"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

The first registration of health food to regulate behavior, to ensure the quality of health food, to protect the human food safety, according to "Food Hygiene", "PRC Administrative Licensing Law," formulated.

Article II The term health food, is claimed to have specific health functions, or to supplement the vitamins, 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; such as product registration, application and transfer of technology to change the product registration 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 to determine the inspection body responsible for registration of health food safety toxicology tests, school function tests (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 includes applications for product registration, change the 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 registration of health food places in the publicity materials of health food registration application projects and the application 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 applicant to declare the information is not complete, does not meet the statutory form, the provinces, autonomous regions and municipalities (food) drug administration departments 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 prescribed 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, to 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 functional health food, health food evaluation and testing methods, and review of technical requirements, etc., and announce it.

Section II product registration application 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 production and sales in China an application for registration of health food.
Imported 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 applicant before applying for health food registration, 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 tasting test, inspection agencies to determine the function of R & D reports.
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. Can not be human or animal test test test food, the report should be developed in the functional reasons and to provide relevant information.

Twenty-one test samples provided by the applicant institution and the receipt of 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, the test 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 acceptance or refusal notice issued .

Meet the requirements of Article 25 applications for registration of provinces, autonomous regions and municipalities (food) drug regulatory departments 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 testing agencies 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 subject to 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 inspection and sample testing agencies, should be taken in 50 days, samples of test and review of test samples and test 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 regulatory department reports 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. Registration granted, issued to the applicant "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 site and test site for 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 complete the inspection within the time limit to work, 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. Registration granted, 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 years + 4-bit bit 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 contents stated in the annex to the application.
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 producing and selling food products. Increasing function of the project to be published the State Food and Drug Administration within the scope of functions.

Article 38 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 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.

Article 40 to change the product name, durability, 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 regulatory 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, to the applicant issued a "health food made changes to approval documents", 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 regulatory departments shall, within 10 days after receiving the application review comments, and declarations shall be submitted to the State Food and Drug Authority, while the testing agencies to identify and provide notice of inspection issued by inspection with samples.
Receive test notification and sample inspection agency, shall, within 30 days for sample testing of samples and test reports submitted to the State Food and Drug Administration, with a copy to inform the inspection of the provinces, autonomous regions and municipalities (food) drug supervision and administration 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, to the applicant issued a "health food made changes to approval documents", 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 shall receive within 5 days after the disclosure of information, information on reporting standards, 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 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 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.
Receive test notification and sample inspection agency, 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 of 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 applications for registration of transfer of technology products, is the health food approval certificate holder, will sell the right product and production technology transfer to full health food production enterprises, and their joint application to the transferee issued by the 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" business.
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" in the territory of the transfer of health food, 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 regulatory department shall within 10 days after receiving the application review comments, and declarations shall be submitted to the State Food and Drug Administration, while the determine the inspection agency issued a notice and provide the test with a test sample.

Article 55 Notice of receipt 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 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. Registration granted, issued to the transferee a new "domestic health food approval certificate" and a new approval number, the certificate is valid unchanged, while the collection and to obtain the cancellation of the original transferor "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", the State Food and Drug Administration to submit the relevant information and samples, together with the transfer contract.
State Food and Drug Administration shall receive within 5 days after the disclosure of information, information on reporting standards, integrity, the form of review, and issued a notice to accept or not accept. To 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 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 applicant. State Food and Drug Administration should be in receipt of the samples within 20 days after the inspection report to review the decision. Registration granted, issued to the transferee a new "imported health food approval certificate" and a new approval number, the certificate is valid unchanged, while the collection and to obtain the cancellation of 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 health food materials is used when the production of excipients and other 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 consumption and production of raw materials used in ordinary food and accessories can be used as health food ingredients 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 The import of raw materials used in health foods and accessories should be in line with our raw materials and auxiliary materials for health food use provisions.

Chapter IV 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 to apply 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.
Listing of approved production of health food labels shall conform to relevant regulations.

Article 69 health food should be named in line with the following principles:
(A) conform to 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 from 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 shall not be used to exaggerate the treatment effect and 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 in accordance with relevant 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 testing agencies 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, inspection agencies is 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 components of landmark detection method, samples of the applicant for inspection or functional components symbolic components in its content changes during shelf life testing.
Health testing, inspection agencies is issued in accordance with relevant state departments or enterprises to provide testing methods, inspection of samples of the applicant and the hygiene and product quality related indicators (other than the effectiveness of the composition or symbolic elements outside) for the detection.
Stability testing, inspection agencies is issued in accordance with relevant state departments or enterprises to provide testing methods, inspection of samples of the applicant and the hygiene and product quality related indicators (other than the effectiveness of the composition or components outside the iconic) in insurance qualitative changes during the tests conducted.
Sample testing, inspection agencies in accordance with the applicant is declared quality standards for 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 for review of the test.

Article 73 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 for testing and examination, and within the time limit prescribed or agreed to issue a test and inspection reports. 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 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 supervision and management departments to provide the information required sampling and testing with the use of samples taken 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 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 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 re-apply for 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 applications, provinces, autonomous regions and municipalities (food) drug regulatory department under the State Food and Drug Administration of the commission, 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 shall not be re-registered, 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 shall receive within 5 days after the disclosure of information, information on reporting standards, 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 to re-register:
(A) is not made within the 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 issued a public notice should be, canceled 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 can not register for notification of receipt within 10 days from the date 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, after receiving the application for review, shall review the matter in accordance with the original application review timelines and requirements, and make a review of the decision. Revocation of the decision not to register, issue to the applicant the appropriate health food approval certificate; maintain the original decision, and 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 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," the provisions of Article 69 deal 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 of 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) other circumstances which shall be canceled.

Article 95 in the health food registration process, the State Food and Drug Administration and the provinces, autonomous regions and municipalities (food) drug administration departments and their staff in violation of the provisions of the following circumstances, in accordance with "administrative license Law "Article 72, seventy-three, seventy-four, seventies 25 of the regulations:
(A) meets the statutory requirements of health food registration application inadmissible;
(B) not accept registration of health food places publicity items for disclosure of information;
(C) in health food acceptance, the review process, not to inform the applicant to fulfill legal obligations;
(D) the applicant to submit application materials of health food is not complete, does not meet the statutory form, not a correction of the applicant must inform all the content;
(E) will not be accepted or not according to instructions not to approve the application for reasons of health food registration;
(F) do not meet the conditions prescribed in this way health food registration application for registration to be granted beyond the statutory authority to make decisions or decisions to grant registration;
(G) comply with the provisions of the application to make the decision not to register or not this approach be made within the prescribed time limit the decision to grant registration;
(H) without charges or not in accordance with the statutory criteria for project fees;
(Ix) ask for or accept property or seek other interests.

Article 96 in the health food registration process, the State Food and Drug Administration to violate the provisions of damage to legitimate rights and interests of the parties shall be in accordance with the provisions of the State Compensation Law compensation.

第九十七条 disclosure of relevant information or providing false materials or samples of health food registration application, the State Food and Drug Administration for the application inadmissible or not registered, the applicant be given a warning; the applicant within one year not the health food again for registration.

Article 98 The applicant fraud, bribery or other improper means to obtain health food approval certificate, the State Food and Drug Administration should revoke the health food approval certificate and cancellation of the health food approval number, the applicant shall within three years again the application for registration of health food.

第九十九条 determine the inspection agency, in violation of the provisions of Article 75, the State Food and Drug Administration should be ordered to make corrections on the illegal fees charged by the State Food and Drug Administration or the relevant government departments and ordered to return; In serious cases, to recover the "health food inspection certificates."

Article 100 of the inspection agency has not determined in accordance with the provisions for testing or inspection or testing during the testing process errors and accidents, the State Food and Drug Administration should be given a warning, shall be imposed; serious cases, to recover. " Health Food Inspection Certificate. "

101 to determine the inspection agency issued a false test or inspection report, to recover the "health food inspection qualification certificate"; there is illegal income, confiscate the illegal income; constitute a crime, be held criminally responsible.
Identified the test or inspection agency issued false test results, resulting in the loss, it shall bear the corresponding legal responsibility.

Chapter IX Supplementary Provisions

Article 22 The duration of the working days, excluding legal holidays.

103 direct contact with health food packaging materials and containers for food or medicine must comply with national requirements, consistent with protection of human health and safety standards.

Article 104 The State Food and Drug Administration responsible for the interpretation.

Article 25 These Measures shall be July 1, 2005 shall come into force.

Prior to the implementation of this approach for health food registration requirements do not meet the provisions hereof, since the effective date of this method to stop execution.

Annex 1:

Product registration application for disclosure of information items

First, the domestic health food registration application to declare the product information items:
(A) the health food registration application form.
(B) The applicant ID card, business license or other proof of legal registration body copy.
(C) to provide for registration of health food generic name registered with the name of the drug has been approved by the retrieval of materials is not the same name (from the State Food and Drug Administration database to retrieve the government website).
(D) the applicant has obtained the patent to others does not constitute an infringement of guarantee.
(E) provides trademark registration documentation (not available without the registered trademark).
(F) R & D reports (including R & D ideas, feature selection process, expected results, etc.).
(G) Product formulation (raw materials and auxiliary materials) and formula basis; source of raw materials and auxiliary materials and use basis.
(H) effectiveness of the composition / landmark composition, content and functional components / landmark composition of the inspection method.
(Ix) diagram and detailed description of the production process and related research materials.
(X) product quality standards and the preparation of instructions (including raw materials, excipients).
(K) direct contact with the product packaging material type, name, quality standards and selection basis.
(L) inspection agency issued the test report and related information, including:
1, the test application form;
2, notice of acceptance testing unit testing;
3, safety toxicology test report;
4, functional learning test report;
5, stimulants, illicit drugs test report (reporting alleviate physical fatigue, weight loss, growth and development to improve the function of registration);
6, the effectiveness of component testing report;
7, stability test report;
8, Hygiene test report;
9, other inspection reports (eg: raw materials appraisal report, strain virulence test reports, etc.).
(Xiii) product labeling, instructions comp.
(Xiv) other information to help product review.
(Xv) the minimum selling two unopened packages of samples.

Note:
1 to fungi, probiotics, nucleic acids, enzymes, amino acid chelate-based products such as an application for registration, in addition to providing the above information must also be provided in accordance with relevant provisions of the relevant declarations.

2, in order to restrict the use of state wildlife-based products application for registration, in addition to providing the above information, must also provide the relevant government departments issued to allow the raw material supply-side development and utilization of documents and materials suppliers and the applicant signed purchase and sales contracts.

3, to supplement the vitamins and minerals for the purpose of application for registration of health food, functional assessment without providing animal test reports and / or human test food test report and function research reports.

4, the function declaration is not in the State Food and Drug Administration announced the project within the scope of the function, except pursuant to the use of raw materials to provide the above information, but also must provide the following information with the relevant new features: (1) research and development functions report include: function name, the application of reason and basis for functional evaluation procedures and test methods and the research process and relevant data, evaluation procedures and the establishment of functional test methods based on scientific literature and so on. (2) the applicant in accordance with the function of evaluation procedures and test methods for product evaluation on the test function self-test report. (3) to determine the inspection agency issued in accordance with the function of evaluation procedures and test methods for function evaluation on the product test reports and test methods for evaluation of the validation report.

5, the same applicant apply for the same product in different dosage forms of registration, if one of the formulations have been carried out in accordance with the provisions of all tests and inspection agency has issued a test report, other formulations can be free for the registered function and safety toxicity study Science test, but must provide a functional study has been carried out toxicology tests and safety trials copy of the report. Qualitative changes in technology affect product safety, functionality, except.

Second, applications for registration of imported health food products to declare items
Imported health food registration application, except under the use of raw materials and reporting functions of health food in accordance with domestic requirements for disclosure of information to provide information, but also must provide the following information:
(A) the producing country (region) issued by the relevant agencies in accordance with local production company corresponding GMP documents.
(B) resident representative of China by the foreign company registration services agencies, should provide a "Chinese resident representative offices of foreign business registration certificate" copy.
Foreign manufacturers within the agency responsible for commissioning registration matters, must provide a notarized power of attorney, and commissioned original agency business license.
(C) products in the producing country (region) more than one year of production and sales documents, the documents should be approved by the producing country (region) of the notary and the Chinese Embassy in the country to confirm.
(D) producing country (region) or international organization concerned with product-related standards.
(E) products in the producing country (region) listed the use of packaging, labeling, instructions really like.
(F) three consecutive batches of samples, their number three times the amount required for the test.

The declarations must be used together with the original Chinese, foreign language information can be attached as a reference. Chinese translation should be notarized by a notary public within the territory, to ensure consistency with the original content; application for registration of product quality standards (in Chinese), must meet the quality standards of Chinese health food form.

Annex 2:

Change Request Application Information Items

First, change the application to declare domestic health food items
(A) change the application form, or health food health food change record table.
(2) change the name of the specific issues, the reasons and basis.
(3) The applicant ID card, business license or other proof of legal registration agency copy.
(D) of the health food approval certificate and its annexes copies.
(E) The proposed amendments to the health food labels, brochures comp, along with detailed description of the amendment.

Note:
1, narrowing the range of suitable people to expand the range of suitable people, note the changes to apply, in addition to providing the above information, products must also provide the location of food production supervision and management of provincial health department has issued production and sales of the product documentation.

2, changing the consumption of the change request (the same product specifications), in addition to providing the above information, must also provide: (1) where production of food production supervision and management of provincial health department has issued production and sales of the product documentation; (2) to reduce the consumption of the change request shall provide the inspection body to determine the change in consumption in accordance with the proposed functional evaluation on the test report issued after the test; (3) increased consumption changes should be provided to determine the application in accordance with the proposed changes to the inspection agency dietary intake of toxicological safety evaluation test test reports issued, and changes in consumption to be compared with the original consumption function evaluation on the test report.

3, changes in product specifications, shelf life and quality standards to apply the changes, in addition to providing the above information, must also provide: (1) where production of food production supervision and management of provincial health department has issued production and sales of the product documentation ; (2) after the change does not affect the basis for product safety and function and associated research data, scientific literature and / or test report. Among them, change the registration of quality standards Quality standards should also provide test data and research literature; (3) of the revised quality standards; (4) the effectiveness of three consecutive batches of samples ingredients or symbolic elements, hygiene stability of self-test report; (5) consecutive three batches of samples, their number three times the amount required for the test (except for changing the shelf life).

4, increase the functional health food items change request, in addition to providing the above information, must also provide: (1) where production of food production supervision and management of provincial health department has issued production and sales of the product documentation; (2) Amendment quality standards; (3) the increase in school test feature functions of the project report.

5, change the product name change application, in addition to providing the above information, it must also be changed to provide the product name and generic drugs have been approved for registration of the same name as the name does not retrieve the material (from the State Food and Drug Administration Government website database retrieval).

6, the applicant's own name and / or address change for the record, other than providing the above information, must also provide the local administrative department for industry and commerce issued by the name of the applicant and / or address of the name change documents.

Second, change the application to declare the import health food items
(A) change the import health food health food import application form or to change the record table.
(2) change the name of the specific issues, the reasons and basis.
(C) by the foreign companies based in China affairs representative for change, should provide "on behalf of foreign companies based in China Registration Certificate" copy.
Foreign manufacturers commissioned agency responsible for domestic matters change, the need to provide a notarized power of attorney and the original agency commissioned by the business license.
(D) of the health food approval certificate and its annexes copies.
(E) producing country (region) of the matter issued by the relevant institutions have been changed documents and related information. The documents must be approved by the host country (region) a notary public and consulates in China confirmed the country.

Note:
1, narrowing the range of suitable people to expand the range of suitable people, note the changes to apply, in addition to providing the above information, after the change must also provide the label instructions is kind.

2, changing the consumption of the change request (the same product specifications), in addition to providing the above information, but also must provide (1) reduce the consumption of the change request shall provide the inspection body to determine the change in consumption in accordance with the proposed functional evaluation on test After the test report issued; (2) increase consumption of the change request should be provided in accordance with the inspection agencies to determine the dietary intake of proposed changes in toxicological safety evaluation test report issued by the trial, and the proposed changes to the original consumption consumption Evaluation of the function compared to the test report; (3) after the change of labels, brochures actual sample.

3, changes in product specifications, warranty, apply quality standards to change, in addition to providing the above information, must also provide: (1) after the change does not affect product safety and function, and related research based on data and scientific literature and / or test report. Among them, the application for registration of changes in quality standards should also provide quality research work of the experimental data and literature; (2) the effectiveness of three consecutive batches of samples ingredients or symbolic composition, hygiene, stability test of self-report; ( 3) test required three consecutive batches of samples (except to change the shelf life); (4) after the change of labels, instructions, and quality standards of the real kind.

4, increase the functional health food items change request, in addition to providing the above information, must also provide:
(1) the increase in school test feature functions of the project report; (2) after the change of labels, instructions, and quality standards for actual sample or comp.

5, health food manufacturers outside of China within the change request to change the production site, in addition to providing the above information, must also provide: (1) The new production site host country (region) administration of the products issued by the appropriate production conditions meet the local quality management standard documents (2) the product is allowed in the new production site where the country (region) free of sales documents; (3) the production of new production sites for three consecutive batches of samples of the efficacy of ingredients or symbolic elements, hygiene, stability, self-test report; (4) testing of new production sites required for the production of three consecutive batches of samples; (5) after the change
Labels, instruction manual actual sample.

6, change the product name change application, in addition to providing the above information, it must also be changed to provide the product name and generic drugs have been approved for registration of the same name as the name does not retrieve the material (from the State Food and Drug Administration Government website database retrieval), and after the change of labels, brochures actual sample or comp.

7, the applicant's own name and / or address change of name for the record, other than providing the above information, but also must provide the producing country (region) issued by the governing body did not change the production site as well as supporting documents after the change of label, manual solid-like.

8, changes within the agency's record matters, in addition to providing the above information, it must also provide the same health food manufacturers commissioned the new Chinese agency also removed the original registration affairs agency commission documents, notarial instrument.

The declarations must be used together with the original Chinese, foreign language information can be attached as a reference. Chinese translation should be notarized by a notary public within the territory, to ensure consistency with the original content; application for registration of product quality standards (in Chinese), must meet the quality standards of Chinese health food form.

Annex 3:

Technology transfer product registration application for disclosure of information items

First, the domestic health food registration application for the transfer of technology products to declare items
(A) Health Food Technology Transfer Product Registration Application Form.
(B) the identity card, business license or other proof of legal registration body copy.
(C) by the notary of the transferor and transferee effective transfer of the contract signed by both parties.
(D) The provincial department of health food production supervision and management of health issued by the transferee a copy of food hygiene permit.
(E) The provincial department of health food production supervision and management issued by the transferee comply with the "health food Good Manufacturing Practice" documents.
(Vi) the original health food approval certificate (including health food approval certificate and its annexes and the documents of approval to change health food).
(G) the transferee of three consecutive production batches of samples, their number three times the amount required for the test.

Second, the imported health food products to the domestic transfer of registration declaration items
Technology transfer in addition to domestic health food registration application products to provide for disclosure of information data items, but also must provide the following information:
Permanent Mission of China by the foreign vendor registration affairs representative, should provide a "Chinese resident representative offices of foreign business registration certificate" copy.
Foreign manufacturers within the agency responsible for commissioning registration matters, must provide a notarized power of attorney, and commissioned original agency business license.

Third, transfer of imported health food products in overseas registration information submitted project
(A) Health Food Technology Transfer Product Registration Application Form.
(B) the transferee producing country (region) to allow the production and sales of documents, the documents should be approved by the producing country (region) of the notary and the Chinese Embassy in the country to confirm.
(C) the transferee country (region) issued by the relevant agencies of the respective product manufacturers comply with local GMP documents.
(D) the transfer contract. The contract must be subjected to side the country (region) notary public and confirmed in local Chinese Embassy or Consulate.
(E) by foreign companies based in China representative office registration services should be provided "on behalf of foreign companies based in China Registration Certificate" copy.
Foreign manufacturers within the agency responsible for commissioning registration matters, must provide a notarized power of attorney, and commissioned original agency business license.
(Vi) the original health food approval certificate (including health food approval certificate and its annexes and the documents of approval to change health food).
(Vii) to determine the inspection agency issued the transferee three consecutive production batches of samples or signs of efficacy ingredient composition, hygiene, stability test of inspection reports;
(Viii) The transferee of three consecutive production batches of samples, their number three times the amount required for the test.

 

Annex 4:

Disclosure of information re-registration project

First, the domestic health food registration application and then return items
(A) domestic health food re-registration application form.
(B) The applicant ID card, business license or other proof of legal registration body copy.
(C) a copy of the health food approval certificate (including health food approval certificate and its annexes and the documents of approval to change health food).
(D) where production of food production supervision and management of provincial health department issued to allow the production and sales of copies of documents.
(E) a summary of sales within five years.
(F) within five years of consumer feedback on the product summary.
(G) the minimum sale of health food packaging, labeling and instructions really like.
Note: The information provided can not be complete, the applicant must make application for re-registration in writing the reasons.

Second, the re-registration application for imported health food items for disclosure of information
(A) re-imported health food registration application form.
(B) foreign companies based in China by the representative body for re-registration matters, should provide a "Chinese resident representative offices of foreign business registration certificate" copy.
Foreign manufacturers within the agency commission responsible for re-registration matters, must provide a notarized power of attorney, and commissioned original agency business license.
(C) a copy of the health food approval certificate (including health food approval certificate and its annexes and Paul
Changes in health food approval documents).
(D) producing country (or region) issued by the relevant agencies in accordance with local manufacturers of the product corresponding
Production quality management standards and allow the production and sales of documents, the documents must be
Subject to country (region) notary public and confirmed in local Chinese Embassy or Consulate.
(E) imports from China within five years, sales summary.
(F) within five years the Chinese consumer feedback on the product summary.
(G) the minimum sale of health food packaging, labeling and instructions really like.

  

Beijing Tong Rui Lian Technology Co., Ltd.
Tel: 86-10-64284605   86-10-84366465
Fax: 86-10-84366465
E-mail:  bj500@126.com      bj2180@gmail.com