EVVet - Best practice guide - Pharmacovigilance
For example, when further information received results in a change from “non-serious” to “serious” classification of a report, the “Most recent info date” may give the impression that the report may not have been submitted within the expedited time-frame. Examples are shown on the following pages for further clarification Example. An AE report has been sent by a MAH to the French ... ................
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