COMPANY CORE SAFETY INFORMATION

It is the reference information by which listed and unlisted are deter-mined for the purpose of periodic reporting for marketed products, but not by which expected and unexpected are determined for expedited reporting.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.

Individual Case Safety Report in Pharmacovigilance

Information to validate an Individual Case Safety Report in Pharmacovigilance when they receive it from a source( Clinical Trial & Spontaneous):

The criteria for a valid case are:

● an identifiable patient;

● a suspect drug;

● a suspect reaction;

● an identifiable HCP reporter.

In the context of expedited reporting, day zero should be considered the day on which the minimum criteria for a reportable adverse reaction report becomes available to the MAH.