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Notice on examination & approval of the import of narcotic drugs and psychotropic substances for clinical use
2013-12-05

I.Project name: Examination & approval of the import & export of narcotic drugs and psychotropic substances

II.Contents of licensing: Examination & approval of the import of narcotic drugs and psychotropic substances for clinical use

III.Basis for implementation: "Drug Administration Law"

IV.Fees: RMB150Yuan
Charging basis: "Notice of The National Development and Reform Commission and the Ministry of Finance on the Adjustment of Fees for Drug Review, Approval and Tests" [J.J.G. (1995) No.340]

V.Quantity restrictions: No quantity limit for the licensing

VI.List of application documents:
Data number (1) Application form for imported of special drugs;
Data number (2) Copies of the purchase contract or orders;
Data number (3) A copy of the "Imported Drug Registration Certificate" or "Pharmaceutical Product Registration Certificate" (original or copy) (import application for special drugs needed in teaching, research and clinical use may not provide these documents);
Data number (4) Copies of import units’ "Drug Distribution License", "business license", "Import and Export Enterprise Qualification Certificate" (or "Foreign trade operators Registration Form"), and "Organization code certificate"; if drug manufacturers import the APIs and intermediates preparations required by productions (including domestically sub-packaged preparations), they should submit the Copies of "Drug production license", "Business license", and "Organization code certificate";
Data number (5) If the export unit is the sales agent for this drug, the applicant needs to provide in addition the documents proving legal qualification of the export unit, the notarized documents and their Chinese translations.
The application for "Narcotic (psychotropic) drugs import license" in initial import of narcotic drugs and psychotropic substances for medical use must be preceded by technical review.

VII.Requirements for application dossier:
(I)General requirements for the dossier:
1.The application form shall be printed or copied single-sided in A4 size paper, the application items and contents should be accurate, complete and clear.
2.The application form shall be filled in a standard manner and the certifying documents must be valid.
3.The applicants should send E-mail, along with the mail or submission of their application dossier, the electronic version of the application form to the following e-mail address: slzx@cfda.gov.cn, which is dedicated for drug registration.
4.All of the above copies shall be stamped with the official seal of the import unit.


(II)Specific requirements for application document:
1.Application form for imported of special drugs;
The form must be accurate, standardized, and meet the requirements of explanatory notes, and must be stamped with the official seal of the units.
The first entry of the application form shall be filled with the name and address of the import unit, which shall be consistent with those in the certificates submitted.
The application form should indicate the specific import and export ports (no more than two).
2.Copies of the purchase contract or orders;
The contract or order shall be signed and sealed by representatives of the buyers and sellers, and the signer's names and duties shall be indicated.

VIII.Application process diagram:

IX.Approval procedures:
(I)Acceptance:
After the Application is made to the Administrative Service Center, and the application dossier submitted in order listed in Article VI of this "Notice", the work staff shall review the format. Where the application item is not subject to administrative approval according to law, a decision of non-acceptance shall be notified to the applicant immediately. Where the application item is not within the functions of the administrative authority, a decision of non-acceptance shall be made immediately, and the applicant shall be informed to launch the application to relevant administrative authority. Where in the application dossier, there are errors that can be corrected on the spot, the applicant shall be allowed to make the corrections on the spot. Where the application dossier is incomplete or does not meet the statutory format, the applicant shall be informed of all the supplements and amendments to be made once and for all on the spot or within five days. If the applicant is not informed within the above-mentioned period, the application shall be deemed as accepted from date of receipt of application materials. Where the application dossier is within the functions of the administrative authority, the application materials are complete and comply with the statutory format, or where the applicant has submitted all supplements and amendments in accordance with the requirements of the administrative authority, the application for administrative approval shall be accepted.

(II)Validation:
CFDA should make a decision for approval or disapproval within be 10 days from the date of acceptance. For qualified application, the "Import license for narcotic drugs" or "Import license for psychotropic substances" shall be issued; for disapprovals, reasons shall be given in writing.

(III)Delivery:
Within 10 days from the date of decision making of administrative examination and approval, CFDA Administrative Service Center shall deliver the decision to the applicants.

X.Commitment time frame:
The administrative approval decision shall be made within 10 days from the date of acceptance.

XI.License validity:
The "Import license for narcotic drugs" and "Import license for psychotropic substances" shall be valid for one year.

XII.Annual inspection or annual review of the license: None

XIII.Authority of Implementation:
Implemented by: CFDA
Accepted at: CFDA Administrative Service Center

XIV.Institutions for inquiries and complaints:
Inquiries: CFDA
Complaints: CFDA Bureau of Investigation and Enforcement, Department of Legal Affairs
Note: The time frame of this Notice counts on working days, excluding legal holidays

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