The Swedish Medical Products Agency (Läkemedelsverket) is Sweden's national competent authority for medicinal products and pharmacovigilance.
Core official resources
- Suspected adverse reactions from medicinal products — national safety-reporting hub.
- Information for pharmaceutical companies — MAH reporting information and EudraVigilance arrangements.
- Why report adverse reactions? — explanation of the role of spontaneous reporting and additional monitoring.
Practical use
The Swedish authority states that national competent authorities and MAHs in the EEA send suspected adverse-reaction reports directly to EudraVigilance. The Swedish pages are therefore most useful for national reporting routes, local safety communications and Swedish authority expectations around medicines safety.