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Processing Authority: Drug Safety Supervising Department of Shanghai Drugs
Administration Bureau
Processing Procedures:
I. Application
The drug manufacturers, teaching
and researching entities, pointing entity to distribute caffeine, and other
enterprises who apply for the employing of caffeine should submit the following
documents:
For initial application enterprises (including one-off
application):
1. Drug manufacturers who use caffeine as raw material:
a.
Written application report for using caffeine;
b. Drug registration number or
clinical trial approval of the compound preparations including caffeine and
other raw material drug that using caffeine as intermediary (xerox
copies);
c. Drug prescriptions (photocopy);
d. Managing mechanism of
caffeine (including system of purchasing, employing, and storage);
e. Promise
letter of the legal entity using caffeine;
f. Letter of introduction from the
entity, ID card and photocopy of the person
2. Using caffeine as raw material in food, beverage, light industry, chemical
industry, and researching entities:
a. Validity testimonial for the entities
that using caffeine (xerox copies);
b. Approval number of the food or
testimonial of the effectual prescription (xerox copies);
c. Testimonial for
the necessity of using caffeine in the production, related technical documents,
and consuming ration of caffeine;
d. The entity with municipal administrating
authority need submit written application with approval of the authority. Entity
without administrating authority need submit written application of the entity
with juridical person status;
e. Managing mechanism of caffeine (including
system of purchasing, employing, and storage);
f. Promise letter of the legal
entity using caffeine;
g. Letter of introduction from the entity, ID card and
photocopy of the person
For non-initial application enterprises:
a.
Written application report for using caffeine;
b. Value-added tax invoice of
purchasing caffeine last time (xerox copies);
c. Letter of introduction from
the entity, ID card and photocopy of the person.
II. Application accepting and approving
Drug Safety Supervising Department
of Shanghai Drugs Administration Bureau will issue the Certificate of Caffeine
Purchase and Use to qualified non-initial applicant within 1working day after
receiving complete application documents; For initial purchasing applicant, the
time will be within 7 working days.
Processing Authority: Drug Safety Supervising Department of Shanghai Drugs
Administration Bureau
Processing Address: Room 1102, No. 189 Pu-An Road
Contact Tel:
021-63879380
Processing Time: Monday 9:00 a.m.―12:00 a.m. and 1:00 p.m.―5:00
p.m.
(Special circumstances will be dealt specially)
Time Limit for Processing: 7 working days for initial purchasing and
employing application, and 1 working day for non-initial application
Processing Address: Room 1102, No. 189 Pu-An Road
Processing Basis:
Administrating Rules on Spirit Drug (February 27th
1988)
Administrating Regulations on Caffeine (promulgated by Order No. 28 of
State Drugs Administration Bureau
Qualified Application Subject:
The drug manufacturers, medical and
researching entities, pointing entity of distributing caffeine, and other
enterprises within Shanghai administration scope, which use caffeine.
Qualification of the applicants:
Drug manufacturers with drug registration
number or clinical trial approval of compound preparations including caffeine;
Drug manufacturers using caffeine as intermediary to produce other medical
raw material;
Teaching and researching entity, and other entity which is
approved to use caffeine;
Pointing entity for the distribution of
caffeine.
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