I. Accepting unit, address and time

Accepting unit: Health Food Acceptance Office of Health Food Evaluation Center of the State Food and Drug Administration of the United States.

Address: Floor 5, Building 1 1, Fanan Li Nan, Chongwen District, Beijing.

Postal code: 10006 1

Second, the health food approval procedures

Domestic health food, by the province, autonomous region, municipality directly under the central government (food) drug supervision and administration department is responsible for the acceptance and form review of domestic health food registration application materials, to apply for registration of health food inspection and sample trial-production on-site verification, organize sample inspection.

When importing health food, the applicant shall submit the application materials and samples to the US Food and Drug Administration.

Three. General requirements of application materials

(1) The home page of application materials is the catalogue of application materials, and the application materials in the catalogue are arranged in the order of "attached materials" in the application form for health food registration. Each document has a cover, which indicates the product name and the applicant's name, and the name of the document is indicated in the upper right corner. There should be obvious difference marks between materials, and the name of the material or the number in the catalogue where the material is located should be indicated. The whole set of materials is bound into a book with punching clips.

(2) The application materials shall be printed on a4 paper (No.4 in Chinese andNo. 12 in English), and the contents shall be complete and clear, and shall 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 also be stamped with the applicant's seal or riding seal page by page (if multiple applicants jointly declare, they should be stamped with the seals of all applicants), and stamped with the seal at the end of the text. The stamped seal shall conform to the relevant provisions of the state and have legal effect.

(4) Where multiple applicants file jointly, a letter of recommendation from the person in charge of the joint filing shall be submitted.

(five) the same content in the application materials (such as product name, applicant's name and address, etc.). ) should be filled in consistently.

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

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

2. It reflects the authenticity of the product, is concise and easy to understand, and conforms to the language habits of China people.

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

4. Generic names shall be accurate and scientific, and words that indicate or imply therapeutic effects or exaggerate functional effects shall not be used.

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

6. Products with supplementary dosage forms shall use the same brand name and common name, but different attribute names.

7. The Chinese name of the imported product should correspond to the foreign name. Free translation, transliteration or a combination of meaning and sound can be used, and free translation is generally the main method.

8 health food naming shall not use the following contents:

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

(2) False, exaggerated and absolute words such as "efficient" and "first generation";

(3) Vulgar or superstitious words;

(4) Foreign letters, symbols, Chinese pinyin, etc. (except registered trademarks);

(5) Do not use homophonic words (words) related to functions;

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

(seven) product formula, production technology, quality standards, labels and instructions, and related foreign language documents shall be translated into standardized Chinese; Abstracts, keywords and contents related to the health care function and safety of products in foreign language references should be translated into standardized Chinese (except foreigners' names and addresses).

(8) The supplementary materials submitted by the applicant shall be provided item by item according to the requirements and contents of the Notice of Comments on Health Food Review, and the Notice of Comments on Health Food Review shall be attached (original or photocopy). When submitting supplementary information, complete information of the revised project shall be provided together with the date of revision, and the official seal consistent with the original applicant shall be affixed.

(9) The specific requirements for the applicant to change the relevant contents of the accepted product application materials are as follows:

1. The product formula, production process, test report and other contents that may involve product safety and function shall not be changed.

2. In addition to the above contents, if it is necessary to change, the applicant shall submit a written application for change to the original acceptance department, explain the reasons for the change, indicate the date of submission, and affix the seal consistent with the original applicant. The applicant should provide complete information about the changed project.

(10) The application materials and samples of products that have not been approved and registered by the State Food and Drug Administration of the United States are generally not returned, except for the power of attorney submitted, the certification documents that the products have been produced and sold in the producing country (or region) for more than one year, the certification documents issued by the relevant institutions of the producing country (or region) that the production enterprises meet the corresponding local production quality management standards, and the original Health Food Approval Certificate (except for re-registered products). If necessary, return it to the applicant.

(eleven) to apply for new product registration, it shall submit 1 original application materials and 8 copies; For the application for product registration of change and technology transfer, 1 original and 6 copies shall be submitted. The copy shall be completely consistent with the original, and shall be copied by the original and kept complete and clear. Among them, the application form, quality standards and label instructions should also be provided in electronic version, and the contents should be consistent with the original.

Four, domestic health food declaration data items

(a) health food registration application form (domestic/imported)

(2) A copy of the applicant's identity card, business license or other legal registration documents.

The copies provided shall be clear and complete, stamped with the seal of the applicant, and the supporting documents shall be within the validity period.

(3) Providing retrieval materials (retrieved from the database of the government website of the State Food and Drug Administration) that the generic name of the health food applied for registration is inconsistent with the name of the drug that has been approved for registration.

The search report that the generic name of the health food applied for registration (except for the name of the raw material) is inconsistent with the name of the drug that has been approved for registration shall be issued by the applicant after searching from the database of the website of the State Food and Drug Administration. For example, after searching, "Yiganling Tablet" is the name of the drug that has been approved for registration, and "XX brand Yiganling Tablet (oral liquid or capsule, etc.). ) "cannot be used as the name of health food.

(4) The applicant guarantees that the patent obtained by others does not constitute infringement.

The applicant shall make a declaration by himself and make a commitment to the declaration. "If there is anything untrue, the applicant is willing to bear the corresponding legal responsibility and bear all the consequences caused by it."

(5) Providing a trademark registration certificate (unregistered trademarks need not be provided)

Trademark registration certificate refers to a copy of the trademark registration certificate approved by the national trademark registration administration department, and it is not necessary to provide it if it is not registered. The scope of use of trademarks should include health food. If the trademark registrant is inconsistent with the applicant, it shall provide the change document of the trademark registrant or the applicant's certificate that the trademark can be legally used.

(six) product research and development report (including research and development ideas, function screening process, expected effect, etc.). )

Provide information according to the requirements of the project for the application materials, including research and development ideas, function screening process, expected effects, etc., and all contents shall be listed separately.

(seven) product formula (raw materials and accessories) and formula basis; Sources of raw materials and auxiliary materials and their use basis

(8) Functional ingredients/iconic ingredients, their contents and inspection methods.

To provide information according to the project requirements of the application materials, the contents of effective ingredients/symbolic ingredients, the contents of effective ingredients/symbolic ingredients and the inspection methods shall be listed respectively, and all items are indispensable.

(nine) the production process flow chart, detailed description and related research materials.

(ten) product quality standards (enterprise standards) and drafting instructions, as well as raw material quality standards.

(eleven) the types, names, quality standards and selection basis of packaging materials in direct contact with products.

(twelve) the inspection report issued by the inspection agency.

(13) Product label and instruction sample

1. The product manual shall be written in the following format and requirements:

Xxxx product manual

This product is a health food made of ××××× and ×××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××

[Main raw materials] List the main raw materials and auxiliary materials in the order of formula writing.

[Active ingredient or iconic ingredient and content] Every 100g( 100ml) contains: the content of active ingredient or iconic ingredient. The content should be a definite value. Nutrient supplements should also indicate the nutrient content of the minimum consumption unit.

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

"Suitable for people"

"Not suitable for people"

[How to eat, how much to eat] ×× times a day, the amount of each time. If you have any special requirements, please indicate.

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

(1) Liquid health food: used volume, in milliliters or milliliters.

(2) Solid and semi-solid health food: edible quality, in mg, g or mg, g. ..

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

[Shelf life] is calculated in months.

[storage method]

【 Precautions 】 This product cannot replace medicine. Precautions should also be added according to product characteristics.

Suitable people, unsuitable people and precautions of health food should be determined according to the claimed health function and product characteristics. (This information is provided according to Supplementary Provisions on the Declaration and Evaluation of Health Food (Trial)).

2. Product labels shall be written in the following formats and requirements:

The preparation of sample product labels shall comply with the relevant provisions of the state, and the contents involved in the instructions shall be consistent with the instructions.

(fourteen) other materials that are helpful for product review.

1. Including documents such as gmp and haccp documents of production enterprises, raw material supply certificates, raw material supply contracts, entrustment agreements, raw material inspection reports or factory certificates, and research and reference materials related to product formula, process, function and safety.

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

(15) Two unopened minimum sales packaging samples.

The sample package provided shall be intact and labeled, and the label shall be consistent with the corresponding contents in the application materials. Sample packaging should be conducive to the preservation of samples, not easy to deteriorate and damage. The sample should be within the warranty period.

Five, imported health food declaration data items

To apply for the registration of imported health food, in addition to providing information according to the application materials and declaration functions, the following information must also be provided:

(1) A certificate issued by the relevant organization of the producing country (region) that the producing enterprise conforms to the corresponding local production quality management standard.

1. If the declared product is produced by an overseas production enterprise entrusted by the applicant, the production enterprise in the certification document shall be the entrusted production enterprise, and the power of attorney entrusted by the applicant shall be provided;

2. The certification documents shall include the name of the organization that issued the certification documents, the name of the product, the name of the production enterprise and the date when the certification documents were issued;

3. The institution that issues the certification documents shall be the competent department or trade association of the country where the product is produced.

(2) A copy of the registration certificate of the resident representative office of a foreign enterprise in China shall be provided for the registration of the resident representative office of a foreign manufacturer in China.

Where an overseas production enterprise entrusts a domestic agency to handle registration matters, it shall provide the notarized original power of attorney and a copy of the business license of the entrusted agency.

The power of attorney entrusted to handle registration affairs shall meet the following requirements:

1. The power of attorney shall specify the name of the company issuing the power of attorney, the name of the entrusted company, the name of the product entrusted for registration, the entrusted matters and the date of issuance of the power of attorney;

2. The entrusting party issuing the power of attorney shall be completely consistent with the name of the applicant;

3. When the entrusted party entrusts another agency to handle the registration affairs again, it shall provide the original and Chinese translation of the applicant's approval document, and the translation shall be notarized by the Chinese notary office.

(3) A certificate that the product has been produced and sold in the producing country (region) for more than one year, notarized by the notary office of the producing country (region) and confirmed by embassies and consulates in China.

Documents certifying that the products have been produced and sold in the producing country (or region) 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 manufacturing enterprise, the name of the product and the date of issuance;

2. The certification documents shall clearly show that the products comply with the laws and relevant standards of the country (or region) and are allowed to be produced and sold in the country (or region). If it is only allowed to be produced in this country (or region) and not allowed to be sold in this country (or region), the application for registration of such products will not be accepted.

3. The institution issuing the certification documents shall be the competent government department or trade association of the producing country.

(4) Relevant standards related to products of producing countries (regions) or international organizations.

(five) the packaging, labels and instructions used in the country (region) of production. It should be listed under the label and instruction sample.

The above application materials must be in Chinese with the original text attached, and foreign materials can be attached for future reference. Chinese translation should be notarized by domestic notary organs to ensure consistency with the original content; The product quality standard (Chinese version) applied for registration must conform to the format of China health food quality standard.

Attention should also be paid 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 shall be original, and shall be notarized by the notary office of the producing country (or region) in the official language of the producing country (or region) and confirmed by the Chinese embassy (consulate) in that country.

3. If the validity period is stipulated in the certification documents and power of attorney, it shall be used within the validity period.

4. The certification documents and power of attorney shall be sealed by the unit or signed by the legal representative (or its authorized person).

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

Six, domestic health food change application data requirements and instructions

1. The functional name, raw (auxiliary) materials, technology, eating method, expanding the range of suitable people, narrowing the range of unsuitable people and other contents that may affect the safety and function of health food specified in the approval certificate shall not be changed.

2. The applicant shall be the holder of the health food approval certificate.

3. To apply for changing the contents specified in the health food approval certificate and its annexes, the applicant shall submit a written application for change, specifying the specific name, reasons and basis of the change, indicating the date of application, and affixing the seal of the applicant.

4. All copies of the application materials shall be stamped with the seal of the applicant.

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

Seven, domestic health food change application declaration data items

(a) to narrow the scope of the applicable population, expand the scope of the inapplicable population, and apply for changing the matters needing attention.

(2) Application for consumption change (product specification unchanged)

(3) Application for change of product specifications, shelf life and quality standards.

(four) to increase the application for change of functional items of health food.

(5) Application for change of product name

(six) the filing matters of the applicant's own name and/or address change.

1. Record Form for Changes of Domestic Health Food.

2. Change the name, reasons and basis of specific matters.

3. A copy of the applicant's ID card, business license or legal registration certificate of other institutions.

4 copies of the approval documents of health food and its attachments.

5. Draft health food labels and instructions to be revised, with detailed revision instructions.

5. Provide the certificate of the change of the applicant's name and/or address issued by the local administrative department for industry and commerce.

Eight, import health food change application requirements and instructions.

1. The functional name, raw (auxiliary) materials, technology, eating method, expanding the range of suitable people, narrowing the range of unsuitable people and other contents that may affect the safety and function of health food specified in the approval certificate shall not be changed.

2. The applicant shall be the holder of the health food approval certificate.

3. To apply for changing the contents specified in the health food approval certificate and its annexes, the applicant shall submit a written application for change, specifying the specific name, reasons and basis of the change, indicating the date of application, and affixing the seal of the applicant.

4. All copies of the application materials shall be stamped with the seal of the applicant.

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

6. If the applicant entrusts a domestic agency to handle the change, the original power of attorney shall be provided (the power of attorney shall meet the requirements of new product application materials).

7. The reason and basis for the change shall include the certificate issued by the management organization of the country (or region) where the product is produced, which shall be notarized by the notary office of the country where the product is produced and confirmed by the embassy (consulate) in China.

8. Labels, instructions (samples) and quality standards approved by the product producing country (region) shall be accompanied by a Chinese translation and notarized by a Chinese notary office.

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

Nine, imported health food change application data items

(a) to narrow the scope of the applicable population, expand the scope of the inapplicable population, and apply for changing the matters needing attention.

(2) Application for consumption change (product specification unchanged)

(3) Application for change of product specifications, shelf life and quality standards.

(four) to increase the application for change of functional items of health food.

(5) An application for the change of overseas production sites of health food production enterprises.

(6) Application for change of product name

(seven) the filing matters of the applicant's own name and/or address name change.

(8) Changing the matters filed by domestic institutions.

Nine, domestic health food technology transfer product registration requirements and instructions.

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

(two) the technology transfer contract signed by the transferor and the transferee shall include the following contents:

1. The transferor shall transfer the formula, production process, quality standards and all technical data related to the production of the transferred products to the transferee at full power, and instruct the transferee to produce three consecutive batches of qualified products.

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

(3) The technology transfer contract shall be clear and complete, and shall not be altered, and shall be notarized by a Chinese notary office.

(4) The hygiene license issued by the provincial health food production supervision and management department and the certification documents conforming to the "Quality Management Standards for Health Food Production" of the transferee shall be within the validity period, and the enterprise name indicated shall be the same as that of the transferee, and the scope of license shall include the declared products.

Ten, domestic health food technology transfer product registration application data items

(a) the application form for the registration of health food technology transfer products.

(two) a copy of the identity card, business license or other legal registration documents.

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

(four) a copy of the transferee's health food hygiene license issued by the provincial health food production supervision and management department.

(five) the certificate issued by the provincial health food production supervision and management department that the transferee conforms to the good production practice of health food.

(six) the original health food approval documents (including health food approval certificate and its attachments and health food change approval).

(seven) three consecutive batches of samples produced by the transferee, the number of which is three times the number required for inspection.

Eleven, the requirements and instructions of the application materials for the transfer of imported health food to China.

(1) If the applicant entrusts a domestic agency to handle the registration affairs, it shall provide the original power of attorney (the power of attorney shall meet the requirements of the relevant power of attorney in the application materials for imported products).

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

Twelve, imported health food to the domestic transfer of product registration information project.

(a) the application form for the registration of health food technology transfer products.

(two) a copy of the identity card, business license or other legal registration documents.

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

(four) a copy of the transferee's health food hygiene license issued by the provincial health food production supervision and management department.

(five) the certificate issued by the provincial health food production supervision and management department that the transferee conforms to the good production practice of health food.

(six) the original health food approval documents (including health food approval certificate and its attachments and health food change approval).

(seven) three consecutive batches of samples produced by the transferee, the number of which is three times the number required for inspection.

(8) A copy of the registration certificate of the resident representative office of a foreign enterprise in China shall be provided for the registration of the resident representative office of a foreign manufacturer in China.

Where an overseas production enterprise entrusts a domestic agency to handle registration matters, it shall provide the notarized original power of attorney and a copy of the business license of the entrusted agency.

Thirteen, the import of health food overseas transfer of product registration information project.

(a) the application form for the registration of health food technology transfer products.

(2) The certificate that the transferee's production country (region) allows the production and sale of the product, which shall be notarized by the notary office of the production country (region) and confirmed by embassies and consulates in China.

(three) the certificate issued by the relevant institutions of the country (region) where the transferee is located that the product manufacturer meets the corresponding local production quality management standards.

(4) Transfer contract. This contract shall be notarized by the notary office of the country (region) where the transferor is located and confirmed by the local embassies and consulates in China.

(5) If a foreign manufacturer's permanent representative office in China handles the registration, it shall provide a copy of the registration certificate of the foreign enterprise's permanent representative office in China.

Where an overseas production enterprise entrusts a domestic agency to handle registration matters, it shall provide the notarized original power of attorney and a copy of the business license of the entrusted agency.

(six) the original health food approval documents (including health food approval certificate and its attachments and health food change approval).

(seven) the inspection report issued by the designated inspection agency on the functional components or iconic components, hygiene and stability tests of three consecutive batches of samples produced by the transferee;

(eight) the number of samples produced by the transferee in three consecutive batches is three times the number required for inspection.

14. reissue the application materials for product registration.

Where the applicant requests to renew the health food approval certificate, it shall submit a written application to the State Food and Drug Administration and explain the reasons. If the applicant applies for a replacement due to loss, it shall submit the original statement of loss published in newspapers and periodicals publicly distributed throughout the country; If the applicant applies for replacement due to damage, it shall return the original health food approval certificate. Upon examination, if it meets the requirements, the health food approval certificate shall be renewed, and the original approval number shall continue to be used, with the same validity period. The original approval date shall be indicated on the reissued health food approval certificate, and the words "reissue" shall be indicated.

Fifteen, health food re registration application data requirements and instructions.

Sixteen, domestic health food re-registration application data items

(1) Application form for re-registration of domestic health food.

(2) A copy of the applicant's identity card, business license or other legal registration documents.

(three) a copy of the health food approval certificate (including the health food approval certificate and its attachments and the health food change approval).

(four) a copy of the certificate issued by the provincial health food production supervision and management department where the product is produced.

(five) a summary of the sales situation in the past five years.

(six) a summary of consumer feedback on products within five years.

(seven) the minimum sales packaging, labels and instructions of health food.

Note: If the above information cannot be provided completely, the applicant must explain it in writing when applying for re-registration.