"Health Food Registration (for Trial Implementation)" (Board Order No. 19)
April 30, 2005 release
State Food and Drug Administration Order No. 19
"Health Food Registration (Trial)" by the State Food and Drug Administration Bureau of Finance Council, is hereby promulgated, July 1, 2005 shall come into force.
April 30, 2005
Health Food Registration (Trial)
Chapter I General Provisions
First to regulate the registration of health food act to ensure the quality of health food, protection of human food safety, according to "Food Hygiene", "PRC Administrative Licensing Law," formulated.
Article The term health food, is claimed to have specific health or to supplement the vitamins and minerals for the purpose of food. Is suitable for specific food groups, is capable of regulating the body functions, not to treat the disease for the purpose, and the human body does not produce any acute, subacute or chronic hazard to food.
The third application in the PRC domestic and imported health food registration, the application of this approach.
Article health food registration, the State Food and Drug Administration based on the applicant's application, in accordance with legal procedures, conditions and requirements of the application for registration of health food safety, efficacy, and quality control of the content label instructions systematic evaluation and review and decide whether to grant approval of its registration process; including product registration applications, change application and technology transfer product registration application for approval.
The state Food and Drug Administration in charge of national health food registration management, responsible for the health food approval.
Provinces, autonomous regions and municipalities (food) drug regulatory department under the State Food and Drug Administration commission, responsible for domestic health food registration application form to receive and review information on the application for registration of health food testing and prototyping the on-site verification, tissue samples for testing.
State Food and Drug Administration inspection agencies to determine the application for registration of health food safety toxicology tests, functional tests science (including animal testing and / or human test food test), functional components or ingredients landmark detection, hygiene test , stability testing, etc.; take sample tests and review tests and other specific tasks.
Article VI of health food registration and management, should follow the science, open, fair, impartial, efficient and convenient for citizens.
Chapter II Application and Approval
Section I General Provisions
Article health food registration applicant refers to the proposed health food registration application, bear the corresponding legal responsibility, and after the application is approved by holders of health food approval certificate.
Within the applicant should be legally registered in China's citizens, legal persons or other organizations.
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 commissioned agent for the territory of China.
Article VIII of health food registration application, including product registration applications, change application, technology transfer product registration application.
Article IX State Food and Drug Administration and the provinces, autonomous regions and municipalities (food) drug regulatory departments shall accept the registration of health food health food premises registration publicity projects and disclosure of information relating to applications for registration, said Pham Van The.
Article 10 The applicant shall apply for registration in accordance with the provisions of health food submitted truthfully complete specification of materials and reflect the true situation and the substance of their claims data responsible for the authenticity.
Article 11 An applicant can submit application materials to correct the wrong spot, the spot should allow the applicant to correct.
Article XII of the information submitted by the applicant are not complete, does not meet the statutory form, the provinces, autonomous regions and municipalities (food) drug administration and the State Food and Drug Administration on the spot or within five days inform the applicant of all necessary correction content, fails to do so, since the date of receipt of declarations shall be accepted. Inadmissible, it shall give reasons in writing.
Article XIII in the review process, need additional information, the State Food and Drug Administration should make one. The applicant shall receive notice of the additional information submitted within five months to meet the requirements of additional information, according to the specified time limit to submit additional information to back the trial. Special circumstances, can not submit additional information within the time limit, and must state Food and Drug Administration to submit a written application and the reasons. State Food and Drug Administration should be made within 20 days of handling.
Article XIV requires additional information registration, examination of its review in the original time limit, based on the extension of 30 days, change the application to extend the 10 days.
Article XV according to the law review, grant registration, the State Food and Drug Administration within the prescribed time limit should be the applicant for registration of health food approval certificate issued and served within 10 days; not registered, it shall be the prescribed time limit inform the applicant in writing, give reasons and inform the applicant of the right to apply for review, administrative reconsideration or bring an administrative lawsuit.
Article 16 The State Food and Drug Administration and the provinces, autonomous regions and municipalities (food) drug administration in the health food registration application review process that matters directly related to the vital interests of others, it shall notify the interested parties. The applicant and interested parties may submit written comments to statements and representations, or to request a hearing according to law.
Article XVII State Food and Drug Administration should, in its notice on the government website set up health food registration application processing, review and approval process of registration of health food information.
Article 18 The State Food and Drug Administration should be based on scientific and technological development and the need to adjust the scope of the functions of health food, health food evaluation and testing methods, and review of technical requirements, etc., and announce it.
Section II product registration and approval
Article 19 The application for registration of products, including domestic and imported health food registration application for health food registration application.
Domestic health food registration application refers to the applicant intends to produce in China, sales of health food registration application.
Import health food registration application refers to the production and sales in China more than a year outside of health food products to be marketed in China an application for registration.
Diershitiao applicants before registration of health food should do the appropriate research.
After completion of the study, the applicant shall sample and trial-related information to the State Food and Drug Administration inspection agencies to determine the relevant testing and detection.
Health functions to be applied in the State Food and Drug Administration announced range, the applicant shall identify the inspection agency to provide product research and development report; not wish to apply for public health functions within the scope of, the applicant shall also conduct its own trials and animal human test food test to determine the function of research and development testing agencies reported.
R & D report should include research and development ideas, feature selection process and the expected results and so on. Functional R & D report should include function names, grounds for the application, inspection and evaluation of functional study methods and test results and so on. Human or animal testing can not test food test, the report should be developed in the functional reasons and to provide relevant information.
Twenty-one institutions received test samples provided by the applicant and the information, shall be in accordance with the State Food and Drug Administration issued a health food inspection and evaluation of technical specifications and other relevant departments and enterprises issued by the inspection method of sample toxicological safety testing, functional testing study, functional components or ingredients landmark detection, hygiene testing, stability testing. The function declaration is not the State Food and Drug Administration announced range, and should also learn its function and its test results and evaluation methods to verify and issue test report.
Article 22 The inspection and test report issued by the agency, applicants may apply for health food registration.
Article 23 The domestic health food registration application, the applicant shall be subject to fill in the "domestic health food registration application form", and claims data and samples submitted to the prototyping of the province, autonomous regions and municipalities (food) drug administration.
Article 24 provinces, autonomous regions and municipalities (food) drug regulatory departments shall receive application materials and samples after 5 days of a reporting norms, integrity, the form of review, and issued a notice to accept or not accept .
Meet the requirements of Article 25 applications for registration of provinces, autonomous regions and municipalities (food) drug administration department shall, within 15 days after accepting the application for testing and prototyping the on-site verification, taking samples for testing, and review comments , together with the claims data submitted to the State Food and Drug Administration, and the inspection agency to determine the issue and provide the test with a test sample notice.
Article 26 required to apply for registration of health food samples should be in line with the "health food Good Manufacturing Practice" workshop production, the process must comply with the "health food Good Manufacturing Practice" requirements.
Article 27 Notice of receipt of test samples and testing agencies, should be taken in 50 days, samples of test and review sample test, and inspection reports submitted to the State Food and Drug Administration, with a copy of the notice of their inspection provinces, autonomous regions and municipalities (food) drug administration department and the applicant. Special circumstances, the inspection agency can not complete the inspection within the time limit, and shall promptly report to the State Food and Drug Administration and the provinces, autonomous regions and municipalities (food) drug administration report and a written explanation.
Article 28 The State Food and Drug Administration received by provinces, autonomous regions and municipalities (food) drug administration review of comments submitted, application materials and samples, meet the requirements, should be organized in the 80 days of food, nutrition, medical, pharmaceutical and other technical personnel to conduct technical review of claims data and administrative review, and make the review decision. Grant registration, the applicant presented the "domestic health food approval certificate."
Article 29 The imported health food registration application, the applicant shall be subject to fill in the "imported health food registration application form", and claims data and samples submitted to the State Food and Drug Administration.
Article 30 The State Food and Drug Administration shall receive application materials and samples after 5 days of a reporting norms, integrity, the form of review, and issued a notice to accept or not accept. Meet the requirements of the application for registration, the State Food and Drug Administration should be within 5 days after receiving the application to determine the inspection agency issued a notice and provide the test with a test sample. Necessary, the State Food and Drug Administration can produce the product and testing on-site field verification.
第三十一条 received notice of inspection and sample testing agencies, should be 50 days for samples testing and review of test samples and test reports submitted to the State Food and Drug Administration, copied to the applicant. Special circumstances, the inspection agency can not be completed within the stipulated time frame inspection, and shall promptly report to the State Food and Drug Administration report and a written explanation.
Article 32 The State Food and Drug Administration should be 80 days after receiving the application program on food, nutrition, medicine, pharmacy and other technical personnel to conduct technical review of claims data and administrative review, and make a review decision. Grant registration, issued to the applicant "imported health food approval certificate."
Article 33 The health food approval certificate is valid for 5 years. Domestic health food approval number format: country food key word G +4 + 4-bit bit's sequence number; imported health food approval number format: country food key word J +4 + 4-bit bit's sequence number.
Section Change Request and Approval
Article 34 refers to the applicant to change the application to change the health food approval certificate and its annexes contain content applications.
Article 35 The applicant shall apply for changes to the health food approval certificate holder.
Article 36 The health food approval certificate set forth in the health food function name, the original (auxiliary) materials, technology, food ways, to expand the scope of suitable people to narrow the scope of suitable groups that may affect the safety, functionality not change the content.
Article 37 apply for suitable people to narrow the scope to expand the range of suitable people, attention, functional items, changes in consumption, product specifications, shelf life and quality standards of care should have been produced food products sold. Increasing function of the project to be published the State Food and Drug Administration within the scope of functions.
Article 38 The application to change the "domestic health food approval certificate" and its contents stated in the annex, the applicant should fill out the "health food made changes to the application form" to the applicant of the province, autonomous regions and municipalities (food) drug administration departments to submit relevant information and instructions.
Article 39 provinces, autonomous regions and municipalities (food) drug administration department shall receive within 5 days after the disclosure of information on the normative claims data, review the form of integrity, and issued a notice to accept or not accept.
Article 40 to change the product name, shelf life, consumption, suitable for narrow range of people, not suitable for people to expand the scope of considerations, and functional changes in the project application, provinces, autonomous regions and municipalities (food) drug administration department shall accept application within 10 days after the review comments, and declarations shall be submitted to the State Food and Drug Administration.
State Food and Drug Administration should review the comments received and within 40 days after the disclosure of information, organization of food, nutrition, medicine, pharmacy and other technical personnel to conduct technical review of claims data and administrative review, and make a review decision. Allowed to change, issued to the applicant "made changes to health food approval document", copied to the provinces, autonomous regions and municipalities (food) drug administration.
Article 41 to change product specifications and quality standards of the change request, provinces, autonomous regions and municipalities (food) drug administration department shall accept the application within 10 days after the review comments, and declarations shall be submitted to the State Food and Drug Authority, and to determine the inspection agency issued a notice and provide the test with a test sample.
Received notice of inspection and sample testing agencies, shall, within 30 days of the sample for sample testing, and inspection reports submitted to the State Food and Drug Administration, copied to the notice of its inspection of the provinces, autonomous regions and municipalities (food) drug supervision and management department and the applicant.
State Food and Drug Administration should review the comments received, reporting data and tissue samples after 50 days of food, nutrition, medicine, pharmacy and other technical personnel to conduct technical review of claims data and administrative review, and make a review decision. Allowed to change, issued to the applicant "made changes to health food approval document", copied to the provinces, autonomous regions and municipalities (food) drug administration.
Article 42 to apply changes "imported health food approval certificate" and its contents stated in the annex, the applicant should fill out the "Application Form for import health food to change," the State Food and Drug Administration to submit the relevant information and instructions.
Article 43 The State Food and Drug Administration should declare the information received after the 5 days of a reporting norms, integrity, the form of review, and issued a notice to accept or not accept.
Article 44 to change the product name, shelf life, consumption, suitable for narrow range of people, not suitable for people to expand the scope of considerations, and functional changes in the project application, the State Food and Drug Administration should accept the application within 40 days after program on food, nutrition, medicine, pharmacy and other technical personnel for disclosure of information in the technical review and administrative review, and make a review decision. Allowed to change, issued to the applicant "to change the import health food approval document."
Article 45 to change product specifications, quality standards and imported health food manufacturers to change production sites in China, changes outside the application, the State Food and Drug Administration should be within 5 days after receiving the application, inspection agencies to determine the inspection notice issued book and provide samples for testing. Necessary, the State Food and Drug Administration of the production site can be verified.
Received notice of inspection and sample testing agencies, shall, within 30 days for sample testing, and inspection reports submitted to the State Food and Drug Administration, copied to the applicant.
State Food and Drug Administration should be 50 days after receiving 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 decision. Allowed to change, issued to the applicant "to change the import health food approval document."
Article 46 of the change the applicant's own name, address, and change agents in China matters, the applicant shall in the matter within 20 days after the change, fill out the required "health food made changes to the record table" or "import health Food change record table ", and the information a report to the State Food and Drug Administration for the record.
Article 47 of the "health food change documents of approval," the validity of the original health food approval certificate for the same period, has expired, the application should be re-registered.
Article 48 requires replacement of health food approval certificate, the applicant should give the State Food and Drug Administration a written application and the reasons. Apply for a replacement due to loss, it shall be submitted in the national newspapers on the public offering statement published in the loss of the original; apply for a replacement due to damage, it shall return the original health food approval certificate. After review, to meet the requirements, replacement health food approval certificate, and continue to use the original license number, validity period unchanged. Replacement of the health food approval certificate should be marked on the original approval date, and indicate "replacement" words.
Section IV technology transfer product registration application and approval
Article 49 The technology transfer product registration application refers to the health food approval certificate holder, product and production technology, production and sales rights transfer solely to health food production enterprises, and their joint application to the transferee issued new health food certificate of approval of behavior.
Article 50 to accept the transfer of the territory of health food production enterprises, must be legally obtained permits and comply with food hygiene and health, "health food good manufacturing practice" companies.
Accept the transfer of foreign health food production enterprises must comply with the appropriate local manufacturing practices.
第五十一条 transferor and transferee shall sign a contract, and all the technical information transferred to the transferee, the transferee guidance in line with the continuous production of three batches of samples of product quality standards.
Article 52 more applicants jointly owned health food approval certificate, technology transfer, the transfer shall be signed jointly signed the contract.
Article 53 has been made in the "domestic health food approval certificate" or "imported health food approval certificate" health food in the territory of the transfer, the health food certificate holder and the transferee shall be jointly fill out the "products of domestic health food registration of technology transfer Application Form "or" technology transfer products imported health food registration application form "to the transferee of the province, autonomous regions and municipalities (food) drug administration departments to submit information and samples, together with the transfer contract.
Article 54 provinces, autonomous regions and municipalities (food) drug regulatory departments shall receive within 5 days after the disclosure of information on the regulatory reporting information, review the form of integrity, and issued a notice to accept or not accept.
Technology transfer of products to meet the requirements of the application for registration, provinces, autonomous regions and municipalities (food) drug administration department shall accept the application within 10 days after the review comments, and declarations shall be submitted to the State Food and Drug Administration, and the determine the inspection agency issued a notice and provide the test with a test sample.
Article 55 Notice of receipt of test samples and testing agencies, shall, within 30 days of the sample for sample testing, and inspection reports submitted to the State Food and Drug Administration, copied to the notice of its inspection of the provinces, autonomous regions and municipalities (food) drug administration department and the applicant.
Article 56 The State Food and Drug Administration should review the comments received, reporting data and samples within 20 days after the inspection report to review the decision. Grant registration, issued to the transferee a new "domestic health food approval certificate" and a new approval number, the certificate is valid constant, while the collection and transfer side of the original cancellation made "domestic health food approval certificate" or "Import health food approval certificate. "
Article 57 has been made "imported health food approval certificate," the transfer of outside health food, health food certificate holder and the transferee shall be jointly fill out the "transfer of technology products imported health food registration application form" to the State Food and Drug Administration to submit the relevant information and samples, together with the transfer contract.
State Food and Drug Administration should declare the information received after 5 days of a reporting norms, integrity, the form of review, and issued a notice to accept or not accept. Meet the requirements, it should be within 5 days after receiving the application to determine the inspection agency issued a notice of inspection and provide samples for testing. Necessary, the State Food and Drug Administration can transferee production site for verification.
Article 58 Notice of receipt of test samples and testing agencies, shall, within 30 days of the sample for sample testing, and inspection reports submitted to the State Food and Drug Administration, copied to the applicant. State Food and Drug Administration inspection report should be in receipt of the samples after 20 days to review the decision. Registration granted to the transferee issued a new "import health food approval certificate" and a new approval number, the certificate is valid constant, while the collection and made off the original transferor "imported health food approval certificate."
Chapter raw materials and auxiliary materials
Article 59 refers to the raw materials of health food health food features associated with the initial material. Health food materials is the production of health foods and other excipients used in additional materials.
Article 60 health food raw materials and auxiliary materials used shall conform to national standards and health requirements. No national standards, industry standards should be provided or developed their own quality standards, and provide the relevant information materials and accessories.
第六十一条 health food raw materials and auxiliary materials used should be safe and harmless to human health. Requirements have limited the material, the amount shall not exceed the relevant national regulations.
Article 62 The State Food and Drug Administration and state health departments for the provision of non-food raw materials and accessories, the goods shall not prohibit the use of raw materials as a health food and accessories.
Article 63 The State Food and Drug Administration announced for health food, the Ministry of Health announced or approved for general food consumption and production of raw materials and auxiliary materials used as raw material for health food and accessories.
Article 64 to apply for registration of health food raw materials and auxiliary materials used in this way is not within the provisions of Article 63 shall be in accordance with relevant provisions of the raw materials and accessories to provide the corresponding toxicological safety evaluation of test reports and related food safety information.
Article 65 The State Food and Drug Administration should be based on scientific and technological development and the need for timely and banned from publication for health food ingredients list.
Article 66 health food products imported raw materials and auxiliary materials used in the health food should be in line with our use of raw materials and auxiliary provisions.
Chapter labels and instructions
Article 67 The registration application for health food products, the applicant shall submit the product instructions and labels of the comp.
Article 68 The application for registration of health food labels, instructions comp should include product name, main raw (and auxiliary) materials, the effectiveness of components / ingredients and symbolic content, health care function, suitable for people, not suitable for people, and food consumption methods, specifications, shelf life, storage methods and precautions.
Approved the listing of the production of health food labels should conform to relevant regulations.
Article 69 health food should be named in line with the following principles:
(A) comply with relevant laws, regulations, rules, standards, specifications requirements;
(B) reflect the true nature of the product, concise, easy to understand, comply with Chinese language and customs;
(C) shall not use generic names of drugs have been approved for registration name.
Article 70 The name should be the health food brand names, generic names, attribute names of three parts. Brand name, common name, attribute name must meet the following requirements:
(A) brand name products can be used either registered trademarks or other name;
(B) the common name should be accurate, science, express or implied not use treatment and exaggerate the function of the text;
(C) the property name should indicate the objective form of the product, its formulation should be standardized and accurate.
第七十一条 State Food and Drug Administration should be based on relevant national standards, regulations, product application materials and sample test cases, the label instructions to review the contents of comp.
Chapter test and inspection
Article 72 toxicological safety testing, is the inspection body in accordance with the State Food and Drug Administration issued a health food safety toxicology evaluation procedures and test methods, the applicant's submission of samples to verify the safety of food the purpose of animal testing, if necessary, for human food tasting test.
Function learning experiments, is the inspection body in accordance with the State Food and Drug Administration issued a health food or business functions to provide evaluation procedures and test methods, the applicant's submission of samples to verify the health functions for the purpose of animal testing and / or human test food test.
Effectiveness of the composition or symbolic component testing is the testing agency in accordance with the State Food and Drug Administration and issued by the relevant departments or enterprises to provide the health effects of food ingredients or ingredients landmark detection method, samples of the applicant for inspection or functional components symbolic components in its warranty period for the detection of content changes.
Hygiene testing, inspection bodies is issued in accordance with relevant state departments or enterprises to provide testing methods, inspection samples of the applicant and hygiene and product quality related indicators (other than the effectiveness of the composition or iconic elements outside) for the detection.
Stability testing, inspection bodies is issued in accordance with relevant state departments or enterprises to provide testing methods, inspection samples of the applicant and hygiene and product quality related indicators (other than the effectiveness of the composition or iconic elements outside) in the insurance qualitative changes during the test conducted.
Sample test, the applicant is a declaration of inspection bodies in accordance with quality standards of food and drug supervision and management departments of the samples of all items tested.
Review of inspection, the applicant is the inspection body's quality standards in effect declared ingredients or components of landmark detection methods are reviewed at the inspection.
Article 73 of the State Food and Drug Administration is responsible for determining bear health food testing, inspection and review of the test sample inspection agency. Specific measures shall be formulated.
Article 74 The inspection agency shall determine the health food inspection and evaluation of technical specifications and other departments issued the inspection and evaluation of methods of testing and inspection, and within the time limit prescribed or agreed upon test and inspection reports issued. Health food inspection and evaluation of technical specifications by the State Food and Drug Administration promulgated.
Article 75 shall be determined in accordance with the state inspection agency service standards, tariff standards and conditions prescribed by law, to the applicant to provide a safe, convenient, stable and reasonably priced service, and to fulfill the universal service obligations.
Article 76 shall be determined according to the law of the inspection agency, testing and inspection to ensure that scientific, standardized, open, fair, fair, not issuing a false report.
第七十七条 applicant shall provide the Food and Drug Administration to provide the information required sampling and testing with the use of samples collected to provide a standard test material.
Article 78 to apply for registration of health food inspection and review of test samples shall not be borne by the trials of the product inspection agencies.
Chapter VI of the re-registration
Article 79 health food re-registration, the State Food and Drug Administration based on the applicant's application, in accordance with legal procedures, conditions and requirements of the health food approval certificate application for the extension of the expiry of the approval process.
Applicants for re-registration of health food health food approval certificate should be the holder.
Article 80 The health food approval certificate is necessary to extend the expiry period, the applicant shall apply for the three months before the expiry of re-registration.
第八十一条 then apply domestic health food registration, the applicant shall be subject to fill in the "domestic health food registration application form and then", and claims data submitted to the applicant of the province, autonomous regions and municipalities (food) drug administration.
Article 82 provinces, autonomous regions and municipalities (food) drug regulatory departments shall receive within 5 days after the disclosure of information on the regulatory reporting information, review the form of integrity, and issued notice of acceptance or will not be accepted.
Meet the requirements of Article 83 re-registration, provinces, autonomous regions and municipalities (food) drug administration by the State Food and Drug Administration commissioned, after accepting the application shall be 20 days to review comments, and report to the State Food and Drug Administration review.
Article 84 The State Food and Drug Administration should review the comments received after the 20 days to review the decision. Not issued within 20 days notice of non re-registration, provinces, autonomous regions and municipalities (food) drug administration re-registration certificate issued to the applicant; not re-registered, the State Food and Drug Administration shall notify the provinces, autonomous regions and municipalities (food) drug regulatory departments shall not be re-registered to the applicant a notice of the reasons.
第八十五条 re-registration application for imported health food products, the applicant shall be subject to fill in the "re-imported health food registration application form", and claims data submitted to the State Food and Drug Administration.
Article 86 The State Food and Drug Administration should declare the information received after the 5 days of a reporting norms, integrity, the form of review, and issued a notice to accept or not accept.
Meet the requirements of Article 87 of the re-registration application, the State Food and Drug Administration should accept the application to review within 20 days after the decision. Meet the requirements to be re-registered, re-registration certificate issued to the applicant; not meet the requirements, it shall not be issued to the applicant for re-registration notice, and the reasons.
Article 88 of the following circumstances of health food, not re-register:
(A) is not within the prescribed time limit for re-registration application;
(B) in accordance with relevant laws and regulations to remove the health food approval certificate;
(C) raw materials, auxiliary materials, products in the food safety problem;
(D) of the raw materials used in products or production processes, etc. is inconsistent with existing regulations;
(E) does not conform to relevant regulations of other circumstances.
Article 89 shall not be re-registered, the State Food and Drug Administration should be announced cancellation of its health food approval.
Chapter Review
Article 90 The applicant of the State Food and Drug Administration made the decision not have objections to registration, registration can not be received within 10 days from the date of notification of the State Food and Drug Administration to submit a written application for review and explain the review reasons.
Article 91 The State Food and Drug Administration received an application for review, shall review the matter in accordance with the original application review timelines and requirements, and make a review of the decision. Decision not to revoke registration, issued to the applicant the appropriate health food approval certificate; to maintain the original decision no longer accepting application for review again, but the applicant in accordance with relevant laws and regulations, the State Food and Drug Administration to apply for administrative reconsideration or bring an administrative lawsuit to the people's court.
第九十二条 review of the matter is limited to the original application and the original declarations.
Chapter VIII of the liability
Article 93 of the following circumstances, the State Food and Drug Administration based on the request of interested party or ex officio, can be verified in accordance with the "Administrative Licensing Law" Article 69 of the provisions dealing with:
(A) the executive staff of abuse of power, dereliction of duty to make the decision to grant registration;
(B) beyond the statutory authority to make the decision to grant registration;
(C) the violation of legal procedures to make the decision to grant registration;
(D) do not have or do not meet the statutory eligibility criteria applicants granted registration.
(E) health food may be revoked approval documents in other cases.
Article 94 of the following circumstances, the State Food and Drug Administration should cancel the corresponding health food approval number:
(A) the health food approval certificate holder to apply for cancellation of;
(B) confirm the existence of product safety issues;
(C) violation of laws and regulations, shall revoke its health food approval certificate;
(D) shall be deleted by the other cases.
(I) ask for or accept property or seek other interests.
Annex 1:
1, the test application form;
2, notice of acceptance testing unit testing;
3, safety toxicology test report;
4, functional learning test report;
6, the effectiveness of component testing report;
7, stability test report;
8, Hygiene test report;
Note:
Annex 2:
Note:
Note:
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