Thông tư 46/2011/TT-BYT nguyên tắc, tiêu chuẩn Thực hành tốt nhà thuốc

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Thông tư 46/2011/TT-BYT của Bộ Y tế về việc ban hành nguyên tắc, tiêu chuẩn “Thực hành tốt nhà thuốc”
Cơ quan ban hành: Bộ Y tế Số công báo: Đã biết
Số hiệu: 46/2011/TT-BYT Ngày đăng công báo: Đã biết
Loại văn bản: Thông tư Người ký: Cao Minh Quang
Ngày ban hành: 21/12/2011 Ngày hết hiệu lực: Đã biết
Áp dụng: Đã biết Tình trạng hiệu lực: Đã biết
Lĩnh vực: Y tế-Sức khỏe
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MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness

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No.: 46/2011/TT-BYT
Hanoi, December 21, 2011

 
CIRCULAR
PROMULGATING PRINCIPLES, STANDARDS “GOOD PHARMACY PRACTICE”
Pursuant to the Pharmacy Law No.34/2005-QH-11 dated June 14, 2005;
Pursuant to the Decree No.188/2007/ND-CP dated December 27, 2007 of the Government regulating functions, duties, powers and organizational structure of Ministry of Health;
Pursuant to the Decree No.79/2006/ND-CP dated August 09, 2006 of the Government detailing the implementation of some Articles of the Pharmacy Law,
The Ministry of Health issues principle and standard of "good pharmacy practice" as follows:
Article 1. Scope of governing
Principle and standard of "Good Pharmacy Practice" issued with this Circular are the drug trading conditions for the drug retail establishments according to the schedule stipulated in Circular No.43/2010/TT-BYT dated December 15, 2010 of the Ministry of Health defining the schedule to implement the principle and standard of "good pharmacy practice" GPP; location and scope of operation of the drug retail establishments.
Article 2. Dossier of registration for inspection of drug retailing conditions by the principles, standards of "good pharmacy practice"
1. An application for registration for inspection of drug retailing conditions by the principles, standards of "good pharmacy practice" (Form No.1/GPP);
2. A list of material facilities and equipment, list of personnel;
3. A GPP self-check list (Checklist) in Appendix II of this Circular.
Article 3. Dossier of registration for re-inspection of drug retailing conditions by the principles, standards of "good pharmacy practice"
An application for registration for re-inspection of drug retailing conditions by the principles, standards of "good pharmacy practice" (Form No.2/GPP).
 After the establishments filed dossiers for re-registration, they are still allowed to trade drug according to the extent specified in the issued certificates of "good pharmacy practice" and qualified certificates of trading drug (still valid).
Article 4. Competence to inspect, component of the inspection team
1. Competence to inspect and issue certificates
Health Departments of the provinces and centrally-run cities (referred to as the Health Departments) are responsible for receiving dossiers, appraising dossiers and establishing the inspection teams and granting certificates of the establishments achieved standard, "good pharmacy practice".
2. Standards of inspectors "good pharmacy practice"
a) The heads of inspection teams must have a degree of pharmaceutical university, have experienced in the management of drug for 2 years or more.
b) Members of the inspection teams must have a university degree or higher.
3. Component of the inspection teams shall be decided by the Directors of Health Departments.
Article 5. The order of inspecting drug retailing conditions by the principles, standards of "good pharmacy practice"
1. The Health Departments issuing the process and complying with process of granting certificates of "Good Pharmacy Practice" must ensure the principles:
a) Within 20 days after receipt of application for accreditation of the drug retail establishments meeting the principle and standard of "good pharmacy practice", the Departments of Health establish the inspection teams and carry out to inspect at the establishments.
b) The Health Departments issue the certificates of qualification of "good pharmacy practice" for the establishments within 05 working days from the date of ending the inspection; or within 10 working days from the date the Departments of Health receive the reports of overcoming the shortcomings mentioned in the inspection records.
c) In case of re-inspection, within 10 working days after receiving the report of remedy and application for inspection of the establishments, the Departments of Health must conduct the inspection.
2. Inspection records accompanying Checklist must be signed to certify by the professional manager and head of the inspection team and is made into 02 copies: 01 copy is stored at the establishment, 01 copy is stored at the Health Department of province, centrally-run city where the establishment operates. (Form No.3/GPP).
Article 6. The validity of qualified certificates of "good pharmacy practice"
Qualified certificates of "good pharmacy practice" have a valid term of 3 years from the signing date (Form No.4/GPP). The certificates which have been issued previously with a valid term of 02 years may continue to extend the operating time for 01 year from the expiry date. The Departments of Health shall issue the Decisions of extending together with the list of the establishments to be extended the certificates’ validity of "good pharmacy practice".
Article 7. Effect
This Circular takes effect from February 05, 2012 and replaces the Decision No.11/2007/QD-BYT dated 24/01/2007 on promulgating the principle and standard of "good pharmacy practice" and the contents related to "good pharmacy practice" in the Decision No.29/2007/QD-BYT dated 11/05/2007 on amending and supplementing some Articles of Decision No.11/2007/QD- BYT.
During the implementation process, if any difficulty arises, the units should promptly reflect to the Drug Administration of Vietnam - Ministry of Health for studying to amend and supplement properly./.
 

 
 
FOR MINISTER
DEPUTY MINISTER




Cao Minh Quang

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