The Danish Medicines Agency monitors the safety of medicines in Denmark and operates the national adverse-reaction reporting system within the EU pharmacovigilance framework.
Core official resources
- Side effects — Danish medicines-safety and pharmacovigilance hub.
- Report side effects of medicines for human use — national electronic reporting route for healthcare professionals, patients, carers and relatives.
- Danish Medicines Agency — national regulatory authority and source of medicines-safety communications.
Practical use
The Danish reporting page was updated in March 2026 and explains the national spontaneous-reporting route. MAH ICSR reporting remains aligned with the EU EudraVigilance framework; national pages are most useful for local case pathways, safety communications and authority-specific instructions.