Draft revision of EudraVigilance access policy for medicines for human use

  • Email
  • Help

Document details

Download document Draft revision of EudraVigilance access policy for medicines for human use
Reference number EMA/759287/2009 Rev. 1
Status draft: consultation closed
First published 2014-08-04
Last updated 2014-08-04

Summary

The EudraVigilance access policy as adopted in December 2010 has been updated whilst maintaining adherence to personal data protection requirements pursuant to the provisions of Regulation (EC) No 45/2001. The aim is to provide the access necessary for those with legal obligations in pharmacovigilance and the highest possible degree of transparency while minimising the necessity to engage in ad-hoc reactive disclosure of information based on individual requests. For this purpose access is being extended from spontaneous reports to reports from non-interventional studies. The mechanisms by which stakeholders are provided with access to EudraVigilance based on defined individual-case-safety-report data elements and in accordance with European Union data protection legislation have been further elaborated based on experience gained so far and taking into account the recent changes in legislation.