Application and Approval of health food:

 

General provisions

A health food registration applicant refers to the proposed health food registration, bear the corresponding legal responsibility, and after obtaining the approval of the application by holding health food approval certificate.

 

Domestic applicant shall be citizens, legal persons or other organizations legally registered in the territory of China. Overseas applicants should be outside the legitimate health food manufacturers. Overseas applicants for import health food registration should have their offices in the territory of China or its agency entrusted to handle the territory of China.

 

2 application for registration of health food products, including applications for registration, change requests, technology transfer product registration application.

 

Article 3 of the State Food and Drug Administration and the provinces, autonomous regions and municipalities (food) drug regulatory departments shall accept registration of health food place public health food registration dossiers and projects related to application for registration represents this essay.

 

Article 10 The applicant shall apply for registration of health food submitted truthfully complete specification of materials and reflect the real situation, and be responsible for the dossier the substance of authenticity.

 

It can be corrected on the spot the presence of errors in the application materials submitted by the applicant 3, shall allow the applicant corrected on the spot.

 

4 Applicant declaration information is not complete, does not meet the statutory form, the entire contents of provinces, autonomous regions and municipalities (food) drug regulatory department of the State Food and Drug Administration on the spot or within five days once inform the applicant to be supplemented , fails to inform, from the date of receipt of the application materials shall be accepted. Inadmissible, it shall give reasons in writing.

 

5 During the review process, required additional information, the State Food and Drug Administration should be made at once. The applicant should submit additional information to meet the requirements within five months after the receipt of the additional information notice, failing to give back the trial deadline for the submission of additional information. Special circumstances, can not submit additional information within the prescribed time limit, it must submit a written application to the State Food and Drug Administration, and explain the reasons. State Food and Drug Administration shall put forward opinions within 20 days.

 

Article XIV need to apply for registration supplementary information, the time limit on the basis of its review of the review of the original time limit on the extension of 30 days, change requests extended by 10 days.

 

6 reviewed according to law, to grant registration, the State Food and Drug Administration should be registered within the prescribed time limit the applicant issued health food approval documents, and served within 10 days; not registered, it should be written within the prescribed time limit inform the applicant, explain the reasons and inform the applicant is entitled to apply for review, administrative reconsideration or bring an administrative lawsuit.

 

7 State Food and Drug Administration and the provinces, autonomous regions and municipalities (food) drug regulatory department found during the review process for health food registration application, the application issues directly related to the vital interests of others, it shall inform the interested party. Applicants and interested parties may submit written comments to state and defense, or required by law to hold a hearing.

 

8 State Food and Drug Administration health food registration application shall make an announcement on the government website received its settings, the review and approval process for registration of health food-related information.

 

9 State Food and Drug Administration should be based on scientific and technological development and the need to adjust the functional scope of health food, health food evaluation and testing methods as well as the review of technical requirements, etc., and make an announcement.

 

Section II product registration application and approval

10 product registration including domestic and imported health food registration application for health food registration application.

Domestic health food registration application refers to the applicant's proposed sale of health food production in the territory of China to apply for registration.

Imported health food registration application refers to has been sold in China to be listed in China's overseas production and sales of more than one year to apply for registration of health food.

 

11 applicant before applying for health food registration, should do the appropriate research. After the study is completed, the applicant shall sample and trial-related information available to the inspection bodies State Food and Drug Administration to determine the related testing and detection.

It intends to apply for health care function within the State Food and Drug Administration announced range, the applicant shall provide a report on the development of products to determine the inspection agency; the applicant should also be tested on animals within its own intention to apply for health care function and range are not released human tasting test, and provide research and development functions report inspection bodies identified.

R & D report should include research and development ideas, feature selection process and the expected results and other content. Research and development functions report should include function names, grounds for the application, functional testing and evaluation methods and school test results and other content. Can not be tested on animals or human tasting test, it should be justified in the functional development of the report and to provide relevant information.

 

After 12 inspection bodies received samples and information provided by the applicant, health food inspection and evaluation of technical specifications shall be in accordance with the State Food and Drug Administration enacted and promulgated by other relevant departments and enterprises to provide test methods for the safety of drug samples NATURAL test, functional test to learn, effective ingredients or ingredients landmark detection, hygiene test, stability test. Function is not declared the State Food and Drug Administration announced that its function should also be verified science test and evaluation methods and test results within the range, and issue test report.

 

After 13 inspection agency issued the test report, the applicant may apply for registration of health food.

 

14 domestic health food registration application, the applicant should fill out the "domestic health food registration application form" in accordance with the provisions and application materials and samples submitted sample trial of the provinces, autonomous regions and municipalities (food) drug regulatory department.

 

15 provinces, autonomous regions and municipalities (food) drug regulatory departments shall, within five days of receiving the application materials and samples after the disclosure of information to normative, integrity formal examination, and issued a notice to accept or not accept.

 

16 pairs of application for registration meets the requirements of the provinces, autonomous regions and municipalities (food) drug regulatory departments shall, within 15 days after accepting the application for testing and prototyping scene verification, extraction test samples, and review comments, and declarations information shall be submitted to the State food and Drug Administration also issued a notice of inspection to determine the inspection agency and provide test samples.

 

17 applications for registration of health food samples required shall be subject to the "health food Good Manufacturing Practice" workshop production, the process must comply with the "health food Good Manufacturing Practice" requirements.

 

18 receive notification and sample inspection agency, it shall, within 50 days of the samples taken samples for examination and review inspection, and the inspection reports submitted to the State Food and Drug Administration, with a copy of its inspection and notification of provinces, autonomous regions and municipalities (food) drug regulatory authorities and the applicant. Special cases, inspection agency can not complete the inspection work within the prescribed time limit, it shall promptly to the State Food and Drug Administration and the provinces, autonomous regions and municipalities (food) drug regulatory department report and a written explanation.

 

19 State Food and Drug Administration review comments received provinces, autonomous regions and municipalities (food) drug regulatory department submitted after the application materials and samples to meet the requirements, shall organize the food, nutrition, medicine, pharmacy in 80 days and other technical personnel to conduct technical review of claims data and administrative review, and make a review of the decision. Grant registration, issued to the applicant "domestic health food approval certificate."

 

20 imported health food registration application, the applicant should fill out the "imported health food registration application form" in accordance with the provisions and submitted to the State Food and Drug Administration to declare information and samples.

 

21 State Food and Drug Administration shall, within five days of receiving the application materials and samples after the disclosure of information to normative, integrity formal examination, and issued a notice to accept or not accept. To meet the requirements of the application for registration, the State Food and Drug Administration shall issue a notice of inspection to determine the inspection agency within 5 days after accepting the application and provide a test sample. If necessary, the State Food and Drug Administration can carry out the verification of the production site and test site products.

 

22 receive notification and sample inspection agency, it shall, within 50 days of the test sample for sample testing and review, and inspection reports submitted to the State Food and Drug Administration, with a copy to the applicant. Special cases, inspection bodies can not be completed within the time limits required inspection, it shall promptly report to the State Food and Drug Administration and a written explanation.

 

23 State Food and Drug Administration shall organize 80 days after accepting the application in food, nutrition, medicine, pharmacy and other technical personnel to conduct technical review of claims data and administrative review, and make a review of the decision. Grant registration, issued to the applicant "imported health food approval certificate."

 

24 health food approval certificate is valid for five years. Domestic health food approval number format: country food key word G + 4 digit year number + 4-bit sequence number; imported health food approval number format: country food key word J + 4 digit year number + 4-bit sequence number.

 

Section Change Request and Approval

25 Change Request means the applicant has proposed changes to health food approval certificate and its annexes apply content enshrined.

 

26 Change the application the applicant shall be health food approval certificate holder.

 

27 health food approval certificate set forth in the name of health food, the original (auxiliary) materials, technology, consumption methods, expanding the range of suitable people, narrow the scope of content suitable for people that may affect the safety function can not be changed.

 

28 apply for suitable people to narrow the scope to expand the range suitable for people, precautions, functional items, changing consumption, product specifications, shelf life and quality standards should be health food products have been manufactured and sold. Increased functionality project must be functional within the State Food and Drug Administration announced range.

 

29 apply for change "domestic health food approval certificate" and its annexes set forth the content, the applicant should fill out the "domestic health food Change Request Form" to the applicant of the provinces, autonomous regions and municipalities (food) drug regulatory department submitted information and instructions.

 

30 provinces, autonomous regions and municipalities (food) drug regulatory departments shall, within five days after receiving the application materials after the declaration of normative data, review the form of integrity, and issued a notice to accept or not accept.

 

31 pairs to change the product name, shelf life, consumption, suitable for people to narrow the scope to expand the range suitable for people, change requests considerations and functional projects, provinces, autonomous regions and municipalities (food) drug regulatory departments shall accept the application after 10 days to review comments, together with the application materials submitted to the State food and Drug Administration.

 

State Food and Drug Administration shall, within 40 days of receipt of the comments and application materials after the organization of food, nutrition, medicine, pharmacy and other technical personnel to conduct technical review of claims data and administrative review, and make a review of the decision. Grant change, issued to the applicant "domestic health food change this document," with a copy of provinces, autonomous regions and municipalities (food) drug regulatory department.

 

32 pairs to change product specifications and quality standards of the change request, provinces, autonomous regions and municipalities (food) drug regulatory department shall review comments within 10 days after accepting the application, together with the application materials submitted to the State Food and Drug Administration, also issued a notice to determine the test and inspection agencies to provide test samples.

 

Receive notification and sample inspection agency, it shall, within 30 days of the sample test samples and test reports submitted to the State Food and Drug Administration, with a copy of its inspection and notification of the provinces, autonomous regions and municipalities (food) drug Regulatory authorities and the applicant.

 

State Food and Drug Administration shall organize review comments received within 50 days, application materials and samples after the food, nutrition, medicine, pharmacy and other technical personnel to conduct technical review of claims data and administrative review, and make a review of the decision. Grant change, issued to the applicant "domestic health food change this document," with a copy of provinces, autonomous regions and municipalities (food) drug regulatory department.

 

33 apply for change "imported health food approval certificate" and its annexes set forth the content, the applicant should fill out the "health food imports Change Request Form" to the State Food and Drug Administration to submit the relevant information and instructions.

 

34 State Food and Drug Administration shall, within five days after receiving the application materials after the declaration of normative data, review the form of integrity, and issued a notice to accept or not accept.

 

35 pairs to change the product name, shelf life, consumption, suitable for people to narrow the scope to expand the range suitable for people, precautions and change requests features projects, the State Food and Drug Administration shall, within 40 days after accepting the application of the organization Food, Nutrition, medicine, pharmacy and other technical personnel to conduct technical review of claims data and administrative review, and make a review of the decision. Grant change, issued to the applicant "imported health food change this document."

 

36 pairs change product specifications, quality standards and imported health food manufacturers to change the change request production site outside of China, the State Food and Drug Administration shall, within five days after receiving the application, issue a notice of inspection to determine the inspection agency and providing test sample. If necessary, the State Food and Drug Administration can carry out the verification of the production site.

 

Inspection agency received notice and samples should be carried out within 30 days of test samples and test reports submitted to the State Food and Drug Administration, with a copy to the applicant.

 

State Food and Drug Administration shall, within 50 days after accepting the application, the organization of food, nutrition, medicine, pharmacy and other technical personnel to conduct technical review of claims data and administrative review, and make a review of the decision. Grant change, issued to the applicant "imported health food change this document."

 

37 pairs changed the applicant's own name, address, and change items in China agency, the applicant shall, within 20 days after the change of the matter, according to the provisions of fill in the "domestic health food change record table" or "imported health food change record table" with the relevant information shall be reported to the State food and Drug Administration for the record.

The same 38 "health food change this document." Validity of the original health food approval certificate validity, expiry, should be re-apply for registration.

 

 

40 technology transfer product registration application refers to the health food approval certificate holder the right to sell the product and production technology transfer to full health food production enterprises, and their joint application to the transferee issued by the new health food approval certificate behavior.

 

41 to accept the transfer of the territory of health food production enterprises, must obtain health food sanitation license law and in line with the "health food Good Manufacturing Practice" business.

To accept the transfer of foreign health food production enterprises must comply with the appropriate local manufacturing practices.

 

42 transferor and the transferee shall sign the contract, all the information and technology transfer to the transferee, the transferee guide the continuous production of three batches of the product in line with the quality standards.

 

More than 43 applicants jointly owned health food approval certificate, when the transfer of technology, should be signed jointly signed a transfer contract.

 

44 has been made "domestic health food approval certificate" or "imported health food approval certificate" health food in the territory assignment, health food certificate holder and the transferee shall be jointly fill out the "domestic health food technology transfer product registration application form" or "technology transfer products imported health food registration application form" to the transferee of the provinces, autonomous regions and municipalities (food) drug administration departments to submit relevant information and samples, together with the transfer of the contract.

 

45 provinces, autonomous regions and municipalities (food) drug regulatory departments shall, within five days after receiving the application materials after the declaration of normative data, review the form of integrity, and issued a notice to accept or not accept.

To meet the requirements of technology transfer product registration application, provinces, autonomous regions and municipalities (food) drug regulatory department shall review comments within 10 days after accepting the application, together with the application materials submitted to the State Food and Drug Administration, at the same time to test inspection agency issued a notice to determine and provide the test sample.

 

46 receive notification and sample inspection agency, it shall, within 30 days of the sample test samples and test reports submitted to the State Food and Drug Administration, with a copy of its inspection and notification of the provinces, autonomous regions and municipalities (food) drug regulatory authorities and the applicant.

 

47 State Food and Drug Administration to review the decision should be made within 20 days after receiving the examination opinions, application materials and samples after the inspection reports. Grant registration, issued to the transferee a new "domestic health food approval certificate" and a new approval number, the certificate validity of the same, while the collection and cancellation of "domestic health food approval certificate" original transferor acquired or "imports health food approval certificate. "

 

48 has been made "imported health food approval certificate" health food overseas assignment, health food certificate holder and the transferee shall be jointly fill out the "transfer of technology products imported health food registration application form," the State Food and Drug Administration submit the relevant information and samples, together with the transfer of the contract.

 

State Food and Drug Administration shall, within five days after receiving the application materials after the declaration of normative data, review the form of integrity, and issued a notice to accept or not accept. To meet the requirements, it shall issue a notice of inspection to determine the inspection agency within 5 days after accepting the application and provide a test sample. If necessary, the State Food and Drug Administration can transferee production site for verification.

 

49 receive notification and sample inspection agency, it shall, within 30 days of the sample test samples and test reports submitted to the State Food and Drug Administration, with a copy to the applicant. State Food and Drug Administration to review the decision should be made within 20 days after receipt of the sample inspection report. Grant registration, issued to the transferee a new "imported health food approval certificate" and a new approval number, the certificate validity of the same, while the collection and cancellation of "imported health food approval certificate" original transferor acquired.

 

Raw materials and accessories

 

50 health food and health food raw materials refers to functions related to the initial material. Health food materials refers to excipients and other additional materials when used in the production of health food.

 

Raw materials and accessories used by 51 health food should be in line with national standards and hygiene requirements. No national standards, industry should be provided to develop its own standards or quality standards, and to provide relevant information to the raw materials and accessories.

 

Raw materials and accessories used by 52 health food should be safe and harmless to human health. Have limited physical requirements, the amount shall not exceed the relevant state regulations.

 

53 State Food and Drug Administration and is not available for raw materials and state departments of health food provisions, prohibit the use of the goods is not as a health food and raw materials.

 

54 State Food and Drug Administration issued a health food that can be used, or the Ministry of Health announced the approval of edible raw materials and auxiliary materials as well as the production of ordinary food can be used as a health food and raw materials.

 

, Should provide the raw materials and the corresponding toxicological safety evaluation test reports and related food safety information in accordance with the relevant provisions in the raw materials and accessories 55 applications for registration of health food is not being used in this way Article 63 of the predetermined range.

 

56 State Food and Drug Administration shall promptly publish a list of materials that can be used to disable and health food according to scientific and technological developments and needs.

 

57 health food raw materials and imported materials used should be consistent with the provisions of the relevant health food raw materials and ingredients used.

 

Label with the description,

 

58 apply for registration of health food products, the applicant shall submit product specifications and labeling comp.

 

59 applications for registration of health food labels, brochures comp content should include product name, main raw (auxiliary) materials, functional ingredients / iconic composition and content, health functions, suitable for groups, suitable for people, consumption and consumption methods, specifications , shelf life, storage methods and precautions.

Approved the listing of the production of health food labels should comply with the relevant provisions of the State.

 

60 health food should be named in line with the following principles:

(A) comply with relevant laws, regulations, rules, standards and specifications;

Real property (ii) reflect the product, concise, easy to understand, comply with Chinese language habits;

 

(A) brand names can be registered trademarks or product names other;

(B) the common name should be accurate and scientific, not use express or implied therapeutic effect and exaggerated function of text;

(Iii) the property name should indicate the objective form of the product, its presentation should be standardized and accurate.

 

62 State Food and Drug Administration should be based on relevant national standards, regulations, and the case of a product dossier sample testing of labels, brochures comp content review.

 

Test and Inspection

 

63 safety toxicology test means health food safety toxicology evaluation procedures and test methods inspection bodies in accordance with the State Food and Drug Administration issued, the applicant's submission of samples to verify the food safety of animals for the purpose of test, if necessary, can be human tasting test.

 

Learn function tests, refers to a health food inspection agency in accordance with the State Food and Drug Administration issued or enterprises to provide evaluation procedures and test methods, sample inspection of the applicant to verify the health functions carried out for the purpose of animal testing and / or human test food test.

 

Effectiveness of components or ingredients landmark detection means effectiveness of health food ingredients inspection agencies in accordance with the State Food and Drug Administration and the relevant departments or enterprises promulgated or iconic component detection methods, the effectiveness of the composition of the sample or the applicant for inspection detection iconic ingredient content and content changes in the shelf life carried out.

 

Hygiene test means testing agencies in accordance with the test methods issued by national authorities or enterprises, and hygiene inspection of samples of the applicant and its product quality-related indicators (in addition to the efficacy of ingredients or symbolic component outside) conducted testing.

 

Stability testing means testing agencies in accordance with the test methods issued by national authorities or enterprises, and hygiene inspection of samples of the applicant and its product quality-related indicators (in addition to the efficacy of ingredients or symbolic component outside) in the shelf life detecting changes undertaken within.

 

Sample test, refer to the total project inspection inspection bodies in accordance with the quality standards declared by the applicant, to sample food and drug administration departments conducted.