| ( 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. |
