On regulating health food items on the notice of administrative licensing


On regulating health food items on the notice of administrative licensing
Security of the State Food 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 are to health food related administrative licensing matter are as follows:

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

Second, apply for re-registration of the domestic health food, in the five-year period the certificate of approval has 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 approval certificate has been produced and sold, re-registration application 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 of functional tests and test, applicants register the transfer of technology products, 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, no 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 Circular, this Circular shall prevail.

State Food and Drug Administration
July 21, 2011

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