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Home Regulations REGULATION (EU) No 520/2012 REGULATION (EU) No 520/2012 Chapter I: Pharmacovigilance system master file
Chapter II: Minimum requirements for the quality systems for the performance of pharmacovigilance activities Section I: General provisions Section II: Minimum requirements for the quality systems for the performance of pharmacovigilance activities by marketing authorisation holders Section III: Minimum requirements for the quality systems for the performance of pharmacovigilance activities by national competent authorities and the Agency
Chapter III: Minimum requirements for the monitoring of data in the Eudravigilance database
Chapter IV: Use of terminology, formats and standards
Chapter V: Transmission of reports of suspected adverse reactions
Chapter VI: Risk management plans
Chapter VII: Periodic safety update reports
Chapter VIII: Post-authorisation safety studies
Chapter IX: Final provisions