Pharmacovigilance System Master File (PSMF) | PharmaBharat Tools

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Pharmacovigilance System Master File (PSMF) | PharmaBharat Tools

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Changes Being Effected(CBE-0)Changes Being Effected in 30 Days(CBE-30)Comparability Protocol Controlled Distribution Direct Healthcare Professional Communication(DHPC)Development Safety Update Report(DSUR)Educational Materials Post-Approval Change Management Protocol(PACMP)Prior Approval Supplement(PAS)Periodic Benefit-Risk Evaluation Report(PBRER)Post-Marketing Postmarketing Commitment(PMC)Postmarketing Requirement(PMR)Pharmacovigilance System Master File(PSMF)Periodic Safety Update Report(PSUR)PSUR Single Assessment(PSUSA)Qualified Person for Pharmacovigilance(QPPV)Risk Evaluation and Mitigation Strategy(REMS)Renewal Risk Minimisation Risk Management Plan(RMP)Signal Management Supplemental NDA(sNDA)Sunset Clause Urgent Safety Restriction(USR)

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RA Post-ApprovalPharmacovigilance System Master File

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Postmarketing Requirement (PMR)Periodic Safety Update Report (PSUR)

Pharmacovigilance System Master File(PSMF)

Post-Approval

Definition

An EU document describing the MAH’s pharmacovigilance system, maintained for inspection and compliance evidence.