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Pharmacovigilance

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Basic Information on the PRAC

The information about the roles and the functioning of the PRAC is available on the official webpage of the European Medicines Agency (EMA), here.

For Patients and Public

For Health Care Professionals

For Industry Representatives

  • What is Pharmacovigilance?
  • How to Report an Adverse Drug Reaction
  • New Safety Information
  • Direct Healthcare Professional Communication
  • Risk minimisation measures (RMM)
  • List of serious adverse reactions
  • Information for Marketing Authorisation Holders
  • Adverse Drug Reactions Reports
  • Pandemic Influenza A/H1N1
  • Information for Marketing Authorisation Holders - Electronic Transmission of ICSRs
  • Seal for Marking of Important Safety Information
  • Pharmacovigilance and Risk Assessment Committee (PRAC) - Links
    • Basic Information on the PRAC
    • Information About the First Meeting of the PRAC
    • Overview of the New Pharmacovigilance Legislation
  • Medicinal Products under Additional Monitoring
  • Signal management
  • Submission of Application Documentation for Assessment of Non-Interventional Trials
  • SCOPE Project
  • Access to Databases of Suspected ADRs
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