Decision No. 38/2007/QD-BYT of the Ministry of Health issues the procedure for amending and supplementing the inspection procedures for pharmaceuticals, replacing the old procedures. This decision shall take effect fifteen days from the date of publication in the Official Gazette.
要点
- The Inspector General of the Ministry of Health proposes to issue the procedure for amending and supplementing the inspection procedures for pharmaceuticals.
- This decision applies to the Director of the Office, the Inspector General, and related Departments under the Ministry of Health, the Vietnam National Pharmaceutical Administration; Directors of Provincial Health Services under centrally governed cities and provinces; and Heads of units under the Ministry of Health.
- The general inspection procedure and the list for inspecting retail drug outlets and wholesale drug outlets issued together with this decision replace the old procedures.
- This decision shall take effect fifteen days from the date of publication in the Official Gazette.
- The new inspection procedures and lists for pharmaceuticals will replace the old ones, including the general inspection procedure; the list for inspecting retail drug outlets and the list for inspecting wholesale drug outlets.
🌐 本文件的社会影响
- Positive impact: Improve the effectiveness of state management in pharmaceutical inspections, ensuring drug safety and quality.
- Negative impact: May increase the workload for related agencies and organizations due to compliance with the new procedures.
❓ 常见问题
Who does this decision apply to?
This decision applies to the Director of the Office, the Inspector General, and related Departments under the Ministry of Health, the Vietnam National Pharmaceutical Administration; Directors of Provincial Health Services under centrally governed cities and provinces; and Heads of units under the Ministry of Health.
When does this decision take effect?
This decision shall take effect fifteen days from the date of publication in the Official Gazette.
What are the new pharmaceutical inspection procedures that replace the old ones?
The new pharmaceutical inspection procedures include the general inspection procedure; the list for inspecting retail drug outlets and the list for inspecting wholesale drug outlets, replacing the old procedures such as the general inspection procedure, the list for inspecting wholesale drug outlets (QTZ3), the list for inspecting pharmacies, drugstores, and drug agents (QTZ5) issued together with Decision No. 3556/2001/QD-BYT dated August 17, 2001 of the Minister of Health.
When does this decision take effect?
This decision shall take effect fifteen days from the date of publication in the Official Gazette.
What contents do the new pharmaceutical inspection procedures include?
The new pharmaceutical inspection procedures include the general inspection procedure; the list for inspecting retail drug outlets and the list for inspecting wholesale drug outlets.
全文
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MINISTRY OF HEALTH |
SOCIALIST REPUBLIC OF VIET NAM |
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Number: 38/2007/QĐ-BYT |
Hanoi, October 25, 2007 |
Pursuant to …;
Regarding the issuance of the amended and supplemented Inspection Procedure and the List of Inspections for Pharmaceuticals
and the List of Pharmaceutical Inspections
THE MINISTER OF HEALTH
Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government detailing the functions, tasks, powers, and organization of the Ministry of Health;
Pursuant to the Inspection Law No. 22/2004/QH11 dated June 15, 2004;
Pursuant to the Drug Law No. 34/2005-QH11 dated June 14, 2005;
Pursuant to Decree No. 77/2006/NĐ-CP dated August 3, 2006 of the Government on the organization and operation of the Health Inspection;
Pursuant to Decree No. 79/2006/NĐ-CP dated August 9, 2006 detailing the implementation of certain provisions of the Drug Law;
Pursuant to Decision No. 2151/2006/QĐ-TTCP dated November 10, 2006 of the General Inspector promulgating the Operation Regulations of the Inspection Team;
Pursuant to Circular No. 02/2007/TT-BYT dated January 24, 2007 of the Minister of Health guiding in detail the implementation of certain provisions regarding the conditions for drug business operations under the Drug Law and Decree No. 79/2006/NĐ-CP dated August 9, 2006 detailing the implementation of certain provisions of the Drug Law.
At the proposal of the Director of the Health Inspection Department,
Pursuant to …;
Article 1. Attached hereto with this Decision is the amended and supplemented Inspection Procedure and the List of Inspections for Pharmaceuticals including: The general inspection procedure; The list of inspections for retail drug outlets and the list of inspections for wholesale drug outlets.
Article 2. This Decision shall take effect 15 days from the date of publication in the Official Gazette. The Inspection Procedure attached hereto shall replace the general inspection procedure, the list of inspections for wholesale chemical drug outlets (QTZ3), and the list of inspections for pharmacies, drugstores, and drug agents (QTZ5) issued together with Decision No. 3556/2001/QĐ-BYT dated August 17, 2001 of the Minister of Health on the issuance of the Inspection Procedure and the List of Inspections for Pharmaceuticals.
Article 3. The Heads of the Office, the Director of the Health Inspection Department, and relevant Departments under the Ministry of Health, the Director of the Vietnam National Pharmaceutical Administration; the Directors of Provincial and Municipal Health Services under the Central Government and Health Services of Ministries and Sectors; and the Heads of units directly under the Ministry of Health are responsible for implementing this Decision./.
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DEPUTY MINISTER |
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