Access policy

The Management Board of the European Medicines Agency first approved the EudraVigilance Access Policy in December 2010. A major revision was adopted by the Management Board in December 2015 based on the 2010 pharmacovigilance legislation. EudraVigilance is a system designed for collecting reports of suspected side effects. These reports are used for evaluating the benefits and risks of medicines during their development and monitoring their safety following their authorisation in the European Economic Area (EEA). It has been in use since December 2001.

The EudraVigilance Access Policy describes how stakeholders, such as national medicines regulatory authorities in EEA countries, healthcare professionals, patients and consumers, as well as marketing-authorisation holders and academia can access information on suspected side effects submitted electronically to EudraVigilance.

The objectives of the policy are:

  • Providing openness to citizens, who are directly affected by the EU Regulatory Network’s decisions relating to the authorisation and supervision of medicinal products, including the monitoring and assessment of the safety of medicines;
  • Facilitating the monitoring of the safety of medicines following their authorisation and marketing;
  • Supporting signal detection and validation activities related to all authorised medicines in the EU;
  • Allowing the use of adverse reaction data for research purposes to contribute to promoting and protecting public health and fostering the innovation capacity of European medical research;
  • Providing promptly all suspected adverse reactions occurring in the EEA to the WHO;
  • Strengthening of the collaboration with medicines regulatory authorities in third countries as regards the safety monitoring of medicines.

The revised policy defines six stakeholder groups and their respective levels of access, for which a summary is provided as follows:

Stakeholder Group (SG) EudraVigilance Data Access Access Pre-requisites & Mechanisms
SG I

Medicines regulatory authorities, the European Medicines Agency and the European Commission
Complete access to all data for signal detection and data analysis Registration with password -protected EudraVigilance access
SG II

Healthcare Professionals and the Public


All spontaneous reports as aggregated data and line listings based on restricted data elements. Adrreports.eu portal
SG III

Marketing-authorisation holders


1. Access to all data elements for cases sent to EV and reports from the medical literature entered by the Agency in EudraVigilance

2. Access to restricted data set for substances for their products for signal detection

3. Access to extended data set for substances for their products including free text case narrative for signal validation

Registration with password-protected EudraVigilance access

 


Confidentiality undertaking and password-protected EudraVigilance access

SG IV

Academia

1. All spontaneous reports as aggregated data and line listings based on restricted data elements (as for Stakeholder Group II)

2. Extended data set based on study protocol (same as for Stakeholder Group III.2) for research purpose

Adrreports.eu portal



Confidentiality undertaking and provision of ad-hoc data set prepared by the Agency

Note: no pre-scrutiny of study protocol or publications

SG V

WHO Uppsala Monitoring Centre
Extended data set as per agreement with WHO Data transfer agreement and daily electronic data transfer
SG VI

Medicines regulatory authorities in
third countries

1. All spontaneous reports as aggregated data and line listings based on restricted data elements (as for SG II)

2. Extended data set on request for safety monitoring

 

Adrreports.eu portal

 


Ad-hoc data set prepared by the Agency

 

 

More information

 EMA
EudraVigilance