In March 2018, the EMA published a EudraVigilance Dos and Don’ts document with the aim to reduce Individual Case Safety Report (ICSR) processing errors. This document was based on the initial operational experience with EudraVigilance (EV) and highlights the following Dos and Don’ts when processing ICSRs.

Do

  • Do consult the guidance issued by ANSM on the transmission of ICSRs. ANSM announced that French imputability is no longer mandatory for Marketing Authorisation Holders (MAH).
  • Do always include a valid organisation registered either as a Gateway Trader or Web-Trader in EudraVigilance
  • Do avoid multiple downloads of the same ICSRs
  • Do always consider a “2 day processing window” in the Export Transformation Loading (ETL) process for ICSRs in EudraVigilance Data Analysis System (EVDAS)
  • Do run the active substance grouping report before retrieving data from EVDAS.
  • Do send an email to duplicates@ema.europa.eu when reviewing cases obtained from EV and there is a suspicion that two or more cases are duplicates of one another

Don’t

  • Don’t send Acknowledgements to EudraVigilance for ICSRs you have downloaded.
  • Don’t send European Economic Area (EEA) cases originating from Competent Authorities back to EudraVigilance without having received new information from the primary source
  • Don’t send nullifications for ICSRs that were sent to EV by other sender organisations
  • Don’t send ICSRs back to EV:
    • that were submitted by other MAHs
    • Medical Literature Monitoring (MLM) ICSRs
    • The reported suspected adverse reaction was upgraded from non-serious to serious
  • Don’t use “Regulatory” for the data element E2B(R3) C.1.8.2, as the source of a C.1.8 Worldwide Unique Case Identification for an MAH
  • Don’t send follow-up reports with additional information obtained from AIFA’s (Italy) national pharmacovigilance database to EudraVigilance

Click here for the full document.

What EUDRAC can do to help?

EUDRAC provides a complete PV service for its clients and also provides support for clients’ existing PV systems, including signal detection. In addition, we keep clients up-to-date on the rapidly changing PV environment through our Global PV intelligence service. For more information on pharmacovigilance services, please contact us here.