chapter two
Application and approval
the first paragraph
general clause
Article 7
The applicant for health food registration refers to the person who applies for health food registration, bears corresponding legal responsibilities and holds the health food approval certificate after the application is approved.
Domestic applicants should be citizens, legal persons or other organizations legally registered in China.
The overseas applicant must be a legal overseas health food production enterprise. The registration of imported health food by an overseas applicant shall be handled by its office in China or its entrusted agency.
Article 8
Health food registration applications include product registration applications, change applications and technology transfer product registration applications.
Article 9
The State Food and Drug Administration of the United States and the (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall publicize the items of the application materials for health food registration and the demonstration text of the relevant registration application forms in the health food registration acceptance places.
Article 10
Applicants applying for health food registration shall truthfully submit standardized and complete materials and reflect the real situation in accordance with the provisions, and be responsible for the authenticity of the substantive contents of their application materials.
Article 11
If there are errors in the application materials submitted by the applicant that can be corrected on the spot, the applicant shall be allowed to correct them on the spot.
Article 12
If the information declared by the applicant is incomplete and does not conform to the statutory form, the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government and the State Food and Drug Administration of the United States shall inform the applicant of all the contents that need to be corrected on the spot or within five days. If the applicant fails to handle it within the time limit, it shall be accepted from the date of receiving the application materials. If it is not accepted, it shall explain the reasons in writing.
Article 13
In the process of review, if supplementary information is needed, the State Food and Drug Administration shall submit it at one time. The applicant shall submit supplementary materials that meet the requirements within 5 months after receiving the notice of supplementary materials. If the supplementary materials are not submitted within the prescribed time limit, they shall be returned. Under special circumstances, if supplementary information cannot be submitted within the prescribed time limit, a written application must be submitted to the State Food and Drug Administration, and the reasons must be explained. The State Food and Drug Administration of the United States shall put forward handling opinions within 20 days.
Article 14
For applications requiring supplementary information, the review time limit is extended by 30 days on the basis of the original review time limit, and the change application is extended by 10 days.
Article 15
If the registration is approved after examination according to law, the State Food and Drug Administration of the United States will issue the health food approval certificate to the registered applicant within the prescribed time limit and deliver it within 10 days; If the registration is not granted, it shall inform the applicant in writing within the prescribed time limit, explain the reasons, and inform the applicant that he has the right to apply for reconsideration, administrative reconsideration or bring an administrative lawsuit according to law.
Article 16
The State Food and Drug Administration of the United States and the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall notify the interested parties if they find that the application matters are directly related to the major interests of others in the process of examining the application for health food registration. Applicants and interested parties may submit written opinions to make statements and arguments, or request a hearing according to law.
Article 17
The State Food and Drug Administration of the United States shall publish the acceptance and examination process of the application for registration of health food and the relevant information of the health food approved for registration on its government website.
Article 18
According to the development and needs of science and technology, the State Food and Drug Administration of the United States will timely adjust the functional scope of health food, the evaluation and inspection methods of health food and the technical regulations for evaluation, and make an announcement.
the second part
Application and approval of product registration
Article 19
Product registration applications include domestic health food registration applications and imported health food registration applications.
The application for registration of domestic health food refers to the application for registration of the applicant to produce and sell health food in China.
The application for registration of imported health food refers to the application for registration of health food that has been produced and sold outside China for more than one year and intends to be listed and sold in China.
Article 20
Before applying for health food registration, the applicant should do a good job in the corresponding research.
After the completion of the research work, the applicant shall provide samples and materials related to the test to the inspection agency determined by the US Food and Drug Administration, and conduct relevant tests and tests.
If the health care function of the application is within the scope announced by the State Food and Drug Administration, the applicant shall provide the product research and development report to the designated inspection institution; If the health care function applied for is not within the scope of publication, the applicant shall also conduct animal tests and human food tasting tests on his own, and provide functional research and development reports to the recognized inspection institutions.
The product R&D report shall include R&D ideas, function screening process and expected results. The function R&D report shall include the function name, application reasons, function inspection and evaluation methods and inspection results, etc. If it is impossible to carry out animal tests or human food tests, it shall explain the reasons in the functional research and development report and provide relevant materials.
Article 21
After receiving the samples and relevant materials provided by the applicant, the inspection institution shall conduct safety toxicology test, functional test, functional component or symbolic component test, hygiene test and stability test on the samples in accordance with the Technical Specification for Inspection and Evaluation of Health Foods promulgated by the US Food and Drug Administration and the inspection methods promulgated by other relevant departments and provided by enterprises. If the declared function is not within the scope announced by the State Food and Drug Administration, the functional inspection and evaluation methods and test results shall be verified, and a test report shall be issued.
Article 22
After the inspection agency issues the inspection report, the applicant may apply for health food registration.
Article 23
To apply for the registration of domestic health food, the applicant shall fill in the application form for the registration of domestic health food in accordance with the regulations, and submit the application materials and samples to the food and drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government where the samples are trial-produced.
Article 24
The (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall, within 5 days after receiving the application materials and samples, formally review the standardization and completeness of the application materials and issue a notice of acceptance or rejection.
Article 25
For those who meet the requirements of the registration application, the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall, within 15 days after accepting the application, check the inspection and sample trial production site, draw inspection samples, put forward examination opinions, submit them to the State Food and Drug Administration together with the application materials, and issue inspection notices to the recognized inspection institutions to provide inspection samples.
Article 26
The samples required to apply for health food registration shall be produced in the workshop that meets the quality management standards for health food production, and the processing process must meet the requirements of the quality management standards for health food production.
Article 27
The inspection institution that receives the inspection notice and samples shall conduct sample inspection and re-inspection on the samples taken within 50 days, submit the inspection report to the State Food and Drug Administration of the United States, and send a copy to the (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government and the applicant. Under special circumstances, if the inspection institution fails to complete the inspection within the prescribed time limit, it shall promptly report to the State Food and Drug Administration and the (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government, and explain the reasons in writing.
Article 28
The State Food and Drug Administration of the United States shall, within 80 days after receiving the evaluation opinions, application materials and samples submitted by the (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government, organize technical personnel of food, nutrition, medicine and pharmacy to conduct technical and administrative evaluation on the application materials, and make an evaluation decision. If the registration is granted, the applicant shall be issued with the Approval Certificate of Domestic Health Food.
Article 29
To apply for the registration of imported health food, the applicant shall fill in the application form for the registration of imported health food as required, and submit the application materials and samples to the State Food and Drug Administration of the United States.
Article 30
The State Food and Drug Administration of the United States shall, within 5 days after receiving the application materials and samples, conduct a formal review of the standardization and completeness of the application materials and issue a notice of acceptance or rejection. For an application for registration that meets the requirements, the State Food and Drug Administration of the United States shall issue an inspection notice to the designated inspection agency within 5 days after accepting the application, and provide samples for inspection. According to needs, the State Food and Drug Administration can inspect the production site and test site of products.
Article 31
The inspection institution that receives the inspection notice and samples shall conduct sampling inspection and reinspection on the samples within 50 days, submit the inspection report to the State Food and Drug Administration of the United States, and send a copy to the applicant. Under special circumstances, if the inspection institution fails to complete the inspection within the prescribed time limit, it shall report to the State Food and Drug Administration in time and explain the reasons in writing.
Article 32
The State Food and Drug Administration of the United States shall, within 80 days after accepting the application, organize technicians in food, nutrition, medicine and pharmacy to conduct technical and administrative review of the application materials and make a review decision. If the registration is granted, the applicant shall be issued with the Approval Certificate for Imported Health Food.
Article 33
Health food approval certificate is valid for 5 years. The format of the approval number of domestic health food is: national food health word G+4-digit year number +4-digit serial number; The format of the approval number of imported health food is: national food health word J+4-digit year number +4-digit serial number.