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

Ⅰ.Project name: health food approval

Ⅱ.Content of licensing: approval for changes of imported health food (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) Application form for change of imported health food or Application form for record change of imported health food;
Data number (2) The names of specific issues for change, reasons, and basis;
Data number (3) 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 (4) Health food approval certificate and a copy of the annex;
Data number (5)Certifying documents and related information issued by relevant authorities of the producing country (region) to prove changes effective. The documents must be confirmed by notary institutions of the host country (region) and the Chinese Embassy in the country;
Data number (6) The documents shall be submitted according to specific changes and the "specific requirements for application documents."

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 specified in Annex II: Dossier items for imported health food’s request of change in the "Provisions for health food registration (interim)". 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 application 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 change of product registration,1 set of original dossier shall be submitted.
4. Except for the "Imported health food registration application form" and testing reports issued by testing institutions, 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 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. The same content in the application dossier (eg product name, name of the applicant, the applicant's address, etc.) shall be consistent.
6. 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).
7. The specific requirements for change of application dossier of product that has been accepted are as follows:
(1) Product formulation, manufacturing process, testing reports, and other content which may implicate product safety and functionality, shall not be changed.

(2) Except for the above contents, the applicant can submit written requests for necessary change to the original acceptance department, explain reasons for the change, specified the date of submission, and stamp with the seal of the original applicant. The applicant shall provide complete information after the change.
8. Documents 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 requests for change 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. The applicant shall apply for change of registration within three months before the expiry of the health food approval certificate; if renewal of registration has been accepted, the application for change of registration of the product shall not be accepted simultaneously; if the product’s change request has been accepted, the applicant shall apply for renewal of registration within 30 days after approval.
11. For products whose registration has been rejected by CFDA, its application dossier and samples are generally not refundable, except for the following: the already submitted "Certificate of entrustment"; proof of the product’s being produced and marketed in the producing country (or region) over a year; documents issued by relevant authorities of the producing country (or region) proving the manufacturer’s compliance of local GMP; and the original "health food approval certificate" (except for product under renewal of registration) -- if these documents are to be refunded, the applicant shall submit a written application within three months upon receipt of the disapproval decision.
12. The following contents set forth the Health food approval certificate, that may affect the safety and function, shall not be changed: name of the health food function, APIs (excipients), technology, consumption methods, expanding the range of applicable population, narrowing the scope of inapplicable population etc.
13. For application of change to the content of health food approval certificate and its attachments, the applicant shall submit a written application and indicate the specific name, reasons and basis for change, indicate the date of application, and stamp the applicant seal.
14. If testing reports are required, they shall be issued by CFDA-designated institutions.
15. If the applicant commissioned domestic agencies for change issues, the original entrustment certificate (which shall comply with the requirements for application dossier of new products) shall be provided.
16. The reasons and basis for change shall include certifying documents issued by regulatory agencies of the producing countries (or regions) approving changes, the documents shall be confirmed by notary institutions of the host country and confirmed by the Chinese Embassy (consulate) in the country.
17. The labels, package inserts (real samples) and quality standards whose request for change has been approved by the producing countries (or regions) shall attach the corresponding Chinese translation, and notarized by notary institutions in China.


(II) Specific requirements for application documents:
(1) Application form for imported health food or for record of change;


(2) The names of specific issues for change, reasons, and basis; The reasons and basis for change shall include certifying documents issued by regulatory agencies of the producing countries (or regions) approving changes, the documents shall be confirmed by notary institutions of the host country and confirmed by the Chinese Embassy (consulate) in the country.


(3) 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.


(4) Health food approval certificate and a copy of the annex;


(5) Certifying documents and related information issued by relevant authorities of the producing country (region) to prove changes effective. The documents must be confirmed by notary institutions of the host country (region) and the Chinese Embassy in the country;


(6) Specific requirements for different change requests

1) The applicant shall be holders of health food approval certificate.
2) For requests of change that narrow the applicable population and expand the scope of inapplicable population, the applicant shall provide, in addition to the above information, the real samples of the labels and package inserts after the change.
3) For change request in consumption (product specifications remain unchanged), the applicant shall provide, in addition to the above information, the following:
① Change request for consumption reduction shall provide the testing report issued by designated testing institutions who performed functionality evaluation testing in accordance with the proposed changes of consumption .
② Change request for increased consumption shall provide the testing report issued by designated testing institutions that performed toxicological & safety evaluation in accordance with the proposed changes of consumption, and the functionality evaluation testing report which compares the original consumption with the changed consumption.
③ Real samples of the changed labels and package inserts.
4) For application changing the product specifications, shelf life and quality standard, the applicant shall provide, in addition to the above information, the following:
① Evidence proving that the changes do not affect product safety and functionality, as well as relevant research data and scientific literature and/or testing reports. Among them, registration application changing the quality standards shall also provide testing data and literature for quality research.
② Self-test report on the effective ingredients or characteristic ingredients, hygiene and stability testing of three consecutive sample batches.
③ Three consecutive batches of required testing samples (except for changing the expiration date).
④ Real sample of labeling, package inserts and quality standard before and after the change.
5) For change request increasing the functions of health food, the applicant shall provide, in addition to the above information, the following:
① Functionality testing report of the increased functions issued by designated institutions
The real samples or manuscripts of changed Labels, package inserts and quality standards .
6) For Health food manufacturer’s requests of changing the production sites outside China, the applicant shall provide, in addition to the above information, the following:
① Certifying documents issued by regulatory authorities the country (region) of the new production site, proving that the production conditions are in compliance with local GMP.
② Documents proving that the product was allowed to be freely marketed in the new production site of the host country (region).
③ Self-test report on the effective ingredients or characteristic ingredients, hygiene and stability testing of three consecutive sample batches produced in the new sites.
④ Three consecutive sample batches produced in the new sites; ⑤ real samples of changed labels and insert sheets.
7) For applications of changing the product name, the applicant shall provide, in addition to the above information, non-duplication information (retrieved from CFDA Government website database) of the proposed generic name with registered drug names, the real samples or manuscripts of the changed labels and package inserts, as well as a letter of commitment of no engagement in illegal activities within two years
8) For record filing issues over the changes of the applicant's own name and/or address, the applicant shall provide, in addition to the above information, documents issued by regulatory authorities of the product-producing countries (regions) to prove that the production site is unchanged, as well as the real samples of the changed labels and package inserts
9) For record filing issues over the changes of domestic agencies, the applicant shall provide, in addition to the above information, certificate of entrustment and notarized documents issued by overseas health food manufacturers to entrust new Chinese agencies and revoke the original agencies.
10) The above application dossier must be in Chinese and attached with the original language, foreign language information can be attached as a reference. The Chinese translation shall be notarized by domestic notary institutions to ensure consistency with the original contents; the quality standard (Chinese version) of the applied product must comply with the format of Chinese health food quality standards.

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 II: Application dossier for change of registration 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:
For applications for change to product specifications, quality standards and overseas production sites of the health food manufacturer, CFDA shall issue a notice within five days after receiving the application, to designated testing institutions and deliver the samples for testing. If necessary, CFDA may conduct inspection on the production and testing site of the product.
For applications for change to product specifications, quality standards and overseas production sites of the health food manufacturer, the testing institutions shall testing the samples within 30 days upon receipt of the testing notice and samples, and deliver the testing to CFDA, with a copy to the applicant. Under special circumstances, if the testing institutions cannot complete the testing within the required time limit, they shall promptly report to CFDA and deliver a written explanation.

(III)Technical review and administrative review:
For requests of changing the product name, shelf life, consumption, narrowing the applicable population and expanding the scope of inapplicable population, CFDA shall perform technical review and administrative approval for the application dossier within 40 days after accepting the application. "Documents approving changes of imported health foods" shall be issued to the applicant if the application is approved.

For applications for changing product specifications, quality standards and imported health food manufacturer’s overseas production sites, CFDA shall perform technical review and administrative approval for the application dossier within 50 days after accepting the application. "Documents approving changes of imported health foods" shall be issued to the applicant if the application is approved.

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.CFDA shall respond within 20 days for the handling of such cases. 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 10days on the basis of the original one. After the review, written explanations shall be made for disapprovals.

(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:
For requests of changing the product name, shelf life, consumption, narrowing the applicable population and expanding the scope of inapplicable population, CFDA shall make decisions for administrative licensing within 40 days after accepting the application.
For applications changing product specifications, quality standards and imported health food manufacturer’s overseas production sites, CFDA shall make decisions for administrative licensing within 50 days after accepting the application.

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

XII.License validity and renewal:
The validity of "Approvals for changes of imported health foods" is the same as that of the original "approval documents for imported health foods", if the validity period is to be extended upon 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 holidays

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