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Regulations
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Introduce: 18 June 1999
Implement: 1 January 2000 |
Measures for Separate Administration of Prescribed and Non-prescribed Medicines (Elementary edition) [40]
《处方药与非处方药分类管理办法(试行)》(国家药品监督管理局令第10号) |
Overall guidance on activities related to prescribed and non-prescribed medicines among pharmaceutical entities, medical institutions, administrative departments, consumers, media. |
The Pharmaceutical Trade License is required for retail pharmacies to sell prescribed medicines and Class A of non-prescribed medicines. Prescribed medicines must be dispensed, purchased, and used with prescriptions from licensed physicians or licensed physician assistants.
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Introduce: 28 December 1999
Implement: 1 January 2000 |
Temporary Provisions for Prescribed and Non-prescribed Medicine Distribution [41]
《处方药与非处方药流通管理暂行规定》(国药管市〔1999〕454号) |
Specific requirements on activities related to prescribed and non-prescribed medicines among pharmaceutical entities, medical institutions, and commercial business. |
The Pharmaceutical Trade License is required for retail pharmacies to sell prescribed medicines and Class A of non-prescribed medicines. Prescribed medicines must be dispensed with prescriptions from licensed physicians or licensed physician assistants, and after a licensed pharmacist or pharmaceutical technician has checked its reasonability and signed. Prescribed and non-prescribed medicines can only be procured from qualified manufacturers or wholesalers, with procurement records being kept for authority inspections. Prescribed and non-prescribed medicines should be allocated separately into different shelves; customers cannot select prescribed medicines by themselves. Retail pharmacies should keep a record of prescriptions for more than two years for authority inspections.
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Introduce: 15 June 1999
Implement: 1 August 1999 |
Measures for the Supervision and Administration of Circulation of Pharmaceuticals (Elementary edition) [Invalid] [42]
《药品流通监督管理办法(暂行)》(国家药品监督管理局令第7号) [失效] |
Requirements on pharmaceutical related activities and punishments of violating these requirements. |
For retail pharmacies, prescribed medicines should be dispensed with prescriptions and under the supervision of licensed pharmacists/pharmaceutical technicians; if they are not presented, the retail pharmacies should note it and stop dispensing prescribed medicines and Class A of non-prescribed medicines. Violating above requirements will result in a warning; a further financial penalty of CNY 1000 will be applied for retail pharmacies who seriously violate or do not correct their practices.
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Introduce: 31 January 2007
Implement: 1 May 2007 |
Measures for the Supervision and Administration of Circulation of Pharmaceuticals [43]
《药品流通监督管理办法》(国家食品药品监督管理局令第26号) |
Introduce: 4 February 2004
Implement: 1 April 2004 |
Measures for the Administration of Pharmaceutical Trade License [Revised] [48]
《药品经营许可证管理办法》(国家食品药品监督管理局令第6号) [已修改] |
Requirements on application, renewal and change of Pharmaceutical Trade License among pharmaceutical entities; Administration and inspection responsibilities of FDAs. |
Requirements of applying for Pharmaceutical Trade License: for retail pharmacies selling prescribed medicines and Class A of non-prescribed medicines, one requirement is that the retail pharmacy must be staffed by licensed pharmacies or other qualified pharmaceutical staff, and these staff should be presented during the business hours. The Pharmaceutical Trade license should be renewed every 5 years.
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Introduce: 17 November 2017
Implement: 17 November 2017 |
Decision of the China Food and Drug Administration to Amend Some Rules [49]
《国家食品药品监督管理总局关于修改部分规章的决定》(国家食品药品监督管理总局令第37号) |
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Strategies and Guidelines
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| 24 October 2003 |
Notice on Strengthening Administration over the Sale of Antimicrobials in Retail Pharmacies to Promote Rational Use of Medicines [45]
关于加强零售药店抗菌药物销售监管促进合理用药的通知(国食药监安[2003]289号) |
The FDAs and retail pharmacies’ roles in rational dispense of antimicrobials in retail pharmacies. |
All antimicrobials not listed as non-prescribed medicines, including antibiotics, thiamines, quinolones, anti-tuberculosis and anti-fungal medicines, must be dispensed with prescriptions from licensed physicians in retail pharmacies since 1 July 2004. Any violation will be punished according to the ‘Measures for the Supervision and Administration of Circulation of Pharmaceuticals (Elementary edition)’.
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| 11 June 2004 |
Notice on Publishing ‘2004–2005 Work Plan related to Separate Administration of Prescribed and Non-prescribed Medicines’ by China Food and Drug Administration [44]
国家食品药品监督管理局关于印发《实施处方药与非处方药分类管理2004–2005年工作规划》的通知
(国食药监安[2004]262号) |
The achievements and barriers related to management of prescribed and non-prescribed medicines; the goal, main principle, and the work plans for various stakeholders between 2004 and 2005. |
Goal: prescribed medicines will be purchased only with a prescription and dispensed and used under pharmacists’ guidance by the end of 2005. Highlights the requirement of dispensing prescribed medicine only with a prescription in retail pharmacies; the business scope of Pharmaceutical Trade License will be narrowed to non-prescribed medicines for those retail pharmacies failed to separately manage medicines from 1 January 2006. Regular inspections on whether prescribed medicines are dispensed with a prescription, the employment and present situation and the performance of licensed pharmacists and pharmaceutical staff in retail pharmacies. Reinforce the pharmaceutical professional qualification system.
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| 20 January 2012 |
Notice on Publishing ‘National Medicine Safety ‘twelve-five’ Programme’ by State Council [51]
国务院关于印发国家药品安全“十二五”规划的通知 (国发[2012]5号) |
A set of principles, objectives, and activities to improve national medicine quality and safety including one part related to promoting the pharmaceutical professional qualification system. |
From 2012, all newly-opened retail pharmacies must be staffed by licensed pharmacist. By 2015, licensed pharmacists are required to be present at retail pharmacies during business hours in order to provide pharmaceutical services to consumers; otherwise, this retail pharmacy’s license of selling medicines will be withdrawn. Reinforce the pharmaceutical professional qualification system.
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| 5 August 2016 |
The National Action Plan to Curb Bacterial Resistance (2016–2020) [37]
遏制细菌耐药国家行动计划(2016–2020年) |
The main goals of this five-year plan and extensive approach to rational use of antimicrobials with measures on multiple stakeholders and components. |
Goal: the rate of dispensing antimicrobials with a prescription only in retail pharmacies reaches 100%. Strictly enforce dispensing antimicrobials only with a prescription in retail pharmacies; retail pharmacies should record the prescriptions for further inspections; increase the punishments for any kinds of practices of dispensing antimicrobials without a prescription.
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