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Drugs
Examination and approval for temporary import of drugs (incl. from Hong Kong, Macao and Taiwan)
2013-12-06

I. Project name: Imported Drug Registration

II. Content of licensing: Examination and approval for temporary import of drugs (incl. from Hong Kong, Macao and Taiwan) (Released on November 5, 2012)

III. Legal basis: "Drug Administration Law", "Regulations for Implementation of Drug Administration Law", and the "Administrative Measures for Imported Crude Drugs (Interim)"

IV. Charges: RMB 2000yuan.
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 dossiers:
Information No (1) "Application Form for Imported Crude Drugs"
Information No (2) Applicants “Drug Distribution License" or "Drug Production License", "Business License "(Photocopy);
Information No (3) Legal registration proof documents of the supplier (such as "Business License", etc.) (photocopy);
Information No (4) Purchase contract (copy);
Information No (5) Crude drugs’ quality standards and their sources.

VII. Requirements for application dossiers:
(I) General requirements for application dossiers:
1. The dossiers should use A4 size paper for print or copy, the content should be complete, standardized and clear; shall not be altered, the data must be real and reliable.
2. Submit a complete set of application dossiers.
3 "Application Form for Imported Crude Drugs": download from CFDA website (www.cfda.gov.cn), fill and print as required and save with the seal of the applicant and the signature of their legal representatives.
4 Along with the submission or mail of the application dossiers, their electronic version shall be sent to the Administrative Service Center by e-mail. e-mail address: slzx@cfda.gov.cn.
5. Foreign materials should be translated into Chinese.
6. All copies shall be stamped with the official seal of the applicant.

(II) Specific requirements for application dossiers:
1. "Application Form for Imported Crude Drugs" should be filled out in an accurate and standardized manner that conforming the described requirements.
(1) Classification of approval documents: for endangered species of crude drugs, the applicant may only apply for "single-use approvals."
(2) Quantity (kg): the quantity applied should be less than or equal to that recorded in the contracts.
(3) Inspection criteria: shall be consistent with the applicable standards in "Catalog of non-initial imported crude drugs" (first batch).
(4) Delivery Port: Fill in according to the relevant provisions of Article IV of the "Administrative Measures for Imported Crude Drugs (Interim)".
(5) Ports or border port (Food) and Drug Administration: Fill in according to the relevant provisions of Article III of the "Administrative Measures for Imported Crude Drugs (Interim)".
(6) The form shall be signed and sealed by the applicant as required.
2. Applicants “Drug Distribution License" or "Drug Production License", "Business License "(Photocopy).
Should be within the validity period, and the information of company name, address and legal representative shall be consistent with those recorded in the application form.
3. Legal registration proof documents of the supplier (such as "Business License", etc.) (photocopy).
Should be within the validity period, and the information of company name, address and legal representative shall be consistent with those recorded in the application form.
4. Purchase contract copy.
The information of the Product, the name and address of the applicant and supplier company should be consistent with the corresponding content in the application form.
5. Crude drugs’ quality standards and their sources.
The information provided shall correspond with the "13 inspection standards" in the application form, and the content should be consistent with the "No.144 notice" or relevant quality standards (eg, ChP standards).

VIII. Diagram of application procedures:

IX. Licensing procedures:
(I) Acceptance:
After the Application is made to the Administrative Service Center, and the application dossiers submitted in order listed in Article VI of this "TIPS", the work staff shall review the format. If the application items are not subject to administrative examination and approval according to law, the decision of non-acceptance shall be immediately made. If the application items are not within the purview of the executive authorities, the decision of non-acceptance shall be immediately made and the applicant shall be informed to apply to related administrative institutions; .If the application dossiers have errors that can be corrected on the spot, the applicant shall be allowed to correct on the sport; if the application dossiers are incomplete or do not meet the statutory form, the applicant should be informed in full to enrich or rectify the relevant contents on the spot or within five days. If they are not informed, the application dossiers shall be deemed accepted from date of receipt. If the application dossiers are within the scope of the administrative institutions, the application materials are complete and comply with the statutory form, or the applicant has submitted all application materials in accordance with the requirements of the administrative authorities for enrichment or correction, the application shall be accepted for administrative examination and approval.


(II) Technical review and decision of administrative licensing:
After the Administrative Service Center accepted the application, CFDA should complete the technical review and administrative examination within 30 days.
During the review process, CFDA shall provide a comprehensive suggestion for supplementary information, if necessary.
The applicant shall submit within four months the appropriate supplementary information after receiving a Notice for additional information, an extent of 20 days on the basis of the original review time limit shall be ;given, withdrawal of review shall be applied to overdue supplementary information. The applicant must submit a written application to CFDA for supplementary information that cannot be submitted within the specified time limits due to force majeure, and explain the reasons.
CFDA shall respond within 20 days for the handling of such cases.


(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.


(IV) Re-review:
With any objections to disapproval decisions made by CFDA, the applicant can submit a written application for re-review within 10 days upon receipt of the decision and elaborate the reasons.
The contents of the review shall be limited only to the original application items and the original application dossiers.
After receiving the application for re-review, CFDA shall re-review the application in accordance with the original time limits and requirements, and make a decision for re-review. If the disapproval decision is cancelled, the appropriate "Approval letter for imported drugs" shall be issued to the applicant; if the original decision is maintained, CFDA shall no longer accept repeated application for re-review.

X. Commitment time frame:
Administrative licensing decision shall be made within 30 days from the date of acceptance.
The above timeframe does not include the time for supplementary information.

XI. License validity:
The validity periods for single-use and repeated-use approval documents are one and two years, respectively.

XII. Authority of implementation:
Authority of implementation: CFDA
Location for acceptance: CFDA Administrative Service Center

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

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 TIPS counts on working days, excluding legal holidays

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