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Home Service Guide Zhengzhou Municipal Food and Drug Administration Text
Drug Retail Enterprise Establishment and LicensingService Guidelines
Date：04/01/2017  
Item Name Drug Retail Enterprise Establishment and LicensingService Guidelines
Rights and Liablities Item No.
Issuing Authority Zhengzhou Area of China (Henan) Pilot Free Trade Zone
Service Subject Legal person
Implementing Basis 1.Article 14 and Article 15 of the Law of the People's Republic of China on Drug Administration;
2.Article 12 of the "the People's Republic of China Drug Administration Law Implementation Regulations";
3.Article 5, Article 9 of the " Measures for the administration of pharmaceutical business license ";
4,."Guidelines for the quality control of pharmaceutical production" and "Guidelines for the on-site inspection of drug quality management practices”.
Application Condition (A) Personnel
1.The legal representative of the enterprise or the person in charge of the enterprise (including the chain store person in charge) should have the qualifications of pharmacists; (ifthe person in charge of businessis holding the same position in other chain stores or single drugstore business, then the enterprise/business must be accompanied by a practicing pharmacist to audit the prescription, and ensure that the practicing pharmacist is on duty;
2. Quality control, procurement, acceptance approval personnel should have a pharmacy or medical, biological, chemical and other related professional education qualifications or have pharmacy professional titles;
3.To be engaged in the operation of Chinese medicine Pieces, the quality control, acceptance, procurement staff should have more than Technical Secondary School education of Chinese medicine or junior professional titlesof Chinese medicine.
Application Materials 1. Preparation of pharmaceutical retail enterprises application form;
2. The original and a photocopy of the education certificate, the qualification certificate and the title certificate; and the personal resume and the professional personnel qualification certificate, the letter of appointment of the legal representative of the enterprise, the person in charge of the enterprise, the person in charge of the quality control (the original file will be returned after check);
3. Proposed business premises, warehouse layout, and the surrounding environment description, to be selected equipment, storage facilities condition statement;
4. The enterprise shall provide the certificate of the property right or the right of use of the premises or warehouse place (provide the Certificate of Registration of the Housing Lease if located within the city area, provide the Certificate of Registration of the Housing Lease or other proof of business use if located within the Shangjie District and the counties); If the business, warehouse place is to set in the residential type of house, a written statement or description of the situation agreed to change the residential house to business use from the house owner need to be provided;
5. Online entry information for the provincial administrative approval system (provide according to the provincial bureau website administrative approval system client program requirements).
Transaction Procdure Acceptance → technical review → on-site inspection → audit → check
Transaction Time Limit 3 working days (excluding expert review, on-site inspection, publicity time)
Implementing Authority Zhengzhou Food And Drug Administration
Charge or not No
Fee Standard None
Fee Basis
Online Application or not No
Business Supervision Department
Office Hours Mon. - Fri. 9: 00-12: 00 13: 00-17: 00
Office Address The 1st and 2nd floor of Building 1, No. 85, Yabao Oriential International Plaza, Jinshui East Road, Zhengzhou.(Zip Code 450046)
Contact Phone 0371-67888393
Complaint Phone 0371-67880110
Relevant Forms
Flow Chart
Common Questions
Notes
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Integrated Service Center of China (Henan) Pilot Free Trade Zone Zhengzhou Area
Add.:1 Yabao·Dongfang International Plaza,No.85 Jinshui East Road,Zhengdong New District,Zhengzhou,Henan,China
Tel.:+86 0371-61170000    0371-67880002 E-mail:zzszzq@126.com
Integrated Service Center of China (Henan) Pilot Free Trade Zone Zhengzhou Area