GovWire

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 theVeterinary Medicines Digital Service (VMDS), a secure messaging service.

Any MAH not signed up to VMDS should register atVeterinary Medicines Digital Service.

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.