Access to EudraVigilance data

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Stakeholders including marketing authorisation holders, regulatory authorities, academia, healthcare professionals and patients can access data held in the EudraVigilance database, based on the European Medicines Agency’s (EMA) EudraVigilance access policy. The policy is designed to provide as much information as possible while meeting data protection obligations.

Objectives of the access policy

The EudraVigilance access policy is based on a proactive approach to disclosing information held in the EudraVigilance database. This brings several benefits, most notably:

  • more effective safety monitoring of authorised medicines;
  • better support for signal detection and evaluation of potential safety issues;
  • more data made available for research;
  • better information on suspected adverse reactions for healthcare professionals and patients.

Revised EudraVigilance access policy (updated)

EMA has revised the EudraVigilance access policy ahead of implementing the new EudraVigilance system in 2017. 

The revised access policy was adopted by the EMA Management Board in December 2015. EMA implemented a further minor technical update of Annex B of the policy in September 2016. The Management Board discussed this update in December 2016. The revised policy will enter into force six months after the Management Board announces that the EudraVigilance database has achieved full functionality, based on an independent audit report. For more information, see:

Revised policy: Stakeholder groups

Different stakeholders have different levels of access, as set out in the below tables. Full details of stakeholder group access levels, including the types of individual case safety report (ICSR) they can access, can be found in the policy.

Marketing authorisation holders
Data elements available
  • Can access a defined set of ICSR data elements for medicines for which they hold a marketing authorisation in the European Economic Area (EEA), in compliance with European Union (EU) personal data protection legislation
  • Cases related to spontaneous reports and reports from non-interventional studies included
  • Senders of ICSRs have access to all data elements for cases they have submitted to EudraVigilance
Access tools
  • Access by EudraVigilance data analysis system (EVDAS), which includes the use of signal detection and data analysis functionalities
  • EU qualified person for pharmacovigilance (or the appointed deputy) nominates authorised personnel through the EudraVigilance registration process
  • For access to case narratives required for the validation of a signal or in the context of other pharmacovigilance assessment procedures, a confidentiality undertaking is required (details outlined in the policy)
Notes

 

EEA national medicines regulatory authorities
Data elements available
  • All data elements for ICSRs submitted to EudraVigilance are accessible
  • Includes spontaneous reports as well as reports from all types of studies
Access tools
  • Access is granted via EVDAS, including data analysis and signal detection tools
  • In Member States, medicines regulatory authorities determine access levels for regional pharmacovigilance centres
  • Authorised personnel of the European Commission, regulatory authorities and the Agency are identified through the EudraVigilance registration process
Notes

 

Academia
Data elements available
  • Defined set of data for spontaneous reports is available to academic institutions
  • Where a research request is submitted, an extended data set can be provided by the Agency following receipt of a signed confidentiality undertaking (details outlined in the policy)
Access tools

 

Healthcare professionals, patients and the general public
Data elements available
  • A restricted set of data elements for spontaneous reports is available and provided alongside detailed guidance on the nature and interpretation of the data 
  • Includes advice to patients not to change their medication without consulting a healthcare professional
Access tools

 

World Health Organization - Uppsala Monitoring Centre (WHO-UMC)
Data elements available
  • A defined set of data elements for ICSRs originating from within the EEA in accordance with EU personal data protection law is provided
  • Includes spontaneous reports and reports of non-interventional studies
Notes
  • Circumstances for the data provision are set out in a data transfer arrangement (details are outlined in the policy)

 

Medicines regulatory authorities outside the EU
Data elements available
  • A defined set of ICSR data elements identical to the one made available to WHO is provided to nominated contacts following receipt of a request (e.g. in the context of the evaluation of a safety issue related to a medicine)

 

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