing an active insecticidal or bactericidal substance, having its own trade name and being directly used to kill insects and bacteria for household and medical use (hereinafter referred to as product).

4. The owner of the product is an organization or individual who performs the following:

a) Supplying the product under their own name or any trademark, design, trade name, or other name or code owned or controlled by that individual or organization;

b) Being responsible for the production, labeling, packaging, or determining the intended use of the product.

5. The owner of the registration certificate for circulation is an organization or individual registering the product for circulation and obtaining a Registration Certificate for Circulation.

6. Legal entity documentation is documentation issued by the competent authority when registering according to the provisions of the Enterprise Law, Investment Law, Trade Law, and Cooperative Law.

7. A valid copy is a copy issued from the original book or a copy issued from the original by a competent authority or organization.

Article 3. List of active substances

1. The list of active substances includes:

a) List of prohibited active substances in products;

b) List of restricted active substances in products.

2. The Minister of Health shall promulgate the List of Prohibited and Restricted Active Substances specified in Clause 1 of this Article based on one or more of the following sources:

a) Warnings from international organizations and usage situations in countries around the world;

b) Data on the safety of chemicals and products.

Chapter II. CHEMICAL PRODUCT PRODUCTION

Article 4. Conditions for Chemical Product Production Facilities

1.[2] (Repealed)

2. Meet the requirements for personnel, physical facilities, and equipment as stipulated in Articles 5 and 6 of this Decree. stipulating as set forth in Articles 5 and 6 of this Decree.

3. Complete the announcement of compliance with production conditions for chemical products as provided for in Article 8 of this Decree.

Article 5. Personnel Conditions

1. 3. Commitment to comply with declared quality standards. At least one full-time specialist in chemical safety meeting the following requirements:

a) Having a degree in chemistry or higher;

b) Working full-time at the production facility.

c)[3] (Repealed)

2.[4] (Repealed)

Article 6. Conditions for Physical Facilities and Equipment

1.[5] Meeting the requirements set out in Section 1 of Chapter II of Decree No. 113/2017/NĐ-CP dated October 9, 2017, providing detailed regulations and guidance on implementing certain provisions of the Chemicals Law.^.

2. Having a laboratory capable of testing the components and active ingredient content of chemical products produced by the facility. In this Circular, the following terms are understood as follows: produced by the production facility business budgets, equipment, materials, supplies,In cases where the production facility does not have its own laboratory, it must enter into a contract with a qualified testing facility as specified in Article 10 of this Decree. business budgets, equipment, materials, supplies, If there is no laboratory, it must have a contract with a competent testing facility as provided for in Article 10 of this Decree.

Article 7. Documents for Announcing Compliance with Production Conditions for Chemical Products

1. Documents for announcing compliance with production conditions:

a) A declaration of compliance with production conditions for chemical products according to Form No. 01 in Appendix I; b) A list of personnel according to the prescribed form; e) |||

c) Floor plan of the factory and warehouse; Seal Registration Certificate e) |||

c)[6] (Repealed)

d) d) List of equipment and means serving production and emergency response to chemical accidents.[7]

d) List of equipment and means serving production and emergency response to chemical accidents;

e)[8] (Repealed)

g)[9] (Repealed)

2. Requirements for documents for announcing compliance with production conditions:

a) The documents for announcing compliance with production conditions shall be made into one paper copy accompanied by an electronic copy in PDF format;

b) The documents in the file must be printed clearly, arranged in accordance with the order specified in Clause 1 of this Article; there should be separation between sections, cover page, and list of documents;

c)[10] (Repealed)

d)[11] Documents specified in Points d and đ of Clause 1 of this Article must be confirmed by the production facility.

Article 8. Announcement of Sufficient Conditions for Production of Formulations

Article 8. Announcement of Compliance with Production Conditions for Chemical Products

1. The production facility submits the documents directly or sends them through postal service to the Department of Health where the production facility is located. If the Department of Health implements online announcements, the production facility submits the documents online.

2. Direct announcement procedure:

a) Before commencing production of chemical products, the legal representative of the production facility is responsible for submitting the documents for announcing compliance with production conditions as specified in Clause 1 of Article 7 of this Decree to the Department of Health where the production facility is located; b) After receiving complete documents, the Department of Health issues the production facility a Receipt for Submission of Documents for Announcing Compliance with Production Conditions for Chemical Products. The Receipt for Submission of Documents for Announcing Compliance with Production Conditions for Chemical Products follows Form No. 01 in Appendix III. issued together with this Decree.

3. Online announcement procedures as stipulated in Chapter VIII of this Decree.

4.[12] Within three working days from the date recorded on the Receipt for Submission of Documents, the Department of Health is responsible for publishing on its website the information: name, address, contact phone number of the production facility.

5. During operation, the production facility is responsible for updating information in the documents for announcing compliance with production conditions within fifteen days from the date of any of the following changes:

a)[13] Changes in personnel: A request for updating information on compliance with production conditions accompanied by the documents specified in Point b of Clause 1 of Article 7 of this Decree;

b) Changes in factory and warehouse area: A request for updating information on compliance with production conditions accompanied by the documents specified in Point d of Clause 1 of Article 7 of this Decree;

c) Changes in equipment and means serving production and emergency response to chemical accidents, chemical products: Culture, A request for updating information on compliance with production conditions accompanied by the documents specified in Point đ of Clause 1 of Article 7 of this Decree;

d) Changes in name, address, contact phone number: Culture, A request for updating information on compliance with production conditions.

6. Within three working days from the date of receipt of the request for updating information on compliance with production conditions as stipulated in Clause 5 of this Article (the date of receipt of the update document is calculated based on the date stamp on the Department of Health's receipt of the document), the Department of Health is responsible for updating the information on its website. of Finance) 7. In cases where the production facility moves location or adds production facilities within the same province, it must reapply for the announcement of compliance with production conditions as stipulated in this Decree. conditions 8. In cases where the production facility changes its production location from one province to another, it must notify the Department of Health of the original production location within fifteen days from the date of moving the production location.

Within three working days from the date of receipt of the notification of the move to a different province by the production facility (the date of receipt of the notification document is calculated based on the date stamp on the Department of Health's receipt of the document), the Department of Health that received the application for announcing compliance with production conditions has the responsibility to terminate the publication of related information about the facility. conditions in accordance with this Decree.

8. In case a production facility changes its production location from one province to another, it must notify the Department of Health where the facility has completed the announcement of sufficient conditions. conditions rights business budgets, equipment, materials, supplies, Industry and not within 15 days from the date of changing the production location.

Within three working days from the date of receiving the notification about the change of production location to another province by the production facility, business budgets, equipment, materials, supplies, (the time of receipt of the notification document is calculated based on dated recorded on the receipt stamp of the of Finance) announcement office), the Department of Health that has received the announcement dossier shall be responsible for terminating the publication of information related to such facility. conditions production shall be responsible for ceasing the publication of relevant information.

Chapter III. INSPECTION AND TESTING OF PRODUCTS

Section 1. INSPECTION OF PRODUCTS

Article 9. Contents and Situations Requiring Inspection

1. Contents of inspection: Determining the components and active substance concentrations in insecticides and bactericides according to the registration dossier for circulation and importation.

2. Situations requiring inspection:

a) Products during production;

b) Products before registration new circulation;

c) Products during circulation in Vietnam as prescribed by the Law on Product Quality.

Article 10. Conditions for Entities Conducting Inspections

1.[14] (Repealed)

2.[15] Meeting the ISO 17025:2005 standard or updated versions certified by accredited certification organizations as stipulated by laws on business conditions for conformity assessment services.

3. Completing the announcement of meeting the conditions for conducting inspections as prescribed in Article 12 of this Decree.

Article 11. Documents for Announcing Meeting the Conditions for Conducting Inspections

1. Announcement of meeting the conditions for conducting inspections according to Form No. 02 in Appendix I issued together with this Decree.

2. List of active substances that the entity can inspect, confirmed by the inspection entity. of 3. A valid copy of the Certificate of Conformity to the ISO 17025:2005 standard or updated version.

Article 12. Announcing Meeting the Conditions for Conducting Inspections

1. Before conducting the first inspection, the inspection entity shall notify the Ministry of Health with the documents as prescribed in Article 11 of this Decree. In cases where the Ministry of Health implements an online system, the entity shall notify through the online form.[16]

2. Within three working days from the date of receipt of the notification from the inspection entity, the Ministry of Health shall be responsible for publicly announcing on its electronic information website the following information: Name, address, contact phone number of the inspection unit; list of chemical types that the unit can inspect.

3. If there are changes to the inspection conditions of the inspection entity compared to the notification dossier of meeting the conditions for conducting inspections already submitted to the Ministry of Health, within five working days from the date of change, the inspection entity shall notify the Ministry of Health with the documents as prescribed in Article 11 of this Decree.

4. In cases where the inspection entity does not meet the conditions announced to the Ministry of Health and fails to rectify within the time limit set by the Ministry of Health, the Ministry of Health will terminate the publication of related information about the inspection entity and issue a notice to the inspection entity regarding the termination of information publication. The inspection entity shall not be allowed to conduct inspections from the date the Ministry of Health issues the notice regarding the termination of information publication related to the inspection entity due to non-compliance with inspection conditions.

Section 2. TESTING OF PRODUCTS

Article 13. Situations Requiring Testing

1. New products

entering circulation. registration 2. Products registering for additional circulation as stipulated in points c and d, Clause 2, Article 21 of this Decree.

Article 14. Conditions for Entities Conducting Testing

1. It must be a healthcare facility.

2. Personnel requirements:

The person in charge of the testing department must have at least three years of experience in product testing.

a)[17] 3. Infrastructure requirements:

b)[18] (Repealed)

Having a testing laboratory managed and operated according to the ISO 17025:2005 standard or ISO 15189:2012 standard or updated versions. In cases involving testing service activities, such activities must be registered in accordance with laws on business conditions for conformity assessment services;

a)[19] c) Possessing sufficient insect, bacterial, and viral strains for the testing process;

b)[20] (Repealed)

4. Completing the announcement of meeting the conditions for conducting testing as prescribed in Article 16 of this Decree.

d)[21] (Repealed)

đ)[22] (Repealed)

e)[23] (Repealed)

4. Completing the announcement of sufficient conditions for conducting trials as stipulated in Article 16 of this Decree.

Article 15. Documents for announcing eligibility to conduct trials

1. The document announcing eligibility to conduct trials according to Model No. 03 in Appendix I issued together with this Decree.

2. A list of trial procedures that the entity is capable of conducting, confirmed by the trial entity.

3. A personnel declaration form as prescribed at Seal Registration Certificate issued together with this Decree.

4. A valid copy of the Certificate of Compliance with ISO 17025:2005 standard or ISO 15189:2012 standard or updated version.

5.[24] (Repealed)

6. A list of equipment and devices serving trial activities, confirmed by the trial entity.

Article 16. Announcing Eligibility to Conduct Trials[25]

1. Before conducting the first trial, the trial entity shall notify the Ministry of Health of the documents as stipulated in Article 15 of this Decree. In case the Ministry of Health implements an online system, the entity shall notify through the online form.

2. Within three working days from the date of receipt of the notification from the trial entity, the Ministry of Health shall be responsible for publicly disclosing on its electronic information website the following information: name, address, contact phone number of the trial entity; list of trial procedures announced by the trial entity as eligible to conduct trials.

3. If the trial entity changes conditions compared to the notification documents previously submitted to the Ministry of Health, within fifteen days from the date of change, the trial entity shall be responsible for notifying the Ministry of Health with the documents as stipulated in Article 15 of this Decree.

4. Within three working days from the date of receipt of the notification from the trial entity as stipulated in Clause 3 of this Article, the Ministry of Health shall be responsible for updating the information on its electronic information website.

5. In case the Ministry of Health discovers that the trial entity does not meet the conditions as notified to the Ministry of Health and fails to rectify within the required time limit, the Ministry of Health shall terminate the publication of related information about the trial entity and issue a notice to the trial entity regarding the termination of information publication. The trial entity shall not be permitted to conduct trials from the date the Ministry of Health issues the notice regarding the termination of information publication related to the trial entity due to non-compliance with the conditions for conducting trials.

Chapter IV. CIRCULATION OF PREPARATIONS

Section 1. CONDITIONS FOR CIRCULATION, REGISTRATION NUMBER FOR CIRCULATION, ORGANIZATIONS ENTITLED TO BE LISTED AS REGISTRATION HOLDER

Article 17. Conditions for Circulation of Preparations

1. Possess a circulation registration number.

2. Be labeled or accompanied by a label containing all the information as prescribed in this Decree.

3. Preparations granted a circulation registration number produced before the expiration of the validity period of the circulation registration number but the registration holder does not continue registration to renew it may still be circulated in the market after the expiration of the old circulation registration number until the expiry date indicated on the preparation label.

Article 18. Circulation Registration Number of Preparations

1. One preparation shall only be granted one circulation registration number.

2. The circulation registration number of a preparation has a validity of five years from the date of issuance. In case a preparation's circulation registration number is renewed, the original circulation registration number remains unchanged.

3. The circulation registration number is issued in the form of a Circulation Registration Certificate. The model of the Circulation Registration Certificate shall comply with the provisions at REGULATIONS ON THE CERTIFICATE DESIGN FOR OUTSTANDING RURAL INDUSTRIAL PRODUCTS issued together with this Decree.

Article 19. Conditions for registered products to be circulated

1. The toxicity of the product does not belong to group Ia, Ib according to the classification of the World Health Organization for insecticide products or group I, II according to the Global Harmonized System (GHS) classification and labeling system. quality of the document simultaneously poor quality of the document -

2. It does not contain active ingredients listed in the prohibited substance list for products.

3. If the product contains active ingredients listed in the restricted use list for products, it can only be circulated within the scope of use specified. registration circulation within the scope of use as prescribed.

4. It must be produced at a facility that has been announced as having the necessary production conditions (for domestically produced products) or hold a Free Sale Certificate (for imported products).

Article 20. Organizations entitled to register for circulation

1. Organizations entitled to register new products for circulation include:

a) Domestic enterprises, cooperatives, individual businesses that are the owners of the product or foreign traders' representative offices in Vietnam where such traders are the owners of the product; of b) Domestic enterprises, cooperatives, individual businesses authorized by the owner of the product;

c) Representative offices of foreign traders in Vietnam authorized by the owner of the product to register. registration;

c) The representative office of foreign traders in Vietnam authorized by the owner of the formulation to register.

2. In cases of supplementary registration, extension of the registration number for circulation, and reissue of the Product Circulation Registration Certificate, the organization entitled to register for circulation is the owner of the registration number. registration circulation supplement, extend registration number and ||| The product owner must clearly state the content of the re-authorization in the Authorization Letter if they allow the authorized organization to further authorize another organization to register the product.

3. In cases where the entity implements audit recommendations, inspections, or financial authorities' requests for activities under its management during the year, the entity must prepare a report on the implementation of audit recommendations, inspections, and financial authorities' requests in accordance with this Circular. Data implemented according to audit recommendations and inspection agencies' requests for projects using state budget investment funds reported according to the model specified in Circular No. 85/2017/TT-BTC dated August 15, 2017 of the Ministry of Finance regarding the final settlement of state budget investment fund usage according to annual fiscal years and other relevant documents shall not be consolidated into the reporting form specified in this Circular. the owner of the formulation permits the authorized entity to further authorize another entity to register the formulation, the content of such re-authorization must be clearly stated in the Authorization Letter.

4. Where the product owner authorizes two or more organizations in Vietnam to register the same product, the Ministry of Health will only accept and process the application from the first organization with a valid Authorization Letter. of to two or more entities in Vietnam to register the same formulation, the Ministry of Health will only accept and process the application from the first entity having a valid Authorization Letter. registration extend the registration number for circulation within the period specified in Clause 2, Article 24 of this Decree.

Section 2. REGISTRATION FOR CIRCULATION

Article 21. Forms of registration for circulation

1. New registration for circulation applies to the following situations:

a) New products manufactured domestically except those produced solely for export;

b) Products already permitted for use abroad but being imported for the first time for use in Vietnam;

c) Products that have been granted a registration number for circulation but did not renew their registration number within the period stipulated in Clause 2, Article 24 of this Decree. registration circulation;

2. Supplementary registration for circulation applies when a product has been granted a registration number for circulation in Vietnam and remains valid, but undergoes one of the following changes:

a) Change in circulation rights; Ownership number registration circulation applies to formulations which have been granted registration numbers but need to be extended according to the provisions of Clause 2, Article 24 of this Decree.

b) Change in the trade name of the product;

c) Change in the production site or production facility;

d) Change in the name and contact address of the registering entity, the name of the production facility, or the production location address;

e) Change in the efficacy, quality standards, or usage methods of the product.

3. Renewal of the registration number for circulation applies to products that have been granted a registration number but need to renew it upon reaching the renewal deadline set out in Clause 2, Article 24 of this Decree. registration circulation applies to registration cases

4. Reissuance of the Product Circulation Registration Certificate applies to situations where the certificate has been lost or damaged. registration circulation lost or damaged. Model No. 04 in Appendix I Certificate registration 3. Authorization letter for registering circulation except in cases provided for in Point a, Clause 1, Article 20 of this Decree.

Article 22. Documents for new registration for circulation

1. A request for new registration for circulation in accordance with Form No. 04 in Appendix I. 5. Test results of the formulation's components and active substance content (to be supplemented with the reply sheet of test results). issued together with this Decree.

2. Legal entity documents of the registering entity and the production facility.

7. Label sample of the formulation.

3. Authorization letter for registration for circulation, except in the case provided for in point a, Clause 1, Article 20 of this Decree. Appendix V issued together with this Decree.

9. Documentation and research results on safety and efficacy or recommendations from the World Health Organization or equivalent international organizations regarding the use of the formulation in household and medical fields (for formulations

4. Technical documentation of the product to be registered, including contents as prescribed.

circulation supplement, extend registration number

5. Test results on the composition and concentration of active ingredients in the product (to be supplemented with the Survey Result Report).

circulation documents into one set of paper copies accompanied by an electronic version in PDF format. In this Circular, the following terms are understood as follows: 6. Survey Result Report (to be supplemented after the Ministry of Health issues a permit for surveying).

Article 23. Documents for supplementary registration of circulation

1. In case of change in ownership of the circulation registration number:

a) Application form registration for supplementary circulation registration according to Form No. 05 in Appendix I e) |||

b) Power of attorney for circulation registration, except in cases provided for in point a, Clause 1, Article 20 of this Decree;

c) Document transferring ownership of the circulation registration number from the owner of the circulation registration number;

d) Document accepting ownership of the circulation registration registration number and commitment to continue ensuring the business of the product in accordance with the dossier approved by the Ministry of Health after accepting the circulation registration number;

đ) Legal entity status documents of the entity accepting the circulation registration circulation applies to formulations which have been granted registration numbers but need to be extended according to the provisions of Clause 2, Article 24 of this Decree.

registration number;

e) New label sample of the product.

2. In case of changing the trade name of the product: a) Application Form No. 05 in Appendix I for supplementary circulation registration according to determines from state budget funds under its management. Appropriate disciplinary measures shall be taken against individuals and units seriously violating the implementation of management, payment, and use of project management costs.

issued together with this Decree

b) Power of attorney for circulation registration of the product under its new trade name, except in cases provided for in point a, Clause 1, Article 20 of this Decree;

c) Free Circulation Certificate of the product under its new trade name (for imported products);

d) New label sample of the product.

3. In case of changing the place of production or production facility: Form No. 05 in Appendix I e) |||

a) Application for supplementary circulation registration according to , Đ b) Legal entity status documents of the new production facility (for facilities within Vietnam), of Finance) notification of change of production location, production business budgets, equipment, materials, supplies, facility (for facilities outside Vietnam);

c) Report on the results of testing the product produced at the new facility;

d) Power of attorney for circulation registration, except in cases provided for in , Đ point a, Clause 1, Article 20 of this Decree;

đ) Free Circulation Certificate, except when the product has been assigned a circulation registration registration number for production in Vietnam and supplementary registration of a production facility abroad;

registration number;

4. In case of changing the name or contact address of the entity, registrationproduction facility name, production location address:

a) Application form registration for supplementary circulation registration according to Form No. 05 in Appendix I e) |||

b) Legal entity status documents of the registering entity, production facility indicating the changes (for facilities within Vietnam), of Finance) notification of change of name and address (for facilities outside Vietnam);

c) New label sample of the product.

5. In case of changing the efficacy, quality criteria, or method of use:

3. In case of changing the place of production or production facility: Form No. 05 in Appendix I e) |||

b) Report on the results of testing the product after the change (except in case of changing the expiration date of the product);

c) Research data on stability (in case of changing the expiration date of the product);

d) Test results of active ingredient components and concentrations (in Model No. 04 in Appendix I case of changing active ingredient components and concentrations);

đ) New label sample of the product.

Article 24. Documents for extending the circulation registration number

1. Documents registration extending the circulation registration number includes the following documents:

a) Application for extending the circulation registration number according to Form No. 06 in Appendix I e) |||

b) Legal entity status documents of the registering entity, production facility;

c) Power of attorney for circulation registration, except in cases provided for in point a, Clause 1, Article 20 of this Decree;

d) Report on the circulation process of the product according to the prescribed form at Appendix VI issued together with this Decree.

2. Time limit for submission of documents registration for extending the circulation registration number is a minimum of three months and a maximum of twelve months before the circulation registration number expires.

Article 25. Documents for reissuing the Certificate of Circulation Registration

1. Application for reissuing the Certificate of Circulation Registration according to Form No. 07 in Appendix I issued together with this Decree.

2. Damaged Certificate of Circulation Registration.

Article 26. Requirements for registration dossier

1. The new registration dossier, additional registration, extended number of registrations shall be compiled into one set of paper copies accompanied by an electronic version in PDF format. registration as stipulated in Articles 22, 23, and 24 of this Decree, with clear separation between sections, cover page, and table of contents. registration 4. Requirements for documents in the registration dossier:

2. Documents in the dossier must be clearly printed, arranged in sequence according to the forms prescribed in Articles 22, 23, and 24 of this Decree, with separation between sections, cover page, and list of documents. registration b) Original or certified true copy of the Free Circulation Certificate for imported formulations. The Free Circulation Certificate must meet the requirements at

3. Documents in English must be translated into Vietnamese and attached with the original documents. Documents in foreign languages other than English must be translated into Vietnamese, and the Vietnamese translation must be notarized in accordance with the provisions of the law.

, the registration applicant

4. Requirements for documents in the registration dossier: registration a) Original Power of Attorney for implementing circulation. The Power of Attorney must meet the requirements stipulated at Appendix VII e) |||

d) Label samples of all packaging sizes according to actual dimensions, confirmed by the registration applicant. In cases where multiple packaging sizes have similar label designs, the applicant must submit the label of the smallest packaging size. If the imported formulation label is in a foreign language, it must be accompanied by a Vietnamese label insert. The labels and label inserts of the formulation must comply with the requirements at Appendix VIII e) |||

b) Original or certified true copy of the Free Circulation Certificate for imported products. The Free Circulation Certificate must meet the requirements stipulated at business budgets, equipment, materials, supplies,5. Other documents in the registration dossier In this Circular, the following terms are understood as follows:c) Original or certified true copy of the result report of the examination conducted by an independent entity (not the production facility, registration facility), and having the necessary conditions to conduct examinations as prescribed in Article 14 of this Decree; registered Original or certified true copy of the test results of the active ingredient content of the product. The test results must be conducted by an entity having the necessary conditions to conduct tests as prescribed in Article 10 of this Decree. In cases where Vietnamese testing facilities lack the capacity to conduct tests, the registration entity may use the test results from the production unit or an independent laboratory meeting ISO 17025:2005 or ISO 15189:2012 standards or their updated versions, and the registration entity must bear legal responsibility for the legality of the test results provided by itself;

d)[26] d) Samples of all packaging labels according to actual size, confirmed by the registration entity. In cases where multiple packaging designs have similar labels, the registration entity submits the label of the smallest packaging design. If the imported product label is in a foreign language, it must be accompanied by a Vietnamese label insert. The labels and label inserts of the product must meet the requirements stipulated at

new registration dossier concerning requests for additional or modified dossiers or permission or denial of trials. Appendix IX issued together with this Decree.

e) Certified true copy of documents regarding the legal status of the registration entity, production entity;

g) Original or certified true copy of notifications of changes in name, address, location, or production facility of foreign entities legalized by consular certification as prescribed.

modifications are noted on the Dossier Receipt Form. If the deadline is exceeded, the new registration dossier will be canceled. registration Other documents in the dossier must be stamped by the registration entity on each page of the documents.

Article 27. Acceptance and review of new registration dossiers

1. The entity registration submits the dossier directly or sends it via post to the Ministry of Health. In case When the Ministry of Health implements online registration, the registration entity submits the dossier online. Online registration is carried out in accordance with the provisions of Chapter VIII of the determines Add

2. After receiving the dossier and the registration dossier review fee, the Ministry of Health will issue a receipt to the registration entity. The receipt follows Model No. 04 in Appendix III issued together with this Decree.

3. Within thirty days from the date recorded on the receipt issued under Clause 2 of this Article, the Ministry of Health has the responsibility to notify the registration entity in writing about requests for supplementary or amended information in the dossier or permission or denial of examination. THE UNIT for the registration applicant

In case of requesting supplementary or amended information, the notification must clearly state the required supplementary or amended information.

In case of denying examination, the reason must be clearly stated.

4. In case the Ministry of Health issues a request for supplementary or amended information, within ninety days from the date recorded on the notification, the registration entity must complete the dossier, provide detailed explanations in writing for the supplementary or amended information, and submit it to the Ministry of Health. The receipt date for the supplementary or amended dossier is recorded on the receipt. If the deadline is exceeded, the new registration dossier will be canceled. MANAGEMENT AND USE OF DEPOSITS AT THE ENVIRONMENT PROTECTION FUNDconcerning permission or denial of trials. In cases of denial of trials, the reasons must be clearly stated.

Supplementary or amended dossiers will be accepted and reviewed in accordance with the provisions of Clause 3 of this Article.

5. In case there is no longer a need for supplementary or amended information, the Ministry of Health must notify the registration entity in writing about permission or denial of examination. In case of denying examination, the reason must be clearly stated. of Finance) upon issuance of the trial permit, the registration applicant is responsible for completing the testing and trials in accordance with Chapter III of this Decree and submitting the test and trial results for registration new registration dossier will be canceled.

6. After obtaining the written permit for examination, the registration entity is responsible for completing the testing and examination in accordance with the provisions of Chapter III of this Decree and submitting the test and examination results to be included in the dossier within twelve months from the date recorded on the examination permit letter. The receipt date for the test and examination results is recorded on the receipt. If the deadline is exceeded, the new registration dossier will be canceled. of Finance) In cases where a registration number for circulation is not issued, the reasons must be clearly stated. MANAGEMENT AND USE OF DEPOSITS AT THE ENVIRONMENT PROTECTION FUND 7. Within thirty days from the date recorded on the receipt issued under Clause 6 of this Article, the Ministry of Health has the responsibility to notify the registration entity in writing about requests for supplementary or amended information or issuance or denial of registration number. registration new registration dossier using imported raw materials for formulation production, the Registration Certificate for Circulation must clearly state the permission to import raw materials according to the model specified at

In case of denying the issuance of the registration number, the reason must be clearly stated.

In case of requesting supplementary or amended information, the notification must clearly state the required supplementary or amended information.

certificates for circulation for submitted dossiers within two years for registration applicants and production facilities whose formulations have been recalled under any of the circumstances stipulated in Clauses 1, 4, and 9, Article 38 of this Decree.

In case the new registration entity uses imported raw materials to produce the product, the Registration Certificate must clearly indicate the permission to import raw materials according to the model prescribed at registration Registration Certificate for Circulation. REGULATIONS ON THE CERTIFICATE DESIGN FOR OUTSTANDING RURAL INDUSTRIAL PRODUCTS issued together with this Decree.

8. Within three working days from the date of issuing the new registration number, the Ministry of Health is responsible for publicly disclosing on its electronic information website the following information:

a) Name of the product; In this Circular, the following terms are understood as follows:;

b) Registration number;

c) Full text of the Registration Certificate.

9. The Ministry of Health will not accept new registration dossiers and will not issue registration numbers for dossiers submitted within two years for registration entities, production entities whose products have been recalled registration numbers under any of the circumstances stipulated in Clauses 1, 4, and 9 of Article 38 of this Decree. ||| number registration 8. Packaging of formulations in granular or powder form must be sufficiently sealed to prevent spillage or require cushioning layers.

Article 28. Acceptance and Review of Supplementary Circulation Registration Application Files

1. The applicant may submit the application files directly or send them via postal service to the Ministry of Health. In cases where the Ministry of Health implements online registration, the applicant shall submit the application files online. Online registration shall be carried out in accordance with the provisions of Chapter VIII of this Decree.

2. Upon receipt of the application files and the supplementary circulation registration application review fee, the Ministry of Health shall issue to the applicant an Application File Receipt Form. registration The Application File Receipt Form shall be in accordance with Model No. 05 in Appendix III. issued together with this Decree.

3. Within thirty days from the date recorded on the Application File Receipt Form, the Ministry of Health shall notify the applicant in writing about:

a) The need to supplement or amend the application files, or agree or disagree with the contents of the supplementary circulation registration application and specify the reasons (in cases where the supplementary circulation registration application does not require testing);

b) The need to supplement or amend the application files, or permit or refuse testing and specify the reasons (in cases where the supplementary circulation registration application requires testing).

4. If the Ministry of Health issues a document permitting testing, within a maximum period of twelve months from the date recorded on the document permitting testing, the applicant must submit the test results to supplement the application files. Beyond this period, the supplementary circulation registration application will be canceled.

5. If the Ministry of Health issues a document requesting supplementation or amendment of the application files, within ninety days from the date recorded on the document, the applicant registration must complete the application files, provide explanations in writing, and submit them to the Ministry of Health. The date of receipt of the supplemented or amended application files will be recorded on the Application File Receipt Form. Beyond this period, the supplementary circulation registration application MANAGEMENT AND USE OF DEPOSITS AT THE ENVIRONMENT PROTECTION FUND will be canceled.

6. If there is no longer a requirement for supplementation or amendment, the Ministry of Health must issue a supplementary Certificate of Circulation Registration.

7. Within three working days from the date of issuance of the supplementary Certificate of Circulation Registration, the Ministry of Health shall publicly disclose the full text of the Certificate of Circulation Registration on its electronic information website. MANAGEMENT AND USE OF DEPOSITS AT THE ENVIRONMENT PROTECTION FUND products must follow the instructions provided by the manufacturer

Article 29. Acceptance and Review of Application Files for Extension of Circulation Registration Number

1. The applicant may submit the application files directly or send them via postal service to the Ministry of Health. In case When the Ministry of Health implements registration online registration, the applicant shall submit the application files online. Online registration shall be carried out in accordance with the provisions of Chapter VIII of this Decree.

2. Upon receipt of the application files and the extension of circulation registration number application review fee, the Ministry of Health shall issue to the applicant an Application File Receipt Form. The Application File Receipt Form shall be in accordance with Model No. 06 in Appendix III. issued together with this Decree.

3. Within thirty days from the date recorded on the Application File Receipt Form specified in Clause 2 of this Article, the Ministry of Health shall notify the applicant in writing about the request to supplement or amend the application files, or permit or refuse the extension of the circulation registration number.

In cases requiring supplementation or amendment of the application files for extension of the circulation registration number, the notification document must clearly specify the required supplementation or amendment contents.

In cases refusing the extension of the circulation registration number, the reasons must be clearly specified.

4. Upon receiving the document requesting supplementation or amendment of the application files, the applicant must supplement or amend the application files along with of Finance) an explanation and submit them to the Ministry of Health within thirty days from the date recorded on of Finance) the notification requesting MANAGEMENT AND USE OF DEPOSITS AT THE ENVIRONMENT PROTECTION FUNDsupplementation or amendment of the application files and at least ten days before the expiration of the circulation registration number's validity. The date of receipt of the supplemented or amended application files will be recorded on the Application File Receipt Form. Beyond this period, the application files for extension of the circulation registration number will be canceled.

The supplemented or amended application files will be reviewed according to the provisions of Clause 3 of this Article.

5. If there is no longer a requirement for supplementation or amendment, the Ministry of Health must extend the circulation registration number.

6. Within three working days from the date of extension of the circulation registration number, the Ministry of Health shall publicly disclose the full text of the new Certificate of Circulation Registration replacing the information specified in Point c, Clause 8, Article 27 of this Decree on its electronic information website.

Article 30. Acceptance and Review of Application for Reissuing the Registration Certificate for Circulation

1. The applicant submits the application at the Ministry of Health.

2. Upon receipt of the application for reissuing the Registration Certificate for Circulation, the Ministry of Health shall issue to the applicant a Receipt for Application Form. The Receipt for Application Form shall be in accordance with Model No. 07 in Appendix III issued together with this Decree.

3. Within ten days from the date recorded on the Receipt for Application Form, the Ministry of Health must reissue the Registration Certificate for Circulation. In case it cannot ||| reissue, there must be of Finance) a written response stating the reasons.

Section 3. TRADE NAME, LABEL, PACKAGING, STORAGE, DISPOSAL OF CHEMICALS AND PREPARATIONS

Article 31. Trade Name of Preparation

1. Each preparation of a manufacturer may only be registered with one trade name in Vietnam.

2. It is not allowed to use the same trade name for two or more preparations of the same manufacturer.

3. The trade name of a preparation must not be identical to the trade name of another preparation that has been issued a circulation number still in effect. registration 4. The trade name of a preparation must not be identical to the active ingredient's name, or the active ingredient's name and quantity, or the active ingredient's name, quantity, and form of preparation.

5. It is not permitted to assign a trade name to a preparation that does not appropriately reflect its efficacy and safety.

Article 32. Labeling of Chemicals and Preparations

1. The labeling of chemicals and preparations shall be carried out in accordance with the provisions set forth in

Appendix IX 2. When there are changes to the content or form of the preparation label beyond those specified in Clause 2, Article 21 of this Decree, the holder of the registration number for circulation must submit a written notice of the change along with a new label sample (including samples of all packaging formats according to actual sizes, in cases where multiple packaging formats have similar designs, the holder of the registration number for circulation submits the smallest format label) to the Ministry of Health for inclusion in the registration file at least fifteen days before the new label goes into circulation. If the Ministry of Health implements online registration, the holder of the registration number for circulation sends the notice of change in content or form of the label online. The submission of the online notice shall be conducted in accordance with the provisions of Chapter VIII of this Decree. issued together with this Decree.

3. Within five working days from the date of receipt of the written notice of label content change (the receipt date is calculated based on the date recorded on the Ministry of Health's incoming document stamp), if the Ministry of Health does not issue a written request for modification or supplementation:

a) The holder of the registration number for circulation is entitled to circulate the new label;

b) The Ministry of Health is responsible for updating the new label sample of the preparation in the registration file for circulation.

Article 33. Packaging of Chemicals and Preparations

1. Preparations circulating in Vietnam must be packaged in containers meeting the following requirements:

a) The quality of the packaging must be sufficiently robust to withstand normal impacts and vibrations during transportation and handling between vehicles and manual or mechanical loading and unloading;

b) The packaging must be structurally sealed enough to prevent leakage of the preparation during transportation or when subjected to shaking, temperature, humidity, and pressure changes;

c) The outer surface of the packaging must be clean and free from any hazardous chemical substances.

2. Parts of the packaging that come into contact with the preparation must meet the following requirements:

a) They must not be affected or deteriorate in quality due to the influence of the packaged preparation;

b) They must not affect the composition, properties, and effects of the preparation.

3. When packaging liquid preparations, sufficient empty space must be left to ensure that the packaging does not leak or deform due to volume expansion caused by temperature changes.

4. Inner packaging made of fragile materials such as glass, ceramic, or certain types of plastic must be securely fixed within the outer packaging using appropriate cushioning materials.

5. Packaging for volatile substances must be sufficiently sealed to ensure that the liquid level does not fall below the limit during transportation.

6. Packaging for liquids must be able to withstand internal pressure generated during transportation.

7. All packaging used for liquid preparations must undergo a leak test before leaving the factory.

8. Packaging for granular or powdered preparations must be sufficiently sealed to prevent spillage or require additional sealed lining layers.

on the product label.

Article 34. Storage of Chemicals and Formulations

The storage of chemicals and formulations must comply with the content of the instructions provided by the manufacturer as indicated on the product label. issued products that have expired and cannot be recycled or do not ensure quality and cannot be remedied; business budgets, equipment, materials, supplies, products that should no longer be used; waste chemicals or unused chemicals during production, business, and use that cannot be recycled. In this Circular, the following terms are understood as follows:.

Article 35. Disposal of Chemicals and Formulations

1. Situations Requiring Disposalof:

a) Chemicals and formulations that have exceeded their shelf life and cannot be recycled or do not meet quality standards and cannot be rectified; environmental protection.

b) Containers holding chemicals and formulations that will no longer be used; waste or unused chemicals and formulations during production, business operations, and usage that cannot be recycled. issued if the formulation is found to be defective or poses a risk of adverse effects on users' health or the environment, the registration number holder

2. issued Chemicals and formulations used by households for household purposes must be disposed of according to the recommendations of the manufacturer and environmental protection laws.

3. Organizations and individuals who have chemicals, formulations, or packaging of chemicals and formulations that must be destroyed shall bear all costs associated with the disposal.

4. Collection and disposal of chemicals, formulations, and their packaging must not cause spillage, dispersion, or increase hazardous waste in the environment and must be processed using appropriate technology as prescribed by environmental protection laws. for 3. In cases where the formulation cannot be remedied or the risk factor adversely affecting users' health or the environment persists beyond the remediation deadline specified in the decision suspending circulation, and the facility has not completed the remediation, the Ministry of Health

Section 4. SUSPENSION OF CIRCULATION OF FORMULATIONS

Article 36. Procedures for Suspending Circulation of Formulations with Warnings from the Formulation Owner or Registration Number Owner

1. In cases where it is determined that formulations have defects or pose risks affecting user health or the environment, the registration number owner shall be responsible for: responsibility for issuing a decision to recall the suspended formulation. The recall decision for the suspended formulation must be published on the Ministry of Health’s website. registration a) Temporarily suspending circulation of the formulation;

b) Issuing a notification to the Ministry of Health and organizations or individuals engaged in distribution of the formulation;

simultaneously announcing in mass media about the suspension of circulation and use of the formulation. The notification must clearly state the batch number, defect factors, or risk factors affecting user health or the environment, as well as whether these can be rectified. of Finance) For formulations that can rectify defects or risk factors affecting user health or the environment: In this Circular, the following terms are understood as follows:a) Within five working days from receiving the notification from the formulation owner or registration number owner, the Ministry of Health shall issue a decision to suspend circulation of the formulation; business budgets, equipment, materials, supplies,b) Within ninety days from the date of the decision to suspend circulation of the formulation, the registration number owner shall complete rectification of defects or risk factors affecting user health or the environment;

2. In cases of supplementary registration, extension of the registration number for circulation, and reissue of the Product Circulation Registration Certificate, the organization entitled to register for circulation is the owner of the registration number. c) After completing rectification, the registration number owner shall submit a report to the Ministry of Health along with documentation proving completion of rectification;

d) Within thirty days from receiving the rectification report from the registration number owner, the Ministry of Health shall issue a decision to terminate the suspension of circulation of the formulation. If the Ministry of Health disagrees with terminating the suspension, they must provide a response detailing the reasons.

3. In cases where formulations cannot rectify defects or risk factors affecting user health or the environment, or if the rectification period specified in the suspension decision has expired without completion of rectification, the Ministry of Health shall be responsible for issuing a decision to recall the suspended formulation. The decision to recall the suspended formulation must be published on the Ministry of Health's electronic information website. registration 4. Content of the Decision to Suspend Circulation or Recall Suspended Formulations:

a) Name of the suspended or recalled formulation; of Finance) b) Batch number of the suspended or recalled formulation;

c) Registration number of the suspended or recalled formulation; component implemented during the investment cycle, at the end of each cycle, the d) Suspension period; of Finance) e) Requirements for handling the recalled formulation.

4. Content of the decision to suspend circulation or recall the suspended formulation: includes a) Name of the suspended or recalled formulation;

b) Batch number of the suspended or recalled formulation;

c) Registration number for circulation of the suspended or recalled formulation;

d) Time

of suspension;

e) Handling requirements for the recalled formulation. 10. The registration number holder discontinues operations or no longer meets the conditions for registering circulation of the formulation.

Article 39. Procedure for Revoking Registration Number for Circulation

Article 37. Suspension Procedure for Products with Warnings Issued by Competent Authorities

1. Within five working days from the date of receipt of notification regarding risk factors that may adversely affect the health of users or the environment, sent by countries where the product is circulating or the World Health Organization, the Ministry of Health shall issue a decision to suspend circulation of the product and send a document requesting the owner of the registration number to report and explain. of 2. Within five working days from the date of receipt of the document from the Ministry of Health, the owner of the registration number for circulation has the responsibility to submit a report to the Ministry of Health. registration 3. Within five working days from the date of receipt of the report from the owner of the registration number for circulation, the Ministry of Health shall assess risk factors that may adversely affect human health and the environment.

4. In cases where it is determined that there are no risk factors, within five working days from the date of assessment results, the Ministry of Health shall issue a decision to terminate the suspension of circulation.

5. In cases where it is determined that there are risk factors that may adversely affect human health or the environment but can be remedied, the Ministry of Health shall issue a document notifying the owner of the registration number for circulation to implement remediation measures as stipulated in Clause 2, Article 36 of this Decree. In this Circular, the following terms are understood as follows:.

6. In cases where it is determined that there are risk factors that may adversely affect human health or the environment and cannot be remedied, depending on the nature and severity of the risk factors, the Ministry of Health shall issue a decision to recall the batch or all products.

Section 5. REVOCATION OF CIRCULATION REGISTRATION NUMBER

Article 38. Circumstances for Revocation of Circulation Registration Number

1. The registration entity falsifies the registration dossier.

2. The product is manufactured at a facility that does not meet production conditions.

3. The product is manufactured with technical specifications that do not match the registration dossier.

4. The product has three batches or more suspended from circulation during the validity period of the registration number.

5. The imported product is withdrawn from circulation in the exporting country.

6. The product with risk factors that may adversely affect human health or the environment is recalled entirely according to Clause 6, Article 37 of this Decree.

7. The product owner or the registration number owner requests withdrawal of the circulation registration number in Vietnam.

8. The product is concluded by competent authorities to infringe intellectual property rights.

9. The registration number owner leases, lends the registration certificate or arbitrarily modifies the content of the registration certificate.

10. The registration number owner ceases operations or no longer meets the conditions for registering the product. of Finance) Article 39. Procedure for Revocation of Circulation Registration Number

1. Within fifteen days from the date of determination of circumstances as stipulated in Article 38 of this Decree, the Ministry of Health shall consider and decide on the revocation of the circulation registration number. registration 2. The decision to revoke the registration number is sent to the registration number owner, the Ministry of Finance (General Department of Customs), the People's Committee of the province, and published publicly on the Ministry of Health’s electronic information website.

1. Within 15 days from the date of identifying the

as stipulated in Article 38 of this Decree, the Ministry of Health shall examine and decide on revoking the registration number for circulation.

2. Decision to revoke the registration number Model No. 04 in Appendix I pursuant to Article 38 of this Decree, the Ministry of Health shall consider and decide on the revocation of the registration number for circulation.

2. Decision to revoke the number registration The circulation permit shall be sent to the owner of the circulation registration number, the Ministry of Finance (General Department of Customs), the People's Committee of the province, and publicly posted on the Ministry of Health’s electronic information website.

Chapter V. PURCHASE AND SALE OF CHEMICAL PRODUCTS

Article 40. Conditions for organizations and individuals purchasing and selling chemical products

1. Personnel:

a) The person responsible for chemical safety must have a secondary level education or higher in chemistry;

b)[27] (Repealed)

2. Material and technical conditions: material, technical:

a) The display area for insecticides and bactericides must be separate from food items;

b) Storage conditions for chemical products must meet the storage requirements indicated on the product label;

c) There must be first aid equipment that meets the initial treatment requirements indicated on the product label.

3.[28] Organizations and individuals purchasing and selling common insecticides and bactericides include: mosquito-repellent incense; household and medical-use mosquito repellent pads; insecticide sprays; insect baits; insect repellent creams, patches, and bracelets for people; mosquito repellent vapor solutions; mosquito repellent treated nets, curtains, and paper; household bactericides do not need to comply with the requirements set forth in Clause 1 and Point c, Clause 2 of this Article.

Article 41. Conditions for service providers using chemical products to eliminate insects and bacteria

1.[29] (Repealed)

2. Individuals directly performing insect and bacteria elimination must be trained in the following areas and confirmed by the service provider's management as having been trained in:³¹:

a) Reading information on the product label;

b) Techniques for eliminating insects and bacteria suitable for the services provided by the organization;

c) Safe use and disposal of insecticides and bactericides.

3.[30](Repealed)

4. Complete the announcement of meeting the conditions for providing insect and bacteria elimination services using chemical products as stipulated in Article 43 of this Decree.

Article 42. Documents for announcing compliance with conditions for providing insect and bacteria elimination services using chemical products

1. A declaration of compliance with conditions for providing insect and bacteria elimination services using chemical products according to Model No. 08 in Appendix I issued together with this Decree.

2.[31] A list of individuals who have received training with confirmation from the organization's management.

3.[32] (Repealed)

Article 43. Announcing compliance with conditions for providing insect and bacteria elimination services using chemical products

1. Service providers submit the application directly or send it via postal service to the Department of Health where the organization is headquartered. In cases where the Department of Health implements online announcements, the organization submits the application online.

1. The production facility submits the documents directly or sends them through postal service to the Department of Health where the production facility is located. If the Department of Health implements online announcements, the production facility submits the documents online.

a) Before providing insect and bacteria elimination services using chemical products, the legal representative of the organization has the responsibility to submit the announcement documents to the Department of Health where the organization is headquartered; conditions ngers; ||| b) After receiving complete documents, the Department of Health issues the organization a receipt for submission of the announcement of compliance with conditions for providing insect and bacteria elimination services using chemical products according to

Model No. 08 in Appendix III 4. Within three working days from the date recorded on the receipt for submission of the announcement documents, the Department of Health is responsible for publishing on its electronic information website the following information: Name, address, contact phone number of the service provider using chemical products to eliminate insects and bacteria. issued together with this Decree.

3. Online announcement procedures as stipulated in Chapter VIII of this Decree.

5. During operation, the service provider using chemical products to eliminate insects and bacteria is responsible for updating the information in the announcement documents within fifteen days from the date of any of the following changes:

a) Changes in personnel: Installation a request for information update accompanied by the documents specified in Clause 2 of Article 42 of this Decree;

b) Changes in equipment and means for insect and bacteria elimination: A request for information update accompanied by the documents specified in Clause 3 of Article 42 of this Decree; Culture, c) Changes in name, address, and contact phone number: A request for information update.

6. Within three working days from the date of receipt of the request for information update as stipulated in Clause 5 of this Article (the date of receipt of the update request is calculated based on the date recorded on the Department of Health's receipt stamp), the Department of Health is responsible for updating the information on its electronic information website.

7. If the organization relocates or adds a service provision location within the same province, it must reapply for the announcement of compliance with conditions as prescribed in this Decree.

8. If the organization relocates from one province to another, it must notify the Department of Health where the organization previously announced compliance with conditions for providing insect and bacteria elimination services using chemical products within fifteen days from the relocation date.

Within three working days from the date of receipt of the notification of relocation to another province by the service provider using chemical products to eliminate insects and bacteria (the date of receipt of the notification is calculated based on the date recorded on the Department of Health's receipt stamp), the Department of Health that previously accepted the application for the announcement of compliance with conditions for providing insect and bacteria elimination services using chemical products must terminate the publication of all related information about the organization.

8. In case a facility changes its location from one province to another, it must notify the Health Department where the facility has completed the declaration of qualification for pest control and sterilization services using formulations within fifteen days from the date of relocation.

Within three working days from the date of receiving the notification about the relocation to another province by the facility providing pest control and sterilization services using formulations (the receipt date of the notification document is calculated based on the date marked on the Health Department's receipt stamp), the Health Department that received the declaration of qualification for pest control and sterilization services using formulations must terminate the publication of all related information about that facility.

Chapter VI. TRANSPORTATION OF CHEMICALS AND PREPARATIONS

Article 44. Principles for the Transportation of Chemicals and Preparations

1. The transportation of chemicals and preparations listed in the dangerous chemicals catalog as prescribed by the law on chemicals, in addition to complying with the provisions of this Decree, must also comply with the regulations on the transportation of hazardous goods.

2. It is not allowed to transport chemicals and preparations that can react with each other on the same means of transport.

Article 45. Requirements for Packaging, Containers, or Containers During Transportation

1. They must be packaged appropriately according to each type of chemical or preparation in accordance with the provisions of Article 33 of this Decree.

2. They must have labels indicating the physical characteristics of the chemicals or preparations affixed. The size of the label indicating the physical characteristics of the chemicals or preparations is 100 mm x 100 mm for each container holding chemicals or preparations, and 250 mm x 250 mm for containers.

3. For chemicals and preparations listed in the dangerous chemicals catalog as prescribed by the law on chemicals, they must have hazardous material labels affixed. The size of the hazardous material label is 100 mm x 100 mm for each container holding chemicals or preparations, and 250 mm x 250 mm for containers. There must be a danger warning sign below the hazardous material label. The size of the danger warning sign is 300 mm x 500 mm.

Article 46. Requirements for Means of Transport

1. Must have fire-fighting equipment suitable for the chemicals or preparations being transported.

2. Must be fully covered to ensure that the chemicals or preparations are not exposed to water during transportation.

3. The size of the hazardous material label affixed to the means of transport is 500 mm x 500 mm.

Article 47. Regulations on the Process of Transporting Chemicals and Preparations

1. During the transportation of chemicals and preparations, the driver of the means of transport must follow the schedule recorded in the transportation contract or related documents between the owner of the means of transport and the owner of the goods.

2. In case of an incident during transportation, the driver, the shipper, and the owner of the means of transport must promptly apply measures to limit consequences, address the incident, and simultaneously report to firefighting forces, relevant authorities, facilities, and local government authorities nearest to the location for coordinated response and resolution of the incident. issued during transportation, the driver, consignor, and vehicle owner must promptly apply measures to limit consequences and rectify the incident, while simultaneously notifying the fire-fighting force, relevant agencies, facilities, and the nearest local authority to coordinate in responding and rectifying the incident.

Chapter VII. EXPORT AND IMPORT OF CHEMICALS AND PREPARATIONS

Article 48. Principles for Implementing Export and Import of Chemicals and Preparations

1. The export and import of chemicals and preparations shall be carried out in accordance with the regulations on the export and import of goods. issued 2. Preparations with valid certificates of circulation may be imported according to demand without quantity or value restrictions, procedures handled at Customs, and without approval from the Ministry of Health. The importer bears full responsibility under the law for its activities.

3. Raw materials for producing preparations that have been registered for circulation may be imported according to production needs, procedures handled at Customs, and without approval from the Ministry of Health. The importer bears full responsibility under the law for its activities. registration 4. In cases where the importing country requires confirmation that the preparation has been circulated in Vietnam, the holder of the registration number for circulation shall implement in accordance with the regulations on certificates of free circulation for products and goods exported and imported.

3. Raw materials for producing formulations that have been issued a circulation registration number can be imported according to production needs through customs procedures without requiring approval from the Ministry of Health. The importer bears full responsibility under the law for their own activities.

4. In cases where the importing country requests confirmation that the formulation has been circulated in Vietnam, the owner of the circulation registration number shall comply with the provisions of the law regarding the Certificate of Free Sale for exported and imported products and goods.

Article 49. Import Permit

1. Types of chemicals and products that must have an import permit include:

a) Chemicals and products imported for research purposes;

b) Products imported to serve aid purposes; use for other special purposes (such as gifts, donations, or when there is no suitable product or method on the market to meet the importing organization's or individual's needs).

2. Documents required for issuing an import permit include:

a) A request for importation according to Form No. 09 in Appendix I e) |||

b) Technical documentation of the chemicals and products including contents as prescribed in Appendix V e) |||

c) For chemicals and products imported for research purposes: A research outline confirmed by the legal representative of the research institution or the manufacturing facility that has published sufficient information conditions rights business budgets, equipment, materials, supplies,;

d) In cases of aid: A certified true copy of the decision approving the receipt of aid from the competent authority and documentation about the consignment requested for importation;

đ) In cases of gifts, donations, or presents: A notification letter regarding the gift, donation, or present and documentation proving that the product requested for importation has been permitted for use by the competent authority in the exporting country;

e) In Model No. 04 in Appendix I cases where there is no suitable product or method on the market to meet the importing organization's or individual's needs: Documentation proving that there is no suitable product or method available on the Vietnamese market in the Field of Teachers and Educational Institution Managers to meet the importing organization's or individual's needs and documentation proving that the product requested for importation has been permitted for use by the competent authority in the exporting country;

g) In cases where products are imported for special purposes other than research with a single import weight of 50 kg or more, a certified true copy of the Good Manufacturing Practice (GMP) certificate or ISO certification of the manufacturing plant and a Free Circulation Certificate must be provided.

Article 50. Procedures for Issuing Import Permits

1. Organizations or individuals requesting importation (hereinafter referred to as the importing organization) submit the application directly or send it via postal service to the Ministry of Health (Health Environment Management Department). In case If the Ministry of Health implements online issuance of import permits, organizations or individuals must submit their applications online. The procedures for applying for an online import permit shall be carried out in accordance with Chapter VIII of this Decree.

2. After receiving the application for an import permit, the Ministry of Health sends the importing organization a Receipt for Application for Import Permit. The Receipt for Application for Import Permit follows Form No. 09 in Appendix III issued together with this Decree.

3. If there is no need for additional or amended documentation in the application for importation, the Ministry of Health is responsible for issuing the import permit. If the permit is not issued, a response must be provided with clear reasons stated.

4. If the application for importation is incomplete, the Ministry of Health must notify the importing organization in writing to supplement or amend the application within 15 days from the date recorded on the Receipt for Application for Import Permit. The notification must clearly state the required supplements, to the relevant national government agency responsible for external management (Ministry of Foreign Affairs, Department of Foreign Affairs, or Provincial People's Committee Office) at the provinces or cities directly under the Central Government where the foreign organization has its headquarters or will carry out activities, programs, or projects..

5. If the Ministry of Health requests MANAGEMENT AND USE OF DEPOSITS AT THE ENVIRONMENT PROTECTION FUNDamendments to the application within 60 days from the date recorded on the notification, the importing organization must complete the application and provide detailed explanations in writing MANAGEMENT AND USE OF DEPOSITS AT THE ENVIRONMENT PROTECTION FUNDsent to the Ministry of Health. The date of receipt of the supplementary or amended application is recorded on the Receipt for Application for Import Permit. If the deadline is exceeded, the application for importation and 6. If there is no longer a need for supplementation, 2. Import procedures shall be carried out in accordance with relevant laws and regulations. will be canceled.

amendments, the Ministry of Health must issue the import permit in accordance with Clause 3 of this Article. to the relevant national government agency responsible for external management (Ministry of Foreign Affairs, Department of Foreign Affairs, or Provincial People's Committee Office) at the provinces or cities directly under the Central Government where the foreign organization has its headquarters or will carry out activities, programs, or projects.7. Within three working days from the date of issuance of the import permit, the Ministry of Health is responsible for publicly disclosing the following information on its electronic information website:

a) Name of the product;

b) Import permit number;

c) Full text of the import permit.

c) Full text of the import permit.

Chapter VIII. ANNOUNCEMENT, ONLINE REGISTRATION

Article 51. Cases for Announcement, Registration, and Application for Import Permit Online

1. Announcement of meeting conditions for production of formulations.

2. Announcement of meeting conditions for conducting formulation testing.

3. Announcement of meeting conditions for conducting formulation trials.

4. Registration for circulation.

5. Notification of additional content or label format according to Clause 2, Article 32 of this Decree.

6. Announcement of meeting conditions for providing insect and bacterial control services using formulations.

7. Application for import permit.

Article 52. Requirements for Online Announcement, Registration, and Application for Import Permit

The announcement, registration, application for import permit, notification of additional content or label format (hereinafter referred to as the registration dossier) online shall be considered valid when it meets the following requirements: MANAGEMENT AND USE OF DEPOSITS AT THE ENVIRONMENT PROTECTION FUND 1. It contains all necessary documents with complete information as required for paper-based dossiers and converted into electronic text. The name of the electronic version must correspond to the type of document in the paper-based dossier.

2. Information for announcement, application for permit is fully and accurately entered based on the information in the electronic versions. of Finance) the electronic version must correspond in the Field of Teachers and Educational Institution Managers to the name of the document in the paper file.

2. The published information, registrationapplication for a permit must be fully and accurately filled out according to the information in the of Finance) electronic versions.

Article 53. Procedures for Online Registration

1. The legal representative declares information, uploads electronic documents, signs the online registration dossier electronically, and pays fees online through the Ministry of Health's or Provincial Health Department's website.

2. After completing the submission of the online registration dossier, the legal representative will receive an online dossier receipt.

3. The agency receiving the online registration dossier will process administrative procedures corresponding to the dossier. registration in accordance with this Decree.

4. The result of the online administrative procedure is an electronic document signed digitally by the receiving agency and has the same legal effect as the results of administrative procedures processed in the traditional manner. of online administrative procedures is an electronic document signed with a digital signature by the agency receiving the file and has the same legal effect as the result of administrative procedures processed in the usual manner.

Article 54. Storage of Online Registration Dossier

1. In cases where it is determined that formulations have defects or pose risks affecting user health or the environment, the registration number owner shall be responsible for: When conducting online registration, organizationindividuals registering (hereinafter referred to as the registration entity) must store the paper-based dossier.

2. In cases where the documents in the registration dossier specified in Clause 1 of this Article are lost or damaged, the registration entity is responsible for notifying the receiving agency in writing and completing the dossier within 60 days from the date of loss or damage of the registration dossier.

3. Within five working days from the expiration of the period stipulated in Clause 2 of this Article, if the registration entity does not complete the dossier, the receiving agency is responsible for:

a) Ceasing the publication on the electronic information portal of information related to formulation production facilities, formulation testing facilities, formulation trial facilities, and insect and bacterial control service provision facilities;

b) Revoking the circulation number, import permit for formulations, and ceasing the publication on the electronic information portal of information related to the circulation registration book and import permit registration of formulations. 2. Import procedures shall be carried out in accordance with relevant laws and regulations. of the In this Circular, the following terms are understood as follows:.

4. The registration entity may not continue operations from the time the receiving agency cancels the information as provided in point a, Clause 3 of this Article. Formulations may not be circulated from the time the receiving agency cancels the information as provided in point b, Clause 3 of this Article.

Chapter IX. IMPLEMENTATION ORGANIZATION

Article 55. Responsibilities of the Ministry of Health

The Ministry of Health shall be responsible before the Government for managing state affairs concerning chemicals and formulations and shall have the following tasks and powers:

1. Submit to the Government and the Prime Minister for issuance and issuance within its authority legal regulatory documents on chemicals and formulations.

2. Implement legal regulatory documents, strategies, policies, and plans on chemicals and formulations.

3. Organize information dissemination, education, and communication on chemicals and formulations.

4. Publicly post on the Ministry of Health’s electronic information website the information stipulated in this Decree.

5. Conduct inspections, handle complaints and denunciations, and address violations of laws in the field of chemicals and formulations.

6. Organize banks international activities on chemicals and formulations.

Article 56. Responsibilities of the Ministry of Industry and Trade

1. Take the lead and coordinate with the Ministry of Health to issue technical standards on safe distances for formulation production facilities and labeling of chemicals and formulations according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). quality of the document simultaneously poor quality of the document (GHS).

2. Carry out inspection and supervision activities on chemicals and formulations circulating in the market as prescribed by law.

Article 57. Responsibilities of the People's Committee of the Province

1. Be responsible for managing chemicals and formulations within their jurisdiction.

2. Publicly post on the People's Committee of the Province’s electronic information website (Department of Health) and send the Ministry of Health information about chemical and formulation production facilities; pest control and disinfection service providers using formulations. In this Circular, the following terms are understood as follows: within the province.

3. Conduct inspections, handle complaints and denunciations, and address violations of laws in the field of chemicals and formulations within the province.

Article 58. Responsibilities of the Owner of the Registration Number for Circulation

1. Ensure the completeness and legality of all documents in the registration dossier submitted to the Ministry of Health or provided ||| upon request (for offline cases). registration 2. Provide complete and accurate information about formulations on labels, packaging, and accompanying documents of chemicals and formulations in accordance with the law on product labeling and the provisions of this Decree.

3. Timely warn about risks that may adversely affect users' health and the environment; provide preventive measures for sellers and consumers; provide information on transportation, storage, preservation, and usage requirements for chemicals and formulations.

4. Immediately cease circulation, notify relevant parties, and take measures to rectify or recall formulations as specified in Articles 36 and 37 of this Decree.

5. Recall and dispose of chemicals and formulations as specified in Articles 36 and 37 of this Decree. In cases where disposal is done through destruction, they must comply with environmental protection laws, other related laws, and bear all costs associated with such destruction.

6. Comply with legal regulations and decisions regarding inspections and supervision by competent state agencies.

Article 59. Organizations and Individuals Using Formulations

7. Other obligations as prescribed by law.

1. For formulations donated or used for special purposes approved by the Ministry of Health for importation, organizations and individuals permitted to import and those using them shall be fully responsible for their use.

2. Require formulation suppliers to provide full information on the hazardous characteristics of the formulations

and requirements to ensure efficacy and safety of the formulations In this Circular, the following terms are understood as follows: ; entitled to compensation In this Circular, the following terms are understood as follows:for damages during the use of the formulations due to inaccurate information from the supplier. 3. Adhere strictly to usage instructions displayed on the formulation label or accompanying documents and be fully responsible if used incorrectly; ensure safety for themselves, the environment, and the community; if causing damage to others’ health, life, or property through the use of chemicals or formulations, they must compensate according to the law. In this Circular, the following terms are understood as follows: Upon discovering that chemicals or formulations do not meet the efficacy standards indicated by the manufacturer on the label or that formulation information does not match the Registration Certificate, organizations and individuals using them must immediately stop using them and report in writing to the Ministry of Health or the Department of Health at the location where the owner of the registration number has its main office or where the individual resides for legal handling. ||| in accordance with the law.

3. Strictly follow the usage instructions displayed on the formulation label or accompanying instructions and bear full responsibility if used incorrectly; ensure safety for oneself, the environment, and the community; if using chemicals or formulations causes health, life, or property damage to others, compensation must be provided according to the law.

4. In case If chemicals or formulations are found not to meet the effectiveness specified by the manufacturer on the label or the formulation information does not match the Circulation Registration Certificate issued, the user organization or individual must temporarily stop using them and report in writing to the Ministry of Health or the Health Department where the circulation registration number holder's main office or residence is located for handling according to the law. registration The circulation registration number holder's main office or residence or place of residence for individuals is located for handling according to the law.

Article 60. Responsibilities of production facilities

1. Ensuring production conditions in accordance with the provisions of this Decree and the declaration of sufficient production conditions of the facility.

2. Retaining the results of testing the components and active substance content of each batch of products before leaving the factory, with a minimum retention period equal to the shelf life of the batch of products. business budgets, equipment, materials, supplies, factory, the minimum retention period being equal to the shelf life of the batch of products. In this Circular, the following terms are understood as follows:.

3. Notifying the Department of Health in writing when the facility no longer meets the production conditions.

Article 61. Responsibilities of testing facilities

1. Ensuring the conditions as prescribed in this Decree and in accordance with the declaration of sufficient conditions for conducting tests of the facility.

2. Conducting tests according to the effects, methods, and dosage indicated on the product label and complying with the testing procedures issued by the Ministry of Health, and reporting the test results accordingly. ANNEX X issued together with this Decree.

3. In cases where the product is permitted to be tested but does not have a testing procedure issued by the Ministry of Health, the facility shall implement the testing and request the Ministry of Health to issue a testing procedure.

4. Being responsible under the law for the testing of products provided by the facility. of implementing the supervision program 5. Reporting semi-annually on the implementation of testing to the Ministry of Health before July 15th of each year and before January 15th of the following year. In case of discovering differences in actual dosage compared to the recommended dosage indicated on the product label or evidence of chemical resistance, the testing facility must report in writing to the Ministry of Health for consideration and resolution.

6. Notifying the Ministry of Health in writing when the facility no longer meets the conditions for conducting tests. business budgets, equipment, materials, supplies, Article 62. Responsibilities of testing facilities In this Circular, the following terms are understood as follows: 1. Ensuring the conditions for testing facilities as prescribed in this Decree and in accordance with the declaration of sufficient conditions for conducting tests of the facility. component implemented during the investment cycle, at the end of each cycle, the.

2. Being responsible under the law for the results of testing products provided by the facility.

3. Notifying the Ministry of Health in writing when the facility no longer meets the conditions for conducting tests.

Article 63. Responsibilities of service providers for insect and bacterial control using products

1a. Organizing training for personnel directly involved in insect and bacterial control at the facility. In cases where training is not organized, the facility owner must send personnel directly involved in insect and bacterial control to attend training programs provided by units that offer such training in accordance with Clause 2, Article 41 of this Decree.

1. Ensuring the conditions for providing services for insect and bacterial control using products in accordance with this Decree and in accordance with the declaration of sufficient conditions for providing services of the facility.

2. Notifying the Department of Health in writing when the facility no longer meets the conditions for providing services.

Chapter X. IMPLEMENTATION PROVISIONS[33].

Article 64. Effective Date In this Circular, the following terms are understood as follows: 2. Clause 12, Article 12 of Decree No.

89/2006/NĐ-CP

dated August 30, 2006 of the Government[34]

on product labels; Clauses 2 and 3, Article 8 of Decree No.

1. This Decree takes effect from July 1, 2016.

108/2008/NĐ-CP supplemented and amended by Clause 8, Article 1 of Decree No. 26/2011/NĐ-CP for dated April 8, 2011 of the Government detailing and guiding the implementation of certain articles of the Chemicals Law; Clause 3, Article 18 of Decree No. 104/2009/NĐ-CP dated November 9, 2009 of the Government on the List of Hazardous Goods and Transport of Hazardous Goods by Road Vehicles ceases to be effective from the date this Decree takes effect. 1. Production facilities for chemicals and products that were operating before the effective date of this Decree may continue to operate but must complete the declaration of sufficient production conditions by July 1, 2017. 2. Testing and evaluation facilities for chemicals and products that were operating in accordance with the law before the effective date of this Decree may continue to operate but must complete the application for declaration of sufficient conditions for testing and evaluation by July 1, 2017. 3. Applications for circulation, import permits received before the effective date of this Decree will continue to be processed in accordance with the law at the time of receipt.

Article 65. Transitional Provisions

4. Raw materials chemicals that have been accepted before the effective date of this Decree and have been registered for circulation will continue to circulate until the end of the registration period.

5. Chemicals and products that have been accepted before the effective date of this Decree and have been registered for circulation will continue to circulate but must complete labeling of chemicals in accordance with this Decree by July 1, 2018.

6. Service providers for insect and bacterial control using products that were operating in accordance with the law before the effective date of this Decree may continue to operate but must complete the declaration of sufficient conditions for providing services by July 1, 2018. registration permits and import licenses accepted before this Decree takes effect shall continue to be processed according to the legal provisions at the time of acceptance.

4. Raw materials that were accepted before this Decree took effect and have been issued a circulation registration number may continue to circulate until the end of the circulation registration period granted.

5. Chemicals and formulations that were accepted before this Decree took effect and have been issued a circulation registration number may continue to circulate but must complete the chemical labeling according to this Decree before July 1, 2018.

6. Facilities providing pest control and sterilization services using formulations that operated in accordance with the law before this Decree took effect may continue to operate these services but must complete the declaration of qualification for service provision before July 1, 2018.

Article 66. Responsibilities for Guidance and Implementation

1. The Minister of Health shall be responsible for guiding, organizing, and supervising the implementation of this Decree.

2. Ministers, heads of ministerial-level agencies, heads of government-affiliated agencies, Chairmen of the National Assembly; At all levels of the people and relevant agencies, organizationindividuals shall be responsible for implementing this Decree./.

ANNEX I

ANNOUNCEMENT DOCUMENTS, REGISTRATION APPLICATIONS FOR CIRCULATION
dated October 1, Decision No. 91/2016/NĐ-CP dated July 1, 2016 of the Government and Decree No. Decision No. 155/2018/NĐ-CP November 12, 2018 SECTOR MANAGING BODIES

Form No. 01¹

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

......¹..., day...month...year 20...

ANNOUNCEMENT DOCUMENT

Qualified for Production of Formulations

Respectfully submitted to:...²....................

1. Name of establishment:...

Headquarter Address:…³........................................................................

Telephone:...Fax:...

Legal representative:

2. Legal Representative of the Production Facility:

Full name:…

Landline Phone determines:…Mobile Phone:…

Fax:…Email:…

3. Production Address:…⁴...........................................................

4. First Announcement □⁵

Reannouncement □ Announcement Number…⁶...............

5. Formulations Produced by the Facility:

^{______________________________}

¹ Place name.

² Department of Health where the production facility is located.

³ Record according to the address on the business registration certificate.

⁴ If it is the same as the business address then record "at headquarters". registration Check the box for first announcement or reannouncement.

⁵ Record the receipt number of the most recent announcement.

⁶ Unit of weight or volume.

⁷ After studying Decree No.../2016/NĐ-CP dated... month... year 2016 of the Government, we announce that our production facility meets the conditions for producing formulations and attach with this document a set of files including the following papers:

Personnel Declaration Form

(Sign directly, write full name and stamp)

Form No. 02

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

......¹..., day...month...year 20...

ANNOUNCEMENT DOCUMENT

Respectfully submitted to: Ministry of Health (Health Environment Management Department)

2. Laboratory Address:…

1. Name of establishment:...

Headquarter Address:…

Telephone:...Fax:...

Legal representative:

3. First Announcement □

After studying Decree No…/2016/NĐ-CP dated... month... year 2016 of the Government, we announce that our testing facility meets the conditions for conducting tests and attach with this document a set of files including the following papers:²

Reannouncement □ Announcement Number…³............

List of Active Ingredients that the Facility Can Test of Finance) Certificate of Compliance with ISO 17025:2005 or updated version

2. First Announcement □

___________________

¹ Place name.

² Record the receipt number of the most recent announcement.

³ Unit of weight or volume.

Implementation Report of Production Projects of Supporting Industry Products Confirmed with Incentives²

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

......¹..., day...month...year 20...

After studying Decree No…/2016/NĐ-CP dated... month... year 2016 of the Government, we announce that our field trial facility meets the conditions for conducting field trials on formulations and attach with this

2. Laboratory Address:…

1. Name of establishment:...

Headquarter Address:…

Telephone:...Fax:...

Legal representative:

announcement document the following files:²

Reannouncement □ Announcement Number…³............

List of Field Trial Procedures that the Facility Can Conduct of Finance) Certificate of Compliance with ISO 17025:2005 or updated version

…requests Industry and new circulation of the formulation as follows:

___________________

¹ Place name.

² Record the receipt number of the most recent announcement.

³ Unit of weight or volume.

Form number 04³

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

......¹..., date..., month..., year...

1. Trade Name:…

2. Laboratory Address:…

²2. Composition and Active Ingredient Content (%):… registration 3. Formulation Type:…

4. Packaging Specifications:…³...................................................................................

5. Production Facility Name:…⁴....................................................

6. Production Address:…Phone:…Fax:…⁵..................................................................................

7. Registration Facility Name⁶.....................................................................................

8. Address: …

9. Phone:…Fax:…

10. Formulation Effect:… registration:...................................................................................................

11. Shelf Life:…

12. Request for Import (if applicable)…

Record the name of the registration facility.⁷.......................................................................

For imported formulations, accurately record the trade name according to the free sale certificate already issued.⁸.........................................................................

- Only list active ingredients and additives that have synergistic effects.⁹.........................................................................

____________________

¹ Place name.

² - Active ingredient content should be recorded in percentage form and specify whether it is by weight/volume (w/v or kl/tt), weight/weight (w/w or kl/kl), or volume/volume (v/v or tt/tt) depending on the nature of the formulation.

³ For in the Field of Teachers and Educational Institution Managers Record the finished product in its packaging without specifying packaging specifications. For example, liquid in spray bottles is a liquid formulation, mosquito coils are solid formulations. For insecticides with formulations such as oil emulsions, suspensions... record the formulation type in Vietnamese and include the abbreviated name in English in parentheses. For example: suspension (SC).

⁴ Clearly state the type of container such as bottle, package, bag... and include the quantity.

Briefly describe the effect of the formulation and clearly specify the usage scope as household or medical or both. For example: mosquito repellent for household use; hand sanitizer for both household and medical use.

⁵ Clearly state the shelf life in years or months from the date of production. In this Circular, the following terms are understood as follows: For imported formulations, clearly specify the import of the formulation (for imported formulations) or the import of raw materials for production for testing and field trials and include the following information:

⁶ Active ingredient content

⁷ Name and address of the manufacturer Industry and SUPPLEMENTAL REGISTRATION APPLICATION FOR CIRCULATION

⁸ …requests supplemental registration for circulation of the formulation as follows: business budgets, equipment, materials, supplies,.

⁹ If includes 5. Content of the request for supplemental circulation:…

Form number 05

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

......¹..., date..., month..., year...

8. Production Address:…Phone:…Fax:…⁴²

2. Laboratory Address:…

...........²9. Registration Facility Name:…

4. Packaging Specifications:…³................................................................................

5. Production Facility Name:…⁴...............................................

6. Production Address:…Phone:…Fax:…⁵...................................................................

7. Registration Facility Name⁶...................................................................

10. Address:… registration 11. Phone:…Fax:…⁷......................................

Record the name of the registration facility.

For imported formulations, accurately record the trade name according to the free sale certificate already issued.

For formulations in spray bottles, they are liquid formulations, mosquito coils are solid formulations. For insecticides with formulations such as oil emulsions, suspensions... record the formulation type in Vietnamese and include the abbreviated name in English in parentheses. For example: suspension (SC).

Clearly state the changes requested regarding ownership of the certificate, trade name, address, contact information, effect, quality standards.

EXTENSION REGISTRATION APPLICATION FOR CIRCULATION NUMBER

…requests extension of the registration number for circulation of the formulation as follows:

___________________

¹ Place name.

² 4. Registration Number for Circulation:…valid until:… registration.

³ 5. Changes during circulation:…

⁴ Clearly state the type of container such as bottle, package, bag... and include the quantity.

Briefly describe the effect of the formulation and clearly specify the usage scope as household or medical or both. For example: mosquito repellent for household use; hand sanitizer for both household and medical use.

⁵ Clearly state the shelf life in years or months from the date of production. In this Circular, the following terms are understood as follows: 6. Production Facility Name:… Industry and 7. Production Address:…Phone:…Fax:…

⁶ Active ingredient content

⁷ 8. Registration Facility Name:…

Form number 06⁴

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

......¹..., date..., month..., year...

9. Address:…
10. Phone:…Fax:…

2. Laboratory Address:…

...........²11. Formulation Effect:…

4. Packaging Specifications:…³................................................................................

5. Production Facility Name:…⁴...............................................

6. Production Address:…Phone:…Fax:…⁵...................................................................

12. Shelf Life:…

5. Changes during circulation:…⁶........................................... .

6. Name of the manufacturing facility:…

7. Production address:…Phone:…Fax:…

8. Name of the registered facility:…

9. Address:…

10. Phone:…Fax:…

11. Effectiveness of the formulation:…⁷.................................................

12. Expiry date:…⁸...................................................................

___________________

¹ Place name.

² Record the registration unit name.

³ 5. Changes during circulation:…

⁴Clearly state the type of container such as bottle, package, bag... and include the quantity.

Briefly describe the effect of the formulation and clearly specify the usage scope as household or medical or both. For example: mosquito repellent for household use; hand sanitizer for both household and medical use.

⁵ In packaged finished products, do not record specifications, packaging. Example: finished product form Industry and spray can are liquid form, mosquito incense is solid form. For insecticides with formulations such as emulsions, suspensions..., record the formulation in Vietnamese accompanied by the abbreviated name of the formulation in English in parentheses. Example: suspension (SC).

⁶ List changes during circulation, clearly state approved changes and unapproved changes.

⁷ Record the effects of the product as per the Certificate. registration for circulation.

⁸ …requests supplemental registration for circulation of the formulation as follows: business budgets, equipment, materials, supplies,.

Form No. 07

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

......¹..., date..., month..., year...

APPLICATION FOR RENEWAL
REGISTRATION CERTIFICATE

2. Laboratory Address:…

........²... requests to renew the registration certificate for the product as follows:

4. Packaging Specifications:…³.......................................................

5. Production Facility Name:…⁴.......................................

3. Reasons for requesting renewal of the registration certificate:...⁵...........................

12. Shelf Life:…

___________________

¹ Place name.

² - Active ingredient content should be recorded in percentage form and specify whether it is by weight/volume (w/v or kl/tt), weight/weight (w/w or kl/kl), or volume/volume (v/v or tt/tt) depending on the nature of the formulation.

³ 5. Changes during circulation:…

⁴ Clearly state the type of container such as bottle, package, bag... and include the quantity.

Briefly describe the effect of the formulation and clearly specify the usage scope as household or medical or both. For example: mosquito repellent for household use; hand sanitizer for both household and medical use.

⁵ Clearly state the reasons for damage or loss.

Form No. 08⁵

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

......¹..., day...month...year 20...

ANNOUNCEMENT DOCUMENT

Meeting the conditions to provide pest control and disinfection services using products

Respectfully submitted to:...²..........................

1. Name of establishment:...

Head office address:³..............................................................................................................

Telephone:...Fax:...

Legal representative:

announcement document the following files:⁴

Reannouncement □ Announcement Number…⁵..........

After studying Decree No.../2016/NĐ-CP dated... day... year 2016 of the Government, we hereby announce that our facility meets the conditions to provide pest control and disinfection services using products and attach this document with the following dossier:

The facility announcing its qualification to provide pest control and disinfection services using products hereby commits to the accuracy of the documents in the announcement dossier./.

__________________

¹ Place name.

² Department of Health where the service-providing facility is located.

³ Record according to the address on the business registration certificate.

⁴ Record the receipt number of the most recent announcement.

⁵ Unit of weight or volume.

Form No. 09

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

......¹..., day...month...year 20...

APPLICATION FOR IMPORT

2. Laboratory Address:…

Name of the entity applying for import:...

Contact address:...

Telephone:...Fax:...

Request to import products for household and medical use as follows:

Purpose of import (specify):...⁵...................................................................

We hereby commit to ensuring the import of the above-mentioned products as follows:

1. Ensuring the efficacy and safety of the product for users and the environment.

2. Ensuring the use of imported products in accordance with the content of the import application document.

If we violate the above commitments, we will fully bear responsibility under the law.

__________________

¹ Place name.

² Accurately record the trade name.

³ Only record active ingredients and additives with synergistic effects, active ingredient content should be recorded in percentage form and clearly specify according to weight/volume (w/v or kl/tt), weight/weight (w/w or kl/kl), or volume/volume (v/v or tt/tt) depending on the nature. quality of the document simultaneously poor quality of the document of the In this Circular, the following terms are understood as follows:.

⁴ Name and address of the manufacturer Industry and SUPPLEMENTAL REGISTRATION APPLICATION FOR CIRCULATION

⁵ Clearly specify the purpose of import for research, aid, or gift...

ANNEX II

PERSONNEL DECLARATION FORM
dated October 1, Decision No. 91/2016/NĐ-CP (as of July 1, 2016 of the Government)

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
----------------

........¹..., day...month...year 20...

PERSONNEL DECLARATION FORM

__________________

¹ Place name

² Record years of work in specific fields, e.g., 05 years of pest control testing or 03 years specializing in chemical safety.

ANNEX III

RECEIPT OF DOSSIER
dated October 1, Decision No. 91/2016/NĐ-CP (as of July 1, 2016 of the Government)

Form No. 01

1. Declaring entity:

Dossier for Announcement of Qualification to Produce Products
_______________

1. Production Facility Name:...

2. Headquarter Address:...

3. Production Address:…

4. Dossier Components:

Form No. 02

1. Declaring entity:

Dossier for Announcement of Qualification to Conduct Testing
____________

1. Testing Facility Name:...

2. Headquarter Address:...

3. Testing Laboratory Address:...

4. Dossier Components:

Implementation Report of Production Projects of Supporting Industry Products Confirmed with Incentives

1. Declaring entity:

Dossier for Announcement of Qualification to Conduct Field Trials
________________

1. Field Trial Facility Name:...

2. Headquarter Address:...

3. Field Trial Laboratory Address:...

4. Dossier Components:

Form number 04

1. Declaring entity:

Dossier for New Registration Application
____________

1. Registration Unit Name:...

2. Headquarter Address:...

3. Dossier Components:

Form number 05

1. Declaring entity:

Dossier for Additional Registration Application
_____________

1. Registration Entity Name:...

2. Headquarter Address:...

3. Dossier Components:

Form number 06

1. Declaring entity:

Dossier for Extension of Registration Number Validity
________________

1. Entity Name registration:...................................................................................................

2. Headquarter Address:...

3. Dossier Components:

Form No. 07

1. Declaring entity:

Dossier for Application to Renew Registration Certificate
____________

1. Registration Unit Name:...

2. Headquarter Address:...

3. Dossier Components:

Form No. 08

1. Declaring entity:

Dossier for Announcement of Qualification to Provide Services
Pest Control and Disinfection Services Using Products
______________

1. Service Provider Name:...

2. Headquarter Address:...

3. Dossier Components:

Form No. 09

1. Declaring entity:

Dossier for Import Application

1. Import Applicant Name:...

2. Headquarter Address:...

3. Dossier Components:

ANNEX IV

REGISTRATION CERTIFICATE
dated October 1, Decision No. 91/2016/NĐ-CP (as of July 1, 2016 of the Government)

CERTIFICATE OF INSURANCE OR OTHER FINANCIAL SECURITY

PRODUCT REGISTRATION FOR INSECTICIDES AND DISINFECTANTS FOR HOUSEHOLD AND MEDICAL USE

CERTIFICATE FOR INSECTICIDE AND DISINFECTANT REGISTRATION FOR HOUSEHOLD AND MEDICAL USE

Trade name of product
__________

Trade name of product

Active ingredient(s)

Active ingredient(s)

Scope and method of application:

Scope and method of application:

Purpose of use

Shelf life

Registration No.Validfromuntil

Number registration Registration No.Validfromuntil

Name of certificate holder

Name of registering entity:...

Address of certificate holder

Address of certificate holder

Address of certificate holder

Name of production unit:…

Name of manufacturer

Address of production site:…

Address of manufacturing site

Source of raw materials:

Source of active ingredients

Notes:…

Notes

ANNEX V

TECHNICAL DOCUMENT CONTENT
dated October 1, Decision No. 91/2016/NĐ-CP (as of July 1, 2016 of the Government)
___________

I. GUIDELINES FOR PREPARING TECHNICAL DOCUMENTS

1. For products containing active ingredients that are being registered for the first time in Vietnam, the technical documents must include all sections as required under Section II.

2. For products where the active ingredients have already been registered in Vietnam, the technical documents shall include the contents specified in Part 1, Part 3 (product documentation) and Part 4 of Section II.

II. REQUIREMENTS FOR TECHNICAL DOCUMENTS:

ANNEX VI¹

REPORT ON THE MARKETING PROCESS
(Adopted along with Decree No. Decision No. 155/2018/NĐ-CP dated November 12, 2018 of the Government)

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
----------------

..., day...month...year 20...

REPORT ON THE MARKETING PROCESS OF PRODUCTS

2. Laboratory Address:…

Name of registration entity:…

Address:…Phone:…Fax:…

Name of production enterprise:...

Address:…Phone:…Fax:…

Name of importing entity (for imported products)…

Address:…

Trade Name:...

Composition and quantity of active ingredients (%):…

Shelf life:…

Form of product and packaging specifications:…

We hereby confirm that the above information is correct. If incorrect, we will bear full responsibility under the law./.

ANNEX VII¹

REQUIREMENTS FOR POWER OF ATTORNEY
(Adopted along with Decree No. Decision No. 155/2018/NĐ-CP dated November 12, 2018 of the Government)
____________

I. Content:

The power of attorney must contain the following complete contents:

- Name and address of the product owner.

- Name and address of the authorized organization or individual.

- Scope of authorization (registering for circulation of products in Vietnam for cases of authorization to register).

- Trade name of the authorized product.

- Address of the product manufacturing facility.

- Duration of authorization.

- Commitment of the product owner to provide complete product information files to the authorized organization or individual to carry out the registration process.

- Name, position, direct signature of the representative of the authorizing party.

2. In cases where the product owner has authorized a registration entity to circulate products in Vietnam and has been issued a registration number, within the validity period of the registration registration number, if the owner authorizes another entity to register for circulation in Vietnam, the new power of attorney must be accompanied by a document approving the discontinuation of registration and requesting withdrawal of the registration registration number held by the current holder of the registration number.

3. Legalization of consular:

Power of attorney from foreign entities to seize, must be legalized according to regulations, except in cases exempted from legalization under international treaties to which Vietnam is a party.

ANNEX VIII

REQUIREMENTS FOR FREE SALE CERTIFICATE
dated October 1, Decision No. 91/2016/NĐ-CP (as of July 1, 2016 of the Government)

I. Content

The Free Sale Certificate (Certificate of Free Sale - CFS) includes certificates with the following contents:

- Name of issuing authority;

- Date of issuance;

- Trade name of the product certified;

- Composition and quantity of active ingredients (mandatory for insecticides);

- Name and address of the manufacturer;

- Confirmation that the product is freely sold in the market of the issuing country;

- Signature and title of the person issuing the certificate.

2. Issuing Country

The issuing country must be the country of manufacture of the product or one of the member countries of the World Trade Organization.

3. Issue date

The CFS must be issued within a period not exceeding 12 months from the date of submission of the registration application.

4. Validity of CFS

The CFS must remain valid for at least six months from the date of submission of the registration application to the receiving authority in cases where the CFS specifies an expiry date.

5. Legalization of consular

The CFS must be legalized according to regulations, except Model No. 04 in Appendix I is exempt from consular legalization according to international treaties to which Vietnam is a member.

ANNEX IX¹

GUIDELINES FOR LABELING CHEMICALS AND PESTICIDES
(Adopted along with Decree No. Decision No. 155/2018/NĐ-CP dated November 12, 2018 of the Government)

Chemicals and pesticides circulating domestically, exported, or imported must be labeled in accordance with the labeling regulations for goods stipulated in Decree number supplemented and amended by Clause 8, Article 1 of Decree No. dated August 30, 2006 of the Government and the guidelines of the Globally Harmonized System of Classification and Labeling of Chemicals as prescribed by the Minister of Industry and Trade. In addition, the labels of chemicals and pesticides must meet the following requirements:

I. FOR PESTICIDES

1. Mandatory information to be included on the label

a) Trade name;

b) Composition and active ingredient concentration;

c) Effectiveness and usage instructions;

d) Storage instructions;

đ) Warning information about health risks to humans and the environment;

e) Measures to take if exposed to the pesticide (through skin, eyes, ingestion, inhalation);

g) Name and address of the manufacturer;

h) Name and address of the unit registrant;

i) Batch production number;

k) Date of manufacture or month and year of manufacture;

l) Expiration date;

m) Registration number registration for circulation in Vietnam.

2. Label format:

a) The letters and characters forming the trade name must be written continuously as per the registration application, with a minimum height equal to the largest character on the label;

b) The label must be printed clearly and legibly, not faded, torn, or damaged during circulation, storage, transportation, and use, with a font size not less than 0.9 mm;

c) The label must be securely attached or printed on the packaging of the pesticide; In this Circular, the following terms are understood as follows:;

d) The background of the label must not use colors that match the toxicity level of the pesticide. In this Circular, the following terms are understood as follows:.

3. Toxicity symbols on the label according to the classification by the World Health Organization

under different general budgets issued For pesticides with toxicity levels classified as Group I, II, or III by the World Health Organization, the label must include additional toxicity symbols as follows:

a) A color strip indicating toxicity placed at the bottom of the label and having a length equal to the width of the label, with a height equivalent to 10% of the label's height.

b) Toxicity and warning symbols corresponding to each type issued of pesticide must be placed above the trade name of the product. In this Circular, the following terms are understood as follows: as follows:

II. FOR CHEMICALS

1. Mandatory information to be included on the label

a) Trade name;

b) Composition and active ingredient concentration;

c) Storage instructions;

d) Warning information about health risks to humans and the environment;

to

Name and address of the manufacturer;

e) Batch production number;

g) Date of manufacture or month and year of manufacture;

2. Label format:

h) Expiration date.

a) The label must be printed clearly and legibly, not faded, torn, or damaged during circulation, storage, transportation, and use, with a font size not less than 0.9 mm;

b) The label must be securely attached or printed on the packaging of the chemical.

ANNEX X
dated October 1, Decision No. 91/2016/NĐ-CP (as of July 1, 2016 of the Government)

ANNEX X

TESTING UNIT

(Attached with detailed testing results)

I. NAME OF THE TESTED CHEMICAL OR PESTICIDE:

1. Sample name:...

2. Composition and active ingredient concentration:...

3. Manufacturer's name:...

4. Manufacturer's address:...

5. Date of manufacture:...

6. Expiration date:...

7. Quantity of samples used for testing and retained:...

II. PURPOSE OF TESTING:

III. TESTING REQUEST UNIT:

IV. TESTING UNIT:

V. DATE AND LOCATION OF TESTING:

VI. DOSAGE AND USAGE METHOD:¹

1. Effectiveness:

VII. RESULTS:

¹ 2. Safety:1. Fulfilling requirements stipulated in Article 13 of Decree No. 135/2021/NĐ-CP.Results must detail the evaluation method and effectiveness of the chemical or pesticide against the tested pests as indicated on the label; the evaluation method and results of the side effects of the tested pesticide on the

participants in the test.

1. Effectiveness:¹

VII. RESULTS:²

VIII. CONCLUSIONS:³

____________________

¹ DIRECTOR/INSTITUTE DIRECTOR use.

² Summary of conclusions regarding the effectiveness of the pesticide based on the usage method and dosage.

³ Summary of the assessment of the side effects of the pesticide on the participants in the test. use Must specify whether the pesticide can be registered for circulation and for what purpose, usage method, and dosage based on the conclusions regarding effectiveness and safety.