Decision No. 12/2007/QD-BYT of the Ministry of Health issues the "Good Distribution Practice" principles applicable to entities participating in pharmaceutical distribution activities within the territory of Vietnam. These principles are conditions for issuing certificates of qualification for pharmaceutical business operations to wholesale drug establishments.
적용 범위
Entities participating in pharmaceutical distribution activities within the territory of Vietnam, specifically wholesale drug establishments.
핵심 사항
- Pharmaceutical distribution entity → must comply with the "Good Distribution Practice" principles to obtain a certificate of qualification for pharmaceutical business operations (Article 2).
- The "Good Distribution Practice" principles apply to entities participating in pharmaceutical distribution activities within the territory of Vietnam (Article 1).
- Wholesale drug establishment → must comply with these principles to obtain a certificate of qualification for pharmaceutical business operations (Article 2).
- The Decision takes effect 15 days from the date of publication in the Official Gazette (Article 3).
- The Vietnam National Medicines Administration → is responsible for organizing the implementation of the application of the "Good Distribution Practice" principles and standards in accordance with current regulations (Article 4).
🌐 이 문서의 사회적 영향
- Positive impact: Strengthening quality and safety management of drugs in the market, protecting consumer rights.
- Negative impact: Increased costs for pharmaceutical distribution entities due to compliance with new principles.
❓ 자주 묻는 질문
Who does the "Good Distribution Practice" principle apply to?
This principle applies to entities participating in pharmaceutical distribution activities within the territory of Vietnam, specifically wholesale drug establishments.
Which entity needs to comply with the "Good Distribution Practice" principle to obtain a certificate?
Wholesale drug establishments need to comply with this principle to obtain a certificate of qualification for pharmaceutical business operations.
When does the Decision take effect?
The Decision takes effect 15 days from the date of publication in the Official Gazette.
Which agency is responsible for organizing the implementation of the application of the "Good Distribution Practice" principle?
The Vietnam National Medicines Administration is responsible for organizing the implementation of the application of the "Good Distribution Practice" principles and standards in accordance with current regulations.
Does the "Good Distribution Practice" principle take effect immediately upon issuance?
No, the Decision takes effect 15 days from the date of publication in the Official Gazette.
전문
Pursuant to …;
REGARDING THE ISSUE OF THE "GOOD DISTRIBUTION PRACTICE PRINCIPLES"
__________________________
THE MINISTER OF HEALTH
Pursuant to the Drug Law dated June 14, 2005;
Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to Decree No. 79/2006/NĐ-CP dated August 9, 2006 detailing the implementation of certain provisions of the Medicine Law;
Pursuant to Decision No. 108/2002/QĐ-TTg dated August 15, 2002 of the Prime Minister approving the "Strategy for the Development of the Pharmaceutical Industry until 2010";
Considering the proposal of the Director of the Vietnam Drug Administration.
Pursuant to …;:
Article 1. The "Good Distribution Practice Principles" attached hereto shall be applied to entities participating in drug distribution activities within the territory of Vietnam.
Article 2. The implementation of the "Good Distribution Practice Principles" according to a phased plan is a condition for issuing certificates of qualification for drug business operations to wholesale drug entities.
Article 3. This Decision takes effect fifteen days from the date of publication in the Official Gazette.
Article 4. The Director of the Vietnam Drug Administration is responsible for organizing the implementation of the application of the "Good Distribution Practice Principles" in accordance with current regulations.
Article 5. The Heads of the Office, Inspectorate of the Ministry of Health, Director of the Vietnam Drug Administration, Heads of subordinate units under the Ministry, Directors of Provincial Health Departments, Central City Health Departments, and Health Services of sectors are responsible for enforcing this Decision./.
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