GMP certification refers to the GMP review experts organized by the Provincial Food and Drug Administration to evaluate enterprise personnel, training, factory facilities, production environment, health conditions, material management, production management, quality management, sales management, etc. A process in which all links involved in an enterprise are inspected and evaluated to see if they meet the regulatory requirements.

Blue hat products are health food labels approved by the State Food and Drug Administration! The special logo for health food in my country is sky blue and in the shape of a hat. It is commonly known in the industry as "blue hat" or "little blue hat".

About drug GMP certification: The "Drug GMP Certificate" is valid for 5 years. The "Drug GMP Certificate" of a newly established pharmaceutical manufacturing enterprise is valid for one year. Drug manufacturers should re-apply for drug GMP certification 6 months before the expiration date. Newly established pharmaceutical manufacturers must apply for reexamination 3 months before the expiration of the "Drug GMP Certificate". After passing the reexamination, a "Drug GMP Certificate" valid for 5 years will be issued.

GMP Certification Information

Drug GMP certification application document requirements 1 Overall situation of the enterprise 1.1 Enterprise information ◆ Enterprise name, registered address; ◆ Enterprise production address, postal code; ◆ Contact person, fax, contact number (including 24 hours of serious drug accidents or recalls) contact person, contact number). 1.2 The company’s pharmaceutical production situation ◆ Briefly describe the company’s production activities approved by the (food) drug supervision and administration department, including import and subpackaging, export, and drug information approved by foreign countries; ◆ Business license, drug production license, and export-related requirements Attach copies of relevant certification documents issued by overseas institutions; ◆All varieties that have obtained approval numbers (can be filled in according to factory locations with different addresses, and indicate whether they are produced year-round, and the output list in the past three years is as an attachment); ◆Production Whether the address has operations for handling highly toxic, sex hormone drugs and other highly active and highly allergenic materials, if so, should be listed and marked in the attachment. 1.3 Scope of this application for drug GMP certification ◆ List the production lines applying for drug GMP certification this time, production dosage forms and varieties, and attach copies of relevant product registration approval documents; ◆ The latest (food) drug regulatory department’s review of the production line inspection status (including inspection date, inspection results, defects and rectification status, and attached with the relevant drug GMP certificate). If the production line has undergone overseas pharmaceutical GMP inspection, the inspection status must also be provided. 1.4 Major changes since the last pharmaceutical GMP certification ◆ Briefly describe the changes in key personnel, equipment, facilities, and varieties since the last certification inspection. 2 The enterprise's quality management system 2.1 Description of the enterprise's quality management system ◆Relevant management responsibilities of the quality management system, including the responsibilities of senior managers, quality management leaders, quality authorized persons and quality assurance departments; ◆Brief description of the elements of the quality management system , such as organizational structure, main procedures, processes, etc. 2.2 Finished product release procedure ◆Overall description of the release procedure and basic information (qualifications, etc.) of the personnel responsible for release. 2.3 Supplier management, entrusted production, and entrusted inspection situations ◆ Outline the requirements for supplier management, and the quality risk management methods used in evaluation and assessment; ◆ Briefly describe the situation of entrusted production; (if any) ◆ Briefly describe the entrustment Inspection situation. (If any) 2.4 The enterprise’s quality risk management measures ◆ Briefly describe the enterprise’s quality risk management policy; ◆ The scope and focus of quality risk management activities, as well as the risk identification, evaluation, control, communication and review under the quality risk management system process. 2.5 Annual product quality review and analysis ◆The situation of the company’s annual product quality review and analysis and the focus of the inspection. 3 Personnel 3.1 Organization chart including quality assurance, production and quality control (including senior managers), as well as the respective organization charts of quality assurance, production and quality control departments; 3.2 Key personnel of the enterprise and those engaged in quality assurance, production and quality control Qualifications of main technical personnel; 3.3 Number of employees in various departments such as quality assurance, production, quality control, storage and shipping. 4 Factory Buildings, Facilities and Equipment 4.1 Factory Building ◆ Briefly describe the building’s construction and use time, type (including structure and materials of internal and external surfaces, etc.), and the area of ??the site; ◆ General floor plan of the factory area, floor plan and flow direction of the production area Figure, indicate proportions.

The cleanliness level of the room, the pressure difference between adjacent rooms, and the production activities carried out in the room should be marked; ◆ Briefly describe the layout of all production lines in the scope of application for certification; ◆ Briefly describe the warehouse, storage area and special storage conditions. 4.1.1 Brief description of the air conditioning purification system ◆The working principle, design standards and operation conditions of the air conditioning purification system, such as air inlet, temperature, humidity, pressure difference, number of air changes, return air utilization, etc. 4.1.2 Brief description of the water system ◆The working principle, design standards, operation conditions and schematic diagram of the water system. 4.1.3 Brief description of other public facilities ◆The working principles, design standards and operation conditions of other public facilities such as compressed air, nitrogen, etc. 4.2 Equipment 4.2.1 List the main instruments and equipment used for production and inspection. 4.2.2 Cleaning and Disinfection ◆ Briefly describe the methods and verification of cleaning, disinfection and use of surfaces of equipment in direct contact with drugs. 4.2.3 Key computerized systems related to drug production quality ◆ Briefly describe the design, use and verification of key computerized systems related to drug production quality. 5 Documents ◆Describe the enterprise’s document system; ◆Briefly describe the drafting, revision, approval, issuance, control and archiving system of documents. 6 Production 6.1 Products produced ◆ Overview of the products produced (brief description); ◆ Process flow chart of the dosage forms and varieties applied for certification this time, and indicate the main quality control points and projects. 6.2 Process Verification ◆ Briefly describe the principles and overall situation of process verification; ◆ Briefly describe the principles of rework and reprocessing. 6.3 Material management and warehousing ◆Handling of raw and auxiliary materials, packaging materials, semi-finished products and finished products, such as sampling, inspection, release and storage; ◆Handling of unqualified materials and products. 7 Quality Control ◆Describe all activities carried out by the enterprise's quality control laboratory, including inspection standards, methods, verification, etc. 8 Shipping, Complaints and Recalls 8.1 Shipping ◆ Briefly describe the controls required for the product during transportation, such as temperature/humidity control; ◆ Methods to ensure product traceability. 8.2 Complaints and Recalls ◆ Briefly describe the procedures for handling complaints and recalls. 9 Self-inspection ◆ Briefly describe the self-inspection system, focusing on the area selection criteria in the planned inspection, the implementation and rectification of self-inspection.

Edit this section of the drug GMP certification process

1. The applicant company shall submit the certification application and application materials to the provincial bureau’s acceptance hall 2. The provincial bureau’s Drug Safety Supervision Office will review the form of the application materials ( 5 working days) 3. The certification center conducts a technical review of the application materials (10 working days) 4. The certification center formulates an on-site inspection plan (10 working days) 5. Provincial bureau approval plan (10 working days) 6. Certification The center organizes and implements on-site certification inspections (10 working days); 7. The certification center conducts a preliminary review of the on-site inspection report (10 working days); 8. The provincial bureau approves the preliminary review opinions of the certification (10 working days); 9. Reports to the national bureau for release Review Announcement (10 working days)

Application for Health Food Blue Hat Mark

Health Food Registration Application Guide 1. Acceptance Unit, Address, Time Acceptance Unit: State Food and Drug Administration Address of the Health Food Acceptance Office of the Health Food Review Center: 5th Floor, Building 11, Fahua Nanli, Chongwen District, Beijing Postal Code: 100061 2. Health Food Approval Procedures Domestic health foods are controlled by the (food) drug regulatory authorities of the provinces, autonomous regions, and municipalities directly under the Central Government. Responsible for the acceptance and formal review of domestic health food registration application materials, verification of on-site testing and sample trial production of health food applications for registration, and organizing the inspection of samples. For imported health food, the applicant shall submit application materials and samples to the State Food and Drug Administration. 3. General requirements for application materials (1) The first page of the application materials is a directory of application materials, and the items in the directory are arranged in the order of the information attached in the "Health Food Registration Application Form". Each item of information must be attached to a cover page, with the product name and applicant's name indicated on the cover page, and the name of the item of information indicated in the upper right corner. Obvious distinguishing marks should be used between each item of information, and the name of each item of information or the serial number in the directory where the item of information is located should be indicated. The entire set of information is bound into a volume with punched clips. (2) The application materials should be printed on A4 size paper (Chinese characters should not be smaller than Song Dynasty size 4, and English characters should not be smaller than size 12). The content should be complete and clear, and no alteration should be allowed.

(3) In addition to the "Health Food Registration Application Form" and the inspection report issued by the inspection agency, the application materials should be stamped page by page with the applicant's seal or seal (if multiple applicants apply jointly, the seals of all applicants should be stamped) , the seal should be affixed to the text. The affixed seal should comply with the relevant national seal regulations and be legally binding. (4) If multiple applicants apply jointly, they should submit a recommendation letter from the person in charge of the joint application. (5) The same content (such as product name, applicant name, applicant address, etc.) in the application materials should be filled in consistently. (6) The product name should include brand name, common name and attribute name. The product name should meet the following requirements: 1. Comply with relevant national laws, regulations, rules, standards and specifications. 2. Reflect the authenticity of the product, be concise and easy to understand, and conform to Chinese language habits. 3. The brand name can be the registered trademark or other name of the product. 4. The common name should be accurate and scientific, and words that express or imply therapeutic effects or exaggerate functional effects are not allowed. 5. The attribute name should indicate the objective form of the product, and its expression should be standardized and accurate. 6. Products in supplement form should use the same brand name and generic name when naming, but different attribute names must be indicated. 7. The Chinese name of imported products should correspond to the foreign name. Free translation, transliteration, or a combination of free translation and transliteration can be used, and free translation is generally used. 8. The following contents shall not be used when naming health food: (1) Professional terms and local dialects that are difficult for consumers to understand; (2) False, exaggerated and absolute words, such as high efficiency, third generation; (3) Vulgar or offensive Words with feudal superstitions; (4) Foreign letters, symbols, Chinese pinyin, etc. (except registered trademarks); (5) Homophones (characters) related to functions are not allowed; (6) People's names and place names are not allowed (except registered trademarks) ). (7) Foreign languages ??in product formulas, production processes, quality standards, labels, instructions and relevant certification documents should be translated into standardized Chinese; abstracts, keywords and parts related to product health functions and safety in foreign references should be translated into standard Chinese. The content should be translated into standard Chinese (except foreigners’ names and addresses). (8) The applicant should submit supplementary information in accordance with the requirements and content of the "Notice of Review Opinions on Health Food", item by item, and attach the "Notice of Review Opinions on Health Food" (original or copy). When submitting supplementary information, the revised and complete information for the project should be provided, the date of modification should be noted, and the official seal consistent with the original applicant should be stamped. (9) For accepted products, the applicant’s specific requirements for changing the relevant content of the application materials are as follows: 1. Product formula, production process, test report and other content that may involve product safety and function must not be changed. 2. In addition to the above, if changes are required, the applicant should submit a written change application to the original acceptance department, explain the reason for the change, indicate the date of submission, and stamp it with the same seal as the original applicant. Applicants should provide complete information about the project after the change. (10) For products that have not been approved for registration by the State Food and Drug Administration, the application materials and samples will generally not be returned, but the submitted "Letter of Power" and proof that the product has been produced and sold in the country (or region) of production for more than one year Documents, certification documents issued by the relevant agencies of the producing country (or region) that the production enterprise complies with the corresponding local production quality management regulations and the original "Health Food Approval Certificate" (except for re-registered products). If it needs to be returned, the applicant should Submit a written application for refund within 3 months of disapproval. (11) An application for new product registration should submit one original copy and 8 copies of the application materials; an application for registration of change and technology transfer products should submit one original copy and 6 copies. The copy should be completely consistent with the original and should be copied from the original and remain complete and clear. Among them, the application form, quality standards, and label instructions should also be provided in electronic versions, and the content should be consistent with the originals. 4. Items of application materials for domestic health food (1) Health food registration application form (domestic/imported) (2) Copies of the applicant’s ID card, business license or other legal registration certification documents of the institution. The copies provided should be clear and complete. The applicant's seal must be stamped, and the certification documents must be within the validity period. (3) Provide search materials showing that the common name of the health food applied for registration does not overlap with the name of the drug that has been approved for registration (retrieval from the State Food and Drug Administration government website database). The common name of the health food applied for registration (in the name of the raw material) The search report that does not have the same name as the drug name that has been approved for registration shall be issued by the applicant after searching from the website database of the State Food and Drug Administration.

For example: after searching, Yiganling Tablets is an approved registered drug name, and the brand Yiganling Tablets (oral liquid or capsules, etc.) cannot be used as a health food name. (4) The applicant shall make a statement on his own that the patents obtained by others do not constitute infringement and shall make a commitment to the statement. If there is any untruth, the applicant is willing to bear the corresponding legal responsibility and bear the consequences. all consequences of this. (5) Provide trademark registration certification documents (not required for unregistered trademarks). Trademark registration certification documents refer to a copy of the trademark registration certificate approved by the national trademark registration management department. If there is no registered trademark, there is no need to provide it. The scope of trademark use should include health food. If the trademark registrant is inconsistent with the applicant, documents proving that the trademark registrant has changed or the applicant can legally use the trademark should be provided. (6) Product R&D report (including R&D ideas, function screening process, expected effects, etc.) This information should be provided in accordance with the "Project Requirements for Application Materials", including R&D ideas, function screening process, and expected effects. Each content should be separately List, none of them can be missing. (7) Product formula (raw materials and excipients) and formula basis; sources and use basis of raw materials and excipients (8) Functional ingredients/iconic ingredients, content and testing methods of functional ingredients/iconic ingredients shall be in accordance with the "Declaration Document Item Requirements" 》To provide this information, the three aspects of functional ingredients/iconic ingredients, content and testing methods of functional ingredients/iconic ingredients should be listed separately and are indispensable. (9) Production process diagram, detailed description and relevant research materials; (10) Product quality standards (enterprise standards) and drafting instructions as well as quality standards for raw and auxiliary materials. (11) Types, names, quality standards and selection basis of packaging materials that are in direct contact with products. (12) Test report issued by the inspection agency (13) Product label and instruction manual sample 1. Product instructions should be prepared in the following format and requirements: Product instructions: This product is a health food made from, as the main raw material, tested by animals and / Or human food test function test proves that it has health care functions (Note: Nutrient supplements do not need to be labeled with animal and/or human food test function test certification, it only needs to indicate that it has supplementary health functions). [Main raw materials] List the main raw materials and auxiliary materials in the order in which the formula is written. [Effective ingredients or iconic ingredients and content] Each 100g (100ml) contains: Content of functional ingredients or iconic ingredients. The content should be a certain value. Nutrient supplements should also be labeled with the nutrient content of the smallest serving unit. [Health Function] Write according to the name of the declared health function. [Suitable crowd] [Unsuitable crowd] [Consumption method and consumption amount] Times per day, amount per time, if there are special requirements, please indicate. [Specification] Indicate the net content of the smallest edible unit. Indicate the net content according to the following measurement units: (1) Liquid health food: use volume, the unit is milliliter or ml. (2) Solid and semi-solid health food: Use mass in milligrams, grams or mg, g. (3) If there are preparations with inner packaging, such as capsules (soft capsules), etc., the quality refers to the quality of the contents. [Shelf life] Measured in months [Storage method] [Notes] This product cannot replace drugs. Precautions should also be added based on product characteristics. The suitable groups, unsuitable groups, and precautions for health foods should be determined based on the declared health functions and product characteristics. (This information is provided in accordance with the "Supplementary Regulations on Health Food Application and Review (Trial)"). 2. Product labels should be written according to the following formats and requirements: Product label samples should be written in compliance with relevant national regulations, and the content of the instructions should be consistent with the instructions. (14) Other information that is helpful for product review 1. Including certification documents such as production enterprise quality assurance system documents (GMP, HACCP), raw material supply certificates, raw material supply and sales contracts, entrustment agreements, raw material inspection reports or factory qualification certificates, etc., and Research and reference materials related to product formula, technology, function, safety, etc. 2. The foreign language materials provided should be translated into standard Chinese. (15) 2 unopened samples in the minimum sales package. The sample packages provided should be complete and undamaged, and should be labeled. The labels should be consistent with the corresponding content in the application materials. The sample packaging should be conducive to the preservation of the sample and not easy to deteriorate or break. Samples should be within the shelf life.

5. Imported health food declaration materials items When applying for imported health food registration, in addition to providing information according to the requirements for domestic health food declaration materials based on the use of raw materials and declared functions, the following information must also be provided: (1) Relevant information about the producing country (region) Certification documents issued by the agency that the production enterprise complies with the corresponding local production quality management standards 1. If the applicant entrusts the overseas production enterprise to produce the declared product, the production enterprise in the certification document should be the entrusted production enterprise, and the applicant must provide the entrusted production The power of attorney; 2. The certification document should state the name of the issuing agency, the product name, the name of the manufacturing enterprise and the date of issuing the document; 3. The agency that issues the certification document should be the competent authority or industry association of the country where the product is produced. (2) If the registration affairs are handled by the permanent representative office of an overseas manufacturer in China, a copy of the "Registration Certificate of the Foreign Enterprise's Permanent Representative Office in China" shall be provided. If an overseas manufacturer entrusts a domestic agency to handle registration matters, it must provide the original notarized power of attorney and a copy of the entrusted agency's business license. The power of attorney for entrusting registration affairs shall meet the following requirements: 1. The power of attorney shall state the name of the unit issuing the power of attorney, the name of the unit entrusted, the name of the product entrusted to apply for registration, the matters entrusted and the date of issuance of the power of attorney; 2. The person who issued the power of attorney shall The name of the entrusting party should be exactly the same as that of the applicant; 3. When the entrusted party entrusts another agency to handle registration affairs again, it should provide the original and Chinese translation of the applicant's approval document. The translation must be notarized by a notary authority in China. (3) Documents proving that the product has been produced and sold in the country (region) of production for more than one year. This certification document should be notarized by the notary authority of the country (region) of production and confirmed by the Chinese embassy or consulate in the country of production that the product is in the country (or region) of production. Certification documents for production and sales for more than one year should meet the following requirements: 1. The certification document should state the name of the document-issuing agency, the name of the applicant, the name of the production enterprise, the product name and the date of issuance of the document; 2. The certification document should clearly indicate The product complies with the laws and relevant standards of the country (or region) and is allowed to be produced and sold in the country (or region). If it is only allowed to be produced in the country (or region) and not sold in the country (region), such products Registration applications will not be accepted. 3. The organization that issues certification documents should be the competent government department or industry association of the producing country. (4) Relevant product-related standards of the producing country (region) or international organization (5) Samples of packaging, labels, and instructions used by the product when it is marketed in the producing country (region). Should be listed under labels and sample instructions. The above application materials must be in Chinese and attached with the original text. Information in foreign languages ??can be attached as a reference. The Chinese translation should be notarized by a domestic notary office to ensure that it is consistent with the content of the original text; the product quality standards (Chinese version) applied for registration must comply with the format of the Chinese health food quality standards. The following matters should also be noted: 1. The product name, applicant name, production company name, and agency name (in Chinese and English) should be consistent. 2. The certification documents and power of attorney should be original, use the official language of the country (or region) of production, and must be notarized by the notary authority of the country (or region) and confirmed by the Chinese embassy (consulate) in the country where it is located. 3. If the validity period is stated in the supporting documents or power of attorney, it shall be used within the validity period. 4. The supporting documents and power of attorney should have the seal of the unit or the signature of the legal representative (or his authorized person). 5. The supporting documents and power of attorney should be translated into Chinese and notarized by a notary office in China. 6. Domestic health food change application application materials requirements and instructions 1. The health food functional name, raw (auxiliary) materials, technology, consumption methods, expansion of the range of suitable people, narrowing of the range of unsuitable people, etc. stated in the health food approval certificate Content that affects safety and functionality must not be changed. 2. The applicant should be a health food approval certificate holder. 3. When applying to change the content stated in the health food approval certificate and its attachments, the applicant shall submit a written change application and indicate the specific name, reason and basis of the change, indicate the date of application, and affix the applicant's seal. 4. All copies of the application materials should be stamped with the applicant’s seal. 5. If a test report needs to be submitted, the test report should be issued by an institution determined by the State Food and Drug Administration.

7. Domestic health food change application application materials items (1) Change application to narrow the scope of suitable groups and expand the scope of unsuitable groups, precautions (2) Change application to change the consumption (product specifications remain unchanged) (3) Change of product specifications , shelf life and quality standards change application (4) Change application to add functional items of health food (5) Change application to change product name (6) Filing matters for changes in the applicant’s own name and/or address 1. Domestic health food change filing surface. 2. Change the name, reason and basis of specific matters. 3. A copy of the applicant’s ID card, business license or other legal registration documents of the institution. 4. A copy of the health food approval document and its attachments. 5. Sample draft of health food labels and instructions to be revised, with detailed revision instructions. 5. Provide documents proving the change of the applicant’s name and/or address issued by the local industrial and commercial administration department. 8. Requirements and instructions for application materials for change application of imported health food 1. Functional name, raw (auxiliary) materials, process, consumption method, expansion of the scope of suitable people, narrowing of the scope of unsuitable people, etc. stated in the health food approval certificate Content that may affect safety and functionality must not be changed. 2. The applicant should be a health food approval certificate holder. 3. When applying to change the content stated in the health food approval certificate and its attachments, the applicant shall submit a written change application and indicate the specific name, reason and basis of the change, indicate the date of application, and affix the applicant's seal. 4. All copies of the application materials should be stamped with the applicant’s seal. 5. If a test report needs to be submitted, the test report should be issued by an institution determined by the State Food and Drug Administration. 6. If the applicant entrusts a domestic agency to handle changes, the original entrustment must be provided (the power of attorney should comply with the requirements for a power of attorney in the new product application materials requirements). 7. The reason and basis for the change should include the certification document issued by the management agency of the country (or region) where the product is produced allowing the change. This certification document should be notarized by the notary authority of the country where the product is located and confirmed by the Chinese Embassy (Consulate) in the country where the product is produced. . 8. Labels, instructions (actual samples) and quality standards approved for change by the country (or region) of product production should be accompanied by a Chinese translation and notarized by a notary authority in China. 9. All copies of the application materials should be stamped with the seal of the applicant or domestic agency. 9. Items of application materials for change application of imported health food (1) Change application to narrow the scope of suitable groups and expand the scope of unsuitable groups and precautions (2) Change application to change the consumption (product specifications remain unchanged) (3) Change of product specifications , Application for change in shelf life and quality standards (4) Application for change to add functional items of health food (5) Application for change within a health food production enterprise to change the production site outside my country (6) Application for change to change the name of the product (7) Applicant Filing Matters for Change of Own Name and/or Address Name (8) Filing Matters for Change of Domestic Agency 9. Application Document Requirements and Instructions for Domestic Health Food Domestic Technology Transfer Product Registration Application (1) All application materials should be stamped with the name of the transferor and Seal of the transferee. (2) The technology transfer contract signed by the transferor and the transferee shall contain the following contents: 1. The transferor shall fully transfer to the transferee the formula, production process, quality standards and all technical data related to the production of the transferred product. and guide the transferee to produce three consecutive batches of qualified products. 2. The transferor shall promise not to produce and sell the product again. (3) The technology transfer contract should be clear, complete, and must not be altered, and should be notarized by a notary office in China. (4) The transferee's health license and certification document complying with the "Health Food Good Manufacturing Practice" issued by the provincial health food production supervision and management department should be within the validity period, and the company name stated should be consistent with the name of the transferee. The scope of the license should include the declared products. 10. Domestic health food technology transfer product registration application materials items (1) Health food technology transfer product registration application form. (2) Copy of ID card, business license or other legal registration documents of the institution. (3) A valid transfer contract signed by both the transferor and the transferee and notarized by a notary authority. (4) A copy of the transferee’s health food hygiene license issued by the provincial health food production supervision and management department. (5) Certification document issued by the provincial health food production supervision and administration department proving that the transferee complies with the Good Manufacturing Practice for Health Food.

(6) Original health food approval documents (including health food approval certificate and its attachments and health food change approval documents). (7) The quantity of samples produced by the transferee for three consecutive batches is three times the quantity required for inspection. 11. Requirements and instructions for declaration documents for the transfer of imported health foods into the country (1) If the applicant entrusts a domestic agency to handle registration matters, the original letter of authorization must be provided (the letter of authorization should comply with the requirements for the letter of authorization in the requirements for declaration documents for imported products) . (2) If imported health food is transferred overseas, the contract must be notarized by the notary authority in the country (region) where the transferee is located and confirmed by the Chinese Embassy (Consulate) in the country where the transferee is located. It should be translated into standard Chinese and notarized by a notary office in China. 12. Items of product registration application materials for imported health food products transferred into the country (1) Health food technology transfer product registration application form. (2) Copy of ID card, business license or other legal registration documents of the institution. (3) A valid transfer contract signed by both the transferor and the transferee and notarized by a notary authority. (4) A copy of the transferee’s health food hygiene license issued by the provincial health food production supervision and management department. (5) Certification document issued by the provincial health food production supervision and administration department proving that the transferee complies with the Good Manufacturing Practice for Health Food. (6) Original health food approval documents (including health food approval certificate and its attachments and health food change approval documents). (7) The quantity of samples produced by the transferee for three consecutive batches is three times the quantity required for inspection. (8) If the registration affairs are handled by the permanent representative office of an overseas manufacturer in China, a copy of the "Registration Certificate of the Foreign Enterprise's Permanent Representative Office in China" shall be provided. If an overseas manufacturer entrusts a domestic agency to handle registration matters, it must provide the original notarized power of attorney and a copy of the entrusted agency's business license. wait!