The Medical Products Agency simplifies the MAH electronic reporting of ADRs
Tuesday, January 05, 2010
The Medical Products Agency (MPA) has decided - in agreement with the European Medicines Agency (EMA) - to simplify the electronic handling of adverse reaction reporting.
Marketing authorisation holders (MAH) no longer need to send reports via the Medical Products Agency, but are instead encouraged to report all adverse reactions, occuring in Sweden, directly to the Eudravigilance database.
Since the Medical Products Agency may perform signal detection in the Eudravigilance database, the European Commission is of the opinion that with direct reporting to Eudravigilance database, the legal demands on the reporting are fulfilled provided that the reports are available within the stipulated 15-day time frame.
The direct reporting to the Eudravigilance database may be started January 15 2010 and all MAHs should be compliant with the new system of reporting ADRs at the latest by March 15, 2010.
The change covers all electronic ADR reporting from MAHs to the MPA. Spontaneous reporting from health care professionals and consumers to the Regional ADR Centres is not affected by the change.