Guidelines for application for registration of health food

1. Acceptance unit, address, time

Acceptance unit: Health Food Evaluation Center of the State Food and Drug Administration Reception Office

Address: 5th Floor, Building 11, Fahua South Lane, Chongwen District, Beijing

Postcode: 100061

2. Health Food Approval Procedures

Domestic health food, the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government is responsible for the acceptance and formal review of domestic health food registration application materials, and the on-site verification of the health food testing and sample trial production of the health food applied for registration. Organize the inspection of samples.

For imported health foods, the applicant shall submit application materials and samples to the State Food and Drug Administration.

3. General requirements for application materials

(1) The first page of the application materials is a directory of application materials. The application information items in the directory are according to the "Attachment" in the "Health Food Registration Application Form" data" in order. Each item of information must be attached to a cover page, with the product name and applicant's name indicated on the cover page, and the name of the item of information indicated in the upper right corner. Obvious distinguishing marks should be used between each item of information, and the name of each item of information or the serial number in the directory where the item of information is located should be indicated. The entire set of information is bound into a volume with punched clips.

(2) The application materials should be printed on A4 size paper (Chinese fonts should not be smaller than 4-point Song font size, and English fonts should not be smaller than 12-point size). The content should be complete, clear, and must not be altered.

(3) In addition to the "Health Food Registration Application Form" and the inspection report issued by the inspection agency, the application materials should be stamped with the applicant's seal or seam seal page by page (if multiple applicants jointly apply, they should Stamped with the seals of all applicants), the seals should be affixed to the text. The affixed seal should comply with the relevant national seal regulations and be legally binding.

(4) If multiple applicants apply jointly, they should submit a recommendation letter from the person in charge of the joint application.

(5) The same content (such as product name, applicant name, applicant address, etc.) in the application materials should be filled in consistently.

(6) Product name should include brand name, common name and attribute name. The product name should meet the following requirements:

1. Comply with relevant national laws, regulations, rules, standards and norms.

2. Reflect the authenticity of the product, be concise and easy to understand, and conform to Chinese language habits.

3. The brand name can be the registered trademark or other name of the product.

4． The common name should be accurate and scientific, and words that express or imply therapeutic effects or exaggerate functional effects are not allowed.

5. The attribute name should indicate the objective form of the product, and its expression should be standardized and accurate.

6． Products in supplementary dosage form should use the same brand name and generic name when naming, but different attribute names must be indicated.

7. The Chinese names of imported products should correspond to their foreign names. Free translation, transliteration, or a combination of free translation and transliteration can be used, and free translation is generally used.

8． The following content shall not be used when naming health food:

(1) Professional terms and local dialects that are difficult for consumers to understand;

(2) False, exaggerated and absolute words, such as "Efficient", "Xth generation";

(3) Words that are vulgar or feudal and superstitious;

(4) Foreign letters, symbols, Chinese pinyin, etc. (registration (Except trademarks);

(5) Homophones (words) related to functions shall not be used;

(6) Personal names and place names (except registered trademarks) shall not be used.

(7) Foreign languages ??in product formulas, production processes, quality standards, labels, instructions and related certification documents should be translated into standardized Chinese; abstracts, keywords and products in foreign references should be translated into Chinese. Contents related to health functions and safety should be translated into standard Chinese (except for foreigners’ names and addresses).

(8) The applicant should submit supplementary information in accordance with the requirements and content of the "Notice of Review Opinions on Health Food", and provide it in an item-by-item order, and attach the "Notice of Review Opinions on Health Food" (original or a copy). When submitting supplementary information, the revised and complete information for the project should be provided, the date of modification should be noted, and the official seal consistent with the original applicant should be stamped.

(9) For products that have been accepted, the applicant’s specific requirements for changing the relevant content of the application materials are as follows:

1. Product formulas, production processes, test reports and other content that may involve product safety and functionality must not be changed.

2. In addition to the above, if changes are required, the applicant should submit a written change application to the original acceptance department, explain the reason for the change, indicate the date of submission, and stamp it with the same seal as the original applicant. Applicants should provide complete information about the project after the change.

(10) For products that have not been approved for registration by the State Food and Drug Administration, the application materials and samples will generally not be returned. However, the submitted "Letter of Power" and the product are in the production country (or region) Documents proving production and sales for more than one year, certification documents issued by relevant institutions in the country (or region) of production that the production enterprise complies with the local corresponding production quality management regulations, and the original "Health Food Approval Certificate" (except for re-registered products), will be returned if necessary. , the applicant shall submit a written application for return within 3 months of receiving the disapproval opinion.

(11) For new product registration applications, one original copy and 8 copies of the application materials should be submitted; for changes and technology transfer product registration applications, one original copy and 6 copies should be submitted. The copy should be completely consistent with the original and should be copied from the original and remain complete and clear. Among them, the application form, quality standards, and label instructions should also be provided in electronic versions, and the content should be consistent with the originals.

IV. Domestic Health Food Application Document Items

(1) Health Food Registration Application Form (Domestic/Imported)

(2) Applicant’s ID card, Copies of business license or other documents proving the legal registration of the organization

The copies provided should be clear and complete, stamped with the applicant's seal, and the certification documents should be within the validity period.

(3) Provide search materials that the common name of the health food applied for registration does not overlap with the name of the drug that has been approved for registration (retrieval from the State Food and Drug Administration government website database)

The search report that the common name of the health food applied for registration (except for the name of the raw material) does not overlap with the name of the drug that has been approved for registration shall be issued by the applicant after searching from the website database of the State Food and Drug Administration. For example, after searching, it is found that "Yiganling Tablets" is an approved registered drug name, and "××× Brand Yiganling Tablets (oral liquid or capsules, etc.)" cannot be used as the name of a health food.

(4) Guarantee from the applicant that the patents obtained by others do not constitute infringement

The applicant shall make a statement on its own and make a commitment to the statement. "If there is any untrue The applicant is willing to bear corresponding legal responsibilities and bear all consequences arising therefrom."

(5) Provide trademark registration certification documents (not required for unregistered trademarks)

Trademark registration certification documents refer to a copy of the trademark registration certificate approved by the national trademark registration management department , if you are not registered, you do not need to provide it. The scope of trademark use should include health food. If the trademark registrant is inconsistent with the applicant, documents proving that the trademark registrant has changed or the applicant can legally use the trademark should be provided.

(6) Product R&D report (including R&D ideas, function screening process, expected effects, etc.)

Provide this information according to the "Project Requirements for Application Materials", including R&D ideas, functions The three aspects of screening process and expected results should be listed separately and each one is indispensable.

(7) Product formula (raw materials and excipients) and formula basis; source and use basis of raw materials and excipients

(8) Functional ingredients/iconic ingredients, content and efficacy Inspection methods of ingredients/iconic ingredients

Provide this information according to the "Requirements for Application Information Items". The three aspects of functional ingredients/iconic ingredients, content and testing methods of functional ingredients/iconic ingredients should be separately List, indispensable items.

(9) Production process diagram, detailed description and related research materials

(10) Product quality standards (enterprise standards) and drafting instructions as well as quality standards for raw and auxiliary materials.

(11) Types, names, quality standards and selection basis of packaging materials that are in direct contact with products.

(12) Test report issued by the inspection agency

(13) Product label and instruction manual sample

1. Product instructions should be written in the following format and requirements:

×××× Product Instructions

This product is a health food made from ×× and ×× as the main raw materials. And/or human food test function test proves that it has the health care function of "health function" can be used).

[Main raw materials] List the main raw materials and auxiliary materials in the order in which the formula is written.

[Effective ingredients or iconic ingredients and content] Each 100g (100ml) contains: Content of functional ingredients or iconic ingredients. The content should be a certain value. Nutrient supplements should also be labeled with the nutrient content of the smallest serving unit.

[Health Function] Write according to the name of the declared health function.

[Suitable crowd]

[Unsuitable crowd]

[Consumption method and consumption amount] ×× times a day, ×× amount each time, such as If there are any special requirements, please indicate them.

[Specification] indicates the net content of the smallest edible unit. Indicate the net content according to the following units of measurement:

(1) Liquid health food: use volume, the unit is milliliter or ml.

(2) Solid and semi-solid health food: Use mass in milligrams, grams or mg, g.

(3) If there are preparations with inner packaging, such as capsules (soft capsules), etc., the quality refers to the quality of the contents.

[Shelf life] is measured in months

[Storage method]

[Notes] This product cannot replace medicine. Precautions should also be added based on product characteristics.

The suitable groups, unsuitable groups, and precautions for health food should be determined based on the declared health functions and product characteristics. (This information is provided in accordance with the "Supplementary Regulations on Health Food Application and Review (Trial)").

2. Product labels should be written according to the following formats and requirements:

Product label samples should be written in compliance with relevant national regulations, and the content of the instructions should be consistent with the instructions.

(14) Other information helpful for product review

1. Including certification documents such as production enterprise quality assurance system documents (gmp, haccp), raw material supply certificates, raw material supply and sales contracts, entrustment agreements, raw material inspection reports or factory certificates, as well as research and references related to product formulas, processes, functions, safety, etc. Documentation, etc.

2. The foreign language materials provided should be translated into standard Chinese.

(15) 2 unopened samples in the minimum sales package

The sample packaging provided should be complete and undamaged, and should be labeled. The labels should be the same as those in the application materials. The content is consistent. The sample packaging should be conducive to the preservation of the sample and not easy to deteriorate or break. Samples should be within the shelf life.

5. Imported health food declaration materials items

To apply for imported health food registration, in addition to providing information according to the requirements for domestic health food declaration materials based on the use of raw materials and declared functions, The following information must be provided:

(1) Documents issued by relevant institutions in the producing country (region) certifying that the production enterprise complies with the corresponding local production quality management regulations

1. If the applicant entrusts the production of the declared product to an overseas production enterprise, the production enterprise in the certification document should be the entrusted production enterprise, and a power of attorney for the applicant's entrusted production must be provided;

2. The certification document should indicate the name of the institution that issued the document, the name of the product, the name of the manufacturer and the date of issuing the document;

3. The agency that issues this certification document should be the competent authority or industry association of the country where the product is produced.

(2) If the registration affairs are handled by the permanent representative office of an overseas manufacturer in China, a copy of the "Registration Certificate of the Foreign Enterprise's Permanent Representative Office in China" shall be provided.

If an overseas manufacturer entrusts a domestic agency to handle registration matters, it must provide the original notarized power of attorney and a copy of the entrusted agency's business license.

The power of attorney entrusting you with registration matters should meet the following requirements:

1. The power of attorney should specify the name of the unit issuing the power of attorney, the name of the unit entrusted, the name of the product to be registered, the matters entrusted and the date of issuance of the power of attorney;

2. The name of the entrusting party issuing the power of attorney should be exactly the same as that of the applicant;

3. When the entrusted party re-entrusts another agency to handle registration matters, it should provide the original and Chinese translation of the applicant's approval document. The translation must be notarized by a notary office in China. < /p>

Documents proving that the product has been produced and sold in the country (or region) of production for more than one year, should meet the following requirements:

1. The certification document should indicate the name of the document-issuing institution, the name of the applicant, the name of the production enterprise, the name of the product and the date of issuing the document;

2. The certification document should 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 that country (or region). If it is only allowed to be produced in that country (or region), it is not allowed to be produced in that country (or region). Sales, registration applications for such products will not be accepted.

3. The agency issuing certification documents should be the competent government department or industry association of the producing country.

(4) Relevant product-related standards of the producing country (region) or international organization

(5) Packaging, labels, and instructions used for the product on the market in the producing country (region) Real sample. Should be listed under labels and sample instructions.

The above application materials must be in Chinese and attached with the original text. Information in foreign languages ??can be attached for reference. The Chinese translation should be notarized by a domestic notary office to ensure that it is consistent with the content of the original text; the product quality standards (Chinese version) applied for registration must comply with the format of the Chinese health food quality standards.

You should also pay attention to the following matters:

1. The product name, applicant name, manufacturer name, and agency name (in Chinese and English) should be consistent.

2. The certification documents and power of attorney should be original and use the official language of the country (or region) of production. They should be notarized by the notary authority of the country (or region) and confirmed by the Chinese Embassy (Consulate) in the country.

3. If the validity period is stated in the supporting documents or power of attorney, it shall be used within the validity period.

4． The certification documents and power of attorney should be accompanied by the unit's seal or the signature of the legal representative (or his authorized person).

5. The supporting documents and power of attorney should be translated into Chinese and notarized by a notary office in China.

VI. Requirements and instructions for application materials for domestic health food change application

1. Contents such as functional names, raw (auxiliary) materials, processes, consumption methods, expansion of the scope of the suitable population, narrowing of the scope of the unsuitable population, etc. that may affect the safety and function stated in the health food approval certificate shall not be changed.

2. The applicant should be a health food approval certificate holder.

3. When applying to change the content stated in the health food approval certificate and its attachments, the applicant shall submit a written change application and indicate the specific name, reason and basis of the change, indicate the date of application, and affix the applicant's seal.

4． All copies of the application materials should be stamped with the applicant's seal.

5. If a test report is required, the test report shall be issued by an institution determined by the State Food and Drug Administration.

7. Domestic health food change application application materials

(1) Change application to narrow the scope of suitable groups, expand the scope of unsuitable groups, and note matters

(2) Change application to change the consumption (product specifications remain unchanged)

(3) Change application to change product specifications, shelf life and quality standards

(4) Add health food functions Project change application

(5) Change application to change product name

(6) Filing matters for change of applicant’s own name and/or address

1 ． Domestic health food change registration form.

2. Change the name, reason and basis for specific matters.

3. Copies of the applicant’s ID card, business license or other legal registration documents of the institution.

4. Copy of the health food approval document and its attachments.

5. Sample draft of health food labels and instructions to be revised, with detailed revision instructions.

5. Provide documents proving the name and/or address change of the applicant issued by the local industrial and commercial administration department.

8. Requirements and instructions for application materials for change application of imported health food

1. The health food functional name, raw (auxiliary) materials, processes, consumption methods, expansion of the scope of the suitable population, narrowing of the scope of the unsuitable population and other contents that may affect the safety and function stated in the health food approval certificate shall not be changed.

2. The applicant should be a health food approval certificate holder.

3． When applying to change the content stated in the health food approval certificate and its attachments, the applicant shall submit a written change application and indicate the specific name, reason and basis of the change, indicate the date of application, and affix the applicant's seal.

4. All copies of the application materials should be stamped with the applicant's seal.

5. If a test report is required, the test report shall be issued by an institution determined by the State Food and Drug Administration.

6. If the applicant entrusts a domestic agency to handle changes, the original entrustment must be provided (the power of attorney should comply with the requirements for a power of attorney in the new product application materials requirements).

7. The reasons and basis for the change should include the certification document issued by the management agency of the country (or region) where the product is produced allowing the change. This certification document should be notarized by the notary authority of the country where the product is located and confirmed by the Chinese Embassy (Consulate) in the country where the product is produced.

8. Changes in labels, instructions (actual samples) and quality standards approved by the country (or region) of product production should be accompanied by a Chinese translation and notarized by a notary authority in China.

9． All copies of the application materials should be stamped with the seal of the applicant or domestic agency.

9. Items of application materials for change application of imported health food

(1) Application for change of narrowing the scope of suitable groups and expanding the scope of unsuitable groups and precautions

(2) Change application to change the consumption (product specifications remain unchanged)

(3) Change application to change product specifications, shelf life, quality standards

(4) Add health food functions Project change application

(5) Change application of a health food production enterprise to change the production site outside my country

(6) Change application to change the product name

(7) Filing matters for changes in the applicant’s own name and/or address

(8) Filing matters for changes in domestic agencies

9. Domestic health food technology transfer products Requirements and instructions for registration application materials

(1) All application materials should be stamped with the seals of the transferor and the transferee.

(2) The technology transfer contract signed by the transferor and the transferee should contain the following contents:

1. The transferor will fully transfer the formula, production process, quality standards and all technical data related to product production to the transferee, and guide the transferee to produce three consecutive batches of qualified products.

2. The transferor shall promise not to produce and sell the product again.

(3) The technology transfer contract should be clear and complete, must not be altered, and should be notarized by a notary office in China.

(4) The transferee’s health license and certification document complying with the "Health Food Good Manufacturing Practice" issued by the provincial health food production supervision and management department should be within the validity period, and the company name stated should be Consistent with the name of the transferee, the scope of the license should include the declared products.

10. Domestic health food technology transfer product registration application materials

(1) Health food technology transfer product registration application form.

(2) Copy of ID card, business license or other legal registration documents of the institution.

(3) A valid transfer contract signed by the transferor and the transferee that has been notarized by a notary office.

(4) A copy of the transferee’s health food hygiene license issued by the provincial health food production supervision and management department.

(5) Certification document issued by the provincial health food production supervision and administration department proving that the transferee complies with the "Good Manufacturing Practice for Health Food".

(6) Original health food approval documents (including health food approval certificate and its attachments and health food change approval document).

(7) The quantity of three consecutive batches of samples produced by the transferee is three times the quantity required for inspection.

11. Requirements and instructions for declaration documents for the transfer of imported health foods into the country

(1) If the applicant entrusts a domestic agency to handle registration matters, the original power of attorney (power of attorney) must be provided It should comply with the requirements on the power of attorney in the imported product declaration materials requirements).

(2) If the imported health food is transferred overseas, the contract must be notarized by the notary authority of the transferee’s country (region) and confirmed by the Chinese embassy (consulate) in the country where the transferee is located. It should be translated into standard Chinese and notarized by a notary office in China.

12. Items of product registration application materials for the transfer of imported health food products into the country

(1) Health food technology transfer product registration application form.

(2) Copy of ID card, business license or other legal registration documents of the institution.

(3) A valid transfer contract signed by the transferor and the transferee that has been notarized by a notary office.

(4) A copy of the transferee’s health food hygiene license issued by the provincial health food production supervision and management department.

(5) Certification document issued by the provincial health food production supervision and administration department proving that the transferee complies with the "Good Manufacturing Practice for Health Food".

(6) Original health food approval documents (including health food approval certificate and its attachments and health food change approval document).

(7) The quantity of three consecutive batches of samples produced by the transferee is three times the quantity required for inspection.

(8) If the registration affairs are handled by the permanent representative office of an overseas manufacturer in China, a copy of the "Registration Certificate of the Foreign Enterprise's Permanent Representative Office in China" shall be provided.

If an overseas manufacturer entrusts a domestic agency to handle registration matters, it must provide the original notarized power of attorney and a copy of the entrusted agency's business license.

13. Items for product registration application for overseas transfer of imported health food

(1) Health food technology transfer product registration application form.

(2) Documents proving that the production country (region) of the transferee allows the production and sale of the product. This certification document should be notarized by the notary authority of the production country (region) and confirmed by the Chinese embassy or consulate in the country where it is located. .

(3) Documents proving that the product manufacturer complies with the corresponding local production quality management regulations issued by relevant institutions in the country (region) where the transferee is located.

(4) Transfer contract. The contract must be notarized by the notary authority in the country (region) where the transferee is located and confirmed by the Chinese embassy or consulate in the place where the transferee is located.

(5) If the registration affairs are handled by the permanent representative office of an overseas manufacturer in China, a copy of the "Registration Certificate of the Foreign Enterprise's Permanent Representative Office in China" shall be provided.

If an overseas manufacturer entrusts a domestic agency to handle registration matters, it must provide the original notarized power of attorney and a copy of the entrusted agency's business license.

(6) Original health food approval documents (including health food approval certificate and its attachments and health food change approval document).

(7) Inspection reports on functional ingredients or iconic ingredients, hygiene, and stability tests of three consecutive batches of samples produced by the transferee issued by the determined inspection agency;

(8) The quantity of samples of three consecutive batch numbers produced by the transferee is three times the amount required for inspection.

14. Items of application materials for re-issuance of product registration application

To request the re-issuance of a health food approval certificate, the applicant should submit a written application to the State Food and Drug Administration and explain the reasons. . If you apply for reissue due to loss, you should submit the original loss statement published in newspapers and periodicals published nationwide; if you apply for reissue due to damage, you should return the original health food approval certificate. After review, if the requirements are met, a health food approval certificate will be reissued and the original approval number will continue to be used, with the validity period remaining unchanged. The reissued health food approval certificate should be marked with the original approval date and the word "reissued".

15. Requirements and instructions for re-registration application materials for health food

16. Items for re-registration application materials for domestic health food

(1) Domestic health food Re-registration application form.

(2) Copies of the applicant’s ID card, business license or other legal registration documents of the institution.

(3) Copies of health food approval documents (including health food approval certificate and its attachments and health food change approval documents).

(4) A copy of the certification document issued by the provincial health food production supervision and administration department in the place where the product is produced allowing the production and sale of the product.

(5) Summary of sales within five years.

(6) Summary of consumer feedback on products within five years.

(7) Samples of minimum sales packaging, labels and instructions for health food.

Note: If the above information cannot be provided completely, the applicant must explain the reasons in writing when submitting the re-registration application