The Norwegian Medical Products Agency (DMP; formerly commonly referred to in English as NOMA) is Norway's national competent authority for medicines. Norway participates in the EEA pharmacovigilance framework.
Core official resources
- Adverse drug reactions and drug safety — national medicines-safety hub.
- Pharmacovigilance FAQ for industry — national clarification of ICSR and EudraVigilance expectations.
- How to report suspected adverse reactions — public and healthcare-professional reporting routes.
Practical use
DMP states that MAHs should report serious and non-serious Norwegian ADRs to EudraVigilance in line with EU legislation and GVP Module VI. Norwegian cases are then rerouted from EudraVigilance to the national authority. The national FAQ is therefore valuable for country-specific implementation details rather than a separate duplicate reporting system.