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Supplementary Rules Promulgated regarding Application Documents and Onsite Inspection for Registration of Infant Milk Powder Formula

China Insight - Lifesciences

Following the promulgation of the Administrative Measures for the Registration of Infant Milk Powder Formula (“Measures”) on 6 June 2016 and effective as of 1 October 2016, the China Food and Drug Administration ("CFDA") further promulgated two detailed rules on 16 November 2016, i.e. Application Documents and their Request for Registration of Infant Milk Power Formula (“Application Documents Request”) and Onsite Inspection Key Point and Judgment Principle for Registration of Infant Milk Power Formula (“Onsite Inspection Principle”).

The above two detailed rules, together with the Measures, constitute the rules on the registration of infant milk powder formula in China. Foreign infant milk powder manufacturers who intend to sell infant milk powder products in China are required to go through the registration formalities in compliance with the above Measures and detailed rules. With these detailed rules* , registration of infant milk powder formula can be thus implemented in practice. 

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*According to the Measures, in principle each manufacturer is only allowed to register up to 3 formula series and 9 formulas in total. 

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China Insight - Supplementary Rules Promulgated regarding Application...
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Authors

Nicolas Zhu
Nicolas Zhu
Partner
Shanghai
Picture of Chenbin Zhang
Chenbin Zhang, LL.M.