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Health food registration information reporting requirements

                   时间:2022-02-22 浏览:379
导读: On the issuance of “health food registration requirements for disclosure of information items (Trial)” notice May 20,2005 Fresh State Drug Administration Note [2005] No. 203 ……
On the issuance of “health food registration requirements for disclosure of information items (Trial)” notice

May 20,2005

Fresh State Drug Administration Note [2005] No. 203

     According to the “health food products registered management approach (draft),” as the guide and standardize reporting and assessment of health food products, I developed the “health food registration requirements for disclosure of information items (draft),” Since July 1, 2005 from the Executive, now be circular.
State Food and Drug Administration.
Health food applications for registration requirements for disclosure of information items (Trial).
  • The general requirements for disclosure of information
  1.  Home for the disclosure of information reporting project directory, the directory information furnished by the project “health food registration application form,” “the accompanying information” order. Each data page seal closures page annotated product name, name of applicant, the data indicate the upper right corner of the name. Between all the information should be clear distinction between the use of signs, and marked all the information or the name of the directory information of the serial number. Package of information with the drilling folders and bound volumes.
  2.  Disclosure of information to use A4 paper to print specifications (not less than 10 lines on the Chinese on the 4th characters, English words shall not be less than on the 12th), which should be complete, clear and may not be altered.
  3. In addition to the “health food registration application forms” and issued by the inspection agency inspection reports, the information should be declared by the applicant seal or stamp page Jifengzhang (joint declaration of the number of applicants, all applicants should be stamping seal) , seals should be decked in the text. The stamp should be in line with the state seal with the provisions of Chapter, and have the force of law.
  4. The number of applicants joint declaration, the declaration shall be submitted to the joint recommendation of the responsible person.
  5. Disclosure of information in the same content (such as product name, name of applicant, the applicant addresses, etc.) should be complete and consistent.
  6. Product names should include brand name, generic and attribute names. Product shall conform to the following requirements:
    (1) In line with the state laws, regulations, rules, standards, norms requirements.
    (2) The authenticity of the product, easily understandable, with Chinese language and customs.
    (3)Brand name products can be used or registered trademarks of other names.
    (4) Generic should be accurate, scientific, and not allowed to use the express or implied therapeutic effect and exaggerated function of the text.
    (5) Attributes of products that should be the objective form, its expression should be standardized and accurate.
    (6) The addition of the product formulations, should be used in naming the same brand name and generic, but to identify different attributes were.
    (7)The Chinese name should be imported products and foreign-language name counterparts. Can be translated,or Italy, and the sound Heyi, general mainly to paraphrase.(8) Health food products not be used in naming the following:
  • Consumer difficult to understand the professional terminology and the local dialect;
  •  False, exaggerated and absolute terms, such as “efficiency”, “generation”;
  •  Vulgar or color with the word feudal superstition;
  •  Foreign letters, symbols, such as the Chinese Phonetic Alphabet (except registered trademarks);
  •  Prohibits the use and function of the homophonic related words (words);
  • Shall not use the names and place names (except registered trademark).
  • Product formulations, production processes, quality standards, labels and brochures and related documents in foreign languages, should be translated into standard Chinese, foreign language references a summary, keywords and products and functional health, safety-related part of the should be translated into standard Chinese (foreigners name, address exception).
  • The applicant to submit additional information, should be “health food review notice” requirement and the contents of the order to provide itemized, together with “health food review notice” (originals or copies). In the submission of additional information, the project should be revised to provide complete information together, and indicate revised dates, and with the applicant consistent with the original seal.
  • The products have been accepted, the applicant for a change of the content of disclosure of information related to specific requirements are as follows:
  1. The product formulation, production process, the test report and other products may involve the safety and function of the contents can not be changed.
  2. In addition to the above, if changes, the applicant shall submit a written Acceptance of applications for changes, the reasons for changes, submitted by the specified date, and with the applicant consistent with the original seal. Applicants should provide changes of the project complete information.
  • Has not been State Food and Drug Administration approved the registration of products, information and samples of their declaration of the general non-refundable, but has been submitted by the “power of attorney”, in the producing countries (or regions) of the production and sales for more than a year that document-producing countries (or regions) issued by the relevant agencies in accordance with local production enterprises corresponding production quality control documents and the “health food approval certificate” Original (re-registered products except) except For refund, the applicant should be received does not approve of the opinions within three months of application for refund in writing.
  •  New applications for registration information should be submitted to declare the original copy of a copy of 8; change in the transfer of technology products and applications for registration should be submitted in an original and photocopy of six. Original copies should be fully matched by the Original Copy and should remain intact and clear. The application form, quality standards, label brochures should also provide electronic versions, and the content should be consistent with the original.
  •  Product registration application form
  1.  Product registration application forms are available from the State Food and Drug Administration Web site (www.sfda.gov.cn) or the State Food and Drug Administration review of health food Centre website (www.bjsp.gov.cn).
  2.  Should be read carefully before completing the guidance notes, as required complete.
  3.  The application form, which must print, the project should be complete integrity, standardized, or alter.
  4.  Health care function should be declared and State Food and Drug Administration announced the names of the same functional health food. Declaration of the new features except.
  5.  The applicant is a legal entity or other organization, the applicant name, address should be “its operational license,” “institution personality registration certificate” in the name, address exactly the same and consistent with the seal; legal representative should be signed and “an independent legal credentials” in the legal representative of the same name; applicant is a legal citizen, the applicant names should be consistent with the ID card and identity card numbers of applicants fill in the name of the applicant.
  6.  A number of applicants joint declaration, should fill in all the names and addresses of the applicant, the applicant should be separately signed, sealed.
  7.  The applicant for products imported products ownership of the owners, manufacturers of products for the actual producers (declare their own products manufactured by the applicant, the applicant shall production enterprises; commissioned by the applicant to declare products offshore production of other enterprises , which is being commissioned by the manufacturing enterprises enterprises).
  • Domestic applications for registration of health food products specific requirements for disclosure of information
  1.  To apply for registration of generic health food products (with the exception of raw materials name) has been approved for registration with the Drug Names Chongming not a search report, by the applicant from the State Food and Drug Administration Web site after its own database retrieval issued. Such as: search, “Yigan Tablets” is the registered name drugs, “XXX licensing Yigan tablet (oral liquid or capsules, etc.)” shall not name as a health food.
  2. Trademark registration certificate documents, national trademark registration is approved by the management of the Trademark registration certificate copies, without providing unregistered. The use of the trademark should include health food products, trademarks registered person inconsistent with the applicant, who should provide registration documents or the applicant can change the legitimate use of the trademark documents.
  3.  R & D (including product development ideas, function selection process, the expected results, etc.)
  • 1, product development ideas
    (1) makes clear that the project is expected to reach health-care products and scientific level functions (2) appropriate to the situation at home and abroad in the crowd, and the market demands of the investigation and analysis; (3) similar product or similar products in the country’s basic conditions, the products are The characteristics and advantages.
  • 2, health screening function:
    (1), which describes the selection formula, including the detailed screening, selection and screening based on the results; (2) A description of the effect of selection of raw materials, raw material consumption and compatibility between human security and the impact of (3) Description The main components of products or signs of components and the process of determining basis (4) of the road design, product forms and formulations selected scientific and rational, and based on feasibility;
  • 3, the expected results
    (1) products on the market, the prospects for the development of products for analysis.
    (2) the products may bring social and economic benefits to be evaluated.
  •  Product Formulation (raw materials and accessories) and the formula basis
  • 1, prescription products (raw materials and auxiliary materials) (1) According to declare health function, according to the original, supplies, the effectiveness of any order of relations between the role of all primary and secondary raw materials, supplies, the name and quantity, supplies, including excipients, filler, forming agents, sweeteners, coloring agent . Original, supplies, the standard norms of the name name, raw materials should also specify different processing specifications (such as Health, salt system, the honeybee, calcined, etc.), if the extracts of raw materials, raw material in the formula should be the name “XXX Extraction of “said. Original, supplies, the amount should be made to the 1000 units in preparation of a formula, such as: made 1000, 1000, 1000 bags, or 1000 ml bottles of 1000, 1000g, and other raw materials used in the calculation formula of not to percentage.
    (2) nutrient supplements type of health food, in addition to formula (1) expression, the product should be marked each of the nutrients consumed per person per day, with the “China Daily residents Dietary Reference Intakes quantity” and “minerals, vitamins types and amount of” corresponding nutrients consumed per person per day recommended that a corresponding list.
  • 2, formula basis
    (1) Description of the original formula, supplies, based on the source and use.
    (2) clarify the formula in the efficacy of raw materials, food safety and effective dose dose.
    (3) using traditional Chinese medicine or health care theory of modern medical theory, detailed product formulation science, rationality and food security.
    The formula provides health care products and food safety functions of the scientific literature, the relationship between information and / or test data. Including the amount of the raw materials and coordination, such as antagonistic interaction between the scientific basis, and contribute to the inclusion of information under review.
    (4) the effectiveness of ingredients and the scientific basis for determining the amount.
    (5) the appropriate people, and not based on the choice of the crowd.
    (6), the original formula, supplies, not “health food products registered management approach (draft),” the provisions of Article 63 of, and in accordance with the relevant provisions of the declaration of the corresponding information.
    (7) the use of the formula fungi, probiotics, nucleic acid, endangered wildlife and developed a special declaration items under review, with the exception of in accordance with the “health food products registered management (tentative)” to provide relevant information, but also in accordance with provided for the review of the corresponding information.
    (8), as raw materials for chemical synthesis products, edible should provide the basis for evaluation of consumption and safety information and the inclusion of other products contribute to the information under review.
    (9) to extract the raw materials should be provided extracts from the production process and quality standards, and were included as an appendix to the production process and product quality standards under.
  • Effective components / landmark composition, content and effectiveness of ingredients / symbol of the composition detection method
  •  1, Bioactive components / elements landmark name, content and method of detection should be listed separately.
  • 2, It should be based on the following two aspects of the effectiveness of components of the products / symbolic elements, and the basis for determining:
  •  (1) Relating to the functions of health care products and ingredients;
  • (2)On behalf of the landmark product ingredients.
  • 3, bioactive components / symbol of the determination of composition detection method:
    According to the state health standards, norms, the State Pharmaceutical standards or the relevant state departments and the formal announcement applies to health food detection method. No detection method, the applicant should provide a detailed detection techniques, methods and results of studies validate the report
  • Production process diagram and detailed description of the study and related information
  • 1, Production process diagram
    Should contain all the production process line, and links to specify all the processes and related technical parameters.
  • 2, The production process
  • (1) A detailed description of the production process, including product development process and all aspects of the various elements of technology parameters and, when necessary, should also specify the corresponding link and equipment used models. For example, the production of solid dosage forms part of the general should contain the original, supplies, pre-processing, feeding, extraction, purification, concentration, drying, mixing, forming agents, sterilization or disinfection, packaging, testing, storage, and all other processes.
  • (2) The impact on the quality of products the key to a detailed explanation or comment.
  • (3) Some of difficulty in preparation of the main line of products or steps set out in the complex, and can be independent of the production process should be described separately described. Such as “XXX extract of” Preparation.
  • (4) on semi-finished products, intermediates and the quality control methods;
  • 3, Relevant research information
  • (1) Brief description of the production process optimization processes, and provide related technical parameters and the test data based on the scientific literature, providing the technology to play the role of raw materials based on effectiveness. Optimization of the process outlined preparations and the basis.
  • (2) the production environment, disinfection, sterilization methods and optimization basis clarify impact of the key product quality and quality control measures; provide relevant data to illustrate the stability of product quality.
  • (3) According to pre-test or laboratory research in the production process of amplification test (usually 10 times magnification), on the formulation of the production process of validation and error corrected and provide certification report, in the self-inspection test the quality of products, provide self-inspection report.
  • 4, Asolid preparation for example, specific requirements are as follows:
  • (1) Pre-treatment
    Net system: detailed description of the process and requirements of the net to the technical indicators.
    Processing: At the “People’s Republic of China Pharmacopoeia” or provincial food and drug supervision and management departments to adopt the norms concocted, did not dish out norms should enact its own processing methods, and to provide basis and processing standards.
  • (2) Processing aids and quality grades
    List used in the production of all processing aids name, source, and quality grade, can be used to provide the basis for the.
  • (3) Feeding
    Sets out in detail the names and dosage of feed.
  • (4) Extraction
    Details extraction methods, equipment requirements, the number of extraction, extraction time, temperature, and the name and amount of solvent.
  • (5) Concentration
    Note enrichment methods, equipment, enrichment temperature, pressure concentration, concentration achieved relative density (Determination temperature).
  • (6) Refining
    Details refining methods and conditions should be marked filtering methods, technical requirements and equipment requirements.
  • (7) drying
    Details drying methods, conditions and equipment requirements.
  • (8) Forming
    Elaborate molding supplies used by the name, dosage, quality and grade molding process parameters, equipment used.
  • (9) sterilization or disinfection
    Detail Product sterilization or disinfection methods, technical parameters and equipment requirements (such as heat sterilization should be specified time, temperature and composition of effectiveness).
  • (10) Description of the production workshop in the environment clean.
  • (11) Packaging
    Should be consistent with food containers and packaging materials health regulations or standards related to pharmaceuticals packaging requirements, and provide proof of the corresponding quality standards.
  • Standards for product quality and presentation (including raw materials, supplies, quality standards)
  • 1, and product quality standards should be consistent with the format of GB/T1.1-2000 “Standardization Guide” in the relevant standards and the preparation of the structure of the provisions of the rules.
  • 2, and the quality standards include information outlined elements (cover, index, the preamble), the norms of the general elements (product name, the scope of the normative references), standardized technical elements (technical requirements, test methods, testing rules, signs, packaging, transport, storage, normative Appendix), as well as the preparation of the quality standards.
  • 3, Attention:
  • (1) Specification of the document quoted the order as follows: the state standards, industry standards, local standards, and related documents. National standards in accordance with the standard order of the size of the order, the full text does not invoke Note Some invoked, it can inject latest version of the standard should be.
  • (2) technical requirements, which must include: the original, supplies, demands, sensory requirements, or signs of the components of composition, physical and chemical indicators, microbial indicators, and the deviation in the net.
  • (3) The effectiveness of ingredients or components of the choice of signs and indicators of the determination of: the applicant in the development of products based on the product formulation, production process, such as its own. If only one product or symbolic components of composition, text can be presented directly to its provisions; if two or more signs of the effectiveness of ingredients or components to the list and marked its numerical indicators. Quality standards should be prepared to provide a detailed note or signs of the components of index components based on the determination of value and reasons. Effectiveness of ingredients or components signs of the guideline values indicated in the following ways:
  • 1) effectiveness of ingredients or components landmark general index value by ≥ 2.
  • 2) the need for the scope of the effectiveness of ingredients or components of the signs, should be indicators of ± X% indicated limited scope, such as the anthraquinone, glycosides, such as aloe ingredients, X Product Development based on the value of information identified.
  • 3) daily intake to strictly control the effectiveness of ingredients or signs of the components (eg, melatonin), which marked the index value should be based on the daily dosage, the ceiling may not exceed permitted intake.
  • (4) quality standards in the general health requirements (physical and chemical indicators and microbial indicator) should be in accordance with relevant state standards, norms and similar food hygiene standard-setting, microbial pathogens indicators items should be listed separately.
  • (5) In addition to these general requirements, the quality standards of the indicators should be based on product formulations, raw materials and the different technology, based on the “health food testing and evaluation of technical specifications (2003 Edition)” to increase the corresponding projects.
  • (6) the units of measurement and numerical representation
    Physical and chemical indicators of measurement units to comply with the provisions of the statutory measurement units. Microbial indicators of the total number of bacteria, fungi, yeast are cfu / g (solid) or cfu / ml (liquids), coliforms are MPN/100g (solid) or MPN/100ml (liquid).
  • (7) normative Appendix
    The development of national standards of the effectiveness of ingredients or components landmark test of raw materials or quality requirements, should be given in the appendix to the normative requirements. Effectiveness of ingredients or components of the signs included in Appendix A detection method for raw materials, quality standards or requirements listed in Appendix B, supplies, quality standards or requirements listed in Appendix C.
    Test methods are given in the following order:
  • A, principle;
  • B, reagents and standard reference substance (annotated source and purity);
  • C, equipment or devices;
  • D, sample preparation;
  • E, the steps;
  • F, the results of expression (including the calculation formula).
  • The end of the standard line
    In the last elements of the standard, the standard should be the end of line (1/3-1/4 page width).
  • Presentation
    The development of enterprise standard indicators, the basis for the test method described for the development of national standards or no standards Ministerial (standardized) test method should be added that the source of methods.
  • Direct contact with the product packaging material type, name, and choose based on quality standards
    1, provide the name of packaging materials (types of), quality standards (standard provenance and standards), and packaging materials should be to standardize the names of the name.
    2, the source of packaging materials provided proof.
    3, in accordance with the nature of products and production, transport, storage and use of the requirements of the course, the basis for the choice of packaging material.
  • Testing agencies issued by the test report and related information
    1, the test report issued by the Organization shall be the State Food and Drug Administration identified the health food inspection agency. Test report shall be valid for testing agencies from the date of issue 2, over the period of the test report inadmissible.
    2, the test report and test data
  • (1) the test report with the following order:
    1) safety of toxicology test report;
    2) functional test reports (including animals function test reports and / or fresh human test pilot reports);
    3) stimulants, such as detection of prohibited drugs (declare alleviate physical fatigue, weight loss, improving the growth and development functions of the applications for registration);
    4) effectiveness of ingredients or components landmark test report;
    5) Stability Test Report;
    6) hygienic test report;
    7) Other inspection reports (such as the identification of raw materials, toxic bacteria test reports, etc.).
    (2) of the trials before the report of examination application forms should be tested units have been received and the test of admissibility notice.
  • 3, the test report shall meet the following requirements:
    (1) test report format should be standardized,Or alter;
    (2) test data should be true, accurate;
    (3) testing agencies legal representative (or their authorized persons) signature and official seal stamping testing agencies;
    (4) In addition to testing the test report concluded the official seal stamping testing agencies, a test report must be more than stamping Jifengzhang seal or page by page;
    (5) report of the test product names, inspection units, samples or production units Preparation name, batch samples should be tested in the application form and the corresponding identical in content.
  • 4, nutrient supplements apply for the registration of health food products without providing functional test report does not provide security toxicology test report must be written statement of reasons.
  • Product labelling, brochures Yanggao
  • 1, The manual should be prepared and the following format:
    Manual , goods from the main raw materials for health foods made by the animal and / or human test fresh function tests proved that the health of  function (Note: nutrient supplements without superscript “animal and / or human Fresh test function tests prove that the “words, simply annotated” with added   health effects “button).
    [Main raw materials] (formula writing by the main order of the original, supplies.)
    [Effectiveness of ingredients or components and content of signs] per 100 g (100ml) with: (effectiveness of the composition or the content of signs. Content should be to determine value. Nutrient supplements also marked the smallest unit of food nutrient content)
    [Health care function] (declared by the health function name written)
    [Appropriate crowd]
    [Inappropriate crowd]
    [Methods and food consumption] (daily  times,  volume, if special requirements should specify)
    [Specification] (1 smallest unit consumption in the net. Marked by the following units of measurement net content)
  • (1) liquid health food: volume, or units ml ml;
  • (2) solid and semi-solid health food: quality, in units of mg or mg g, g;
  • (3) For the preparation of packaging, such as capsules (Soft Capsules), the quality of content means the quality.
    [Durability] (in months for the units)
    [Storage method]
    [Notes] This can not be a substitute for drugs. (It should also be based on product features increased attention matters)
  • 2, the label should prepare the following requirements:
  • Yanggao prepared by the label should be consistent with the relevant state regulations, the content of the statement should be consistent with the specification.
  • Other products help assess the information
    Production enterprises, including quality assurance system documentation (GMP, HACCP) proved that the supply of raw materials, raw materials supply and marketing contracts, commissioned by the agreement, raw materials or pre-inspection reports, such as that of a certificate of competency, as well as documents and product formulations, processes, functions, and security-related research , reference information.
    Home state that should be provided under the documents, data, name and category directory, and use clear identification of the documents, data distinction.
  • Did not unseal the smallest sample packaging sales
    The packaging should provide sample integrity, non-destructive, and should be labelled, labels and disclosure of information should be the corresponding identical in content. Sample packaging should be conducive to the preservation of samples.
    Fourth, applications for registration of imported health food products specific requirements for disclosure of information
    Apply for registration of imported health food products, should be based on the use of raw materials and reporting functions, in addition to health food products in accordance with domestic submitted applications for registration information, should also pay attention to the following matters:
  • (1) Product names, names of the applicants, production enterprises name, agency name (in English) should be consistent.
  • (2) document, the original power of attorney should be used producing countries (or regions) of the official text, required by the host country (or region) and the legalization of civil authorities in the host country (Link) Museum confirmed.
  • (3) documents describing the validity of the power of attorney should be valid for use.
  • (4) documents, instructions should be flat seal or legal representative (or their authorized persons) signature.
  • (5) documents, instructions should be translated into Chinese by the Chinese authorities in the notary notarized.
  • (6) producing countries or regions issued by the manufacturing enterprises in line with the corresponding local production quality control documents should meet the following requirements:
  • 1, commissioned by the applicant to declare products offshore production enterprise production, the production of documents in the enterprise should be for the production of the enterprise, and the applicant must provide the production of the power of attorney;
  • 2, should be enshrined in the document issued by the name of the paper, product names, product names and the date of issue papers;
  • 3, the document issued by the institutions should be the production of the competent government departments or industry associations.
  • (7) registration handled by the power of attorney must comply with the following requirements:
  • 1, in the power of attorney should contain instructions issued by the name, the name was commissioned by the commission to apply for registration of the product name, commissioned issues and instructions issued by the date;
  • 2, the instructions issued by the commission should be fully consistent with the name of the applicant;
  • 3, has been commissioned by the other side once again agency for registration, it shall provide the applicant and the authorized Chinese translation of the original documents, asked China to the civil authorities in notarized.
  • (8) product in the producing countries (or regions) production and sales for more than one year with the supporting documents, should meet the following requirements:
  • 1, the paper documents should contain the names of organizations issued, the applicant name, product names, product names and the date of issue papers;
  • 2, the document should be clearly marked with the product line with the national (or regional) legal and related standards and permit in the country (or region) production and sales, such as restricted in the country (or region) production, but not in the country ( or region) sales, applications for registration of such products inadmissible;
  • 3, the document certifying agencies should be producing competent government departments or industry associations.
  • (9) product in the producing countries (or regions) listed the use of the packaging, labelling, brochures should be arranged in real-labels, brochures Yanggao under.
  • And health food change specific requirements for disclosure of information
    (A) The applicant should be a health food approval certificate holders.
    (B) Application for approval of changes in health food and certificates describing the contents of the annex, the applicant must submit a written application and write the change of the specific name change, the reasons and basis, indicating the date of application, the applicant stamping seal.
    (C) A copy of all information furnished in the applicant shall be stamping seal.
    (D) Required to submit test report, the test report by the State Food and Drug Administration identified the bodies produce.
    (E) Changes in health food imports in addition to the above request for information, they need attention to the following matters:
  • 1, commissioned by the applicant in the agency for change matters, to provide instructions (original power of attorney should comply with the new requirements for disclosure of information products in the instructions required);
  • 2, the reasons and basis for change should include the production of country (or region) issued by the regulatory body to allow the changes of the supporting documents, the documents shall be submitted to the host country and notary notarized in China so that the host country (Link) confirmed Museum ;
  • 3, the production of countries (or regions) approved the label change, the instruction (it is like) and quality standards should be accompanied by Chinese translation, and notarized by the Chinese authorities in notarized;
  • 4, declare all information or copies of the applicant shall be decked in the agency’s seal.
  • 6, the transfer of technology applications for registration of products specific requirements for disclosure of information
  • (A) All information should be declared stamping the transferor and transferee to seal.
  • (B) The transferor and the transferee signed technology transfer contracts should contain the following elements:
  • 1, the transferor will transfer product formulations, production technology, quality and production standards and all relevant technical information transferred to the transferee credentials, and to provide guidance to the transferee to produce consecutive three batches of qualified products.
  • 2, the transferor should be a commitment to stop the production and marketing of the product.
  • (C) The transfer of technology contract should be clear, complete, or alter, should be notarized by the Chinese authorities in notarized.
  • (D) the provincial health food production supervision and management departments issued by the transferee health permits and comply with “good manufacturing practice health food” should be valid documents, describing the corporate name shall be consistent with the transferee’s name, declaration should include the scope permitted products.
  • (E) the transfer of technology products imported health food registration information needed to declare meet the following requirements:
  • 1, commissioned by the applicant for registration in the agency’s affairs, to provide instructions (original power of attorney to declare imported products should meet the information requirements of the instructions required).
  • 2, imported health food products overseas assignment, the contract required to withstand side of the country (region) and the notary notarized so that the host country China (Link) Museum confirmed. Norms should be translated into Chinese, and notarized by the Chinese authorities in notarized.
  • 7, the registration of health food products to specific requirements for disclosure of information
  • (1) sales within five years should include a summary of the product each year in China’s domestic sales, sales regions, such as food crowd.
  • (B) within five years of product feedback summary of the supervision and management departments should include a report on the results of spot checks on consumer complaints, such as China and a summary of the report.
  • (C) sales in China in the smallest sales packaging, labels and leaflets is like (no sales, may provide).
  • (4) health food imports for re-register, if the applicant in the agency commissioned for the re-registration, to provide instructions (original power of attorney should comply with the new requirements for disclosure of information products in the instructions required).
  • (5) The above information can not be provided, it shall apply in writing and state the grounds.
  • More declare knowledge, invited China to declare the registration network
Second, imports of the approval process for health foods
Health food imports to the declaration of the examination, collates information reporting, evaluation, approval, and several other steps.
Inspection: First of all health food imports to the Food Sanitation Supervision, Inspection and the Ministry of Health carried out by various testing, including health sciences, stability, security features evaluation, testing whether a product complies with health food hygiene requirements, the stability of ingredients, whether long-term use security, whether there is a health-care capabilities. Collating information reported: After the end of the test, in accordance with accreditation requirements, organize several review information submitted to the Office of the Ministry of Health approval.
Accreditation: the Ministry of the Commission on Accreditation of technical information to conduct a comprehensive audit.
Ratification: The Ministry of Health in accordance with the views of the Vetting Committee, to Health Minister signature, approved the issuance of administrative circular published list.
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