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List Item EU VICH Adverse Event Report Implementation Guide (PDF/1.2 MB) AdoptedFirst Published: 23/11/2021 Legal Effective Date.pdf

eu-vich-adverse-event-report-implementation-guide_en.pdf
Preview of List item EU VICH adverse event report implementation guide (PDF/1.2 MB) AdoptedFirst published: 23/11/2021 Legal effective date
🔗 Source: ema.europa.eu
📊 Size: 1.2 MB
👤 Author: European Medicines Agency
⬇️ Downloads: 525

Summary

The European Medicines Agency (EMA) has published the EU VICH adverse event report implementation guide, which provides guidance on reporting adverse events for veterinary medicines in the European Union. The guide outlines the legal basis, VICH guidelines, and step-by-step process for reporting adverse events, as well as the main functional components of EudraVigilance Veterinary, including registration, security, data protection, and reporting. It also covers system and testing requirements, service level agreements, and system failure procedures. The guide includes information on message headers, adverse event reports, attachments, and additional ISO/HL7 VICH data fields, as well as business rules for AER message processing and AER acknowledgement messages.

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Description

The European Medicines Agency (EMA) has published the EU VICH adverse event report implementation guide, which provides guidance on reporting adverse events...

Technical Information

  • File Format: PDF
  • File Size: 1.2 MB
  • Pages: 44
  • Language: EN
  • Author: European Medicines Agency
  • Total Downloads: 525
  • Last Updated: 4 weeks ago

Document Overview

This PDF document about List item EU VICH adverse event report implementation guide (PDF/1.2 MB) AdoptedFirst published: 23/11/2021 Legal effective date provides comprehensive information and guidance. Whether you're a beginner or advanced user, this resource offers valuable insights into List item EU VICH adverse event report implementation guide (PDF/1.2 MB) AdoptedFirst published: 23/11/2021 Legal effective date.

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