Access to EudraVigilance data

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.

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.

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

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 revised policy entered into force following the launch of the new EudraVigilance system on 22 November 2017.

The EudraVigilance access policy was further revised in 2019. Revision 4 refers to the update of references in accordance with Regulation (EU) 2016/679, the General Data Protection Regulation (GDPR) and Regulation (EU) 2018/1725, the EU Data Protection legislation (EU DPR).

For more information, see:

• European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use - Revision 4

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 EudraVigilance Access Policy - Confidentiality undertaking for marketing authorisation holders is required (details outlined in the policy)
Notes	Can also use the post-authorisation module of the EudraVigilance database management system (EDBMS) On 23 July 2018 EMA published guidance to clarify the obligations of marketing authorisation holders to record information on ICSRs they access in EudraVigilance. Recording by marketing authorisation holders of information on suspected adverse reactions held in EudraVigilance

 

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	Can also make use of the EudraVigilance clinical trial (EVCT) and post-authorisation modules (EVPM) of the EudraVigilance database management system (EDBMS)

 

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 EudraVigilance Access Policy - Confidentiality undertaking for academia (details outlined in the policy)
Access tools	Publicly accessible European database of suspected adverse drug reaction reports

 

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	Publicly accessible European database of suspected adverse drug reaction reports

 

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)