Reference Safety Information (RSI) is a vital component within periodic benefit-risk evaluation reports for medicinal products. It encompasses all pertinent safety details that are present in the reference product information, which is prepared by the marketing authorization holder.
This information is mandated to be included in product listings across all countries where the marketing authorization holder markets the product unless specific modifications are mandated by local regulatory authorities.
The Reference Safety Information serves as a concentrated subset of the information within the marketing authorization holder’s reference product information for the purpose of periodic benefit-risk assessment. When the reference product information corresponds to the company core data sheet, the corresponding Reference Safety Information is identified as the company core safety information.
Confounding by Indication
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