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Applications for registration of health food products imported file


Applications for registration of health food products imported file:

First, the imported health food registration application form;
Second, the applicants ID card, business license or other proof of legal registration agency copy;
Third, to provide for registration of health food generic name registered with the name of the drug has been approved by the same name does not retrieve materials from the State Food and Drug Administration Government website database search;
Fourth, the applicant has obtained the patent to others does not constitute an infringement of guarantee;
Fifth, to provide trademark registration documentation is not available without the registered trademark;
6, the product R & D reports, including research and development ideas, feature selection process, expected results, etc.;
Seven, product formulations and recipes based on raw materials and auxiliary materials; source of raw materials and auxiliary materials and use basis;
Eight functional components / landmark composition, content and functional components / symbolic composition of the inspection methods;
Nine, sketch and detailed description of the production process and related research materials;
Ten, product quality standards and the preparation of instructions, including raw materials, excipients;
XI, direct contact with the product packaging material type, name, and selected on the basis of quality standards;
XII inspection agency issued the test report and related information, including:
1, the test application form;
2, notice of acceptance testing unit testing;
3, safety toxicology test report;
4, functional learning test report;
5, stimulants, illicit drugs test report declared alleviate physical fatigue, lose weight, improve the function of growth and development of applications for registration;
6, the effectiveness of component testing report;
7, stability test report;
8, Hygiene test report;
9, other inspection reports, such as: material identification reports, test reports and other virulent strains;
XIII, product labels, brochures comp;
Fourth, the other helps the product review information;
Fifth, the minimum selling two unopened packages of samples;
XVI-producing countries of the region issued by the relevant agencies in accordance with local production companies manufacturing practices relevant supporting documents;
XVII permanent representative of China by the foreign company registration services agencies, should provide a "Chinese resident representative offices of foreign business registration certificate," a copy; foreign manufacturers commissioned the agency responsible for domestic matters of registration, must provide notarized The original power of attorney and the agency entrusted business license;
Eighth, product production and sales in the producer regions more than one year certificate, the certificate should be approved by the producing country (region of the notary public and consulates in China confirmed the country;
Ninth, producing regional or international organization concerned with product-related standards;
XX products listed in the producer regions used in packaging, labeling, instructions is kind;
Twenty-first, three consecutive batches of samples, their number three times the amount required for the test;


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