Benefit-risk report (BRR) and signal notification submissions
Once a VMP is on the UK market an MAH must record and submit the results of their signal management process, alongside sales and worldwide authorisation status data.
Documents
Details
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. This must be sent to the VMD via the Benefit-risk report and Signal notification template.
The Benefit-risk report including sales data and worldwide authorisation status information should either be submitted as one complete document annually or can be split into multiple submissions.
If multiple submissions are made at different timepoints, one must contain at a minimum the benefit-risk statement and validated signals which are deemed:
- not to suggest a new risk
- change to the benefit-risk balance, or
- require further investigation, if any have been detected during the reporting period
The remaining submission(s) must contain the sales data and worldwide authorisation status between them, and be received at least once annually.
In addition, MAHs must notify the VMD of all validated signals which following assessment:
- suggest a new risk
- change to the benefit-risk balance, or
- require further investigation using the Signal notification option or Urgent signal notification option on the BRR/Signal template
BRRs and Signal notifications should be submitted using the Veterinary Medicines Digital Service (VMDS), a secure messaging service.
Any MAH not signed up to VMDS should register at Veterinary Medicines Digital Service - GOV.UK (www.gov.uk).
For full details of submission of the BRR and Signal notifications refer to the guidance in Guideline IV Signal management, including benefit-risk reports .