DECREE NO. 129/2024/ND-CP AMENDING AND COMPLEMENTING CERTAIN ARTICLES OF DECREE NO. 91/2016/ND-CP OF THE GOVERNMENT ON THE MANAGEMENT OF CHEMICALS AND PESTICIDES USED IN DOMESTIC AND HEALTH SECTORS ISSUED ON JULY 1, 2016; DECREE NO. 155/2018/ND-CP OF THE GOVERNMENT AMENDING AND COMPLEMENTING CERTAIN PROVISIONS RELATED TO CONDITIONS FOR BUSINESS OPERATIONS UNDER THE SUPERVISION OF THE MINISTRY OF HEALTH ISSUED ON NOVEMBER 12, 2018

DECREE

AMENDMENTS AND SUPPLEMENTS TO CERTAIN ARTICLES OF DECREE NO. 91/2016/NĐ-CP JULY 1, 2016 OF THE GOVERNMENT ON THE MANAGEMENT OF CHEMICALS, PESTICIDES, AND DISINFECTANTS USED IN DOMESTIC AND HEALTH SECTORS; DECREE NO. 155/2018/NĐ-CP NOVEMBER 12, 2018 OF THE GOVERNMENT AMENDING AND SUPPLEMENTING CERTAIN PROVISIONS RELATED TO BUSINESS CONDITIONS UNDER THE MINISTRY OF HEALTH'S ADMINISTRATIVE SUPERVISION DECREE NO. 155/2018/NĐ-CP OF November 12, 2018 ISSUED BY THE GOVERNMENT AMENDING, COMPLEMENTING CERTAIN PROVISIONS RELATED TO CONDITIONS FOR BUSINESS INVESTMENT FALLING WITHIN THE SCOPE OF MANAGEMENT BY THE MINISTRY OF HEALTH9. AMEND AND SUPPLEMENT POINTS c, e; ADD POINT h OF CLAUSE 4, ARTICLE 26 AS FOLLOWS:

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On the basis of Law on Government Organization dated June 19, 2015; Law Amending and Supplementing Certain Provisions of the Law on Government Organization and the Law on Local Administration dated November 22, 2019;

On the basis of Law on Chemicals dated November 21, 2007;

On the basis of Investment Law dated June 17, 2020;

At the proposal of the Minister of Health;

The Government promulgates this Decree amending and supplementing certain Articles of Decree No. 91/2016/NĐ-CP dated July 1, 2016 of the Government on the management of chemicals, pesticides, and disinfectants used in domestic and health sectors; Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain provisions related to business conditions under the administrative supervision of the Ministry of Health. Article 1. Amending and supplementing certain Articles of Decree No. 91/2016/NĐ-CP dated July 1, 2016 of the Government on the management of chemicals, pesticides, and disinfectants used in domestic and health sectors "Article 8. Announcement of sufficient production conditions for products

1. Prior to commencing production of products, the legal representative of the production facility shall submit the announcement dossier, including documents as stipulated in Article 7 of this Decree, to the Department of Health at the location of the production facility through direct submission, online submission, or postal service. The production facility may commence production after the Department of Health publicly discloses the information specified in Clause 2 of this Article on its electronic information website.

1. Unit prices for construction projects published by the People's Committee of the province in accordance with Clause 2, Article 26 of Decree No. 10/2021/NĐ-CP serve as the basis for determining and managing construction investment costs within the province. The unit prices for construction projects published by the People's Committee of the province are determined based on construction norms issued by competent authorities and the cost factors' prices specified in Clause 3, Clause 4, and Clause 5 of this Article, consistent with the time of determining the unit price for construction projects. Cost factors' prices include: material prices, labor unit prices, machinery and equipment rental prices.

2. Within three working days from the date of receiving the announcement dossier from the production facility, the Department of Health shall be responsible for publicly disclosing such information on its electronic information website and sending it to the Ministry of Health, including the name, address, and contact phone number of the production facility.

3. Within fifteen days from the date of any change in the name or address, the production facility shall be responsible for notifying such changes to the Department of Health at the location of the production facility.

Annually, the production facility shall be responsible for notifying other changes (if any) not covered by this clause to the Department of Health at the location of the production facility to update the information.

4. Within three working days from the date of receiving the notification from the production facility as stipulated in Clause 3 of this Article, the Department of Health at the location of the production facility shall be responsible for updating the information on its electronic information website and sending the updated information to the Ministry of Health."

2. Supplementing Point d of Clause 2 of Article 9 as follows:

"d) Products that have been registered for circulation but have changed in active ingredient content or form."

"1. A product can only be granted one registration number for circulation, including cases where the product has different fragrances."

4. Amending and supplementing Point c of Clause 1 of Article 20 as follows:

3. Amend and supplement Clause 1 of Article 18 as follows:

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

5. Supplementing Point d of Clause 1; amending and supplementing Points b and đ of Clause 2 of Article 21 as follows:

a) Supplementing Point d of Clause 1:

"d) Products that have been registered for circulation but have changed in active ingredient composition or added synergists."

b) Amending and supplementing Point b of Clause 2:

"b) Changing the product name shall be carried out in the following cases: for export purposes; infringement of intellectual property rights;"

c) Amending and supplementing Point đ of Clause 2:

"đ) Changing the effect, dosage, usage method, active ingredient content, synergist content, form, shelf life, source of active ingredients."

6. Amending and supplementing Clauses 5, 6, and 9 of Article 22 as follows:

a) Amending Clause 5:

"5. Test results of active ingredient content in the product."

b) Amending and supplementing Clause 6:

"6. Survey result report:

a) Shall be submitted together with the dossier in the following cases:

- Domestic insecticides containing active ingredients, active ingredient content, and form according to the World Health Organization's recommendations and consistent with the Ministry of Health's regulations on prohibited and restricted active ingredients in domestic and health sector insecticides and disinfectants;

- Domestic disinfectants containing Ethanol or Isopropanol or a mixture of Ethanol and Isopropanol with a total content from 60% to 90%, and may contain up to 0.5% Chlorhexidine.

b) Shall be supplemented to the dossier after the Ministry of Health approves the survey for cases not covered by point a of this clause."

c) Amending and supplementing Clause 9:

"9. For products containing new active ingredients or having a new form or usage scope or effects first registered in Vietnam, the dossier must include documentation and research results on safety and efficacy or recommendations for the use of the product in the domestic and health sectors by the World Health Organization or another international organization or the competent authority in the country of production or export."

7. Supplementing Point đ of Clause 2; amending and supplementing the title of Clause 5 and Point d of Clause 5 of Article 23 as follows:

a) Supplementing Point đ of Clause 2:

"đ) Official document from the competent state agency regarding intellectual property rights infringement of the product name."

b) Amending and supplementing the title of Clause 5:

"5. In cases of changing the effect, dosage, usage method, active ingredient content, synergist content, form, shelf life, source of active ingredients:"

c) Amending and supplementing Point d of Clause 5:

"d) Test results of active ingredient content for cases of changing active ingredient content or form;"

8. Amending and supplementing Clause 2 of Article 24 as follows:

"2. The deadline for submitting the application for extending the registration number for circulation is at least three months and at most twelve months before the registration number expires;

In case the applicant fails to submit the application within the prescribed period due to force majeure such as natural disasters, catastrophes, epidemics, fires, etc., they may submit the application later in accordance with the regulations but not later than twelve months from the expiration date, accompanied by an explanatory document."

9. Amending and supplementing Points c, e; supplementing Point h of Clause 4 of Article 26 as follows:

a) Amending and supplementing Point c:

a) AMEND AND SUPPLEMENT POINT c:

(as of October 10, 2024 issued by the Government)

"c) The original or a valid copy of the Result Report of the test conducted by an independent entity that has been officially announced to meet the conditions for conducting tests according to regulations, excluding production facilities and registration entities. For bactericidal products, the results of tests conducted by independent testing facilities abroad designated, recognized by the competent authority of the host country, or accredited organizations meeting the ISO/IEC 17025, ISO 15189 standards or other quality management standards for laboratories serving testing purposes shall be accepted;"

In case the Result Report of the test is from an independent testing facility abroad, the Result Report must include microbial criteria and bactericidal effectiveness as specified in the testing procedure issued by the Ministry of Health and legalized by the consular authorities according to regulations.

b) Amend and supplement Point e:

"e) A valid copy of the document regarding the legal status of the registration entity and the production facility, stamped by the issuing unit;"

c) Supplement Point h:

"h) A valid copy of the document from the competent state agency regarding intellectual property violations concerning the product name."

10. Amend and supplement Clause 3, 4 and Clause 6 of Article 27 as follows:

a) Amend and supplement Clause 3:

"3. Within thirty days from the date recorded on the Receipt of Application Form stipulated in Clause 2 of this Article:"

a) For applications for the circulation of products as prescribed in Point a, Clause 6 of Article 22 of this Decree, the Ministry of Health shall notify in writing the new registration entity about the request for additional information, amendments to the application or issuance or non-issuance of the registration number for circulation.

In case there is a request for additional information or amendments to the application, the notification must clearly specify the required additional information or amendments. If the registration number for circulation is not issued, the reason must be clearly stated.

b) For applications for the circulation of products not as prescribed in Point a, Clause 6 of Article 22 of this Decree, the Ministry of Health shall notify in writing the new registration entity about the request for additional information, amendments to the application, or approval or disapproval of the test. The time for research and processing of new product registration applications as prescribed in Clause 9 of Article 22 of this Decree shall not exceed ninety days.

In case there is a request for additional information or amendments to the application, the notification must clearly specify the required additional information or amendments. If the test is not approved, the reason must be clearly stated.

b) Amend and supplement Clause 4:

"4. In case the Ministry of Health issues a document requesting additional information or amendments to the application, within ninety days from the date recorded on the document, the registration entity must submit a document to the Ministry of Health explaining the additional information or amendments. If the deadline is exceeded, the new application for circulation will be canceled. The receipt of the additional or amended application is recorded on the Receipt of Application Form.

In case the registration entity fails to submit the application within the prescribed period due to force majeure such as natural disasters, catastrophes, epidemics, fires, etc., they may submit the application late, not exceeding twelve months from the expiration date of the supplementary application, accompanied by an explanatory document.

The additional or amended application will be received and reviewed according to the provisions of Clause 3 of this Article.

c) Amend and supplement Clause 6:

"6. After receiving the document approving the test, the registration entity is responsible for completing the test and submitting the Result Report of the test to the application within thirty-six months from the date recorded on the document approving the test. The receipt of the Result Report of the test is recorded on the Receipt of Application Form. If the deadline of thirty-six months is exceeded, the new application for circulation will be canceled."

11. Amend and supplement Clause 5 of Article 28 as follows:

"5. In case the Ministry of Health issues a document requesting additional information or amendments to the application, within ninety days from the date recorded on the document, the supplementary registration entity must complete the application, explain in writing, and submit it to the Ministry of Health. The receipt of the additional or amended application is recorded on the Receipt of Application Form. If the deadline is exceeded, the supplementary application for circulation will be canceled.

In case the registration entity fails to submit the application within the prescribed period due to force majeure such as natural disasters, catastrophes, epidemics, fires, etc., they may submit the application late, not exceeding twelve months from the expiration date of the supplementary application, accompanied by an explanatory document."

12. Amend and supplement Clause 4 of Article 29 as follows:

"4. Upon receiving a document requesting additional information or amendments to the application, the registration entity must submit the additional or amended application along with an explanatory document to the Ministry of Health within thirty days from the date recorded on the notification document requesting additional information or amendments to the application and at least ten days before the registration number for circulation expires. The receipt of the additional or amended application is recorded on the Receipt of Application Form. If the deadline is exceeded, the application for extending the registration number for circulation will be canceled.

In case the registration entity fails to submit the application within the prescribed period due to force majeure such as natural disasters, catastrophes, epidemics, fires, etc., they may submit the application late, not exceeding twelve months from the expiration date of the supplementary application, accompanied by an explanatory document.

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

13. Supplement Clause 6 of Article 31 as follows:

"6. The product name shall not mislead about the nature, function, composition, and origin of the product."

14. Amend and supplement Article 43 as follows:

"Article 43. Announcement of Qualification for Providing Pest Control and Bactericidal Services Using Products

1. Before providing pest control and bactericidal services using products, the legal representative of the service provider entity shall submit the announcement application including the documents as prescribed in Article 42 of this Decree to the Department of Health where the service provider's headquarters is located through direct submission, online submission, or postal submission. The service provider can provide services after the Department of Health publicly announces the information as prescribed in Clause 2 of this Article on its electronic information website.

2. Within three working days from the date of receipt of the announcement application from the service provider, the Department of Health shall publicize the information on its electronic information website and send the following information to the Ministry of Health: the name, address, and contact phone number of the service provider."

3. Within fifteen days from the date of any change in name or address, the service provider shall be responsible for notifying such changes to the Department of Health where the provider's headquarters is located.

Annually, the service provider shall be responsible for notifying other changes (if any), outside those specified in this clause, to the Department of Health where the provider's headquarters is located to update information.

4. Within three working days from the date of receiving the notification from the service provider as stipulated in Clause 3 of this Article, the Department of Health where the provider's headquarters is located shall be responsible for updating the information on its electronic information website and sending the Ministry of Health the changed information.

15. Amend Point e of Clause 2 of Article 49 as follows:

“e) In cases where there are no suitable products or methods meeting the needs of organizations or individuals, proof must be provided that the imported preparation has been approved for use by the competent authority of the exporting country.”

16. Amend and supplement Clause 1 of Article 53 as follows:

“1. The legal representative declares information, uploads electronic documents, signs digitally into the online registration file, and pays fees and charges online according to the procedure on the National Public Service Portal or the Ministry of Health’s Electronic Information Website or the Department of Health’s Electronic Information Website.”

17. Amend and supplement Clause 1 of Article 54 as follows:

“1. In cases where organizations or individuals register online, all documents created entirely in electronic form and legally signed with digital signatures by authorized persons need not be stored in paper form.”

18. Amend and supplement Clause 2 of Article 55 as follows:

“2. Organizations implementing chemical and preparation regulations; seeking advisory opinions or organizing meetings of the Advisory Council to issue certificates of registration for circulation of insecticides and bactericides for household and medical use containing active ingredients or having product forms or usage scopes or effects first registered in Vietnam.”

19. Amend and supplement Clause 2, and add Clause 4 of Article 57 as follows:

a) Amend and supplement Clause 2:

“2. Direct the Department of Health to publicly post on its electronic information website and send the Ministry of Health information about facilities that have announced their qualification for production, testing, trial, and pest control services using preparations within the province.”

b) Add Clause 4:

“4. Direct the Department of Health to regularly report annually, sending the Ministry of Health before December 25 or submitting ad hoc reports upon request of the Ministry of Health. The data cut-off period for the annual report is from December 15 of the previous year to December 14 of the reporting year. The outline of the report is prescribed in Appendix XI issued together with this Decree.”

20. Add Appendix XI issued together with this Decree.

21. Replace the phrase "ISO 17025:2005 standard or ISO 15189:2012 standard or updated version" with "recognized as conforming to ISO/IEC 17025 or ISO 15189" in Clause 4 of Article 15 and Form No. 02 of Appendix I.

22. Replace the phrase "trade name" with "preparation name" in Clause 3 and Point a of Clause 4 of Article 2; Points b and c of Clause 2 of Article 23; Title of Section 3 of Chapter IV; Clauses 1 and 2 of Article 31; Form No. 07 and Form No. 09 of Appendix I;

Replace the phrase "trade name of the preparation" with "preparation name" in Clause 2 of Article 23; Title of Article 31, Clauses 3 and 4 of Article 31; Appendix IV; Appendix V;

Replace the phrase "trade name for the preparation" with "preparation name" in Clause 5 of Article 31.

23. Replace the phrase "Ministry of Health" with "Department of Health" in Clause 6 of Article 61 and Clause 3 of Article 62.

24. Replace the phrase "Ministry of Health (Health Environment Management Department)" with "Department of Health" in Form No. 02 and Form No. 03 of Appendix I.

Article 2. Amend and supplement some Articles of Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain provisions related to investment and business conditions within the scope of management of the Ministry of Health.

1. Amend Clause 5 of Article 9 as follows:

“2. Recognized as conforming to ISO/IEC 17025.”

2. Amend Clause 6 of Article 9 as follows:

“6. Article 12 of Decree No. 91/2016/NĐ-CP shall be amended as follows:

Article 12. Announcement of Meeting Conditions for Testing

1. Before conducting the first test, the testing facility shall submit the announcement dossier in accordance with Article 11 of this Decree to the Department of Health at the location where the facility is based through direct submission, online submission, or postal service. The facility may conduct tests after the Department of Health publicly discloses the information specified in Clause 2 of this Article on its electronic information website.

2. Within three working days from the date of receiving the announcement dossier from the testing facility, the Department of Health shall be responsible for publicly disclosing the information on its electronic information website and sending it to the Ministry of Health, including the name, address, contact phone number of the testing facility, and the list of active substances that the facility can test.

3. Within fifteen days from the date of any changes in the name, address, or list of active substances that the facility can test, the testing facility shall be responsible for submitting a notification of such changes to the Department of Health at the location where the facility is based.

Annually, the testing facility shall be responsible for submitting notifications of other changes (if any) outside those specified in this clause to the Department of Health at the location where the facility is based to update the information.

4. Within three working days from the date of receiving the notification from the testing facility as stipulated in Clause 3 of this Article, the Department of Health at the location where the facility is based shall be responsible for updating the information on its electronic information website and sending the updated information to the Ministry of Health.”

3. Amend and supplement Clause 9 of Article 9 as follows:

“9. Article 16 of Decree No. 91/2016/NĐ-CP shall be amended as follows:

Article 16. Announcement of Meeting Conditions for Clinical Trials

1. Before conducting the first clinical trial, the clinical trial facility shall submit the announcement dossier comprising the documents specified in Article 15 of this Decree to the Department of Health at the location where the facility is based through direct submission, online submission, or postal service. The facility may conduct clinical trials after the Department of Health publicly discloses the information specified in Clause 2 of this Article on its electronic information website.

2. Within three working days from the date of receiving the announcement dossier from the clinical trial facility, the Department of Health shall be responsible for publicly disclosing the information on its electronic information website and sending it to the Ministry of Health, including the name, address, contact phone number of the clinical trial facility, and the list of clinical trial procedures that the facility has been announced as meeting the conditions for conducting clinical trials.

3. Within fifteen days from the date of any changes in the name, address, or list of clinical trial procedures that the facility can conduct, the clinical trial facility shall be responsible for submitting a notification of such changes to the Department of Health at the location where the facility is based.

Annually, the clinical trial facility shall be responsible for submitting notifications of other changes (if any) outside those specified in this clause to the Department of Health at the location where the facility is based to update the information.

4. Within three working days from the date of receiving the notification from the clinical trial facility as stipulated in Clause 3 of this Article, the Department of Health at the location where the facility is based shall be responsible for updating the information on its electronic information website and sending the updated information to the Ministry of Health.”

4. Amend and supplement Clause 10 of Article 9 as follows:

“d) The original or a valid copy of the Test Result of the active substance content of the preparation. The test result must be conducted by a facility that has been announced as meeting the conditions for conducting tests according to regulations or the test result of an overseas testing facility recognized as conforming to ISO/IEC 17025 or ISO 15189 or equivalent;

In case the test result of an overseas testing laboratory is used, the test result must be legalized consularly in accordance with regulations.”

5. Replace the phrase "ISO 17025:2005 standard or ISO 15189:2012 standard or updated version" with "recognized as conforming to ISO/IEC 17025 or ISO 15189" in Clause 8 of Article 9 and Model No. 03 of Appendix I.

6. Replace the phrase "trade name" with "preparation name" in Model No. 04, Model No. 05, and Model No. 06 of Appendix I; Appendix VI.

Article 3. Repeal and replace certain provisions of Decree No. 91/2016/NĐ-CP and Decree No. 155/2018/NĐ-CP

1. Repeal and replace certain provisions of Decree No. 91/2016/NĐ-CP as follows:

a) Repeal Clause 1, Article 14; Clause 8, Article 38; Model No. 01, Model No. 02, Model No. 03 and Model No. 08 of Appendix III.

b) Replace Appendix VIII with Appendix VIII of this Decree.

2. Repeal and replace certain provisions of Decree No. 155/2018/NĐ-CP as follows:

a) Repeal Clause 3 and Clause 4, Article 9.

b) Replace Appendix VII and Appendix IX with Appendix VII and Appendix IX of this Decree.

Article 4. Transitional Provisions

1. Production facilities, purchase and sale, export, import, testing, trial products for insecticides and bactericides used in household and medical fields that have submitted files to the Ministry of Health before this Decree takes effect shall continue to implement according to the provisions of Decree No. 91/2016/NĐ-CP and Decree No. 155/2018/NĐ-CP, except where the facility voluntarily completes the file in accordance with this Decree.

2. Products bearing labels complying with the provisions of Decree No. 43/2017/NĐ-CP dated April 14, 2017 of the Government on product labeling, Decree No. 111/2021/NĐ-CP dated December 9, 2021 of the Government amending and supplementing some articles of Decree No. 43/2017/NĐ-CP dated April 14, 2017 of the Government on product labeling and Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing some regulations related to business conditions under the management of the Ministry of Health which were produced, imported, circulated before the effective date of this Decree shall continue to be circulated and used until their expiration date indicated on the product label.

3. Labels complying with the provisions of Decree No. 43/2017/NĐ-CP dated April 14, 2017 of the Government on product labeling, Decree No. 111/2021/NĐ-CP dated December 9, 2021 of the Government amending and supplementing some articles of Decree No. 43/2017/NĐ-CP dated April 14, 2017 of the Government on product labeling and Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing some regulations related to business conditions under the management of the Ministry of Health which were printed before the effective date of this Decree may continue to be used for producing products, but not exceeding two years from the effective date of this Decree.

Article 5. Implementation Provisions

This Decree takes effect from November 30, 2024.

Article 6. Responsibility for Implementation

1. The Minister of Health shall be responsible for organizing the implementation of this Decree.

2. The Ministers, Heads of ministerial-level agencies, Heads of government agencies, Chairmen of provincial People's Committees directly under the Central Government, and relevant agencies, organizations, and individuals shall be responsible for implementing this Decree.

ANNEX

(Attached to Decree No. 129/2024/NĐ-CP dated October 10, 2024 of the Government)

IV. PETITION AND PROPOSAL

Appendix VII

REQUIREMENTS FOR POWER OF ATTORNEY

1. Content:

The power of attorney must include the following contents:

a) Name and address of the owner of the product;

b) Name and address of the entity or individual authorized.

c) Scope of authorization (registration name for circulation of the product in Vietnam for cases of registration authorization);

d) Name of the authorized product;

đ) Address of the production facility of the product;

e) Term of authorization;

g) Commitment of the product owner to provide complete product information to the authorized organization or individual to carry out the registration process;

h) Name, position, and direct signature of the representative of the authorizing party;

2. If the product owner has already authorized another entity to register the product for circulation in Vietnam and has been issued a registration number, within the validity period of the registration number, if the owner authorizes another entity to register the product 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 existing registration number.

If the product owner does not produce the product directly, they must provide documentation proving ownership of the product.

3. Legalization of Consular Documents:

Powers of attorney from entities outside Vietnam must be legalized in accordance with the regulations, except in cases exempted from legalization under international treaties to which Vietnam is a party.

Appendix VIII

REQUIREMENTS FOR CERTIFICATE OF FREE SALE

1. Content

The Certificate of Free Sale includes certificates containing the following information:

a) Name of the issuing authority;

b) Date of issuance of the certificate;

c) Name of the product covered by the certificate;

d) Active ingredients and their concentrations (mandatory for insecticides);

đ) Name and address of the manufacturer;

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

g) Signature and position of the person issuing the certificate.

2. Issuing Country of the Certificate of Free Sale

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

3. Validity of the Certificate of Free Sale

The minimum validity of the Certificate of Free Sale is six months from the date of submission of the application for circulation. In cases where the Certificate of Free Sale has less than six months remaining validity at the time of submission, it will still be accepted, but the registering entity is responsible for submitting a new Certificate of Free Sale before the current Certificate of Free Sale expires.

If the Certificate of Free Sale does not indicate an expiry date, its validity period is 36 months from the date of issue.

4. Legalization of Consular Documents

The Certificate of Free Sale must be legalized in accordance with the regulations, except in the following cases where exemption from legalization is granted:

a) Exempted from legalization under international treaties to which Vietnam is a party (original or certified copy of the Certificate of Free Sale).

b) A free circulation certificate that is publicly available on the official electronic information page of the authority issuing the free circulation certificate and can be searched (a copy of the free circulation certificate stamped by the entity named in the registration for circulation and information about the search link);

c) The diplomatic mission of Vietnam in the country issuing the free circulation certificate has a document confirming that the content on the free circulation certificate is correct (the original confirmation document from the diplomatic mission of Vietnam and a copy of the free circulation certificate stamped by the entity named in the registration for circulation);

Appendix IX

GUIDELINES FOR LABELING CHEMICALS AND PESTICIDES, DISINFECTANTS

Chemicals and pesticides circulating domestically and imported must bear labels in compliance with the labeling regulations for goods stipulated in Decree No. 43/2017/ND-CP dated April 14, 2017 of the Government on product labeling, Decree No. 111/2021/ND-CP dated December 9, 2021 of the Government amending and supplementing certain articles of Decree No. 43/2017/ND-CP dated April 14, 2017 of the Government on product labeling, and the guidelines of the Globally Harmonized System for chemical classification and labeling as prescribed by the Minister of Industry and Trade, and meet the following requirements:

I. FOR PESTICIDES

1. Mandatory contents to be marked on the label

a) Name of pesticide;

b) Quantity;

c) Date of production;

d) Expiry date;

đ) Ingredients, active substance content, and synergistic additives (if any);

e) Production batch number;

g) Registration number for circulation in Vietnam;

h) Warning information about health and environmental hazards;

i) Effects and usage instructions;

k) Storage instructions;

l) Disposal instructions;

m) Hazard pictograms according to GHS;

n) Name and address of the manufacturing facility;

o) Name, address, and telephone number of the entity named in the registration for circulation of the pesticide;

p) Name and address of the importing entity (for imported pesticides);

q) Measures to take if contaminated by the pesticide;

r) Country of origin.

2. Label format

a) The words and characters forming the name of the pesticide must be written continuously as per the registration application for circulation, 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;

c) The label must be firmly affixed or printed on the pesticide packaging;

d) The background of the label must not use colors identical to those indicating the toxicity level of the pesticide.

3. Toxicity symbols on the label according to WHO classification

For chemicals and pesticides classified as groups I, II, and III under the WHO toxicity classification, 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 symbols and corresponding warning symbols for each type of chemical or pesticide must be placed above the product's pesticide name as follows:

II. FOR CHEMICALS

1. Mandatory contents to be marked on the label

a) Name of chemical;

b) Ingredients, active substance content;

c) Storage instructions;

d) Warning information about health and environmental hazards;

đ) Name and address of the manufacturing facility;

e) Production batch number;

g) Date of production;

h) Expiry date.

2. Label format

a) The label must be printed clearly and legibly, not faded, torn, or damaged during circulation, storage, transportation, and use;

b) The label must be firmly affixed or printed on the chemical packaging.

ANNEX XI

REPORT ON THE MANAGEMENT OF CHEMICALS AND PESTICIDES

FOR DOMESTIC USE AND HEALTHCARE PROVINCE PEOPLE'S COMMITTEE...

Number: .../......

REPORT

I. DIRECTIVE AND ADMINISTRATIVE CONTROL

1. Directive and guidance documents.

2. Communication and dissemination of laws

3. Inter-departmental coordination activities for chemical management

4. Administrative procedures implemented at the unit:

Administrative procedure

Announcement of eligibility for pesticide production

2. Number of inspected and audited entities according to plan and spot checks (if any), including:

a) Number of production facilities;

b) Number of trading facilities;

c) Number of user facilities;

d) Number of testing facilities;

đ) Number of trial facilities;

e) Number of service providers for pest control and disinfection using pesticides.

3. Number of facilities penalized for administrative violations, including:

4. Number of facilities referred to investigation agencies (if any):

III. LIMITATIONS AND CONSTRAINTS

c) Number of user facilities;

d) Number of testing facilities;

đ) Number of trial facilities;

e) Number of service providers for pest control and disinfection using pesticides.

3. Number of facilities penalized for administrative violations, including:

4. Number of facilities referred to investigation agencies (if any):

Describe the limitations, advantages, and difficulties in organizing and implementing state management of chemicals and pesticides for domestic use and healthcare.

IV. RECOMMENDATIONS AND PROPOSALS

Propose recommendations and solutions to overcome difficulties.

STATE PETITIONS AND PROPOSALS FOR SOLUTIONS TO OVERCOME DIFFICULTIES.

Propose recommendations and solutions to address difficulties.