Company Core Data Sheet (CCDS)

Abstract

ICH: “A document prepared by the marketing authorisation holder containing, in addition to all relevant safety information, material relating to indications, dosing, pharmacology and other areas that are not necessarily safety related” (ICHe2c); syn. international prescribing information, “virtual SPC”, core data sheet (CDS); central document that may be prepared by the marketing authorisation holder concerning a medicinal product covering material relating to safety, indications, dosing, pharmacology, and other information as a reference; synthesis of general information for prescribers on the correct use of a drug including risks; it is the reference document by which expected and unexpected adverse drug reactions are determined and is therefore always included in a drug safety update report; if there is an EC SPC this will take the place of the CCDS; the safety information contained within its central document (CCDS) would be referred to as “Company Core Safety Information” (CCSI) → see also drug safety updates, summary of product characteristics (SPC), patient information leaflet (PIL), Periodic Safety Update Report (PSUR).

Keywords

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