Changes regardig adverse reaction reporting arising from clinical trials

SUSAR reports

Hereby we inform the applicants, that from 1-Oct-2011 SUSAR-s must be reported via the EudraVigilance system to organisation ID: „OGYI”. (At the same time you should continue to send spontaneous reports to organisation ID: „OGYIP”.)

Annual safety reports

From 1-Sept-2011 following the requirements of ICH E2F guidline only the Development Safety Update Report format on CD is accepted. The subject identification ID for the submissions is : 4105. As of 1-Oct-2011 DSURs must be addressed to the Clinical Trials Unit.

SUSAR line listings:

As of 1-Oct-2011 SUSAR Line Listings must be addressed to the Clinical Trials Unit. CD format is required. Subject Identification ID: 4105.