Decree 32/2026/NĐ-CP – amending the animal husbandry and veterinary decrees

Pursuant to the Law on Organization of the Government No. 63/2025/QH15;

Pursuant to the Law on Organization of Local Government No. 72/2025/QH15;

Pursuant to the Law on Animal Husbandry No. 32/2018/QH14;

Pursuant to the Veterinary Law No. 79/2015/QH13 amended and supplemented according to Law No. 21/2017/QH14;

Pursuant to Law No. 146/2025/QH15 amending and supplementing certain articles of 15 Laws in the field of agriculture and environment;

At the proposal of the Minister of Agriculture and Environment;

The Government issues a Decree amending and supplementing certain articles of the decrees in the field of livestock and veterinary medicine.

Chapter I. AMENDING AND SUPPLEMENTING CERTAIN ARTICLES OF DECREE NO. 13/2020/NĐ-CP

DATED JANUARY 21, 2020, AMENDED AND SUPPLEMENTED BY

DECREE NO. 46/2022/NĐ-CP DATED JULY 13, 2022

Article 1. Amend and supplement item a, clause 1, Article 5

"a) The Ministry of Agriculture and Environment shall take the lead, in coordination with the Ministry of Science and Technology and relevant ministries and sectors, to organize investigations, surveys, collection, and preservation of newly discovered livestock genetic resources;".

Article 2. Supplement Article 8a before Article 9

"Article 8a. Publication of information on complete compound feed products, concentrated feed

1. The dossier for the publication of information on complete compound feed products, concentrated feed includes:

a) For complete compound feed, concentrated feed produced domestically, it includes the documents prescribed in points b, c, d, đ, and e, Clause 2, Article 8b of this Decree;"

b) For complete mixed feed and imported concentrated feed, the documentation includes the materials specified in points b, c, d, đ, e, and g of Clause 3, Article 8b of this Decree. The dossier must be the original or a certified copy and a Vietnamese translation certified by the organization or individual making the product information declaration for complete mixed feed or concentrated feed. In case the original is not in English, the Vietnamese translation must be certified.

2. Organizations and individuals access the Ministry of Agriculture and Environment's electronic portal to self-declare product information for complete mixed feed or concentrated feed. The product information declared must match the declaration dossier as stipulated in Clause 1 of this Article.

Immediately after self-declaring the product information, organizations and individuals are entitled to produce and trade the product and are responsible for the quality and safety of the declared product.

Article 3. Supplement Article 8b after Article 8a

"Article 8b. Disclosure of information on feed supplement products

1. Feed supplement products must be reviewed by the Chairman of the Provincial People's Committee for publication on the electronic portal of the Ministry of Agriculture and Environment. This regulation does not apply to single raw materials.

2. The dossier requesting the declaration of information on domestically produced feed supplement products includes:

a) An application for product information declaration;

b) Certificate of eligibility for livestock feed production;

c) Lease or feed processing contracts in the case of organizations or individuals renting or processing at animal feed production facilities that have been granted a Certificate of Eligibility for Animal Feed Production;

d) Applicable publication standards;

d) Test result sheets of quality and safety indicators of the product according to applicable publication standards and corresponding national technical regulations issued by laboratories designated by the Ministry of Agriculture and Environment;

e) Sample of the product label.

3. The dossier to request the announcement of imported supplementary feed product information includes:

a) An application for product information declaration;

b) Certificate of Free Sale or an equivalent document issued by the competent authority of the country of origin;

c) One of the quality management system certificates (ISO), Good Manufacturing Practice (GMP), Hazard Analysis and Critical Control Points (HACCP), or an equivalent certificate in the field of animal feed of the production facility;

d) The product information sheet provided by the manufacturing organization or individual includes the ingredients, uses, instructions for use; quality standards, safety standards as prescribed by the Minister of Agriculture and Environment;

đ) The applied public standard of the organization or individual registering in accordance with the law on product and goods quality; the product's supplementary label displayed in Vietnamese as prescribed;

e) Test result sheets of quality and safety indicators of the product issued by a testing laboratory designated by the authority of the country of origin or recognized by an international accreditation organization or regional accreditation organization, or a laboratory designated by the Ministry of Agriculture and Environment;

g) Sample of the product label provided by the producing organization or individual.

The dossier must be the original or a certified copy and a Vietnamese translation certified by the organization or individual declaring the imported dietary supplement product. In case the original is not in English, the Vietnamese translation must be certified.

4. The dossier for re-declaration of dietary supplement product information includes: Application for re-declaration of product information.

5. The dossier for changing dietary supplement product information includes:

a) Application for changing information;

b) Applicable declared standard;

c) Sample of the product label;

d) Certificate of eligibility for animal feed production (for domestically produced animal feed);

đ) For imported feed additives, it is required to additionally provide the original or a certified copy of the certificate confirming the content change from the manufacturer; a certified copy of the Business Registration Certificate or a certificate from the competent state management agency in case of changing the name of the production facility or the trade name of the imported animal feed.

The dossier includes the original or a certified copy and a Vietnamese translation certified by the organization or individual changing the information of the imported feed product. If the original is not in English, the Vietnamese translation must be certified.

6. The announcement, re-announcement, and change of information of feed additive products are carried out according to the following sequence:

a) Organizations and individuals submit 01 (one) set of dossiers requesting product announcement, re-announcement, or information change for supplementary food products to the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of animal husbandry and veterinary via access to the National Public Service Portal;

b) Within 01 (one) working day from the date of receiving the dossier, the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of animal husbandry and veterinary shall check the components of the dossier, and in case the dossier is incomplete, it must be notified on the National Public Service Portal;

c) Within 15 (fifteen) working days for disclosure of information on supplementary feed products; 05 (five) working days for re-disclosure of information on supplementary feed products; 10 (ten) working days for changes in information on supplementary feed products, from the date of receipt of a complete and valid dossier, the agency assigned by the President of the provincial-level People's Committee to handle administrative procedures in the field of animal husbandry and veterinary health shall organize the appraisal and announcement, re-announcement and change of information on supplementary feed products on the website of the Ministry of Agriculture and Environment. In case of disagreement, clearly state the reason for the organization or individual.".

Article 4. Amendments and supplements to the name and some clauses of Article 10

1. To amend and supplement the name of Article 10 as follows:

"Article 10. Issuance, re-issuance and revocation of certificates of eligibility for animal feed production.".

2. Clause 1 is amended as follows:

1. The competent authorities for granting, reissuing, and revoking the Certificate of Eligibility for animal feed production are regulated as follows:

a) The agency assigned by the Minister of Agriculture and Environment to handle administrative procedures in the field of livestock and veterinary issues shall grant, reissue, and revoke the Certificate of Eligibility for animal feed production for facilities producing animal feed for export according to the requirements of the importing country;

b) The agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of livestock and veterinary issues shall grant, reissue, and revoke the Certificate of Eligibility for animal feed production for facilities producing animal feed in the locality, except in cases specified in point a of this clause.

3. Amend and supplement point b, clause 3 as follows:

"b) For facilities producing complete compound feed, concentrated feed, and supplementary feed:

Within 10 (ten) working days from the date of receiving the complete dossier, the competent authority shall appraise the content of the dossier.

In case the dossier does not meet the requirements, the competent authority shall request the organization or individual to supplement and complete the dossier.

In the case that the application meets the requirements, within 15 (fifteen) working days, the competent authority shall establish a team to assess the actual conditions of the animal feed production facility according to the contents stipulated in Clause 2, Article 11 of this Decree and prepare the Minutes according to Form No. 05.TACN Appendix I issued together with this Decree.

In cases where the facility does not meet the conditions, within 06 (six) months from the date of completion of the assessment, the organization or individual shall remedy the issues and submit a written report on the remediation results to the competent authority for verification and re-assessment of the actual conditions (if necessary).

In cases where the facility meets the conditions, within 03 (three) working days from the date of completion of the actual conditions assessment, the competent authority shall issue a Certificate of Eligibility for Animal Feed Production according to Form No. 06.TACN Appendix I issued together with this Decree. In cases of non-issuance, a written response shall be given clearly stating the reason.

4. Amend point b of clause 5 as follows:

"b) Within 03 (three) working days from the date of receipt of a complete and valid dossier, the competent authority shall re-issue the Certificate of Eligibility for Animal Feed Production according to Form No. 06.TACN Appendix I issued together with this Decree. In cases of non-issuance, a written response shall be given clearly stating the reason."

5. Add clause 6a after clause 6 as follows:

“6a. The Certificate of Eligibility for Animal Feed Production of an animal feed production establishment issued by the Agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of livestock and veterinary will expire in the case that the Agency assigned by the Minister of Agriculture and Environment to handle administrative procedures in the field of livestock and veterinary issues a Certificate of Eligibility for Animal Feed Production to that establishment upon the request of the importing country.”

6. Amend and supplement point a, clause 7 as follows:

“a) Establishments falling under the cases specified in points a, c, d, and đ of clause 3, Article 39 of the Law on Animal Husbandry;”.

Article 5. Amend and supplement clauses 5 and 6 of Article 11

1. Amend and supplement clause 5 as follows:

“5. The frequency of supervisory evaluations to maintain the conditions for animal feed production is regulated as follows:

a) The frequency of supervisory assessments to maintain livestock feed production conditions is 48 (forty-eight) months once. For the facilities specified in point c, clause 3, Article 10 of this Decree, the first supervisory assessment shall be conducted within 12 months from the date of issuance of the Certificate of Eligibility for livestock feed production.

b) In the case of livestock feed production facilities that have been granted a Quality Management System (ISO) certificate, Good Manufacturing Practice (GMP), Hazard Analysis and Critical Control Points (HACCP), or an equivalent certificate in the field of livestock feed, supervisory assessments shall be carried out with a frequency of 60 (sixty) months once;

c) In case a facility is found to have signs of violating livestock feed laws, the competent authority shall conduct inspection and unscheduled supervisory assessment."

2. Amend and supplement clause 6, Article 11 as follows:

6. The supervision and evaluation of maintaining the conditions for animal feed production shall be conducted as follows: Within 06 (six) months prior to the time of supervision assessment specified in points a and b, Clause 5 of this Article, the competent authority that issues the Certificate of Eligibility for Animal Feed Production shall notify the organization or individual in writing. Within 20 (twenty) working days from the date of notification, the evaluation agency shall establish an evaluation team and organize an assessment of the actual conditions at the facility in accordance with the provisions of point a, Clause 1, Clauses 2, 3, and 4 of this Article. Within no more than 05 (five) working days from the date of completion of the assessment, the competent authority shall issue a Notification of Evaluation Results according to Form No. 13.TACN Appendix I issued together with this Decree.

In cases where the establishment does not meet the conditions, within 06 (six) months from the date of completion of the surveillance assessment, the organization or individual must rectify the issues and send a written report of the rectification results to the competent authority for verification and re-evaluation of the actual conditions (if necessary).

Article 6. Amendments and supplements to certain clauses of Article 13

1. Amend and supplement clause 1 as follows:

"1. The Chairman of the Provincial People's Committee shall grant import permits for animal feed that has not been announced on the Ministry of Agriculture and Environment's electronic information portal for introduction at fairs, exhibitions, adaptive breeding, research, testing, sample analysis in laboratories, or for production and processing for export purposes."

2. Amend and supplement clause 7 as follows:

7. The order and procedures for granting permits for the import of animal feed that have not been published on the electronic information portal of the Ministry of Agriculture and Environment are regulated as follows:

a) Organizations and individuals submit 01 (one) set of application documents for the import license of animal feed that has not been published on the electronic information portal of the Ministry of Agriculture and Environment to the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of animal husbandry and veterinary (at the location where the organization or individual has its headquarters or the import border gate) either directly, online, or via postal services;

b) The agency assigned by the Chairman of the Provincial People’s Committee to handle administrative procedures in the field of animal husbandry and veterinary medicine shall immediately respond regarding the completeness of the dossier in cases of direct submission; respond regarding the completeness of the dossier within 01 (one) working day in cases of submission via online environment or postal service in writing;

c) Within 10 (ten) working days from the date of receiving a complete and valid dossier, the agency assigned by the Chairman of the Provincial People’s Committee to handle administrative procedures in the field of animal husbandry and veterinary medicine shall appraise and decide on the issuance of an import permit for animal feed that has not been publicly announced on the electronic information portal of the Ministry of Agriculture and Environment according to Form No. 09.TACN, Appendix I issued together with this Decree. In case of non-issuance, respond in writing and clearly state the reason.

Article 7. Amendments and supplements to Article 18 "Article 18. State inspection of the quality of imported animal feed

1. State inspection of the quality of imported animal feed is regulated as follows:

a) Authority for inspection: Chairman of the Provincial People's Committee;

b) Content of inspection: Inspect import dossiers including information related to the imported shipment (name of goods; brand, type; technical specifications; origin, manufacturer; weight/quantity; invoice); conduct actual checks on specifications, packaging, labeling, expiry date, origin, and other sensory indicators of the product; take samples for testing, evaluate conformity in terms of product quality and safety;

c) Inspection procedures and processes: Conduct in accordance with provisions of the law on product and goods quality.

2. Animal feed is exempt from quality inspection upon import in the following cases:

a) Temporary imported and re-exported, re-imported animal feed for processing according to the requirements of foreign partners;

b) Transit, transshipment, or re-exported animal feed;

c) Animal feed sent from abroad to bonded warehouses;

d) Animal feed for display at fairs, exhibitions, or advertising;

e) Animal feed samples for analysis at testing laboratories;"

e) Animal feed samples for testing to serve trials, inspection, certification of compliance with national technical regulations, inter-laboratory testing;

g) Animal feed for scientific research;

h) Animal feed of incoming persons within the tax exemption quota;

i) Imported animal feed serving urgent needs decided by the Government or the Prime Minister based on the proposal of the Ministry of Agriculture and Environment;

k) Animal feed provided as aid, serving for the conservation, rescue of animals, and adaptive breeding;

l) Imported animal feed used for experimental animals not for commercial purposes.

3. Reduction of state inspection on the quality of imported animal feed shall be carried out in accordance with the provisions of the law on product and goods quality.

Article 8. Amendment and Supplementation of Article 21

"Article 21. Livestock farming scale management

1. Large-scale farm livestock production is managed according to the provisions of Article 23 and Article 24 of this Decree.

2. Medium-scale and small-scale farm livestock production must meet the conditions stipulated in Clause 1, Article 55 and Clause 2, Article 57 of the Law on Livestock.

The agency assigned by the Chairman of the Provincial People's Committee is responsible for inspecting the livestock conditions of medium-scale and small-scale farm livestock establishments as prescribed in Clause 1, Article 55, and Clause 2, Article 57 of the Law on Animal Husbandry. The frequency of periodic inspections is once every three (3) years; sudden inspections are conducted when signs of violations are detected or when there are denunciations, complaints about livestock conditions, or according to the directives of the higher management authority.

In case of violations, the livestock establishment must commit to rectifying and ensuring livestock conditions within six (6) months from the date the violation is detected and submit a report on the rectification results to the inspection agency. The inspection agency conducts an actual inspection of the rectification results if necessary.

Article 9. Amendments and supplements to Article 22

“Article 22. Determination of livestock density

The area of agricultural land used as a basis to determine livestock density includes the total area of types of agricultural land in accordance with the provisions of land law.”

Article 10. Amendments and supplements to certain clauses of Article 23

1. Amend and supplement clause 3 as follows:

“3. The order and procedures for granting a Certificate of Sufficient Livestock Conditions for large-scale farm livestock are stipulated as follows:

a) Organizations and individuals submit the dossiers specified in Clause 2 of this Article to the competent authority prescribed in Clause 1 of this Article;

b) Within 05 (five) working days from the date of receiving a complete and valid dossier, the competent authority shall appraise the content of the dossier.

In case the dossier does not meet the requirements, the competent authority shall request the organization or individual to supplement and complete the dossier.

In case the dossier meets the requirements, within 15 (fifteen) working days, the competent authority shall establish a team to evaluate the actual conditions of the livestock facility in accordance with the provisions of Article 24 of this Decree.

In cases where the facility does not meet the conditions, within 06 (six) months from the date of completion of the assessment, the organization or individual shall remedy the issues and submit a written report on the remediation results to the competent authority for verification and re-assessment of the actual conditions (if necessary).

In case the facility meets the conditions, within 05 (five) working days from the date of completion of the actual condition assessment, the competent authority shall issue a Certificate of Eligibility for Livestock Farming according to Form No. 05.ĐKCN Appendix I issued together with this Decree. In case of refusal, a written response must be provided stating the reasons.

2. Amend and supplement Clause 5 as follows:

"5. The procedure for re-issuing the Certificate of Eligibility for Livestock Farming for large-scale farm breeding is prescribed as follows:

a) Organizations or individuals submit the dossiers specified in Clause 4 of this Article to the competent authority specified in Clause 1 of this Article;

b) Within 03 (three) working days from the date of receipt of a complete and valid dossier, the competent authority shall re-issue the Certificate of Eligibility for Livestock Farming according to Form No. 05.ĐKCN Appendix I issued together with this Decree. In case of refusal, a written response must be provided stating the reasons."

Article 11. Amend and supplement Clause 4, Article 24

"4. The frequency of monitoring and evaluation to maintain livestock farming conditions for large-scale farm livestock is once every 36 (thirty-six) months.

In cases where the facility does not meet the conditions, within 06 (six) months from the date of completion of the assessment, the organization or individual shall remedy the issues and submit a written report on the remediation results to the competent authority for verification and re-assessment of the actual conditions (if necessary).

In the event that a facility shows signs of violating livestock farming conditions, the competent authority specified in Clause 5 of this Article shall conduct a sudden evaluation and monitoring."

Article 12. Amendments and supplements to point c, Clause 4, Article 31

c) Procedures for recognizing the results of trials

Organizations or individuals with livestock waste treatment products under trial shall submit 01 (one) set of dossiers as prescribed in point b, clause 4 of this Article to the Agency assigned by the Minister of Agriculture and Environment to handle administrative procedures in the field of livestock and veterinary affairs.

Within 10 (ten) working days from the date of receipt of a complete and valid dossier, the agency assigned by the Minister of Agriculture and Environment to handle administrative procedures in the field of animal husbandry and veterinary medicine shall establish a council to evaluate the trial results, including: the agency assigned by the Minister of Agriculture and Environment to handle administrative procedures in the field of animal husbandry and veterinary medicine, relevant units, and technical experts.

Within 05 (five) working days from the date of receiving the completed dossier according to the opinion of the Appraisal Council, the agency assigned by the Minister of Agriculture and Environment to handle administrative procedures in the field of animal husbandry and veterinary shall review and issue a decision recognizing livestock waste treatment products containing new substances that have been tested, according to Form No. 05.MTCN Appendix I issued together with this Decree. In case of non-recognition, a written response must be provided stating the reasons.

Article 13. Amendments and supplements to certain clauses of Article 32a

"Article 32a. Issuance, re-issuance, and revocation of the Certificate of Eligibility for the Production of Livestock Waste Treatment Products

1. Amend and supplement clause 1 as follows:

“1. The Chairman of the Provincial People's Committee shall issue, reissue, or revoke the Certificate of Eligibility for the production of livestock waste treatment products in the locality.

2. Amend and supplement clause 3 as follows:

“3. Procedures for issuing the Certificate of Eligibility for the production of livestock waste treatment products

a) Organizations and individuals shall submit one (1) set of application dossier for the issuance of the Certificate of Eligibility for the production of livestock waste treatment products to the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of animal husbandry and veterinary (the place where the organization or individual has the production facility);

b) Agencies assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of animal husbandry and veterinary medicine must immediately respond regarding the completeness of the dossier for cases of direct submission; respond regarding the completeness of the dossier within 01 (one) working day for cases of submission via online environment or postal service in writing.

In cases where the dossier meets the requirements, within 17 (seventeen) working days from the date of receiving a valid dossier, the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of livestock and veterinary shall establish a team to assess the actual conditions of the production facility, with the assessment content in accordance with the regulations in Form No. 09.MTCN and prepare an assessment report according to Form No. 10.MTCN Appendix I issued together with this Decree.

In case the facility does not meet the conditions, within 06 (six) months from the date of completion of the assessment, the facility shall remedy the deficiencies and send a written report on the results of the remediation to the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures for verification and re-assessment of actual conditions (if necessary).

In case the facility meets the conditions, within 03 (three) working days from the date of completion of the actual condition assessment, the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures shall issue the Certificate of Eligibility for Production of Livestock Waste Treatment Products according to Form No. 11.MTCN Appendix I issued together with this Decree. In case it is not issued, a written response must be provided stating the reasons.

3. Amend and supplement Clause 5 as follows:

"5. Procedures and steps for re-issuing the Certificate of Eligibility for Production of Livestock Waste Treatment Products

a) Organizations and individuals shall submit 01 (one) set of application dossiers for re-issuance of the Certificate of Eligibility for Production of Livestock Waste Treatment Products to the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of livestock and veterinary.

The dossiers include: an application for re-issuance of the Certificate of Eligibility for Production according to Form No. 06.MTCN Appendix I issued together with this Decree and documents related to changes in information of the organization or individual in the Certificate.

b) The agency assigned by the Chairman of the Provincial People’s Committee to handle administrative procedures in the field of animal husbandry and veterinary medicine shall immediately respond regarding the completeness of the dossier in cases of direct submission; respond regarding the completeness of the dossier within 01 (one) working day in cases of submission via online environment or postal service in writing;

c) Within 03 (three) working days from the date of receiving a complete and valid dossier, the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of animal husbandry and veterinary shall review and decide on reissuing the certificate of eligibility for the production of livestock waste treatment products according to Form No. 11.MTCN Appendix I issued together with this Decree. In case of non-issuance, a written response must be provided stating the reasons.

Article 14. Amendments and supplements to certain clauses of Article 32b

1. Amend and supplement clause 2 as follows:

2. The competent authority shall establish a Team to assess the actual conditions of livestock waste treatment product production facilities. The assessment team includes: the Head of the team who is a leader at the department level or higher and at least one member with a university degree or higher in the fields of animal husbandry, veterinary medicine, chemistry, biotechnology, or environmental technology.

2. Amend and supplement clause 3 as follows:

3. The frequency of supervisory assessments to maintain the conditions of livestock waste treatment product production facilities is 48 (forty-eight) months/time. In the case that the facility has been granted a Certificate of Management System (ISO), Good Manufacturing Practice (GMP), Hazard Analysis and Critical Control Points (HACCP), or an equivalent certificate in the production of livestock waste treatment products, supervisory assessments are conducted at a frequency of 60 (sixty) months/time. In case a facility is found to show signs of legal violations or there are complaints or denunciations regarding quality, or according to the directives of higher management authorities, the competent authority shall conduct an unscheduled inspection.

3. Amend and supplement clause 4 as follows:

4. The supervision assessment of maintaining conditions for the production of livestock waste treatment products is carried out as follows: Within 06 (six) months before the supervision assessment, the competent authority shall notify the organization or individual in writing. Within 20 (twenty) working days from the date of notification, the competent authority shall establish an assessment team and organize the assessment of actual conditions at the facility in accordance with Form No. 09.MTCN Appendix I issued together with this Decree. Within no more than 05 (five) working days from the date of completion of the assessment, the competent authority shall notify the assessment results according to Form No. 12.MTCN Appendix I issued together with this Decree.

In cases where the facility does not meet the conditions, within 06 (six) months from the date of completion of the assessment, organizations or individuals shall remedy the deficiencies and submit a written report on the results of the remediation to the competent authority for inspection and reevaluation of the actual conditions (if necessary).

Article 15. Amendment and supplementation of certain forms

Amend Form No. 01.TACN, Form No. 06.TACN, Form No. 07.TACN, Form No. 09.TACN, Form No. 01.ĐKCN, Form No. 02.ĐKCN, Form No. 03.ĐKCN, Form No. 04.ĐKCN, Form No. 05.ĐKCN, Form No. 06.ĐKCN, Form No. 02.MTCN, Form No. 03.MTCN, Form No. 04.MTCN, Form No. 05.MTCN, Form No. 06.MTCN, Form No. 07.MTCN, Form No. 08.MTCN, Form No. 09.MTCN, Form No. 10.MTCN, Form No. 11.MTCN, Form No. 12.MTCN, Form No. 13.MTCN, Form No. 14.MTCN, Form No. 15.MTCN according to the forms in Appendix I issued together with this Decree.

Article 16. Replacement and abolition of certain phrases

1. Replace the following phrases:

a) Replace the phrase “Ministry of Agriculture and Rural Development” with the phrase “Ministry of Agriculture and Environment” in point b, clause 9, Article 4; points b, c, d, clause 1, points b, c, clause 2, point c, clause 3, Article 5; point b, clause 2, Article 5a; clause 4, Article 9; clause 4, Article 12; title of Article 13; point a, clause 2, Article 20; clause 2, Article 28; clauses 2 and 5, Article 30; clause 1, Article 31; clause 9, Article 32; clauses 3 and 6, Article 32d; point b, clause 2, clause 3, Article 32đ; point d, clause 3, Article 32h; clauses 6 and 8, Article 34; points b and c, clause 3, Section II, Form No. 04.TACN Appendix I; item number 14, Section II, Appendix Table of feed production condition assessment in Form No. 05.TACN Appendix I, and Section IV, Form No. 16.TACN Appendix I;

b) Replace the phrase “Department of Animal Husbandry” with the phrase “The agency assigned by the Minister of Agriculture and Environment to manage in the field of husbandry and veterinary medicine” in point b, clause 3, Article 11; clause 1, Article 14; clauses 1 and 3, Article 16; point a, clause 1, Article 17; point b, clause 4, Article 19; clause 6, Article 23; point b, clause 2 and clause 5, Article 24; clause 2, Article 30; point d, clause 4, Article 31; clause 5, Article 32d; point a, clause 1, point a, clause 2, Article 32đ; point b, clause 4, Article 32e; point b, clause 2, Article 32g; clause 8, Article 34; and Form No. 13.TACN Appendix I;

c) Replace the phrase “Department of Agriculture and Rural Development” with the phrase “The agency assigned by the Chairman of the Provincial People’s Committee to manage in the field of husbandry and veterinary medicine” in point b, clause 1, Article 17; point a, clause 2, Article 20; clause 1, Article 23; clause 5, Article 24; point a, clause 2, Article 32đ; point b, clause 2, Article 32g; and Form No. 13.TACN Appendix I.

2. Abolish the following phrases:

Abolish the phrase ", declaration of conformity" in Clause 4 Article 9, Clause 1 Article 30, Clause 9 Article 32, "; declaration of conformity" in Point a Clause 3 Part II of Form No. 04.TACN Appendix I, Point a, Serial No. 14 Section II Appendix Table of content for evaluating the conditions for animal feed production in Form No. 05.TACN Appendix I; "declaration of conformity" in Section IV of Form No. 16.TACN Appendix I; "conformity declaration" in Point b Clause 3, Point d Clause 4 Article 30.

Article 17. Abolish the following contents

Abolish Article 6; Article 7; Article 8; Clauses 2, 3, 4, and 5 of Article 14; Article 15; Article 18a; item c of Clause 4 of Article 23; Article 27; item d of Clause 2 of Article 31; Clause 6 and item a of Clause 7 of Article 32a; Clause 3 of Article 32c; Clause 10 of Section I and the content “Raw materials used in the finished product must have a minimum shelf life equal to the shelf life of the finished product. In cases where the raw materials have a shelf life shorter than that of the finished product, organizations and individuals must have measures to ensure that it does not affect the quality of the finished product.” in item d of Clause 3 of Section II of Form No. 04.TACN; serial number 10 of Section I of the Appendix Table of evaluation of feed production conditions of Form No. 05.TACN, Form No. 10.TACN, Form No. 11.TACN, Form No. 12.TACN, Form No. 14.TACN, Form No. 15.TACN, Form No. 16.TACN, Form No. 17.TACN, Appendix I; Appendix II; Appendix III; Appendix V; Appendix VI and Appendix VIII.

Chapter II. AMENDING AND SUPPLEMENTING SOME ARTICLES OF DECREE NO. 35/2016/NĐ-CP

AMENDED AND SUPPLEMENTED ON MAY 15, 2016 ACCORDING TO

CLAUSE 2 ARTICLE 2 OF DECREE NO. 123/2018/NĐ-CP DATED SEPTEMBER 17

THE YEAR 2018 AND DECREE NO. 80/2022/NĐ-CP DATED OCTOBER 13

YEAR 2022

Article 18. Amendment and supplementation of Clause 3, Article 12

"3. Storage area for raw materials, auxiliary materials, and finished drugs must have an area appropriate to the scale of production and ensure the following conditions:

a) There is a separate warehouse to store raw materials, auxiliary materials, and finished drugs;

b) There is a separate external warehouse to store solvents and flammable raw materials;

c) Floor, walls, and ceiling in accordance with the regulations at point c, clause 2 of this Article;

d) Equipment and means to ensure storage conditions."

Article 19. Amendment and supplement of certain points and clauses of Article 14

1. Amend and supplement clause 1 as follows:

"1. The dossier for applying for the Certificate of Good Manufacturing Practice (GMP) for veterinary drugs (hereinafter referred to as the GMP Certificate) includes:

a) GMP inspection registration form according to Form No. 01.QLT Appendix IA issued together with this Decree;

b) Organizational chart and personnel of the establishment;

c) Program, training documents, and GMP training evaluation results at the establishment;

d) List of production, storage, and quality control equipment;

đ) List of standard operating procedures;

e) List of items currently produced or planned for production;"

g) Register the environmental impact assessment or environmental report in accordance with the environmental law;

h) GMP self-inspection minutes.

The GMP inspection registration dossier must have a cover page and a table of contents, arranged in the order of the table of contents, with separation between sections."

2. Amend and supplement point b, clause 2 as follows:

"b) Within 18 (eighteen) working days from the date of receiving a complete and valid dossier, the agency assigned by the Minister of Agriculture and Environment to handle administrative procedures in the field of livestock and veterinary medicine shall make a decision to establish a GMP inspection team, simultaneously notify the inspection schedule to the facility, and conduct the inspection."

3. Amend and supplement certain points of clause 3 as follows:

"c) Inspect all activities of the veterinary drug manufacturing facility according to GMP, the facility's registration dossier, and current professional regulations. GMP inspection minutes according to Form No. 02.QLT Appendix IA issued together with this Decree.

d) Conduct online inspections and evaluations in cases of natural disasters or when regulations on the prevention and control of dangerous diseases must be applied and direct on-site inspections and evaluations cannot be carried out to issue certificates. Direct on-site evaluations will be conducted after localities control natural disasters and epidemics according to regulations; immediately revoke the certificate for cases where organizations or individuals violate the law and handle violations according to legal regulations.

4. Amend and supplement point a, clause 4 as follows:

"a) Based on the Inspection Record, the Head of the Inspection Team shall propose to the head of the agency assigned by the Minister of Agriculture and Environment to handle administrative procedures in the field of livestock and veterinary to issue a GMP Certificate for establishments that meet GMP conditions. The GMP Certificate follows Form No. 03.QLT Appendix IA issued together with this Decree."

Article 20. Amendments and supplements to point a, clause 1, Article 15

"a) Application for GMP inspection extension according to Form No. 01.QLT Appendix IA issued together with this Decree."

Article 21. Amendments and supplements to clause 1, Article 16

"1. Procedure for re-issuing the GMP Certificate in case of errors; changes in information related to the registering organization."

a) Organizations and individuals submit 01 (one) set of documents for re-issuance of the GMP Certificate to the Agency assigned by the Minister of Agriculture and Environment to handle administrative procedures in the field of livestock and veterinary according to one of the following forms: online, by postal service, or directly.

The file includes: An application for reissuance according to Form No. 04.QLT Appendix IA issued together with this Decree and related documents concerning the content changes;

b) In case the file is incomplete or invalid, within 03 (three) working days from the date of receiving the file, the Agency assigned by the Minister of Agriculture and Environment to handle administrative procedures in the field of livestock and veterinary will guide organizations and individuals to complete the file;

c) Within 05 (five) working days from the date of receiving a complete and valid file, the Agency assigned by the Minister of Agriculture and Environment to handle administrative procedures in the field of livestock and veterinary shall reissue the GMP Certificate. In case of non-issuance, respond in writing and specify the reason.".

Article 22. Adding Article 16a after Article 16

"Article 16a. Sequence and procedures for issuing, reissuing, extending, and revoking the Certificate of Eligibility for Veterinary Drug Production"

1. The application dossier for the issuance of a Certificate of Eligibility for Veterinary Drug Production (except for the production of veterinary pharmaceuticals and vaccines) includes:

a) Registration form according to Form No. 05.QLT Appendix IA issued together with this Decree;

b) A detailed explanatory report on the facilities and technical aspects of veterinary drug production according to Form No. 06.QLT Appendix IA issued together with this Decree;

c) Environmental registration or an environmental assessment document in accordance with the environmental laws.

2. Procedures for issuing the Certificate of Eligibility for Veterinary Drug Production:

a) Organizations and individuals producing veterinary drugs shall submit the application dossier for the issuance of the Certificate of Eligibility for Veterinary Drug Production (except for the production of veterinary pharmaceuticals and vaccines) to the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of livestock and veterinary medicine;

b) Within 05 (five) working days from the date of receiving complete and valid dossiers, the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of livestock farming and veterinary medicine shall carry out the inspection of the production facility. In cases where the conditions are met, within 03 (three) working days from the date of completion of the inspection, the agency shall issue a Certificate of Eligibility for Veterinary Drug Production. In cases where the certificate is not issued, a written response must be provided stating the reasons.

The inspection minutes of veterinary drug production conditions shall follow Form No. 07.QLT in Appendix IA issued together with this Decree, and the Certificate of Eligibility for Veterinary Drug Production shall follow Form No. 08.QLT in Appendix IA issued together with this Decree.

c) Conduct online inspections and evaluations in cases of natural disasters or when regulations on the prevention and control of dangerous epidemics must be applied, making it impossible to carry out direct on-site inspections and evaluations to issue certificates. On-site evaluations will be conducted after localities have controlled natural disasters and epidemics according to regulations; immediately revoke certificates in cases where organizations or individuals violate legal provisions and handle violations in accordance with the law.

3. Procedures for reissuing a Certificate of Eligibility for Veterinary Drug Production (excluding production of veterinary pharmaceuticals and vaccines) in cases of errors or changes in information related to the registering organization or individual.

a) The application dossier for re-issuance includes: The re-issuance application form according to Form No. 14.QLT Appendix IA issued together with this Decree; documents related to the content of changes in information of the registered organization or individual;

b) Organizations or individuals submit the application dossier for re-issuance of the Certificate of Eligibility for Veterinary Drug Production to the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of animal husbandry and veterinary medicine; within 05 (five) working days from the date of receiving a complete and valid dossier, the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of animal husbandry and veterinary medicine shall re-issue the Certificate of Eligibility for Veterinary Drug Production. In case of non-issuance, a written response stating the reason shall be provided.

4. Procedures and formalities for the extension of the Certificate of Eligibility for Veterinary Drug Production (except for the production of veterinary drugs in the form of pharmaceuticals and vaccines)

Before 03 (three) months from the expiration date of the Veterinary Drug Production Eligibility Certificate, organizations or individuals who wish to continue producing veterinary drugs shall submit an application for the renewal of the Certificate. The order and procedures for renewal shall be carried out in accordance with the provisions at point a, clause 1 and clause 2 of this Article.

Article 23. Amendment and supplementation of Article 17

"Article 17. Conditions for trading veterinary drugs

Organizations and individuals trading veterinary drugs shall implement according to the provisions of Article 92 of the Law on Veterinary Medicine and meet the following conditions:

1. Have equipment to ensure the storage conditions stated on the product label; have thermometers and hygrometers to monitor the storage conditions of the products.

2. For facilities trading vaccines and biological products, they must have backup generators, equipment, and means of transporting and distributing vaccines to ensure the storage conditions stated on the product label."

Article 24. Supplement Article 17a after Article 17

Article 17a. Procedures for granting, re-granting, extending, and revoking the Certificate of Eligibility for Veterinary Drug Trading

1. The application dossier for the Certificate of Eligibility for Veterinary Drug Trading includes:

a) Registration form according to Form No. 09.QLT Appendix IA issued together with this Decree;

b) Detailed explanation of facilities and technical conditions according to Form No. 10.QLT Appendix IA issued together with this Decree;

c) Veterinary practice certificate.

2. Procedures for granting the Certificate of Eligibility for Veterinary Drug Trading

a) Organizations and individuals trading veterinary drugs submit the application dossier for the Certificate of Eligibility for Veterinary Drug Trading to the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of livestock and veterinary affairs;

b) Within 05 (five) working days from the date of receiving a valid dossier, the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of livestock and veterinary medicine shall inspect the conditions of veterinary drug trading establishments. If the conditions are met, within 03 (three) working days from the date of completing the inspection, a Certificate of Eligibility for Veterinary Drug Trading must be issued. In case of non-issuance, a written response must be provided stating the reasons.

The inspection record of veterinary drug trading conditions shall follow Form No. 11.QLT, Appendix IA issued together with this Decree, and the Certificate of Eligibility for Veterinary Drug Trading shall follow Form No. 12.QLT, Appendix IA issued together with this Decree.

c) Conduct online inspections and evaluations in cases of natural disasters or when regulations on the prevention and control of dangerous epidemics must be applied, making it impossible to carry out direct on-site inspections and evaluations to issue certificates. On-site evaluations will be conducted after localities have controlled natural disasters and epidemics according to regulations; immediately revoke certificates in cases where organizations or individuals violate legal provisions and handle violations in accordance with the law.

3. Procedure for re-issuing the Certificate of Eligibility for Veterinary Drug Trading in case of errors or changes in information related to the registered organization or individual:

a) The application dossier for re-issuance includes: The re-issuance application form according to Form No. 14.QLT Appendix IA issued together with this Decree; documents related to the content of changes in information of the registered organization or individual;

b) Organizations or individuals submit a registration dossier for re-issuance of the Certificate of Eligibility for Veterinary Drug Trading to the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of animal husbandry and veterinary medicine; within 05 (five) working days from the date of receiving a complete and valid dossier, the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of animal husbandry and veterinary medicine shall re-issue the Certificate of Eligibility for Veterinary Drug Trading. In case of non-issuance, a written response must be provided stating the reasons.

4. Procedure for extending the Certificate of Eligibility for Veterinary Drug Trading

Before the period of 03 (three) months counting from the expiration date of the Certificate of Eligibility for Veterinary Drug Trading, organizations or individuals wishing to continue trading veterinary drugs must submit an application for the renewal of the Certificate. The order and procedures for renewal shall be carried out in accordance with the provisions at point a, clause 1, and clause 2 of this Article.

Article 25. Amendment and supplementation of Article 18

"Article 18. Conditions for importing veterinary drugs

Organizations and individuals importing veterinary drugs shall comply with the provisions of Article 94 of the Law on Veterinary Medicine, Article 17 of this Decree, and meet the following conditions:

1. Have a warehouse that ensures the conditions specified in Clause 3, Article 12 of this Decree.

2. Have a thermometer and hygrometer to monitor product storage conditions. For facilities importing vaccines and biological products, there must be a separate storage warehouse."

Article 26. Supplement Article 18a after Article 18

"Article 18a. Procedures for granting, re-granting, renewing, and revoking the Certificate of Eligibility for Veterinary Drug Importation

1. The application dossier for granting the Certificate of Eligibility for Veterinary Drug Importation includes:

a) Registration form according to Form No. 09.QLT Appendix IA issued together with this Decree;

b) Detailed explanation of facilities and technical conditions according to Form No. 10.QLT Appendix IA issued together with this Decree;

c) Veterinary practice certificate.

2. Procedures for issuing the Certificate of Eligibility for Importing Veterinary Drugs

a) Organizations and individuals importing veterinary drugs shall submit the registration dossier for the issuance of the Certificate of Eligibility for Importing Veterinary Drugs to the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of livestock and veterinary.

b) Within 5 (five) working days from the date of receiving a complete and valid dossier, the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of livestock and veterinary shall inspect the conditions of the veterinary drug import facility. If eligible, within 3 (three) working days from the date of completing the inspection, the Certificate of Eligibility for Importing Veterinary Drugs shall be issued. In case of non-issuance, a written response stating the reasons shall be provided.

Inspection record of veterinary drug import conditions according to Form No. 11.QLT Appendix IA issued together with this Decree, Certificate of eligibility for importing veterinary drugs according to Form No. 13.QLT Appendix IA issued together with this Decree;

c) Conduct online inspections and evaluations in cases of natural disasters or when regulations on the prevention and control of dangerous epidemics must be applied, making it impossible to carry out direct on-site inspections and evaluations to issue certificates. On-site evaluations will be conducted after localities have controlled natural disasters and epidemics according to regulations; immediately revoke certificates in cases where organizations or individuals violate legal provisions and handle violations in accordance with the law.

3. Procedures for re-issuing the Certificate of Eligibility for Importing Veterinary Drugs in case of errors or changes in information related to the registering organization or individual

a) The application dossier for re-issuance includes: The re-issuance application form according to Form No. 14.QLT Appendix IA issued together with this Decree; documents related to the content of changes in information of the registered organization or individual;

b) Organizations and individuals submit the application for re-issuance of the Certificate of Eligibility to Import Veterinary Drugs to the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of animal husbandry and veterinary medicine; within 05 (five) working days from the date of receiving a valid application, the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of animal husbandry and veterinary medicine shall re-issue the Certificate of Eligibility to Import Veterinary Drugs. In case of non-issuance, a written response stating the reason shall be provided.

4. Procedures and processes for extending the Certificate of Eligibility to Import Veterinary Drugs

Before 03 (three) months from the expiration date of the Certificate of Eligibility for Importing Veterinary Drugs, organizations or individuals who wish to continue importing veterinary drugs must submit an application to extend the Certificate. The order and procedures for extension shall be carried out according to the provisions at point a, clause 1 and clause 2 of this Article.

5. Veterinary drug manufacturing facilities that already have a Good Manufacturing Practice (GMP) certificate or a certificate of eligibility for veterinary drug production issued by a competent authority in Vietnam that is still valid when importing veterinary drugs; raw materials for the production and business of veterinary drugs of the same type currently permitted for production do not need to go through the procedure for issuing a Certificate of Eligibility for Importing Veterinary Drugs.

Article 27. Amendments and supplements to certain clauses of Article 19

1. Amend and supplement clause 3 as follows:

"3. Equipped with machinery and instruments ensuring sampling, analysis, calibration, and accurate data processing."

2. Amend and supplement Clause 4 as follows:

"4. There is a place for keeping laboratory animals; there is a separate toxicity testing area for vaccines and microorganisms."

3. Amend and supplement Clause 5 as follows:

"5. There is a system for treating waste, water, and air emissions."

Article 28. Amend and supplement Clause 1 of Article 20

"1. Places for breeding livestock and aquaculture must meet the following conditions:

a) There are pens or ponds, tanks for raising animals with an area ensuring a stocking density suitable for testing requirements;

b) There is a sufficient number of animals to meet testing according to the regulations of the Ministry of Agriculture and Environment; there is a separate place for keeping laboratory animals, a system for treating waste and wastewater, and an area for handling animal carcasses and specimens;

c) The place for producing, processing, and storing animal feed must be separated from the place for storing hazardous chemicals and have measures to prevent insects and harmful animals."

Article 29. Amend and supplement Clause 1 of Article 21

"1. Persons practicing in diagnosing, treating, performing surgery on animals, and consulting on activities related to the veterinary field must at minimum have an intermediate-level degree in veterinary medicine or veterinary husbandry for practicing veterinary medicine for terrestrial animals, or an intermediate-level degree in aquaculture or aquatic pathology for practicing veterinary medicine for aquatic animals.

Persons practicing vaccination for animals must at minimum be trained in vaccination techniques."

Article 30. Addition of Article 21a after Article 21

"Article 21a. Procedures for issuing, reissuing, and renewing Veterinary Practice Certificates

1. The application file for issuing a Veterinary Practice Certificate includes:

a) An application form according to Form No. 01.HNTY Annex IB issued together with this Decree;

b) Professional diploma or Certificate of having completed professional training appropriate to each type of veterinary practice. In case the professional diploma does not indicate the specialty, additional documents confirming the specialty issued by the training institution must be provided;

c) Health certificate;

d) For foreigners, in addition to the provisions at points a, b, and c of this clause, they must also have a Work Permit or a certificate confirming that they are not subject to the requirement of obtaining a work permit.

2. Procedures for issuing Veterinary Practice Certificates

a) Individuals who wish to be issued a Veterinary Practice Certificate must submit an application to the Agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of livestock and veterinary medicine as prescribed in Clause 1 of this Article;

b) Within 05 (five) working days from the date of receiving a valid dossier, the agency assigned by the Chairman of the Provincial People’s Committee to handle administrative procedures in the field of animal husbandry and veterinary medicine shall consider and decide on the issuance of a Veterinary Practice Certificate. In case of refusal, a written reply must be given stating the reasons.

3. Procedure for renewing the Veterinary Practice Certificate

a) Before 30 (thirty) days from the expiry date of the Veterinary Practice Certificate, individuals who wish to renew the certificate must submit their dossiers to the agency assigned by the Chairman of the Provincial People’s Committee to handle administrative procedures in the field of animal husbandry and veterinary medicine;

b) The dossier includes: Renewal application form according to Form No. 02.HNTY Appendix IB issued together with this Decree; Health certificate; Work permit or confirmation of exemption from work permit (for foreigners);

c) Within 03 (three) working days from the date of receiving a complete and valid dossier, the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of animal husbandry and veterinary medicine shall review and decide on the extension of the veterinary practice certificate. In case of non-extension, a written response shall be given stating the reason.

4. Procedures for reissuing the veterinary practice certificate

a) Individuals registering for reissuance of the veterinary practice certificate due to errors or information changes shall send the dossier to the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of animal husbandry and veterinary medicine;

b) The dossier for reissuing the veterinary practice certificate includes: a reissuance application according to Form No. 03.HNTY Appendix IB issued together with this Decree;

c) Within 03 (three) working days from the date of receiving a complete and valid dossier, the agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of animal husbandry and veterinary medicine shall review and decide to reissue the veterinary practice certificate. In case of refusal, a written response must be provided, clearly stating the reasons.

5. The veterinary practice certificate is valid for 05 years from the date of issuance. In the case of reissuing a veterinary practice certificate, its validity shall extend until the expiration date of the previously issued certificate.

Article 31. Amendments and supplements to Article 22

"Article 22. Veterinary practice certificate

1. The veterinary practice certificate shall be issued to individuals who meet the practice conditions prescribed in Article 108 of the Veterinary Law; Articles 21 and 21a of this Decree.

2. The form of the veterinary practice certificate is prescribed as follows:

a) For new issuance or renewal, it shall apply the Form No. 04.HNTY Appendix IB issued together with this Decree;

b) For reissuance, apply Form No. 05.HNTY Appendix IB issued together with this Decree.

3. Veterinary practice certificates are used nationwide.

Article 32. Replacing or abolishing certain phrases as follows:

1. Replace the following phrases:

a) Replace the phrase "Ministry of Agriculture and Rural Development" with the phrase "Ministry of Agriculture and Environment" in Point a, Clause 2 and Points a, b, Clause 4 of Article 6; Clauses 1 and 2 of Article 10; Article 11 and Point d, Clause 2 of Article 16;

b) Replace the phrase "Department of Animal Health" with the phrase "Agency assigned by the Minister of the Ministry of Agriculture and Environment to manage the field of livestock and veterinary" in Point b, Clause 2 of Article 7; Clauses 1 and 2 of Article 10; Article 11.

c) Replace the phrase "Department of Animal Health" with the phrase "Agency assigned by the Minister of the Ministry of Agriculture and Environment to handle administrative procedures in the field of livestock and veterinary" in Points a and c, Clause 2, Point b, Clause 4 of Article 14; Clause 1 of Article 15; Clause 2 of Article 16;

d) Replace the phrase "Director General" with the phrase "Chief" in Point b, Clause 4 of Article 14.

2. Abolish the following phrases:

Abolish the phrase 'The Minister of Agriculture and Rural Development shall guide the dossier for granting extensions, revoking, modifying, and supplementing the GMP Certificate.' in Article 16.

Article 33. Abolish the following contents:

Abolish Clause 1 of Article 1; Articles 4 and 5 of Section I; Point a, Clause 2 of Article 7; Point a, Clause 2 of Article 8; Clause 6 of Article 19; Appendices I, II, and III.

Chapter III. IMPLEMENTATION PROVISIONS

Article 34. Implementation provisions

1. This Decree shall take effect from January 21, 2026.

2. Repeal point b, clause 2, Article 20 of Decree No. 66/2016/NĐ-CP dated July 1, 2016, of the Government stipulating the conditions for investment and business in plant protection and quarantine; plant varieties; raising common wild animals; livestock; aquaculture; food, which was amended by point a, clause 7, Article 1 of Decree No. 123/2018/NĐ-CP dated September 17, 2018, of the Government amending and supplementing a number of decrees stipulating conditions for investment and business in the agricultural sector.

3. Repeal Article 5, clauses 1, 2, 3, 4, and 5 of Article 6, clauses 1, 2, 3, 4, and 5 of Article 7 of Decree No. 131/2025/NĐ-CP dated June 12, 2025, of the Government stipulating the division of authority of two-level local governments in the state management sector of the Ministry of Agriculture and Environment.

4. Repeal Articles 8; 9; 10; 11; Clause 1 and Clause 5 of Article 12; Clause 9 of Article 63; ordinal numbers 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, and 16 of Appendix II of Decree No. 136/2025/NĐ-CP dated June 12, 2025, of the Government stipulating decentralization and delegation in the field of agriculture and environment.

Article 35. Transitional Provisions

1. Legal normative documents and administrative documents issued by state agencies or competent authorities before the effective date of this Decree shall continue to be effective until the state agencies or competent authorities issue replacement documents under this Decree.

2. Documents, permits, and certificates that are the result of administrative procedures resolved and issued by the competent authority or person before the effective date of this Decree, and which have not expired or lapsed, shall continue to be applied and used according to the duration stated on those documents, permits, or certificates until they expire. In case an organization or individual wishes to amend, supplement, reissue, or extend a document, permit, or certificate, they shall submit a written request to the competent authority or person stipulated in this Decree for resolution.

3. Organizations and individuals that have had administrative procedures handled by state agencies or competent authorities before the effective date of this Decree, but have not received the results of such procedures, shall continue to have their procedures processed in accordance with the laws at the time of receipt; except in cases where organizations or individuals request implementation according to the provisions of this Decree.

4. Agencies assigned by the Minister of Agriculture and Environment to handle administrative procedures in the field of livestock and veterinary medicine shall carry out inspections and reduce inspections of imported feed quality that are being conducted online on the National Single Window Portal until December 31, 2026.

The Chairman of the Provincial People's Committee shall organize the implementation of inspection and reduction of inspection for the quality of imported animal feed from January 1, 2027. In cases where the Provincial People's Committee has a sectoral system connected to the National Single Window Portal to inspect and reduce the inspection of imported animal feed before December 31, 2026, the Chairman of the Provincial People's Committee shall organize the inspection and reduction of inspection of imported animal feed from the date of connection.

5. The agency assigned by the Minister of Agriculture and Environment to handle administrative procedures in the field of livestock and veterinary shall appraise for announcement, re-announcement, and change of information of feed supplement products currently being implemented online on the electronic portal of the Ministry of Agriculture and Environment until December 31, 2026.

The Chairman of the Provincial People's Committee shall organize appraisals to announce, re-announce, and change information on supplementary feed products from January 1, 2027. In cases where the Provincial People's Committee has a specialized system connected to the Electronic Information Portal of the Ministry of Agriculture and Environment for announcing, re-announcing, and changing information on supplementary feed products before December 31, 2026, the Chairman of the Provincial People's Committee shall organize appraisals to announce, re-announce, and change information on supplementary feed products from the date of connection.

Appendix I

LIVESTOCK FORMS

(Attached to Decree No. 32/2026/NĐ-CP

dated January 21, 2026, of the Government)

Form No. 01.TACN

APPLICATION FOR ISSUANCE/REISSUANCE OF CERTIFICATE

OF ELIGIBILITY FOR LIVESTOCK FEED PRODUCTION

___________

To: ..................................................

1. Name of the applying establishment: ..........................................................................................................

- Head office address: .........................................................................................................

- Production address: ..........................................................................................................

- Facility code (if any): .......................................................................................................

- Phone number:.................... Fax number:....................... E-mail:................................................

- Business registration certificate or Investment license or Establishment decision: ...................................................................................................

2. Registration for issuance/re-issuance of the Certificate of Eligibility for Animal Feed Production/Certificate of Eligibility for Animal Feed Production according to the requirements of the importing country, specifically as follows:

3. Initial issuance registration: ☐

Re-issuance registration: ☐

Reason for re-issuance registration:

We commit to complying with the regulations on conditions for animal feed production according to the law.

Form No. 06.TACN

DECISION

Regarding the issuance of the Certificate of Eligibility for Livestock Feed Production

__________

ISSUING AUTHORITY4

Pursuant to ...5......;

Pursuant to .........;

At the proposal of ............

DECIDES:

Article 1. To grant the Certificate of Eligibility for animal feed production to ......................6 with the following detailed information:

- Headquarters address: ......

- Production address: .......

- Facility code (if any): ............................

- Phone number: ........ Business registration number: ..........

Certified as eligible for animal feed production for...............7. The A/B/C/TACN8 certificate issued together with this Decision.

Article 2. This Decision takes effect from the date of signing and issuance.

The production facility granted the Certificate shall be subject to supervisory evaluation to maintain conditions as prescribed in ..........9

The duration of the supervisory evaluation starts from the effective date of this Decision.

Article 3. ........10

______________________________

1 Name of the direct managing agency or organization (if any).

2 Abbreviation of the agency or organization issuing the decision.

3 Location.

4 Authority of the head of the agency or organization to issue the decision.

5 Legal or regulatory bases for issuing the decision.

6 Name of the facility granted the Certificate of Eligibility for Animal Feed Production.

7 Type of product: Specify the type of animal feed (complete compound feed, concentrate feed, traditional feed, mixed supplement feed, single-ingredient supplement feed, antibiotic-containing animal feed).

8 - A: is the administrative unit code of the locality (where the production facility is located).

- B: is the serial number of the facility granted the Certificate of Production Eligibility starting from number 001.

- C: Is the year the certificate is issued.

- TACN: Abbreviation of “animal feed”. In cases where the Certificate is issued by the Department of Animal Husbandry and Veterinary, add the symbol “/CNTY” after the TACN symbol.

9 Laws and legal documents regulating the evaluation and supervision of maintaining conditions for animal feed production.

10 Organizations and individuals are responsible for implementing the Decision.

11 Abbreviation of the drafting unit’s name.

DECISION

Regarding the re-issuance of the Certificate of eligibility for animal feed production

__________

AUTHORITY ISSUING 15

Pursuant to ...16......;

Pursuant to.......;

At the proposal of .............

DECIDES:

Article 1. Re-issue the Certificate of eligibility for animal feed production to ...............17 with the following detailed information:

1. Content already granted in the Feed Production Eligibility Certificate number 18.... dated.... of ......

- Name of the facility: ......

- Head office address: .......

- Production address: .......

- Facility code (if any): ........................

- Phone number: ............ Business registration number: .......

2. Content of reissuance

- Facility name:....

- Head office address:.......

- Production address:.......

- Facility code (if any):............................

- Phone number: ......

Business registration number: ...........

- Reason for reissuance: ......

Article 2. This Decision takes effect from the date of signing and issuance.

The production facility is reissued the Certificate of compliance subject to supervision and maintenance of conditions according to the regulations at .........19

Article 3. .........20

________________________

12 Name of the directly managing authority/organization (if any).

13 Abbreviation of the name of the authority/organization issuing the decision.

14 Place name.

15 Authority to issue the decision of the head of the authority/organization.

16 Basis for issuing the decision.

17 Name of the facility granted the Certificate of eligibility to produce animal feed.

18 Certificate number has been issued.

19 Legal documents regulating the assessment and supervision for maintaining feed production conditions.

20 Organization or individual responsible for executing the Decision.

1 Abbreviation of the drafting unit's name.

CERTIFICATE OF SUITABILITY

FOR ANIMAL FEED PRODUCTION

Code: A/B/C/TACN

Name of facility....................................... Head office address:.......................................................

Phone number:......................................................... Fax number:........................................

Production address: .........................................................................................................

Phone number:......................................................... Fax number:.......................................

Facility code (if any): ................................

Business registration certificate/Investment license/Establishment decision: .................

Qualified to produce animal feed for:

- Product type: Specify the type of animal feed (complete compound feed, concentrated feed, traditional feed, mixed type supplementary feed, single ingredient type supplementary feed).

- Production of animal feed containing antibiotics*.

In case of re-issuance of the Certificate, clearly state “This certificate replaces the Certificate with code ........, dated .......”. The code of the re-issued Certificate does not change compared to the code of the originally issued Certificate.

Note:

- After issuance, it is requested to send 01 photocopy of the Certificate to the Agency authorized by the Minister of Agriculture and Environment to handle administrative procedures in the field of animal husbandry and veterinary / the Agency authorized by the Chairman of the Provincial People's Committee to handle administrative procedures in the field of animal husbandry and veterinary.

*: In case the facility does not produce animal feed containing antibiotics, this content should not be recorded.

Form No. 07.TACN

APPLICATION FOR IMPORT OF FEED

THAT HAS NOT BEEN PUBLICLY ANNOUNCED

________________________

To: ................

Unit name: ................................................................................................................

Address: ...................................................................................................................

Phone: ...................................; Fax: ........................; Email: ........................

1. Request to import the following feed:

2. Import period: ......................................................................................

3. Purpose of import (Clearly state the purpose of import for introduction at fairs, exhibitions, adaptive farming, research, testing, sample analysis at laboratories, or for production, processing for export purposes)...

4. Time, export border gate, importing country (for production, processing for export purposes) .................................................................................................................................

5. Implementation time (Specify the time for introduction at fairs, exhibitions, adaptation breeding, research, trial, sample analysis in the laboratory, or for production, processing for export purposes): ....................

6. Plan for handling products after fairs, exhibitions, analysis: ........

The enterprise commits to fully comply with the current laws and regulations related to animal feed.

______________________________

2 Authorities authorized to grant import permits for animal feed that have not yet been publicly announced.

Form No. 09.TACN

To: ..........................................*

.......(1).... has received Document No. ............. dated .............. from ....(2).... requesting certification that the animal feed is eligible for import ...(3).... After reviewing the dossier, .....(1).... provides the following comments:

1. Agrees that ...(2)... may import the animal feed products listed below ...(3)...:

2. Import period: .......................................................

3. The above-mentioned animal feed products are only to be used for ...(3)... and must not be used for any other purpose.

4. Samples of the products after being displayed and introduced at fairs, exhibitions/research/used as analytical samples in laboratories must be handled in accordance with the provisions of the law.

(1) Name of the issuing organization.

(2) Name of the importing organization or individual.

(3) Clearly state the purpose of import: for introduction at fairs, exhibitions/for acclimation/for research/for trial/testing/to be used as samples for laboratory analysis or for production, processing for the purpose of export.

Form No. 01.ĐKCN

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

______________________________

APPLICATION FOR ISSUANCE/REISSUANCE OF CERTIFICATE

MEETS THE CONDITIONS FOR LIVESTOCK RAISING

To: .............................................................

Full name of the farm owner ..................................................................................

ID card/Citizen identification number/Passport number.... issued on ...../..../...... Place of issue: ..............

1. Name of the livestock facility: ..............................................................................................

2. Livestock facility code: ..........................................................................................

3. Location of the livestock facility: .....................................................................................

4. Type of livestock:

Cattle: .....................................................................................................................;

Poultry: ....................................................................................................................;

Other livestock: ...........................................................................................................;

5. New registration: □ Re-registration: □

Reason for re-issuance request (provide details): ................................................................................

Attached documents (if any): ...................................................................................

I commit and take full responsibility before the law for the legality, accuracy, and truthfulness of the declared content.

Form No. 02.DKCN

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

_____________________________

EXPLANATORY STATEMENT

Regarding livestock farming conditions

_______

I. GENERAL INFORMATION ABOUT THE LIVESTOCK FARM

1. Name of the livestock facility: ...............................................................................................

2. Livestock facility code (if any): ................................................................................

3. Full name of the owner of the livestock facility: ...............................................................................

4. Address:........................ Phone number:............................. Email:............................

5. Type of construction (new/old/expanded):...................................................................

6. Total area of the livestock facility: ........... m2, including:

a) Area of animal pens (m2):...................................................................................

b) Area of waste treatment zone (m2):.........................................................................

II. LIVESTOCK FARMING CONDITIONS

1. Animal barns: General description of overall design, farm layout, type of pens, equipment.

2. Management records: notebooks used for the livestock farming process.

Form No. 03.DKCN

GUIDELINES

Assessing the actual conditions of livestock farms

___________

A. PRINCIPLES OF ASSESSMENT

1. Recording the assessment report: Fully and accurately record information according to the form; if correcting content already recorded in the Report, it must be confirmed with the signature of the Head of the assessment team.

2. How to record: Record the assessment result of each criterion as "met" or "not met"; use the symbol X or √ to mark the evaluation level for each criterion; explain in detail the criteria that are met and not met.

3. Applicable criteria;

- Criteria from 1 to 3 are used for evaluation to issue the initial Certificate.

- Indicators 4 to 5 apply to the assessment of monitoring the maintenance of conditions.

B. ASSESSMENT GUIDELINES

Form No. 04.DKCN

MINUTES

Assessment of livestock conditions

_______

1. Basis for assessment:.............................................................................................................

2. Assessment time:................................................................................................................

3. Name of the livestock facility being assessed:...............................................................................

4. Livestock farm code (if any):.....................................................................................

5. Location:.....................................................................................................................

Phone:..........................................................., Email....................................................

6. Representative of the evaluation team:

Mr./Ms.:...................................................................... Position:........................................

Mr./Ms.:................................................................... Position:............................................

7. Representative of the livestock farm:

Mr./Ms.:................................................................... Position:............................................

Mr./Ms.:................................................................... Position:............................................

8. Evaluation content: The evaluation content and evaluation method are carried out according to the Appendix attached to this Minutes.

Sampling (if any): ................................................................................................................

9. Conclusion of the Evaluation Team: .............................................................................................

10. Comments of the Facility: .............................................................................................................

The minutes have been read aloud to all parties for acknowledgment and agreement on signing. The minutes are made in 04 copies, each party keeps 02 copies with equal legal validity.

Appendix

TABLE OF LIVESTOCK CONDITION ASSESSMENT CONTENT

(Attached to the Livestock Condition Assessment Minutes No:..../BB-LC)

_________

Conclusion:

Form No. 05.DKCN

DECISION

Regarding the issuance of a Certificate of Livestock Farming Eligibility

__________

ISSUING AUTHORITY 26

Based on ...27......;

Pursuant to.......;

According to the proposal of.......... .

DECIDES:

Article 1. Granting the Certificate of Eligibility for Livestock Farming to .........................28 with the following detailed information:

- Head office address: ......

- Production address: ......

- Facility code (if any): ........................

- Telephone: ....... Enterprise code: ..........

Certified as eligible for livestock farming .............29. The certificate with code A/B/C/ĐKCN30 is issued together with this Decision.

Article 2. This Decision takes effect from the date of signing and issuance.

The livestock facility is granted a Certificate of compliance with conditions subject to supervision and evaluation according to the provisions at ........31.

The duration of the supervisory evaluation starts from the effective date of this Decision.

Article 3. .......32.

___________________________

23 Name of the directly governing agency or organization (if any).

24 Abbreviations of the names of agencies, organizations issuing decisions.

25 Place names.

26 Authority to issue decisions of the head of an agency or organization.

27 Bases for issuing decisions.

28 Name of the facility granted the Certificate of Eligibility for Animal Husbandry.

29 Type of livestock: clearly state the type of livestock and the number of animals according to the designed capacity.

30 - A: is the code of the local administrative unit (where the production facility is located).

- B: is the serial number of the facility granted the Certificate of Eligibility for Animal Husbandry, starting from number 001.

- C: Is the year the certificate is issued.

- ĐKCN: Abbreviation of “Điều kiện chăn nuôi” (Conditions for Animal Husbandry).

In the case of re-issuing the Certificate, clearly state “This certificate replaces the certificate with code number....., dated.....”. The code number of the re-issued certificate does not change compared to the code number of the certificate initially issued.

31 Legal normative documents stipulating the evaluation, supervision, and maintenance of livestock farming conditions.

32 Organizations and individuals responsible for implementing the Decision.

33 Abbreviation of the drafting unit's name.

DECISION

Regarding the reissuance of the Certificate of Livestock Farming Eligibility

_________

ISSUING AUTHORITY37

Pursuant to ...38.....;

Pursuant to ........;

At the proposal of ......... .

DECIDES:

Article 1. Reissue the Certificate of Livestock Farming Eligibility to .......................39 with the following detailed information:

1. Content previously issued in the Certificate of Livestock Farming Eligibility number40.....date.... of....

- Facility name: .....

- Head office address: .....

- Production address: .....

- Facility code (if any): ..................

- Telephone: ........

Enterprise code: ..........

2. Content of reissuance

- Facility name:....

- Head office address: ......

- Production address: ......

- Facility code (if any): ..............

- Phone: ........

Enterprise code: ........

- Reason for reissuance:

Article 2. This Decision takes effect from the date of signing and issuance.

The production facility is reissued a Certificate of Compliance subject to surveillance assessment in accordance with .......41

Article 3. ..........1

_____________________________

34 Name of the directly managing authority/organization (if any).

35 Abbreviation of the authority/organization issuing the decision.

36 Location.

37 Authority of the head of the agency/organization to issue the decision.

38 Legal basis for issuing the decision.

39 Name of the facility granted the Certificate of Livestock Eligibility.

40 Code of the Certificate previously issued.

41 Legal document regulating the surveillance assessment to maintain livestock conditions.

1 Organization or individual responsible for executing the Decision.

2 Abbreviation of the drafting unit name.

CERTIFICATE

MEETS THE CONDITIONS FOR LIVESTOCK RAISING

Code: A/B/C/Certificate of Trademark Registration

_______

Name of organization/individual:......................................................................................................

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

Phone number: ............................................ , Email: .........................................................

Name of livestock facility ........................................................................................................

Livestock facility code (if any): .....................................................................................

Address of livestock facility: .................................................................................................

Phone number: .................................................... Email: ..................................................

Business registration/Investment license/Establishment decision: ...............................

Certified as a facility meeting livestock breeding conditions.

Type of livestock: specify the type of livestock and the number of animals according to the designed capacity.

Note: After issuing the Certificate of Eligibility for Animal Husbandry, it is requested that the issuing agency send 01 photocopy of the Certificate to the Agency assigned by the Minister of Agriculture and Environment to handle administrative procedures in the field of animal husbandry and veterinary medicine.

Form No. 06.ĐKCN

NOTICE

Regarding the results of monitoring the conditions of animal husbandry

for large-scale farm livestock production

To: .......................(1)

Pursuant to Decree No. 13/2020/NĐ-CP dated January 21, 2020 of the Government providing detailed guidance on the Law on Livestock; Decree No. 46/2022/NĐ-CP dated July 13, 2022 of the Government amending and supplementing a number of articles of Decree No. 13/2020/NĐ-CP dated January 21, 2020 of the Government providing detailed guidance on the Law on Livestock;

Pursuant to the results of the supervision assessment in the Livestock Condition Assessment Minutes dated ................ and the remediation report of ...........................(1) (if any);

.....................(2) notifies the results of the supervision assessment of livestock conditions for large-scale farm livestock of ...............................(1), with a Livestock Condition Certification with code number ............ as follows:

- The facility has maintained livestock conditions and is allowed to continue livestock activities in accordance with regulations (for cases where the supervision assessment results are satisfactory).

- Facility revoked of the Livestock Production Eligibility Certificate (in cases where the facility does not remediate the non-compliant criteria recorded in the evaluation report within the committed timeframe).

(1): Name of the facility being monitored and evaluated.

(2): Name of the authority issuing the Livestock Production Eligibility Certificate.

Form No. 02.MTCN

INFORMATION ABOUT THE PRODUCTION FACILITY

LIVESTOCK WASTE TREATMENT PRODUCTS

1. Information about the information-announcing facility

Facility name: ....................................................................................................................

Facility code (if any): ..................................................................................................

Address: ........................................................................................................................

Phone: ....................................................; Email: .................................................

Representative: ............................................................................................................

2. Information about the manufacturing facility

Name of the manufacturing facility:

Facility code (if any): .................................................................................................

Address: .......................................................................................................................

Phone: ..............................................; Email: ......................................................

Representative: ..........................................................................................................

3. Information about the documented product

Attached documents include: .............................................................................................

We commit and take responsibility for the accuracy of the above information.

Form No. 03.MTCN

APPLICATION FOR RECOGNITION OF PRODUCT TEST RESULTS

DISPOSAL OF LIVESTOCK WASTE CONTAINING NEW SUBSTANCES

To: ...........................................

Name of organization or individual: .....................................................................................................

Address: ...........................................................................................................................

Phone: ....................................................; Email: ....................................................

Representative: ...............................................................................................................

Information about livestock waste treatment product containing new substances proposed for recognition:

Summary of testing/research process: .........................................................

It is requested ........................... to carry out the procedures for recognizing livestock waste treatment products containing the new substance mentioned above.

Form No. 04.MTCN

REPORT

Test results of livestock waste treatment products containing the new substance

Report on the results of the trial of animal waste treatment products of the testing facility includes the following contents:

1. Name of testing facility: ................................................................................................

Facility code (if any): .....................................................................................

2. Name of organization or individual requesting the test: ..................................................................

3. Name of the livestock waste treatment product under testing, accompanied by documents on composition, effectiveness, storage, usage, labeling, and packaging:

4. Condition of the livestock waste treatment product before testing:

5. Content of the testing: .......................................................................................

6. Location, time, scale, and method of testing: ................................

7. Testing results: ................................................................................

8. Conclusions and recommendations: ....................................................................................

Form No. 05.MTCN

DECISION

Regarding the recognition of livestock waste treatment products

containing new substances that have been tested

_________

HEAD OF THE AGENCY ISSUES DECISION

Pursuant to the Law on Animal Husbandry dated November 19, 2018;

Pursuant to the Law amending and supplementing certain provisions of 15 Laws in the field of agriculture and environment dated .......;

Pursuant to ................................................................................................;

Pursuant to ...........................................................................................;

At the proposal of ..............................................................................

DECIDES:

Article 1. Recognize the livestock waste treatment product containing new substances listed in the attached list as a tested livestock waste treatment product and permitted for use in livestock farming.

Article 2. This decision takes effect from the date of signing.

Article 3. ..................................., ............................., the relevant organizations and individuals are responsible for implementing this Decision.

Form No. 06.MTCN

APPLICATION FOR ISSUANCE/REISSUANCE OF CERTIFICATE OF ELIGIBILITY

FOR THE PRODUCTION OF LIVESTOCK WASTE TREATMENT PRODUCTS

(AND SUPPLEMENTARY FEED*)

To: ................................................

1. Name of the establishment: ................................................................................................................

- Establishment code (if any): ...................................................................................................

- Address: ......................................................................................................................

- Phone number: ....................................; E-mail: ..........................................................

2. Request for issuance/reissuance of the certificate of eligibility for production:

3. Registration for Certificate Issuance

□

Re-issuance Registration

□

Reason for re-issuance: ....................................................................................................

4. Livestock waste treatment products and supplementary feed products*

- Produced on the same production line

□

- Produced on different production lines

□

5. Dossier and documents attached to this paper (if any), including:

............................................................................................................................................

We commit to complying with the regulations on production conditions for livestock waste treatment products (and supplementary feed products*).

Note:

*: In case the facility simultaneously produces livestock waste treatment products and supplementary feed products.

Form No. 07.MTCN

EXPLANATORY NOTE ON PRODUCTION FACILITY CONDITIONS FOR

LIVESTOCK WASTE TREATMENT PRODUCTS

(Attached to the application for certification of production eligibility)

handling of livestock waste (and supplementary feed*) on .... day .... month .... year .....)

1. Name of the facility: ................................................................................................................

- Facility code (if any): ...............................................................................

- Production address: ........................................................................................................

- Phone number: ....................................; E-mail: .........................................................

2. Intended products to be produced: ....................................................................................

3. Certificate of standard-compliant system (attached with a copy certified by the facility)

- Good Manufacturing Practices (GMP)

Yes □ No □

- Hazard Analysis and Critical Control Points (HACCP) system

Yes □ No □

- Food Safety Management System (ISO 22000)

Yes □ No □

- Quality Management System (ISO 9001)

Yes □ No □

- Other system: .......................................

Yes □ No □

4. Detailed explanation of the production conditions for livestock waste treatment products (and supplemental animal feed*)

a) Production location: ......................................................................................................

b) Workshops, equipment: ...........................................................................................

c) Description of information about the facility that has implemented environmental protection measures in accordance with the provisions of the environmental protection law: ...................................................................................................

d) Documents attached to the explanatory report (if any) include: .............................................

Note:

*: In case the facility simultaneously produces livestock waste treatment products and supplementary feed products.

Form No. 08.MTCN

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

_______________________

PROCESS

Quality control, biosafety of the product treatment manufacturing facility

livestock waste

(Attached to the application for issuance of the Certificate of eligibility for product manufacturing

livestock waste on day... month... year...

The quality control and biosafety procedures of the facility producing livestock waste treatment products include the following contents:

1. Water quality control for production purposes

- Technical requirements for water quality for production;

- Water quality assessment plan, remedial measures if not met;

- Department or person responsible.

2. Raw material control

- Technical requirements for each type of raw material before storage and before production; methods for arranging and identifying each batch of raw materials to ensure traceability, easy first-in-first-out and last-in-last-out handling;

- Plan for inspection and evaluation of raw material quality; inspection and evaluation criteria;

- Measures for preserving raw materials, plan for monitoring quality during storage, measures to handle materials if quality and safety standards are not met;

- Department or person responsible.

3. Finished product control

- Technical requirements for each type of finished product;

- Methods for arranging each batch of products to facilitate traceability;

- Plan for inspecting and confirming finished product quality;

- Measures for warehouse storage to prevent environmental impact on product quality; measures to handle products if quality standards are not met;

- Department or person responsible.

4. Production process control

- Input requirements for production activities (personnel, machinery and equipment, raw materials, production methods);

- Regulations on recording documents for each production stage regarding time, quantity, type of products produced;

- Specify the department or person responsible.

5. Storing finished product samples

- Regulations on sample quantity retention, sample storage duration;

- Regulations on recording information to identify and trace product origin;

- Regulations on sample storage duration and methods for handling samples after the storage period expires;

- Specify the department or person responsible.

6. Workshop hygiene

- Regulations on cleaning methods, frequency, cleaning chemicals (if any) for each area, surfaces in contact with products;

- Specify the department or person responsible.

7. Waste collection and disposal

- Regulations on collection areas, frequency of moving waste out of the production area and storage to the gathering area. In case of hiring a waste treatment facility, specify the requirements for the facility’s capacity documents as required by law;

- Specify the department or person responsible.

Form No. 09.MTCN

GUIDELINES FOR ASSESSING PRODUCTION CONDITIONS

LIVESTOCK WASTE TREATMENT PRODUCTS

A. PRINCIPLES OF ASSESSMENT

1. Fill in the evaluation form

- Record complete information according to the regulations in the form.

- Verify and record accurate information.

- If corrections are made to the content already recorded in the Minutes, it must have the confirmation signature of the Head of the evaluation team.

2. Evaluation principles

- No additions or omissions of content are allowed.

- The evaluation result of the indicator is “Pass” or “Fail”.

- Use the symbol X or √ to mark the evaluation level determined for each criterion.

- Must provide detailed explanations for criteria met and not met; each unmet criterion must be specified.

3. Applicable criteria

- Criteria from Section 1 to Section 8 apply to facilities producing livestock waste treatment products registering for Certification.

- Criteria from Section 1 to Section 13 apply to the monitoring evaluation to maintain conditions of facilities producing livestock waste treatment products.

- For the Certificate-level assessment, the evaluation criterion “Building a quality control and biosafety management system” is an assessment of the content regarding the establishment of a quality control and biosafety management system for the product intended for production.

- For the assessment of monitoring the maintenance of production conditions, the evaluation criterion “Applying a quality control and biosafety management system during production” is an assessment of the application of the product’s quality control and biosafety management system during the production process.

B. GUIDELINES FOR EVALUATING EACH CRITERION

I. INITIAL ASSESSMENT OR WHEN PRODUCTION CONDITIONS CHANGE

1. The production site is located in an area not polluted by hazardous waste or toxic chemicals

Requirements: The production site must be built in a location that avoids contamination from hazardous waste, toxic chemicals from the surrounding environment such as waste sources from hospitals, landfills, flooding... In case the location cannot be replaced, control measures must be established such as partitions, ventilation systems, or enclosed rooms with ventilation.

Assessment method: Observe the site to assess environmental factors affecting product safety and quality. Compare related test results and location records to evaluate the level of contamination when necessary.

2. Factories, equipment

a) Must have a factory with a solid structure, ensuring quality control and biosafety requirements

Requirements: The factory must have a solid structure, sufficient working space, and reasonably arranged movement directions for raw materials, products, and personnel. The floor must be waterproof, not peeling, free of cracks, and easy to clean.

Assessment method: Observe the current condition of the factory.

b) The areas for storing raw materials, materials, and finished products must ensure no cross-contamination; there should be storage rooms or specialized tools to preserve products with specific characteristics according to the manufacturer's recommendations.

Requirement: Areas storing raw materials that make up products, packaging, components for equipment, supporting production chemicals (cleaning agents, lubricating oils, gasoline, vaporizable chemicals, etc.) must be physically separated to prevent cross-contamination of foreign substances or chemicals into raw materials, affecting the quality and safety of the products. For areas storing volatile materials, a well-ventilated and ventilated design is necessary. Each type of raw material must be stored under proper technical conditions according to the storage requirements provided by the manufacturer or supplier, ensuring that the storage process does not affect quality (e.g., temperature, humidity, light, etc.).

Assessment method: Observe the site regarding the arrangement and distribution of areas and storage facilities. Review the technical records of raw materials and products (applicable published standards, product labels, attached documents, etc.) to determine compliance.

Note: Physical separation includes the use of walls, partitions, or sufficient spatial separation to prevent the risk of cross-contamination.

3. Production lines and equipment in contact with raw materials or finished products are made of easily cleanable materials.

Requirement: Surfaces of equipment that come into contact with raw materials or finished products must be made of suitable materials that are impermeable, rust-resistant, non-corrosive, do not have the potential to release heavy metals (e.g., Pb, As, Hg, Cd...) into products and are easy to clean.

Assessment method: Observe the site, review the technical documents related to equipment and utensils surfaces. Examine inspection and cleaning records.

4. Equipment for collecting and treating waste without causing environmental pollution in the production area

Requirement: Equip with appropriate types of trash bins for waste segregation (household waste, recyclable, and hazardous waste), hazardous waste bins must have tight-fitting lids after use. Waste storage areas must be separated from production areas. Hazardous waste storage must be kept separately, sealed, and locked.

Evaluation method: Observe the on-site locations where different types of waste are stored; the containers for each type of waste, labeling.

5. In the case of a facility producing microbial biomass for the production of microbial biological products, it must have equipment for preparing media, maintaining, and culturing microorganisms.

Requirement: There must be equipment for preparing media, maintaining, and culturing microorganisms to serve production, such as: analytical balance, shaker, sterilizing autoclave, incubator, drying oven, microwave, microbiological workbench, refrigerator, fermenter or fermentation equipment...

Assessment method: Direct observation and review of technical information and equipment condition to evaluate suitability.

6. There must be a laboratory or a contract with a competent laboratory to test quality during the production process.

Requirements:

- There is a testing laboratory to control the quality of production stages, for each batch of raw materials and finished products; personnel in charge must have suitable competence and expertise in quality inspection; clear quality standards must be established. The results of quality inspections for each stage must be recorded and stored for each batch of goods.

- Evaluation method: Observation of the laboratory site, certification records, equipment calibration records, storage records, and staff competency records (degrees, training certificates).

7. Establishing and applying a quality control and biosafety system

a) Quality control of water used for production

Requirement: Water used for production must meet the quality according to the corresponding national technical regulations or must meet the corresponding quality and microbiological requirements of the produced product. The technical indicators that need to be controlled must be specified in writing and approved by the authorized person.

Assessment method: Review periodic water inspection records as required by technical standards.

Note: The authorized person is the owner of the facility or a person assigned by the owner and responsible for approval.

b) Raw material control

Requirements:

Carry out inspection and verification of origin and quality compliance, such as: expiration date, origin documents, quality certificates (CO, CA), sensory quality evaluation, or checking parameters such as moisture content or impurities. Technical parameters that need to be controlled must be specified in writing and approved by the authorized person.

- Raw materials not meeting technical specifications must be controlled to prevent misuse.

- Raw materials must be arranged with a gap from the floor and walls; each batch must be identified to ensure traceability and facilitate first-in-first-out, last-in-last-out procedures.

Evaluation method: Review records of raw material incoming and outgoing inspections. Observe the site for arrangement and identification of materials.

c) Finished product control

Requirements:

- Finished products are inspected to confirm quality according to technical specifications before approval, with inspection records, documented and approved by the authorized person.

- Finished products are stored and kept in the warehouse to avoid environmental impacts affecting product quality, arranged separately from the floor, organized by batch for easy traceability.

- Finished products must be inspected before dispatch (expiration date, external condition such as tearing, deformation, dirt, etc.).

- Arranged finished products must have space from the ground and walls; each batch must be identified to ensure traceability, facilitating the first-in, first-out, last-in, last-out management.

- Control requirements must be specified in writing and approved by the authorized person.

Evaluation method: Observe actual operations, check records for finished product batches that have been shipped, and inventory data.

d) Production process control

Requirements:

- Input requirements for production activities must be ensured, including manpower, machinery, equipment, appropriate production methods, and raw materials meeting the requirements.

- Product technical standards must be specified in writing.

- There must be records of each production stage.

- Control requirements must be specified in writing and approved by the authorized person.

Evaluation method: On-site observation, record checking.

đ) Finished product sample retention

Requirements: Each batch of goods must retain a sufficient sample for analysis according to the applied declared technical standards and corresponding national technical regulations. Labels must be affixed clearly stating the product name, batch (or production date), and expiration date. The stored products must be clearly identifiable, easy to locate, and easy to inspect. The requirements to be controlled must be specified in writing and approved by the authorized person.

Evaluation method: Observe the sample storage arrangement area, identification labels. Review records of sample storage dates, sample disposal times, and assess condition throughout the storage period.

e) Factory cleaning

Requirement: Specify cleaning methods, frequency, cleaning chemicals (if any) for each area and product-contact surface. Control requirements must be documented and approved by an authorized person.

Evaluation method: On-site observation, record checking.

g) Waste collection and disposal

Requirement: Establish regulations for waste collection areas; specify the frequency of moving waste out of production areas or warehouses (at least daily) to the collection area. Hire waste treatment facilities with capacity according to legal requirements. Control requirements must be documented and approved by an authorized person.

Evaluation method: On-site observation, record checking.

8. There is a technical manager with a university degree or higher in one of the specialties of animal husbandry, veterinary medicine, chemistry, biotechnology, or environmental technology.

Requirement: Must have a university degree or higher trained in animal husbandry, veterinary medicine, chemistry, biotechnology, or environmental technology. Must have a labor contract with the technical manager.

Assessment method: Review the labor contract, related diploma records, and interview regarding understanding of control activities for the product.

II. EVALUATION OF SUPERVISION AND MAINTENANCE CONDITIONS

In addition to the criteria in Section I, the following criteria must be evaluated:

9. Apply quality control and biosafety systems during production according to the contents in Section 7; record and maintain documentation during production to serve traceability.

Requirement: The procedures and regulations stated in Section 7 must be applied and fully recorded and maintained during production to serve traceability.

Evaluation method: Follow the corresponding instructions in Section 7.

10. Implement the announcement of applicable standards as prescribed

Requirement: Have complete documentation of the announcement of applicable standards for each product.

Evaluation method: Check the products that have been produced and circulated; check the documentation of the announcement of applicable standards for each type of product; assess the conformity of the stored documents with actual production.

11. Implementation of product labeling

Requirement: The information on the product label must comply with current regulations on product labeling.

Evaluation method: Inspect the actual labels of manufactured and circulated products; compare with regulations on product labeling and the applicable declared standards to assess the conformity of the labeling.

12. Disclosure of product information on the Information Portal of the Ministry of Agriculture and Environment

Requirement: Products must be disclosed on the Information Portal of the Ministry of Agriculture and Environment before being circulated on the market according to regulations.

Assessment method: Check the product information published on the electronic information portal of the Ministry of Agriculture and Environment; compare the disclosure documents with the actual products being produced and circulated for evaluation.

13. Compliance with inspection and examination by competent state agencies according to legal regulations

Requirement: The facility being inspected and examined must cooperate and comply with regulations.

Assessment method: Evaluate through compliance with legal regulations and cooperation with the state agency during inspection and examination.

C. HANDLING OF EVALUATION RESULTS

1. Evaluation for Certificate issuance

The facility is proposed to be granted the Certificate when 100% of the evaluation criteria are met.

2. Supervision assessment to maintain conditions

- The facility will maintain the Certificate when 100% of the evaluation criteria are met.

- The facility must suspend production during the waiting period for corrective actions if 06 or more criteria are not met.

- The facility will have the Certificate revoked if corrective actions are not completed within the prescribed time.

Form No. 10.MTCN

MINUTES

Assessment of production conditions for livestock waste treatment products

No.: ........../BB-ĐKSX

______

1. Basis of evaluation, evaluation date: ........................................................................

2. Name of the facility being evaluated: ....................................................................

- Establishment code (if any): ...................................................................................................

- Address: ................................................................................................................

- Phone number: ...................................... , Email: .........................................................

- Name and Business Registration Certificate/Investment License/Establishment Decision number: .................................

Issuing authority: ........................................................ Date of issue: ................................

- Certificate of a system conforming to standards:

3. Assessment location:

- Address: ...................................................................................................................

- Phone: ........................................................ , Email: .......................................

4. Members of the assessment team:

- Mr./Ms.: .............................................................................. Position: ....................

- Mr./Ms.: .............................................................................. Position: ....................

- Mr./Ms.: .............................................................................. Position: ....................

5. Representative of the facility:

- Mr./Ms.: .............................................................................. Position: ....................

- Mr./Ms.: .............................................................................. Position: ....................

- Mr./Ms.: .............................................................................. Position: ....................

6. Manufactured product:.......................................................................................

7. Evaluation content

8. Sample collection (if any):

a) Information about the sample collected (type of sample, sample quantity; packaging condition, sample preservation...)

b) Specify the analysis indicators (Sampling record attached):

9. Evaluation team’s comments:

10. Facility’s comments:

The minutes have been read aloud to all parties and signed in agreement. The minutes are made in 02 copies, each party keeps 01 copy with the same legal value.

Form No. 11/MTCN

DECISION

Regarding the issuance of Certificates of Eligibility for Product Processing

livestock waste (and supplementary feed *)

__________

ISSUING AUTHORITY47

Pursuant to ...48....;

Pursuant to .......;

According to the proposal of .......... .

DECIDES:

Article 1. Grant the Certificate of Eligibility for the production of livestock waste treatment products (and supplementary animal feed*) to ...........................49 with the following detailed information:

- Head office address: ........

- Production address: ........

- Facility code (if any): .......................

- Phone number: .........

Enterprise code: ....................

Certified to meet the conditions for manufacturing livestock waste treatment products (and supplemental animal feed*) for ...............50. The A/B/C/MTCN51 code certificate issued together with this Decision.

Article 2. This Decision takes effect from the date of signing and issuance.

The production facility granted the Certificate is subject to evaluation and supervision to maintain conditions as prescribed in ........52.

The duration of the supervisory evaluation starts from the effective date of this Decision.

Article 3. .......53.

_____________________________

44 Name of the directly managing authority or organization (if any).

45 Abbreviation of the name of the authority or organization issuing the decision.

46 Location.

47 Authority to issue decisions of the head of the agency or organization.

48 Legal basis for issuing the decision.

49 Name of the facility granted the Certificate for meeting the conditions to manufacture livestock waste treatment products (and supplemental animal feed*).

50 Product type: Record the name of the livestock waste treatment product (and supplementary animal feed*).

51. - A: is the administrative unit code of the locality (where the manufacturing facility is located).

- B: is the serial number of the facility granted the Certificate of Production Eligibility starting from number 001.

- C: Is the year the certificate is issued.

- MTCN: Abbreviation of “livestock environment”.

In case of re-issuance of the Certificate, clearly state “This certificate replaces Certificate number......., dated......”. The re-issued Certificate number does not change from the number of the originally issued Certificate.

52 Legal documents regulating the assessment and supervision of maintaining production conditions for livestock waste treatment products (and supplementary animal feed*).

53 Organizations and individuals responsible for implementing the Decision.

54 Abbreviation of the drafting unit name.

DECISION

Regarding the re-issuance of the Certificate of Eligibility for Manufacturing Waste Treatment Products

livestock waste (and supplementary feed *)

_________

ISSUING AUTHORITY

Pursuant to ...;

Pursuant to ........;

At the proposal of ........ .

DECIDES:

Article 1. Re-issuing the Certificate of Eligibility for Manufacturing Livestock Waste Treatment Products (and supplementary feed*) to .................... with the detailed information as follows:

1. Contents that were previously issued in the Certificate of Eligibility for Manufacturing Livestock Waste Treatment Products (and supplementary feed*) with certificate number ....... dated .... by ........

- Name of the facility: ......

- Head office address: ......

- Manufacturing address: ......

- Facility code (if any): .....................

- Phone: ........

- Business code: ........

2. Content of reissuance

- Facility name:....

- Head office address: ......

- Manufacturing address: ......

- Facility code (if any):............................

- Phone: ........

- Business code: ........

- Reason for re-issuance: ......

Article 2. This Decision takes effect from the date of signing and issuance.

The manufacturing facility issued the Certificate of Eligibility is subject to supervision and evaluation to maintain conditions as stipulated in ...........

Article 3. ............

_________________________

55 Name of the directly supervising agency or organization (if any).

56 Abbreviation of the name of the agency or organization issuing the decision.

57 Place name.

58 Authority to issue the decision of the head of the agency or organization.

59 Bases for issuing the decision.

60 Name of the facility granted the Certificate of eligibility for the production of livestock waste treatment products (and supplementary animal feed*).

61 Certificate number already issued.

62 Legal document regulating the assessment, supervision, and maintenance of conditions for livestock waste treatment product production.

63 Organization or individual responsible for implementing the Decision.

64 Abbreviation of the drafting unit's name.

CERTIFICATE OF ELIGIBILITY FOR PRODUCTION

FOR LIVESTOCK WASTE TREATMENT PRODUCTS/

(AND SUPPLEMENTARY FEED*)

No.: A/B/C/MTCN

________

Facility name................................................................................................................

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

Phone number:......................................................, Email:.......................................

Manufacturing address: ....................................................................................................

Phone number: ..................................................., Email:.........................................

Facility code (if any):..............................................................................................

Business registration/Investment license/Establishment decision: ........................

Certified eligible for production:

1. Livestock waste treatment products (specify the type of product).

2. Supplemental animal feed*.

Note:

After issuance, please send 01 photocopy of the Certificate to the Agency assigned by the Minister of Agriculture and Environment to manage the state in the field of animal husbandry and veterinary medicine.

*: In case the facility simultaneously produces livestock waste treatment products and supplementary feed products.

Form No. 12.MTCN

NOTICE

Regarding the results of the monitoring assessment of production conditions

for livestock waste treatment products

To: ....................................(1)

Pursuant to the Law on Animal Husbandry dated November 19, 2018;

Pursuant to the Law amending and supplementing certain provisions of 15 Laws in the field of agriculture and environment dated .......;

Pursuant to Decree No. 13/2020/NĐ-CP dated January 21, 2020 of the Government providing detailed guidance on the Law on Livestock; Decree No. 46/2022/NĐ-CP dated July 13, 2022 of the Government amending and supplementing a number of articles of Decree No. 13/2020/NĐ-CP dated January 21, 2020 of the Government providing detailed guidance on the Law on Livestock;

Pursuant to the results of the monitoring assessment recorded in the Minutes of Assessment of Production Conditions for Livestock Waste Treatment Products No. ............ dated .............. and the corrective report of ...............(1) (if any);

........(Notifying agency)........... notifies the results of the evaluation of production conditions for livestock waste treatment products for ...................(1) holding a Certificate of Eligibility for the production of livestock waste treatment products with the number ........... as follows:

- The company is allowed to continue production because it has maintained the production conditions for livestock waste treatment products according to regulations (in the case of a successful surveillance evaluation).

- The company must temporarily suspend production (if only partially suspended, clearly state the part suspended) from ........ to ........ to wait for rectification (in the case that rectification is required).

- The company will have its Certificate of Eligibility for the production of livestock waste treatment products revoked (in the case of failing to rectify within the committed time).

(1): Name of the facility being monitored and evaluated.

Form No. 13.MTCN

APPLICATION FOR PRODUCT IMPORT.

DISPOSAL OF LIVESTOCK WASTE CONTAINING NEW SUBSTANCES

To: ...........................................

Name of organization or individual:.................................................................................................

Address:.......................................................................................................................

Facility code (if any):.................................................................................................

Phone number:......................................., Email:..........................................................

1. Request to import the following livestock waste treatment products:

2. Purpose of import: .....................................................................................................

3. Import duration: .....................................................................................................

4. Import customs gate: .....................................................................................................

5. Time and place of display at fair, exhibition (or research/testing/analysis at the laboratory): .......................................................................

6. Plan for handling samples after the fair, exhibition (or research/testing/analysis at the laboratory): .........................................................................................

We commit to fully comply with the current legal regulations regarding livestock waste treatment products.

Form No. 14.MTCN

RESEARCH/TESTING PROPOSAL

Livestock waste treatment products

I. GENERAL INFORMATION

1. Name of the organization or individual registering for research/testing:....................................

Address:.....................................................................................................................

Phone number:......................................., Email:.........................................................

2. Name of the research/trial facility:......................................................

Facility code (if any):.................................................................................................

Address:......................................................................................................................

Phone number:...................................., Email:............................................................

3. Information about the product registered for research/trial

a) Product name, ingredients, uses, expiration date, warnings (if any):...

b) Manufacturer: ............................................................................................

c) Other documents related to the product: .................................................

4. Scientific basis and current application status of the product domestically and internationally (Describe the scientific information of the product, the components of the product, and the current status, effectiveness of use domestically and internationally)

II. CONTENT OF RESEARCH/TRIAL

1. Content

a) Evaluation of the composition and quality of the product according to the applied announced standards;

b) Evaluation of safety for livestock and the environment during the use of the product;

c) Evaluating the effectiveness of the product in treating livestock waste.

2. Research methods and experimental layout

a) Research methods;

b) Experimental layout.

3. Environmental protection measures during the trial process

4. Implementation plan

5. Expected results

Form No. 15.MTCN

To: ..................................

....................... has received Document No. ................ dated .............. from the organization/individual requesting to import livestock waste treatment products containing new substances for use as trade fair/exhibition samples, research/testing samples, laboratory analysis samples, or for production/processing purposes for export. After reviewing the application, ................ provides the following opinions:

1. .....................................agrees to allow................................(Name of organization/individual, address) to import the product................, quantity.............. for................(specify the purpose of import), specifically:

2. Import time: ..............................................................................................

3. Import port: ................................................................................................

4. The above-mentioned livestock waste treatment products are only to be used as samples for trade fairs, exhibitions/research/testing/analysis samples in laboratories/for production, processing for export purposes and must not be used for any other purposes.

5. Product samples after being displayed and introduced at fairs, exhibitions/researched/tested in laboratories must be handled according to the provisions of the law.

Appendix IA

SAMPLE FORMS ON VETERINARY MEDICINES

(Attached to Decree No.: 32/2026/NĐ-CP)

dated January 21, 2026, of the Government)

Form No. 01.QLT

APPLICATION FOR REGISTRATION/RENEWAL OF GMP INSPECTION

To (*)………………….

Pursuant to (**) ……………………………………………………………………………………..

1. Name of the establishment: …………………………………………………………………………………

2. Factory address: …………………………………………………………………………..

3. Enterprise registration certificate: ………………………………………………

4. Veterinary practice certificate of the person directly managing veterinary drug production: No …., date.... month.... year ...., issued by....; Person directly managing veterinary drug testing: No …., date.... month.... year ...., issued by....

5. Certificate of Good Manufacturing Practice (GMP) (for establishments renewing GMP inspection): No ……………., date.... month.... year ....

6. Telephone: …………………...

Request (*)…………………. to proceed with the inspection for issuance/renewal of the Certificate of Good Manufacturing Practice (GMP-WHO (ASEAN)) for our facility for the following veterinary drug manufacturing lines (***)

- …………………………………..

- …………………………………..

- …………………………………..

Attached dossiers include:

- …………………………………..

Notes

(*) The agency assigned by the Minister of Agriculture and Environment to handle administrative procedures;

(**) Current legal documents;

(***) Specify veterinary drug manufacturing lines non-beta-lactam or beta-lactam.

Form No. 02.QLT

GMP INSPECTION REPORT

Based on Decision No. ... dated ... month ... year ……… of ………………….. regarding the establishment of the GMP inspection team at the facility

Inspection team composition:

1 ……………………………….. - Team Leader.

2 ……………………………….. - Member.

3 ……………………………….. - Member.

………………………………………………

…………………………………. - Member, Secretary.

FACILITY NAME:

- Address:

- Person in charge:

- Registration for inspection proposed on ……………. by ………….

- Date of inspection: ………………………….

- Inspection content: ………………………………….

- Representative of the establishment:

1 ………………………………………

2………………………………………

I. OPINIONS OF THE INSPECTION TEAM:

After reviewing the documents, listening to the establishment's report, and conducting an on-site inspection, the Inspection Team has the following opinions:

A. Strengths:

1. Organization and personnel: …………….

2. Training:....

3. Facilities:...

4. Equipment: ….

5. Hygiene and sanitary conditions: ….

6. Evaluation: ….

7. Records and documents: …..

8. Complaints and recalls: ….

9. Self-inspection:...

10. Quality control:...

11. Warehouse:...

B. Recommendations

1. Organization and personnel: ………

2. Training:....

3. Facilities:...

4. Equipment: ….

5. Hygiene and sanitary conditions: ……

6. Evaluation: ……

7. Records and documents: ………

8. Complaints and recalls: …….

9. Self-inspection:...

10. Quality control: ...

11. Warehouse:...

C. Existing issues:

……….

II. INSPECTION TEAM'S CONCLUSION:

……………………………………………………………………………………………….

……………………………………………………………………………………………….

III. FACILITY'S OPINION

……………………………………………………………………………………………….

……………………………………………………………………………………………….

This minutes are made in 03 copies. The facility keeps 01 copy, the inspection agency keeps 02 copies.

Form No. 03.QLT

SAMPLE GMP CERTIFICATE

Form No. 04.QLT

APPLICATION FOR GMP CERTIFICATE REISSUANCE

To (*) : ………………..

Based on (**) …………………………………………………………………………………

REGISTERING ORGANIZATION, INDIVIDUAL:

Name: ……………………………………………………………………………………….

Address: ……………………………………………………………………………………

Phone number: …………………………………………………………………………….

We request re-issuance of the GMP Certificate: No.... date....month….. year ....

Reason for re-issuance request:

- Errors

- Changes in information related to the registering organization.

Attached documents:

Relevant documents regarding changes or additions (if any);

Note:

(*) The agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures;

(**) Current legal normative documents.

Form No. 05.QLT

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

______________________

REGISTRATION/EXTENSION APPLICATION FOR INSPECTION

VETERINARY DRUG PRODUCTION CONDITIONS

To (*):

Pursuant to (**): …………………………………………………………………………..

Name of the facility: ………………………………………..

Facility address: ……………………………………….

Phone number: ………………………………… Fax: ……………………….

Owner of the facility: ……………………………………….

Permanent address: …………………………………

Veterinary practice certificate of the person directly managing veterinary drug production: No ……., date.... month.... year ...., place of issue....; Person directly managing the testing of veterinary drugs: No ……..…, date.... month year..., place of issue....

Certificate of eligibility for veterinary drug production (excluding production of pharmaceutical-form veterinary drugs and vaccines) (for facilities requesting an extension for inspection of veterinary drug production conditions): No ……….. date.... month.... year ....

Types of products registered for production and circulation:

□ Herbal medicine □ Biological preparations

□ Chemicals □ Other types

Requesting (*) ……………. to check

re-issue/renew the Certificate of Eligibility for Veterinary Drug Production for our facility.

Attached dossiers include:

- ………;

Note:

(*) The agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures;

(**) Current legal normative documents.

Form No. 06.QLT

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

______________________

DETAILED EXPLANATORY DOCUMENT ON FACILITIES AND TECHNICAL ASPECTS

VETERINARY DRUG MANUFACTURING

To: (*)…………………………..

Name of the Facility registering for inspection: …………………………………………………………..

Address: …………………………………………………………….................................

Phone number: ……………………………………….., Email: …………………………..

Type of product registered for production:

□ Herbal medicine □ Biological preparations

□ Chemicals □ Other types

Please explain the conditions for veterinary drug production, specifically as follows:

1. Production location

2. Production workshop

3. Equipment and tools used in production

4. Warehouse system

5. Sterilization handling area

6. Area for weighing and distributing raw materials

7. Area for mixing, portioning, and storing semi-finished products

8. Product finishing area

9. Sanitation area

10. Wastewater and waste collection and treatment system

11. Packaging

12. Labeling

13. Disinfection, sterilization

14. Production personnel

15. Personal hygiene

16. Occupational hygiene

17. Water used in the facility

18. Implement regulations on batch records

19. Implement quality management:

- Testing laboratory

- Laboratory staff

- Equipment

- Regulations on raw material inspection, finished product inspection, sample retention, and sample testing

Note: (*) Agency assigned by the Provincial People's Committee Chairman to handle administrative procedures.

Form No. 07.QLT

INSPECTION MINUTES

VETERINARY DRUG PRODUCTION CONDITIONS

I. GENERAL INFORMATION:

1. Facility name: ………………………………………………………………………………..

2. Address: ……………………………………………………………………………………

3. Business registration number (if any):

……..…………. Date of issue ….. Place of issue …..

4. Phone number: ……………………………………………………… Fax number (if any):

5. Code (if any): ………………………………………………………………………….

6. Manufactured products: ………………………………………………………………………

7. Inspection date: ……………………………………………………………………………

8. Form of inspection: ………………………………………………………………………

9. Inspection team members:

1) ……………………………………………………………………………………………….

2) ……………………………………………………………………………………………….

3) ……………………………………………………………………………………………….

10. Representative of the facility:

1) ……………………………………………………………………………………………….

2) ……………………………………………………………………………………………….

II. GROUP OF EVALUATION CRITERIA:

Part 1. General criteria

Part 2. Implement regulations on batch records

Part 3. Implement quality management (KCS)

III. GROUP OF INDICATORS NOT EVALUATED AND REASONS:

IV. SAMPLE COLLECTION (if any) AND SPECIFICATION OF ANALYSIS INDICATORS (attached with the Sample Collection Report):

1. Information about the collected sample (type of sample; number of samples; packaging condition, sample preservation ...)

2. Specification of analysis indicators:

V. OPINIONS OF THE INSPECTION TEAM:

1. Comments of the inspection team:

2. Proposal for classification of the facility:

VI. OPINIONS OF THE FACILITY REPRESENTATIVE:

GUIDELINES

INSPECTION OF VETERINARY MEDICINE MANUFACTURING FACILITY CONDITIONS

I. CLASSIFICATION GUIDANCE

1. Definition of fault level

- Critical error (Se): Deviation from standards and regulations, affecting product quality and consumer health.

- Major error (Ma): Deviation from standards and regulations, which if prolonged, will affect product quality but not to a critical level.

- Minor error (Mi): Deviation from standards and regulations, which may affect product quality or complicate hygiene control, but is not severe.

2. Evaluation results:

Note: (-) Not assessed

3. Explanation:

3.1. Basis for qualification for veterinary drug production when meeting one of the following conditions:

- No critical errors, no major errors, and total minor error deviations do not exceed 9 expense groups.

- No critical errors and one of the following two cases:

+ No major errors, the number of minor errors ranges from 10 to 15 spending groups; or

+ The number of major errors does not exceed 10 and the total number of minor and major errors does not exceed 15 indicator groups.

3.2. Facilities not qualified for veterinary drug production.

- There is at least 01 serious error

- One of the following 2 cases:

+ There are at least 11 major errors;

+ There are fewer than 11 major errors and the total number of minor and major errors exceeds 15 criteria groups.

II. INSPECTION METHOD:

A. Recording the inspection minutes:

- Record full information according to the regulations in the minutes template.

- Verify and record accurate information.

- If corrections are made on the minutes, they must be confirmed by the signature of the Head of the inspection team.

B. Evaluation principles:

- Do not add or remove any content; the evaluation level has been specified in each criteria group.

- For each criterion, only determine the error level in the columns marked with [ ], and do not determine the error level in columns without [ ].

- Use the symbol x or mark the positions of the determined evaluation level for each criteria group.

- The overall evaluation result of a criteria group is the highest evaluation level of the criteria within the group, recorded as follows: Ac (achieved), Mi (minor error), Ma (major error), Se (serious error).

- Must provide a detailed explanation of identified errors for each criterion and the timeframe within which the facility must rectify those errors. For criteria not evaluated, the reason must be clearly stated in the column “Explanation of errors and corrective actions.”

C. Groups of criteria and inspection methods:

1. General assessment of the production facility

1.1. Criterion 1: Production location

1.1.1. Requirement: The location for constructing the production facility must comply with local planning and be separated from residential areas and public works.

1.1.2. Method: On-site inspection of the facility:

- Not polluted by the external environment;

- Separated from residential areas, schools, government offices, hospitals, diagnostic and testing facilities;

- Has water and electricity sources ensuring the facility’s operations;

- Does not affect the surrounding environment.

1.1.3. Assessment:

- Complies with the requirements in Section 1.1.1 and is assessed as satisfactory.

- Does not meet one of the requirements in Section 1.1.1 for a major fault assessment.

1.2. Criterion 2: Manufacturing workshop

1.2.1. Requirement: Arrange production in a one-way flow, design and arrange areas appropriately, minimize confusion or cross-contamination in production; have all production areas fully equipped; facilitate inspection and supervision; ensure environmental sanitation conditions; easy to clean, disinfect, and sterilize; prevent dust and intrusion by pests.

1.2.2. Method:

Review design documents, conduct on-site inspections, and interview (when necessary) to determine:

- The workshop is solidly and sturdily constructed, suitable for the nature and scale of production, able to withstand adverse natural impacts such as weather, flooding, moisture, and the intrusion of insects or other animals;

- The floor is solid, elevated, smooth, non-slip; capable of withstanding the pressure of machinery in operation;

- Walls and ceilings are made of durable, solid materials;

- Floors are free of cracks, do not absorb or retain water, are easy to clean, and resistant to disinfectant chemicals;

- Each area must ensure compliance with veterinary hygiene standards as prescribed.

1.2.3. Evaluation:

- Meeting the requirements of Section 1.2.1 is rated as compliant.

- Not arranging production according to a one-way line or failing to ensure environmental hygiene conditions is rated as a major violation.

- Not meeting any of the remaining requirements in Section 1.2.1 is rated as a minor violation.

1.3. Indicator 3: Equipment and tools used in production

1.3.1. Requirements: the quantity, type, and capacity of equipment must be suitable for each production line, convenient for operations, cleaning, sterilization, maintenance; equipment and tools must be made of appropriate materials and have regulations on operation, adjustment, inspection, and maintenance.

1.3.2. Method:

Review the list of equipment, documentation, and inspect in practice and interview (if necessary) to determine:

- Quantity and type of equipment and tools made of suitable materials for each production line that are easy to clean and maintain.

- Availability of cleaning procedures that ensure no contamination or cross-contamination between products.

- Regulations on operation, adjustment, inspection, and maintenance.

1.3.3. Evaluation:

- If it meets the requirements in Section 1.3.1, the assessment is satisfactory.

- If it does not meet the requirements in terms of quantity or type of equipment for each production line: assessment is major non-compliance.

- Does not meet one of the remaining requirements in Section 1.3.1 for minor non-conformance.

1.4. Criterion 4: Warehouse System

1.4.1. Requirement: The warehouse area must be appropriate for the scale of production; equipped with adequate devices suitable for storage conditions; have regulations on arranging and inspecting raw materials and products in storage; managed and monitored by books or computer.

1.4.2. Method: Check on-site and interview (if necessary) to determine:

- Whether there is a warehouse or separate area for raw materials, auxiliaries, packaging, finished products; a separate warehouse outside for storing solvents and flammable/explosive raw materials, with a designated place for segregating rejected raw materials, semi-finished products, and finished products.

- Warehouse area suitable for the scale of production.

- Sufficient equipment necessary to ensure product quality according to storage requirements, specifically:

- Stored under normal conditions: temperature below 30°C;

- Cooled storage: temperature from 8 - 15°C;

- Cold storage: temperature from 2 - 8°C;

- Frozen storage: temperature ≤ -10°C;

- Avoid direct sunlight and contamination from the external environment;

- Have documentation from the facility specifying the arrangement, storage of products, regular inspection procedures, and timely detection and handling of incidents during storage;

- Have sufficient equipment to check storage indicators, with a regular recording regime of technical parameters.

1.4.3. Assessment:

- Compliant with the requirements in Section 1.4.1, the assessment is satisfactory.

- Non-compliant regarding warehouse capacity and warehouse construction materials to ensure drug quality, or lacking sufficient equipment and means to ensure product quality according to required storage conditions, the assessment is a major fault.

- Non-compliant with any of the other requirements in Section 1.4.1, the assessment is a minor fault.

1.5. Criterion 5: Sterilization handling area

1.5.1. Requirement: There must be a separate area for handling packaging and tools; materials and structures must be appropriate; equipment, tools, and chemicals must be complete and suitable; there must be regulations on sterilization handling.

1.5.2. Method:

Check the design records and conduct on-site inspections and interviews (if necessary) to determine:

- There is a place for mechanical and chemical hygiene handling of directly packaged materials: tubes, bottle shells, bottles, stoppers; tools and equipment used for compounding, personal protective equipment. The floor at the mechanical hygiene handling area must have a slope of about 1.5° towards the drainage channel and have enough friction to prevent slipping;

- Drying and sterilization of bottles, tubes, stoppers, tools, and personal protective equipment meet the requirements of each production stage;

- There are sufficient equipment, tools, and chemicals suitable for the sterilization process;

- There are documents regulating the hygiene regime and sterilization process for directly used packaging, production tools, and labor protection equipment.

1.5.3. Evaluation:

- Compliant with the requirements in Section 1.5.1, the evaluation is satisfactory.

- Lack of documents regulating sterilization is considered a minor non-compliance.

- Non-compliance with any of the other requirements in Section 1.5.1 is considered a major non-compliance.

1.6. Criterion 6: Weighing and raw material dispensing area

1.6.1. Requirement: There should be a separate area for weighing and dispensing raw materials, with measures to ensure no cross-contamination between different types of raw materials.

1.6.2. Method: Check design documents and actual conditions to determine:

- There is a separate raw material weighing room. In cases where there is no separate raw material weighing room, measures must be in place to ensure no cross-contamination between different types of raw materials;

- Have sufficient scales, tools for weighing and they are cleaned and kept hygienic after use.

1.6.3. Evaluation:

- Compliant with the requirements in Section 1.6.1: evaluated as satisfactory

- Not compliant with the requirements in Section 1.6.1: evaluated as a critical defect.

1.7. Criterion 7: Area for compounding, portioning, and storing semi-finished products

1.7.1. Requirement: Equipment and tools must be sufficient, appropriate, and easy to clean.

1.7.2. Method: Check design records and actual conditions, interview (if necessary) to determine:

- Walls and ceilings must be easy to clean, the junctions between the floor and walls and between walls and ceilings must be rounded;

- For powder drug production lines: there must be dehumidifying equipment;

- There must be a separate storage area for semi-finished products if they have not been portioned or dosed.

1.7.3. Evaluation:

- Compliant with the requirements in Section 1.7.1: evaluated as satisfactory.

- Not compliant with any of the requirements in Section 1.7.1: evaluated as a serious defect.

1.8. Criterion 8: Product finishing area

1.8.1. Requirement: Equipment and tools are complete and appropriate

1.8.2. Method: Check design documents and actual conditions, interview (if necessary) to determine:

- Arranged adjacent to the portioning and dosing area to facilitate the reception of products waiting for packaging;

- Sufficient equipment and tools suitable for packaging, labeling, and transporting products to the finished goods warehouse.

1.8.3. Evaluation:

- Compliant with the requirement in Section 1.8.1: rated as satisfactory.

- Not compliant with any of the requirements in Section 1.8.1: rated as minor nonconformance.

1.9. Criterion 9: Sanitary area

1.9.1. Requirement: Proper arrangement; sufficient necessary equipment for personal hygiene.

1.9.2. Method: Check actual conditions and interview (if necessary) to determine:

- Has a separate area, suitable structure;

- Has sufficient appropriate equipment.

1.9.3. Evaluation:

- Compliant with the requirement in Section 1.9.1: rated as satisfactory.

- Does not meet one of the requirements in Section 1.9.1 for minor defect assessment.

1.10. Criterion 10: Wastewater and waste collection and treatment system

1.10.1. Requirement: There is a wastewater collection and treatment system that meets the requirements; there are regulations on wastewater inspection; there are regulations on waste collection and treatment.

1.10.2. Method: Check documents and reality to determine:

- The wastewater treatment system must be designed appropriately for the workshop and production scale, ensure the collection of wastewater from all drainage sources, and not cause pollution to the production workshop area and surroundings.

- Each area in the facility must have suitable, easy-to-transport waste containers. Wastewater must be treated to meet standards before being discharged into the environment.

- There are regulations on wastewater inspection; waste collection and treatment.

1.10.3. Evaluation:

- Compliance with Section 1.10.1 is rated as satisfactory.

- No wastewater treatment system or an inappropriate one is rated as a major violation.

- Not meeting one of the other requirements in Section 1.10.1 is rated as a minor violation.

1.11. Indicator 11: Packaging

1.11.1. Requirement: Suitable packaging, proper handling, and storage

1.11.2. Method: Actual inspection to determine:

- Types of direct packaging that do not affect the quality of the medicine, avoiding negative impacts from external factors such as light, humidity, and microorganisms throughout the storage process;

- Glass packaging that is sturdy and durable, suitable for sterilization, transportation, and storage.

1.11.3. Evaluation:

- Complies with the requirements in Section 1.11.1, evaluation is pass.

- Non-compliance regarding materials, evaluation is major defect.

- Improper handling and storage, evaluation is minor defect.

1.12. Criterion 12: Labeling

1.12.1. Requirement: Accurate according to the approved marketing authorization label; fully records content as regulated.

1.12.2. Method: Actual inspection.

1.12.3. Evaluation:

- Complies with the requirements in Section 1.12.1, evaluation is pass.

- Non-compliance with the requirements in Section 1.12.1, evaluation is major defect.

1.13. Criterion 13: Sterilization and detoxification

1.13.1. Requirement: There must be specific regulations regarding the disinfection and sterilization regime for factories, equipment, tools, protective clothing; appropriate means, tools, and chemicals; measures to distinguish sterilized tools.

1.13.2. Method: Check documentation and conduct on-site inspection, interview (if necessary).

1.13.3. Evaluation:

- Compliant with item 1.13.1: evaluated as satisfactory.

- No documented regulations on disinfection and sterilization: minor non-compliance.

- Non-compliance with any other requirement in item 1.13.1: major non-compliance.

1.14. Indicator 14: Personnel involved in production

1.14.1. Requirement: Direct production managers must have professional certificates; drug testing personnel must have professional certificates.

1.14.2. Method: Check documentation and interview (if necessary).

1.14.3. Evaluation:

- Compliant with the requirement in item 1.14.1: evaluated as satisfactory.

- Does not meet one of the requirements in Section 1.14.1 for minor nonconformance.

1.15. Criterion 15: Personal Hygiene

1.15.1. Requirement: Have regulations on personal hygiene in production; properly follow personal hygiene practices.

1.15.2. Method: Review records and actual practices, interview (if necessary) to determine:

People working in the veterinary drug production area must meet the following requirements:

- Have sufficient health according to the regulations of the Ministry of Health and undergo regular health check-ups;

- Receive training in professional expertise, personal hygiene, and industrial hygiene in veterinary drug production;

- People working in the veterinary drug production area must comply with veterinary hygiene regulations.

1.15.3. Evaluation:

- Conforms to the requirements in Section 1.15.1: evaluated as satisfactory.

- No document regulating personal hygiene in production: evaluated as minor non-compliance.

- Does not meet one of the other requirements in Section 1.15.1: evaluated as major non-compliance.

1.16. Indicator 16: Occupational hygiene

1.16.1. Requirement: There are regulations on the issuance and use of personal protective equipment; replacement and sterilization of protective equipment after each production shift; ventilation and dust extraction devices are available.

1.16.2. Method: Check records and actual conditions, interview (if necessary) to determine:

- Must have personal protective equipment for each individual appropriate to the assigned work;

- Must have deodorizing, ventilation, and dust extraction equipment with suitable capacity; Must provide safety equipment for users of thermal, electrical, mechanical, and pneumatic devices;

- Must have regulations on labor protection, proactive measures and means to prevent and promptly resolve potential incidents.

1.16.3. Evaluation.

- Complies with the requirements in Section 1.16.1, evaluation is satisfactory.

- No regulations on the issuance and use of labor protection equipment, evaluation is minor non-compliance.

- Does not comply with one of the remaining requirements in Section 1.16.1, evaluation is major non-compliance.

1.17. Criterion 17: Water used in the facility

1.17.1. Requirement: There must be sufficient clean water for production and hygiene needs; water samples must be tested according to regulations.

1.17.2. Method: Check documentation and actual conditions to determine:

- The water supply system ensures quality meets safety and hygiene standards;

- Water used for production must meet the production requirements;

- Pipelines and storage tanks are designed appropriately, without leaks, easy to clean, and must be tightly covered;

- Inspect sampling operations and water analysis results.

1.17.3. Evaluation:

- Compliant with the requirements in Section 1.17.1 – rated as satisfactory.

- Production water does not meet hygiene regulations – rated as a major nonconformity.

- Non-compliance with any other requirements in Section 1.17.1 – rated as a minor nonconformity.

2. Implementation of batch record regulations

2.1. Criterion 1: Prepare batch records for each product

2.1.1. Requirement: Each batch of product must have its own record.

2.1.2. Method: Check the documentation.

2.1.3. Evaluation:

- Compliant with the requirement in Section 2.1.1 – rated as satisfactory.

- Non-compliant with the requirement in Section 2.1.1 – rated as a major nonconformity.

2.2. Criterion 2: Have all types of documents and monitoring forms

2.2.1. Requirement: Each batch file must have complete documents to track all stages from the production order to the sale of the product to the customer.

2.2.2. Method: Check the documentation and conduct interviews (if necessary).

2.2.3. Evaluation:

- Complies with the requirement in Section 2.2.1 is rated as pass.

- Does not comply with one of the requirements in Section 2.2.1 is rated as minor defect.

2.3. Criterion 3: Having test certificates for each batch

2.3.1. Requirement: Each product batch must have test certificates for semi-finished and finished products.

2.3.2. Method: Check the documentation.

2.3.3. Evaluation:

- Complies with the requirement in Section 2.3.1 is rated as pass

- Does not comply with one of the requirements in Section 2.3.1 is rated as major defect.

3. Quality control (QC) implementation

3.1. Criterion 1: Having a QC room

3.1.1. Requirement: There must be an appropriate QC room.

3.1.2. Method: Check the design documents and perform actual inspection to determine:

- The QC room must be separated from the production area. Areas conducting biological and microbiological tests must be isolated from each other;

- Sufficient space is required to avoid cross-contamination and to store samples and standards.

3.1.3. Evaluation.

- Compliant with the requirement in Section 3.1.1: rated as pass.

- Not compliant with the requirement in Section 3.1.1: rated as major nonconformance.

- No QC room: rated as critical nonconformance.

3.2. Criterion 2: QC Personnel

3.2.1. Requirement: must have a professional practice certificate

3.2.2. Method: Check documentation files, interview (if necessary).

3.2.3. Assessment:

- Compliant with the requirement in Section 3.2.1: rated as pass.

- QC personnel without a professional practice certificate: rated as major nonconformance.

3.3. Criterion 3: Equipment

3.3.1. Requirement: Have full and appropriate equipment to serve the product quality inspection work.

3.3.2. Method: Check the equipment list and actual items to determine:

- UV-visible spectrophotometer, high-performance liquid chromatography (HPLC), ...

- Analytical balance

- Moisture meter

- Technical balance

- Double-distilled water system

- Drying oven (50-250°C)

- Incubator

- Sterile incubation cabinet

- Optical microscope

- pH meter

- Colony counter

- Sterilization steam pot;

- Glassware and equipment for testing.

3.3.3. Evaluation:

- Compliant with the requirements in Section 3.3.1: evaluation is satisfactory

- For production facilities that do not have suitable equipment to analyze product quality: major nonconformance.

- Noncompliant with any other requirements in Section 3.3.1: minor nonconformance.

3.4. Criterion 4: Raw material inspection

3.4.1. Requirement: All incoming raw materials at the facility must be sampled for inspection or have an analysis certificate from the supplier.

3.4.2. Method: Check documentation records.

3.4.3. Evaluation:

- Compliant with the requirement in Section 3.4.1: evaluation is satisfactory.

- Noncompliant with the requirement in Section 3.4.1: major nonconformance.

3.5. Criterion 5: Semi-finished product inspection

3.5.1. Requirement: Each batch of semi-finished products must be sampled for inspection.

3.5.2. Method: Check documentation records.

3.5.3. Evaluation:

- Compliant with the requirement in Section 3.5.1: evaluation is satisfactory.

- Noncompliant with the requirement in Section 3.5.1: minor nonconformance.

3.6. Criterion 6: Finished product inspection

3.6.1. Requirement: Each batch of finished products must be sampled and inspected before being stored in the warehouse.

3.6.2. Method: Check documentation records.

3.6.3. Evaluation:

- Compliant with the requirement in Section 3.6.1 is rated as pass.

- Non-compliant with the requirement in Section 3.6.1 is rated as a major defect.

3.7. Criterion 7: Retention and inspection of retained samples according to regulations

3.7.1. Requirement: Each batch of products must have retained samples taken and inspected according to regulations before being stored in the warehouse.

3.7.2. Method: Check documentation records and actual practice to determine:

- Whether there is a written regulation on retention and inspection of retained samples;

- Whether retained samples are taken and inspected according to regulations.

3.7.3. Evaluation:

- Compliant with the requirement in Section 3.7.1 is rated as pass;

- No written regulation on retention and inspection of retained samples is rated as a minor defect;

- No retained samples and inspection of retained samples is rated as a major defect.

Form No. 08.QLT

CERTIFICATE

CERTIFIED ELIGIBLE FOR VETERINARY DRUG PRODUCTION

No.: …………/GCN-SX

Name of unit: ……………………………………………………….……………………………

Address: ………………………………………….………………………………………………

Phone/Tel: ………………………………………………………………………………

Recognized as meeting the conditions for producing veterinary drugs for: (*)

……………………………………………………………………………………………………

……………………………………………………………………………………………………

……………………………………………………………………………………………………

……………………………………………………………………………………………………

……………………………………………………………………………………………………

This certificate of eligibility is valid until: day.... month.... year...

Note: (*) specify the production line of the product, such as herbal medicine production line, chemical, biological products, etc.

Form No. 09.QLT

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

______________________

APPLICATION FOR ISSUANCE/RENEWAL OF CERTIFICATE OF ELIGIBILITY

FOR TRADING/IMPORTING VETERINARY DRUGS

To: ……………………..

Pursuant to (**) ……………………………………………………….

Name of establishment: ……………………………………

Address of establishment: ………………………………

Phone number: ………………………………

Owner of the establishment: ……………………………………

Permanent address: …………………………..

Certificate of eligibility for trading/importing veterinary drugs (in case the establishment is renewing the Certificate of eligibility for trading/importing veterinary drugs): number …… dated .... month .... year ....

Types of products for business:

□ Pharmaceutical drugs □ Vaccines, biological products

□ Chemicals

□ Others

We kindly request your unit to carry out the inspection for issuance/renewal of the Certificate of eligibility for trading/importing veterinary drugs for our establishment.

Note:

(*) The agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures;

(**) Current legal normative documents.

Form No. 10.QLT

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

______________________

DETAILED EXPLANATORY REPORT ON MATERIAL AND TECHNICAL FACILITIES

FOR MANUFACTURING/IMPORTING VETERINARY MEDICINES

To: ………………………..

Registered facility name for inspection: …………………………………………………………………

Address: ………………………………………………………………………………………….

Phone number: …………………... Email: ……………………………………………………..

Type of business registration: ……………………………………………………………….

Explanation of the conditions for trading/importing veterinary drugs as follows:

1. Facilities: (describe the structure, scale of the premises, display/sales areas).

2. Equipment: (fully list the names and quantities of equipment used for storing veterinary drugs such as cabinets, counters, shelves, hygrometers, thermometers, refrigerators, ………….).

3. Records and documents: (business registration certificate, professional license, records of purchases and sales, ...).

4. List of products sold at the establishment.

Note: (*) Agency assigned by the Provincial People's Committee Chairman to handle administrative procedures.

Form No. 11.QLT

INSPECTION MINUTES

CONDITIONS FOR SELLING/IMPORTING VETERINARY MEDICINES

I. GENERAL INFORMATION:

1. Facility name: …………………………………………………………………………………

2. Address: ………………………………………………………………………………………

3. Business registration certificate (if any) number: ……………. date of issue ....... place of issue ………….

4. Phone number: ……………………………………………………………………………….

5. Code (if any): ……………………………………………………………………………..

6. Products sold: ………………………………………………………………………

7. Inspection date: ………………………………………………………………………………

8. Form of inspection: …………………………………………………………………………

9. Inspection team members:

- ………………………………………………………………………………………………….

- ………………………………………………………………………………………………….

- ………………………………………………………………………………………………….

10. Representative of the facility:

- ………………………………………………………………………………………………….

- ………………………………………………………………………………………………….

II. GROUP OF EVALUATION CRITERIA:

III. INDICATORS NOT EVALUATED AND REASONS FOR NOT EVALUATING

……………………………………………………………………………………………..

IV. SAMPLING (if any) AND SPECIFICATION OF ANALYSIS INDICATORS (attached with Sampling Report)

1. Information about the sample collected (type of sample; quantity of samples; condition of packaging, sample preservation, etc.),

2. Specification of analysis indicators:

V. OPINIONS OF THE INSPECTION TEAM

1. Comments of the inspection team:

2. Conclusion of the inspection team:

VI. OPINION OF THE REPRESENTATIVE OF THE FACILITY

INSPECTION GUIDELINES FOR CONDITIONS

VETERINARY MEDICINE TRADING/IMPORTING ESTABLISHMENT

I. CLASSIFICATION GUIDANCE

1. Definition of fault level

- Serious Error (Se): A deviation from technical standards that affects product quality and impacts consumer health.

- Major Error (Ma): A deviation from technical standards that, if prolonged, will affect product quality but is not yet serious.

- Minor Error (Mi): A deviation from technical standards that may affect product quality or hinder hygiene control, but is not yet major.

2. Evaluation results:

Note: (-) Not assessed

3. Explanation:

3.1. Veterinary drug business establishments are eligible if they meet one of the following conditions:

- No serious errors, no major errors, and the total number of minor errors does not exceed 2 groups of criteria.

- No serious errors, 1 major error, and the total number of minor and major errors does not exceed 3 groups of criteria.

3.2. Establishments are not eligible for veterinary drug business if

- There is a serious error or there are major errors in 2 or more groups of criteria.

II. INSPECTION METHOD:

A. Recording the inspection minutes:

- Record full information as prescribed in the minutes template;

- Verify and record accurate information;

- If corrections are made in the minutes, they must have the confirmation signature of the head of the inspection team.

B. Evaluation principles:

- Do not add or remove any content; the evaluation level has been specified in each criteria group.

- For each criterion, only determine the error level in the columns marked with [ ], and do not determine the error level in columns without [ ].

- Use the symbol x or mark the positions of the determined evaluation level for each criteria group.

- The overall evaluation result of a criteria group is the highest evaluation level of the criteria within the group, consistently recorded as follows: Ac (satisfactory), Mi (minor error), Ma (major error), Se (serious error).

- Must provide a detailed explanation of the identified errors for each indicator and the deadline for the facility to correct those errors. For indicators that are not assessed, the reason must be clearly stated in the column 'Explanation of errors and corrective actions.'

C. Groups of criteria and inspection methods:

1. Indicator 1: Facilities

1.1. Requirements: Fixed, separate location; arranged in a high, airy, safe place, away from pollution sources; constructed with sturdy materials; ceiling with dust protection, walls and ceiling flat, easy to clean; area suitable for business scale; display area; drug storage area; separate area for selling, distinct from other goods.

1.2. Method: Actual inspection to determine:

- Has a fixed address.

- Area suitable for business/import scale.

- Arranged in a high, airy, safe place, away from pollution sources.

- Ceiling with dust protection, walls and ceiling flat, easy to clean.

- There is a display area; there is a drug storage area and it is separated from other goods.

1.3. Evaluation:

- Compliant with the requirements in Section 1.1, evaluation is satisfactory.

- If there is no separate fixed location or dedicated area for displaying and storing drugs, it is considered a major violation.

- If not compliant with any of the remaining requirements in Section 1.1, it is considered a minor violation.

2. Criterion 2: Equipment

2.1. Requirement: Have sufficient equipment to store drugs to prevent adverse effects from light, temperature, humidity, contamination, and insect intrusion; have storage equipment that meets the storage requirements indicated on the label.

2.2. Method: Check the equipment list and conduct an actual inspection to determine:

- Whether there are sufficient cabinets and counters for drug storage;

- Whether cabinets, counters, and shelves are easy to clean;

- Whether there are thermometers, hygrometers, and records for monitoring;

- Facilities have equipment to ensure that storage and sales of medicines are well-ventilated;

- Have sufficient equipment to store medicines according to the instructions provided by the manufacturer on the label;

- Facilities trading in vaccines must have cold storage equipment and backup means to store vaccines and biological products in case of a power outage; there must be a thermometer to monitor temperature and daily records.

- For facilities importing veterinary vaccines, there must be dedicated transportation means to ensure storage requirements are met during transport and distribution to the point of consumption.

2.3. Assessment:

- Complies with the requirements in Section 2.1: assessment is pass.

- Does not have sufficient equipment to store medicines according to the manufacturer’s instructions: assessment is a serious defect.

- Does not comply with any of the other requirements in Section 2.1: assessment is a major defect.

3. Criterion 3: Documentation

3.1. Requirements: The facility must have a Business Registration Certificate; a Veterinary Practice Certificate; employee records (if any); records related to pharmaceutical business activities; track the import and export of each type of veterinary drug and monitor batch numbers and drug expiration dates.

3.2. Method: Review document records and conduct interviews (if necessary)

3.3. Evaluation:

- Compliant with the requirements in Section 3.1 is rated as satisfactory.

- Non-compliance with any of the requirements in Section 3.1 is rated as minor or major non-compliance.

4. Indicator 4: Source of drugs

4.1. Requirements: All drugs sold at the facility must have a legal origin and have sufficient labels according to regulations; have a List of pharmaceutical products for sale; arranged according to the storage conditions stated on the label.

4.2. Method: Review document records and conduct actual inspections to determine:

- The list of pharmaceutical products for sale;

- Each product has a label correctly stated according to regulations;

- Separate areas or separate rooms for medicines and insecticidal chemicals;

- Arranged according to storage conditions stated on the label.

4.3. Evaluation:

- Compliant with the requirements in Section 4.1, evaluation is satisfactory.

- Not compliant with any of the requirements in Section 4.1, evaluation is a major fault.

- Products not arranged according to storage conditions stated on the label, evaluation is a serious fault.

Form No. 12.QLT

CERTIFICATE

CERTIFIED FOR VETERINARY MEDICINE BUSINESS

No.: ……../GCN-BB

Name of establishment: ……………………………………………………………………………………

Address: …………………………………………………………………………………………………..

Phone/Tel: ………………………………………………………………………………

Owner: ……………………………………………………………………………………………………

Residential address: ……………………………………………………………………………………

Recognized as qualified for trading in veterinary medicines for: (*)

……………………………………………………………………………………………………..

……………………………………………………………………………………………………..

……………………………………………………………………………………………………..

……………………………………………………………………………………………………..

This certificate of eligibility is valid until: day …… month … year ...

Note: (*) specify the type of products allowed for trading such as vaccines, pharmaceuticals, chemicals, ...

Form No. 13.QLT

CERTIFICATE

CERTIFIED FOR IMPORT OF VETERINARY MEDICINES

No.: ……../GCN-NK

Name of establishment: ……………………………………………………………………………………

Address: …………………………………………………………………………………………………..

Phone/Tel: ………………………………………………………………………………

Owner: ……………………………………………………………………………………………………

Residential address: ……………………………………………………………………………………

Recognized as qualified to import veterinary drugs for: (*)

……………………………………………………………………………………………………..

……………………………………………………………………………………………………..

……………………………………………………………………………………………………..

……………………………………………………………………………………………………..

This certificate of eligibility is valid until: day …… month … year ...

Note: (*) Specify the type of products allowed for import such as vaccines, pharmaceuticals, chemicals, etc.

Form No. 14.QLT

APPLICATION FOR RE-ISSUANCE

Certificate of Eligibility for Production/Trading/Importing Veterinary Medicines

To: (*) ..................................

Based on (**) ………………………………………………………………………………..

REGISTERING ORGANIZATION, INDIVIDUAL:

Name: ……………………………………………………………………………………………..

Address: ………………………………………………………………………………………….

Phone number: ………………………………………………………..

We hereby request the reissuance of the Certificate of Eligibility for Production/Trading/Importing Veterinary Medicines: Number …………….. dated …… month ……… year …………..

Reason for re-issuance request:

- Errors

- Changes in information related to the registering organization.

Attached dossiers include:

- ………;

Note:

(*) The agency assigned by the Chairman of the Provincial People's Committee to handle administrative procedures;

(**) Current legal normative documents.

Appendix IB

FORMS RELATED TO VETERINARY PRACTICE

(Attached to Decree No. 32/2026/NĐ-CP

dated January 21, 2026, of the Government)

Form No. 01.HNTY

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

______________________

REGISTRATION FORM

FOR VETERINARY PRACTICE CERTIFICATE

To: …………………………

My name is: ………………………………………………………………………………..

Date of birth: ………………………………………………………………….

Citizen identification number/personal identification number: …………….. Date of issue ………………

For foreigners: work permit or Certificate of not being eligible for a work permit number: ………….., date of issue …………., place of issue …………..

Place of residence: …………………………………………………………

Professional qualification: ..................................................

Date of issue: ………………………………………………………..

Phone number: …………………………………………………….

Hereby, I request your esteemed agency to issue a Practice Certificate:

□ Vaccination, disease treatment, minor surgery (castration, tail docking) of animals, consulting on activities related to the veterinary field.

□ Medical examination, disease diagnosis, animal surgery, animal disease testing.

□ Trading veterinary drugs used for terrestrial animals.

□ Trading veterinary drugs used for aquatic animals.

□ Production of veterinary drugs for terrestrial animals.

□ Production of veterinary drugs for aquatic animals.

□ Export and import of veterinary drugs for terrestrial animals.

□ Export and import of veterinary drugs for aquatic animals.

□ Testing of veterinary drugs for terrestrial animals.

□ Testing of veterinary drugs for aquatic animals.

□ Inspection of veterinary drugs for terrestrial animals.

□ Inspection of veterinary drugs for aquatic animals.

I hereby commit to strictly comply with the laws and regulations of the veterinary sector.

Attached is the original health check certificate.

Form No. 02.HNTY

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

______________________

REGISTRATION FORM

RENEWAL OF VETERINARY PRACTICE CERTIFICATE

To: ……………

My name is: ………………………………………………………………………………..

Date of birth: ………………………………………………………………….

Citizen identification number/personal identification number: …………….. Date of issue ………………

For foreigners: work permit or Certificate of not being eligible for a work permit number: ………….., date of issue …………., place of issue …………..

Place of residence: …………………………………………………………

Professional qualification: ..................................................

Phone number: …………………………………………………….

Has been issued a Veterinary Practice Certificate by …………………………..:

□ Vaccination, disease treatment, minor surgery (castration, tail docking) of animals, consulting on activities related to the veterinary field.

□ Medical examination, disease diagnosis, animal surgery, animal disease testing.

□ Trading veterinary drugs used for terrestrial animals.

□ Trading veterinary drugs used for aquatic animals.

□ Production of veterinary drugs for terrestrial animals.

□ Production of veterinary drugs for aquatic animals.

□ Export and import of veterinary drugs for terrestrial animals.

□ Export and import of veterinary drugs for aquatic animals.

□ Testing of veterinary drugs for terrestrial animals.

□ Testing of veterinary drugs for aquatic animals.

□ Inspection of veterinary drugs for terrestrial animals.

□ Inspection of veterinary drugs for aquatic animals.

Registration number: ……../……-CCHNTY. The certificate is valid until ……………

Hereby, I request your esteemed agency to extend the above Practice Certificate.

Attached is the original health check certificate.

Form No. 03.HNTY

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

______________________

REGISTRATION FORM

REISSUE OF VETERINARY PRACTICE CERTIFICATE

To: ………………………

My name is: ………………………………………………………………………………..

Date of birth: ………………………………………………………………….

Citizen identification number/personal identification number: …………….. Date of issue ………………

For foreigners: work permit or Certificate of not being eligible for a work permit number: ………….., date of issue …………., place of issue …………..

Place of residence: …………………………………………………………

Professional qualification: ..................................................

Phone number: …………………………………………………….

Has been issued a Veterinary Practice Certificate by …………………………..:

□ Vaccination, disease treatment, minor surgery (castration, tail docking) of animals, consulting on activities related to the veterinary field.

□ Medical examination, disease diagnosis, animal surgery, animal disease testing.

□ Trading veterinary drugs used for terrestrial animals.

□ Trading veterinary drugs used for aquatic animals.

□ Production of veterinary drugs for terrestrial animals.

□ Production of veterinary drugs for aquatic animals.

□ Export and import of veterinary drugs for terrestrial animals.

□ Export and import of veterinary drugs for aquatic animals.

□ Testing of veterinary drugs for terrestrial animals.

□ Testing of veterinary drugs for aquatic animals.

□ Inspection of veterinary drugs for terrestrial animals.

□ Inspection of veterinary drugs for aquatic animals.

Registration number: ……../……-CCHNTY. The certificate is valid until ……………

Today, I propose that your agency reissue the above Professional Practice Certificate.

Reason: ……………………………………………

(Clearly state the reason such as: Mistake / due to information change, if due to information change: need to clearly state what information you want to change and how)

Form No. 04.HNTY

VETERINARY PRACTICE CERTIFICATE SAMPLE (in case of new issuance or renewal)

CERTIFICATE

OF VETERINARY PRACTICE

Pursuant to the Veterinary Law No. 79/2015/QH13, as amended and supplemented;

Pursuant to Decree No. 35/2016/NĐ-CP dated May 15, 2016 of the Government detailing a number of articles of the Law on Veterinary Medicine, as amended and supplemented;

Based on ………………………………………………

Based on Decision No. .... /QĐ-…………………….

HEAD OF THE AGENCY ISSUING THE VETERINARY PRACTICE CERTIFICATE

Issued to Mr./Ms.: …………………………………….

Date of birth: ………………………………….

Citizen identification number/personal identification number: ………….. date of issue ......

For foreigners: work permit or Certificate of non-requirement for work permit number: ...... , date ………, issued by ..... , place of issue ………

Residence: …………………………………………………….

Professional qualification: ……………………………………….

Authorized to practice: ….……………………………………

……………………………………………………………………

Form No. 05.HNTY

VETERINARY PRACTICE CERTIFICATE TEMPLATE (in case of reissuance)

CERTIFICATE

OF VETERINARY PRACTICE

Pursuant to the Veterinary Law No. 79/2015/QH13, as amended and supplemented;

Pursuant to Decree No. 35/2016/NĐ-CP dated May 15, 2016 of the Government detailing a number of articles of the Law on Veterinary Medicine, as amended and supplemented;

Based on ………………………………………………

Based on Decision No. .... /QĐ-…………………….

HEAD OF THE AGENCY ISSUING THE VETERINARY PRACTICE CERTIFICATE

Issued to Mr./Ms.: …………………………………….

Date of birth: ………………………………….

Citizen identification number/personal identification number: ………….. date of issue ......

For foreigners: work permit or Certificate of non-requirement for work permit number: ...... , date ………, issued by ..... , place of issue ………

Residence: …………………………………………………….

Professional qualification: ……………………………………….

Authorized to practice: ….……………………………………

……………………………………………………………………