EMA: Standard operating procedure for handling of standard requests for data analysis.

This document describes the process which is followed by members of the Section for Signal Detection and Data Analysis (P-PV-SDA) in situations when a standard request for data analysis, i.e. information about an adverse reaction associated with a medicinal product contained in EudraVigilance is received from within the European Medicines Agency, the European Commission, the Committee for Medicinal Products for Human Use (CHMP), the rapporteurs and other parties bound by confidentiality agreements. This procedure also applies to requests for Access to information or documents from other parties, taking into account the levels of access as outlined in the EudraVigilance Access Policy.