The Management Board of the European Medicines Agency approved the EudraVigilance Access Policy in December 2010. 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 research organisations, can access information on suspected side effects submitted electronically to EudraVigilance.
The policy aims to:
- improve public health by facilitating the safety-monitoring of medicines;
- support signal-detection activities in the context of spontaneous reporting for authorised medicines;
- inform healthcare professionals and the general public by publishing information related to spontaneous reports for authorised medicines;
- allow EudraVigilance data to be used for research purposes.
The policy defines four main stakeholder groups and their respective levels of access.
|Stakeholder groups||Access to||Access via|
|Stakeholder group I
National medicines regulatory authorities in the European Economic Area (EEA), the European Medicines Agency and the European Commission
|All data fields||Password-protected system for signal detection and data analysis|
|Stakeholder group II
Marketing-authorisation holders and sponsors of clinical trials
|- All data fields (if sender of the safety information)
- Defined data fields (if not sender of the safety information)
|Password-protected system for signal detection and data analysis|
|Stakeholder group III
General public, including healthcare professionals, patients and consumers
|Defined data fields||Public-facing website|
|Stakeholder group IV
|Defined data fields||Password-protected system for signal detection and data analysis|