Health food filing refers to the process that health food production enterprises submit materials showing product safety, health care function and quality controllability to food and drug supervision and management departments for filing, disclosure and future reference in accordance with legal procedures, conditions and requirements. Below, I will share with you the interpretation and analysis of the management measures for health food registration and filing. Welcome to read and browse.

1. What is the legislative basis of the Measures?

The Measures are formulated in accordance with Articles 74, 75, 76, 77, 78 and 82 of the Food Safety Law of the People's Republic of China.

2. What are the scope of application and basic principles of the Measures?

The Measures stipulate that these Measures shall apply to the registration, filing, supervision and management of health food within the territory of the People's Republic of China. The registration and filing of health food should follow the principles of science, openness, justice, convenience and efficiency.

3. What is the meaning of health food registration in the Measures?

The "Measures" stipulate that the registration of health food refers to the examination and approval process in which the food and drug supervision and administration department systematically evaluates and reviews the safety, health care function and quality controllability of the health food applied for registration according to the application of the registration applicant and in accordance with legal procedures, conditions and requirements, and decides whether to approve the registration.

4. What is the meaning of health food filing in the Measures?

Health food filing refers to the process that health food production enterprises submit materials showing product safety, health care function and quality controllability to food and drug supervision and management departments for filing, disclosure and future reference in accordance with legal procedures, conditions and requirements.

5. How does the Measures stipulate the acceptance department of health food registration applications?

China food and drug administration administrative acceptance agency (hereinafter referred to as the acceptance agency) is responsible for accepting the registration of health food.

Six, the "Measures" on the health food filing materials receiving department is how to provide?

China food and drug administration administrative acceptance agency is responsible for receiving the relevant imported health food filing materials.

The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for receiving relevant health food filing materials.

Seven, the "measures" of food and drug supervision and management departments at all levels of responsibility is how to divide?

According to the Measures, china food and drug administration is responsible for the registration management of health foods and the filing management of health foods imported for the first time that are supplemented with vitamins, minerals and other nutrients, and guides and supervises the work related to the registration and filing of health foods undertaken by the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government.

The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for the record management of health food within their respective administrative areas, and cooperate with china food and drug administration to carry out on-site verification of health food registration.

City and county food and drug supervision and management departments are responsible for the supervision and management of registered and filed health foods within their respective administrative areas, and undertake other tasks entrusted by the food and drug supervision and management departments at higher levels.

8. How are the main responsibilities of the Measures for applicants or filers, evaluation institutions and administrative departments divided?

The applicant or filer is responsible for the authenticity, completeness and traceability of the application materials, and for the safety, effectiveness and quality controllability of the products.

The review institution is responsible for organizing review experts to review the application materials, organizing inspection institutions to carry out on-site verification according to actual needs, organizing inspection institutions to carry out review inspection, completing technical review within 60 days, and submitting comprehensive review conclusions and suggestions to the General Administration.

The administrative department is responsible for the registration and filing management of health food.

9. What important adjustments have been made to the supervision of health food registration and filing in the Measures?

Compared with the previous registration management system, the Measures, based on the new food safety law, implement a classified management system combining registration and filing for health foods.

Health foods that use raw materials other than the catalogue of health food raw materials and health foods imported for the first time shall be registered and managed.

For the use of raw materials have been included in the catalogue of health food raw materials and imported for the first time belongs to supplement vitamins, minerals and other nutrients of health food for the record management. For the first time, the health food that is supplemented with vitamins, minerals and other nutrients should be listed in the catalogue of health food raw materials.

The claimed health care function of the product should have been included in the list of health food functions. The catalogue of raw materials of health food and the catalogue of health functions allowed to be claimed by health food shall be formulated, adjusted and promulgated by the General Administration jointly with the health administrative department of the State Council and the State Administration of Traditional Chinese Medicine, and relevant supporting management measures shall be formulated separately.

X. What are the important adjustments to the registration procedures of health food in the Measures?

The "Measures" stipulate that the application for health food registration shall be undertaken by the accepting institution of the General Administration. Taking acceptance as the starting point of registration and approval, the production site verification and review inspection will be adjusted to the technical review, and specific and strict restrictions and requirements will be put forward on the review content, review procedures, overall time limit and judgment basis.

Technical review shall be carried out according to procedures such as verification of application materials, on-site verification, dynamic sampling and recheck inspection. If any link fails to meet the requirements, the review institution may terminate the review and put forward suggestions on not registering.

XI. What adjustments have been made to the requirements of supplementary materials for technical review of health food in the Measures?

If the evaluation institution considers it necessary for the registration applicant to supplement the materials, it shall inform all the contents that need to be supplemented at one time. The applicant for registration shall provide supplementary materials at one time in accordance with the requirements of the notice of correction within 3 months. If the applicant for registration fails to submit supplementary materials or make corrections within the time limit, which is not enough to prove the product safety, health care function and quality controllability, the evaluation institution shall terminate the evaluation and put forward suggestions on not registering.

Twelve, the "measures" on the health food technology transfer procedures have any adjustment?

Where the registrant of health food transfers technology, the transferee shall re-apply for product registration under the guidance of the transferor. Product technical requirements shall be consistent with the original application materials. The review institution simplifies the review procedures in accordance with relevant regulations.

Thirteen, the "measures" provisions of the health food record management what are the key contents?

After the food and drug supervision and administration department receives the filing materials, if the filing materials meet the requirements, it shall be filed on the spot; If it does not meet the requirements, it shall inform the record holder to correct the relevant materials at one time.

The food and drug supervision and administration department shall complete the filing of the record information for future reference and issue the record number.

For the health food filed, the food and drug supervision and administration department shall make a filing voucher in the format required by the relevant requirements, and publish the information published in the filing information form on its website.

Where the registered health food raw materials have been included in the catalogue of health food raw materials and meet the relevant technical requirements, the health food registrant shall apply for change of registration, or apply for renewal of registration upon expiration, and shall go through the filing procedures.

Fourteen, the "measures" provisions of the qualification requirements of registered applicants what are the main?

The applicant for registration of domestic health food shall be a legal person or other organization registered in China; The applicant for registration of imported health food shall be an overseas manufacturer of listed health food. An application for registration of imported health food shall be handled by its permanent representative office in China or its entrusted agency in China.

Where the contents stated in the health food registration certificate and its annexes are changed, the health food registrant shall apply for the change. Where the name of the registrant changes, the applicant for registration after the change shall apply for the change.

When the validity period of the health food registration certificate expires, it shall be the health food that has been produced and sold, and provide an analysis report on the consumption of people and a self-inspection report on the operation of the production quality management system.

15. What are the main requirements of the Measures for the qualifications of filers?

The filer of domestic health food should be a health food production enterprise, and the original registrant can be the filer; The filer of imported health food shall be the overseas manufacturer of listed health food.

Sixteen, what is the key supporting work for the implementation of the "measures"?

According to the newly revised Food Safety Law, the catalogue of health food raw materials and the catalogue of health functions that allow health food to claim are the necessary conditions and prerequisite for the implementation of health food registration and filing management. At present, the General Administration is working with the health administrative department of the State Council and the State Administration of Traditional Chinese Medicine to formulate relevant management measures and supporting catalogues, and strive to introduce them as soon as possible.

Seventeen, after the implementation of the "Measures", what measures will be taken to apply for the registration of existing health food and approve the registered products?

After the implementation of the "Measures", our bureau will carry out the review work in accordance with the new regulations. For the existing health foods that have been approved for registration, the cleaning and replacement work shall be carried out in stages, in compliance with laws and regulations, and steadily. Through cleaning and replacement, the evaluation standards of new and old products are consistent. The cleaning and replacement plan shall be stipulated separately.

Eighteen, "measures" on the naming of health food provisions how to implement?

The "Measures" clearly defined the naming of health food, which was formed on the basis of soliciting opinions from enterprises, industry organizations, grass-roots supervision departments and experts, and was publicly solicited on the website of the State Council Legislative Affairs Office on August 20 15. On August 25th, 20 15, the General Administration issued the Announcement on Further Standardizing the Naming of Health Foods, which made it clear that the General Administration would no longer approve health foods named with words expressing the functions of products, and required the registered products to change their names according to relevant regulations. Considering the market awareness of the names of listed health foods, the General Administration of Health recently issued the Announcement on Matters Related to the Naming of Health Foods, giving manufacturers a certain transition period, allowing the labeling of new product names as well as the original product names. At present, the General Administration is further studying the naming of health food, and standardizing the naming of health food and technical review by formulating guidelines and review rules.

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