“Marketing Authorization Holders (MAHs) are expected to review and assess reports of suspected adverse reactions from the medical literature to identify and record Individual Case Safety Reports (ICSRs).”
If a pharmacovigilance case is detected in a journal, the clock starts on day ZERO of the receipt of the physical/hard copy of the local journal by the organisation/MAH/applicant and should be considered equal to performing a literature search in an electronic database.
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(Q&A: What is the day zero for ICSRs Described in Physical/hardcopy Local journals?)
