Joint Controllership Arrangement: EudraVigilance Human (EV) Personal Data Capture

13 July 2022 — EMA published legal framework for the purpose of processing personal data captured in EudraVigilance Human (EV) administered by EMA

Amongst the European Commission (hereinafter referred to as ‘Commission’ or ‘European Commission’), the European Medicines Agency (hereinafter also referred to as ‘the Agency’ or ‘EMA’), and the Member States of the European Union (EU)/European Economic Area (EEA) (hereinafter referred to as ‘MS’ or ‘Member States’) represented by National Competent Authorities (hereinafter referred to as ‘NCAs’).

Each of them a ‘Party’ and hereinafter collectively referred to as ‘Parties’, to be considered as ‘joint controllers’ for the purpose of processing personal data captured in EudraVigilance Human (EV) administered by EMA and covering the following system components:

1. EudraVigilance Gateway – the data processing network;

2. EudraVigilance Database Management system comprising the EudraVigilance Clinical Trials Module (EVCTM), the EV Post-Authorization Module (EVPM) and data quality management functionalities (recoding and duplicate detection);

3. EudraVigilance web reporting application (EVWEB) including Individual Case Safety Report (ICSR) creation, submission, re-routing to NCAs of Member States, querying and for EVPM ICSR download by marketing authorization holders;

4. EudraVigilance Data Warehouse and Analysis System (EVDAS) including signal detection, safety monitoring and data analysis functionalities;

5. Public Adverse Drug Reaction Reports portal (ADRReports.eu);

6. Extended Medicinal Products Dictionary (xEVMPD).

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