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Health Food
Notice on registration of overseas transfer of imported (incl. from Hong Kong, Macao and Taiwan) health food products
2013-12-05

I.Project name: health food approval

II.Content of licensing: Registration of overseas transfer of imported (incl. from Hong Kong, Macao and Taiwan) health food products

III.Basis for implementation: "People's Republic of China Food Hygiene Law," "Provisions for Health Food Registration (Interim)", "Focuses for Acceptance and Inspection of Health Food Examination and Approval"

IV.Fees: No charge

V.Quantity restrictions: No quantity limit for the licensing

VI.List of application documents:
Data number (1) Application form for registration of health food technology transfer;
Data number (2) Certifying documents of the transferee’s countries (regions) to allow the production and sales of the product, which shall be notarized by the notary institutions of the country (region), and confirmed by the Chinese Embassy in the country;
Data number (3) Certifying documents issued by related authorities of the transferee’s country (region) to prove the product manufacturer’s compliance with local GMP;
Data number (4) The transfer contract must notarized by the notary institutions of the transferee's country (region), and confirmed by the Chinese Embassy;
Data number (5)Registration affairs run by Overseas Pharmaceutical Manufacturers’ Permanent Representative Agencies in China shall provide a copy of "Registration certificate of Overseas Pharmaceutical Manufacturers’ Permanent Representative Agencies in China". For registration affairs run by domestic agencies entrusted by overseas manufacturers, the applicant shall provide the original notarized certificate of entrustment and the copies of business licenses of the agencies.
Data number (6) Original proof of health food approval documents (including health food approval certificate and its attachments, and approval documents for changes of health foods);
Data number (7) Testing report issued by designated testing institutions on the effective ingredients or characteristic ingredients, hygiene and stability testing of three consecutive sample batches;
Data number (8) Letter of commitment of no engagement in illegal activities within 2 years;
Data number (9) Three consecutive batches of the samples produced by the transferee, the amount of which shall triple the amount required for testing.

VII.Requirements for application dossier:
(I) General requirements for the dossier:
1. The first page of the dossier is a list of the application documents, which shall be arranged in order required by the "attached information" in "Application form for registration of health food technology transfer". Each dossier shall have a cover page indicating the name of the product and the applicant, and the dossier title shall be marked at the upper right corner. The dossier shall be distinguishable with clear markers, and the name and serial number of the dossier shall be indicated. The full set of dossier shall be punched and bound into a book.
2. The dossier shall be printed in A4 size paper (Chinese characters not less than font-size junior 4 in Song typeface, English not less than font-size 12), the contents shall be complete, clear, without alteration.
3. For registration application for product technology transfer, a full set of original documents shall be submitted.
4. Except for the "Health food registration application form", testing report issued by the testing institutions, notarized documents, the dossier shall be stamped page by page or cross-page stamped, for joint application, the seals of all applicants shall be stamped, and technology transfer shall be stamped with the seals of both the transferor and the transferee. the seal shall be stamped in the text place. The seals shall comply with the state’s relevant provisions for standard management and legally binding. If the applicant for imported health food has no official seal, the signature or signature seal of the legal representative will do.
5. For joint application, the applicants shall provide a letter of recommendation of the person in charge.
6. The same content in the application dossier (eg product name, name of the applicant, the applicant's address, etc.) shall be consistent. The same content of electronic version and text version (product name, name & address of the applicant, product formulation, development unit name & address, product acceptance number) shall be consistent.
7. Foreign language in product formulations, production processes, quality standards, labels and package inserts and other relevant documents shall be translated into standard Chinese; the same rule applies to the abstracts, keywords and contents related to product health functions and safety in foreign references (except for foreign names and addresses).
8. Dossier for non-initial application shall provide the copy of the Notice for Withdrawal of Review or Notice of Disapproval (stamped with official seal of the applicant), as well as the grounds for re-application, which shall be attached to the dossier's first page.
9. In registration of health food technology transfer, the name and address of the applicant's business license shall be consistent with those in the health food approval certificate. In the case of inconsistency, the applicant shall be required to provide supporting information has been filed (stamped with the official seal of the applicant).
10. The applicant shall apply for change and registration of product technology transfer three months before the expiry of the health food approval certificate; if renewal application has been accepted, the application for change and technology transfer shall not be accepted simultaneously; if the product’s change request and technology transfer has been accepted, the applicant shall apply for renewal within 30 days after approval
11. The above-mentioned photocopies must be stamped with the official seal of the holders of the originals.


(II) Specific requirements for application documents:
1. Application form for registration of health food technology transfer;
(1) Application form for registration of health food technology transfer can be downloaded from CFDA website (www.cfda.gov.cn) or CFDA Health Food Evaluation Center Web site (www.bjsp.gov.cn).
(2) The form shall be filled as per the requirements of detailed instructions.
(3) The contents of the application form must be printed to fill in, the entries shall be complete, standardized and without alteration.
(4) Health functions being applied shall be consistent with those announced by CFDA. Except for application of new functions
(5) The applicant of imported health food products shall be the owners of the products, while manufacturers of the products are the actual producers (if the applied product are produced by the applicant, the manufacturer is the applicant; if the applied product is produced by overseas enterprises upon entrustment, the manufacturers shall be entrusted enterprises).
(6) Product name shall include the brand name, generic name and attribute names.
2. Certifying documents of the transferee’s countries (regions) to allow the production and sales of the product, which shall be notarized by the notary institutions of the country (region), and confirmed by the Chinese Embassy in the country;
3. Certifying documents issued by related authorities of the transferee’s country (region) to prove the product manufacturer’s compliance with local GMP;
4. Contract of transfer. The contract must be notarized by notary institutions of the country (region), and confirmed by Chinese embassies and consulates there. Shall be translated into standard Chinese and notarized by notary organization within China.
5. Registration affairs run by Overseas Pharmaceutical Manufacturers’ Permanent Representative Agencies in China shall provide a copy of "Registration certificate of Overseas Pharmaceutical Manufacturers’ Permanent Representative Agencies in China". For registration issues run by domestic agencies entrusted by overseas manufacturers, the applicant shall provide the original notarized certificate of entrustment, as well as a copy of the business license of the agency entrusted (the applicant shall separately apply for renewal, changes, replacement, error correction and other issues, one application can be submitted only after the completion of another).
6. Original proof of health food approval documents (including health food approval certificate and its attachments, and approval documents for changes of health foods);
7. Testing report issued by designated testing institutions on the effective ingredients or characteristic ingredients, hygiene and stability testing of three consecutive sample batches;
8. Letter of commitment of no engagement in illegal activities within 2 years;
9. Three consecutive batches of the samples produced by the transferee, the amount of which shall triple the amount required for testing.

VIII.Application process diagram:

IX.Approval procedures:
(I)Acceptance:
After the application is filed to the Administrative Acceptance Service Center, and the application dossier submitted is in accordance with the list in VI of this Notice, the format examination shall be conducted by the work staff of the Center in accordance with the "Provisions for Health Food Registration" Annex III: Application dossier for registration of overseas transfer of imported health food products". 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)Inspection and verification:
From the date of acceptance, CFDA issued a notice to designated testing institution within five days and provide testing samples. If necessary, CFDA can perform inspection on the transferee’s production site.
Testing institutions shall test the samples within 30 days after receiving notice of testing and samples, the testing report will be submitted to CFDA, with a copy to the applicant.

(III)Technical review and administrative review:
CFDA shall make the decision for review within 20 days after receipt of the sample testing report. During the review process, CFDA shall propose requests for supplementary information once for all to the applicant. The applicant shall submit supplementary information as required within five months after the receipt of requests, in case of failure of submitting the supplementary information within specified time limit, the application shall be rejected for review.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. The time for submission of supplementary information shall not be included in the time frame of licensing, the time limit of its review shall be extended by 30days on the basis of the original one. If registration is approved, CFDA shall issue a new "Imported health food approval certificate" and a new approval number to the transferee, the validity of the certificate is unchanged, while the transferee’s original "Imported health food approval certificate" shall be confiscated and canceled. Written explanations shall be given to rejected applications.

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

X.Commitment time frame:
The decision for licensing shall be made within 55 days from the date of acceptance.

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

XII.License validity and renewal:
The validity of the new "Imported health food approval certificate" is the same with that of the original certificate, if the validity period needs to be extended after expiry, the applicant shall apply for renewal three months before the expiry.

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 Notice counts on working days, excluding legal holidaysnd complaints:

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