On regulating health food items on the notice of administrative licensing
Security of the State Food and Drug Administration [2011] No. 321

Provinces, autonomous regions and municipalities Food and Drug Administration (Drug Administration), the unit:

In order to regulate and strengthen the administration of health food license management, according to "Health Food Registration (for Trial Implementation)" the relevant provisions, now on administrative health food licensing matter are as follows:

A health food product registration process, you need additional information, additional information submitted by the time limit of five months. Because of special circumstances not submitted on time, can be extended to one year program, the applicant submitted additional information should be provided relevant information note.

Second, apply for re-registration of the domestic health food approval certificate in a five-year period have not been produced and sold, in accordance with relevant regulations and procedures to carry out prototyping, on-site verification, inspection and technical review of such work. In the five-year period the certificate of approval has production and sales, application re-registration to provide the State Food and Drug Administration to determine the registration of product quality inspection agency issued the inspection report.

Third, the same applicant to declare the same raw materials and primary materials, different product formulations, the applicant shall provide the choice of different formulations of scientific, rational basis.

Fourth, the same raw materials and primary materials, taste or color of a different health food products, such as registration of new products did not carry out toxicological safety assessment evaluation test and functional test, the applicant in the application of technology transfer product registration, should make them the two types of tests.

Fifth, technology transfer product registration application or change the product name, the applicant shall provide 2 years free of illegal activities in their undertaking.

The notice from September 1, 2011 shall come into force. Prior to release of the relevant provisions are inconsistent with the provisions of this notice, subject to the notification requirement.

State Food and Drug Administration
July 21, 2011

  

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