EudraVigilance database - EMEA

Opinion of 7 September 2009 on a notification for prior checking regarding the EudraVigilance database (Case 2008-402)

EMEA manages the EudraVigilance database whose originates from National Competent Authorities, Market Authorization Holders and sponsors of clinical trials.  The purpose of the database is to evaluate suspected adverse reactions to medicinal products for human use. The EDPS considers that the processing is lawful to the extent that EMEA follows the recommendations included in the Opinion, particularly those regarding the data quality principle.

The EDPS recommended, among others, that EMEA:

• Engages in an examination of the possibility to minimize the personal data recorded in ICRs as well as of the possibility to anonymise or pseudoanonymise personal information contained in ICRs;
• Considers whether a  limited conservation period would fulfill the purposes sought by the data processing;
• Adopts the security measures described in this Opinion.