MPA receives electronic reports through a so called Gateway. When there are disturbances in the traffic, this will be announced here.
According to the EU regulations the MAH shall report adverse reactions electronically to MPA. In order to receive electronic reports MPA has a so called Gateway. This receives incoming reports and forwards them to EMEA.
When there are disturbances in the traffic, i.e. when our gateway or the gateway of EMEA for some reason cannot receive or send reports and acknowledgement reports, we will give information on this page.
The Medical Products Agency simplifies the MAH electronic reporting of ADRs
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.
Monday 1 June, 2009
As from Friday night the transmission of electronic ADR reports is working. Our system has been updated with a new way of communicating with EMEA.
Previously sent reports for which acknowledgment has not been received must be re-sent.
Disturbances 29 May, 2009
Friday afternoon, 29 May
The transmission of electronic ADR reports is still working very slowly and is occasionally blocked for several hours.
In order to facilitate the transmission of accumulated reports we would be grateful if you would send no more reports until Monday 1 June. More information then.
Friday morning, 29 May
As from 12.44 GMT 28th May the gataway is running. However, the long stop in deliverance generates many automatic re-sendings and an intense load on the gateway. The system is halted now and then and we do not expect normal speed until Friday morning 29th May at the earliest. We will return with more information.
Seemingly all reports as of 19 May and onwards will be delivered to us and we will be able to send acknowledgment messages.
Disturbances 25 May, 2009
The performance of our gateway is currently not optimal.
The problem is expected to be solved on Tuesday 26.
Disturbances 26 September, 2007
As from noon 26 September the MPA has communication difficulties and we have not been able to send acknowledgment to received reports. We will solve this as soon as possible.
Disturbances 28 June, 2007
At the moment there is problem with the traffic of "ICHICSR" och "ICHICSRACK" at the EMEA gateway. We expect the situation to be rectified Thursday 28th of June, late in the afternoon.