Decision No. 08/2004/QĐ-BNN stipulates the implementation of Good Manufacturing Practice (GMP) principles and standards of ASEAN at all veterinary drug manufacturing facilities. These facilities must be granted a GMP Certificate to circulate their products.
적용 범위
All veterinary drug manufacturing facilities nationwide
핵심 사항
- All veterinary drug manufacturing facilities must apply the Good Manufacturing Practice (GMP) principles and standards of ASEAN.
- A GMP Certificate is a mandatory condition for obtaining a product circulation permit for veterinary drugs.
- The Director of the Department of Animal Health is responsible for guiding, inspecting, and urging the implementation of GMP.
🌐 이 문서의 사회적 영향
- Positive impacts include improving the quality of veterinary drug products, ensuring food safety and animal health. However, enterprises will need to invest to meet GMP standards, which may impose financial burdens.
❓ 자주 묻는 질문
What should veterinary drug manufacturing facilities do?
Veterinary drug manufacturing facilities must apply the Good Manufacturing Practice (GMP) principles and standards of ASEAN and obtain a GMP Certificate to circulate their products.
How long is the validity period of the GMP Certificate?
Information regarding the validity period of the GMP Certificate is not mentioned in this document.
Are there any regulations on the inspection and supervision of GMP implementation?
The Decision assigns the responsibility to the Director of the Department of Animal Health to guide, inspect, and urge the implementation of GMP.
How will veterinary drug manufacturing facilities be affected?
Enterprises will need to invest to meet GMP standards, imposing financial burdens. However, this also helps improve product quality and ensure food safety.
When does this Decision take effect?
This Decision takes effect fifteen days after its publication in the Official Gazette of the Government.
전문
Pursuant to …;
MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT
Regarding the implementation and application of the principles and standards "Good Manufacturing Practices for Medicines" (GMP) of the Association of Southeast Asian Nations (ASEAN)
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THE MINISTER OF AGRICULTURE AND RURAL DEVELOPMENT
Pursuant to Decree No. 86/2003/NĐ-CP dated July 18, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;
Pursuant to the Veterinary Medicine Management Charter issued pursuant to Decree No. 93/CP dated November 27, 1993 of the Government guiding the implementation of the Animal Health Ordinance;
At the proposal of the Director of the Department of Animal Health, the Head of the Science and Technology Division,
DECISION:
Article 1. Implement and apply the principles and standards "Good Manufacturing Practices for Medicines" (GMP) of the Association of Southeast Asian Nations (ASEAN) at all veterinary medicine production facilities.
Article 2. The implementation and application of the ASEAN GMP principles and standards is one of the basic criteria for considering and issuing marketing authorization (MA) for veterinary medicine products.
Article 3. This Decision shall take effect fifteen days from the date of publication in the Official Gazette of the Government.
Article 4. The Director of the Department of Animal Health shall be responsible for guiding, inspecting, urging the implementation and application, and issuing the GMP Certificate.
Article 5. The Heads of the Office, the Director of the Department of Animal Health, the Head of the Science and Technology Division, the Heads of relevant units, and the owners of veterinary medicine production facilities nationwide shall be responsible for implementing this Decision./.
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DEPUTY MINISTER |
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(Signed) |
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BUU BA BONG |
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