I. Accepting unit, address and time

Accepting unit: Health food accepting office of the Health Food Evaluation Center of the State Food and Drug Administration

Address: 5th floor, Building 11, Fahua Nanli, Chongwen District, Beijing

Postal code: 161

II. Procedures for the examination and approval of health food made in China

. The (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for the acceptance and formal examination of the application materials for registration of domestic health food, the on-site verification of the health food test and sample trial-production applied for registration, and the organization of sample inspection.

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

III. General requirements for application materials

(1) The first 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 piece of information is covered with a cover page, with the product name and the name of the applicant indicated on the cover page, and the name of the information is indicated in the upper right corner. Clear distinguishing marks shall be used between the materials, and the names of the materials or the serial numbers in the catalogue where the materials are located shall be indicated. The whole set of materials is bound into a book with punching clips.

(2) The application materials shall be printed on A4-sized paper (no less than No.4 in Chinese and No.12 in English), and the contents shall be complete and clear, and shall not be altered.

(3) In addition to the Application Form for Health Food Registration and the inspection report issued by the inspection agency, the application materials shall be stamped with the applicant's seal or riding seal page by page (if multiple applicants jointly declare, all applicants' seals shall be affixed), and the seal shall be affixed at the text place. The stamped seal shall conform to the relevant provisions of the state and have legal effect.

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

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

(6) The product name shall include brand name, generic name and attribute name. The product name shall meet the following requirements:

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

2. reflect the authenticity of the product, concise and easy to understand, in line with Chinese language habits.

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

4. Common names should be accurate and scientific, and words that express or imply therapeutic effects and 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 with supplementary dosage forms should be named with the same brand name and generic name, but with different attribute names.

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

8. When naming health food, the following contents shall not be used:

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

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

(3) vulgar or superstitious words;

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

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

(6) People's names and place names (except registered trademarks) shall not be used.

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

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

(9) For the accepted products, the specific requirements for the applicant to change the relevant contents of the 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 that of the original applicant. The applicant should provide complete information about the changed project.

(1) The application materials and samples of products that have not been approved and registered by the State Food and Drug Administration are generally not returned, except for the submitted Power of Attorney, 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 in 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.

(11) The application for new product registration shall submit 1 original and 8 copies of the application materials; The application for product registration of change and technology transfer shall be submitted in 1 original and 6 copies. 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 content should be consistent with the original.

iv. application materials for domestic health food

(1) application form for health food registration (domestic/imported)

(2) photocopy of the applicant's ID card, business license or legal registration certificate of other institutions

The photocopy provided should be clear and complete, stamped with the applicant's seal, and the certificate should be within the validity period.

(3) provide retrieval materials (retrieved from the database of the government website of the State Food and Drug Administration) that the common names of health foods applied for registration are not the same as those of drugs approved for registration.

The retrieval report that the common names of health foods applied for registration (except those named after raw materials) are not the same as those of drugs approved for registration shall be issued by the applicant after retrieval 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 "×××× brand Yiganling Tablet (oral liquid or capsule, etc.)" cannot be used as the name of health food.

(IV) Guarantee that the patent obtained by others by the applicant does not constitute infringement

The applicant shall make a statement by himself and make a commitment to the statement. "If there is any falsehood, the applicant is willing to bear the corresponding legal responsibility and bear all the consequences arising therefrom".

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

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

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

Provide this information according to the Project Requirements for Application Materials, including R&D ideas, function screening process and expected effect, and each content should be listed separately, and none of them is indispensable.

(7) product formula (raw materials and auxiliary materials) and formula basis; Sources of raw materials and auxiliary materials and basis for their use

(8) Effective ingredients/iconic ingredients, contents and inspection methods of effective ingredients/iconic ingredients

Provide this information according to the Project Requirements of Application Materials, and the contents of effective ingredients/iconic ingredients, contents and inspection methods of effective ingredients/iconic ingredients should be listed separately, and there are no missing items.

(9) production process diagram, detailed description and relevant research materials

(1) product quality standards (enterprise standards) and drafting instructions, as well as quality standards for raw materials.

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

(12) test report issued by inspection agency

(13) sample product label and instruction manual

1. The product instruction manual should be prepared according to the following formats and requirements:

p>×××× product instruction manual

This product is a health food made from ×××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××

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

[ effective component or iconic component and content] contains: the content of effective component or iconic component per 1g(1ml). Content should be a definite value. Nutrient supplements should also be marked with the nutrient content of the minimum consumption unit.

[ health function] is written according to the declared health function name.

[ Suitable crowd]

[ Unsuitable crowd]

[ Edible method and consumption] is ×× times a day, and the amount of each time is ××. If there are special requirements, please indicate.

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

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

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

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

[ Shelf life] is measured in months

[ Storage method]

[ Precautions] This product cannot replace medicines. Precautions should also be added according to product characteristics.

The suitable crowd, unsuitable crowd and precautions of health food should be determined according to the declared health function and product characteristics. (Provide this information according to Supplementary Provisions on the Declaration and Evaluation of Health Food (Trial)).

2. The product label shall be written in the following format and requirements:

The sample product label shall be written in accordance with the relevant national regulations, and the contents involved in the instruction manual shall be consistent with the instruction manual.

(14) Other materials that are helpful for product review

1. Including the quality assurance system documents (GMP, HACCP) certificates of production enterprises, raw material supply certificates, raw material supply and marketing contracts, entrustment agreements, raw material inspection reports or ex-factory certificates and other supporting documents, as well as research and references related to product formula, technology, function and safety.

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

(15) Two unopened samples of the minimum sales package

The sample packages provided should be intact and undamaged, and should be labeled, and the labels should 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 break. The samples should be within the warranty period.

v. Application materials for imported health food

To apply for the registration of imported health food, in addition to providing materials according to the application materials of domestic health food, the following materials must be provided:

(1) Certification documents issued by relevant institutions in the producing country (region) that the production enterprise meets the corresponding local production quality management standards

1. Certification that the declared products are produced by overseas production enterprises entrusted by the applicant.

2. The certification document shall specify the name of the organization that issued the document, the name of the product, the name of the manufacturer and the date when the document was issued;

3. The institution that issued the certification document should be the competent department or trade association of the country where the product is produced.

(2) If the permanent representative office of an overseas manufacturer in China handles the registration, a copy of the Registration Certificate of the Permanent Representative Office of a Foreign Enterprise in China shall be provided.

if an overseas manufacturer entrusts a domestic agency to handle the registration matters, it is required to provide a notarized original power of attorney and a copy of the business license of the entrusted agency.

The power of attorney entrusted to handle the 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 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 entrusting another agency to handle the registration affairs, the entrusted party shall provide the original and Chinese translation of the applicant's approval document, and the translation shall be notarized by a notary office in China.

(3) the certification document that the product has been produced and sold in the producing country (region) for more than one year, which shall be notarized by the notary office of the producing country (region) and confirmed by the embassy or consulate in China.

The certification document that the product has been produced and sold in the producing country (region) for more than one year shall meet the following requirements:

1. The certification document shall specify the name of the document issuing institution, the name of the applicant and the manufacturer.

2. The certification 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) but not sold in the country (region), the application for registration of such products will not be accepted.

3. The institution that issues the certification documents should be the competent government department or trade association of the producing country.

(4) relevant product-related standards of the producing country (region) or international organizations

(5) samples of packaging, labels and instructions for the products listed in the producing country (region). It should be listed under the label and manual sample.

The above application materials must be in Chinese with the original text attached, and the materials in foreign languages can be attached for reference. The Chinese translation shall be notarized by a domestic notary office 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.

We 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 supporting documents and power of attorney shall be original, and shall be in the official language of the country (or region) where they are produced, and 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.

3. if the validity period is specified 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 company 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.

VI. Requirements and explanations of application materials for change of domestic health food

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

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

3. To apply for changing the contents stated in the health food approval certificate and its annexes, the applicant shall submit a letter.