Reference safety information

In periodic benefit-risk evaluation reports for medicinal products, all relevant safety information contained in the reference product information (e.g. 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 it markets the product, except when the local regulatory authority specifically requires a modification (see GVP Annex IV, ICH-E2C(R2) Guideline)15 .

It is a subset of information contained within the marketing authorisation holder’s reference product information for the periodic benefit-risk evaluation report. Where the reference product information is the company core data sheet, the reference safety information is the company core safety information (see GVP Annex IV, ICH-E2C(R2) Guideline).

See also Company core data sheet, Company core safety information