Application dossiers for Imported Health Food Alteration

时间： 2022-03-03 作者：来源：

导读： ( Ⅰ) Application form for imported health food or filing form for imported health food.( Ⅱ)The name of alteration Article and it

( Ⅰ) Application form for imported health food or filing form for imported health food.

( Ⅱ)The name of alteration Article and its reason and foundation.

(Ⅲ) In the event of the alteration application of foreign manufacturer conducted by its permanent

representative office in China, the applicant must provide the copy of the Registration Certificate for

Foreign Company s Permanent Representative Office in China.

In the event of the alteration for foreign manufacturer entrusting the agency in China, the applicant must

provide the notarized original letter of trust and the copy of the business license of the trusted agency.

( Ⅰ) The copies of approval document of health food and its appendixes.

( Ⅱ) The document granted by the relevant agency of the manufacturing country (region) to testify that the

Article has been altered and the relevant materials. The document must be validated by the notary office in

the manufacturing country (region) and the Chinese embassy or consulate in the manufacturing country

(region).

Note:

1. In the event of the application for reducing the range of suitable users, expanding the range of unsuitable

users and altering precautions, besides the above-mentioned dossiers, the applicant must provide the sample

of the label and package insert after the alteration.

2. In the event of the application for dosage alteration (product specifications do not change), besides the

above-mentioned Articles, the applicant must provide: (1) the application for dosage reduction should

provide the test report granted by the designated inspection institution which conducts the function

assessment test according to the planned dosage reduction; (2) the application for dosage increase should

provide the test report granted by the designated inspection institution which conducts the toxicology safety

test according to the planned dosage increase, as well as the function assessment report according to the

comparison between the planned dosage alteration and the original dosage. (3) The label and package insert

after alteration.

3. In the event of the application for alteration of product specifications, storage life and quality standard,

besides the above-mentioned Articles, the applicant must provide: (1) the foundation to testify that the

alteration will not affect the safety and function of the product and relevant research data, scientific

documents and/or test report, in which, the registration application for quality standard alteration should
provide the test dossiers and documents about the quality research; (2) the self-test report on the active

ingredient or badge substance, hygiene, stability of the products from three consecutive lot numbers; (3) three

consecutive lot numbers of samples for inspection (storage life alteration excluded); (4) the samples of label,

package insert and quality standard after alteration.

4. In the event of alteration application for increasing health food function Articles, besides the

above-mentioned Articles, the applicant must provide: (1) the function test report for the increased function

Article; (2) the label, package insert or quality standard after the alteration and their sample copies.

5. In the event of the application inside the health food manufacturing enterprise for altering production site
outside of Chinese territory, besides the above-mentioned Articles, the applicant must provide: (1) the

document granted by the administrative departments to testify that the production conditions conform to

relevant local production quality administration standard; (2) the document to testify that free sale of the
product is permitted in the country where new production site is located; (3) self-test report of active

ingredient or badge substance, hygiene, stability of three consecutive lot numbers of products manufactured

at the new production site; (4) samples for inspection of three consecutive lot numbers manufactured at the

new production site. (5) the label and package insert after alteration.

6. In the event of the application for altering product name, besides the above-mentioned Articles, the

applicant must provide the product s generic name to be used after alteration and the search materials to

testify that the name is different from the drug names whose registration have been approved (searching from
the data base of the website of the State Food and Drug Administration), as well as the label, package insert

after the alteration.

7. In the event of filing Articles of the name and/or address alteration of the applicant, besides the

above-mentioned Articles, the applicant must provide the documents granted by the manufacturing country
(region) s administration departments to testify that the production site has not been altered and provide the

label and package insert after the alteration.

8. In the event of the application for filing of the agency alteration in Chinese territory, besides the

above-mentioned Articles, the applicant must provide the letter of trust and notarization to testify that foreign

health food manufacturer entrusts Chinese agency with the registration application and at the same time

withdraw the trust with the original agency.

The application Articles must use Chinese language with the original language attached, and the Articles in

foreign language can be enclosed as reference. The Chinese version should be notarized by the notary office

in Chinese territory to ensure that it is consistent with the content of original version; The product quality

standard (Chinese version) for the registration application must conform to the product standard format for

health food in China.

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