4. EudraVigilance: Access to data held in 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	Complete access to all data for signal detection and data analysis Includes spontaneous reports as well as reports from all types of studies	EC and EMA: Registration with password -protected EudraVigilance access. NCAs: via EVDAS, incl. data analysis and signal detection;

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.

SG III Marketing-authorisation holders	Access to defined set of ICSR data elements for medicines for which they hold a marketing authorisation in the EEA, restricted data set for signal detection extended data set including free text case narrative for signal validation Includes cases related to spontaneous reports and reports from non-interventional studies Senders of ICSRs: all data elements for cases they have submitted to EV Access to reports from the medical literature entered by the EMA in EV	Registration with password-protected access to EV by EV data analysis system (EVDAS); includes the use of signal detection and data analysis functionalities. can also use the post-authorisation module of the EV database management system (EDBMS) Confidentiality undertaking for access to case narratives for signal validation or other PV assessment procedure

SG IV Academia	All spontaneous reports as aggregated data and line listings based on restricted data elements (as for Stakeholder Group II) Extended data set based on study protocol (as for Stakeholder Group III) for research purposes	adrreports.eu web portal Confidentiality undertaking and provision of ad-hoc data set prepared by the EMA

SG V WHO Uppsala Monitoring Centre	Extended data set as per agreement with WHO for ICSRs from within the EEA ncludes spontaneous reports and reports of non-interventional studies	Data transfer agreement and daily electronic data transfer

SG VI Medicines regulatory authorities outside the EU	All spontaneous reports as aggregated data and line listings based on restricted data elements (as for SG II) Extended data set on request for safety monitoring	adrreports.eu web portal Ad-hoc data set prepared by the EMA