One, acceptance unit, address, time
Acceptance unit: State Food and Drug Administration Health Food Evaluation Center, Health Food Acceptance Division
Address: 5/F, No. 11 Building, Fahua South Lane, Chongwen District, Beijing
Postal Code: 100061
Second, the approval of health food work Procedures
Domestic health food, by the provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration is responsible for the domestic health food registration application information acceptance and formal review, the application for registration of health food testing and sample trial site verification, organization of the sample for testing.
Imported health food, the applicant will declare the information and samples sent to the State Food and Drug Administration.
Three, the general requirements for the declaration of information
(a) the declaration of information for the first page of the declaration of information items directory, directory of declared information items according to the "Application for Registration of Health Food" in the "attached information" order. Each item of information plus a cover page, the cover page indicates the name of the product, the name of the applicant, the upper right corner of the name of the information. The information should be used between the obvious signs of distinction, and indicate the name of the information or the information in the catalog of the serial number. The whole set of information with a perforated binder bound into a book.
(b) the declaration of information printed on a4-size paper (Chinese shall not be less than the Song font size 4, English shall not be less than 12 characters), the content should be complete, clear, and shall not be altered.
(c) In addition to the "Application for Registration of Health Food" and the inspection report issued by the inspection agency, the declaration of information should be stamped page by page with the applicant's seal or seal (multiple applicants jointly declared, should be stamped with all the applicant's seal), the seal should be stamped in the text. The seal should be stamped in accordance with the relevant provisions of the state seal, and has the force of law.
(d) more than one applicant joint declaration, should be submitted to the joint declaration of the person in charge of the recommendation.
(E) declaration of the same content (such as product name, applicant's name, applicant's address, etc.) should be filled out before and after the same.
(F) The product name should include brand name, common name and attribute name. Product name should meet the following requirements:
1. In line with relevant state laws, regulations, rules, standards and norms.
2. Reflect the authenticity of the product, concise and easy to understand, in line with Chinese language habits.
3. The brand name can be a registered trademark of the product or other names.
4. General name should be accurate, scientific, shall not use the express or implied therapeutic effect and exaggerated functional role of the text.
5. Attribute name should indicate the objective form of the product, its expression should be standardized and accurate.
6. Supplementary dosage form of the product, in the naming of the same brand name and generic name should be used, but need to indicate the different properties of the name.
7. Chinese names of imported products should correspond to the foreign name. Can be used in Italian translation, phonetic translation or meaning, phonetic translation, generally to the Italian translation is given priority to.
8. Health food naming shall not use the following:
(1) the consumer is not easy to understand the terminology and local dialects;
(2) false, exaggerated and absolutized words, such as "high efficiency", "the x-generation ";
(3) vulgar or feudal superstitious words;
(4) foreign letters, symbols, hanyu pinyin, etc. (except for registered trademarks);
(5) shall not be used in functionally related harmonic words;
(6) shall not be used in the names of people and places (except for registered trademarks).
(7) product formulations, production processes, quality standards, labels and instructions and relevant documents in foreign languages should be translated into standardized Chinese; foreign language references in the abstract, keywords and health care functions of the product and safety-related parts of the content should be translated into standardized Chinese (except for the names and addresses of foreigners).
(viii) The applicant shall submit supplementary information in accordance with the requirements and contents of the "Notice of Health Food Review Opinions" to provide item-by-item order, and attach the "Notice of Health Food Review Opinions" (original or copy). When submitting the supplementary information, the complete revised information of the item shall be provided together with the date of revision and stamped with the official seal consistent with that of the original applicant.
(IX) has been accepted by the product, the applicant proposed to change the content of the declaration of information on the specific requirements are as follows:
1. Product formulations, production processes, test reports, and other content that may relate to product safety and functionality shall not be changed.
2. In addition to the above, if there is a need to change, the applicant should be submitted to the original acceptance of the department to submit a written application for change, explaining the reasons for the change, indicating the date of submission, stamped with the original applicant's seal. The applicant shall provide complete information about the project after the change.
(J) has not been approved by the State Food and Drug Administration registration of the product, its declaration of information and samples are generally not returned, but has been submitted to the "power of attorney", the product in the production country (or region) production and sales for more than a year of documents, the production country (or region) of the relevant organizations issued by the manufacturer in line with the corresponding local production of quality management standards and documents and the "Certificate of Approval for Health Food
(k) new product registration application should be submitted to the original declaration of information 1, 8 copies; change and technology transfer product registration application should be submitted to the original 1, 6 copies. Copies should be identical to the original, should be copied from the original and keep complete and clear. Among them, the application form, quality standards, labeling instructions should also provide an electronic version, and the content should be consistent with the original.
Four, domestic health food declaration information items
(a) health food registration application form (domestic/imported)
(b) the applicant's ID card, business license or other legal registration documents of other organizations
Provide a copy should be clear, complete and stamped applicant's seal, the documents should be in effect.
(C) to provide the application for registration of the generic name of health food and has been approved for registration of the name of the drug does not overlap the search materials (from the State Food and Drug Administration government website database)
application for registration of the generic name of health food (except for the name of raw materials) and has been approved for registration of the name of the drug does not overlap the retrieval of the search report, from the applicant to search the database of the State Food and Drug Administration website on their own. Drug Administration website database after the search issued by the applicant. For example, if the search shows that "Yi-Liver Ling Tablets" is an approved and registered drug name, "×××× Brand Yi-Liver Ling Tablets (Oral Liquid or Capsules, etc.)" shall not be used as the name of the health food.
(D) the applicant of the patent obtained by others does not constitute infringement of the guarantee
by the applicant to make their own statement, and to make a commitment to the statement, "if there is any inaccuracy, the applicant is willing to bear the corresponding legal responsibility, and bear all the consequences arising therefrom".
(E) Provide documents proving trademark registration (not required for unregistered trademarks)
Documents proving trademark registration are copies of trademark registration certificates approved by the state trademark registration administration, which are not required for unregistered ones. The scope of use of the trademark shall include health food, and if the trademark registrant is not the same as the applicant, the document of change of the trademark registrant or the document proving that the applicant can legally use the trademark shall be provided.
(F) product research and development report (including research and development ideas, functional screening process, expected results, etc.)
Provide the information according to the "Declaration of Information Project Requirements", including research and development ideas, functional screening process, the expected results of the three aspects of the contents should be listed separately, the absence of one is indispensable.
(VII) product formulations (raw materials and auxiliary materials) and the basis for the formulation; sources of raw materials and auxiliary materials and the basis for the use of
(VIII) efficacy of the ingredients / iconic ingredients, content and efficacy of the ingredients / iconic ingredients of the test method
Provide the information in accordance with the "reporting requirements for the project", the efficacy of the ingredients / iconic ingredients, content and efficacy of the ingredients / iconic ingredients of the test method should be listed separately. test methods should be listed separately, not missing items.
(ix) production process diagrams, detailed descriptions and related research data
(x) product quality standards (enterprise standards) and drafting instructions and quality standards for raw and auxiliary materials.
(k) direct contact with the product packaging materials, types, names, quality standards and selection basis.
(xii) test report issued by the inspection agency
(xiii) product labels, sample instructions
1. Product instructions should be prepared in accordance with the following format and requirements:
×××× Product Instructions
This product is made of xxx, xxx as the main raw materials of health food, animal and/or human trial food function test proved that It has the health care function of xxx (Note: Nutrient supplements do not need to be labeled with the words "animal and/or human trial food function test proof", but only need to indicate that it "has the health care function of supplementing ××××").
[Main Ingredients] List the main ingredients and excipients in the order in which they are written in the formula.
[Efficacy or iconic ingredients and content] per 100g (100ml) contains: efficacy or iconic ingredient content. The content should be a determined value. Nutrient supplements should also be labeled with the nutrient content of the smallest edible unit.
[Health function] written in accordance with the name of the declared health function.
[Suitable for the crowd]
[Unsuitable for the crowd]
[Serving method and serving size] x x times a day, x x amount each time, if there are special requirements, it should be indicated.
[Specifications] Indicate the net content of the smallest serving unit. The net content shall be indicated according to the following units of measurement:
(1) Liquid health food products: by volume, in milliliters or ml.
(2) Solid and semi-solid health food products: by mass, in milligrams, grams, or mg, g.
(3) If there is an inner packaging of the preparation, such as capsule (softgel capsule), etc., the mass means the mass of the content.
[Shelf life] in months
[Storage method]
[Precautions] This product is not a substitute for medication. Precautions should also be added according to product characteristics.
The suitable population, unsuitable population and precautions for health food shall be determined according to the declared health function and the characteristics of the product. (Provide the information according to the "Supplementary Provisions on Declaration and Evaluation of Health Food (Trial Implementation)").
2. Product labels should be prepared in accordance with the following format and requirements:
The preparation of product labeling samples should be consistent with the relevant state regulations, involving the content of the manual should be consistent with the manual.
(xiv) other information to help the product review
1. Including the manufacturer's quality assurance system documents (gmp, haccp) proof, proof of supply of raw materials, raw material supply and marketing contracts, commissioning agreements, raw material inspection reports or factory certificates and other supporting documents, as well as product formulations, processes, functionality, safety and other related research, references and other information.
2. Provide foreign language information, should be translated into standardized Chinese.
(xv) unopened minimum sales package of 2 samples
Provided sample packaging should be intact, undamaged, should be labeled, labeling should be consistent with the declaration of information in the corresponding content. Sample packaging should be conducive to the preservation of samples, not easy to deteriorate, broken. Samples should be within the shelf life.
V. Imported health food declaration items
Apply for registration of imported health food, in addition to the use of raw materials and declared function in accordance with the domestic health food declaration information requirements to provide information, but also must provide the following information:
(a) the country (region) of the relevant agencies of the production of the manufacturer in line with the corresponding production of local quality management standard Documentation
1. Declaration of the product by the applicant entrusted to overseas production enterprises, the production of documents should be entrusted to the production of enterprises, while the need to provide the applicant entrusted to the production of the power of attorney;
2. Documents should be set out in the issuance of the name of the document agency, the product name, the name of the producer and the date of issuance of the document;
3. Issuance of the documents should be the production of the product should be the agency should be the product of the production of documents;
4. The organization issuing the document shall be the competent authority of the country in which the product is produced or the industry association.
(2) If the registration affairs are handled by the permanent representative office of the overseas manufacturer in China, a copy of the Certificate of Registration of the Permanent Representative Office of Foreign Enterprises in China shall be provided.
If the overseas manufacturer entrusts the agency in China to be responsible for the registration matters, the original notarized power of attorney and a copy of the business license of the entrusted agency shall be provided.
The power of attorney entrusted with the registration shall meet the following requirements:
1. The power of attorney shall contain the name of the unit to which the power of attorney is issued, the name of the unit entrusted with the name of the product entrusted with the application for registration, entrusted matters and the date of issuance of the power of attorney;
2. The commissioning party to the power of attorney issued by the applicant's name should be identical;
3. The party to which the power of attorney is entrusted again When the delegated party entrusts another agent to handle the registration affairs, it shall provide the original of the applicant's approved documents and the Chinese translation, which shall be notarized by a notary public in China.
(C) the product in the production country (region) production and sales for more than one year of documents, the documents should be notarized by the production country (region) of the notary public and the Chinese Embassy or Consulate in the host country to confirm
Products in the production country (or region) production and sales for more than a year of the documents, should meet the following requirements:
1. The documents should contain the document issuing organization's name, the applicant's name, the production enterprise The name of the organization, the name of the applicant, the name of the manufacturer, the name of the product and the date of issuance of the document;
2. The document should clearly indicate that the product in line with the country (or region), the law and relevant standards, allowing the production and sale in the country (or region), such as only permitted to be produced in the country (or region), not in the country (or region), the sales, the application for registration of such products are not admissible.
3. Issuance of supporting documents should be the production of government authorities or industry associations.
(D) the production country (region) or international organizations and product-related standards
(E) products in the production country (region) listed on the use of packaging, labeling, instructions for the actual sample. Should be listed under the labeling, specification samples.
The above information must be declared in Chinese and the original language, foreign language information can be attached as a reference. The Chinese translation should be notarized by a notary public in the territory to ensure consistency with the original text; the product quality standards (Chinese text) applied for registration must be in line with the format of China's health food quality standards.
The following matters should also be noted:
1. The name of the product, the name of the applicant, the name of the manufacturer, the name of the agency (in Chinese and English) should be consistent.
2. Proof of documents, power of attorney should be the original, should be used in the country of production (or region) of the official text, need to be notarized by the country (or region) notary public and China's embassy (consulate) in the host country to confirm.
3. Certificates, power of attorney contained in the validity period, should be used within the validity period.
4. Documents, power of attorney should be unit seal or legal representative (or his authorized) signature.
5. Supporting documents, power of attorney should be translated into Chinese and notarized by a notary public in China.
6, domestic health food change application requirements and instructions
1. Health food certificate of approval of health food contained in the functional name, raw materials (auxiliary), technology, consumption methods, expand the scope of the population, reduce the scope of the unsuitable population and other factors that may affect the safety, function of the content shall not be changed.
2. The applicant shall be the holder of the health food approval certificate.
3. Apply for a change in health food approval certificate and its annexes to the content of the applicant shall submit a written application for change and change the specific name of the matter, the reasons for and the basis for the date of application, stamped with the applicant's seal.
4. All copies of the declaration should be stamped with the applicant's seal.
5. Need to submit a test report, the test report should be determined by the State Food and Drug Administration issued by the agency.
VII. Domestic health food change application declaration items
(a) reduce the scope of the appropriate population, expand the scope of the unsuitable population, precautions for the change of the application
(b) change the amount of change in the application of the consumption (the product specifications remain unchanged)
(c) change the product specifications, shelf life, and change in the quality standards of the application
(d) increase the functionality of health food items shall be issued by the State Food and Drug Administration to determine the agency. (D) Change application for increasing the functional items of health food
(E) Change application for changing the name of the product
(F) Matters to be filed in case of change of the applicant's own name and/or address
1. Change filing form of domestically produced health food.
2. Change the name of the specific matters, reasons and basis.
3. A copy of the applicant's identity card, business license or other legal registration documents.
4. A copy of the health food approval documents and their attachments.
5. To amend the health food labeling, specification samples, with detailed instructions for revision.
5. Provide the local administration for industry and commerce issued by the applicant's name and / or address name change documents.
VIII, imported health food change application requirements and instructions
1. Health food certificate of approval contained in the functional name of the health food, raw materials (auxiliary), technology, consumption methods, expand the scope of suitable for the population, reduce the scope of inappropriate people, etc., which may affect the safety, function of the content shall not be changed.
2. The applicant shall be the holder of the health food approval certificate.
3. Apply for a change in health food approval certificate and its annexes to the content of the applicant shall submit a written application for change and change the specific name of the matter, the reasons for and the basis for the date of application, stamped with the applicant's seal.
4. All copies of the declaration should be stamped with the applicant's seal.
5. Need to submit a test report, the test report should be determined by the State Food and Drug Administration issued by the agency.
6. The applicant entrusted to the domestic agency for the change, the need to provide the original entrusted (the power of attorney should be consistent with the requirements of the new product declaration information requirements of the power of attorney).
7. Changes in the reasons and bases, should include the product production country (or region) management agency issued by the matters allowed to change the documents, the documents should be notarized by the country's notary public and the Chinese Embassy (Consulate) in the country to confirm.
8. Product production country (or region) approved changes in labeling, instructions (actual sample) and quality standards should be accompanied by a Chinese translation, and notarized by a notary public in China.
9. Declaration of all copies of the information should be stamped with the seal of the applicant or agent in the territory.
9. Imported health food change application declaration items
(1) reduce the scope of the appropriate population, expand the scope of the unsuitable population, the change of precautions
(2) change in the amount of change in the application of the consumption (product specifications remain unchanged)
(3) change in product specifications, shelf life, quality standards change application
(4) increase the functional items of health food
(5) increase the number of health food products, the number of applications, the number of applications, the number of applications and the amount of food products, the number of applications and the amount of food products. (D) increase the functional items of health food change application
(E) health food manufacturers within the country outside of the change in production site change application
(F) change the name of the product change application
(VII) the applicant's own name and/or address name changes in the record
(VIII) change in the domestic agency for the record
(2) The technology transfer contract signed by both the transferor and the transferee shall contain the following contents:
1. The transferor shall transfer the formula of the transferred product, the production process, the quality standard and all the technical information related to the production of the product to the transferee in its entirety, and shall instruct the transferee to produce three consecutive batches of qualified product.
2. The transferor shall undertake not to produce and sell the products again.
(3) The technology transfer contract shall be clear and complete, shall not be altered, and shall be notarized by a notary public in China.
(d) the provincial health food production supervision and management department issued by the transferee's health license and compliance with the "Good Manufacturing Practice in Health Food" documents should be valid, the name of the enterprise should be the same as the transferee's name, the scope of the license should include the declared products.
X. Domestic health food technology transfer product registration information items
(a) health food technology transfer product registration application form.
(B) ID card, business license or other legal registration documents of other institutions.
(C) notarized by a notary public notarized by the transferor and transferee both signed a valid transfer contract.
(d) provincial health food production supervision and management department issued by the transferee's health food health license copy.
(v) Documents proving that the transferee complies with the Good Manufacturing Practice for Health Food issued by the provincial health food production supervision and management department.
(vi) Original health food approval documents (including health food approval certificate and its annexes and health food change approval documents).
(vii) Samples of three consecutive lot numbers produced by the transferee, the quantity of which is three times of the quantity required for inspection.
Xi, imported health food to the territory of the transfer of declaration information requirements and instructions
(a) the applicant entrusted to the domestic agent for registration affairs, the original power of attorney (power of attorney should be in line with the imported products to declare the information requirements of the power of attorney).
(2) imported health food transferred outside the country, the contract is required to be notarized by the transferee's country (region) notary public and confirmed by the Chinese Embassy (Consulate) in the country. Should be translated into standardized Chinese and notarized by a notary public in China.
XII, imported health food to the territory of the transfer of product registration information items
(a) health food technology transfer product registration application form.
(B) ID card, business license or other legal registration documents of other institutions.
(C) notarized by a notary public notarized by the transferor and transferee both signed a valid transfer contract.
(d) provincial health food production supervision and management department issued by the transferee's health food health license copy.
(v) Documents proving that the transferee complies with the Good Manufacturing Practice for Health Food issued by the provincial health food production supervision and management department.
(vi) Original health food approval documents (including health food approval certificate and its annexes and health food change approval documents).
(vii) Samples of three consecutive lot numbers produced by the transferee, the quantity of which is three times the amount required for inspection.
(viii) If the registration affairs are handled by the permanent representative office of the foreign manufacturer in China, a copy of the Certificate of Registration of the Permanent Representative Office of Foreign Enterprises in China shall be provided.
If an agent in China is entrusted by a foreign manufacturer to handle registration matters, the original notarized power of attorney and a copy of the business license of the entrusted agent shall be provided.
Thirteen, imported health food products outside the transfer of product registration information
(a) health food technology transfer product registration application form.
(B) the transferee production country (region) allows the production and sale of the product documents, the documents should be produced by the country (region) of the notary public notarization and confirmation of the Chinese Embassy or Consulate in the country.
(C) the transferee's country (region) of the relevant organizations issued by the product manufacturer in line with the corresponding local production quality management standards.
(d) the transfer contract. The contract must be notarized by the transferee's country (region) notary public and the Chinese Embassy or Consulate in the location of confirmation.
(v) If the registration affairs are handled by the permanent representative office of the foreign manufacturer in China, a copy of the Certificate of Registration of the Permanent Representative Office of Foreign Enterprises in China shall be provided.
If the overseas manufacturer entrusts an agent in China to be responsible for registration matters, the original notarized power of attorney and a copy of the business license of the entrusted agent shall be provided.
(F) the original health food approval documents (including health food approval certificate and its annexes and health food change approval).
(vii) Inspection reports on the efficacy ingredients or signature ingredients, hygiene and stability tests of samples of three consecutive batches produced by the transferee issued by the determined inspection agency;
(viii) Samples of three consecutive batches produced by the transferee in a quantity of three times the amount required for the inspection.
Fourteen, reissued batches of product registration application filing information items
Request for reissue of health food approval certificate, the applicant shall submit a written application to the State Food and Drug Administration and explain the reasons. Application for reissuance due to loss, should be submitted to the national public circulation of the original statement of loss published in the newspaper; due to damage to apply for reissuance, should be returned to the original health food approval certificate. Upon examination, if it meets the requirements, the certificate of approval for health food shall be reissued, and the original approval number shall continue to be used, with the same validity period. Replacement of the health food approval certificate should be marked on the original approval date, and indicate "reissued".
Fifteen, health food re-registration requirements and instructions
Sixteen, domestic health food re-registration declaration items
(a) domestic health food re-registration application form.
(B) the applicant's identity card, business license or other legal documents to prove registration.
(3) health food approval documents (including health food approval certificate and its annexes and health food change approval).
(d) product production where the provincial health food production supervision and management departments to allow the production and sale of the product copies of documents.
(E) a summary of sales within five years.
(F) five years of consumer feedback on the product summary.
(VII) the minimum sales package of health food, labeling and instructions of the actual sample.
Note: If the above information cannot be provided in full, the applicant must state the reasons in writing when filing an application for re-registration