Electronic transmission of individual case safety reports by the Marketing authorisation holder

The reporting of Adverse Drug Reactions (ADRs) occurring in Norway should be in line with the requirements of EU directive 2001/83 and Regulation 726/2004 and the guidelines for Good Pharmacovigilance Practices (GVP) module VI.

The Marketing authorisation holder (MAH) shall report all serious and non-serious ADRs occurring in Norway to EV. Hence, the MAHs should no longer send reports originating from Norway directly to NOMA. ADRs occurring in other EU/EEA-countries and outside the EEA should also be reported to EV, in line with the requirements in the legislation/GVP VI.

Norwegian ADRs reported by marketing authorisation holders, will be rerouted from EV to NOMA.

All reports NOMA receives directly from healthcare professionals via the regional pharmacovigilance centres and directly from patients in Norway will be submitted to EV and will be made available to the MAHsfor downloading.

See Frequently Asked Questions (FAQ) on electronic transmission of individual safety reports

See more information from EMA:

EudraVigilance Change Management

Eudravigilance training and support

Good Pharmacovigilance Practices, Module VI, Rev 2