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Application for Signature Card of Purchase and Use of Narcotics/Class I Psychotr

[2008-12-23 16:54:10]

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.
Source: 上海市人民政府
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