Health care products approval application process

Definition of health food declaration: also known as health food registration declaration, refers to the examination and approval process that the US Food and Drug Administration systematically evaluates and reviews the safety, effectiveness, quality controllability and label instructions of the health food applied for registration according to the applicant's application and legal procedures, conditions and requirements, and decides whether to approve its registration; Including the approval of product registration applications, change applications and technology transfer product registration applications. It was finally approved: Shi Guojianzi G20 140774.

Materials to be submitted for health food registration and declaration:

1, application form for registration of domestic health food.

2. A copy of the applicant's ID card, business license or legal registration certificate of other institutions.

3. Provide retrieval materials (retrieved from the database of the government website of the State Food and Drug Administration) that the common name of the health food applied for registration is inconsistent with the name of the drug that has been approved for registration.

4. The applicant guarantees that the patent obtained by others does not constitute infringement.

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

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

7 product formula (raw materials) and formula basis; Sources of raw materials and auxiliary materials and the basis for their use.

8. Effective ingredients/iconic ingredients, their contents and test methods.

9, production flow chart and its detailed description and related research data.

10, product quality standards and their compilation instructions (including raw and auxiliary materials quality standards).

1 1. Types, names, quality standards and selection basis of packaging materials in direct contact with products.

12, the test report issued by the inspection agency and its related materials.

Legal basis: People's Republic of China (PRC) Social Insurance Law.

Article 4 Employers and individuals who pay social insurance premiums according to law in People's Republic of China (PRC) have the right to inquire about payment records and personal rights and interests records, and ask social insurance agencies to provide social insurance consultation and other related services.

Individuals enjoy social insurance benefits according to law and have the right to supervise the payment of their own units.

Fifth people's governments at or above the county level shall incorporate social insurance into the national economic and social development plan.

The state raises social insurance funds through multiple channels. People's governments at or above the county level shall give necessary financial support to social insurance.

The state supports social insurance through preferential tax policies.