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Pharmacovigilance
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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
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
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
