Decision No. 11/2007/QD-BYT of the Minister of Health promulgates the principles and standards for "Good Pharmacy Practice", applicable to retail drug establishments, which are conditions for issuing a Certificate of Adequate Conditions for Drug Business. The Decision takes effect fifteen days from the date of publication in the Official Gazette.
적용 범위
Retail drug establishment
핵심 사항
- Retail drug establishment → must apply the principles and standards for "Good Pharmacy Practice" to be eligible for a Certificate of Adequate Conditions for Drug Business.
- Retail drug establishment → must comply with the principles and standards for "Good Pharmacy Practice" as prescribed.
🌐 이 문서의 사회적 영향
- Positive impact: Strengthening drug quality management, protecting patient rights;
- Negative impact: May increase operational costs for retail drug establishments.
❓ 자주 묻는 질문
What principles must retail drug establishments comply with?
Retail drug establishments must comply with the principles and standards for "Good Pharmacy Practice" as stipulated in this Decision.
When does this Decision take effect?
This Decision takes effect fifteen days from the date of publication in the Official Gazette.
What must retail drug establishments do to obtain a Certificate of Adequate Conditions for Drug Business?
Retail drug establishments must implement the principles and standards for "Good Pharmacy Practice" and meet the requirements as prescribed.
Who is responsible for implementing and monitoring the application of the principles and standards for "Good Pharmacy Practice"?
The Director of the Vietnam National Medicines Administration is responsible for guiding, inspecting, and supervising the implementation of the principles and regulations for "Good Pharmacy Practice".
To which retail drug establishments does this Decision apply?
This Decision applies to all retail drug establishments.
전문
Pursuant to …;
Regarding the issuance of Good Pharmacy Practice principles and standards
__________________________________
THE MINISTER OF HEALTH
Pursuant to the Medicine Law number 34/2005-QH11 dated June 14, 2005;
Pursuant to the Government Decree number 49/2003/NĐ-CP dated May 15, 2003 detailing the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to the Government Decree number 79/2006/NĐ-CP dated August 9, 2006 detailing the implementation of certain provisions of the Medicine Law;
Considering the proposal of the Director of the Vietnam National Medicines Administration.
DECISION:
Article 1The Good Pharmacy Practice principles and standards are hereby issued together with this Decision.
Article 2Implement the Good Pharmacy Practice principles and standards at retail drug outlets.
These Good Pharmacy Practice principles and standards are conditions for issuing the Certificate of Adequate Conditions for Drug Business to retail drug outlets according to the schedule specified in this Decision.
Article 3. The Standard Measurement Quality Control Department shall be responsible for organizing and guiding the implementation of the Regulations adopted herein.
Article 4. The Director of the Vietnam National Medicines Administration is responsible for guiding, inspecting, and monitoring the implementation of the Good Pharmacy Practice principles and standards.
Article 5. The Head of the Office, the Inspector General of the Ministry of Health, the Director of the Vietnam National Medicines Administration, the Heads of subordinate units under the Ministry, the Directors of Provincial Health Services under central cities and provinces, and health sectors are responsible for enforcing this Decision. /
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