Benefit-risk report (BRR) and signal notification submissions
Benefit-Risk Submission Report (BRSR) and Pharmacovigilance Sales Submission (PSS) templates and guidance for completion of BRSRs, PSSs and signal notifications.
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Following the placing of a VMP on the market in the UK, an MAH must record and submit the results of their signal management process, alongside sales and worldwide authorisation status data.
Signal notifications for signals that suggest a new risk or change to the benefit-risk balance should be submitted using the Benefit-Risk Submission Report (BRSR) within the timelines specified in Guideline IV Signal management, including benefit-risk reports.
The annual benefit-risk statement, worldwide authorisation status data and signal/regulatory action data for valid signals that do not meet the criteria for signal notifications must be submitted once annually using the BRSR.
Sales data should be submitted via the Pharmacovigilance Sales Submission (PSS) either once annually or on a rolling basis across the year.
BRSRs, PSSs and Signal notifications should be submitted using the Veterinary Medicines Digital Service (VMDS), a secure messaging service, or using the VMD Industry Pharmacovigilance Reporting Service which can be accessed at Report pharmacovigilance data for veterinary-medicines.
Any MAH not signed up to VMDS should register at Veterinary Medicines Digital Service. To register for the VMD Industry Pharmacovigilance Reporting Service email: PHVReportingService@vmd.gov.uk.
For full details of submission of the BRSR, PSS and Signal notifications refer to the guidance in Guideline IV Signal management, including benefit-risk reports.