Filing issuance and form requirements on the foreign dietary supplements entering China as health food
Q: What is the requirement for the issuance of a power of attorney when applying for a login account?
A: In addition to the qualification document of the overseas manufacturer, the imported health food manufacturer should also submit the power of attorney of the contact person when applying for a login account.
The power of attorney of the contact person shall contain the authorization of the overseas manufacturer entrusting the contact person to apply for the health food filing management system login account only. Relevant information needs to be provided in accordance with the requirements of Item 6.8 in the Work Guideline on the Filing of Health Food (for Trial Implementation).
Q: What is the requirement for the issuance of the supporting document?
A: The issuing institution: The supporting documents issued by the foreign institutions shall be issued by the government department in charge or legal service agency of the country (region) where the product is produced. The original copy of the supporting documents shall be stamped by the department and institution or signed by the legal representative (or its authorized person).
The content issued : It should be listed item by item according to the specific requirements of 6.1, 6.2, and 6.3 in the Work Guideline for the Filing of Health Food (for Trial Implementation). No item shall be missed.
The supporting document issued by the overseas agency must be notarized by the notary organization of the manufacturing country and confirmed by the Chinese consulate in the manufacturing country.
The supporting documents shall be used within the validity period if there is any.
Q: What is the form requirement for the filing documents?
A: The main supporting document of the filing subject must be written in the official language of the country (region) where the product is produced. In case of non-English official languages, an English translation of the supporting document shall be submitted, and be notarized by the notary organization of the producing country (region) and confirmed by the Chinese consulate in the manufacturing country.
When the product is applied for filing, the documents written in Chinese shall be submitted, with the documents written in foreign languages attached.
Requirements on imported health food filing subject :
The filing subject must be an overseas manufacturer of already marketed health food. The overseas manufacturer (filing subject) refers to a legal person or other organization that meets the market launch requirements of the country (region) where the filing subject is located. The manufacturing country (region) refers to the country (region) where the imported health food is marketed.
Imported health food filing procedures and requirements
The imported health food filing subject shall carry the qualification documents issued by the government department in charge or legal service agency of the country (region) where the product is produced, with the marketed health food overseas manufacturer as the filing subject, and apply for the filing management information system login account at the administrative service department of CFDA on site. The login account will be issued to the filing subject after the inspection and approval of the acceptance department.
After obtaining the login account of the filing management information system, the filing subject shall enter the system through the website http://bjba.zybh.gov.cn to fill in the relevant information of the filing subject and the products for filing item by item as requested after a careful reading, print item by item the filing application form automatically generated by the system attached with the bar code and check code, product formula, label and instruction, technical specifications and etc., and stamp thefiling subject’s official seal on texts of the above-mentioned materials together with other documents for filing (For details, see No.6 the Items and Requirements for the Filing documents of Imported Health Food) page by page(not including inspection reports by the inspection agencies, notary documents and supporting documents). In case that the filing person has no seal, it can be replaced by the signature or personal seal of the legal representative.
The filing subject shall clearly scan all the paper documents for filing into a colored electronic edition (in PDF format) and upload them to the health food filing management information system. Submit them after confirmation. The full set of paper documents for filing shall be submitted to the administrative and acceptance department of CFDA.
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