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China - Interim Administrative Measures for Health Food Registration
(Decree of the State Food and Drug Administration No. 19)
August 2005
Reviewed and approved by the State Food and Drug Administration (SFDA), the Interim Administrative Measures for Health Food Registration was hereby promulgated and shall go into effect as of July 1, 2005.
Zheng Xiaoyu, Director
April 30, 2005
Chapter I General Principles
Article 1 These Measures are formulated in accordance with the Food Hygiene Law of the People's Republic of China and the Administrative Licensing Law of the People's Republic of China to standardize the registration of health food, ensure the quality of health food, and guarantee the human food safety.
Article 2 Health food in the Measures refers to food claiming that it has certain health improving functions or is able to supply vitamins and mineral. It is good for a particular group of people and able to adjust body functions. But, it is not used to cure certain diseases. It will not have any form of harm whether it is acute or sub-acute or chronic.
Article 3 The Measures apply to the registration of domestic and imported health food within the territory of the People's Republic of China.
Article 4 Health food registration refers to that further to the application filed by the applicant, the State Food and Drug Administration, in accordance with the legal procedure, conditions and requirements, conducts a systematic review of the safety, effectiveness, quality control of health food and the content of the instruction. The State Food and Drug Administration decides whether to permit it to enter the process of examination and approval of its registration. It includes examinations and approvals of applications for product registration, alteration, and technology transfer product registration.
Article 5 The State Food and Drug Administration is responsible for the regulation of national health food registration and examination and approval of health food.
Drug (Food) administrative departments in provinces, autonomous regions and municipalities entrusted by the State Food and Drug Administration, are responsible for examining domestic health food registration application package, checking the experiments of health food that applies for registration and sample experimental production, and arranging for the examination of samples.
The examination agencies designated by the State Food and Drug Administration are responsible for the health food safety toxicology test, functionality test (including animal test or human trial test), effective or marker ingredient test, hygiene test, and stability test. They will carry out the sample product test and reexamination test.
Article 6 The administration of health food registration should follow the principles of being scientific, open, equal, fair, effective and convenient.
Chapter II Application, Examination and Approval
Section One General Provisions
Article 7 A health food registration applicant refers to the one who files health food registration application, bears corresponding legal responsibilities, and is granted the health food approval certificate after the application is approved.
A domestic applicant is a legally registered citizen, legal person or other organization in China.
An overseas applicant refers to a legitimate foreign health food manufacturer. When an overseas applicant intends to handle the imported health food registration, it should be done by its representative office or authorized agent in China.
Article 8 A health food registration application includes applications for product registration, alteration and technology transfer product registration.
Article 9 The State Food and Drug Administration and drug (food) administrative departments in provinces, autonomous regions and municipalities should publish the items of application materials for health food registration and the sample of relevant registration application forms at the place where the application is processed.
Article 10 Health food registration applicants should submit standard and complete documents and report on a true basis as required, and should be responsible for the authenticity of the submitted documents and other materials.
Article 11 Applicants are allowed to correct the mistakes in submitted application materials if they can be corrected immediately.
Article 12 When materials submitted by applicants are not complete and in compliance with statutory format, drug (food) administrative departments in provinces, autonomous regions and municipalities and the State Food and Drug Administration should, immediately or within five days, advise the applicants of all the materials that should be added and corrected. If the notification is overdue, the day when the application materials are received is taken as the day of acceptance. If the application is denied for acceptance, the applicant should be notified in writing of the reasons.
Article 13 In the course of examination, if any further materials are required, the State Food and Drug Administration should inform the applicant at one time. An applicant should submit satisfactory additional materials as required within five months after receiving the notification. If the applicant fails to do so, the examination will be terminated. Under special circumstances where an applicant is unable to supply the additional materials in due course, the applicant should file written application to the State Food and Drug Administration and make explanations. The State Food and Drug Administration should respond with a decision within 20 days.
Article 14 If any additional materials are required for registration application, the original examination period is extended by 30 days. In case of alteration application, it is extended by 10 days.
Article 15 If the product is granted registration after examination by law, the State Food and Drug Administration should issue a health food approval certificate to the applicant for registration within the period as stipulated, and send it to the applicant within 10 days. If the application is denied, the State Food and Drug Administration should inform the applicant of the denial and explain the reason of rejection within the period as stipulated, and advise the applicant of the rights to apply for reexamination or administrative reconsideration or file administrative litigation in accordance with laws.
Article 16 The State Food and Drug Administration and drug (food) administrative authorities in provinces, autonomous regions and municipalities should give notice to the interested parties, if it is found in course of examination of health food registration application that the application directly involves the material interests of others. Applicants and interested parties may submit written opinions to make a statement and argument, or request for a hearing in accordance with laws.
Article 17 The State Food and Drug Administration should provide relevant information in connection with the acceptance of health food registration application, examination process and health food approved for registration on its official website.
Article 18 Based on the development and requirement of science and technology, the State Food and Drug Administration should make adjustment of function scope, evaluation and testing methods for health food as well as technical standards of evaluation, and should make an announcement thereof.
Section Two Product Registration Application, Examination and Approval
Article 19 Product registration applications include domestic health food registration application and imported health food registration application.
Domestic health food registration application refers to the registration application for health food that the applicant intends to manufacture and sell in China.
Imported health food registration application refers to the registration application for health food which has been manufactured and sold overseas for more than one year and the applicant intends to market within the territory of China.
Article 20 An applicant, before applying for health food registration, should make relevant researches.
After such researches have been completed, the applicant should provide samples and test related materials to the testing agencies designated by the State Food and Drug Administration for corresponding testing and examination.
If the functions of health food submitted are within the scope published by the State Food and Drug Administration, the applicant should supply a product research and development report to the designated testing agency. If the functions of health food submitted are out of that published, the applicant should conduct its own animal test and human trial test and supply a function research and development report to the designated testing agency.
The product research and development report should include information on basic concept of research and development, function screening process and expected effects. The function research and development report should include information on the name of function, reason for application, function test, evaluation methods and test results. If it is impossible to conduct animal test and human trial test, the applicant should articulate reasons why it is impossible to do so in the function research and development report and supply relevant information.
Article 21 Receiving the sample and relevant materials supplied by an applicant, the testing agencies should, in accordance with health food examination and evaluation technical norms published by the State Food and Drug Administration and the testing methods issued by other related departments or provided by the enterprise, carry out safety toxicology tests, function tests, effective or marker ingredient tests, hygiene tests and stability tests of the sample. If the function of health food submitted are out of the scope published the State Food and Drug Administration, the testing agencies should also check its function tests and evaluation methods as well as test results, and issue a test report.
Article 22 Only after the testing agencies have issued a test report, the applicant may apply for health food registration.
Article 23 To apply for domestic health food registration, an applicant should complete the Application Form for Domestic Health Food Registration as required and send the application materials and sample products to local drug (food) administrative departments in provinces, autonomous regions and municipalities.
Article 24 After receiving the application materials and sample products, drug (food) administrative departments in provinces, autonomous regions and municipalities should review whether the format of application materials are standard and complete and give an acceptance or rejection notice within five days.
Article 25 For satisfactory registration application, drug (food) administrative departments in provinces, autonomous regions and municipalities should, within 15 days after the application is accepted, check testing and sample production sites, choose samples to be used for tests and give examination opinions that are reported to the State Food and Drug Administration along with the submitted materials. Meanwhile, drug (food) administrative departments in provinces, autonomous regions and municipalities should send a notification of test to the designated testing agencies and provide the samples for testing.
Article 26 The samples required for health food registration application should be produced in workshops that conform to Good Manufacture Practice for Health Food and the course of processing thereof should also be compliance with the Good Manufacture Practice for Health Food.
Article 27 Within 50 days after receiving the test notification and sample products, the testing agencies should carry out sample and recheck examinations of the chosen sample products and send a test report to the State Food and Drug Administration while make a copy for drug (food) administrative departments in provinces, autonomous regions and municipalities that give the test notification and the applicant. In exceptional cases where the test agencies are unable to finish the work in due time, the test agencies should report to the State Food and Drug Administration and drug (food) administrative departments in provinces, autonomous regions and municipalities on a timely basis, and attach written explanations.
Article 28 After receiving the examination opinions, application materials and sample products from drug (food) administrative departments in provinces, autonomous regions and municipalities, the State Food and Drug Administration should arrange food, nutrition, medical, pharmaceutical and other technical personnel to perform technical evaluation and administrative examination of the submitted materials that meet the requirements and make a decision after the examination within 80 days. If registration is granted, a Domestic Health Food Approval Certificate should be issued to the applicant.
Article 29 Applying for imported health food registration, an applicant should complete the Application Form for Imported Health Food Registration as required, and send the application materials and sample products to the State Food and Drug Administration.
Article 30 After receiving the application materials and sample products, the State Food and Drug Administration should review whether the format of application materials are standard and complete and should give an acceptance or rejection notice within five days. For satisfactory registration application, the State Food and Drug Administration should provide a test notification and sample products for tests to the designated testing agencies within five days after the application is accepted. If necessary, the State Food and Drug Administration may examine the production and testing sites of the product.
Article 31 Within 50 days after receiving the test notification and sample products, the testing agencies should carry out sample and recheck examinations of the sample products and send a test report to the State Food and Drug Administration while make a copy for the applicant. In exceptional cases where the test agencies are unable to finish the work in due time, the test agencies should report to the State Food and Drug Administration on a timely basis, and attach written explanations.
Article 32 After accepting the application, the State Food and Drug Administration should arrange food, nutrition, medical, pharmaceutical and other technical personnel to perform technical evaluation and administrative examination of the submitted materials and make a decision after the examination within 80 days. If registration is granted, an Imported Health Food Approval Certificate should be issued to the applicant.
Article 33 The health food approval certificate will be valid for a period of 5 years. The format of registered number of approval for the domestic health food is as follows: GuoShiJianZi G + 4-digit year number + 4-digit serial number. The format of registered number of approval for the imported health food is as follows: GuoShiJianZi J + 4-digit year number + 4-digit serial number.
Section Three Alteration Application, Examination and Approval
Article 34 Alteration application refers to the application by an applicant for change of items stated on health food approval certificate and its attachment.
Article 35 An applicant applying for alteration should be the holder of health food approval certificate.
Article 36 Items such as function name, raw and supplementary materials, manufacturing techniques, eating instruction, expansion of applicable population or reduction of inapplicable population for the health food stated on the health food approval certificate that might have an impact on safety and function should not be altered.
Article 37 The health food involved in the application for reduction of applicable population, expansion of inapplicable population, precautions, function items, change of dosage, product specifications, best before date or quality standards should be the product that has been manufactured and sold. The newly added function items must be those within the scope published by the State Food and Drug Administration.
Article 38 Applying for altering the contents of Domestic Health Food Approval Certificate and its attachments, an applicant should complete the Application Form for Domestic Health Food Alteration, and send relevant materials and statements to local food (drug) administrative departments in provinces, autonomous regions and municipalities where the applicant is located.
Article 39 Drug (food) administrative departments in provinces, autonomous regions and municipalities should examine whether the format of application materials are standard and complete and give an acceptance or rejection notice within five days after receiving the application materials.
Article 40 In relation to alteration application for change of product name, best before date, dosage, reduction of applicable population, expansion of inapplicable population, precautions and function items, drug (food) administrative departments in provinces, autonomous regions and municipalities should give examination opinions and report to the State Food and Drug Administration along with the submitted materials within 10 days after accepting the application.
The State Food and Drug Administration should, within 40 days after receiving the examination opinions and application materials, arrange food, nutrition, medical, pharmaceutical and other technical personnel to perform technical evaluation and administrative examination of the submitted materials and make a decision after the examination. If alteration is granted, an Approval for Domestic Health Food Alteration should be issued to the applicant and copied to drug (food) administrative departments in provinces, autonomous regions and municipalities.
Article 41 In relation to application for alteration of product specifications and quality standards, drug (food) administrative departments in provinces, autonomous regions and municipalities should give examination opinions and report to the State Food and Drug Administration along with the submitted materials within 10 days after accepting the application, and meanwhile provide a test notification and sample products for test to the designated testing agencies.
Within 30 days after receiving the test notification and sample products, the testing agencies should carry out sample examinations and send a test report to the State Food and Drug Administration while make a copy for drug (food) administrative departments in provinces, autonomous regions and municipalities that give the test notification and the applicant.
The State Food and Drug Administration should, within 50 days after receiving the examination opinions, application materials and sample products, arrange food, nutrition, medical, pharmaceutical and other technical personnel to perform technical evaluation and administrative examination of the submitted materials and make a decision after the examination. If alteration is granted, an Approval for Domestic Health Food Alteration should be issued to the applicant and copied to drug (food) administrative departments in provinces, autonomous regions and municipalities.
Article 42 Applying for altering the contents of Imported Health Food Approval Certificate and its attachment, an applicant should complete the Application Form for Imported Health Food Alteration, and send relevant materials and statements to the State Food and Drug Administration.
Article 43 The State Food and Drug Administration should check whether the format of application materials are standard and complete and give an acceptance or rejection notice within five days after receiving the application materials.
Article 44 In relation to alteration application for change of product name, best before date, dosage, reduction of applicable population, expansion of inapplicable population, precautions and function items, the State Food and Drug Administration should arrange food, nutrition, medical, pharmaceutical and other technical personnel to perform technical evaluation0 and administrative examination of the submitted materials and make a decision after the examination within 40 days after accepting the application. If alteration is granted, an Approval for Imported Health Food Alteration should be issued to the applicant.
Article 45 In relation to alteration application for change of product specifications and quality standards as well as the overseas production location by the producer of imported health food, the State Food and Drug Administration should provide a test notification and sample products for test to the designated testing agencies within five days after accepting the application. If necessary, the State Food and Drug Administration may examine the production site of the product.
Within 30 days after receiving the test notification and sample products, the testing agencies should carry out sample examination and send a test report to the State Food and Drug Administration while make a copy for the applicant.
Within 50 days after accepting the application, the State Food and Drug Administration should arrange food, nutrition, medical, pharmaceutical and other technical personnel to perform technical evaluation and administrative examination of the submitted materials and make a decision after the examination. If alteration is granted, an Approval for Imported Health Food Alteration should be issued to the applicant.
Article 46 In relation to the change of an applicant's own entity name, address and representative agency in China, the applicant should complete the Record Form for Domestic Health Food Alteration or the Record Form for Imported Health Food Alteration as required within 20 days after the subject item has been altered, and should report to the State Food and Drug Administration for record along with relevant materials.
Article 47 The valid period of the Approval for Health Food Alteration is identical to that of the original health food approval certificate. Upon the expiration of the valid period, application for re-registration should be performed for both them.
Article 48 Requesting for reissuing of health food approval certificate, an applicant should send written application to the State Food and Drug Administration and make explanations. Applying for reissuing as a result of loss, an applicant should submit the original lost property notice published on a national newspaper; applying for reissuing as a result of damage, an applicant should return the original health food approval certificate. If qualified after examination, the health food approval certificate will be reissued with the original registered number of approval and the valid period will remain the same as before. Reissued health food approval certificate should bear the original date of approval and the printed word of "Reissued".
Section Four Technology Transfer Product Registration Application, Examination and Approval
Article 49 Technology transfer product registration application refers to the act that a holder of the health food approval certificate transfers the right to produce and sell its products and the production technology to another producer of health food, and jointly apply with that health food producer for the issuance of a new health food approval certificate to the transferee.
Article 50 The domestic health food producer as a transferee must be an enterprise that has obtained the health food sanitation license in accordance with law and is in compliance with the Good Manufacture Practice for Health Food.
The foreign health food producer as a transferee must be in compliance with corresponding local standards of production quality control.
Article 51 The transferor should conclude a contract with the transferee to transfer all of the technical information to the transferee and direct the transferee to product three batches of products in a row that meet the quality standards for the product.
Article 52 In case that more than one applicant jointly owns the health food approval certificate, they should cosign the transfer contract at the time of technology transfer.
Article 53 When health food with the Domestic Health Food Approval Certificate or Imported Health Food Approval Certificate is transferred within China, the holder of health food certificate and the transferee should jointly complete the Application Form for Domestic Health Food Technology Transfer Product Registration or the Application Form for Imported Health Food Technology Transfer Product Registration, and send relevant materials and sample products to local drug (food) administrative departments in provinces, autonomous regions and municipalities where the transferee is located, along with the transfer contract.
Article 54 Drug (food) administrative departments in provinces, autonomous regions and municipalities should examine whether the format of application materials are standard and complete and give an acceptance or rejection notice within five days after receiving the application materials.
For the satisfactory application for technology transfer product registration, drug (food) administrative departments in provinces, autonomous regions and municipalities should give examination opinions and report to the State Food and Drug Administration along with the submitted materials within 10 days after accepting the application, and meanwhile provide a test notification and sample products for test to the designated testing agencies.
Article 55 Within 30 days after receiving the test notification and sample products, the testing agencies should carry out sample examinations and send a test report to the State Food and Drug Administration while make a copy for drug (food) administrative departments in provinces, autonomous regions and municipalities that give the test notification and the applicant.
Article 56 The State Food and Drug Administration should make a decision after the examination within 20 days after receiving the examination opinions, application materials and test report of the sample product. If registration is granted, a new Domestic Health Food Approval Certificate should be issued to the transferee with new registered number of approval, the valid period of certificate should remain the same as before, meanwhile, the original Domestic Health Food Approval Certificate or Imported Health Food Approval Certificate previously obtained by the transferor should be collected and cancelled.
Article 57 When health food with the Imported Health Food Approval Certificate is transferred outside China, the holder of health food certificate and the transferee should jointly complete the Application Form for Imported Health Food Technology Transfer Product Registration, and send relevant materials and sample products to the State Food and Drug Administration, along with the transfer contract.
The State Food and Drug Administration should check whether the format of application materials are standard and complete and give an acceptance or rejection notice within five days after receiving the application materials. For the satisfactory application, the State Food and Drug Administration should provide a test notification and sample products for tests to the designated testing agencies within five days after the application is accepted. If necessary, the State Food and Drug Administration may examine the production site of the transferee.
Article 58 Within 30 days after receiving the test notification and sample products, the testing agencies should carry out sample examinations and send a test report to the State Food and Drug Administration while make a copy for the applicant. The State Food and Drug Administration should make a decision after the examination within 20 days after receiving the test report of the sample product. If registration is granted, a new Imported Health Food Approval Certificate should be issued to the transferee with new registered number of approval, the valid period of certificate should remain the same as before, meanwhile, the original Imported Health Food Approval Certificate previously obtained by the transferor should be collected and cancelled.
Chapter III Raw Materials and Supplementary Materials
Article 59 Raw materials of health food refer to the primary materials that have a connection with the functions of health food. Supplementary materials of health food refer to the excipient and other additional materials that are used to produce health food.
Article 60 Raw materials and supplementary materials used in the production of health food should comply with national standards and hygiene requirements. In absence of national standards, industry standards or self-stipulated quality standards should be provided and information on the raw materials and supplementary materials should be supplied.
Article 61 Raw materials and supplementary materials used to produce health food should be safe and harmless for human health. In case of materials with a limit on usage, the use level should not exceed the limit set by relevant state regulations.
Article 62 Raw materials and supplementary materials that are not allowed to be used in health food or prohibited for use by the State Food and Drug Administration and other government departments should not be used as the raw materials or supplementary materials of health food.
Article 63 Raw materials and supplementary materials that are allowed to be used in health food as announced by the State Food and Drug Administration, eatable as announced or approved by the Ministry of Health or used in the production of general food can be used as the raw materials and supplementary materials of health food.
Article 64 If the raw materials and supplementary materials used in the production of the health food involved in registration application are not covered under Article 63 of these Measures, the applicant should, in accordance with relevant stipulations, provide the relevant test report of toxicological evaluation of safety for the raw material and supplementary material and the related information on food safety.
Article 65 Based on the development and requirement of science and technology, the State Food and Drug Administration should, on a timely basis, publish a list of raw materials that are allowed or prohibited for use in health food.
Article 66 Raw materials and supplementary materials used in the production of imported health food should comply with various Chinese regulations on the use of raw materials and supplementary materials in health food.
Chapter IV Labels and Instructions
Article 67 In the course of product registration application for health food, an applicant should submit the draft sample of product instructions and labels.
Article 68 The draft sample of labels and instructions of the health food involved in the registration application should include product name, main raw (supplementary) materials, effective/marker ingredients and their content, healthcare functions, applicable population, inapplicable population, dosage and usage, specification, best before date, storing method and precautions.
The label of the health food produced and marketed after approval should comply with relevant state regulations.
Article 69 Naming of health food should comply with following principles:
(1) In compliance with relevant national laws, regulations, standards and requirements;
(2) Reflecting the true nature of the product, clear, easy to understand and in compliance with the convention of Chinese language;
(3) Drug name that has been approved and registered should not be used as general name.
Article 70 Name of health food should consist of three parts - brand name, general name and attribute name. They must comply with the following requirements:
(1) The registered trade mark or other names of the product can be used as the brand name;
(2) The general name should be accurate and scientific, words that indicate therapeutic effect, whether expressly or impliedly, or exaggerate its functions and effects are not allowed to be used;
(3) The attribute name should indicate the authentic configuration of the product, its representation should be standard and accurate.
Article 71 The State Food and Drug Administration should examine the draft sample of labels and instructions according to relevant national standards, regulations, product application materials and sample test results.
Chapter V Test and Examination
Article 72 Safety toxicology test means that the testing agencies, in accordance with the procedures of toxicological evaluation of health food safety and the testing method issued by the State Food and Drug Administration, carry out animal tests of the sample product submitted by the applicant to verify its food safety. If necessary, human trial test could be carried out.
Function test means that the testing agencies, in accordance with the procedures of function evaluation of health food and the testing method by the State Food and Drug Administration or provided by the enterprise, carry out animal tests and/or human trial tests of the sample product submitted by the applicant to verify its healthcare functions.
Effective or marker ingredient test means that the testing agencies, in accordance with the testing method for effective or marker ingredients of health food issued by the State Food and Drug Administration and relevant departments or provided by the enterprise, test the content of effective or marker ingredients of the sample product submitted by the applicant and their content changes during the valid period.
Hygiene test means that the testing agencies, in accordance with the testing method issued by relevant government sectors or provided by the enterprise, test the hygiene and product quality related indicators (other than effective or marker ingredients) of the sample product submitted by the applicant.
Stability test means that the testing agencies, in accordance with the testing method issued by relevant government sectors or provided by the enterprise, test the change of hygiene and product quality related indicators (other than effective or marker ingredients) of the sample product submitted by the applicant during the valid period.
Sample test means that the testing agencies, in accordance with the quality standards submitted by the applicant, carry out a full examination of the sample product provided by the food and drug administrative department.
Recheck test means that the testing agencies carry out an examination to recheck the testing method for effective or marker ingredients in the quality standards submitted by the applicant.
Article 73 The State Food and Drug Administration is responsible for designating the test agencies for health food tests, sample tests and recheck tests. The detailed measures will be formulated separately.
Article 74 The designated testing agencies should, in accordance with the health food testing and evaluation technical norms published by the State Food and Drug Administration and the testing and evaluation methods issued by other relevant departments, carry out tests and examinations and provide test and examination reports within the stipulated or agreed time. Health food testing and evaluation technical norms should be formulated and published by the State Food and Drug Administration.
Article 75 The designated testing agencies should, in accordance with the national service standards and charging standards and the conditions stipulated according to law, provide secure, convenient, stable and reasonably priced services to the applicant and fulfill the obligations of universal service.
Article 76 The designated testing agencies should act in accordance with law to ensure that the tests and examinations are scientific, standard, open, fair and just. They must not provide false reports.
Article 77 Applicants should provide food and drug administrative departments with relevant information required for sampling and cooperate in selecting samples for test to provide standard substance to be tested.
Article 78 Sample test and recheck test of the health food involved in the registration application should not be conducted by the testing agencies that are responsible for the tests of the product.
Chapter VI Re-registration
Article 79 Health food re-registration refers to the process of examination and approval of application for extending the valid period of the health food approval certificate upon its expiration by the State Food and Drug Administration according to an applicant's application and statutory procedures, conditions and requirements.
The applicant for health food re-registration should be the holder of the health food approval certificate.
Article 80 If extension of the valid period of the health food approval certificate is required upon its expiration, the applicant should apply for re-registration three months in advance prior to the expiration of the valid period.
Article 81 To apply for domestic health food re-registration, an applicant should complete the Application Form for Domestic Health Food Re-registration as required, and send the application materials to local drug (food) administrative departments in provinces, autonomous regions and municipalities where the applicant is located.
Article 82 Drug (food) administrative departments in provinces, autonomous regions and municipalities should examine whether the format of application materials are standard and complete and give an acceptance or rejection notice within five days after receiving the application materials.
Article 83 For satisfactory re-registration applications, drug (food) administrative departments in provinces, autonomous regions and municipalities with the authorization of the State Food and Drug Administration should provide examination opinions and report to the State Food and Drug Administration for examination within 20 days after accepting the application.
Article 84 The State Food and Drug Administration should make a decision after the examination within 20 days after receiving the examination opinions. If there is no notification of denial of re-registration issued within 20 days, drug (food) administrative departments in provinces, autonomous regions and municipalities should issue a re-registration certificate to the applicant. In case of denial of re-registration, the State Food and Drug Administration should notify the drug (food) administrative departments in provinces, autonomous regions and municipalities to give a notification of denial of re-registration and reasons for it to the applicant.
Article 85 Applying for imported health food re-registration, an applicant should complete the Application Form for Imported Health Food Re-registration as required, and send the application materials to the State Food and Drug Administration.
Article 86 The State Food and Drug Administration should check whether the format of application materials are standard and complete and give an acceptance or rejection notice within five days after receiving the application materials.
Article 87 For satisfactory re-registration application, the State Food and Drug Administration should make a decision after the examination within 20 days after accepting the application. If qualified, re-registration will be granted and a re-registration certificate will be issued to the applicant. If unqualified, a notification of denial of re-registration will be provided to the applicant and the reasons for it will be given.
Article 88 In case of any of the following circumstances of health food, re-registration will be denied:
(1) Failure to submit the re-registration application within the specified time;
(2) Cancellation of the health food approval certificate in accordance with relevant laws and regulations;
(3) Raw materials, supplementary materials and products with food safety problems;
(4) Materials or manufacturing techniques used for the product is incompatible with the existing regulations;
(5) Other circumstances that are incompatible with relevant state regulations.
Article 89 In case of denial of re-registration, the State Food and Drug Administration should make a public announcement to cancel its registered number of approval for health food.
Chapter VII Reexamination
Article 90 If an applicant disagrees with the refusal made by the State Food and Drug Administration, the applicant may submit a written application for reexamination to the State Food and Drug Administration and provide reasons for reexamination within ten days after receiving the notification of denial of re-registration.
Article 91 After receiving the request for reexamination, the State Food and Drug Administration should, in accordance with the time limit and requirements of examination for the original application items, conduct the reexamination and make a decision after that. If the denial of registration is withdrawn, a corresponding health food approval certificate should be issued to the applicant. If the original decision is maintained, no more application for reexamination will be accepted. However, the applicant may apply with the State Food and Drug Administration for administrative reconsideration or turn to the People's Court for administrative litigation in accordance with relevant laws.
Article 92 The scope of reexamination is confined to the original application items and application materials.
Chapter VIII Legal Liabilities
Article 93 In any of the following circumstances, the State Food and Drug Administration may, on the basis of the request of the interested parties or its function and power, take actions in accordance with the provisions of Article 69 of Administrative Licensing Law after verification:
(1) A staff of administrative departments abuses his or her powers to grant registration;
(2) Exceeding one's statutory authority to grant registration;
(3) Violating legal procedures to grant registration;
(4) Granting registration to an applicant who is unqualified for application or doe not meet the statutory requirements;
(5) Other circumstances where the health food approval certificates could be cancelled in accordance with law.
Article 94 In any of the following circumstances, the State Food and Drug Administration should cancel the corresponding registered number of approval for health food:
(1) A holder of health food approval certificate applies for cancellation;
(2) It is confirmed that the product has potential safety concerns;
(3) As a result of violation of laws and regulations, the health food approval certificate should be cancelled;
(4) Other circumstances where the certificate should be cancelled according to law.
Article 95 In the process of health food registration, if the State Food and Drug Administration and drug (food) administrative departments in provinces, autonomous regions and municipalities and their working personnel violate the provisions of these Measures, it should be handled in accordance with Article 72, 73, 74 and 75 of the Administrative Licensing Law in case of any of the following circumstances:
(1) Refusal to process health food registration application which meets the legal requirements;
(2) Refusal to publish the items of application materials for health food registration at the place where the application is processed;
(3) Failure to fulfill the legal obligation of advising applicants in the course of processing and examining health food registration application;
(4) In case of incompleteness and noncompliance with statutory format of the health food application materials submitted by applicants, failure to advise the applicants at one time of all the materials that should be added and corrected;
(5) Failure to explain reasons why the health food registration application is refused to be processed or rejected in accordance with law;
(6) Granting registration to health food registration application that does not meet the conditions stipulated in these Measures or granting registration beyond the legitimate authority;
(7) Refusal to grant registration to applications that comply with these Measures or failure to grant registration within the time limit specified in these Measures;
(8) Charging without authorization or out of accordance with the standards for statutory items;
(9) Asking for or taking bribery, or seeking for other interests.
Article 96 During the process of health food registration, the State Food and Drug Administration should provide compensation according to the state compensation law if it causes damage to the lawful rights and interests of the parties concerned as a result of its violation of these Measures.
Article 97 If an applicant hides relevant information or provides false materials or sample products to apply for health food registration, the State Food and Drug Administration will refuse to process the application or grant registration and will give a warning to the applicant. The applicant will not be allowed to file registration application for the health food again within one year.
Article 98 If an applicant obtains the health food approval certificate by cheating, bribery and other illicit means, the State Food and Drug Administration should cancel its health food approval certificate and registered number of approval for the health food. The applicant will not be allowed to file registration application for the health food again within three years.
Article 99 If the designated testing agencies violate the provisions of Article 75 of these Measures, the State Food and Drug Administration should order them to make corrections within a definite time. As for fees charged in violation of law, the State Food and Drug Administration or other relevant government departments should order them to refund the amount; the Qualification Certificate for Health Food Testing will be revoked in serious cases.
Article 100 If the designated testing agencies fail to conduct test or examination in accordance with these Measures or make errors in the process of testing and examination, the State Food and Drug Administration should give a warning and order them to make corrections within a definite time; the Qualification Certificate for Health Food Testing will be revoked in serious cases.
Article 101 If a designated testing agency issues a false test or examination report, its Qualification Certificate for Health Food Testing will be revoked; illegal gains will be confiscated, if any. In the event of constitution of a crime, the criminal liability will be investigated in accordance with law.
In case of losses as a result of untruthfulness of test or examination results provided by a designated testing agency, it shall bear the corresponding legal liabilities.
Chapter IX Supplementary Provisions
Article 102 Working periods mentioned in these Measures are calculated on the basis of working days, excluding statutory holidays.
Article 103 Packaging materials and containers that have direct contact with health food should comply with the state requirements for that of food or medicine and the standards for ensuring human health and safety.
Article 104 The State Food and Drug Administration should be responsible for the interpretation of these Measures.
Article 105 These Measures shall go into effect as of July 1, 2005.
Regulations on health food registration issued prior to the implementation of these Measures should be terminated since the date of implementation of these Measures if in conflict with these Measures.
Appendix I: Application Items for Product Registration
(Non-official translation)
1. Application Items for Domestic Health Food Registration
1) Application Form for Health Food Registration.
2) Photocopies of an applicant's identity card, business license or certificates for legal registration with other government agencies.
3) Provision of reference information proving that the general name of the health food involved in the registration application is not the duplication of a drug name that has been approved and registered (searching the online database of the State Food and Drug Administration).
4) Letter of guarantee that the applicant does not constitute an infringement of the patents already obtained by others.
5) Provision of trademark registration certificate (not required if trademark is not registered yet).
6) A product research and development report (including basic concept of the research and development, function screening process and expected effects).
7) Product formulation (raw materials and supplementary materials) and its basis; sources of raw materials and supplementary materials and basis of their usage.
8) Effective/marker ingredients, content and testing methods for effective/marker ingredients.
9) Diagram of production process and its detailed explanation and relevant research materials.
10) Product quality standards and explanation for their preparation (including quality standards for raw material and supplementary materials).
11) Category, name, quality standards and selection basis of packing materials that have direct contact with the product.
12) Test reports issued by testing agencies and their related materials, inlcuding:
A. Test Application Form;
B. Notification of test acceptance by the testing agencies;
C. Safety toxicology test report;
D. Function test report;
E. Test reports on stimulant, illegal drugs, etc. (registration application for functions including alleviation of physical fatigue, losing weight, and improving growing functions);
F. Effective ingredient test report;
G. Stability test report;
H. Hygiene test report;
I. Other test reports (including examination report on raw material, test report on bacterial virulence).
13) Draft sample of product labels and instructions.
14) Other materials contributing to product evaluation.
15) Two sealed samples in minimum sales package.
Notes:
a. In terms of registration application for products made from fungus, beneficial bacterium, nucleic acid, enzyme preparation and amino acid chelate, relevant application materials should be provided according to pertinent regulations in addition to the above mentioned materials.
b. In terms of registration application for products made from wild animals and plants that are restricted for use by the state, the certificate issued by relevant government departments to the supplier of raw materials for development and utilization of such raw materials and the purchase-and-sale contract made by and between the supplier of raw materials and the applicant should be provided, in addition to the above mentioned materials.
c. In terms of registration application for health food aiming to supply vitamins and minerals, the test report on animal function evaluation and/or human trial test report and function research and development report are not required.
d. In terms of registration application for functions that are out of the scope of function items published by the State Food and Drug Administration, in addition to provision of the above mentioned materials on the basis of use of raw materials, the following materials in connection with the new functions should be provided: (1) Function research and development report, including function name, reasons and basis for application, function evaluation process and testing methods and research process and relevant data, basis for the establishment of function evaluation process and testing methods and scientific documentation. (2) Self-examination report on function evaluation test of product by an applicant in accordance with the function evaluation process and testing methods. (3) Test report on function evaluation of product in accordance with the function evaluation process and testing methods and verification report on evaluation of test methods that are issued by the designated testing agencies.
e. In terms of registration application for different dosage forms of the same product by the same applicant, if one of those dosage forms has gone through all the tests as required and the testing agencies have issued their test reports, the registration of other dosage forms could be exempt from function and safety toxicology tests, however photocopies of those test reports should be provided. Material change in production process that has an impact on product safety and functions should be excluded.
2. Application Items for Imported Health Food Registration
In terms of registration application for imported health food, in addition to provision of materials on the basis of use of raw materials and functions and in accordance with the requirements of application materials for domestic health food, the following materials should be provided:
1) Documentary evidence issued by relevant authorities of the country of production to prove that the producer complies with corresponding local standards of production quality control.
2) If the registration issue is handled by a foreign producer's representative office in China, the photocopies of Registration Certificate of Foreign Enterprises' Representative Offices in China should be provided.
If the registration issue is handled by a representative agency in China with the authorization of a foreign producer, the original notarized letter of authorization and the photocopies of business license of the authorized representative agency should be provided.
3) Documentary evidence proving that the product has been produced and marketed in the country of production for more than one year, which should be notarized by a notary organ of the country of production and confirmed by the Chinese Embassy or Consulate in that country.
4) Relevant standards of the country of production or international organizations that are in connection with the product.
5) Samples of packages, labels and instructions of the product marketed in the country of production.
6) Sample products from three consecutive batches, three times of the quantity required for test.
The aforesaid application materials should be prepared in Chinese with the original text. Materials in foreign languages could be attached for reference. The Chinese translation should be notarized by a domestic notary organ to ensure its consistency with the original. Quality standards of the product to be registered (Chinese version) should be in conformity with the format of quality standards of Chinese health food.
| Date Modified: 2005-08-31 | Important Notices |