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Company Core Safety Information (CCSI)

All relevant safety information contained in the company core data sheet prepared by the marketing authorization holder and which the marketing authorization holder requires to be listed in all countries where the company markets the product, except when the local regulatory authority specifically requires a modification. It is the reference information by which listed and unlisted are determined for the purpose of periodic reporting for marketed products, but not by which expected and unexpected are determined for expedited reporting.

Company core data sheet (CCDS)

A document prepared by the marketing authorization holder containing, in addition to safety information, material relating to indications, dosing, pharmacology and other information concerning the product.

In accordance with ICH E2C (R1) recommendations, it is a common practice for MAHs to prepare their own CCDS, which includes sections relating to safety, indications, dosing, pharmacology, and other information concerning the medicinal product. The core safety information contained within the CCDS is referred to as the CCSI. A practical option is for MAHs to use the latest CCDS in effect at the end of the reporting interval as the reference product information for both the risk sections of the PBRER as well as the main approved indications for which benefit is evaluated. When the CCDS for a medicinal product does not contain information on approved indications, the MAH should clearly specify which document is used as the reference information for the approved indications in the PBRER.

When there is no CCDS or CCSI for a product, e.g., where the product is approved in only one country or region or for established/generic products on the market for many years, the MAH should clearly specify the reference information being used. This may comprise national or regional product information such as the US Package Insert (USPI) or European Summary of Product Characteristics (SmPC), or the Japanese package insert, as appropriate.

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