How to submit application documents for infant and young children formula with active strains added?
For the formula of active strains added, it is necessary to submit related documents such as strain traceability and bacterial contamination prevention and control, including source description of strains, strain identification report and prevention and control measures for possible product bacterial contamination due to the use of strains (such as active strains quality specifications and test reports, active strains management, process control related to finished product production and related item testing in finished products).
Source: SAMR
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