Circular No. 46/2011/TT-BYT stipulates principles and standards for 'Good Pharmacy Practice' applicable to retail drug establishments. This circular specifies the application registration dossier, inspection authority, and inspection procedures, as well as the validity period of the Certificate of Compliance with 'Good Pharmacy Practice'.
适用范围
Retail drug establishments shall follow the timeline set forth in Circular No. 43/2010/TT-BYT.
要点
- Retail drug establishments must submit an application registration dossier for drug retail conditions inspection according to the 'Good Pharmacy Practice' principles and standards, including an application form, a declaration of physical facilities and equipment, a staff list, and a self-inspection report on GPP.
- The Department of Health is responsible for receiving applications, reviewing them, and forming inspection teams to issue Certificates of Compliance with 'Good Pharmacy Practice'.
- The Certificate of Compliance with 'Good Pharmacy Practice' has a validity period of three years, and old certificates will be extended for one additional year.
- During business operations, retail drug establishments must comply with regulations regarding re-inspections and rectification of deficiencies as required by the Department of Health.
- This circular takes effect from February 5, 2012, and replaces previous decisions.
🌐 本文件的社会影响
- Positive impact: Helps improve pharmaceutical management quality and ensure drug safety for users.
- Negative impact: May impose financial and time burdens on retail drug establishments.
❓ 常见问题
What documents must retail drug establishments prepare for registration and inspection?
Retail drug establishments must submit an application form, a declaration of physical facilities and equipment, a staff list, and a self-inspection report on GPP according to the Checklist in Appendix II of this circular.
What is the validity period of the Certificate of Compliance with 'Good Pharmacy Practice'?
The Certificate of Compliance with 'Good Pharmacy Practice' has a validity period of three years from the date of issuance. Old certificates will be extended for one additional year.
What inspection and certification authority does the Department of Health have?
The authority to inspect and issue Certificates of Compliance with 'Good Pharmacy Practice' belongs to the Departments of Health of provinces and centrally-administered cities.
If a retail drug establishment fails to meet requirements after inspection, what actions should they take?
Retail drug establishments must rectify deficiencies as required by the Department of Health and report back for re-inspection within ten working days.
Which decisions does this circular replace?
This circular replaces Decision No. 11/2007/QĐ-BYT and related provisions concerning 'Good Pharmacy Practice' in Decision No. 29/2007/QĐ-BYT.
全文
CIRCULAR
Issuing Good Pharmacy Practice Principles and Standards
______________________
Pursuant to the Medicine Law No. 34/2005/QH11 dated June 14, 2005;
Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 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 of the Government detailing the implementation of certain provisions of the Drug Law,
The Ministry of Health issues the Good Pharmacy Practice Principles and Standards as follows:
Article 1. Scope of Regulation
The Good Pharmacy Practice Principles and Standards issued together with this Circular are conditions for retail drug sales according to the roadmap set forth in Circular No. 43/2010/TT-BYT dated December 15, 2010 of the Ministry of Health on the roadmap for implementing Good Pharmacy Practice Principles and Standards GPP; geographical area and scope of operation of retail drug outlets.
Article 2. Application for Inspection of Retail Drug Sales Conditions According to Good Pharmacy Practice Principles and Standards
1. Application for Inspection of Retail Drug Sales Conditions According to Good Pharmacy Practice Principles and Standards (Form No. 1/GPP);
2. Inventory of Physical Facilities and Equipment, Staff List;
3. Self-inspection Report According to the Checklist (Checklist) at Appendix II of this Circular.
Article 3. Application for Re-inspection of Retail Drug Sales Conditions According to Good Pharmacy Practice Principles and Standards
Application for Re-inspection of Retail Drug Sales Conditions According to Good Pharmacy Practice Principles and Standards (Form No. 2/GPP). Retail outlets that have submitted re-inspection applications may continue to operate within the scope specified in the previously issued Good Pharmacy Practice Certificate and Drug Business License (still valid).
Article 4. Inspection Authority and Inspection Team Composition
1. Inspection Authority and Issuance of Certificates Provincial Departments of Health (referred to as Provincial Health Departments) shall be responsible for receiving applications, reviewing applications, forming inspection teams, and issuing Certificates confirming that retail outlets meet Good Pharmacy Practice Standards.
2. Qualifications of Inspectors for Good Pharmacy Practice
a) The head of the inspection team must hold a bachelor's degree in pharmacy and have at least two years of experience in pharmaceutical management.
b) Members of the inspection team must hold a bachelor's degree or higher.
3. Composition of the Inspection Team is decided by the Director of the Provincial Department of Health.
Article 5. Procedure for Inspecting Retail Drug Sales Conditions According to Good Pharmacy Practice Principles and Standards
1. Provincial Health Departments shall issue and follow procedures for issuing Certificates confirming that retail outlets meet Good Pharmacy Practice Standards, ensuring the following principles:
a) Within twenty days from the date of receipt of the application requesting certification of a retail outlet meeting Good Pharmacy Practice Principles and Standards, the Provincial Health Department shall form an inspection team and conduct inspections at the facility.
b) The Provincial Health Department shall issue a Certificate confirming Good Pharmacy Practice within five working days from the date of completion of the satisfactory inspection; or within ten working days from the date the Provincial Health Department receives the report on corrective actions taken in response to deficiencies noted in the inspection report.
c) In cases requiring re-inspection, within ten working days from the date of receipt of the report on corrective actions and the request for re-inspection from the facility, the Provincial Health Department shall conduct the re-inspection.
2. The inspection report accompanied by the checklist must be signed and confirmed by the professional manager and the head of the inspection team, making two copies: one copy retained by the facility, one copy retained by the Provincial Health Department where the facility operates. (Form No. 3/GPP).
Article 6. Term of Validity of the Certificate of Good Pharmacy Practice
The Certificate of Good Pharmacy Practice has a term of validity of three years from the date of issuance (Form No. 4/GPP). Certificates issued previously with a validity period of two years shall be extended for an additional year from the expiration date. The Department of Health issues the Decision on extension along with the list of establishments eligible for extending the validity of the Certificate of Good Pharmacy Practice.
Article 7. Effective Date
This Circular takes effect from February 5, 2012, and replaces Decision No. 11/2007/QĐ-BYT dated January 24, 2007, regarding the principles and standards of Good Pharmacy Practice and related contents concerning Good Pharmacy Practice in Decision No. 29/2007/QĐ-BYT dated May 11, 2007, amending and supplementing certain articles of Decision No. 11/2007/QĐ-BYT.
During implementation, if there are difficulties or obstacles, units are requested to promptly report to the Drug Administration - Ministry of Health for research and appropriate amendments and supplements.
DEPUTY MINISTER
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