The reporting of Adverse Drug Reactions (ADR) occurring in Norway should be in line with the requirements of EU Directive 2010/84/EC, Regulation (EC) No 1235/2010 and the guidelines for Good Pharmacovigilance Practices (GVP) module VI.

NOMA receives ADR reports from:

NOMA is responsible for forwarding information regarding all serious ADRs occurring in Norway to the EMA (for details see GVP, module VI). Hence, the MAHs should not send serious reports originating from Norway directly to the EMA, as this will result in duplicates in the European database (EudraVigilance). Serious adverse drug reactions occurring in other EU/EEA-countries should be reported to the competent authority in the Member State in whose territory the incident occurred. The MAHs are responsible for reporting adverse drug reactions occurring in countries outside the EEA to the EMA.

Non-serious ADRs are collected by the MAHs and sent to the relevant competent authorities as Periodic Safety Update Reports (PSURs). NOMA informs the MAHs of non-serious ADRs though annual/semi-annual line-listings.

Please note that NoMA would prefer not to receive reports originating outside the EEC. Such reports should be sent to the EudraVigilance (EV) database only.

Publisert: 27.06.2016

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