Ⅰ.Project name: health food approval
Ⅱ.Content of licensing: Renewal of registration of imported health food products (incl. from Hong Kong, Macao and Taiwan)
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) Imported health food registration application form;
Data number (2) 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 (3) 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 (4) Documents issued by the relevant authorities of the producing countries (or regions) to prove the manufacturer’s compliance with the corresponding local GMP, and to allow the production and sale of the product, which must be notarized by the notary institutions of the country (region) and confirmed by Chinese embassies and consulates;
Data number (5)A summary of imports & sales in China within five years;
Data number (6) A summary of Chinese consumers’ feedback of the product within five years
Data number (7) Real samples of the health food’s minimum sales package, labels and package inserts
Data number (8) The fomula, production process and funtional component content or major component content and the detection methods of the health food. and quality standard；
Data number (9) Technical requirements and Confirmation form of successful upload of technical requirements;
Data number (10) letter of commitment
VII.Requirements for application dossier:
(I) General requirements for the dossier:
1. The first page of the application dossier is a list of the application documents, which shall be arranged in order required by the "attached information" in "Health food registration application form". 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 renewal of application, the applicant shall submit 1 full set of original application dossier and 8 copies, the copies shall be copied from the original and fully consistent with the original, and shall remain intact and clear.
4. Except for the "Health food registration application form", testing report issued by the testing institutions, notarized documents, the application 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 application for renewal of registration, 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. If renewal of application has been accepted, registration application for changes and technology transfers shall no longer be accepted; if the registration applications for product change and technology transfer that are already accepted, the applicant shall submit an application for renewal within 30 days after approval.
(II) Specific requirements for application documents:
1. Application form for renewal of registration of imported health food;
(1) Application form for renewal of registration of health food 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. 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 foreign manufacturers, the applicant shall provide the original notarized certificate of entrustment (which shall comply with the requirements for application documents of new products) and the copies of business licenses of the agencies.
3. Original proof of health food approval documents (including health food approval certificate and its attachments, and approval documents for changes of health foods);
4. Documents issued by the relevant authorities of the producing countries (or regions) to prove the manufacturer’s compliance with the corresponding local GMP, and to allow the production and sale of the product, which must be notarized by the notary institutions of the country (region) and confirmed by Chinese embassies and consulates; The proof document must meet the following requirements:
(1) If the applied product is produced by overseas manufacturers upon the applicant’s entrustment, the applicant shall provide documents proving that the manufacturer has been trusted, as well as the certificate of entrustment.
(2) The certifying documents shall specify the name of institution issuing the documents, product name, manufacturer name and date of issuance.
(3) The institution issuing the documents shall be authorities or industry associations of the producing country.
5. A summary of imports & sales in China within five years;
6. A summary of Chinese consumers’ feedback of the product within five years
7. Real samples of the health food’s minimum sales package, labels and package inserts
8. The health food’s recipes, technologies, functional components or characteristic ingredients, testing methods, and product quality standards, which shall be consistent with the corresponding contents in the approval documents.
9. Technical requirements and Confirmation form of successful upload of technical requirements;
10. Letter of commitment.
(1) If the technical requirements are unchanged, the applicant shall provide a letter of commitment.
(2) If the functionality evaluation methods and other technical requirements have changed, the applicant shall provide the testing reports and other relevant information proving the product’s compliance with the existing standards.
11. If the above information cannot be provided completely, the applicant must give written explanations in renewal of application.
VIII.Application process diagram:
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 IV: Application dossier for renewal of registration of imported health food ". 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.
From the date of acceptance, CFDA shall make the decision for examination and approval within 20 days. 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. In case the applicant can't submit the supplementary information within specified time limit under special condition, he /she shall apply to CFDA in written and provide reason, CFDA shall make settlement opinions within 20 days. 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. For qualified applications, the product shall be re-registered, and renewal certificate shall be issued to the applicant; for rejected applications, the product will not be re-registered, CFDA shall issue a public notice to cancel the approval No. of the health food.
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 20 days from the date of acceptance.
XI.Authority of Implementation:
Implemented by: CFDA
Accepted at: CFDA Administrative Service Center
XII.License validity and renewal:
"Renewal certificate of imported health food" is valid for five years, 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:
Complaints: CFDA Bureau of Investigation and Enforcement, Department of Legal Affairs
Note: The time frame of this Notice counts on working days, excluding legal holidays