Decision No. 71/2007/QD-BNN stipulates procedures for testing and field trials of veterinary medicines. It applies to organizations and individuals within and outside Vietnam involved in activities related to veterinary medicines in Vietnam. Notably, it covers the establishment of files, assessment, implementation of contracts, evaluation of results, and recognition of test and trial outcomes.
적용 범위
Organizations and individuals within and outside Vietnam engaged in research, production, business, import, testing, and field trials of veterinary medicines in Vietnam.
핵심 사항
- Entities with veterinary medicines must establish test and trial files including registration certificates, technical files, testing reports, contracts, and test and trial outlines.
- The file review period is 45 working days from the date of receipt of valid files.
- Testing and trial entities must meet veterinary hygiene conditions, technical infrastructure, housing facilities, and hold a practice certificate.
- Test and trial criteria include safety, efficacy, and other technical indicators.
- Test and trial decisions must specify the entity name, location, tested medicine, duration, scale, and test criteria.
🌐 이 문서의 사회적 영향
- Facilitate the research and development of new veterinary medicines in Vietnam.
- Reduce safety risks for users of animal-origin products.
- Accelerate access to foreign veterinary medicines in the Vietnamese market.
❓ 자주 묻는 질문
Which entities can conduct tests and trials of veterinary medicines?
Organizations and individuals within and outside Vietnam involved in activities related to veterinary medicines in Vietnam may conduct them.
What is the duration of the file review process for tests and trials?
45 working days from the date of receipt of valid files.
What conditions must testing and trial entities meet?
They must ensure veterinary hygiene, have technical infrastructure, housing facilities, and hold a practice certificate issued by the Department of Animal Health.
What does the test and trial criteria include?
It includes safety, efficacy, and other technical indicators such as animal health status, recovery rate, and antibody protection rate.
What information must be included in test and trial decisions?
Specify the entity with the medicine, testing entity, location, tested medicine, duration, scale, and test criteria.
전문
Article 1. The attached Decision "Regulations on Procedures for Testing and Field Trials of Veterinary Medicines" is hereby issued with this Decision.
Article 2. This Decision shall take effect fifteen days from the date of publication in the Official Gazette. All previous regulations that conflict with this Decision are hereby abolished.
Article 3. The Director of the Office, the Director of the Department of Animal Health, and relevant organizations and individuals are responsible for implementing this Decision./.
REGULATIONS
PROCEDURES FOR TESTING AND FIELD TRIALS OF VETERINARY MEDICINES
(Issued together with Decision No. 71/2007/QĐ-BNN dated August 6, 2007 of the Minister of Agriculture and Rural Development
PART I
GENERAL PROVISIONS
Article 1. Scope of Regulation
These regulations provide for procedures for testing and field trials of veterinary medicines, vaccines, biological products, microorganisms, and chemicals used in veterinary medicine (hereinafter referred to as veterinary medicines).
Article 2. Applicability
Domestic and foreign organizations and individuals engaged in research, production, business, importation, testing, and field trials of veterinary medicines within the territory of Vietnam must comply with these regulations and other relevant legal documents.
Article 3. Definitions
In this regulation, the following terms are understood as follows:
1. Veterinary drugs Refers to substances or compounds derived from animals, plants, microorganisms, minerals, or chemicals used to prevent, diagnose, treat diseases, or to restore, adjust, or improve animal body functions, including drugs, chemicals, vaccines, hormones, certain biological products, and certain microorganisms used in veterinary medicine.
2. New veterinary medicine Refers to a veterinary medicine containing a new active ingredient formula, a new combination of active ingredients, a new formulation, a new indication, or a new route of administration.
3. New active ingredient Refers to an active ingredient appearing for the first time on the Vietnamese market.
4. Testing of veterinary medicines Refers to the trial use of veterinary medicines not included in the List of Permitted Circulating Veterinary Medicines, List of Permitted Circulating Biological Products, Microorganisms, and Chemicals Used in Veterinary Medicine (hereinafter referred to as the List of Permitted Circulating Veterinary Medicines) to determine the characteristics, efficacy, and safety of the veterinary medicine on some animals at the testing facility.
5. Field trial of veterinary medicines Refers to the examination and determination of the characteristics, efficacy, and safety of samples of veterinary medicines produced abroad when registering for initial import into Vietnam on some animals at the field trial facility.
Article 4. Cases requiring testing and field trials of veterinary medicines
1. Cases requiring testing
New veterinary medicines produced domestically when applying for circulation registration or veterinary medicines already listed in the List of Permitted Circulating Veterinary Medicines but have changes as stipulated in Clause 1, Article 58 of Decree No. 33/2005/NĐ-CP dated March 15, 2005 of the Government guiding the detailed implementation of certain provisions of the Ordinance on Veterinary Medicine (hereinafter referred to as Decree No. 33).
2. Cases requiring field trials
Veterinary medicines produced abroad not listed in the List of Permitted Circulating Veterinary Medicines when applying for initial import registration into Vietnam or veterinary medicines already listed in the List of Permitted Circulating Veterinary Medicines but have changes as stipulated in Clause 1, Article 58 of Decree No. 33.
Chapter II
PROCEDURES FOR TESTING AND FIELD TRIALS OF VETERINARY MEDICINES
Article 5. Procedures and formalities for testing and evaluating veterinary drugs
The testing and evaluation of veterinary drugs shall be carried out in accordance with the following procedures:
1. Prepare the testing and evaluation dossier for veterinary drugs.
2. Organize the review, notify the results, and issue the Decision on testing and evaluating veterinary drugs.
3. Implement the testing and evaluation contract and outline between the entity holding the drug and the entity conducting the testing and evaluation.
4. Examine and recognize the results of testing and evaluating veterinary drugs, submit to the Scientific Council of the Ministry of Agriculture and Rural Development for examination and approval to supplement the List of veterinary drugs permitted for circulation in Vietnam.
Article 6. File testing and evaluating veterinary drugs
1. Entities or individuals having veterinary drugs for testing and evaluating must prepare a dossier including:
a) Application for testing and evaluating veterinary drugs (Annex 1) along with a list of types of drugs to be tested and evaluated;
b) Technical dossier of each type of drug to be tested and evaluated, prepared in accordance with Article 8 of Chapter II of Decision No. 10/2006/QĐ-BNN dated February 10, 2006, issued by the Minister of Agriculture and Rural Development on procedures for registering production, importation, circulation of veterinary drugs, raw materials for veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary practice;
c) Test report from the National Veterinary Drug Testing Center, clearly stating the result: "The drug meets the standards for use in veterinary practice";
d) Testing and evaluation contract (Annex 2);
In cases where the entity holding the drug has facilities meeting the conditions for testing and evaluating, a contract is not required but there must be an opinion from the supervising unit.
e) Testing and evaluation outline;
f) Certificate of competence for testing and evaluating veterinary drugs of the owner or technical manager of the testing and evaluation facility, issued by the Animal Health Service.
2. The testing and evaluation dossier for veterinary drugs must be written in Vietnamese and submitted to the Animal Health Service in two copies.
Article 7. Contract for testing and evaluating veterinary drugs
The contract for testing and evaluating veterinary drugs shall be signed between the entity holding the drug and the entity conducting the testing and evaluation based on mutual agreement between both parties regarding the contents of testing and evaluating the drug and related issues. Testing and evaluating veterinary drugs must be conducted through a contract. The entity holding the drug shall bear legal responsibility for the safety and quality of the product being tested and evaluated.
Article 8. Review of the testing and evaluation dossier for veterinary drugs and response time
1. Within 45 working days from receipt of a valid dossier, the Animal Health Service shall be responsible for:
a) Reviewing the dossier and replying to the entity holding the drug for testing and evaluating;
b) Assigning a supervisory unit to conduct a review of the hygiene conditions at the testing and evaluation facility and the testing and evaluation outline;
c) Issuing the Decision on testing and evaluating based on the report on the hygiene conditions at the testing and evaluation facility and the testing and evaluation outline from the supervisory unit.
The entity holding the drug for testing and evaluating shall be responsible for providing additional information when requested. The waiting period for providing additional information shall not be included in the review period.
2. The Animal Health Service shall be responsible for replying in writing to the entity holding the drug for testing and evaluating, specifying the reasons if it does not issue the Decision on testing and evaluating.
Article 9. Content of the Decision testing and evaluating veterinary drugs
1. The content of the Decision on testing and evaluating veterinary drugs includes:
a) Name of the entity holding the drug for testing and evaluating;
b) Name of the testing and evaluation facility;
c) Location of implementation;
d) Name of the drug;
đ) Duration of testing and evaluating;
e) Scale: including species of animals, quantity, specificity, age group;
f) Testing and evaluation criteria;
g) Responsibilities of the entity holding the drug and the testing and evaluation facility;
h) Responsibilities of the specialized veterinary supervisory unit for testing and evaluating.
2. After receiving the Decision on testing and evaluating, the entity holding the drug shall send one copy to the supervisory unit for testing and evaluating and one copy to the testing and evaluation facility.
Article 10. Conditions for testing and evaluation facilities
Testing and evaluation facilities must meet the following conditions:
1. Ensuring veterinary hygiene conditions as prescribed in Clause 2, Article 55 of Decree 33.
2. Having sufficient technical infrastructure, animal housing, and various types of animals for testing and evaluation.
3. The owner or technical manager of the testing and evaluation facility must hold a practice certificate issued by the Department of Animal Health.
4. Veterinary drug testing and evaluation facilities must be appraised by authorized veterinary agencies on the conditions stipulated in Clauses 1, 2, and 3 of this Article and recognized by the Department of Animal Health.
Article 11. Requirements for test animals
1. Must have species, sex, age, and weight suitable for the intended use of the drug.
2. Must be clinically healthy.
3. Must not have antibodies corresponding to the type of vaccine or biological product being tested or evaluated.
Chapter III
CONTENT OF TESTING AND EVALUATION
Article 12. Index Testing and evaluation of veterinary pharmaceuticals and chemicals
1. Safety criteria:
a) For the designated animal species using the drug.
b) For drug users and consumers of animal-derived products (applicable to new drugs researched by manufacturers).
2. Efficacy criteria: For the designated animal species using the drug.
a) The condition of the animals after testing and evaluation.
b) The percentage of animals cured after testing and evaluation.
3. Other technical criteria (listed in the registration dossier).
Article 13. Scale and duration of testing and evaluation of veterinary pharmaceuticals and chemicals
1. Scale of testing and evaluation
a) Number of animals for testing and evaluation:
- Poultry: from 200 to 300 heads;
- Pigs: from 20 to 50 heads;
- Cattle, buffalo, goats, sheep, horses: from 10 to 20 heads;
- Pets: from 10 to 20 heads.
b) In each specific case, the number of animals for testing and evaluation and the amount of serum to be collected for reliable statistical results will be specifically defined in the testing and evaluation decision.
2. Duration of testing and evaluation is determined for each type of drug or chemical.
Article 14. Criteria for testing and evaluating vaccines and biological products
1. Safety criteria.
a) For the designated animal species using the vaccine or biological product.
b) For vaccine or biological product users.
c) For the health of consumers of animal-derived products.
2. Efficacy criteria: For the designated animal species using the vaccine or biological product.
a) The percentage of animals with antibodies after vaccination.
b) Protection rate.
3. Other technical criteria (listed in the registration dossier).
Article 15. Scale and duration of testing and evaluation of vaccines and biological products
1. Scale of testing and evaluation
a) Number of animals for testing and evaluation:
- Poultry: from 200 to 500 heads;
- Pigs: from 20 to 50 heads;
- Cattle, buffalo, goats, sheep: from 20 to 50 heads;
- Horses: from 10 to 20 heads;
- Birds and pets: from 10 to 20 heads.
b) In each specific case, the number of animals for testing and evaluation and the amount of serum to be collected for antibody testing to achieve reliable statistical results will be specifically defined in the testing and evaluation decision.
c) For avian influenza vaccines, each cage must have 1% of sentinel animals that are not vaccinated.
2. Duration of testing and evaluation is determined for each type of vaccine or biological product.
Article 16. Reporting of testing and evaluation results
Facilities conducting testing and evaluation must report the results to the Department of Animal Health within 15 days from the end of the testing and evaluation process. The report must be based on the testing and evaluation outline, including the contents specified in Appendix 3, and must be confirmed by the supervising unit.
Chapter IV
RESPONSIBILITIES OF THE PARTIES INVOLVED
Article 17. Responsibilities of the entity with veterinary drug testing and evaluation facilities
1. Propose locations and draft testing and evaluation outlines.
2. Sign veterinary drug testing and evaluation contracts with testing and evaluation entities and fully implement the terms of the signed contracts.
3. Carry out all contents recorded in the testing and evaluation decision. In case of any changes to the decision's contents, report in writing to the Department of Animal Health detailing the reasons, and only continue testing and evaluating if approved by the Department of Animal Health.
4. Honestly evaluate testing and evaluation results and prepare veterinary drug testing and evaluation reports to submit to the Department of Animal Health.
5. Bear legal responsibility for the accuracy of veterinary drug testing and evaluation result reports.
Article 18. Responsibilities of the testing and evaluation entity
1. Strictly implement signed contracts with the entity having drugs for testing and evaluation.
2. Honestly evaluate testing and evaluation results and cooperate with the entity having drugs to prepare veterinary drug testing and evaluation reports to submit to the Department of Animal Health.
3. Bear legal responsibility for the accuracy of veterinary drug testing and evaluation result reports.
Article 19. Responsibilities of Provincial and Central City Animal Health Sub-departments
1. Review the conditions for testing and evaluating veterinary drugs as stipulated in Clauses 1, 2, and 3 of Article 10 of this Regulation and report the results to the Department of Animal Health.
2. Supervise the process of testing and evaluating pharmaceuticals, chemicals used in animal health according to the Decision of the Department of Animal Health.
3. Confirm testing and evaluation result reports.
Article 20. Responsibilities of units under the Department of Animal Health
1. Review the conditions for testing and evaluating veterinary drugs as stipulated in Clauses 1, 2, and 3 of Article 10 of this Regulation and report the results to the Department of Animal Health.
2. Supervise the process of testing and evaluating pharmaceuticals, vaccines, biological preparations, microorganisms, and chemicals used in animal health according to the Decision of the Department of Animal Health.
3. Confirm testing and evaluation result reports.
Article 21. Responsibilities of the Department of Animal Health
1. Guide organizations and individuals in registering and implementing veterinary drug testing and evaluation in accordance with current regulations.
2. Review and evaluate files and issue testing and evaluation decisions for veterinary drugs.
3. Evaluate veterinary drug testing and evaluation results, submit to the specialized council of the Ministry of Agriculture and Rural Development for review and approval to supplement the list of veterinary drugs permitted for circulation in Vietnam.
Chapter V
IMPLEMENTATION
Article 22. The Director of the Department of Animal Health and the heads of related agencies are responsible for enforcing this Regulation./.
DEPUTY MINISTER
관계도
문서를 클릭하면 열립니다. 빨간 테두리＝효력을 변경하는 관계.