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Provisions for Health Food Registration (Trial)
 
2011/8/9 14:25:29¡¡Source: ¡¡Hits:

Provisions for Health Food Registration (Trial)

Order of the State Food and Drug Administration

No.19

The Provisions for Health Food Registration (Trial), adopted at the executive meeting of the State Food and Drug Administration, is hereby promulgated and shall go into effect as of July 1, 2005.

Commissioner: Zheng Xiaoyu

April 30, 2005

Provisions for Health Food Registration (Trial)

¡¡¡¡Chapter 1¡¡General Provisions

¡¡¡¡Article 1¡¡The Provisions is formulated in accordance with the Food Hygiene Law of the People¡¯s ¡¡¡¡¡¡Republic of China and the Administrative Permission Law of the People¡¯s Republic of China to standardize health food registration, ensure the quality of health food and human food safety.

¡¡¡¡Article 2¡¡¡°Health food¡± in the Provisions refers to food with claims of having certain health care functions or serving the purpose of supplementing vitamins and minerals, which is suitable for specific groups of people, able to adjust body functions ¨C not made for curing diseases and will not cause any acute, sub-acute or chronic hazard to human body.

¡¡¡¡Article 3¡¡The Provisions applies to the registration of domestic and import health food within the territory of the People's Republic of China.

¡¡¡¡Article 4¡¡¡°Health food registration¡± refers to the review and approval process where, on the basis of the application filed by the applicant, the State Food and Drug Administration, in accordance with the legal procedures, conditions and requirements, conducts a systematic evaluation and examination on the safety, effectiveness, quality controllability of health food and content of the label and insert sheet, and decides whether or not to approve the registration, including the examination and approval of application for product registration, change or for registration of technology transfer product.

¡¡¡¡Article 5¡¡The State Food and Drug Administration is in charge of health food registration nationwide and responsible for examination and approval of health food.

¡¡¡¡The (food and) drug regulatory department of an province, autonomous region or municipality directly under the Central Government, authorized by the State Food and Drug Administration, is responsible for acceptance and preliminary review of application materials for registration of a domestic health food, on-site inspection on the test and trial sample production of the health food for registration, and arrangements for sample testing.

¡¡¡¡The testing institution designated by the State Food and Drug Administration is responsible for the toxicology test of safety, function test (including animal test and/ or human test), functional ingredient or major ingredient test, hygiene test and stability test for the health food for registration; it also undertakes specific work such as sample testing and verification testing.

¡¡¡¡Article 6¡¡Administration of health food registration shall follow the principles of being science-based, transparent, fair, just, efficient and convenient for people.

Chapter 2¡¡Application and Approval

¡¡¡¡Section 1¡¡General Rules

¡¡¡¡Article 7¡¡An applicant for health food registration refers to the one who files an application for health food registration, bears corresponding legal responsibilities and holds the health food approval certificate after the application is approved.

¡¡¡¡A domestic applicant shall be a citizen, legal person or other organization in China.

¡¡¡¡An overseas applicant shall be a legitimate overseas health food manufacturer. An import health food registration from an overseas applicant shall be handled by its representative office or authorized agent in China.

¡¡¡¡Article 8¡¡The application for health food registration includes the application for product registration, change or for registration of technology transfer product.

¡¡¡¡Article 9¡¡The State Food and Drug Administration and the (food and) drug regulatory department of an province, autonomous region or municipality directly under the Central Government shall publish the items of application dossier for health food registration and the model text of related registration application form at the acceptance place.

¡¡¡¡Article 10¡¡An applicant for health food registration shall submit a standard and complete dossier and provide true information as required, and shall be responsible for the authenticity of the content of the application dossier submitted.
 
¡¡¡¡Article 11¡¡Where there is an error that can be corrected on-site in the dossier, an on-site correction shall be allowed.
 
¡¡¡¡Article 12¡¡Where a dossier is incomplete or not conformed with the defined format, the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government and the State Food and Drug Administration shall inform the applicant on-site or within five days, at one time, of what to be supplemented or corrected; if the applicant is not informed within the timeline, the application is regarded as accepted on the date the dossier is received. If the application is not accepted, the reasons shall be given in writing

¡¡¡¡Article 13¡¡In the process of examination, if any supplementary document is required, the State Food and Drug Administration shall give the applicant a one-off notice. The applicant shall submit the required supplementary document within five months after the notice is received. If the applicant fails to submit the document within the specified time limit, the examination shall be terminated. Under special circumstances where an applicant fails to provide the supplementary document within the time limit, the applicant shall submit a written application to the State Food and Drug Administration and explain the reasons. The State Food and Drug Administration shall give its opinion on handling the matter within 20 days.

¡¡¡¡Article 14¡¡If any supplementary document is required for a registration application, the original time limit for examination shall be extended by 30 days. In the case of application for change, it shall be extended by 10 days.

¡¡¡¡Article 15¡¡Where a product is approved for registration after examination in accordance with law, the State Food and Drug Administration shall issue a health food approval document to the applicant within the specified time limit, which shall reach the applicant within 10 days. Where an application is rejected, the State Food and Drug Administration shall inform the applicant of the rejection and explain the reasons thereof in writing within the specified time limit, and notify the applicant of the right to apply for reexamination, administrative reconsideration or to bring an administrative suit by law.

¡¡¡¡Article 16¡¡Where the State Food and Drug Administration or the (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government finds, in the process of examining registration application of a health food, that the application directly involves the vital interests of others, it shall notify the interested parties. The applicant or an interested party may submit written opinions to state and defend the case or request a hearing in accordance with law.

¡¡¡¡Article 17¡¡The State Food and Drug Administration shall provide information relating to acceptance of health food registration application, the examination process and approved health food on its official website.

¡¡¡¡Article 18¡¡The State Food and Drug Administration shall timely adjust the scope of functions and evaluation and testing methods of health food, as well as technical requirements for evaluation, in the light of the need for development of science and technology, and make an announcement thereof.

¡¡¡¡Section 2¡¡Application and Approval of Product Registration

¡¡¡¡Article 19¡¡Product registration application includes application for registration of domestic health food and application for registration of import health food.

¡¡¡¡Application for registration of domestic health food refers to application for registration of a health food that the applicant intends to produce and market in China.

¡¡¡¡Application for registration of import health food refers to application for registration of a health food which has been produced and marketed outside of China for more than one year and is to be marketed within the territory of China.

¡¡¡¡Article 20¡¡An applicant shall conduct relevant research before applying for a health food registration. After the research is completed, the applicant shall provide samples and test-related data to the testing institution designated by the State Food and Drug Administration for relevant test and examination.

¡¡¡¡Where a health care function to be applied for registration is within the scope published by the State Food and Drug Administration, the applicant shall provide a product research and development report to the designated testing institution; where a health care function to be applied for registration is not within th

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