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Processing Authority: Circulation Management Office
under Shanghai Food and Drug Administration
Processing Address: Room 1103,
Shuguang Tower, No. 189, Pu'an Road, Shanghai
Contact Tel:
021－63855666
Processing Time: Tuesdays or Thursdays: 9:00~11:00 and
13:30~17:00
Processing Procedures:
(I) Any and all of applicants shall
apply to Shanghai Food and Drug Administration in writing for incorporation and
present any and all of materials as follows (each in duplicate and stamped with
the official seal):
1. the profiles of incorporators, investors or
cooperation partners, and the cooperation contract or agreement;
2. the xerox
copies of the personal identity cards of the legal representative, partners or
investors (with the original whereof which will be returned upon review) of the
proposed enterprises, and resumes whereof;
3. the documentation of academic
credential of junior college or higher, the supporting documents for experience
or experiences directly engaging in the drug operation for three years or more
or the xerox copy of the qualification certificate of licensed pharmacist
whereof (with the original whereof which will be returned upon review) of the
key officers (general manager) of the proposed enterprise;
4. the
documentation of academic credential of undergraduate or higher and the xerox
copy of the qualification certificate of licensed pharmacist whereof (with the
original whereof which will be returned upon review) of the key officer in
charge of the drug operation quality management;
5. the documentation of
academic credential of undergraduate or above, the supporting documents for
experiences engaging in the quality management of drug wholesale enterprise for
three years or more, and the xerox copy of the qualification certificate of
licensed pharmacist whereof (with the original whereof which will be returned
upon review) of the key officer in charge of the quality management
department;
6. the proposed business scope of drugs;
7. the feasibility
project plan of the modern logistic system and information system;
8. the
profiles of the proposed registered office, the place of business operation,
equipments, storage facilities and surrounding sanitation environment, the house
muniment of title or certificate of right to use, or agreement with
9. the
letter of commitment; and
10. other relevant materials provided by laws,
regulations, and/or rules.
(II) Shanghai Food and Drug Administration shall,
upon application, make the processing decision subject to Article 8.2 of
Measures for Administration of License of Drug Operation.
(III) Shanghai Food
and Drug Administration shall, within 30 working days upon acceptance of
application, conduct the due review of the materials necessary for such
application subject to the Measures for Administration of License of Drug
Operation and Notice on Forwarding Measures for Administration of License of
Drug Operation, and make the decision of approval or not with a notice to the
applicant in writing. In case of nor-approval, causes shall be given to the
applicant who shall be informed that they can, within 60 days upon receipt of
the notice in writing, apply to State Food and Drug Administration or Shanghai
Municipal People's Government for the administrative review, or , within 3
months upon receipt of the notice in writing, file an administrative lawsuit in
People's Court of Luwan District in case of demurral against the very
decision.
(IV) The applicant shall, upon completion of incorporation
preparation, apply to Shanghai Food and Drug Administration for inspection and
present any and all of materials as follows (stamped with the official
seal):
1. the Application Form for License of Drug Operation;
2. the
original and xerox copy of the supporting documents for approval of the proposed
enterprise issued by the competent industrial and commercial
administration;
3. the situation and network drawing of the institutional
framework and quality department of the proposed enterprise;
4. the quality
management files;
5. the name list of personnel of the quality-related
departments (quality management, inspection before acceptance, conservation,
warehouse) and of medical specialty;
6. the xerox copy of the qualification
certificate of the personnel of medical specialty and the registration
certificate of the licensed pharmacist (with the original whereof which will be
returned upon review);
7. the originals and xerox copies of the catalog of
storage facilities, the plane layout of the place of business operation and
warehouse, and the house muniment of title or the certification of right to use
or the lease contract;
8. the originals and xerox copies of contracts of the
modern logistic system and information system upon completion of projects for
practical use; and
9. other relevant materials provided by laws, regulations,
and rules.
(V) Shanghai Food and Drug Administration shall, within 30 working
days upon receipt of the complete materials necessary for such application, make
the decision of issuing the License of Drug Operation or not subject to the
Implementation Standard for Inspection of Incorporating Drug Wholesale
Enterprise (for trial implementation) and Notice on Forwarding Measures for
Administration of License of Drug Operation. In case of prerequisites are
satisfied, Shanghai Food and Drug Administration will, within 10 days upon
approval, issue the License of Drug Operation to the very applicant. In case of
nor-approval, notice in writing with causes shall be given to the very applicant
who shall be informed that they can, within 60 days upon receipt of the notice
in writing, apply to State Food and Drug Administration or Shanghai Municipal
People's Government for the administrative review, or, within 3 months upon
receipt of the notice in writing, file an administrative lawsuit in People's
Court of Luwan District in case of demurral against the very decision. The
applicant may, upon meeting prerequisites, re-apply for inspection and license
according to the applicable law.
(VI) Any hearing of defending presentation
shall be subject to the applicable provisions of the Law of the People's
Republic of China on Administrative Licenses.
Application for Alteration of Registration Items:
(I)
Alteration of license items in the License of Drug Operation refers to the
alteration made by the drug wholesale enterprise holding the License of Drug
Operation in terms of the mode of business operation, scope of business
operation, registered address, address of business operation, address of
warehouse (including addition or deduction of warehouses), legal representative,
key officer, and/or key quality officer.
(II) In case of any separation,
merger or change of business operation of the very enterprise, the License of
Drug Operation shall be re-applied and re-issued subject to the Measures for
Administration of License of Drug Operation under No. 6 Order of State Food and
Drug Administration and Notice on Forwarding Measures for Administration of
License of Drug Operation under Hu Shi Yao Jian Liu Tong [2004] No. 227 of
Shanghai Food and Drug Administration.
(III) Procedures for Application for
Alteration
1. Any and all of applicants shall, 30 days prior to any
alteration, apply to Shanghai Food and Drug Administration, and shall not make
any alteration of license items without approval wherefrom
2. The competent
food and drug administration shall suspend the acceptance of application for
alteration of the License of Drug Operation by the enterprise who is subject to
the case investigation by the competent food and drug administration due to
illegal operation, which is not closed, or to the administrative punishment,
which is not enforced.
3. Any and all of drug wholesale enterprises applying
for alteration of the license items in the License of Drug Operation shall apply
to Shanghai Food and Drug Administration in writing (in case of alteration of
the license items in the License of Drug Operation by the non-corporate branch
affiliated to the incorporated enterprise, the letter of application for such
alteration endorsed by the superior corporate shall be presented), illustrate
the purpose(s) and cause(s) of such alteration, the operation condition of the
very enterprise, and profiles of personnel of medical specialty and warehouse,
present the copy of License of Drug Operation and the xerox copy of Business
License (with the original whereof which will be returned upon review), and
other materials related to such alteration as well as any and all of the
relevant materials as follows (each in duplicate and stamped with the official
seal):
(1) in case of alteration of registered(business operation) address,
or address of warehouse (including addition or deduction warehouses):
(a) the
plane layout of the place of business operation and warehouse;
(b) xerox
copies of the house muniment of title or the certification of right to use or
the lease contract (with the original whereof which will be returned upon
review);
(2) in case of alteration of the legal representative (key officer),
type of incorporation, and/or the affiliated entity of the enterprise:
(a)
the document of approval by the superior authority or the resolution of the
board of directors whereof;
(b) the xerox copy of the academic background,
title of a technical or professional post, and the personal identity card (with
the original whereof which will be returned upon review) of the legal
representative (key officer) after alteration; and
(c) other relevant
materials provided by laws, regulations, and rules.
(3) in case of alteration
of scope of business operation
(a) the xerox copy of the qualification
certificate of personnel of medical specialty via qualification certification in
accordance with law, and the registration certificate and personal identity card
of the licenses pharmacist (with the original whereof which will be returned
upon review)
(b) the xerox copies of the house plane layout and the house
muniment of title or the certification of right to use or the lease contract
(with the original whereof which will be returned upon review) of the warehouse
and additional warehouse(s);
(c) the drug operation quality management
system seasoned with the scope of business operation; and
(d) other relevant
materials provided by laws, regulations, and rules.
(IV) Review and Approval
of Alteration of License Items
Shanghai Food and Drug Administration shall,
within 30 working days upon receipt of the complete materials necessary for such
application, make the decision of approval or not, and, in case of approval,
issue the official document of "approving alteration of the license item(s) in
License of Drug Operation" to the very applicant. In case of nor-approval,
notice in writing with causes shall be given to the very applicant applying for
alteration of the legal representative (key officer), type of incorporation,
and/or affiliated entity who shall, upon receipt of the said official document,
apply to Shanghai Food and Drug Administration for competing any and all of
formalities necessary for alteration of the License of Drug Operation.
(V)
Inspection of Alteration of License Items
1. Any and all of enterprises
applying for alteration of registered (business operation) address, warehouse
address (including addition or deduction of warehouses), and/or scope of
business operation whereof shall, upon receipt of the official document of
"approving alteration of the license item(s) in License of Drug Operation",
conduct the incorporation preparation, and, upon completion of such preparation,
present the Application and Review Form for Inspection of Alteration of Drug
Operation Enterprise in Shanghai to report situations related to such
incorporation preparation and necessary for illustration.
2. Shanghai Food
and Drug Administration shall, within 20 working days upon receipt of the
complete materials necessary for such application, organize the inspection,
issue a new original of the License of Drug Operation based upon the altered
contents to and take back the original of the previous License of Drug Operation
from those meeting prerequisites, and record the altered contents into the copy
of the License of Drug Operation with the unchanged valid term subject to the
Implementation Standard for Inspection of Incorporating Drug Wholesale
Enterprise (for trial implementation) and Notice on Forwarding Measures for
Administration of License of Drug Operation. In case of prerequisites are not
satisfied, notice in writing with causes shall be given to the very applicant
who shall be informed that they can, within 60 days upon receipt of the notice
in writing, apply to State Food and Drug Administration or Shanghai Municipal
People's Government for the administrative review, or, within 3 months upon
receipt of the notice in writing, file an administrative lawsuit in People's
Court of Luwan District in case of demurral against the very decision. The
applicant may, upon meeting prerequisites, re-apply for inspection and license
according to the applicable law.
3. Any hearing of defending presentation
shall be subject to the applicable provisions of the Law of the People's
Republic of China on Administrative Licenses.
(VI) Alteration of registration
items refers to alteration of other items other than the above items.
1. Any
and all of the drug wholesale enterprises applying for alteration of their names
shall, upon the Notice of Pre-Approval of Business Name issued by the competent
industrial and commercial administration, go to Shanghai Food and Drug
Administration to complete any and all of formalities necessary for such
alteration of registration.
2. In case of any alteration of registration
items in the License of Drug Operation, the original license-issue authority
shall record the contents and time of alteration in the copy of the License of
Drug Operation, issue a new original of the License of Drug Operation based upon
the altered contents, and take back the previous original of the License of Drug
Operation with the unchanged valid term
(VII) Any hearing of defending
presentation shall be subject to the applicable provisions of the Law of the
People's Republic of China on Administrative Licenses.
Processing Basis:
Pharmaceutical Administration Law of the People's Republic of China under No. 45
Presidential Order of the People's Republic of China promulgated on February
28th, 2001;
Regulations of Implementation of Pharmaceutical Administration
Law of the People's Republic of China under No. 360 Order of State Council
promulgated on August 4th, 2002;
Measures for Administration of License of
Drug Operation under No. 6 Order of State Food and Drug Administration
promulgated on February 4th, 2004;
Notice on Forwarding Measures for
Administration of License of Drug Operation under Hu Shi Yao Jian Liu Tong
[2004] No. 224 of Shanghai Food and Drug Administration promulgated on March
31st, 2004; and
Reply on Approval of Imposing Charges for Review of Licenses
of Drug Production/Operation Enterprises under Hu Cai Zong (2000) No. 45 and Hu
Jia Xing (2000) No. 153 jointly issued by Shanghai Finance Bureau and Shanghai
Pricing Bureau.
Qualified Application Subject: Any and all of enterprises
intending to start drug wholesale businesses shall comply with the requirements
for reasonable distribution of the drug wholesale enterprises at the provincial,
autonomous region's or municipal level as well as the configuration standard as
follows:
1. They possess rules and systems that ensure the quality of the
drugs they operated;
2. The very enterprise, the legal representative or key
officer whereof, or the key quality officer is not subject to situations
provided in Articles 76 and 83 of the Pharmaceutical Administration Law of the
People's Republic of China;
3. They have employed a certain number of the
licensed pharmacists in conformity with the scale of their business operation.
The key quality officer shall hold an undergraduate degree or higher and shall
be a licensed pharmacist.
4. They have the atmospheric temperature warehouse,
cooling warehouse and refrigerated warehouse that can assure the quality of drug
storage and adapt to the varieties and scale of operation. There exist the
special storage rack suitable for drug storage and installations and equipments
of modern logistic system for realizing drug being sent into warehouse,
transmitted, classified, put in shelf, sent out of warehouse in the
warehouse.
5. There exists the independent computer management information
system which can cover the full flow of buy-in, storage, sales, operation, and
quality control of drugs inside the enterprise, fully record the information on
the enterprise's operation and management and implementation of the Drug Good
Supply Practice, meet requirements of the Drug Good Supply Practice for each
phase of drug operation, and possess the conditions to accept supervision and
administration by the competent local food and drug administration.
6. There
exist the conditions of the Drug Good Supply Practice for place of drug
operation and auxiliary and office houses, for warehouse management, for safety
control of drug quality within the warehouse, for drug being sent into and out
of warehouse, for the inventory maintenance and conservation.
Business
operation of narcotics, psychotropic substances, poisonous substances for
medical treatment, and preventative biological products shall be subject to the
state regulations, if any.
Scope of Application for
Alteration:
Application by any and all of drug wholesale enterprises holding
the License of Drug Operation of Shanghai Municipality for alteration of license
items or registration items in the License of Drug
Operation.
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