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Pharmacovigilance

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PSUR and PSUSA procedures

Information on periodic safety update reports (PSURs), PSUR submission requirements, PSUR single assessment procedures (PSUSAs) and the European Union reference dates (EURD) list is available here.

For Patients and Public

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  • 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
    • PSUR and PSUSA procedures
    • Adverse Drug Reactions in Summaries of Product Characteristics and Patient Information Leaflets
    • Instructions for Submitting Applications for Scientific Advice
    • Risk Management Plan
    • Inclusion of information as regard the medicinal product status under additional monitoring
  • Adverse Drug Reactions Reports
  • Information for Marketing Authorisation Holders - Electronic Transmission of ICSRs
  • Seal for Marking of Important Safety Information
  • Pharmacovigilance and Risk Assessment Committee (PRAC) - Links
  • Medicinal Products under Additional Monitoring
  • Signal management
  • Submission of Application Documentation for Assessment of Non-Interventional Trials
  • Access to Databases of Suspected ADRs
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