Execution authority: Circulation Management Division of Shanghai Food and Drug Administration, Shuguang Building, 11th Floor, 189 Pu'an Road, Shanghai

9:00-11:00 and 13:30-17:00, every Tuesday and Thursday

Circulation Management Division of Shanghai Food and Drug Administration (Room 1103, 189 Pu'an Road). Contact phone: 021-63855666

Time for acceptance: 9:00-11:00 and 13:30-17:00, every Tuesday and Thursday.

Application procedure:
Execution procedure: (I) The applicant shall submit a project preparation application, in written form, and following documents to Shanghai Food and Drug Administration, in duplicate copies and with official seal:
1. Basic information and cooperation contract/agreement of the founder, investing enterprise (person) or partner;
2. Copy of ID card and person resume of the legal representative, the partner or the investor of the enterprise to be established (however the ID card must be checked visually);
3. Copy of diploma over college education, certificates of experience in direct drug business at least for three years or certificate of practicing apothecary of the principal (general manager) (however the original copy must be checked visually);
4. Copy of diploma of at least university education and certificate of practicing apothecary of the principal for quality management (however the original copy must be checked visually);
5. Copy of diploma of at least university education, certificate of experience in quality management in a drug whole enterprise for at least three years and certificate of practicing apothecary of the head of quality management department (however the original copy must be checked visually);
6. Business scope;
7. Feasibility report and prospectus of modern logistics system and information system;
8. Environment background, house ownership certificate or certificate of right of use or lease contract of the registered place, business place, equipment, storage facilities and peripheral surrounding.
9. Commitment form;
10. Other relevant documents required by laws and regulations.
(II) Shanghai Food and Drug Administration shall consider the application as per the second item of Article 8 of "Measures on Management of License of Drug Business".
(III) Shanghai Food and Drug Administration shall examine the application materials as per "Measures on Management of License of Drug Business" and "Notification on Forward of 'Measures on Management of License of Drug Business'" within 30 working days since accepting the application and send written notification to the applicant. For the application rejected, the Administration shall notify the applicant of the reason for rejection and that he can apply to State Food and Drug Administration or Shanghai Municipal Government for reconsideration of administrative actions within 60 days or lodge a suitcase to Luwan District Court within 3 months since receiving the written notification, when he disagrees with the rejection.

(IV) After finish the project preparation, the applicant shall apply to Shanghai Food and Drug Administration for examination and approval, with submitting following documents, with official seal:
1. "Application Form for License of Drug Business";
2. Original and duplicate copy of verification document of the enterprise, issued by the authority for industry and commerce;
3. Institutional framework, quality department and network chart of the enterprise;
4. Quality management documents;
5. Name list of quality-related department, such as quality management, examination and approval, maintenance and warehouse, and professional pharmaceutical staff;
6. Copy of qualification certificate of professional pharmaceutical staff and registration certificate of practicing apothecary (however the original copy must be checked visually);
7. List of storage equipments, plan drawing of business place and warehouse and both original and duplicate copy of house ownership certificate or certificate of right of use or lease contract;
8. Original and duplicate copy of completion contract of the modern logistics system and information system;
9. Other relevant documents required by laws and regulations.
(V) Shanghai Food and Drug Administration shall organize the examination and approval and make decision whether to issue the "License of Drug Business" as per "Standards on the Implementation of Examination and Approval for the Establishment of Drug Wholesale Enterprise (Trial)" and "Notification on Forward of 'Measures on Management of License of Drug Business'" within 30 working days since receiving the all application materials. For the qualified applicant, the Administration shall issue and send the "License of Drug Business" to the applicant within 10 working days since making the decision to approve the application; for the unqualified applicant, it shall notify the applicant of the reasons for rejection and that he can apply to State Food and Drug Administration or Shanghai Municipal Government for reconsideration of administrative actions within 60 days or lodge a suitcase to Luwan District Court within 3 months since receiving the written notification, when he disagrees with the rejection. The applicant rejected at the first time shall submit a second application when the enterprise is qualified.

(VI) The statement, argument and hearing shall be subject to the regulations of "Administrative Approval Law".
Application for change of content:
(I) The change of items approved in "License of Drug Business" refers to that application made by the drug wholesale enterprise with "License of Drug Business" for the change of business mode, business scope, registered address, business location, warehouse location (including addition and reduction of warehouse), legal representative or principal of the enterprise and the quality principal.

(II) Should split, merger and change of business mode occur in the enterprise, the enterprise shall obtain a new "License of Drug Business" subject to "Measures on Management of License of Drug Business", No. 6 Decree of State Food and Drug Administration, and "Notification on Forward of 'Measures on Management of License of Drug Business'", No. HUSHIYAOJIANLIUTONG (2004) 227 issued by Shanghai Food and Drug Administration.

(III) Procedure of application for change

1. The applicant shall submit his application to Shanghai Food and Drug Administration 30 days before the change takes into effect. If rejected, the applicant shall not take the change.
2. Should the enterprise be investigated as a recorded case by the administrative authorities for food and drug for its illegal operation and the case not be settled, or the enterprise be decided to bear an administrative punishment but not be enforced, the administrative authorities for food and drug shall suspend accepting the application for change of "License of Drug Business".

3. The drug wholesale enterprise that applies for change of items of "License of Drug Business" shall submit a written application to Shanghai Food and Drug Administration (Should the applicant for change of items of "License of Drug Business" is a non-corporate branch organization of a business corporation, it must submit the application form for change with the comment of superintendent corporation), to explain the reasons for change and state the objective of such change and the condition of business operation, staffing of medical technicians and storage. It also shall submit the duplicate copy of "License of Drug Business", copy of business license (however the original copy must be checked visually) and relevant documents, as well as following documents (in duplicate copies and with official seal):

(1) Change of registered address (business location) and warehouse location (including addition and reduction of warehouses)
(a) Layout plan of business place and warehouse;
(b) Copy of house ownership certificate or certificate of right of use or lease contract (however the original copy must be checked visually).
(2) Change of legal representative (principal), economic nature and subjection
(a) Approval of superintendent authority and solution of board of directors
(b) Copy of certificate of education, professional title and ID card of the new legal representative (principal) (however the original copy must be checked visually);
(c) Other relevant documents required by laws and regulations.
(3) Change of business scope
(a) Copy of qualification certificate, practicing apothecary certificate and ID card of the professional medical staff whose qualification is admitted legally (however the original copy must be checked visually);
(b) Copy of layout plan of the warehouse and new warehouse buildings and the house ownership certificate or certificate of right of use or lease contract (however the original copy must be checked visually);
(c) Quality management system suitable for the drug business;
(d) Other relevant documents required by laws and regulations.
(IV) Examination and approval of the application for change of items formerly permitted
Shanghai Food and Drug Administration shall examine the application and make decision within 15 working days since receiving the complete application materials. Should the application be approved, the Administration shall issue the "Approval of Change of Items in 'License of Drug Business'". Should the application be rejected, the Administration shall notify the applicant of the reasons for rejection in a written form. After receiving the "Approval of Change of Items in 'License of Drug Business'", the enterprise that applies for change of legal representative (principal), economic nature and/or subjection shall process the formality of change of "License of Drug Business" at Shanghai Food and Drug Administration.

(V) Examination of the items changed
1. The applicant enterprise that applies for change of registered address (business location), warehouse location (including addition and reduction of warehouse) and/or business scope shall conduct the project preparation as per the stipulations since receiving the "Approval of Change of Items in 'License of Drug Business'". With the project preparation accomplished, it shall submit the "Application Form for Examination of Change of Items of Drug Business in Shanghai", reporting the project preparation condition and other matters necessary for explanation.

2. Shanghai Food and Drug Administration shall organize the examination and approval and make decision whether to issue the License of Drug Business as per "Standards on the Implementation of Examination and Approval for the Establishment of Drug Wholesale Enterprise (Trial)" and "Notification on Forward of 'Measures on Management of License of Drug Business'" within 20 working days since receiving the all application materials. For the qualified applicant, the Administration shall issue a new original copy of "License of Drug Business", with the same period of validity, recording the new items, draw back the former original copy of "License of Drug Business" and record the items changed in the duplicate copy of the "License of Drug Business"; for the unqualified applicant, it shall notify the applicant of the reasons for rejection and that he can apply to State Food and Drug Administration or Shanghai Municipal Government for reconsideration of administrative actions within 60 days or lodge a suitcase to Luwan District Court within 3 months since receiving the written notification, when he disagrees with the rejection. The applicant rejected at the first time shall submit a second application when the enterprise is qualified.

3. The statement, argument and hearing shall be subject to the regulations of "Administrative Approval Law".
(VI) Change of registered items refers to the change of other items than those mentioned above.
1. The change of enterprise name shall be registered at Shanghai Food and Drug Administration, with the "Notification on Approval of Preselected Enterprise Name" issued by the administrative authority for industry and commerce.
2. As for the change of items registered in the "License of Drug Business", the original issuing authority shall record the content and time of change in the duplicate copy of "License of Drug Business" and issue a new original copy of "License of Drug Business" in conformity with the contents changed and draw back the former original copy of "License of Drug Business". The new "License of Drug Business" shall have the same period of validity.

(VII) The statement, argument and hearing shall be subject to the regulations of "Administrative Approval Law".
Standard and basis of charge:
Submitted to:
Execution address:
audituser：
Basis of execution: "Pharmaceutical Administration Law of the People's Republic of China", No. 45 President Decree, issued on Feb. 28, 2001;

"Regulations on the Implementation of Pharmaceutical Administration Law of the People's Republic of China", No. 360 State Council Decree, issued on Aug. 4, 2002;

"Measures on Management of License of Drug Business", No. 6 Decree of State Food and Drug Administration, issued on Feb. 4, 2004;

"Notification on Forward of 'Measures on Management of License of Drug Business'", No. HUSHIYAOJIANLIUTONG (2004) 227, issued by Shanghai Food and Drug Administration on Mar. 31, 2004;

"Reply of Agreement on Charging for the Review of License of Drug Business", No. HUCAIZONG (2000) 45 and No. HUJIAHANG (2000) 153, issued by Shanghai Finance Bureau and Shanghai Price Bureau.

Contact phone:
Website:
Duration of service:
Time limit:
Applicant's qualification: The establishment of drug wholesale enterprise shall meet the requirement on reasonable layout of drug wholesale enterprises stipulated by the government of province, autonomous region and the municipality directly under central government, and shall be qualified with following requirements:

1. Regulations to guarantee the quality of drugs are adopted;

2. Article 76 and Article 83 of "Pharmaceutical Administration Law of the People's Republic of China" are not applicable to the enterprise, its legal representative or principal and principal for quality management;

3. Have a proper amount of practicing apothecaries suitable to the scale of business. The principal for quality management must have the education level of or over university level and be a practicing apothecary;

4. Have room temperature warehouses, cool warehouses and cold warehouses qualified to secure the storage quality of drugs and with suitable to the drug types and business scale. There must be special racks for drug storage and the devices and equipment of modern logistics system for the warehousing, conveyance, inspection and selection, shelving and delivery.

5. Have independent computer-managed information system, able to cover the whole process from purchase, storage, sales, operation and quality control of drugs, record the management of business and the implementation of "Regulations on Quality Management of Drugs", fulfill the requirements of "Regulations on Quality Management of Drugs" on managerial sectors of the drug business and make the enterprise qualified to receive the supervision of local authority for food and drug;

6. Be qualified to the requirements of "Regulations on Quality Management of Drugs" on business location, auxiliary and office places, warehouse management, quality security of drugs in warehouse, acceptance and delivery, storage and maintenance.

Should there be other regulations on narcotic drugs, psychotropic drugs, medical toxic drugs and preventive bioproducts, such regulation shall prevail.

Range of application:

The drug wholesale enterprise with the "License of Drug Business" issued in Shanghai applies for change of items in the "License of Drug Business".