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What conditions do companies need to apply for health care products?

The "Health Food Management Measures" issued by the Ministry of Health in 1996 defined health food as: food with specific health functions, that is, suitable for consumption by specific groups of people, regulating body functions, and not used to treat diseases. food for the purpose. In 2005, when my country implemented the "Health Food Registration Management Measures (Implementation)", health food was defined as: food that claims to have specific health functions or for the purpose of supplementing vitamins and minerals. That is, food that is suitable for consumption by specific groups of people, has the ability to regulate body functions, is not intended to treat diseases, and does not cause any acute, subacute or chronic harm to the human body.

Domestic health food product registration application application materials items: (1) Health food registration application form.

(2) Copies of the applicant’s ID card, business license or other legal registration documents of the institution.

(3) Provide search materials (searched from the State Food and Drug Administration government website database) 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.

(4) The applicant’s guarantee that the patent obtained by others does not constitute infringement.

(5) Provide trademark registration certification documents (not required for unregistered trademarks).

(6) Product research and development report (including research and development ideas, function screening process, expected effects, etc.).

(7) Product formula (raw materials and auxiliary materials) and formula basis; source and use basis of raw materials and auxiliary materials.

(8) Functional ingredients/iconic ingredients, content and testing methods of functional ingredients/iconic ingredients.

(9) Schematic diagram of the production process and its detailed description and related research materials.

(10) Product quality standards and their preparation instructions (including quality standards for raw materials and excipients).

(11) Types, names, quality standards and selection basis of packaging materials that are in direct contact with products.

(12) Test report and related information issued by the inspection agency, including:

1. Test application form;

2. Inspection by the inspection unit Acceptance notice;

3. Safety toxicology test report;

4. Functional test report;

5. Testing of stimulants, banned drugs, etc. Report (registration application for relieving physical fatigue, losing weight, and improving growth and development functions);

6. Functional ingredient test report;

7. Stability test report;

8. Hygiene test report;

9. Other inspection reports (such as raw material identification report, strain virulence test report, etc.).

(13) Samples of product labels and instructions.

(14) Other information helpful for product review.

(15) Two unopened samples in the smallest sales package.