EMA consults on updates to its policy on access to EudraVigilance

EMA has launched a six-week public consultation on its updated EudraVigilance access policy. 

 Some key changes are:

  • Addition of the Uppsala Monitoring Centre (UMC) of the World Health Organisation (WHO) as a new stakeholder group
  • Enhanced access of marketing-authorisation holders
  • Access to more detailed ICSR data for researchers
  • Addition of international medicines regulatory authorities as a new stakeholder group
  • Increased emphasis on confidentiality of personal data

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