Decision No. 1516/BYT-QD requires the implementation of the principles and standards of "Good Manufacturing Practice for Medicinal Products" (GMP) of ASEAN at all facilities producing modern pharmaceutical products. This aims to ensure product quality and is one of the criteria for granting registration numbers.
适用范围
Facilities producing modern pharmaceutical products, the Vietnam National Pharmaceutical Administration, the Director of the Ministry of Health's Office, the Vietnam National Pharmaceutical Corporation, Directors of health departments of centrally governed cities and provinces, and directors of permitted production facilities.
要点
- Facilities producing modern pharmaceutical products → apply ASEAN GMP.
- The Vietnam National Pharmaceutical Administration → guide, inspect, and monitor the implementation of GMP.
🌐 本文件的社会影响
- Enhance the quality of modern pharmaceutical products, protect public health.
- Production facilities need to invest to comply with new regulations, which may increase operational costs.
❓ 常见问题
How will the implementation of ASEAN GMP affect production facilities?
Production facilities must adhere to GMP principles and standards, which may require investment in infrastructure and production processes to ensure quality.
Will this impact the issuance of registration numbers for modern pharmaceutical products?
Yes, the application of GMP is one of the basic criteria for granting registration and circulation of modern pharmaceutical products.
Who is responsible for guiding and inspecting the implementation of GMP?
The Vietnam National Pharmaceutical Administration is responsible for guiding, inspecting, and monitoring the implementation of GMP principles and standards.
When does this decision take effect?
This decision takes effect from the date of signing.
How are previous regulations conflicting with this new decision abolished?
Previous regulations conflicting with those in this decision are abolished.
全文
Pursuant to …;
Regarding the implementation and application of the "Good Manufacturing Practice" (GMP) principles and standards of the Association of Southeast Asian Nations (ASEAN)
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THE MINISTER OF HEALTH
- Based on the Law on People's Health Protection dated July 11, 1989 and the Drug Regulations issued together with Decision No. 23/HĐBT dated January 24, 1991 of the Council of Ministers (now the Government).
Pursuant to …;
Article 1: Implement and apply the "Good Manufacturing Practice" (GMP) principles and standards of the Association of Southeast Asian Nations (ASEAN) at all new drug manufacturing facilities.
Article 2: The implementation and application of the "Good Manufacturing Practice" (GMP) principles and standards of the Association of Southeast Asian Nations (ASEAN) are among the basic criteria for considering and allowing a new drug product to be registered and circulated.
Article 3: The Director of the Vietnam National Medicines Administration shall be responsible for guiding, inspecting, and monitoring the implementation and application of the "Good Manufacturing Practice" (GMP) principles and standards of the Association of Southeast Asian Nations (ASEAN).
Article 4: This Decision takes effect from the date of signature. All previous regulations that conflict with the provisions of this Decision are hereby abolished.
Article 5: The Heads of the Office, the Director of the Vietnam National Medicines Administration, the General Directors of the Vietnam Pharmaceutical Corporation, the Directors of Provincial and Central City Health Departments, and the Directors of authorized new drug manufacturing facilities nationwide shall be responsible for enforcing this Decision.
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