Chinese(GB)     
Contact CFDA
   
HOME ABOUT CFDA WHAT'S NEW LAWS & REGULATIONS REGULATORY GUIDE DATA SEARCH SITE MAP
  Search      
Home >> Regulatory Guide  
Drugs
Review of the supplementary application for imported drugs (incl. from Hong Kong, Macao and Taiwan)
2013-12-06

I. Project name: Imported Drug Registration

II. Content of licensing: review of supplementary application for imported (incl. from Hong Kong, Macao and Taiwan) crude drugs, including the 1 and 2 supplementary application items in registration affairs as stated in Annex I of the "Administrative Measures for Imported Crude Drugs (Interim)", namely:
1. Change of applicant name
2. Change of the port of arrival


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

IV. Charges: No charge

V. Quantity restrictions: No quantity limit for the licensing

VI. List of application dossiers:
(I) Change of applicant name
Applicants should submit one copy of the following information.
Information No (1) "Application Form for Imported Crude Drugs"
Information No (2) Original "Approval letter for imported drugs";
Information No (3) Applicants “Drug Distribution License" or "Drug Production License", "Business License "(Photocopy);
Information No (4) Applicants “Drug Distribution License" or "Drug Production License", "Business License "(Photocopy);
Information No (5) The proof documents (copies) for approved change of corporate name and other items in "Drug Distribution License" or "d Drug Production License ", and "Business License".


(II) Change of the port of arrival
Applicants should submit one copy of the following information.
Information No (1) "Application Form for Imported Crude Drugs"
Information No (2) Original "Approval letter for imported drugs";
Information No (3) Purchase contract (copy).

VII. 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.

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) Administrative licensing decision:
CFDA should complete the administrative review within 20days after receiving supplemental application.
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 "Application Form for Imported Crude 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 20 days from the date of acceptance.
The above timeframe does not include the time for supplementary information.

XI. License validity:
The validity date of the "Approval letter for supplementary application for imported crude drugs" is the same as that of the original approval letter.

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

HOME | ABOUT CFDA | WHAT'S NEW | LAWS AND REGULATIONS | REGULATORY GUIDE | DATA SEARCH
| SITE MAP |
© CFDA
Constructed and Maintained by the Information Center of CFDA