Consolidated Document number 28/VBHN-BNNPTNT stipulates the management of veterinary drugs.

MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT -------	SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom - Happiness ---------------
Number: 28/VBHN-BNNPTNT	Hanoi, September 23, 2024

 

CIRCULAR

REGULATIONS ON THE MANAGEMENT OF VETERINARY MEDICINES

Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016, issued by the Minister of Agriculture and Rural Development on the management of veterinary medicines, which took effect from July 19, 2016, has been amended and supplemented by:

1. Circular No. 18/2018/TT-BNNPTNT dated November 15, 2018, issued by the Minister of Agriculture and Rural Development to amend and supplement, abolish some articles of Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016, issued by the Minister of Agriculture and Rural Development on the management of veterinary medicines, which took effect from February 14, 2019;

2. Circular No. 12/2020/TT-BNNPTNT dated November 9, 2020, issued by the Minister of Agriculture and Rural Development on the management of veterinary medicines containing narcotic substances and precursors; prescription and veterinary prescriptions; amending and supplementing some articles of Circular No. 18/2018/TT-BNNPTNT, which took effect from December 25, 2020;

3. Circular No. 13/2022/TT-BNNPTNT dated September 28, 2022, issued by the Minister of Agriculture and Rural Development to amend and supplement some articles of circulars on the management of veterinary medicines, which took effect from November 12, 2022;

4. Circular No. 09/2024/TT-BNNPTNT dated June 28, 2024, issued by the Minister of Agriculture and Rural Development to amend and supplement some articles of Circular No. 13/2016/TT-BNNPTNT dated June 2, 2016, issued by the Minister of Agriculture and Rural Development on the management of veterinary medicines.

Pursuant to the Law on Veterinary Medicine dated June 19, 2015;

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

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

Pursuant to Decree No. 89/2006/NĐ-CP dated August 30, 2006, issued by the Government on product labeling;

Pursuant to Decree No. 132/2008/NĐ-CP dated December 31, 2008, issued by the Government detailing certain provisions of the Law on Product Quality;

Pursuant to Decree No. 181/2013/NĐ-CP dated November 14, 2013, issued by the Government detailing certain provisions of the Law on Advertising;

BASED ON THE DECREE NO. 199/2013/NĐ-CP OF NOVEMBER 26, 2013 OF THE GOVERNMENT PROVIDING FOR THE FUNCTIONS, TASKS, POWERS, AND ORGANIZATIONAL STRUCTURE OF THE MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT;

Pursuant to Decree No. 35/2016/NĐ-CP dated May 15, 2016, issued by the Government detailing certain provisions of the Law on Veterinary Medicine;

At the proposal of the Director of the Animal Health Department,

The Minister of Agriculture and Rural Development issues this Circular on the management of veterinary medicines.[1]

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

Thông tư này quy định chi tiết khoản 4 Điều 38 Luật Thủy sản số 18/2017/QH14 đã được sửa đổi, bổ sung tại điểm c khoản 21 Điều 14 Luật số 146/2025/QH15.

This Circular stipulates the registration for circulation, testing, production, trading, export, import, inspection, quality control, recall, destruction, and advertising of veterinary medicines.

Thông tư này áp dụng đối với tổ chức, cá nhân có liên quan đến hoạt động kinh doanh đối tượng thủy sản nuôi chủ lực trên lãnh thổ Việt Nam.

This Circular applies to organizations and individuals within the country, and foreign organizations and individuals involved in the registration for circulation, testing, production, trading, export, import, inspection, quality control, recall, destruction, and advertising of veterinary medicines in Vietnam..

Article 2. Interpretation of Terms

In these provisions, the following terms are understood as follows:

1. Production of veterinary medicines includes forms of manufacturing, processing, and repackaging of veterinary medicines.

2. New medicine refers to a medicine with a new formula containing a new active ingredient, a new combination of active ingredients, a new dosage form, a new indication, or a new route of administration.

3. New active ingredient is an active ingredient registered for circulation in Vietnam for the first time.

4. Original medicine (innovative medicine) is a medicine granted a patent, with a stable production process, and has obtained a circulation permit.

5. Generic medicine is a type of medicine produced similarly to the original medicine regarding formula, dosage form, efficacy, indication, dosage, and duration of drug withdrawal after the expiration of the patent or exclusive rights.

6. Brand name is a trade name established by the medicine manufacturer, different from the generic name or international nonproprietary name.

7. Medicine label is the printed, drawn text, images, symbols directly printed or embossed on the commercial packaging of the medicine, or firmly affixed to the commercial packaging of the medicine.

8. Labeling of medicines is the act of displaying essential and primary information about the medicine on the label to help users identify, select, and use the medicine correctly, and serve as a basis for competent authorities to conduct inspections, supervision, and management.

9. Primary label of the medicine is the label initially printed or affixed firmly on the commercial packaging of the medicine after completing the final packaging process in the production line.

10. Secondary label is the label that translates mandatory information from the primary label into Vietnamese and supplements mandatory information in Vietnamese according to the law that the primary label of the medicine lacks.

11. Commercial packaging of medicines is the packaging containing the medicines and circulating together with them, including two types:

a) Direct packaging is the packaging that comes into direct contact with the medicines;

b) Outer packaging is the packaging used to package one or several units of medicines with direct packaging.

12. Name and address of the organization or individual responsible for the medicine are the name and address of the organization or individual producing, exporting, importing, or entrusting the export and import of the medicine.

13. Packaging specification of the medicine is the quantity of medicine expressed by net weight, actual volume, or number counted in a single unit of packaging.

14. Batch production number is a symbol consisting of numbers or letters, or a combination of both, used to identify a batch of medicine and allow tracing the entire history of that batch, including all stages of the production process, quality inspection, and distribution.

15. Date of manufacture is the time mark indicating the completion of the production, processing, bottling, packaging, or other final steps of a batch of medicine.

16. Expiry date of the medicine is the time limit set for a batch of medicine beyond which it may not be used.

17. Country of origin of the medicine is the country or territory where the entire medicine was produced or where the final basic processing stage was carried out in cases where multiple countries or territories participated in the production process.

18. Instructions for use are information related to the method of use, necessary conditions for use and storage, warnings of hazards, and procedures for handling hazardous incidents to guide users to use the medicine effectively, safely, and reasonably.

The instructions for use leaflet is the document accompanying the commercial packaging of the medicine, recording the instructions for use and other contents as prescribed.

19. State inspection of veterinary drug quality is the act of state agencies examining and evaluating the quality of veterinary drugs, production, importation, circulation, where management measures for quality have been applied by organizations and individuals engaged in production and business.

20. Qualified drugs are veterinary drugs that meet registered quality standards according to the Pharmacopoeia standards, National Technical Regulations on veterinary drugs, National Standards on veterinary drugs, or the manufacturer's own standards, and have been approved by competent management authorities.

21. Unqualified drugs are veterinary drugs that do not meet the registered quality standards with competent management authorities.

22. A production batch is a specific quantity of veterinary drugs, uniform in quality, produced through a single process or a series of processes and marked on the packaging label with the same batch number.

23. An imported batch is a specific quantity of raw materials or veterinary drugs from one or more production batches of a product manufactured by the same facility, imported by the same organization, in the same shipment, and having the same import documentation.

Chapter II

REGISTRATION FOR CIRCULATION, TESTING, PRODUCTION, SALE, AND IMPORT OF VETERINARY DRUGS

Section 1. REGISTRATION FOR CIRCULATION OF VETERINARY DRUGS

Article 3. Documents for registration of circulation of veterinary drugs

1. For new veterinary drugs in pharmaceutical, chemical, or biological preparation forms, the registration documents include:

a) Application for circulation registration in accordance with the form prescribed in Appendix I attached to this Circular;

b) Summary of product characteristics in accordance with the form prescribed in Appendix VIII attached to this Circular;

c) Product label samples, usage instructions;

d) Certificate of Good Manufacturing Practice (GMP) or certificate of quality management system (ISO) for certain types of chemicals, and certificate of circulation issued by the competent state authority of the producing country for imported drugs;

đ) Production process;

e) Quality standards and testing methods;

g) Reports on data proving safety including toxicity research materials (acute, subchronic, chronic, cellular, carcinogenicity);

h) Reports on data proving efficacy including experimental pharmacological studies; pharmacodynamics, pharmacokinetics, and bioavailability of the product;

i) Residue studies in all animal species designated for drug use to determine the withdrawal period;

k) Research materials on stability and shelf life of the drug;

l) Research materials on dosage and treatment regimen for each designated animal species;

m) Quality analysis report of the manufacturer and quality analysis report of the designated veterinary drug testing agency in Vietnam;

n) Testing results;

o) Commitment to not violate intellectual property regulations in accordance with the form prescribed in Appendix VII attached to this Circular;

p) Other technical information (if applicable).

2. For pharmaceutical, chemical, or biological preparations exempted from testing under Article 11 of this Circular, the registration documents include:

a) The contents prescribed in points a, b, c, d, đ, e, k, m, o, p of Clause 1 of this Article;

b) Information about the original drug, generic drug (product name, manufacturer name, formula, formulation, function, indication, contraindication, dosage, withdrawal period, precautions for designated animals, users, and other technical characteristics of the product).

3. For vaccines and antibodies, the registration documents include:

a) Application for circulation registration in accordance with the form prescribed in Appendix II attached to this Circular;

b) Summary of product characteristics in accordance with the form prescribed in Appendix VIII attached to this Circular;

c) Product label samples, usage instructions;

d) Certificate of GMP, product circulation permit issued by the competent state authority of the producing country for imported products;

đ) Production process;

e) Quality standards and testing methods for vaccines and antibodies;

g) Reports on data proving safety and efficacy of the product, including research materials on antigen content and duration of immunity for vaccines;[2];

h) Residue studies in all designated animal species to determine the withdrawal period for vaccines and antibodies;

i) Research materials on stability, summary production records of three consecutive batches, and proposed shelf life;

k) Method for determining dosage and usage regimen for each designated animal species;

l) Quality analysis report of the manufacturer, quality analysis report of the designated veterinary drug testing agency in Vietnam;

m) Report on testing results regarding efficacy and safety of the product;

n) Related materials including: origin, history, and stability of the original microorganism strain used for vaccine and antibody production; information and characteristics of the original microorganism strain used for domestic vaccine and antibody production; related materials on copyright and application of vaccine and antibody production certification (if applicable);[3]o) Other technical information such as laboratory testing results, data on circulation of the product in other countries around the world (if applicable);

4. For diagnostic biological preparations (test kits), the registration documents include:

p)[4](Repealed)

4. For biological diagnostic products (test kits), the registration dossier shall include:

a) Application for circulation registration in accordance with the form prescribed in Appendix III attached to this Circular;

b) Summary of product characteristics in accordance with the form prescribed in Appendix VIII attached to this Circular;

c) Product label samples; usage instructions;

d) Certificate of GMP or certificate of quality management system (ISO) or equivalent certificate, product circulation permit issued by the competent state authority of the producing country for imported products;

đ) Quality analysis report of the biological preparation from the manufacturing facility, quality analysis report of the biological preparation from the designated veterinary drug testing agency in Vietnam;

e) Reports on data proving analytical sensitivity;

g) Reports on data proving product specificity;

h) Production process;

i) Quality standards and testing methods for biological preparations;

g) Report on data proving the specificity of the product;

h) Production process;

i) Quality standards and methods for testing biological products;

k) Research materials on stability, production batch summary records of three consecutive batches, and proposed shelf life;

l) Report on testing results, including content related to analytical sensitivity and product specificity;

m) Related documents including: origin, history of the original microorganism strain used for biological product production; documents related to intellectual property rights and application of biological product manufacturing certification (if applicable);

n) Other technical information (if any).

5. For veterinary drugs from herbal medicines, the registration dossier shall include:

a) Application for circulation registration in accordance with the form prescribed in Appendix I attached to this Circular;

b) Summary of product characteristics in accordance with the form prescribed in Appendix VIII attached to this Circular;

c) Product label samples, usage instructions;

d) Certificate of Good Manufacturing Practice (GMP), certificate of circulation issued by the competent authority of the producing country for imported drugs;

đ) Production process;

e) Quality standards and testing methods;

g) Report on data proving the safety and efficacy of the product;

h) Studies on residues in all animal species designated for drug use to determine the withdrawal period;

i) Research materials on stability and shelf life of the drug;

k) Research materials on dosage and treatment regimen for each designated animal species;

m) A commitment not to violate intellectual property law regulations as prescribed in Appendix VII attached hereto;

n) Other technical information (if any).

6. For veterinary drugs already having a circulation certificate in Vietnam produced through contract manufacturing or repackaging, the registration dossier shall include:

a) Application for contract manufacturing or repackaging according to the model prescribed in Appendix X attached hereto;

b) Product summary information (name, ingredients, formulation, packaging specifications, indications, usage instructions, shelf life);

c) Product label samples, user guide sheets (registered labels, contract-manufactured labels, repackaged labels);

d)[5](Repealed)

đ)[6](Repealed)

e) Contract for contract manufacturing or repackaging of veterinary drugs between the contracting party and the contractor;

g) Production process of the contracting party;

h) Quality standards and testing methods for raw and auxiliary materials, intermediates, and finished products of the contracting party;

i) Quality analysis report of the contractor;

7. For veterinary drugs without a circulation certificate in Vietnam produced for export, the registration dossier shall include:

a) Application for production for export according to the model prescribed in Appendix XI attached hereto;

b) Summary of product characteristics in accordance with the form prescribed in Appendix VIII attached to this Circular;

c) Product label samples, usage instructions;

d) GMP certificate of the production facility;

đ) Production process;

e) Quality standards and testing methods;

h) Commitment that exported drugs will not be sold in Vietnam;

i) Commitment not to violate intellectual property law regulations as prescribed in Appendix XII attached hereto.

Article 4. Requirements for Contract Manufacturing and Repackaging of Veterinary Drugs

1. Only veterinary drugs with valid circulation certificates in Vietnam or veterinary drugs without circulation certificates in Vietnam intended for export may be contract manufactured or repackaged.

2. The contractor must be a production facility certified by the Department of Animal Health with a Good Manufacturing Practice (GMP) certificate or a certificate of compliance with production conditions suitable for the registered veterinary drug contract manufacturing or repackaging.

Article 5. Contract for Contract Manufacturing and Repackaging of Veterinary Drugs

The contract for contract manufacturing and repackaging of veterinary drugs must be in writing and comply with current Vietnamese laws, in addition to containing the following contents:

1. Agreement on the supply of raw and auxiliary materials, provision of production processes, technical standards, and testing methods for raw and auxiliary materials, intermediates, finished products, and other relevant documents related to contract manufacturing and repackaging.

2. Rights and responsibilities of each party regarding quality inspection of raw and auxiliary materials, intermediates, finished products, packaging procedures, and labeling of products, clearly stipulating the signing of batch test reports and release certificates for finished products.

3. Rights and responsibilities of each party regarding the retention of production records, quality inspection records, distribution, circulation of drugs, storage of drug samples, resolution of issues related to quality, complaints, and market product recalls.

Article 6. Provisions on language and form of application files

1. Language used in registration files

a) Registration files for veterinary drugs produced domestically must be written in Vietnamese;

b) Registration files for veterinary drugs produced abroad must be written in Vietnamese or English. In cases where the file is written in English, information in the drug usage guide, product summary characteristics must be written in Vietnamese.

2. Form of application files

a) For submission of registration files for veterinary drugs through postal service or directly[7] must be drafted on A4 paper size, securely bound. The file must have a cover page and table of contents, arranged according to the correct sequence of the table of contents, with clear separation between sections. Separation sections must be numbered for easy reference; each veterinary drug must have its own registration file;

b) Types of Good Manufacturing Practice certificates, ISO certificates, certificates of eligibility for veterinary drug production, certificates of eligibility for veterinary drug import, quality analysis reports (CoA), product circulation certificates (CFS, CPP, MA), production processing contracts, veterinary drug distribution agreements included in the registration file may be submitted in original or certified copies by the registering enterprise.

3[8]. Forms of submitting application files include online, through postal service, or directly.

Article 7. Naming of veterinary drugs

1. The Ministry of Agriculture and Rural Development encourages registration entities to use international nonproprietary names (INN) for drug names.

2. In cases where drug names are not based on INN, the registration entity can name the drug as a trade name. The trade name of veterinary drugs must comply with the following principles:

a) Not overstating the therapeutic effects of the drug;

b) Not misstating the therapeutic effects and pharmacological actions of the drug;

c) Not violating Vietnamese customs, traditions, and aesthetics;

d) Not conflicting with intellectual property rights of other individuals or organizations that are protected;

đ) Not being identical or similar to the names of drugs already registered by other entities;

e) Not naming different drugs with the same name if they have different active ingredients;

g) Not naming the same drug differently if they have the same formulation and production process from the same manufacturer.

Article 8. Review of application files, issuance of veterinary drug circulation certificates, and response deadlines

1. Review of application files, issuance of veterinary drug circulation certificates

a) The Department of Animal Health receives registration files for circulation, reviews the files, convenes a specialized scientific council on veterinary drugs, issues veterinary drug circulation certificates according to the model prescribed in Appendix IX attached to this Circular, and submits to the Ministry of Agriculture and Rural Development for recognition and inclusion in the list of permitted veterinary drugs circulating in Vietnam.

The specialized scientific council on veterinary drugs is established by the Director of the Department of Animal Health. The council meets at least once every three months to evaluate the results of the file review, testing, and trials, and recommends to the Director of the Department of Animal Health to issue veterinary drug circulation certificates;

b) For veterinary drugs that already have circulation certificates in Vietnam and are registered for production processing or distribution, the Department of Animal Health reviews the registration files, issues circulation certificates for processed or distributed veterinary drugs according to the model prescribed in Appendix XIII attached to this Circular; submits to the Minister of Agriculture and Rural Development for recognition and inclusion in the list of permitted veterinary drugs circulating in Vietnam. For veterinary drugs without circulation certificates in Vietnam produced for export, the Department of Animal Health reviews the registration files, issues circulation certificates for exported veterinary drugs according to the model prescribed in Appendix XIV attached to this Circular or as required by the importing country.

2. Validity of veterinary drug circulation certificates

a) Veterinary drug circulation certificates are valid for five years from the date of issuance;

b) Circulation certificates for processed or distributed veterinary drugs are valid for the duration of the production processing or distribution contract plus the product's shelf life, but not exceeding five years from the date of issuance.

3. Time limit for response

a) Within ten days from the date of receipt of the registration file, the Department of Animal Health has the responsibility to notify the registering organization or individual to complete the file for cases where the file does not meet requirements;

b) The Department of Animal Health has the responsibility to review the file and respond within the following timeframes: twenty days from the date of receipt of a valid file for export production, processing, or distribution registration; forty days from the date of receipt of a valid file for registration of drugs exempted from trials, biological preparations for diagnosis; six months from the date of receipt of a valid file for new drug, vaccine, antibody, or herbal medicine registration.

Article 9. Documents for reissuing the veterinary drug circulation certificate

1. Changes in the composition, formula, preparation form, route of administration, dosage, therapeutic indication of veterinary drugs; changes in production methods and procedures that affect product quality; re-evaluation of the quality, efficacy, and safety of veterinary drugs as prescribed. The documents for reissuing the veterinary drug circulation certificate shall be carried out according to the provisions of Article 3 of this Circular.

2. Loss, error, damage; change or supplement of product name; name and registration address of the establishment; name and production address of the establishment; packaging specifications of the product; label format; expiration date and discontinuation time of the drug; contraindications; treatment regimen; changes that do not affect the quality, efficacy, and safety of veterinary drugs. The documents include: Application for reissuing the veterinary drug circulation certificate according to the model prescribed in Appendix IV attached to this Circular; evidence proving the changed content; old and new label samples; veterinary drug circulation certificate already issued (original or certified copy by the registering enterprise), except in cases of loss.

Article 10. Documents for extending the veterinary drug circulation certificate

1. Extension application for the veterinary drug circulation certificate according to the model prescribed in Appendix V attached to this Circular.

2. Copy of the valid veterinary drug circulation certificate.

3. Certificate of Good Manufacturing Practice (GMP) or ISO certification or certificate of compliance with conditions for producing veterinary drugs or certificate of compliance with conditions for importing veterinary drugs; circulation certificate issued by the competent authority of the country of production for imported drugs.

4. Product quality analysis report from the production facility or from the designated veterinary drug testing agency in Vietnam issued within 12 months from the date of submission of the documents for pharmaceuticals, chemicals, biological products;[9] for pharmaceuticals, chemicals, biological products; product quality analysis reports from the production facility and from the designated veterinary drug testing agency in Vietnam issued within 12 months from the date of submission of the documents[10] for vaccines, antibodies.

5. Contract for manufacturing, processing, or sharing veterinary drugs between the commissioning party and the receiving party for processed or shared drugs.

6. Report on product stability under storage conditions.

7. Circulation report of the drug according to the model prescribed in Appendix VI attached to this Circular.

Section 2. TESTING OF VETERINARY DRUGS

Article 11. Cases where veterinary drugs are exempted from testing

1. Veterinary drugs produced based on original drugs, generic drugs for pharmaceuticals, chemicals, biological products; imported veterinary drugs excluding vaccines, antibodies that have been approved for circulation in the United States, Japan, Australia, Canada, and Europe.

2. Based on the ability to produce veterinary drugs in other countries outside the scope defined in Clause 1 of this Article, the Department of Animal Health will consider submitting to the Minister of Agriculture and Rural Development for supplementation of countries whose veterinary drugs are exempted from testing.

Article 12. Requirements for test animals

1. Suitable species, sex, age, and weight for the intended use of the drug.

2. Clinically healthy for vaccines, antibodies.

3. Free from antibodies corresponding to the type of vaccine or antibody being tested.

Article 13. Criteria for testing veterinary drugs in the form of pharmaceuticals, chemicals, biological products (excluding vaccines and antibodies)

1. Safety criteria

a) For animal species designated for drug use: animals do not die and develop normally;

b) For aquaculture environment: DO, pH, clarity;

c) Residue criteria for animal products: pre-harvest or slaughter withdrawal period.

2. Efficacy criteria for animal species designated for drug use

a) Condition of animals after testing: animals no longer exhibit clinical symptoms of disease;

b) Proportion of animals cured after testing.

3. Other technical criteria (listed in the registration dossier).

Article 14. Scale and duration of testing for veterinary drugs in the form of pharmaceuticals, chemicals, biological products (excluding vaccines and antibodies)

1. Testing scale

a) For terrestrial animals: at least 300 poultry; at least 40 pigs; at least 20 cattle, buffalo, goats, sheep, horses, dogs, cats; other livestock quantities determined by the Department of Animal Health and recorded in the test permit;

b) For aquatic animals: conduct tests under laboratory conditions and in at least three breeding ponds or cages.

2. Duration of testing is determined based on the treatment regimen of the drug.

Article 15. Criteria for testing vaccines and antibodies

1. Safety criteria for animal species designated for use according to the technical file of the drug.

2. Efficacy criteria for animal species designated for use.

a) Proportion of animals with antibody levels reaching protective thresholds after injection;

b) Protection rate.

3. Other technical criteria (listed in the registration dossier).

Article 16. Scale and duration of testing for vaccines and antibodies

1. Testing scale

a) Poultry at least 300; pigs at least 40; cattle, buffalo, goats, sheep, horses, dogs, cats at least 20; fish at least 1000;

b) In special cases, the number of animals for testing is specifically defined in the test permit;

c) The determination of the number of serum samples for antibody testing must ensure reliable statistical biological results.

2. Duration of testing is determined for each type of vaccine and antibody.

Article 17. Criteria and scale of testing for diagnostic biological products (test kits)

1. Criteria according to the manufacturer's basic standards, including:

a) Analytical sensitivity;

b) Specificity.

2. Testing scale: Conducted in laboratories, at least 30 reactions for each product type.

Article 18. Registration and reissuance of test permit for veterinary drugs

1. Application forms for registration and reissuance of test permits for veterinary drugs according to the model prescribed in Appendix XV, XVII issued together with this Circular.

2. Report on the assessment of facilities meeting the testing conditions as stipulated in Clause 2, Article 45 of this Circular.

3. Technical documentation for each type of tested drug includes:

a) Summary characteristics of the product according to the model prescribed in Appendix VIII issued together with this Circular;

b) Technical information about the quality of the product;

c) Technical information about the safety and efficacy of the product;

d) Quality analysis report of the product by the manufacturer (original or certified copy by the registering entity);

đ) Quality analysis report of the product by the designated veterinary drug testing agency in Vietnam (original or certified copy by the registering entity);

e) Test plan;

g) Testing contract between the registering entity and the testing entity (original or certified copy by the registering entity).

Article 19. Veterinary drug testing permit and report on testing results

1. The model of veterinary drug testing permit shall be in accordance with the form prescribed in Appendix XVI attached to this Circular.

2. The entity registering for testing shall report to the Department of Animal Health the testing results not later than fifteen days from the date of completion of the testing process. The report shall be based on the testing outline, including the contents prescribed in Appendix XVIII attached to this Circular and shall be confirmed by the supervising unit.

Section 3. PRODUCTION, SALE, IMPORT OF VETERINARY DRUGS

Article 20. Registration for issuance, extension, reissuance of certificates of compliance for veterinary drug production conditions and methods for evaluating the suitability of veterinary drug products

[11]

1. The application form for registration for issuance, extension, reissuance of certificates of compliance for veterinary drug production conditions shall be in accordance with the form prescribed in Appendices XIX and XXXI attached to this Circular.

2. A detailed description of the material and technical facilities for veterinary drug production shall be in accordance with the form prescribed in Appendix XXI attached to this Circular.

3. The model of inspection record for veterinary drug production conditions and the model of certificate of compliance for veterinary drug production conditions shall be in accordance with the forms prescribed in Appendices XXIII and XXV attached to this Circular.

4. The application form for registration for issuance, extension, reissuance of certificates of good manufacturing practices for veterinary drugs shall be in accordance with the forms prescribed in Appendices XXVIII and XXXI attached to this Circular; the model of inspection record for good manufacturing practices for veterinary drugs and the model of certificate of good manufacturing practices for veterinary drugs shall be in accordance with the forms prescribed in Appendices XXIX and XXX attached to this Circular.

5[12]The evaluation of the suitability of domestically produced veterinary drug products shall be conducted according to Method 1 (Typical Sample Testing) prescribed in Circular No. 28/2012/TT-BKHCN dated December 12, 2012 of the Minister of Science and Technology on the announcement of conformity and compliance and methods for evaluating conformity with standards and technical regulations (hereinafter referred to as Circular No. 28/2012/TT-BKHCN).

6[13]Online inspection and evaluation shall be carried out in cases where natural disasters occur or measures must be taken to prevent and control dangerous diseases, making it impossible to conduct direct inspections and evaluations at the site to issue certificates of compliance for veterinary drug production conditions. Direct inspections at the site will be conducted after localities have controlled natural disasters and diseases in accordance with regulations; certificates shall be immediately revoked for entities and individuals violating laws and dealt with according to legal provisions.

Article 21. Registration for issuance, extension, reissuance of certificates of compliance for veterinary drug sale and import conditions

1. The application form for registration for issuance, extension, reissuance of certificates of compliance for veterinary drug sale and import conditions shall be in accordance with the form prescribed in Appendices XX and XXXI attached to this Circular.

2. A detailed description of the material and technical facilities for veterinary drug sale and import shall be in accordance with the form prescribed in Appendix XXII attached to this Circular.

3. The model of inspection record for veterinary drug sale and import conditions and the model of certificate of compliance for veterinary drug sale and import conditions shall be in accordance with the forms prescribed in Appendices XXIV, XXVI, and XXVII attached to this Circular.

4[14]When importing veterinary drugs or raw materials for veterinary drug production for business purposes, if the veterinary drug production entity already has a Good Manufacturing Practice (GMP) certificate or a certificate of compliance for veterinary drug production conditions issued by the Department of Animal Health that is still valid, they do not need to go through the procedure for obtaining a certificate of compliance for veterinary drug import conditions for the same type of veterinary drug currently permitted for production.

5[15]Online inspection and evaluation shall be carried out in cases where natural disasters occur or measures must be taken to prevent and control dangerous diseases, making it impossible to conduct direct inspections and evaluations at the site to issue certificates of compliance for veterinary drug sale and import conditions. Direct inspections at the site will be conducted after localities have controlled natural disasters and diseases in accordance with regulations; certificates shall be immediately revoked for entities and individuals violating laws and dealt with according to legal provisions.

Section 4. IMPORT OF VETERINARY DRUGS AND RAW MATERIALS FOR VETERINARY DRUGS

Article 22. Registration for Importing Veterinary Drugs and Raw Materials for Veterinary Drugs

1. The import dossier for veterinary drugs without a certificate of circulation to prevent and control animal diseases, to mitigate the consequences of natural disasters includes:

a) An application form for importing veterinary drugs according to the model prescribed in Appendix XXXII issued together with this Circular. At the same time, send via email (Word or Excel version).

b) A copy of the business registration certificate or enterprise registration certificate or investment permit of the organization or individual applying for the import permit for veterinary drugs, corresponding to their business activities.

c) Certificate of Good Manufacturing Practice (GMP) or Quality Management System Certification (ISO) or other equivalent certificates for certain common chemicals.

d) Product Circulation Certificate (CFS, CPP, MA) issued by the competent authority of the exporting country.

đ) Product Quality Analysis Certificate (CoA) from the manufacturer.

e) Product label.

2. The import dossier for veterinary drug samples for testing, trial, and registration for circulation includes:

a) An application form for importing veterinary drugs according to the model prescribed in Appendix XXXII issued together with this Circular. At the same time, send via email (Word or Excel version).

b) A copy of the business registration certificate or enterprise registration certificate or investment permit of the organization or individual applying for the import permit for veterinary drugs for organizations importing for the first time.

c) Certificate of Good Manufacturing Practice (GMP) or Quality Management System Certification (ISO) or other equivalent certificates for certain common chemicals.

d) Product Circulation Certificate (CFS, CPP, MA) issued by the competent authority of the exporting country.

đ) Product Quality Analysis Certificate (CoA) from the manufacturer.

e) [16]Summary of product characteristics according to the model prescribed in Appendix VIII issued together with this Circular.

3[17].  The import dossier for veterinary drugs for participating in exhibitions, fairs, scientific research, treating rare animals includes:

a) An application form for importing veterinary drugs according to the model prescribed in Appendix XXXII issued together with this Circular. At the same time, send via email (Word or Excel version).

b) A copy of the business registration certificate or enterprise registration certificate or investment permit of the organization or individual applying for the import permit for veterinary drugs for organizations importing for the first time.

c) A copy of documentation proving the purpose of importing veterinary drugs.

d) Product Quality Analysis Certificate (CoA) from the manufacturer.

đ)[18]Summary of product characteristics according to the model prescribed in Appendix VIII issued together with this Circular;

e) Product label.

4. The import dossier for veterinary drugs to treat animals temporarily imported for re-export, transiting through Vietnam; temporarily imported for processing and export under contracts signed with foreign organizations and individuals, includes:

a) An application form for importing veterinary drugs according to the model prescribed in Appendix XXXII issued together with this Circular. At the same time, send via email (Word or Excel version).

b) Product Quality Analysis Certificate (CoA) from the manufacturer.

c) A copy of documentation proving the purpose of importing veterinary drugs.

d) Product label.

5. The import dossier for raw materials, veterinary drugs, and microorganisms for researching and producing veterinary drugs, diagnosing, testing, and veterinary inspection includes:

a) An application form for importing veterinary drugs according to the model prescribed in Appendix XXXII issued together with this Circular. At the same time, send via email (Word or Excel version).

b) A copy of the business registration certificate or enterprise registration certificate or investment permit of the organization or individual applying for the import permit for veterinary drugs for organizations importing for the first time.

c) Product Quality Analysis Certificate (CoA) from the manufacturer.

d)[19]Summary of product characteristics according to the model prescribed in Appendix VIII issued together with this Circular;

đ) Product label.

6. The import dossier for veterinary drugs donated by international organizations and other non-commercial imports.

a) An application form for importing veterinary drugs according to the model prescribed in Appendix XXXII issued together with this Circular. At the same time, send via email (Word or Excel version).

b) A copy of the business registration certificate or enterprise registration certificate or investment permit of the organization or individual applying for the import permit for veterinary drugs, corresponding to their business activities.

c) Certificate of Good Manufacturing Practice (GMP) or Quality Management System Certification (ISO) or other equivalent certificates for certain common chemicals.

d) Product Circulation Certificate (CFS, CPP, MA) issued by the competent authority of the exporting country.

đ) Product Quality Analysis Certificate (CoA) from the manufacturer.

e) Product label.

7.[20]The import dossier for raw materials for veterinary drugs (excluding the import dossier for raw materials for veterinary drugs that are solvents and excipients, which include the documents specified in points a, d, đ of this clause), includes:

a) An application form for importing veterinary drugs according to the model prescribed in Appendix XXXII issued together with this Circular. At the same time, send via email (Word or Excel version).

b) Certificate of Good Manufacturing Practice (GMP) or Quality Management System Certification (ISO) or other equivalent certificates for certain common chemicals.

c) Product Circulation Certificate (CFS, CPP, MA) issued by the competent authority of the exporting country.

d) Product Quality Analysis Certificate (CoA) from the manufacturer.

đ) A copy of the certificate of eligibility for importing veterinary drugs of the establishment applying for the import permit issued by the Department of Animal Health for establishments importing raw materials for veterinary drugs for the first time.

e) Report on the quantity, purpose of using antibiotic raw materials, address of the establishment purchasing antibiotic raw materials of the previous batch of antibiotic raw materials imported, when submitting the application for importing the next batch of antibiotic raw materials to the Department of Animal Health according to the model prescribed in Appendix XXXIV issued together with this Circular.

8. The import dossier for vaccines and microorganisms listed in the Catalogue of Veterinary Drugs Permitted for Circulation in Vietnam or already having a circulation certificate in Vietnam includes:

a) An application form for importing vaccines and microorganisms according to the model prescribed in Appendix XXXIII issued together with this Circular. At the same time, send via email (Word or Excel version).

b) A copy of the certificate of eligibility for importing veterinary drugs of the establishment applying for the import permit issued by the Department of Animal Health for organizations importing for the first time.

9. The GMP, ISO, CFS, CPP, MA, CoA certificates accompanying the registration dossier may be submitted in original or certified copies stamped by the registering enterprise.

10. The import permit for veterinary drugs and raw materials for veterinary drugs is valid for a maximum of one year from the date of issuance.

Chapter III

LABELING OF VETERINARY DRUGS

Article 23. Types of veterinary drugs that must be labeled

1. Drugs circulating domestically; drugs for export and import must be labeled in accordance with the provisions of this Circular, except for cases specified in Clause 2 of this Article.

2. In cases where foreign organizations or individuals importing Vietnamese drugs require labeling according to the purchase and sale contract and bear responsibility for their requirements, the exporting organization or individual may implement according to the contract provided that these requirements do not alter the nature of the drug, do not violate Vietnamese laws and the laws of the importing country.

Article 24. Responsibilities for labeling veterinary drugs

1. For veterinary drugs produced in Vietnam for domestic circulation, the organization or individual producing the drug shall be responsible for the labeling.

2. For veterinary drugs produced in Vietnam for export, the organization or individual exporting the drug shall be responsible for the labeling.

3. In cases where veterinary drugs already having a certificate for circulation in Vietnam cannot be exported and are returned to domestic circulation, the organization or individual bringing the drug into circulation shall label it in accordance with the provisions of Article 26 of this Circular.

4. In cases where the organization or individual responsible for labeling the drug according to the provisions of Article 9 of Decree No. 43/2017/ND-CP dated April 14, 2017 of the Government on product labels (hereinafter referred to as Decree No. 43/2017/ND-CP)[21] requests another organization or individual to perform the labeling, that organization or individual still bears responsibility for the label of the drug.

5. Veterinary drugs imported into Vietnam with original labels that do not comply with the provisions of this Circular, the importing organization or individual must affix additional labels in accordance with Clause 3 of Article 26 of this Circular before putting them into circulation and must retain the original label.

6. Organizations and individuals producing and trading in drugs must comply with the provisions of the law on intellectual property and bear legal responsibility for intellectual property issues regarding the contents marked on the drug label.

Article 25. Position, size, color of characters, symbols, and images on the drug label

1. Position of the veterinary drug label

The veterinary drug label must be displayed (printed, affixed, attached, or mounted) on the commercial packaging of the drug at a position that can be easily observed and clearly identify all required label contents without disassembling parts of the drug, in accordance with the provisions of Article 4 of Decree No. 43/2017/ND-CP.[22].

2. Size of the veterinary drug label

The organization or individual responsible for labeling the drug must determine the size of the label but must ensure that all mandatory contents as prescribed in Article 27 of this Circular are fully recorded and easily readable by the naked eye.

3. Color of characters, symbols, and images on the drug label

The colors of letters, numbers, drawings, images, signs, symbols, and markings on the drug label must be clear. For mandatory contents as prescribed, letters and numbers must have contrasting colors compared to the background of the label according to the provisions of Article 6 of Decree No. 43/2017/ND-CP.[23]

Article 26. Languages presented on the drug label

1. Mandatory contents on the veterinary drug label must be recorded in Vietnamese, except for cases specified in Clause 4 of this Article.

2. Veterinary drugs produced and circulated domestically, in addition to complying with the provisions of Clause 1 of this Article, the contents on the label may also be recorded simultaneously in another language. Contents recorded in another language must correspond to the Vietnamese content. The size of the characters in another language must not exceed the size of the characters of the Vietnamese content.

3. Veterinary drugs imported into Vietnam whose original labels do not display or do not sufficiently display mandatory contents in Vietnamese must have additional labels displaying mandatory contents in Vietnamese while retaining the original label of the drug.

4. The following contents may be recorded in other languages based on Latin alphabets:

a) Trade name, generic name, or international nonproprietary name of the drug;

b) International nonproprietary name or scientific name of the components, quantified components of the drug when they cannot be translated into Vietnamese or can be translated but do not make sense in Vietnamese;

c) Name and address of foreign enterprises manufacturing or holding the right to manufacture the drug.

5. The contents recorded on the veterinary drug label, including additional labels and the user guide, must ensure truthfulness, clarity, accuracy, and reflect the true nature of the drug.

Article 27. Content to be recorded on veterinary drug labels

1. Mandatory content to be displayed on veterinary drug labels. The veterinary drug label must include the following information:

a) Name of the veterinary drug;

b) Active ingredient components, quantitative active ingredient components (concentration or dosage);

c) Packaging specifications;

d) Indications, usage methods, contraindications; time to stop using the drug for egg, meat, milk harvesting for each designated animal species;

đ) Formulation type, registration number, production batch number, production date, expiration date, phrase "For veterinary use only";

e) Warning signs: For toxic veterinary drugs in Category A, the phrase (in black font): "Do not exceed prescribed dosage" must be added; for toxic veterinary drugs in Category B, the phrase (in red font): "Do not exceed prescribed dosage" must be added. For prescription veterinary drugs, the Rx symbol must be placed at the top left corner of the drug name and the phrase "Prescription Drug" must be included;[24];

g) Name and address of the organization or individual responsible for the veterinary drug;

h) Origin of the veterinary drug: For veterinary drugs produced in Vietnam for domestic circulation, if the production location's address has already been indicated, it is not mandatory to indicate the origin;

i) Usage instructions, storage instructions

In cases where all the aforementioned contents cannot be displayed, the label must at least include the contents specified in points a, b, c, đ, e, g, h of this Clause. Other mandatory contents must be recorded on secondary labels or in the drug usage guide, with the main label indicating where these contents are recorded.

2. Additional content that may be displayed on veterinary drug labels

Besides the mandatory contents stipulated in Clause 1 of Article 27 of this Circular, additional information such as quality standard codes can be added to the label. Such information must be truthful and accurate, without misleading the nature or efficacy of the drug, nor misrepresenting other label contents.

3. Content to be recorded on labels of raw materials for veterinary drugs. Labels of raw materials for veterinary drugs must include the following information:

a) Name of the raw material;

b) Concentration or dosage (if applicable);

c) Raw material standards;

d) Net weight or volume;

đ) Production batch number, production date;

e) Expiration date, storage conditions;

g) Registration number (if applicable);

h) Name and address of the production facility;

i) Origin of the raw material (for raw materials produced in Vietnam for domestic circulation, if the production location's address has already been indicated, it is not mandatory to indicate the origin);

k) Name and address of the importing facility for imported raw materials;

l) Warning signs.

4. Content to be recorded on blister pack labels of veterinary drugs. Blister pack labels of veterinary drugs must at least include the following information:

a) Name of the veterinary drug;

b) Active ingredients, concentrations: for combined veterinary drugs containing three or fewer active ingredients, all active ingredients and their respective concentrations must be listed;

c) Production batch number, expiration date, registration number;

d) Name of the production facility. The name of the production facility may be abbreviated but must ensure that the name of the production facility is recognizable.

Blister packs must be contained within outer packaging that fully displays the contents required under Clause 1 of Article 27 of this Circular.

5. Content to be recorded on direct package labels with small dimensions

a) For direct package labels of veterinary drugs with small dimensions and special designs that cannot display all mandatory contents as stipulated in Clause 1 of Article 27 of this Circular, the minimum required contents are: name of the veterinary drug; active ingredients, concentrations: for combined veterinary drugs containing three or fewer active ingredients, all active ingredients and their respective concentrations must be listed; volume or weight; production batch number, expiration date, registration number; abbreviated name of the production facility but must ensure recognizability;

b) Direct packages containing various types of veterinary drugs must be contained within outer packaging that fully displays the contents required under Clause 1 of Article 27 of this Circular.

Article 28. Labeling of Veterinary Medicines

1. Name of veterinary medicine

a) The name of the veterinary medicine shall be self-assigned by organizations or individuals producing and trading veterinary medicines. The name must not mislead about the nature and efficacy of the medicine. The writing of the name on the label must be bold and prominent.

In cases where the brand name is a single substance, the generic name or international non-proprietary name must be immediately recorded after the brand name;

b) The name may be based on: the generic name; the international non-proprietary name (INN); the brand name.

2. Active ingredients, dosage or concentration

a) Record all active ingredients and excipients used to produce and exist in the finished product, including cases where the form of raw materials has been changed during production as stipulated in Clause 1, Article 16 of Decree No. 43/2017/NĐ-CP;[25];

b) Record all active ingredients, dosages or concentrations for the smallest unit of dose or smallest unit of packaging, without necessarily recording the components and dosage of excipients. The name of the active ingredient must be recorded according to the generic name or international non-proprietary name;

c) Units of measurement

Record units of measurement on the label using either the full name or symbol of the unit of measurement. International units of activity can be used for certain special active ingredients as prescribed.

3. Packaging specifications

a) Recording packaging specifications of the medicine involves recording the quantity, net weight, actual volume contained in the commercial packaging of the medicine;

b) Packaging specifications of the medicine must be recorded according to natural counting;

c) Specific recording methods for some types and forms of veterinary medicines are as follows: veterinary medicine in tablet form: record the number of tablets and the active ingredient content of each tablet; veterinary medicine in powder form: record the net weight; veterinary medicine in liquid form: record the actual volume; animal stimulants and other active ingredients: record in International Units (IU or UI);

d) In cases where there are multiple units of packaging within one commercial package of the medicine, the dosage of each unit of packaging and the number of units of packaging must be recorded.

4. Indications, usage, contraindications, and withdrawal period

a) The treatment indications for each species of animal recorded on the label must be consistent with the efficacy of the medicine;

b) Usage must clearly record the route of administration, dosage, and duration of use;

c) Contraindications must clearly record the situations in which the medicine should not be used;

In cases where there are no contraindications, it must be clearly stated that there are none;

d) Indications, usage, and contraindications can be recorded in one of two ways: directly on the commercial packaging of the medicine or, if the label area on the outer packaging is insufficient to record these contents, the label must include the phrase "Indications, usage, contraindications: please read in the instructions for use" and must provide an instruction leaflet attached to the commercial packaging of the medicine;

e) Withdrawal period: record the detailed withdrawal period for each species of animal designated for use. In cases where there is no withdrawal period, it must be clearly stated that there is none.

The withdrawal period must correspond to the time recorded in the registration dossier.

5. Formulation, circulation registration number, batch number, date of manufacture, expiration date, storage conditions

a) The formulation of veterinary medicines records: tablets, powders, injectable solutions, injectable suspensions, injectable powders, oral solutions, and other formulations;

b) The circulation registration number is a code issued by the Department of Animal Health to certify that a veterinary medicine product has been registered for circulation in Vietnam;

c) Batch number, recorded as follows: Batch Number or Production Batch Number. The structure of the batch number is determined by the manufacturer;

d) The method of recording day, month, year for the date of manufacture, expiration date, and specific storage period is as follows: the date of manufacture and expiration date on the label must be fully recorded or abbreviated in uppercase letters as: NSX, HSD, in the order of day, month, year of the Gregorian calendar. Each digit representing day, month, or year is recorded in two digits, and the year may be recorded in four digits. The digits representing day, month, and year of a specific time point must be recorded on the same line; the method of recording day, month, year for the date of manufacture and expiration date is stipulated in Article 14 of Decree No. 43/2017/NĐ-CP;[26]if the characters "NSX", "HSD" cannot be recorded together with the digits representing day, month, and year, then guidance must be provided on the label; if the date of manufacture and expiration date are recorded in a foreign language on the label, then a supplementary label must record: date of manufacture, expiration date or abbreviate in uppercase letters NSX, HSD see “Mfg Date” “Exp Date” on the packaging;

e) Storage conditions are climatic factors to prevent changes in the quality of the medicine. The necessary conditions for storing the medicine must be clearly recorded on the label. For example: Store in a dry, well-ventilated place, temperature not exceeding 30°C.

6. Warning signs

a) Injectable medicines and injectable powder medicines must clearly record the route of administration. The route of administration can be abbreviated: intramuscular injection (IM), subcutaneous injection (SC), intravenous injection (IV);

b) Eye drops and eye ointments must record the phrase "Eye Drops";

c) Topical medicines must record the phrase "For External Use Only";

d) Oral medicines packed in tubes must record the phrase "Not for Injection";

e) For certain chemicals used in veterinary medicine, it is necessary to record specific quality indicators, and if they are flammable, explosive, toxic, corrosive chemicals, additional warnings must be added, and if they are contained in pressurized containers, the container number, filling capacity, and hazard warnings must also be added;

f) On the label of veterinary medicines, any warnings (if applicable) must be recorded to ensure safety when used to treat animals;

g) Method of recording warning signs

Warning signs and words must be printed clearly and prominently to be easily recognizable; if a type of veterinary medicine has multiple warning signs, all such signs must be fully recorded.

7. Name and address of organization or individual responsible for producing the medicine

a) The name and address of the organization or individual responsible for producing the medicine must not be abbreviated;

b) The method of recording the name and address of the organization or individual responsible for the medicine is stipulated in Appendix XXXV accompanying this Circular.

c) In the case where the label includes the name and address of the distribution facility, the name and address of the distribution facility must be printed in the same location as those of the production facility and must not exceed the size of the production facility's name.

d) The name of the organization or individual responsible for the drug must be fully recorded with the name as stated in relevant legal documents concerning the establishment of that facility. A trade name may also be included but must not exceed the size of the full name.

đ) Address of the production facility, packaging facility, franchising facility, manufacturing facility, and distribution facility: record the house number, street (village, hamlet), commune (ward, town), district (city district, provincial city, provincial capital), province (central直辖市或省会城市), 自治区（中央直辖市或自治区）。

8. Origin of veterinary drugs

a) For imported drugs: indicate "produced at" or "origin" followed by the name of the country or territory where the drug was produced.

b) For drugs produced in Vietnam for domestic circulation, if the label already includes the address of the production facility, there is no mandatory requirement to indicate the origin of the drug.

c) The origin of the drug must be indicated on both the outer and direct packaging labels of the drug.

9. Instructions for using veterinary drugs

a) Drugs labeled according to the provisions of this Circular must have a Vietnamese usage guide. The content of the usage guide can be printed directly on the packaging or intermediate label instead of being provided separately.

The font size and color of the text on the usage guide must be large enough and clear to easily read the contents with the naked eye.

b) The content of the drug usage guide is specified in Appendix XXXVI issued together with this Circular.

10. Method of labeling supplementary labels

Supplementary labels must be affixed to the outer packaging of veterinary drugs and must not obscure the original label's content. The content on supplementary labels must not mislead the original label's content, and the organizations or individuals labeling must bear legal responsibility for the accuracy and truthfulness of the additional information. The method of labeling supplementary labels is as follows:

a) If the supplementary label has sufficient area, all mandatory content as stipulated in Clause 1, Article 27 of this Circular must be printed.

b) If the supplementary label has limited space and cannot print all mandatory content, it must at least include the following: drug name; active ingredient, dosage, or concentration; name of the organization or individual responsible for the drug; registration number; packaging specifications; production date, expiration date, batch number; origin of the drug.

Any other mandatory content not included must be printed in the usage guide. In such cases, the supplementary label must include the statement: "Additional information please refer to the accompanying usage guide," and consider the part indicated on the supplementary label as part of the supplementary label.

c) If the original label uses Latin script and the following information is already present on the original label, it is permissible not to translate into Vietnamese and need not be shown on the supplementary label: brand name, generic name, or international nonproprietary name of the drug; international nonproprietary name or scientific name of each component of the drug when it cannot be translated into Vietnamese or can be translated but does not make sense; name and address of foreign enterprises producing or franchising the production of the drug.

Chapter IV

TESTING OF VETERINARY DRUGS

Article 29. Veterinary drug testing system

1. Testing facilities under the Department of Animal Health: The Central Veterinary Drug Testing Center I and the Central Veterinary Drug Testing Center II.

2. Service-providing testing facilities.

Article 30. Activities of veterinary drug testing facilities

1. Testing facilities under the Department of Animal Health:

a) [27]Conduct testing and evaluate the quality of domestically produced, exported, imported, and circulating veterinary drugs nationwide;

b) Test the quality of registered circulating veterinary drugs;

c) Review quality standards for veterinary drugs and other products at the request of the Ministry of Agriculture and Rural Development;

d) Provide testing services;

đ) Other activities as prescribed by relevant laws.

2. Service-providing testing facilities

Conduct testing services for raw materials, semi-finished products during production, and finished veterinary drugs for manufacturing and trading entities to support state management and inspection work on drug quality.

3. Veterinary drug testing facilities must be designated by competent authorities when performing testing activities to serve state management work according to the provisions of the law.

4.[28] Veterinary drug testing facilities have the following responsibilities:

a) Issue test results on the quality of veterinary drugs or conformity assessment results within five working days for raw materials, pharmaceuticals, chemicals, biological preparations tested for sensory, physical, and chemical criteria; fourteen days for raw materials, pharmaceuticals, chemicals, biological preparations tested for microbial contamination and sterility criteria; twenty-one days for vaccines and antibodies tested for sterility or purity and safety criteria; sixty days for vaccines and antibodies tested for efficacy criteria from the date of receiving samples;

b) Retain samples of veterinary drugs from tested batches under storage conditions indicated on the label until the expiration date of the veterinary drugs.

Article 31. Provisions on the application of veterinary drug testing methods

[29]

1. Veterinary drug testing must be conducted according to registered or designated testing methods as prescribed by law.

2. For veterinary drugs without registered, designated, or temporarily designated testing methods, quality evaluation shall be based on the acceptance of testing quality results from the competent authority of the exporting country or accredited laboratories recognized by organizations participating in mutual recognition agreements (MRA) within the Asia Pacific Laboratory Accreditation Cooperation (APLAC); International Laboratory Accreditation Cooperation (ILAC) or reference laboratories of the World Organisation for Animal Health (OIE).

Chapter V

VETERINARY DRUG QUALITY CONTROL

Article 32. Basis for establishing veterinary drug quality standards and basis for veterinary drug quality control

1. Basis for establishing veterinary drug quality standards

a) National technical standards for veterinary drugs;

b) National standards for veterinary drugs;

d)[30]c) Standards in the Vietnamese Pharmacopoeia or international standards: European Union (EU), United Kingdom, United States, Japan. Application must include all provisions on quality criteria, quality levels, and testing methods specified in that pharmacopoeia.

ASEAN standards for veterinary vaccines; World Organisation for Animal Health (OIE) guidelines for diagnosing and testing veterinary vaccines and international standards for veterinary drugs to which Vietnam is a member.

Article 33. State Inspection of Veterinary Drug Quality in Production

1. Inspecting Authority: The Department of Animal Health

2. Basis for Conducting Inspection

a) Information and warnings about exported veterinary drugs that do not comply with conditions stipulated in Article 32 of the Product and Goods Quality Law;

b) Products circulating on the market that do not meet announced standards or corresponding technical regulations through product quality inspection and supervision, or when there are recommendations from competent authorities regarding product quality.

3. Form of Inspection: carried out in the form of an inspection team.

4. Content of Inspection

a) Inspection of compliance with requirements specified in Good Manufacturing Practices (GMP) and other relevant legal provisions;

b) Inspection of drug registration, product stability research, and labeling of veterinary drugs according to regulations;

c) Sampling Cases: During the inspection at production facilities, if products showing signs of non-compliance with quality standards or such signs appear during circulation on the market, samples should be taken for quality testing. The samples must be sent to recognized or designated testing institutions for analysis. The test results from these institutions serve as legal grounds for the inspecting authority to proceed with further actions during the inspection process.

5. Procedure and Formalities for Inspection: implemented according to Clause 3, Article 29 of the Product and Goods Quality Law.

6. Handling Inspection Results: carried out according to Article 30 of the Product and Goods Quality Law.

Article 34. State Inspection of Imported Veterinary Drug Quality

[31]

1. Inspecting Authority: The Department of Animal Health.

2. Inspection Object: Imported veterinary drugs must undergo quality inspection upon entry into Vietnam, except in cases stipulated in Clause 3 of this Article.

3. Cases Where Imported Veterinary Drugs Are Exempted from Quality Inspection:

a) Imported veterinary drugs for testing, trial, and registration for circulation;

b) Imported veterinary drugs for treating animals temporarily imported for re-export or transiting through Vietnam;

c) Imported veterinary drugs used as raw materials for diagnosis, testing, and veterinary inspections;

d) Raw materials for veterinary drugs;

đ) Cases exempted from quality inspection upon importation as stipulated in Clause 3, Article 1 of Decree No. 74/2018/ND-CP dated May 15, 2018, amending and supplementing Decree No. 132/2008/ND-CP dated December 31, 2008, detailing certain provisions of the Product and Goods Quality Law (hereinafter referred to as Decree No. 74/2018/ND-CP);

e) Cases stipulated in Clause 2, Article 4 of Decree No. 154/2018/ND-CP dated November 9, 2018, amending and supplementing, abolishing certain investment and business conditions under the management of the Minister of Science and Technology and some specialized inspection regulations (hereinafter referred to as Decree No. 154/2018/ND-CP).

4. Documents, Procedures, and Content of State Inspection of Imported Veterinary Drug Quality:

a) Implemented according to Clause 3, Article 1 of Decree No. 74/2018/ND-CP; Clause 1, Clause 3, Article 4 of Decree No. 154/2018/ND-CP;

b) A quality certificate is the result of conformity assessment against national technical regulations and announced standards; a quality certificate from the exporting country is a certificate of analysis (CoA) issued by the manufacturer or the competent authority of the exporting country. In cases where there is no recognized or designated conformity assessment organization or the product has not been declared compliant, the quality certificate for the imported batch is the result of product quality testing conducted by a designated laboratory according to the law or acceptance of the manufacturer's test results when there is no designated testing method or acceptance of test results according to Clause 2 of this Circular;

c) For the application for quality inspection of imported batches of vaccines and veterinary antibodies, the importer is responsible for supplementing the quality certificate within 60 days from the date of application.

5.[32] The conformity assessment of imported veterinary drugs shall be carried out according to Method 1 (Typical Sample Testing) stipulated in Circular No. 28/2012/TT-BKHCN.

6. Handling Violations During Inspection: carried out according to Article 36 of the Product and Goods Quality Law.

Article 35.

[33]

(Repealed)

Article 36. State Inspection of Veterinary Drug Quality Circulating in the Market

1. Inspection Authority

a) The Department of Animal Health conducts inspections on veterinary drug quality nationwide;

b) Provincial animal health management agencies conduct inspections on veterinary drug quality at retail stores and distributors within their jurisdiction.

2.[34] The content, procedures, and steps for inspecting the quality of veterinary drugs circulating in the market shall be carried out in accordance with Circular No. 26/2012/TT-BKHCN dated December 12, 2012, issued by the Minister of Science and Technology regarding the inspection of goods' quality circulating in the market, and Circular No. 12/2017/TT-BKHCN dated September 28, 2017, issued by the Minister of Science and Technology amending and supplementing certain provisions of Circular No. 26/2012/TT-BKHCN dated December 12, 2012, issued by the Minister of Science and Technology regarding state inspection of goods' quality circulating in the market.

Article 37. Inspection of Veterinary Drug Production Facilities in Exporting Countries

1. Based on international treaties or agreements on veterinary drugs with the animal health management agencies of exporting countries, the Department of Animal Health decides to establish inspection teams, plans, and contents for on-site inspections of veterinary drug production facilities in exporting countries to Vietnam.

2. Funding for inspections: allocated annually from the state budget according to current regulations and other sources as stipulated by law.

Article 38. State Inspection of Veterinary Drug Quality for Export

1. Inspecting Authority: The Department of Animal Health.

2. Inspection Objectives and Contents

a) Veterinary drugs intended for export registered by the exporter: based on the exporter's requirements;

b) Non-compliant exported veterinary drugs returned: as specified in Clause 4, 5, and 6 of Article 33 of this Circular.

3. Basis for Inspection: announced standards; import country regulations, contracts, or international treaties and mutual recognition agreements on conformity assessment results.

4. Application Documents for Export Product Quality Inspection According to Exporter Requirements Include:

a) A veterinary drug export quality inspection application form as prescribed in Appendix XL attached to this Circular;

b) Announced standards and testing criteria;

c) Quality analysis reports of the designated veterinary drug testing agency in Vietnam for the required testing criteria (original or certified copy).

5. Procedures for Export Product Quality Inspection

a) The exporter directly submits or sends by mail one set of export product quality inspection application documents to the Department of Animal Health;

b) Within five working days from receiving complete applications, the Department of Animal Health will review the documents and notify the results using the model form prescribed in Appendix XLI attached to this Circular.

Chapter VI

PROCEDURES AND REQUIREMENTS FOR THE RECALL AND DESTRUCTION OF VETERINARY DRUGS

Article 39. Recall Procedures for Veterinary Drugs

1. When the competent state authority discovers veterinary drugs that must be recalled according to Clause 1 of Article 105 and Clause 1 of Article 106 of the Law on Animal Health, they must immediately seal the drugs and recommend the competent animal health authority to issue a recall decision.

2. The recall of veterinary drugs found not meeting quality standards through inspection, according to applicable technical regulations and registered standards, shall be conducted as follows:

a) In cases where samples are taken from production or export/import facilities (hereinafter referred to as the facility):

Within 15 days for pharmaceuticals, chemicals, biological products, and 60 days for vaccines and antibodies from the date of sampling, the Department of Animal Health will inform the facility about the test results and request immediate recall of non-compliant batches. Within five working days from receiving the notification, the facility may appeal to the Department of Animal Health regarding the test results. If there is no appeal beyond this period, the Department of Animal Health will issue a national recall decision.[35] In case of appeal, the Department of Animal Health will retest the samples. If the retest results still show non-compliance, the Department of Animal Health will issue a national recall decision; if the retest confirms compliance, the batch can continue to circulate in the market.

b) In cases where samples are taken from retailers in provinces or centrally-administered cities:

Within 15 days for pharmaceuticals, chemicals, biological products, and 60 days for vaccines and antibodies from the date of sampling, the sampling agency will inform the retailer, producer, or importer of the non-compliant batch and immediately seal it. Within five working days from receiving the notification, the facility may appeal to the sampling agency regarding the test results. If there is no appeal or if the retest results still show non-compliance, the sampling agency will issue a recall decision within its jurisdiction and notify the Department of Animal Health and the producer or importer.

Within 15 days for pharmaceuticals, chemicals, biological products, and 60 days for vaccines and antibodies from the date of sampling, the Department of Animal Health will inform the facility about the test results and request immediate recall of non-compliant batches. Within five working days from receiving the notification, the facility may appeal to the Department of Animal Health regarding the test results. If there is no appeal beyond this period, the Department of Animal Health will issue a national recall decision.[36] Upon receiving the notification of non-compliant batches from the sampling agency, the Department of Animal Health will immediately take samples from the production or import facilities for retesting. If the retest results still show non-compliance, the batch will be sealed at the production or import facility. Within five working days from receiving the notification, the facility may appeal to the Department of Animal Health regarding the test results. If there is no appeal beyond this period, the Department of Animal Health will issue a national recall decision.

3. The production, import, and retail facilities whose drugs have been recalled must carry out the recall according to the competent authority's decision. After completing the recall, the facility must report the results to the issuing authority.

4. For nationally-recalled veterinary drugs, the Department of Animal Health will issue a recall decision and notify on its website within 24 hours. The provincial animal health management agency is responsible for supervising the recall within its jurisdiction.

4. For veterinary drugs that must be recalled nationwide, the Department of Animal Health issues a decision to recall and within 24 hours must announce it on the unit's electronic news page, the provincial specialized management agency for animal husbandry is responsible for supervising the recall within its jurisdiction.

5. For veterinary drugs that must be recalled within the province or city, the provincial specialized veterinary management agency shall issue a recall decision and must notify on the unit's electronic news page within 24 hours, while also being responsible for supervising the recall within its jurisdiction.

Article 40. Handling of Recalled Veterinary Drugs

1. For veterinary drugs with certificates of circulation in Vietnam but with labels not in compliance with legal regulations or failing to meet registered quality standards, the entity responsible for the veterinary drugs shall immediately carry out the recall and handling as follows:

a) Recall and destroy veterinary drugs violating quality level 1, including: active ingredients not in accordance with registration; drugs altered in form (clumping, turbidity, color change, sedimentation, layering, deformation); drugs without active ingredients or lacking the main active ingredient listed on the label; vaccines failing to meet one of the three criteria: sterility or purity, safety, efficacy; drugs subject to urgent recall by foreign regulatory authorities for imported drugs;

b) Recall, recycle, or re-export veterinary drugs violating quality level 2, including: drugs failing to meet one of the quality standard criteria registered (sensory; physical and chemical; bacterial contamination, sterility; drug content outside the permitted range ±10% compared to the labeled content, for veterinary drug products containing probiotics, probiotic content lower than 90% of the labeled content; net weight or volume outside the permitted range according to the current Vietnamese Pharmacopoeia);

c) Recall and correct labeling errors for veterinary drugs with labels not in compliance with legal regulations on product labeling;

d) In cases where veterinary drugs as specified in point b of this clause cannot be recycled or re-exported, they must be destroyed.

3. Entities required to destroy veterinary drugs must carry out destruction in accordance with hazardous waste management regulations under environmental protection laws and bear all costs.

4. The competent state authority decides on the destruction of veterinary drugs and issues a decision to establish a destruction committee for veterinary drugs. The committee includes the lead agency for destruction, representatives from the specialized veterinary management agency, and representatives from the natural resources and environment agency.

Chapter VII

ADVERTISING OF VETERINARY DRUGS

Article 41. Content of Advertising for Veterinary Drugs

1. Advertising for veterinary drugs must include the following contents except as provided in Clause 2 of this Article:

a) Trade name and formulation of the veterinary drug;

b) Uses and precautions for use and storage of the veterinary drug;

c) Name and address of the organization or individual registering and distributing the drug.

2. The content of advertising for veterinary drugs on boards, signs, billboards, price shelves, other objects, objects in the air, underwater, mobile objects, electronic devices, terminal devices, and other telecommunications equipment, means of transportation, and product carriers does not necessarily have to contain all mandatory contents.

3. The content of advertising for veterinary drugs must be confirmed by the competent authority as stipulated in Article 42 of this Circular.

Article 42. Authority to Issue Certificates Confirming Advertising Content for Veterinary Drugs

1. The Department of Animal Health shall issue certificates confirming the content of advertising for veterinary drugs for press, electronic information pages, electronic devices, terminal devices, and other telecommunications equipment, printed products, audio recordings, video recordings, and other technological products at the central level and nationwide distribution.

2. The provincial specialized veterinary management agency shall issue certificates confirming the content of advertising for veterinary drugs for the following advertising media:

a) Press, electronic information pages, electronic devices, terminal devices, and other telecommunications equipment, printed products, audio recordings, video recordings, and other technological products at the local level;

b) Advertising boards, banners, signs, light boxes, dedicated advertising screens;

c) Means of transportation;

d) Trade fairs, seminars, conferences, event organizations, exhibitions, cultural and sports programs;

đ) Product carriers, advertising objects;

e) Other advertising media as prescribed by law.

Article 43. Documents, procedures, and formalities for issuing a certificate confirming the content of veterinary drug advertisements

1. Submitting application

a) Organizations and individuals submit the documents directly or send them via postal service to the competent state agency as prescribed in Article 42 of this Circular;

b) Number of sets of documents: 01 set.

2. Documents

a) A request form for confirmation of the content of veterinary drug advertisements according to the model prescribed in Appendix XLII issued together with this Circular;

b) A copy of the registration certificate for veterinary drugs;

c) The advertised product (the advertisement content and form are presented through images, sound, voice, writing, symbols, color, light, and similar forms);

d) A list of speakers providing complete information about their professional qualifications or scientific titles for the case of trade fairs, seminars, conferences, event organizations, exhibitions, cultural and sports programs (stamped with the confirmation seal of the enterprise);

3. Examination of documents and issuance of a certificate confirming the content of veterinary drug advertisements

a) Within five working days from the date of receiving the application for confirmation of the content of veterinary drug advertisements, the competent state agency prescribed in Article 42 of this Circular shall notify the organization or individual applying for the purpose of completing the documents in cases where the requirements are not met;

b) Within ten days from the date of receiving all valid documents, the competent state agency prescribed in Article 42 of this Circular shall issue a certificate confirming the content of veterinary drug advertisements according to the model prescribed in Appendix XLIII issued together with this Circular. In cases where the certificate is not issued, the competent state agency must provide a written response and specify the reasons for non-issuance.

Chapter VIII

RESPONSIBILITIES OF THE PARTIES INVOLVED

Article 44. Veterinary Administration Bureau

1. Directing and guiding professional matters related to veterinary drug management; inspecting the quality of veterinary drugs at production facilities, import-export, trading, and circulation on the market.

2. Examining documents, evaluating, and recognizing facilities meeting the conditions for producing and importing veterinary drugs.

3. Examining documents and issuing a permit for veterinary drug trials.

4. Examining documents and issuing a certificate of circulation for veterinary drugs.

5. Organizing inspections and quality checks of veterinary drugs, responsibilities, and authorities of agencies under the Veterinary Administration Bureau, provincial specialized veterinary management agencies in managing veterinary drugs. Develop annual plans to check the quality of veterinary drugs circulating on the market.

6. Annually, develop plans for managing and monitoring imported antibiotic raw materials for veterinary drug production to be submitted to the Ministry of Agriculture and Rural Development for approval.

7. Receiving and examining the content of veterinary drug advertisements within the authority prescribed in Clause 1, Article 42 of this Circular; issuing certificates confirming the content of advertisements.

Article 45. Agencies under the Veterinary Administration Bureau

1. Conduct inspections on the quality of imported and circulating veterinary drugs.

2[37]. Evaluate the conditions of veterinary drug trial facilities according to Article 88 of the Law on Animal Husbandry, Article 20 of Decree No. 35/2016/NĐ-CP dated May 15, 2016, and Clause 5, Article 2 of Government Decree No. 123/2018/NĐ-CP dated September 17, 2018 amending and supplementing certain decrees on investment and business conditions in the agricultural sector (hereinafter referred to as Decree No. 123/2018/NĐ-CP), upon request of the Veterinary Administration Bureau.

3. Supervise the process of veterinary drug trials according to the trial permit; confirm the report on the results of veterinary drug trials.

Article 46. Provincial veterinary management agency

1. Carry out quality inspection of veterinary drugs within the area under management in accordance with regulations.

2. Organize training and disseminate legal provisions on the production, trading, and use of veterinary drugs for relevant organizations and individuals.

3. Supervise the testing process of veterinary drugs (excluding vaccines and antibodies) according to the drug testing permit; confirm the report on the results of veterinary drug testing.

4. Review registration files, assess and recognize establishments meeting conditions for trading veterinary drugs.

5. Receive and review the content of advertisements for veterinary drugs within the authority stipulated in Clause 2, Article 42 of this Circular; issue certificates confirming advertisement content.

6. Summarize and report on the situation of trading, quality inspection, use, inspection and supervision results, and handling of violations of veterinary drugs within the managed area to the Department of Animal Health every six months and annual comprehensive reports or ad hoc reports as required by the Department of Animal Health.

Article 47. Establishment registering drug testing

1. Develop a testing outline;

2. Sign a veterinary drug testing contract with the testing establishment and fully implement all terms of the signed contract.

Article 48. Establishment registering circulation of veterinary drugs

1. Bear responsibility before the law and consumers for the quality of veterinary drugs produced, circulated, and distributed by the establishment.

2. Be subject to inspection and audit by state agencies with competent authority.

3. Report on the situation of producing and trading veterinary drugs to the management agency when requested.

4. Notify the animal health management agency in case of dissolution or discontinuation of production of registered products.

5. Be entitled to transfer research results; testing results, and transfer product copyright in accordance with laws on intellectual property and other related legal documents.

Article 49. Establishment producing, trading, and importing veterinary drugs

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1. The production establishment must ensure the conditions prescribed in Article 90, Clause 2, Article 91 of the Law on Animal Health, Article 12, Article 13 of Decree No. 35/2016/ND-CP dated May 15, 2016, and Clause 1, Article 2 of Decree No. 123/2018/ND-CP.

2. The trading establishment must ensure the conditions prescribed in Article 92, Clause 2, Article 93 of the Law on Animal Health, Article 17 of Decree No. 35/2016/ND-CP dated May 15, 2016, and Clause 2, Article 2 of Decree No. 123/2018/ND-CP.

3. Importing establishment

a) Ensure the conditions prescribed in Article 94, Clause 2, Article 95 of the Law on Animal Health, Article 18 of Decree No. 35/2016/ND-CP dated May 15, 2016, and Clause 3, Article 2 of Decree No. 123/2018/ND-CP;

b) Only sell raw materials for veterinary drugs to establishments meeting the conditions for trading raw materials for veterinary drugs, establishments meeting the conditions for producing veterinary drugs, and not sell raw materials for veterinary drugs to distributors, retail stores selling veterinary drugs, people, or breeding and aquaculture establishments for use.

Chapter IX

IMPLEMENTATION

[39]

Article 50. Implementation Provisions

1. This Circular takes effect from July 19, 2016.

2. This Circular abolishes the following provisions:

a) Contents regarding testing and evaluating veterinary drugs prescribed in Decision No. 18/2002/QD-BTS dated June 3, 2002, promulgating the Regulation on Testing of Aquatic Species Breeds, Feed, Drugs, Chemicals, and Biological Preparations Used in Aquaculture;

b) Article 1 and Article 2 of Circular No. 47/2010/TT-BNNPTNT dated August 3, 2010, of the Ministry of Agriculture and Rural Development supplementing some provisions on administrative procedures of Decision No. 71/2007/QD-BNN dated August 6, 2007; Decision No. 98/2007/QD-BNN dated December 3, 2007; Decision No. 118/2008/QD-BNN dated December 11, 2008, and Circular No. 06/2010/TT-BNNPTNT dated February 2, 2010;

c) Article 1 of Circular No. 20/2011/TT-BNNPTNT dated April 6, 2011, of the Ministry of Agriculture and Rural Development amending, supplementing, and abolishing some provisions on administrative procedures in the field of veterinary medicine according to Resolution No. 57/NQ-CP dated October 15, 2010;

d) Article 19, Article 20, and Article 21 of Circular No. 04/2015/TT-BNNPTNT dated February 12, 2015, of the Ministry of Agriculture and Rural Development guiding the implementation of some contents of Decree No. 187/2013/ND-CP dated November 20, 2013 of the Government detailing the implementation of the Law on Trade concerning international trade activities and agency, purchase, sale, processing, and transit of goods with foreign countries in the fields of agriculture, forestry, and fisheries;

đ) Article 2 of Circular No. 10/2016/TT-BNNPTNT dated June 1, 2016, of the Ministry of Agriculture and Rural Development promulgating the List of Veterinary Drugs Permitted for Circulation and Prohibited for Use in Vietnam, announcing HS codes for imported veterinary drugs permitted for circulation in Vietnam;

3. This Circular replaces the following documents:

a) Circular No. 02/2009/TT-BNN dated January 14, 2009, of the Ministry of Agriculture and Rural Development guiding procedures for recalling and disposing of veterinary drugs;

b) Circular No. 03/2009/TT-BNN dated January 14, 2009, of the Ministry of Agriculture and Rural Development prescribing labeling of veterinary drugs;

c) Decision No. 71/2007/QD-BNN dated August 6, 2007, of the Ministry of Agriculture and Rural Development promulgating regulations on the procedure and procedures for testing and evaluating veterinary drugs;

d) Decision No. 98/2007/QD-BNN dated December 3, 2007, of the Ministry of Agriculture and Rural Development supplementing and amending Decision No. 71/2007/QD-BNN dated August 6, 2007;

đ) Decision No. 72/2007/QD-BNN dated August 6, 2007, of the Ministry of Agriculture and Rural Development promulgating regulations on quality inspection of veterinary drugs;

e) Decision No. 100/2007/QD-BNN dated December 3, 2007, of the Ministry of Agriculture and Rural Development supplementing and amending Decision No. 72/2007/QD-BNN dated August 6, 2007;

g) Decision No. 10/2006/QD-BNN dated February 10, 2006, of the Ministry of Agriculture and Rural Development promulgating regulations on procedures for registering production, importation, and circulation of veterinary drugs, raw materials for veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary medicine;

h) Decision No. 99/2007/QD-BNN dated December 3, 2007, of the Ministry of Agriculture and Rural Development amending and supplementing Decision No. 10/2006/QD-BNN dated February 10, 2006;

i) Circular No. 51/2009/TT-BNNPTNT dated August 21, 2009, of the Ministry of Agriculture and Rural Development prescribing inspection and certification of conditions for production and trading of veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary medicine, aquatic animal health.

k) Circular No. 07/2012/TT-BNNPTNT dated February 13, 2012 of the Ministry of Agriculture and Rural Development stipulating procedures for registration, inspection, and certification of veterinary drug production facilities meeting Good Manufacturing Practice (GMP) standards;

l) Circular No. 08/2012/TT-BNNPTNT dated February 13, 2012 of the Ministry of Agriculture and Rural Development stipulating procedures for registering the production and processing of veterinary drugs;

m) Circular No. 33/2011/TT-BNNPTNT dated May 6, 2011 of the Ministry of Agriculture and Rural Development promulgating national technical regulations on hygiene conditions for veterinary drug business establishments and hygiene conditions for veterinary drug testing and trial establishments;

Article 51. Transitional Provisions

1. Applications for testing, trial, production processing, circulation of veterinary drugs submitted before this Circular takes effect shall be processed according to the provisions of Decision No. 10/2006/QĐ-BNN dated February 10, 2006 of the Ministry of Agriculture and Rural Development promulgating regulations on procedures for registering the production, importation, circulation of veterinary drugs, raw materials for veterinary drugs, biological products, microorganisms, chemicals used in veterinary practices; Decision No. 71/2007/QĐ-BNN dated August 6, 2007 of the Ministry of Agriculture and Rural Development promulgating regulations on the procedures for testing and trial of veterinary drugs; Circular No. 08/2012/TT-BNNPTNT dated February 13, 2012 of the Ministry of Agriculture and Rural Development stipulating procedures for registering the production processing of veterinary drugs and amended decisions;

2. Management of biological products, microorganisms, chemicals, minerals used in aquaculture shall be carried out according to the provisions of Circular No. 23/2015/TT-BNNPTNT dated June 22, 2015 of the Ministry of Agriculture and Rural Development on management of products for treatment and environmental improvement used in animal husbandry and aquaculture as follows:

a) For applications submitted before July 1, 2016, they shall be implemented according to the provisions of Circular No. 23/2015/TT-BNNPTNT dated June 22, 2015 of the Ministry of Agriculture and Rural Development on management of products for treatment and environmental improvement used in animal husbandry and aquaculture;

b) Products that have been permitted to circulate continue to be circulated until the end of the period specified in the permit or five years from the date of issuance (for permits without a specified circulation period). Renewal or extension shall be carried out according to the provisions of point c or point d of Clause 2 of this Article;

c) Products with disinfectant, sterilization, and decontamination functions and containing active ingredients listed in Appendix XLIV attached hereto shall be implemented according to the provisions of this Circular from the date this Circular takes effect;

d) Products not covered by point c of this Clause with functions of decomposing organic matter, creating natural feed, stabilizing breeding environment, and supplementing minerals shall be managed according to the regulations on feed management from the date this Circular takes effect;

3. For products specified in Part C of Appendix IC of Circular No. 10/2016/TT-BNNPTNT dated June 1, 2016 of the Ministry of Agriculture and Rural Development on the issuance of the list of veterinary drugs permitted to circulate and prohibited from use in Vietnam, and announcement of HS codes for imported veterinary drugs permitted to circulate in Vietnam:

a) Products with disinfectant, sterilization, and decontamination functions and containing active ingredients listed in Appendix XLIV attached hereto shall continue to be implemented according to the provisions of the Law on Veterinary Medicine and this Circular;

b) Products not covered by point a of this Clause that are permitted to circulate shall continue to be circulated until the end of the period specified in the permit, after which they shall be implemented according to the provisions of point d of Clause 2 of this Article;

4. Production and business establishments with active ingredients as stipulated in Appendix XLIV attached hereto, if not yet issued certificates of compliance for veterinary drug production and business or GMP certificates, within twelve months from the date this Circular takes effect, such establishments shall apply for certificates of compliance for veterinary drug production and business according to the provisions of the Law on Veterinary Medicine and this Circular;

5.[40] The publication of conformity declarations for veterinary drugs shall be carried out according to the provisions of the law from February 14, 2024.

Article 52. Implementation Organization

During the implementation process, if there are difficulties or need for amendments or supplements, agencies, organizations, and individuals are requested to promptly reflect such issues to the Ministry of Agriculture and Rural Development for consideration and resolution./.

 

Place of Receipt: - Office of the Government (for publication in the Official Gazette and posting on the Government Portal website); - Minister (for signature); - Deputy Ministers of the Ministry of Agriculture and Rural Development; - Legal Department (for information); Provincial People's Committees under the Central Government; - Units under the Ministry of Agriculture and Rural Development; - Veterinary Administration, units under the Veterinary Administration; - Departments of Agriculture and Rural Development of provinces and centrally governed cities; - File: VT, TY.

CERTIFIED CONSOLIDATED DOCUMENT DEPUTY MINISTER DEPUTY MINISTER Phùng Đức Tiến

 

 

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