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Drugs
Examination and approval for review of import (incl. from Hong Kong, Macao and Taiwan) of packaging materials and containers in direct contact with drugs
2013-12-06

I. Project name: Examination and approval for packaging materials and containers in direct contact with drugs

II. Content of licensing: Examination and approval for review of import (incl. from Hong Kong, Macao and Taiwan) of packaging materials and containers in direct contact with drugs

III. Legal basis: "Drug Administration Law", " Regulations for Implementation of Drug Administration Law", " Regulations for Management of Packaging Materials and Containers in Direct Contact with Drugs"

IV. Charges: No charge

V. Quantity restrictions: No quantity limit for the licensing

VI. List of application dossiers:
"Drug PMC Supplementary Application Form"
Information Number (1) photocopy of Drug PMC approval documents;
Information No (2) Originals of quality inspection report of three batches of the applied products after variety changes issued by inspection agencies set or designated by CFDA;
Information No (3) Originals of the Cleanliness inspection reports of clean room (area) of production sites issued by inspection agencies set or determined by CFDA;
Information No (4) Source proof, quality standards and ex-factory quality inspection report of changed raw materials;
Information No (5) Source proof, quality standards and safety amount of changed excipients;
Information No (6) Comparative study data of production process before and after the changes;
Information No (7) Registration standards before and after the change and explanations for such changes;
Information No (8) Originals of quality self-test reports of three batches of the applied products after the changes;
Information No (9) Stability test data (including quality standards of test drugs) of the applied PMC together with the drugs;
Information No (10): floor plan of production site and clean room (area) after the change;
Information No (11) Relevant documents, notarized document and their Chinese translation for applications for changes of "Company name" or "registered address" approved by competent authority of importing country of the drug PMC manufacturers;
Information No (12) For imported PMC manufacturers entrust new Chinese agencies to apply for registration application, entrustment documents, notarized document and their Chinese translation. A copy of the new Chinese agency’s Business License, and proof documents of waiver of agenting from the original agency.
For different supplementary applications, the above information shall be submitted in accordance with Annex V of "Regulations for the management of packaging materials and containers in direct contact with drugs".

VII. Requirements for application dossiers:
(I) General requirements for application dossiers:
1. The first page of the application dossiers should be a project directory in which the application items shall be arranged in the order specified in Annex V of the "Regulations for the management of packaging materials and containers in direct contact with drugs" (CFDA Order No. 13). Each data shall indicate on the cover: PMC names, data item number, item name, applicant’s contact name, phone, address.
2. The Dossier should use A4 paper to print or copy, the contents should be clear and not to be altered. The Information should be complete and standardized, the data truthful and reliable.
3. The dossiers should be enclosed in sets into a Portfolio, whose envelope shall be marked with: Application classification, registration category, PMC name, X set/ Xth bags/ X in total, original/copy, the contact person, telephone, and name of the agency for registration application.
4. Submit two sets of complete application dossiers (1set of originals, one set of copies), 3 copies of the application forms (2 in the originals, 1 in the copies).
5. "Drug PMC Supplementary Application Form": Download from CFDA website (www.cfda.gov.cn) The "Application Form for Developing the Offer Program ", fill in as required for print and filing.
6. Along with the submission or mail of the application dossiers, their electronic version shall be sent to the following Administrative Center by e-mail. e-mail address: slzx@cfda.gov.cn.
7. The data verification code of the electronic application forms should be consistent with paper application forms.
8. All application materials should be in Chinese accompanied by English translations, or other languages for reference. Chinese translation should be consistent with the original content.

(II) Specific requirements for application dossiers:
1. "Drug PMC Supplementary Application Form": should be filled according to the explanatory notes, with signatures or seals (if any) of all the applicants.
2. Proof documents:
(1) Drug PMC approval documents or copies of alteration proof documents issued by CFDA
(2) Relevant documents, notarized document and their Chinese translation for applications for changes of "Company name" or "registered address" approved by competent authority of importing country of the drug PMC manufacturers;
The applicant shall submit copies of the proof documents issued by the government departments of country of origin to approve its engagement in the production and distribution of drug PMC (similar to Chinese Business License, Production License or Registration Certificate, etc.), the original copy of notarized documents issued by public notary office and their Chinese translation. If the above-mentioned special approval documents are not required by the government of the country of origin, such information need not to be submitted after explanation of related information.
(3) Originals of the entrustment documents from overseas manufacturers to Chinese agencies for registration application, originals and Chinese translations of notarized documents issued by public notary offices of the country of origin
(4) Copies of Chinese domestic agency’s "Business License" or "Registration Certificate of Foreign Enterprises’ Permanent representative office in China "
3. Other information shall be filed in accordance with Annex V of the "Provisions for the management of packaging materials and containers in direct contact with drugs" (CFDA Order No.13).

VIII. Diagram of application procedures:

Items call for technical review:

Items not call for technical review:

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:
After acceptance, if CFDA considers it as necessary, the technical review shall be organized and completed within 40days. If additional information is needed, CFDA shall issue a Notice for supplementary information to inform the applicant in full of the required supplementary information, the latter shall supplement the information once for all within four months. If they failed to do so within the time limit specified, the application for review shall be rejected


(III) Administrative licensing decision:
CFDA shall complete the examination and approval within 20 days after completion of the technical review. The decision shall be made in the "Approval letter for drug PMC supplementary application"; explanations shall be made for disapprovals; and renewal of "Registration certificate for Drug PMC" or "Registration certificate for import of drug PMC" shall be accompanied by announced cancellation of the original certificates. (Note: CFDA shall complete the examination and approval within 20 days after completion of the technical review, if not, an extension of 10 days can be granted upon approval of competent CFDA leaders; application for an extension above 10 days shall be submitted to the State Council for approval.)


(IV) 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.


(V) Re-review:
If the applicants disagree with the decision of disapproval, they can apply to CFDA for reconsideration within 10days upon receipt of the disapproval decision. The contents of the reconsideration shall be limited to the original application items and the original dossiers and samples submitted.
After receiving the application for reconsideration, CFDA shall make the decision for re-review within 50 days. If the original disapproval decision is canceled after re-review, the appropriate Drug PMC approval documents shall be issued; if the original decision is maintained, repeated application for reconsideration shall not be accepted by CFDA.

X. Commitment time frame:
(I) Supplementary application that needs for technical review:
Administrative licensing decision shall be made within 60 days from the date of acceptance. (Note: CFDA shall complete the examination and approval within 20 days after completion of the technical review, if not, an extension of 10 days can be granted upon approval of competent CFDA leaders; application for an extension above 10 days shall be submitted to the State Council for approval.) The above timeframe does not include the time for supplementary information and the corresponding review.


(II) Supplementary application that do not need technical review:
Administrative licensing decision shall be made within 20 days from the date of acceptance. (Note: CFDA shall complete the examination and approval within 20 days after completion of the technical review, if not, an extension of 10 days can be granted upon approval of competent CFDA leaders; application for an extension above 10 days shall be submitted to the State Council for approval.) The above timeframe does not include the time for supplementary information and the corresponding review.

XI. License validity and renewal:
The "Approval letter for drug PMC supplementary application," or renewed "Registration certificate for import of drug PMC " has the same validity as the original document, if production or import is still necessary, application for renewal shall be made six months before the expiry.

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

XIII. Authority of implementation:
Authority of implementation: CFDA
Location for acceptance: 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 TIPS counts on working days, excluding legal holidays

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