BRSR Submission Guidelines Overview

"BRSR Submission Guidelines Overview

These guidelines provide technical instructions for completing the Benefit-Risk Submission Report (BRSR) for veterinary medicinal products in Great Britain. Key points include:

1. Submission: The BRSR must be completed in English and submitted via the VMDS Benefit-Risk Report (BRR) and signal notification submissions page.
2. Template Requirements: Several columns in the template require specific data, including ISO 3166 country codes, evaluation results, suggested actions, and details of closed signals.
3. Adverse Event Data: Include data on the number of animals affected, species, breed, age, and whether the product was used as per label recommendations.
4. Naming Conventions: Additional documents must follow a naming format including submission category, date, MA number, or Product Group Code (PGC), and document number.
5. Line Listings: The second sheet should provide adverse event details, such as MA number, country, report ID, date of onset, and a narrative description.
6. Product Authorization: The third sheet outlines the product's worldwide authorization status, including the country, product name, and marketing status during the reporting period.
7. Deadlines: The BRSR is due two months before the submission deadline and must cover all UK and third-country adverse events, including validated signals and proposed actions by the MAH or regulators."

Source:https://assets.publishing.service.gov.uk/media/66c70b08e7b39a1b6c5c293e/PCDOCS-_2828075-v3-Technical_guidance_for_completion_of_the_Benefit-Risk_Submission_Report__BRSR_.pdf##~https://www.gov.uk/government/publications/benefit-risk-report-brr-and-signal-notification-submissions#full-publication-update-history

Region: United Kingdom