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08 feb EMA say: day zero starts at receipt of physical/hard copy local journals! Implications: contradictions with GVP, low impact on patient safety, higher costs for MAH

EMA posted the following interpretation of the Pharmacovigilance Inspectors Working Group in January 2023: “For ICSRs, medical literature containing the minimum criteria, the clock starts (day zero) on the day when the physical/hard copy local journal is received by the organisation/Marketing authorisation holder/Applicant, and this should be considered...