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Home Service Guide Zhengzhou Municipal Food and Drug Administration Text
The Class II Psychotropic Drugs, Medical Toxic Drugs Retail Approval Service Guidelines
Date：04/04/2017  
Item Name The Class II Psychotropic Drugs, Medical Toxic Drugs Retail Approval 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. Regulations of the People's Republic of China on the Implementation of the Drug Administration Law of the People's Republic of China (promulgated by the State Council Decree No. 360 of the People's Republic of China on August 4, 2002) Article 12: Where a pharmaceutical retail enterprise is set up, the sponsor shall submit application to the local Municipal drug regulatory agencies, or the county-level drug regulatory agencies directly set by provincial, autonomous regions and municipalities directly under the Central Government Drug Administration. The drug regulatory authority that receives the application shall, within 30 working days from the date of receipt of the application, make a decision on whether or not to approve the construction, based on the local resident population, geographical, traffic conditions and actual needs decision according to the provisions of the State Administration of Drug Administration. After the applicant has completed the preparation of the proposed enterprise, it shall apply to the original examination and approval authority for acceptance. The original examination and approval authority shall, within 15 working days from the date of receipt of the application, organize the acceptance inspection according to the conditions set forth in Article 15 of the Drug Administration Law; if it meets the conditions, it shall issue the "Drug Operation Permit".
2. Regulations on the Administration of Narcotic Drugs and Psychotropic Substances (promulgated by Decree No. 442 of the State Council of the People's Republic of China on August 3, 2005) Article 31: With the approval of the municipal pharmaceutical supervision and administration department in the district where the district is located, unified distribution, unified management of drug retail chain enterprises can engage inclass II psychotropic drugs retail business.
3. Measures for the Administration of Medicinal Toxic Drugs (Decree No. 23 of the State Council of the People's Republic of China on November 15, 1998) Article 5: The acquisition and operation of toxic drugs shall only be carried out by the pharmaceutical business units designated by the pharmaceutical administrative departments; medication prescription can only be dealt by the state-owned pharmacies, medical units. No other unit or individual may engage in the acquisition, operation, and formulation of toxic drugs.
Application Condition
Application Materials 1. "Application Form for Fixed - point Narcotic Drugs and Psychotropic Drugs operation and trading";
2. copyof the "drug business license", "corporate business license", "drug management quality management certification certificate" stamped with the official seal;
3. To be engaged in the Class II psychotropic drugs retail stores list, and copy of their "drug business license", "business license" stamped with the official seal, and the statement of the implementation of a unified enterprise purchase, unified distribution, unified management of the drugs;
4. Personal info of the Enterprise and stores responsible person, the quality control person in charge, specifically the management person ofclass II psychotropic drug;
5. The safety management system, and the security facilities details of the enterprise, and stores operating the class II psychotropic drugs;
6. Enterprise safety management and the submission of business information to the drug regulatory authority or its designated agency network description materials and operating manual.
Application material for the medical use of toxic drugs retail approval:
1. Medical toxic drug retail enterprise application form;
2. the legal representative power of attorney, a copy of the agent identity card (signed by agent);
3. copy of the "drug business license", "corporate business license", "drug quality management certificate “of enterprises to be engaged in medical use of toxic drug retail;
4. storage facilities floor plan (marked with medical toxic drugs storage or counter location);
5. enterprises and stores responsible person, the quality control person in charge, specifically the medical use of toxic drugs operation personnel information (including their education certificate, qualifications, training permit, etc.);
6. security measures of storage;
7. intended medical use of toxic drugs directory and the purchase channel description;
8. medical toxic drug management system directory.
Transaction Procdure Acceptance → technical review → on-site inspection → audit → check→ announcement.
Transaction Time Limit 1 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