Company Core Safety Information (CCSI) pertains to the comprehensive safety information present within the company’s core data sheet. This information is meticulously prepared by the marketing authorization holder and is mandated to be included in product listings across all countries where the company markets the product. However, exceptions arise if the local regulatory authority explicitly mandates a modification to the safety information. Essentially, CCSI ensures that consistent safety details are accessible and accessible across all regions of product distribution.
Signal Management Process
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