EudraVigilance Access | PharmaBharat Tools

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EudraVigilance Access | PharmaBharat Tools

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Expedited Report Reference Safety Information(RSI)Company Core Data Sheet(CCDS)EudraVigilance FAERS(FAERS)Expected Adverse Reaction Unexpected Adverse Reaction Electronic Submission Gateway Clinical Trial Safety Reporting SUSAR(SUSAR)Investigator Brochure(IB)ICSR Submission Log Reference Safety Information Update Expedited Reporting Timeline 7 Day Expedited Reporting Timeline 15 Day Foreign Report Domestic Report Global Case Management Local Operating Company(LOC)Reportability Assessment Multiple Report Submission Submission Acknowledgment Reference Listed Drug(RLD)SmPC(SmPC)Reportability Decision Development Core Safety Information(DCSI)Annual Report FDA Addendum Report Null Report Safety Update Report Safety Variation CHMP Opinion EudraVigilance Access EV Gateway FDA ESG Submission Rejection Acknowledgment Message Duplicate Report to Authority Follow-Up Submission Amendment Report Withdrawal Report Reportability Review Authority-Specific Requirements Local Label Core Data Sheet Company Core Safety Information(CCSI)Listed Reaction Unlisted Reaction Expectedness Reclassification Day Zero Reset Advisory Committee Safety Regulatory Submission Tracking Submission Deadline Timeline Tracking Response to Authority Submission Package Electronic Submission Paper Submission Submission Number Authority Case Number Periodic Reconciliation Global Safety Database Safety Data in Label Acknowledgment(ACK)CIOMS Form(CIOMS I)Direct Reporting Downstream Reporting EudraVigilance(EV)Expedited Reporting FDA Adverse Event Reporting System(FAERS)15-Day Report Local Reporting Requirements MedWatch Nullification Periodic Reporting Regulatory Authority(RA)Safety Report Submission 7-Day Report Spontaneous Reporting Rate(SRR)Stimulated Reporting Submission Tracking Suspected Unexpected Serious Adverse Reaction(SUSAR)Underreporting

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PV Regulatory ReportingEudraVigilance Access

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CHMP Opinion EV Gateway

EudraVigilance Access

Regulatory Reporting

Definition

Access rights and processes for MAHs to submit and (where allowed) query EudraVigilance.

Example

MAH submits via EV Gateway with secure access.

Regulatory source

EMA EV

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