Decree 129/2024/ND-CP amend Decree 91/2016/ND-CP management of insecticidal or germicidal preparations, and Decree 155/2018/ND-CP

Pursuant to the Law on Organization of the Government dated June 19, 2015; the Law Amending and Supplementing a Number of Articles of the Law on Organization of the Government and the Law on Organization of Local Administration dated November 22, 2019;

Pursuant to the Law on Chemicals dated November 21, 2007;

Pursuant to the Law on Investment dated June 17, 2020;

At the proposal of the Minister of Health;

The Government hereby promulgates the Decree amending and supplementing a number of articles of the Government's Decree No. 91/2016/ND-CP dated July 1, 2016, on management of insecticidal or germicidal chemicals and preparations for household and medical use, and the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018, amending and supplementing a number of articles concerning business investment conditions under state management of the Ministry of Health.

Article 1. Amending and supplementing a number of articles of the Government's Decree No. 91/2016/ND-CP dated July 1, 2016, on management of insecticidal or germicidal chemicals and preparations for household and medical use

1. To amend and supplement Article 8 as follows:

“Article 8. Announcement of eligibility to produce preparations

1. Before producing preparations, a production establishment’s at-law representative shall send its dossier of announcement prescribed in Article 7 of this Decree directly, or online or by post to the provincial-level Health Department of the locality where the production establishment is headquartered. The establishment may produce preparations after the information specified in Clause 2 of this Article is disclosed by the provincial-level Health Department on its website.

2. Within 3 working days from the date on which the production establishment's dossier of announcement is received, the provincial-level Health Department shall disclose on its website and send to the Ministry of Health information about the name, address and telephone number of the production establishment.

3. Within 15 days after having one of the changes in the name, address and telephone number, the production establishment shall send a notice of such changes to the provincial-level Health Department of the locality where it is headquartered;

On an annual basis, the production establishment shall send notice of changes (if any) other than those specified in this Clause to the provincial-level Health Department of the locality where it is headquartered for information updating.

4. Within 3 working days from the date on which the production establishment’s notice is received in accordance with Clause 3 of this Article, the provincial-level Health Department of the locality where the production establishment is headquartered shall update the information on its website and send information about changes to the Ministry of Health.”

2. To add Point dd Clause 2 Article 9 as follows:

“d) Preparations which have been granted a circulation registration number but the content of active ingredients or preparation formulation has been changed.”

3. To amend and supplement Clause 1 Article 18 as follows:

“1. Each preparation may be granted only one circulation registration number, including cases where the preparation has many different scents.”

4. To amend and supplement Point c Clause 1 Article 20 as follows:

“c) Vietnam-based representative offices of foreign traders that are authorized by owners of preparations to carry out registration.”

5. To add Point d Clause 1; amend and supplement Points b and dd Clause 2 Article 21 as follows:

a) To add Point d to Clause 1 as follows:

“d) Preparations which have been granted a circulation registration number but the active ingredient or resonance additive has been changed.”

b) To amend and supplement Point b Clause 2 as follows:

“b) Change of the name of the preparation for export purpose; in case of intellectual property infringement;”.

c) To amend and supplement Point dd Clause 2 as follows:

“dd) Change of effects, dosage, use method, active ingredient content, resonance additive content, formulation of preparation, expiry date, source of active ingredients.”

6. To amend and supplement Clauses 5, 6 and 9 Article 22 as follows:

a) To amend Clause 5 as follows:

“5. Results of testing of the contents of active ingredients of the preparation.”

b) To amend and supplement Clause 6 as follows:

“6. The assay result slip:

a) To be submitted together with the dossier, for:

- Insecticidal preparations for household use, containing active ingredients, contents of active ingredients and preparation formulation according to the recommendations of the World Health Organization and in accordance with the Ministry of Health's regulations on the list of active ingredients banned from use or restricted from use in insecticidal or germicidal preparations for household and medical use;

- Germicidal preparations for household use, that contain the active ingredient Ethanol or Isopropanol or a mixture of Ethanol and Isopropanol with a total content of 60% to 90% and may contain no more than 0.5% Chlorhexidine.

b) To be added to the dossier after the Ministry of Health issues a written approval of assay, for the cases not specified at Point a of this Clause.”

c) To amend and supplement Clause 9 as follows:

“9. For preparations containing active ingredient or with a formulation, or having the scope of use or effect registered for the first time in Vietnam, the dossier must comprise: Research documents and results on safety and efficacy or warnings of the World Health Organization or other international organizations or competent agencies of the country producing and exporting the preparation, on the use of preparations in household and medical fields.”

7. To add Point dd Clause 2; amend and supplement the title of Clause 5 and Point d Clause 5 Article 23 as follows:

a) To add Point dd Clause 2 as follows:

“dd) The competent state agency's document on intellectual property infringement regarding the name of the preparation.”

b) To amend and supplement the title of Clause 5 as follows:

“5. In case of change of effects, dosage, use method, active ingredient content, resonance additive content, formulation of preparation, expiry date, source of active ingredients:”

c) To amend and supplement Point d Clause 5 as follows:

“d) Results of testing of the contents of active ingredients, for change of the contents of active ingredients or formulation of the preparation;”.

8. To amend and supplement Clause 2 Article 24 as follows:

“2. The line limit for submission of a dossier for registration of extension of circulation registration number is three months at least and 12 months at most before the expiry date of circulation registration numbers;

If the registering establishment fails to submit the dossier on time due to force majeure events, such as natural disasters, catastrophes, epidemics, fires, etc., the dossier may be submitted later than prescribed time limit, but not more than 12 months from the deadline for modifying the dossier, and preparing a written explanation.”

9. To amend and supplement Points c and e; add Point h Clause 4 Article 26 as follows:

a) To amend and supplement Point c as follows:

“c) The original or a valid copy of the slip of the result of the assay performed by an independent establishment that has announced the eligibility to carry out assays as prescribed, excluding establishments producing and registering preparations. Particularly for germicidal preparations, the result of the assay performed by an independent assaying establishment located in another country that is designated and recognized by the competent agency of the host country, or recognized by an accreditation organization as conforming to ISO/IEC 17025 or ISO 15189 standard or standards on quality management of testing laboratories serving testing;

In case of using the slip of the result of the assay of an independent assaying establishment located in another country, such slip must specify the microbiological indicators and bactericidal efficiency specified in the assay process issued by the Ministry of Health and be consularly legalized as prescribed.”

b) To amend and supplement Point e as follows:

“e) Copies of papers on the legal entity status of the registering establishment or production establishment, stamped by the registrant;”.

c) To add Point h as follows:

“h) Valid copies of documents of the competent state agency on intellectual property infringement regarding the name of the preparation.”

10. To amend and supplement Clauses 3, 4 and 6 Article 27 as follows:

c) To amend and supplement Clause 3 as follows:

“3. Within 30 days from the date indicated on the dossier receipt referred to in Clause 2 of this Article:

a) The Ministry of Health shall notify in writing to the registering establishment of its request for supplementation and modification of the dossier or of the grant of, or refusal to grant, a circulation registration number, for the dossier of registration for circulation of preparation specified at Point a Clause 6 Article 22 of this Decree;

If requesting supplementation and modification of the dossier, the notice must clearly indicate the contents to be supplemented and modified. If refusing to grant a circulation registration number, the Ministry shall clearly state the reason.

b) The Ministry of Health shall notify in writing to the registering establishment of its request for supplementation and modification of the dossier or of the approval or disapproval of, the assay, for the dossier of registration for circulation of preparation not specified at Point a Clause 6 Article 22 of this Decree. The maximum duration for studying and processing the dossier for new circulation registration of preparation specified in Clause 9 Article 22 of this Decree is 90 days;

If requesting supplementation and modification of the dossier, the notice must clearly indicate the contents to be supplemented and modified. If refusing to approve an assay, the Ministry shall clearly state the reason.”

b) To amend and supplement Clause 4 as follows:

“4. In case the Ministry of Health issues a written request for supplementation and modification of the dossier, within 90 days from the date indicated on the request, the registering establishment shall send a written explanation of the supplementation and modification to the Ministry of Health. Past this time limit, the new circulation registration dossier shall become invalid. The date of receipt of the supplemented and modified dossier shall be recorded on the dossier receipt;

If the registering establishment fails to submit the dossier according to the prescribed time limit due to force majeure events, such as natural disasters, catastrophes, epidemics, fires, etc., the dossier may be submitted later, but not more than 12 months from the deadline for modifying the dossier, and preparing a written explanation;

The supplemented and modified dossier shall be received and appraised under Clause 3 of this Article.”

c) To amend and supplement Clause 6 as follows:

“6. After obtaining a written assay approval, the registering establishment shall carry out the assay and submit the assay result slip to the dossier within 36 months from the date indicated on the written assay approval. The date of receipt of the assay result slip shall be recorded on the dossier receipt. Past the 36-month limit, the new circulation registration dossier shall become invalid.”

11. To amend and supplement Clause 5 Article 28 as follows:

“5. In case the Ministry of Health issues a written request for supplementation and modification of the dossier, within 90 days from the date indicated on the request, the registering establishment shall complete the dossier and prepare written explanations and send them to the Ministry of Health. The date of receipt of the supplemented and modified dossier shall be recorded on the dossier receipt. Past this time limit, the submitted dossier shall become invalid;

If the registering establishment fails to submit the dossier according to the prescribed time limit due to force majeure events, such as natural disasters, catastrophes, epidemics, fires, etc., the dossier may be submitted later, but not more than 12 months from the deadline for modifying the dossier, and preparing a written explanation.”

12. To amend and supplement Clause 4 Article 29 as follows:

“4. After receiving a written request for supplementation and modification of the dossier, the registering establishment shall supplement and modify the dossier and prepare written explanations and send them to the Ministry of Health within 30 days from the date indicated on the written request and at least 10 days before the expiry date of the circulation registration number. The date of receipt of the supplemented and modified dossier shall be recorded on the dossier receipt. Past this time limit, the dossier of registration for extension of the circulation registration number shall become invalid.

If the registering establishment fails to submit the dossier according to the prescribed time limit due to force majeure events, such as natural disasters, catastrophes, epidemics, fires, etc., the dossier may be submitted later, but not more than 12 months from the deadline for modifying the dossier, and preparing a written explanation;

The supplemented and modified dossier shall be appraised under Clause 3 of this Article.”

13. To add Clause 6 Article 31 as follows:

“6. The name of the preparation must not mislead about the nature, uses, ingredients and origin of the preparation.”

14. To amend and supplement Article 43 as follows:

“Article 43. Announcement of eligibility to provide insecticidal and germicidal services using preparations

1. Before providing insecticidal and germicidal services using preparations, a service provider’s at-law representative shall send its dossier of announcement, comprising documents prescribed in Article 42 of this Decree directly, or online or by post to the provincial-level Health Department of the locality where the service provider is headquartered. The service provider may provide services after the information specified in Clause 2 of this Article is disclosed by the provincial-level Health Department on its website.

2. Within 3 working days from the date on which the service provider's dossier of announcement is received, the provincial-level Health Department shall disclose on its website and send to the Ministry of Health information about the name, address and telephone number of the service provider.

3. Within 15 days after having one of the changes in the name and address, the service provider shall send a notice of such changes to the provincial-level Health Department of the locality where it is headquartered;

On an annual basis, the service provider shall send notice of changes (if any) other than those specified in this Clause to the provincial-level Health Department of the locality where it is headquartered for information updating.

4. Within 3 working days from the date on which the service provider’s notice is received in accordance with Clause 3 of this Article, the provincial-level Health Department of the locality where the service provider is headquartered shall update the information on its website and send information about changes to the Ministry of Health.”

15. To amend Point e Clause 2 Article 49 as follows:

“e) For products and use methods needed by the organization or individual applying for an import license which are unavailable on the market: Documents proving that products applying for import license have been permitted for use by the exporting country’s competent agency.”

16. To amend and supplement Clause 1 Article 53 as follows:

“1. The at-law representative shall declare information, download electronic files and put digital signatures in the online registration dossier and pay online charges and fees according to the process on the National Public Service Portal, or the website of the Ministry of Health or the provincial-level Heath Department.”

17. To amend and supplement Clause 1 Article 54 as follows:

“1. In case where an organization or individual makes online registration, and all documents are created electronically and bear a lawful digital signature of the competent person, paper dossiers shall not be preserved.”

18. To amend and supplement Clause 2 Article 55 as follows:

“2. To organize the implementation of legal documents on chemicals and preparations; consult or hold a meeting of the consultancy council to grant the circulation registration certificate of insecticidal or germicidal preparations for household and medical use, for preparations containing active ingredients or having product forms or scopes of use or effects registered for the first time in Vietnam.”

19. To amend and supplement Clause 2 and add Clause 4 Article 57 as follows:

c) To amend and supplement Clause 2 as follows:

“2. To direct the provincial-level Health Department to disclose on its website and send to the Department of Health the information about establishments announced their eligibility for production, carrying out testings, conducting assays, and establishments announced their eligibility to provide insecticidal and germicidal services using preparations in the locality.”

b) To add Clause 4 as follows:

“4. To direct the provincial-level Health Department to make annual reports, and send them to the Ministry of Health before December 25, or make irregular reports at the Ministry of Health's requests. The period for closing data of an annual report starts from December 15 of the preceding year to December 14of the reporting year. The report form shall comply with Appendix XI to this Decree.”

20. To add Appendix XI to this Decree.

21. To replace the phrase “ISO 17025:2005 or ISO 15189:2012 standard or its new version” with the phrase “recognized as conforming to ISO/IEC 17025 or ISO 15189 standard” in Clause 4 Article 15 and Form No. 02 of Appendix I.

22. To replace the phrase “trade name” with the phrase “name of the preparation” in Clause 3 and Point a Clause 4 Article 2; Points b and c Clause 2 Article 23; title of Section 3 Chapter IV; Clause 1 and Clause 2 Article 31; Form No. 07 and Form No. 09 of Appendix I;

To replace the phrase “trade name of the preparation” with the phrase “name of the preparation” in the title of Clause 2 Article 23; title of Article 31, Clauses 3 and 4 Article 31; Appendix IV; Appendix V;

To replace the phrase “trade name for the preparation” with the phrase “name of the preparation” in Clause 5 Article 31.

23. To replace the phrase “the Ministry of Health” with the phrase “the provincial-level Health Department” in Clause 6 Article 61 and Clause 3 Article 62.

24. To replace the phrase “The Ministry of Health (the Health Environment Management Agency) with the phrase “the provincial-level Health Department” in Form No. 02 and Form No. 03 of Appendix I.

Article 2. Amending and supplementing a number of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018, amending and supplementing a number of articles concerning business investment conditions under state management of the Ministry of Health

1. To amend Clause 5 Article 9 as follows:

“2. Be recognized as conforming to ISO/IEC 17025.”

2. To amend Clause 6 Article 9 as follows:

“6. To amend Article 12 of Decree No. 91/2016/ND-CP as follows:

Article 12. Announcement of eligibility for testing

1. Before conducting testing for the first time, the testing establishment shall send its dossier of announcement prescribed in Article 11 of this Decree directly, or online or by post to the provincial-level Health Department of the locality where it is headquartered. The establishment may conduct testing after the information specified in Clause 2 of this Article is disclosed by the provincial-level Health Department on its website.

2. Within 3 working days from the date on which the testing establishment's dossier of announcement is received, the provincial-level Health Department shall disclose on its website and send to the Ministry of Health information about the name, address and telephone number of the testing establishment; and the list of active ingredients that the establishment is capable of testing.

3. Within 15 days after having one of the changes in the name, address and the list of active ingredients that the establishment is capable of testing, the testing establishment shall send a notice of such changes to the provincial-level Health Department of the locality where it is headquartered;

On an annual basis, the testing establishment shall send notice of changes (if any) other than those specified in this Clause to the provincial-level Health Department of the locality where it is headquartered for information updating.

4. Within 3 working days from the date on which the testing establishment’s notice is received in accordance with Clause 3 of this Article, the provincial-level Health Department of the locality where the establishment is headquartered shall update the information on its website and send information about changes to the Ministry of Health.”

3. To amend and supplement Clause 9 Article 9 as follows:

“9. To amend Article 16 of Decree No. 91/2016/ND-CP as follows:

Article 16. Announcement of eligibility for assay

1. Before conducting assay for the first time, the assaying establishment shall send its dossier of announcement prescribed in Article 15 of this Decree directly, or online or by post to the provincial-level Health Department of the locality where it is headquartered. The establishment may conduct assay after the information specified in Clause 2 of this Article is disclosed by the provincial-level Health Department on its website.

2. Within 3 working days from the date on which the assaying establishment 's dossier of announcement is received, the provincial-level Health Department shall disclose on its website and send to the Ministry of Health information about the name, address and telephone number of the assaying establishment; and the list of assay processes that the assaying establishment announces its eligibility to undertake.

3. Within 15 days after having one of the changes in the name, address and the list of assay processes that the assaying establishment announces its eligibility to undertake, the assaying establishment shall send a notice of such changes to the provincial-level Health Department of the locality where it is headquartered;

On an annual basis, the assaying establishment shall send notice of changes (if any) other than those specified in this Clause to the provincial-level Health Department of the locality where it is headquartered for information updating.

4. Within 3 working days from the date on which the assaying establishment’s notice is received in accordance with Clause 3 of this Article, the provincial-level Health Department of the locality where the establishment is headquartered shall update the information on its website and send information about changes to the Ministry of Health.”

4. To amend and supplement Clause 10 Article 9 as follows:

“d) The original or valid copy of the test results for active ingredient content of the preparation. The test results must be performed by an establishment that has announced its eligibility to conduct testing according to regulations or the test results of a foreign testing establishment recognized as conforming to ISO/IEC 17025 or ISO 15189 or equivalent;

In case of using testing result of a testing laboratory in a foreign country, such testing result must be consularly legalized as prescribed.”

5. To replace the phrase “ISO 17025:2005 or ISO 15189:2012 standard or its new version” with the phrase “recognized as conforming to ISO/IEC 17025 or ISO 15189 standard” in Clause 8 Article 9 and Form No. 03 of Appendix I.

6. To replace the phrase “trade name” with the phrase “name of the preparation” in Forms No. 04, 05 and 06 of Appendix I; Appendix VI.

Article 3. Repealing and replacing a number of provisions of Decree No. 91/2016/ND-CP and Decree No. 155/2018/ND-CP

1. To repeal and replace a number of provisions of Decree No. 91/2016/ND-CP as follows:

a) To repeal: Clause 1 Article 14; Clause 8 Article 38; Forms No. 01, 02, 03 and 08 of Appendix III.

b) To replace: Appendix VIII with Appendix VIII to this Decree.

2. To repeal and replace a number of provisions of Decree No. 155/2018/ND-CP as follows:

a) To repeal: Clause 3 and Clause 4 of Article 9.

b) To replace: Appendix VII and Appendix IX with Appendix VII and Appendix IX to this Decree.

Article 4. Transitional provisions

1. Establishments producing, trading, exporting, importing, conducting testing and assay of insecticidal or germicidal preparations for household and medical use that have submitted dossiers at the Ministry of Health before the effective date of this Decree may continue to follow provisions of Decree No. 91/2016/ND-CP and Decree No. 155/2018/ND-CP, unless such establishments voluntarily to complete their dossiers in accordance with this Decree.

2. Preparations with labels in accordance with the Government's Decree No. 43/2017/ND-CP dated April 14, 2017, on goods labeling, the Government’s Decree No. 111/2021/ND-CP dated December 9, 2021, amending and supplementing a number of articles of Government's Decree No. 43/2017/ND-CP dated April 14, 2017, on goods labeling, and the Government's Decree No. 155/2018/ND-CP dated November 12, 2018, amending and supplementing a number of articles concerning business investment conditions under state management of the Ministry of Health, that have been produced, imported or circulated before the effective date of this Decree, may continue to be circulated and used until the expiry date indicated their labels.

3. Preparation labels complying with the Government's Decree No. 43/2017/ND-CP dated April 14, 2017, on goods labeling, the Government’s Decree No. 111/2021/ND-CP dated December 9, 2021, amending and supplementing a number of articles of Government's Decree No. 43/2017/ND-CP dated April 14, 2017, on goods labeling, and the Government's Decree No. 155/2018/ND-CP dated November 12, 2018, amending and supplementing a number of articles concerning business investment conditions under state management of the Ministry of Health, that have been produced, or printed before the effective date of this Decree, may continue to be used for production of preparations, but not more than 2 years from the effective date of this Decree.

Article 5. Effect

This Decree takes effect from November 30, 2024.

Article 6. Responsibility for implementation

1. The Minister of Health shall organize the implementation of this Decree.

2. Ministers, Heads of ministerial-level agencies, Heads of Government-attached agencies, chairpersons of People’s Committees of provinces and centrally run cities, and related agencies, organizations and individuals shall implement this Decree./.

* All Appendices are not translated herein.