Company core safety information (CCSI)

For medicinal products, all relevant safety information contained in the company core data sheet prepared by the marketing authorisation holder and which the marketing authorisation holder requires to be listed in all countries where the company markets the product, except when the local regulatory authority specifically requires a modification (see GVP Annex IV, ICH-E2C(R2) Guideline).

It is the reference information by which listed and unlisted are determined for the purposes of periodic reporting for marketed products, but not by which expected and unexpected are determined for expedited reporting (see GVP Annex IV, ICH-E2C(R2) Guideline).

See also Company core data sheet