Drug Retail Enterprise Acceptance Inspection Service Guidelines
Date:04/01/2017  
Item Name Drug Retail Enterprise Acceptance Inspection Service 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 Regulations of the People's Republic of China on the Administration of Drug Administration;
3. Article 5 and Article 9 of the Measures for the Administration of Drug Operation Licenses;
Application Condition The same as listed in the Drug Retail Enterprise Establishment and Licensing Service Guidelines
In the following circumstances, the City Council shall not accept the application:
1. If provided the false materials or acted fraud in the application process, there will be no acceptance of application for at least of one year period in accordance with the "Administrative Licensing Law";
2. Other laws and regulations stipulated do not accept conditions.
Application Materials Application material list (2 copy)
1. Application form for drug business license;
2. The City Council decision to agree on the establishment of enterprise;
3. A copy of the "Pre-approval Notice" or "Business License" issued by the administrative department for industry and commerce;
4. Certificate of pharmaceutical technical personnelqualification and a copy of the letter of appointment;
5. Catalog of enterprise quality management documents (including quality control system, job responsibilities, operating procedures, archives, records, and vouchers, etc.);
6. 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;
7. Enterprise main facilities and equipment directory;
8. Online entry information for the provincial administrative approval system (provide according to the provincial bureau website administrative approval system client program requirements).
The above materials, if the application if filed by an enterprise, shall be stamped with an official seal. If filed by a person, then the stamp is not required.
Transaction Procdure Acceptance → technical review → on-site inspection → audit → check→ announcement
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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