Processing Authority: Safety Control Office under Shanghai Food and Drug
Administration; the food and drug sub-administration at district/county
level
Processing Procedures:
1. Application
Any and all of medical
institutions shall, upon application for the Signature Card of Purchase and Use
of Narcotics/Class I Psychotropic Drugs, present any and all of materials as
follows:
a. the report of application in writing;
b. the relevant
documents of approving use of narcotics/Class I psychotropic drugs by the public
health administration at district/county level upon due review;
c. the
Application Form for Signature Card of Purchase and Use of Narcotics/Class I
Psychotropic Drugs (in duplicate);
d. the (xerox copy of the) license for
practice of medical institution;
e. the name list of doctors who are entitled
to prescribe narcotics; and
f. the management system of narcotics//Class I
psychotropic drugs (Five Specials: special safekeeping person, special locked
counter, special accounting book, special registration book, and special
prescription, buy-in, use and storage)
2. Acceptance, Review, and
Approval
1) Any and all of medical institutions shall, upon application for
the Signature Card of Purchase and Use of Narcotics/Class I Psychotropic Drugs,
apply to the competent food and drug sub-administration which governs the place
where they are located, which shall, upon first review, report to Shanghai Food
and Drug Administration for final review and approval.
2) The competent food
and drug sub-administration which governs the place where they are located
shall, within ten working days upon receipt of the complete materials necessary
for such application, complete the review of materials and filed survey.
Shanghai Food and Drug Administration shall, within five working days, complete
the due review whereof.
Processing Address: Room 1102, No. 189, Pu'an Road,
Shanghai
Processing Basis: 1. Measures for Administration of Narcotics
promulgated by State Council on November 28th, 1987;
2. Measures for
Administration of Psychotropic Drugs promulgated by State Council on November
28th, 1987; and
3. Measures for Administration of Supply of Narcotics/Class I
Psychotropic Drugs by Medical Institutions under Guo Yao Guan An [2000] No.
60
Contact Tel: 021-63879380
Processing Time: Mondays: 9:00~12:00
Time
Limit for Processing: the sub-administration: within 2 working days for
confirmation of acceptance; and within 10 working days for first review;
and
the municipal administration: within 5 working days for final
review.
Qualified Application Subject:
Any and all of medical
institutions
1. that are within the administrative jurisdiction of Shanghai
Food and Drug Administration (excluding medical institutions of the Chinese
People's Liberation Army and military police); and
2. that hold relevant
documents of approving use of narcotics/Class I psychotropic drugs by the public
health administration at district/county level upon due
review;
Qualifications/Prerequisites for Application:
Any and all of
medical institutions with certain number of sickbeds and conditions for medical
operation or certain medical technologies. |
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