Project name: Health food approval
2、 Licensed content: Registration of imported (including Hong Kong, Macao and Taiwan) health food products
3、 Implementation basis: Food Hygiene Law of the People's Republic of China, Measures for the Administration of Health Food Registration (for Trial Implementation), and Key Points for the Acceptance and Examination of Health Food Administrative Licensing
4、 Fees
5、 Quantity limit: This license has numerous restrictions
6、 List of materials submitted by the applicant:
Document No. (I) Registration Application Form for Imported Health Food;
Data No. (2) Copies of the applicant's ID card, business license or other legal registration documents;
Data No. (III) Provide the retrieval materials that the common name of the health food applied for registration does not duplicate the name of the drug approved for registration (retrieved from the database of the government website of the State Food and Drug Administration);
Data No. (4) Letter of guarantee that the applicant does not constitute infringement of the patent obtained by others;
Document number (V): provide certification documents for trademark registration (not required for unregistered trademarks);
Data No. (VI) Product research and development report (including research and development ideas, function screening process, expected effect, etc.);
Data No. (VII) Product formula (raw materials and accessories) and formula basis;
Data No. (VIII) Effective ingredient/symbolic ingredient, content and inspection method of effective ingredient/symbolic ingredient;
Data No. (IX) Production process diagram and its detailed description and relevant research data;
Data No. (X) Product quality standard and its preparation description (including the quality standard of raw materials and auxiliary materials);
Data No. (XI) Type, name, quality standard and selection basis of packaging materials directly contacting products;
Data No. (XII) Test report and relevant data issued by the inspection agency;
Data No. (XIII) Sample of product label and manual;
Data No. (XIV) Product technical requirements and confirmation of successful uploading of product technical requirements;
Data No. (XV) Other data helpful for product review;
Data No. (XVI) Two unopened samples of * small sales package;
Data No. (XVII) If the function is not within the scope of the functional items announced by the State Food and Drug Administration, the data shall also be provided according to the relevant requirements;
Document No. (XVIII) Certificate issued by the relevant authorities of the producing country (region) that the product manufacturer meets the corresponding local production quality management specifications;
Document No. (XIX) If the registration is handled by the permanent representative office of the foreign manufacturer in China, a copy of the Registration Certificate of the Permanent Representative Office of Foreign Enterprises in China shall be provided; If an overseas manufacturer entrusts a domestic agency to handle registration matters, it shall provide the original notarized power of attorney and the copy of the business license of the entrusted agency;
Data No. (XX) Certification document that the product has been produced and sold in the country (region) of production for more than one year, which shall be notarized by the notary office of the country (region) of production and confirmed by the Chinese embassy or consulate in the country of production;
Data No. (XXI) Relevant standards related to products of the producing country (region) or international organizations;
Data No. (XXII) The actual samples of the packaging, labels and instructions of the products listed in the manufacturing country (region) shall be listed under the label and instructions;
Data No. (XXIII) The quantity of samples with three consecutive batch numbers is three times of the quantity required for inspection.
7、 Requirements for application materials:
（1） General requirements for application materials:
1. The first page of the application materials is the catalogue of the application materials. The application materials in the catalogue are arranged in the order of "attached materials" in the Health Food Registration Application Form. Each item of data shall be attached with a cover page, on which the product name and applicant name shall be indicated, and the name of the item of data shall be indicated in the upper right corner. All materials shall be clearly marked with distinguishing marks, and the name of each material or the serial number in the directory where the material is located shall be indicated. The whole set of data shall be bound into a volume with punching clips.
2. The application materials shall be printed on A4 size paper (no less than Song typeface small 4 characters in Chinese and no less than 12 characters in English), and the contents shall be complete and clear, and shall not be altered.
3. For new product registration application, one original and eight copies of application materials shall be submitted. The copy shall be identical with the original, and shall be copied from the original and kept complete and clear.
4. In addition to the Application Form for Registration of Imported Health Food and the inspection report issued by the inspection agency, the application materials shall be stamped with the applicant's seal or cross page seal page by page (if multiple applicants apply jointly, all the applicant's seals shall be stamped), and the seal shall be stamped on the text. The seal affixed shall comply with the relevant provisions of the state and have legal effect. If the applicant for imported health food does not have a seal, it can be replaced by the signature or seal of the legal representative.
5. In case of joint declaration by multiple applicants, a recommendation from the person in charge of joint declaration shall be submitted.
6. The same content (such as product name, applicant name, applicant address, etc.) in the application materials shall be filled in consistently. The same content (product name, applicant name, applicant address, product formula, name of trial production unit, address of trial production unit, name of test unit, product acceptance number) of the electronic version and the written version shall be consistent.
7. The foreign language in the product formula, production process, quality standards, labels, instructions and relevant supporting documents shall be translated into standard Chinese; Abstracts, key words and contents related to product health function and safety in foreign references shall be translated into standard Chinese (excluding foreign names and addresses).
8. For the application materials not applied for the first time, a copy of the notice of withdrawal or disapproval (with the official seal of the applicant affixed) shall be provided, and the reasons for re application shall also be provided, which shall be attached to the first page of the application materials.
（2） Specific requirements for application materials:
1. Application Form for Registration of Imported Health Food.
(1) The application form for registration of imported health food can be downloaded from the website of the State Food and Drug Administration () or the website of the State Food and Drug Administration (www.) for health food review *.
(2) Please read the instructions carefully before filling in the form and fill in as required.
(3) The contents of the application form must be printed and filled in, and the items filled in should be complete and standardized, and should not be altered.
(4) The declared health function shall be consistent with the functional name of health food published by the State Food and Drug Administration. The new functions declared are excluded.
(5) The applicant of imported health food is the owner of the product ownership, and the manufacturer is the actual producer of the product (if the declared product is produced by the applicant itself, the manufacturer is the applicant; if the declared product is produced by other overseas enterprises entrusted by the applicant, the manufacturer is the entrusted enterprise).
(6) Product name shall include brand name, common name and attribute name.
2. Copies of the applicant's ID card, business license or other legal registration documents. The copies provided shall be clear, complete and sealed.
3. Search materials where the generic name of the health food applied for registration does not duplicate the name of the drug approved for registration.
(1) Retrieve description without duplicate name.
(2) Provide a web page printing that retrieves the common name of the health food applied for registration from the database of the government website of the State Food and Drug Administration and does not duplicate the name of the drug approved for registration.
4. The applicant's guarantee that the patent obtained by others does not constitute infringement.
The letter of guarantee provided by the applicant shall include the patent inquiry about the health food, to prove that the application does not involve infringement of other people's existing patent rights, to guarantee that it does not infringe other people's patent rights, and to undertake full responsibility for possible infringement consequences.
5. Certificate of trademark registration (not required for unregistered trademarks).
The trademark registration certificate refers to the photocopy of the trademark registration certificate approved by the national trademark registration administration department, which is not required for unregistered ones. The scope of use of the trademark shall include health food. If the trademark registrant is inconsistent with the applicant, the trademark registrant change document or the applicant's certificate of legal use of the trademark shall be provided. The copies provided shall be clear, complete and sealed.
6. Product research and development report (including research and development ideas, function screening process, expected effect, etc.). It includes research and development ideas, function screening process and expected effect. Each content should be listed separately.
7. Product formula (raw materials and excipients) and formula basis.
(1) Product formula (raw materials and auxiliary materials).
(2) Formulation basis.
(3) List the name and dosage of raw and auxiliary materials according to the specified formula expression format.
(4) The product formula (raw materials and excipients) and formula basis shall be listed separately, and the contents shall be complete.
8. Effective ingredient/symbolic ingredient, content and inspection method of effective ingredient/symbolic ingredient.
The three aspects of effective ingredients/symbolic ingredients, content and inspection methods of effective ingredients/symbolic ingredients shall be listed separately.
9. Production process diagram, detailed description and relevant research data.
(1) The production process diagram and its detailed description as well as the relevant research data shall be listed separately, and the contents shall be consistent.
(2) The production process diagram shall include all production process routes and links, and indicate all process processes and relevant technical parameters.
(3) The production process description shall describe the production process in detail, including all links of the product production process and the process technical parameters of each link; Indicate the equipment and model used in the corresponding link; If the extract is used as raw material, the production process of the extract is provided.
(4) Relevant research materials.
(5) Inspection report of three batches of samples.
(6) The health food produced by the separation and purification process of macroporous adsorption resin shall comply with the Provisions on Application and Evaluation of Health Food Produced by the Separation and Purification Process of Macroporous Adsorption Resin (Trial).
10. Product quality standards and their preparation instructions (including the quality standards of raw materials and auxiliary materials).
(1) If the enterprise standard involves the name of the applicant, it should be consistent with the name of the applicant in the application form.
(2) The appendix in the enterprise standard shall be listed item by item according to the regulations, and the contents shall be complete and complete.
11. The type, name, quality standard and selection basis of packaging materials directly contacting the product.
(1) Provide the name (type) and quality standard of packaging materials.
(2) Provide the source certification of packaging materials.
(3) Provide basis for selection of packaging materials.
12. Test report and relevant data issued by the inspection agency.
(1) The inspection agency issuing the inspection report shall be the health food inspection agency determined by the State Food and Drug Administration. The validity period of the inspection report is 5 years from the date of issuance by the inspection agency. The inspection report beyond the validity period will not be accepted.
(2) The test reports are arranged in the following order:
① Inspection application form (attached to the corresponding test report).
② The inspection acceptance notice of the inspection unit (attached to the corresponding test report).
③ Safety toxicology test report.
④ Functional test report (including animal function test report and/or human feeding test report).
⑤ Test report of doping and illegal drugs (application for registration of alleviating physical fatigue, improving growth and development function).
⑥ Test report of functional ingredient or symbolic ingredient.
⑦ Stability test report.
⑧ Hygienic test report.
⑨ Other inspection reports (such as raw material variety identification report, strain virulence test report, etc.).
(3) The inspection report shall meet the following requirements:
① The format of the inspection report shall be standardized and shall not be altered.
② The legal representative of the inspection agency (or its * person) shall sign and affix the official seal of the inspection agency.
③ In addition to the official seal of the inspection agency at the inspection conclusion, the inspection report with more than one page must be stamped with the cross page seal or the official seal page by page.
(4) The product name, inspection unit, sample production or trial production unit name and sample batch number in the inspection report shall be consistent with the corresponding contents in the inspection application form. In case of any change, the applicant and the inspection agency shall provide a written explanation.
(5) The application for registration of health food with nutrient supplements does not need to provide a functional test report; If no safety toxicology test report is provided, reasons must be stated in writing.
(6) The application materials shall include a copy of the certificate issued by the Ethics Committee that allows the human feeding test to be carried out. The copy must be stamped with the seal of the inspection agency and attached to the human feeding test report.
(7) When the same applicant applies for the registration of products with the same raw materials and main auxiliary materials and different dosage forms, the applicant shall provide scientific and reasonable basis for the selection of different dosage forms. If all the inspection reports have been provided for the product registration of one of the dosage forms, the safety toxicology and functional test can be exempted for the product registration of other dosage forms, but the instructions for the exemption of relevant tests and the copies of the safety toxicology and functional test reports of all the tested products need to be provided.
(8) The raw materials of health food are the same as the main auxiliary materials, involving the registration of products with different tastes and colors. If all the test reports have been provided for the registration of products with one taste and color, the registration of products with other tastes and colors can be exempted from safety toxicology and functional tests, but the instructions for exemption from relevant tests should be provided, And copies of safety toxicology and functional test reports of all tested products.
13. Sample of product labels and instructions.
The sample of product labels and instructions shall be provided in accordance with the Project Requirements for Registration and Application Materials of Health Food (Trial).
The suitable group, unsuitable group and precautions of health food shall be determined according to the declared health function and product characteristics, and the information shall be provided according to the Supplementary Provisions on Application and Evaluation of Health Food (Trial).
14. Confirmation of successful uploading of product technical requirements and product technical requirements.
15. The certificate issued by the relevant authorities of the producing country (region) that the product manufacturer conforms to the corresponding local production quality management specifications.
(1) If the declared product is produced by an overseas manufacturer entrusted by the applicant, the manufacturer in the certification document shall be the entrusted manufacturer, and the power of attorney for the entrusted production of the applicant shall be provided.
(2) The certificate shall specify the name of the issuing institution, the name of the product, the name of the manufacturer and the date of issuing the document.
(3) The institution issuing the certificate shall be the competent department or industry association of the country where the product is produced.
16. If the registration is handled by the permanent representative office of the foreign manufacturer in China, a copy of the Registration Certificate of the Permanent Representative Office of Foreign Enterprises in China shall be provided.
If an overseas manufacturer entrusts a domestic agency to handle registration matters, it shall provide the original notarized power of attorney and the copy of the business license of the entrusted agency.
The power of attorney for entrusted registration affairs shall meet the following requirements:
(1) The power of attorney shall specify the name of the issuing unit, the name of the entrusted unit, the name of the product entrusted to apply for registration, the entrusted items and the date of issuance of the power of attorney.
(2) The name of the entrusting party issuing the power of attorney shall be exactly the same as that of the applicant.
(3) When the entrusted party entrusts another agency to handle registration matters, it shall provide the original and Chinese translation of the applicant's approval documents, which shall be notarized by a notary office in China.
17. The certification document that the product has been produced and sold in the manufacturing country (region) for more than one year shall be notarized by the notary office of the manufacturing country (region) and confirmed by the embassy or consulate in the host country.
The supporting documents for the products produced and sold in the country (or region) of production for more than one year shall meet the following requirements:
(1) The certification document shall specify the name of the issuing institution, the name of the applicant, the name of the manufacturer, the name of the product and the date of issuing the document.
(2) The supporting documents shall clearly indicate that the product complies with the laws and relevant standards of the country (or region) and is allowed to be produced and sold in the country (or region). If it is only allowed to be produced in the country (or region) and not sold in the country (region), the application for registration of such products will not be accepted.
(3) The institution issuing the certificate shall be the competent government department or industry association of the production country.
18. Relevant product related standards of the producing country (region) or international organizations.
19. The actual samples of packaging, labels and instructions of the products listed in the manufacturing country (region). It shall be listed under the label and sample manual.
20. Other data helpful to product review.
(1) Provide legal registration documents of raw material production enterprises.
(2) Provide inspection reports of raw materials and auxiliary materials.
(3) Provide purchase and sales invoices of raw materials. If the raw materials are presented as gifts, the relevant certificates issued by the raw material manufacturer shall be provided. If the applicant purchases raw materials from the raw material distributor, the copy of the supply agreement between the distributor and the raw material manufacturer shall also be provided.
(4) If the extract is used as the raw material, the production process and quality standard of the extract shall also be provided and stamped with the official seal of the supplier.
(5) Provide the entrusted processing agreement between the applicant and the sample trial manufacturer.
(6) Provide the valid business license and hygiene license of the sample trial production unit, and the hygiene license includes the dosage form of the declared product.
(7) The formula uses fungi, probiotics, nucleic acids, endangered wild animals and plants, coenzyme Q10, soybean isoflavones and other items that have been clearly specified. In addition to providing relevant information in accordance with the Measures for the Registration and Administration of Health Food (for Trial Implementation), relevant information should also be provided in accordance with the relevant provisions.
(8) Edible basis, consumption amount and safety evaluation data shall be provided for the products with chemical synthesis as raw materials.
(9) References.
(10) The home page shall provide a directory indicating the name and category of each document and data under this item, and distinguish each document and data with obvious identification marks.
21. The quantity of samples with three consecutive batch numbers is three times of the quantity required for inspection.
22. Two unopened samples of * small sales package.
The sample package provided shall be complete and undamaged, and shall be labeled, which shall be consistent with the corresponding contents in the application materials. The sample packaging shall be conducive to the preservation of samples and not easy to deteriorate and break. The samples shall be within the warranty period.
23. The above application materials must be in Chinese and attached with the original text, and the materials in foreign languages can be attached for reference. The Chinese translation shall be notarized by a domestic notary office to ensure that it is consistent with the original content; The product quality standard (Chinese version) applied for registration must conform to the format of the Chinese health food quality standard.
24. Attention should also be paid to the following matters:
(1) In the product registration application form, the applicant for the imported product is the owner of the product ownership, and the manufacturer is the actual producer of the product (if the declared product is produced by the applicant itself, the manufacturer is the applicant; if the declared product is produced by other overseas enterprises entrusted by the applicant, the manufacturer is the entrusted enterprise).
(2) The product name, applicant name, manufacturer name and agency name (in Chinese and English) shall be consistent.
(3) The supporting documents and power of attorney shall be original, and shall be in the official language of the production country (or region). They shall be notarized by the notary office of the country (or region) where they are located and confirmed by the Chinese embassy (consulate) in the country where they are located.
(4) If the validity period is specified in the certification documents and the power of attorney, it shall be used within the validity period.
(5) The supporting documents and power of attorney shall be sealed by the unit or signed by the legal representative (or its * person).
8、 Schematic diagram of application process:
9、 Licensing program:
（1） Acceptance:
The applicant submitted an application to the administrative acceptance service *, submitted the application materials in accordance with the catalogue listed in Article 6 of the Instructions, and the staff of the acceptance * conducted a formal review of the application materials in accordance with Annex I of the Administrative Measures for the Registration of Health Food: Application Materials for the Registration of Imported Health Food Products. If the application item does not need to obtain an administrative license according to law, the applicant shall be informed immediately that it is not accepted; If the application matters are not within the scope of the administrative organ's functions and powers according to law, it shall immediately make a decision not to accept the application and inform the applicant to apply to the relevant administrative organ; If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot; If the application materials are incomplete or do not conform to the legal form, the applicant shall be informed of all the contents that need to be supplemented and corrected on the spot or once within five days. If the applicant fails to inform within the time limit, the application materials shall be accepted as of the date of receipt; If the application items fall within the scope of the administrative organ's functions and powers, the application materials are complete and conform to the legal form, or the applicant submits all the supplemented and corrected application materials according to the requirements of the administrative organ, the administrative license application shall be accepted.
（2） Inspection and verification:
After the administrative acceptance service * is accepted, the State Food and Drug Administration will issue an inspection notice to the designated inspection agency and provide samples for inspection within 5 days. If necessary, the National Bureau can check the production site and test site of the product.
The inspection agency shall, within 50 days after receiving the inspection notice and the samples, conduct sample inspection and recheck inspection on the samples taken, transfer the inspection report to the State Food and Drug Administration, and send a copy to the applicant. Under special circumstances, if the inspection agency is unable to complete the inspection within the specified time limit, it shall report to the State Food and Drug Administration in a timely manner and explain the reasons in writing.
（3） Technical review and administrative review:
After accepting the application, the State Food and Drug Administration shall conduct technical review and administrative review of the application materials within 80 days, and make a licensing decision. In the process of examination, if supplementary materials are needed, the State Food and Drug Administration shall propose them at one time. The applicant shall submit the qualified supplementary materials within 5 months after receiving the notice of supplementary materials. If the applicant fails to submit the supplementary materials within the prescribed time limit, the application shall be rejected. Under special circumstances, if the supplementary materials cannot be submitted within the specified time limit, a written application must be submitted to the State Food and Drug Administration and the reasons must be explained. The State Food and Drug Administration shall put forward handling suggestions within 20 days. The time for the applicant to supplement the information is not included in the time limit for permission, and the time limit for examination is extended by 30 days on the basis of the original time limit for examination. If the registration is approved after examination, the Approval Certificate of Domestic Health Food will be issued. If the registration is not granted, the reasons shall be explained in writing.
（4） Delivery:
SFDA administrative acceptance service * will deliver the administrative licensing decision to the applicant within 10 days from the date of making the administrative licensing decision.
（5） Review:
If the applicant has any objection to the decision made by the State Food and Drug Administration not to register, he/she can submit a written review application to the State Food and Drug Administration and explain the reasons for the review within 10 days from the date of receiving the notice of not to register.
After receiving the reexamination application, the State Food and Drug Administration shall conduct reexamination according to the time limit and requirements of the original application, and make a reexamination decision. If the decision not to register is revoked, the applicant shall be issued with the corresponding health food approval certificate; If the original decision is upheld, the application for reexamination will no longer be accepted, but the applicant can apply to the State Food and Drug Administration for administrative reconsideration or file an administrative lawsuit with the people's court in accordance with relevant laws and regulations.
10、 Commitment time limit:
The administrative licensing decision shall be made within 85 days from the date of acceptance.
11、 Implementing authority:
Implementing authority: State Food and Drug Administration
Place of acceptance: Administrative acceptance service of the State Food and Drug Administration*
12、 Validity and renewal of permit:
The validity period of the Approval Certificate for Imported Health Food is 5 years. If the validity period of the Approval Certificate for Imported Health Food needs to be extended upon expiration, the applicant shall apply for re registration three months before the expiration of the validity period.
13、 Annual license review or annual inspection: nothing
14、 Consultation and complaint receiving institution:
Consultation: State Food and Drug Administration
Complaints: Supervision Bureau of the State Food and Drug Administration, Law Enforcement Supervision Division of the Department of Policies and Regulations
Note: The working period of this notice is calculated in working days, excluding legal holidays name="ContentEnd"/>
