4. EudraVigilance
1. EudraVigilance
1.7. Access to data held in EudraVigilance
Different stakeholders such as NCAs in EEA countries, healthcare professionals, patients and consumers, as well as MAHs and academia can access data held in the EudraVigilance database. Access is defined based on the stakeholder's interests and needs as well as the requirement to comply with applicable personal data protection legislation.
Therefore, the access is subdivided in different levels, taking into consideration that, due to the often-detailed nature of the information, not all data elements can be disclosed to avoid a potential re-identification of data subjects. Six stakeholder groups are defined, following the EudraVigilance access policy rules. (see 4.4 (2))
The table below gives an overview of the different stakeholder groups, their data access and access provisions.
Table 2: Overview of stakeholder groups and their access to data elements in EudraVigilance. (adapted from EudraVigilance access policy and EudraVigilance User Manual for online access (Version 2.0))
Stakeholder Group (SG) |
EudraVigilance(EV) Data Access |
Access Pre-requisites & Mechanisms |
SG I Medicines regulatory authorities in the EEA, the EMA and EC |
|
EC and EMA: Registration with password -protected EudraVigilance access. NCAs: via EVDAS, incl. data analysis and signal detection; |
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|
|
SG II Healthcare Professionals and the Public |
All spontaneous reports as aggregated data and line listings and ICSR forms based on restricted data elements. |
adrreports.eu web portal; no authorisation for accessing the ICSR data set is required. |
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|
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SG III Marketing-authorisation holders |
|
Registration with password-protected access to EV
Confidentiality undertaking for access to case narratives for signal validation or other PV assessment procedure |
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|
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SG IV Academia |
|
adrreports.eu web portal
Confidentiality undertaking and provision of ad-hoc data set prepared by the EMA |
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|
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SG V WHO Uppsala Monitoring Centre |
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Data transfer agreement and daily electronic data transfer |
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SG VI Medicines regulatory authorities outside the EU |
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adrreports.eu web portal Ad-hoc data set prepared by the EMA |