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:
The reform of the EU rules on data protection will support the recovering but still fragile European economy, said the European Data Protection Supervisor following the presentation of his Annual Report of activities for 2013 to the Committee on Civil Liberties, Justice and Home Affairs (LIBE) at the European Parliament.
Opinion on the Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs and agricultural matters