2016-03-01 16:17
The food and Drug Administration issued the ＂measures for the administration of health food registration and filing＂
In order to implement the new "food safety law" about health care food product registration and filing management new mode and new requirements, to further implement the spirit of the reform of the administrative examination and approval system, and strengthen the health food registration management norms, February 26, 2016, State Food and drug supervision and Management Bureau Bi Jingquan director signed Decree No. 22 of the "health food registration and filing management approach." In this way a total of 8 chapters 75, will take effect on July 1, 2016, the main contents include:
One is to adjust the management mode of health food products listed. In accordance with the newly revised "food safety law", according to the requirements of the risk management and the way to health food products listed management model adjusted by the original single registration system for registration and filing of combining management mode, State Food and Drug Administration regulations responsible for health food registration management, and imports for the first time belongs to supplement the vitamins, minerals and other nutrients of health food and filing management. Provinces, autonomous regions and municipalities directly under the central government, food and drug supervision and administration department in charge of the administrative areas of other health food registration management.
The two is the optimization program of health food registration. The approach in accordance with the production of health food raw materials directory outside the raw material of health food, and imported for the first time health food (belonging to the supplement of vitamins, minerals and other nutrients health food except must be registered by the product and by the evaluation institutions unified organization of the field of nuclear check and review test, the process closely link. Institutional review according to the actual needs of the organization of verification institutions to carry out on-site verification, inspection agencies to carry out check inspection, clear the technical review, on-site verification and check inspection work mechanism, program requirements, deadlines; the provisions of the data review, on-site verification, review inspection, technical comprehensive review each link without the, institutional review can terminate the review, recommendations will not be registered, in order to reduce the waste of review resources; the provisions of the will review procedures from the registration to make a decision after adjusting for the conclusion of the review made, registered before a decision is made, the prominent review organizations to strengthen and communication between applicants for registration.
Three is to strengthen the health food registration certificate management. The provisions of health food registration certificate is valid for 5 years, and indicate the product name, registered people name and address, registration number, issued date and period of validity, health function, functional components or signs of composition and content, product specifications, shelf-life, appropriate to the crowd, not suitable for people, matters needing attention, and health food registration certificate Annex shall specify product labeling, specification of the main content and the technical requirements for products. At the same time, the provisions of domestic health food registration number format: country food key note G+4 years +4 No. order number; imported health food registration number format: country food key note J+4 years +4 No. order no..
Four is a clear record of health food requirements. The way to clear the use of raw materials has been included in the directory of health food raw materials and imported for the first time in health food belongs to the supplement of vitamins, minerals and other nutrients health food should be for the record, the provisions of domestic health food registration shall be health food production enterprises, the original registrant can as a record; imported health food registration shall be listed is the health food overseas manufacturers. The provision of food and drug supervision and Administration Department of the receipt of the record filing materials, record filing materials to meet the requirements, on the spot record, record number is issued. And for the record table information publish information on its website to be published; do not meet the requirements shall inform the record correction related materials. At the same time, the provisions of the domestic health food registration number format: Food and health by G+4 bit in No. 2 provincial administrative area code + 6 bit sequence number; imported health food registration number format: healthy food preparation J+4 in number +00+6 bit order numbering.
Five is the strict health food naming rules. The approach of the provisions of the health food name shall not use false, exaggerated or absolute, express or implied, prevention, treatment and other words; clearly not use a function name or description of product function Related words; the provisions of the same enterprise shall not use the same formula, registration or filing for the record with a different name of health food, shall not use the same name registration or filing for different formulations of health food.
The six is to strengthen the health food registration and filing penalties for violations. The provisions of health food registration or filing shall be responsible for the traceability of authenticity, integrity, information submitted by the. The provisions of the applicant for the registration of conceal the real situation or provides false materials for applying for registration, shall not accept the application or registration shall not be granted, and a warning is given, and the applicant within one year shall not re apply for registration of health food. Constitutes a crime, shall be investigated for criminal responsibility according to law. At the same time, the provisions of the registration applicant to cheat, bribery or other improper means to obtain health food registration certificate of and withdraw the registration certificate of health food, impose a fine of not less than 10000 yuan but not more than 30000 yuan following a fine, and is licensed to people within 3 years shall not re apply for registration. Constitutes a crime, shall be investigated for criminal responsibility according to law.
The State Food and Drug Administration requirements around the food and drug regulatory departments conscientiously do a good job in the publicity of the "health food registration and filing management approach" to carry out the work, further standardize the health food registration and filing management behavior, continuously improve the supervision ability and level, to ensure the public health and safety.
The newly revised food safety law stipulates strict supervision and management of special food. To implement the law on health food market access supervision put forward requirements, unified and standardized health food registration management, the General Administration of in soliciting public and listen to the views of many aspects of food production enterprises, local food and drug regulatory departments, relevant experts and industry organizations, on the basis, after repeated research and feasibility studies, forming a "health food registration and filing management approach" (hereinafter referred to as the "rules"). The "measures" will be implemented in July 1, 2016. The relevant issues are hereby interpreted as follows:
First, the "measures" of the legislation is based on what?
In accordance with the "food safety law of the people's Republic of China in seventy-fourth, 75, 76, 77, 78, 82 and other relevant provisions, formulate the" measures ".
Two, the "measures" the scope of application and basic principles is what?
The "measures" provisions in these Measures shall be applicable to the health food of the people's Republic of China and the supervision and administration of the registration and filing. Health food registration and filing work should follow the scientific, open, fair, convenient and efficient principles.
Three, the "measures" in the health food registration means what?
The provisions of the measures, health food registration is refers to the food and drug supervision and management departments according to the applicant for the registration application, in accordance with legal procedures, conditions and requirements, to the application for registration of health food safety, health care function and quality control of the relevant application materials for system evaluation and review, and decide whether to approve the registration approval process.
Four, the "measures" in the health food for what is the meaning?
Health food for the record, is refers to the health food production enterprises in accordance with legal procedures, conditions and requirements that would indicate product safety, health care function and quality control of materials submitted food and drug supervision and Administration Department of the archive, open, for future reference.
Five, the "measures" of the health food registration acceptance department is provided?
The State Food and drug administration administrative agencies (hereinafter referred to as the accepting institutions) shall be responsible for accepting the registration of health food.
Six, the "measures" on health food record materials receiving department is provided?
The State Food and Drug Administration accepted the administrative agency responsible for receiving the relevant archival materials imported health food.
Provinces, autonomous regions and municipalities directly under the central government, food and drug supervision and administration department is responsible for receiving the relevant archival materials of health food.
Seven, the "measures" of various food and drug supervision and management departments is how to divide?
The provisions of the measures, the State Food and drug administration responsible for health food registration management, and imports for the first time belongs to supplement the vitamins, minerals and other nutrients health food record management, and guide the supervision of the province, autonomous region, municipal food and drug supervision and administration department take the health food registration and filing work.
Province, autonomous region, municipal food and drug supervision and administration department responsible for within their respective administrative areas health food record management, and with the State Food and drug administration to carry out the health food registration on-site verification work.
City and county food and drug supervision and administration department responsible for the supervision and management of the administrative areas of registration and filing of health food, to undertake other work entrusted by the food and drug supervision and management departments.
Eight, the "measures" of the applicant or the record and evaluation institutions and administrative departments of the main responsibilities is how to divide?
The applicant or the filing of the application materials of the authenticity, integrity, traceability and responsible, responsible for product safety, efficacy and quality control.
Evaluation institutions responsible for organization expert review of the application materials are reviewed, and according to the actual needs of the organization of inspection agencies to carry out on-site verification and inspection agencies to carry out check inspection, within 60 days to complete the technical review, to the administration submitted a comprehensive review of the conclusions and recommendations.
The administrative department responsible for health food registration and filing management.
Nine, the "measures" of the health food registration and filing supervision are important to adjust?
Compared with the previous registration management system, the "measures" on the basis of the new food safety law, registration and filing combined classification management system for health food.
The use of raw materials other than raw material of health food and health food directory first import health food registration management.
Health food for the use of raw materials has been included in the directory and health food raw materials imported for the first time to supplement the vitamins, minerals and other nutrients for management. For the first time the imported health food belongs to supplement the vitamins, minerals and other nutrients, the nutrients should be included in the health food raw material list.
The function of health care products claim should be the function of health food has been included in the directory. Health food raw materials directory and allow health food that health care function directory by the administration of public health under the State Council administrative department, State Administration of traditional Chinese medicine department in conjunction with the formulate, adjust and publish relevant management measures shall be formulated separately.
Ten, the "measures" of health food registration procedures are important to adjust?
The "measures" provisions for health food registration administration by accepting institutions bear. To the admissibility of the starting point for registration approval, production on-site verification and review test adjustment to the technical review link, and the evaluation content, evaluation procedure, the overall time limit and determined on the basis of the proposed specific strict restrictions and requirements.
According to the technical review of the application materials, on-site verification, dynamic verification, sampling check testing procedures carried out, any link does not meet the requirements, evaluation institutions can terminate the review, put forward proposals shall not be registered.
Eleven, the "measures" on health care food technical review of the requirements of what adjustments?
Review of agencies that need to register the applicant to supplement the materials, should all be supplemented once informed. The applicant shall be registered within 3 months in accordance with the requirements of a correction notice to provide supplementary materials. Registration to the applicant if it fails to submit supplementary materials or fails to complete corrections, not enough to prove that product safety, health care function and quality control and evaluation institutions shall terminate the review, put forward proposals will not be registered.
Twelve, the "measures" on health food technology transfer program what adjustments?
Health food registration technology transfer, the transferee shall re submit the product registration applications where the transferor under the guidance of. The technical requirements for products should be consistent with the original application materials. Simplified evaluation institutions review procedures in accordance with the relevant provisions.
Thirteen, the "measures" provisions of the health food registration management focus on the content of what?
Food and drug supervision and Administration Department of the receipt of the record filing materials, record filing materials to meet the requirements, on the spot record; does not meet the requirements shall inform the record correction related materials.
Food and drug supervision and management departments shall complete the registration information of the archive for future reference work, and issued a record number.
Health food for the record, food and drug supervision and management departments should be in accordance with the relevant requirements of the format product registration certificate, and the record table information publish information on its website to be published.
Obtained registration of health food raw materials has been included in the directory of health food raw materials, and in accordance with the relevant technical requirements, health food registration for change of registration, or period to apply for renewal of registration, shall be handled in accordance with the procedures for the record.
Fourteen, the "measures" provisions of the applicant's qualifications for what?
Domestic health food registration applicant shall be in the registration as a legal person or any other organization within the territory of China; imported health food registration applicant shall be listed overseas health food manufacturers. For imported health food registration shall, by the permanent representative offices of China or handled by the agency entrusted China territory.
Health food registration certificate and its attachments specified changes, shall be made by the health food registration application for change. The change of the name of the registered person, shall be made by the applicant for registration after the change for change.
Health food registration certificate at the expiry of the validity period for renewal, should be have been produced sales of health food, and to provide crowd edible situation analysis report and the production of quality management system running self inspection report etc..
Fifteen, the "measures" on the record of the qualification requirements for what?
For people of domestic health food should be health food production enterprises, the original registrant may as a record of people; people for imported health food, health food should be listed overseas manufacturers.
Sixteen, the implementation of the "measures" focus on supporting the work is what?
According to the newly revised "food safety law", the raw materials of health food and health care function allows the directory directory of health food claims is the implementation of the necessary conditions of health food registration and filing management and foundation. At present, the State Administration of taxation is in conjunction with the health administrative department of the State Council, the State Administration of traditional Chinese medicine department to make relevant management measures and supporting directory, strive for the early introduction of.
Seventeen, the "measures" after the implementation of the existing health food registration application and approval of registered products will take what measures?
The "measures" after the implementation, I board will conduct a review in accordance with the new regulations. To the approved health food registration, to carry out clean-up replacement work in batches to take and compliance in accordance with the law, the principle of steady progress. Through the cleaning card, so that the old and new products review standards consistent. The cleaning card proposalseparately.
Eighteen, the "measures" on health food naming rules on how to perform?
"Measures" of health food named made clear provisions. These Provisions is to solicit the enterprises, industry organizations, primary regulators and expert opinions based on the formation, and has in August 2015 in the State Council Legislative Affairs Office website to solicit opinions from the public. 2015 August 25, Administration issued "on further regulate the naming of health foods related matters notice", clear administration no longer approved to contain statements of product function Related words named health food, and request that have been registered with the approval of the related products in accordance with the relevant provisions of the change of product names. Considering the health food market name recognition of the problem have been listed Administration recently released "on the naming of health foods related matters notice", to the production enterprises of the transition period, allowing new product name is mark the original product name tagging. At present, the State Administration of taxation is further study the naming problem through the development of health food, health food naming guidelines and evaluation rules, norms and technical evaluation of health food supervision and naming.
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