I. Project name: Examination and approval for packaging materials and containers in direct contact with drugs
II. Content of licensing: Registration renewal 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:
"Application form for registration renewal of Drug PMC"
Information No (1) Drug PMC approval documents or alteration proof documents issued by CFDA;
Information No (2) Manufacturer’ legal production qualification documents, notarized documents and their Chinese translations;
Information No (3) Overseas Pharmaceutical Manufacturers’ entrustment of Chinese agents for application shall provide entrustment documents, notarized documents and Chinese translations. Chinese agents’ Business License or " Registration Certificate of Foreign Enterprises Permanent Representative in China " of Overseas Pharmaceutical Manufacturers’ Chinese Permanent Representatives;
Information No (4) Quality inspection report of three batches of applied product issued by drug packaging inspection agency set or determined by CFDA;
Information No (5) Clean room (area) cleanliness inspection reports and self-test report of three batches of products;
Information No (6) Formulations of Applied product;
Information No (7) Elaborations of applied products’ production process and main production and testing equipments;
Information No (8) Quality standards of applied products;
Information No (9) Summary report of the products’ sales and quality status within three years in China;
Information No (10) Performance of the required formalities for registration approval or renewal.
Specific requirements for the above application dossiers are detailed in Annex IV 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 IV 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),3copies of the application forms (2 in the originals, 1 in the copies).
5. "PMC Registration 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: email@example.com.
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. "PMC Registration Renewal 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) Manufacturer’ legal production qualification documents, notarized documents and their Chinese translations
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. Test reports:
(1) Original copy of quality inspection report of three batches of the applied product issued by drug PMC inspection agencies set or determined by CFDA, that may be submitted separately after the technical review process.
(2) Original of Clean room (area) cleanliness inspection reports within one year of the application date shall be submitted.
(3) The self-test report of three batches of the applied products shall be submitted
(1) If changes occur as compared to the contents of the last registration, the specific changes should be noted and indicated on the Application Form.
(2) If quality standards are changed, the applicant should provide the original quality standards, the revised quality standards and the instructions for revision.
(3) Changes of the foreign manufacturers should be indicated on the application form.
(4) For changes of agencies, the applicant shall provide the entrustment documents, notarized documents and their Chinese translations of new Chinese agencies authorized by overseas manufacturers of the imported drug PMC. A copy of the new Chinese agency’s Business License, and proof documents of waiver of agenting from the original agency.
5. Final Report:
Should include annual sales in China, drug manufacturers using such PMC, list of drug products packaged with such PMC, the user's evaluation, quality inspection, drug PMC manufacturer’s self-test pass rate for this product, quality accidents and government quality sampling etc.
6. Other information shall be filed in accordance with Annex IV 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:
IX. Licensing procedures:
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) PMC Registration inspection:
The applicants shall submit three consecutive batches of samples to drug PMC inspection agencies set or determined by CFDA. Drug PMC inspection agency shall perform test within 60 days after receiving the registration notice and samples, issue test report and submit to CFDA. CFDA shall conduct on-site inspection of the development of imported drug PMC and production conditions, and take samples.
(III) Technical review:
CFDA shall organize and complete the technical review within 50 days after receiving the test report and opinions, if additional information is needed, CFDA shall issue a notice for supplementary information to inform in full the applicant of the required supplementary information. The applicants shall complete once for all the required information within four months, if they failed to do so, the application for review shall be rejected.
(IV) Administrative licensing decision:
CFDA shall complete the examination and approval within 20 days after completion of the technical review. If a decision cannot be made within 20 days, an extension of 10 days may be granted upon approval of competent CFDA leaders. For compliance, registration renewal and renewal of "Registration Certificate for import of drug PMC " shall be approved.If the requirements are not met, a "Notice of approval opinion" shall be issued.(Note: CFDA Shall complete the examination and approval within 20 days after completion of the technical review; if CFDA failed to so, an extension of 10 days can be granted upon consent of the competent CFDA leaders)
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.
(VI ) 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:
Administrative licensing decision shall be made within 130 days from the date of acceptance.(Note: CFDA Shall complete the examination and approval within 20 days after completion of the technical review; if CFDA failed to so, an extension of 10 days can be granted upon consent of the competent CFDA leaders.)
The above timeframe does not include the time for supplementary information and the corresponding review.
XI. License validity and renewal:
"Registration Certificate for Import of Drug PMC" is valid for five years. If the import is still necessary upon expiry of the Registration Certificate, the applicant shall apply for renewal 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:
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