How to register health food in pharmacies?

1. The filer should enter the State Food and Drug Administration’s health food registration information system and apply for a login account in accordance with the requirements of the "Health Food Registration Information System Filer User Manual";

2. When applying for a login account, the following information should be filled in: name and address of the filing person, production license number and validity period, business license information, legal representative information, contact information;

3. Transfer the business license, Food production license certification documents, trademark certificates, legal representative ID cards or passports, and power of attorney documents must be clearly scanned into color electronic versions and uploaded to the health food registration management information system.

Measures for the registration management of medical devices and health products?

The state’s supervision of medical devices and health care products is very strict. Medical devices and health products must be registered with the Provincial Market Supervision and Administration Bureau.

Also, from September 1, 2020, Zhejiang Province will no longer handle the registration of advertisements for drugs, medical devices, and health food from other places before they are released in Zhejiang Province.

Does the commissioned production of health food still need to be registered?

Article 76 of the "Food Safety Law": Health foods using raw materials other than those listed in the health food raw material catalog and health foods imported for the first time must be registered with the Food and Drug Administration Department of the State Council. However, if the health food imported for the first time contains nutritional supplements such as vitamins and minerals, it must be reported to the Food and Drug Administration of the State Council for filing. Other health foods should be reported to the food and drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government for filing.

Imported health foods should be products approved for sale by the competent authorities of the exporting country (region).

What is the registration certificate for health products?

To apply for health food registration, the following materials should be submitted:

(1) Health food registration form, and a legal responsibility commitment letter from the filer responsible for the authenticity of the submitted materials;

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(2) Copy of registration certification document of the filing party;

(3) Product technical requirements materials;

(4) Certificate issued by a legally qualified inspection agency Full project inspection report that meets product technical requirements;

(5) Other materials indicating product safety and health functions.

(6) Product formula materials, including the names and dosages of raw materials and auxiliary materials, production processes, and quality standards. If necessary, the basis for the use of raw materials, description of the parts to be used, inspection certificates, and varieties should also be provided in accordance with regulations. Identification report, etc.;

(7) Product production process materials, including production process flow diagram and description, key process control points and descriptions;

(8) Safety and health functions Evaluation materials, including safety, health function test evaluation materials of raw materials and products outside the catalog, and crowd consumption evaluation materials; test reports on functional ingredients or iconic ingredients, hygiene, stability, strain identification, strain virulence, etc., and Test reports involving stimulants, prohibited drug ingredients, etc.;

(9) Types, names, relevant standards, etc. of packaging materials that directly contact health food;

(10) Product labels and instructions Sample manuscript; search materials showing that the common name in the product name does not overlap with the registered drug name;

When applying for imported health food registration, in addition to submitting the above materials, you should also submit:

(1) Qualification certification document issued by the competent government department or legal service agency of the country (region) where the product is produced, proving that the registration applicant is an overseas manufacturer of listed health foods;

(2) The government of the country (region) where the product is produced Documents certifying that the health food has been on the market for more than one year issued by the competent department or legal service agency, or a safety report on the product’s overseas sales and consumption by the population;

(3) The country (region) or international country where the product is produced; Organize technical regulations or standards related to health foods;

(4) Actual samples of packaging, labels, and instructions for products marketed in the producing country (region).

If the overseas registration applicant's permanent representative office in China handles the registration affairs, the "Registration Certificate of the Foreign Enterprise's Permanent Representative Office in China" and its copy shall be submitted; the overseas registration applicant entrusts a domestic agency to handle the registration. If registering a matter, the notarized original power of attorney and a copy of the business license of the entrusted agency shall be submitted.

What materials are needed for health food registration and filing management?

The materials required for health food registration and filing management are as follows:

1. Health food filing registration form, and the legal responsibility commitment letter of the filer responsible for the authenticity of the submitted materials

2. Registration certification documents for the filing party (scans of business license, unified social credit code/organization code and other legal person organization certification documents that comply with legal requirements, as well as scanned copies of production license certification documents containing health food categories) The original registrant should also provide a scanned copy of the health food registration certificate. If the original registrant does not have a production license certificate for the health food category, it is exempted from providing it.)

3. Product formula materials ( The product formula table is automatically generated based on the information filled in by the filer, including the names and dosages of raw materials and auxiliary materials)

4. Product production process materials (including main processes, key process control points, etc., the raw materials use premixed, For encapsulation and microencapsulation, the pre-treatment process should also be provided. The process flow diagram, process description and production process description of the product technical requirements should be consistent)

5. Safety and health function evaluation. Materials (Provide self-inspection reports on functional ingredients or iconic ingredients, hygiene, stability, etc. of three batches of products produced by pilot-scale or above-scale processes or an inspection report issued by a qualified inspection agency. The original registrant adjusts product formula or product technology If you are required to apply for filing, relevant information should be provided in accordance with 5.5.1; if the product formula and product technical requirements have not been adjusted, the inspection report submitted during the original application can be provided and explained)

6. Direct contact. Types, names, and relevant standards of packaging materials for health food (list the types, names, standard numbers, full text of the standards, and basis for use of packaging materials that directly contact the product.)

7. Sample product labels and instructions< /p>

8. Product technical requirements materials (the content of product technical requirements should be complete, consistent with the test results of the inspection report, and comply with current regulations, technical specifications, national food safety standards and the provisions of the "Health Food Raw Materials Catalog".)

9. A full-item inspection report issued by a legally qualified inspection agency that meets the product technical requirements (this inspection report and the inspection report in item 5 are issued by the same inspection agency, then they should be three different ones) Inspection report of the batch of products. If the original registrant has not adjusted the product formula and product technical requirements, the inspection report submitted during the original application can be provided)

10. Product name materials (provide the product name and product technical requirements). Search materials with non-duplicate names of health food approved for registration or filing, and print them out after searching from the government website database of the State Food and Drug Administration)

11. Other indications of product safety. Materials with health functions