Eudravigilance: communication to the (future) partners (marketing authorisation holders, promoters of clinical studies…) of electronic reporting of adverse effects.
The FAMHP would like to inform partners and future partners of electronic reporting of adverse effects (of medicines for human use) about the current status of the problems related to the local Eudravigilance program and the treatment of the electronic reports in this program during the Christmas Holidays (25th of December 2010 until 2nd of January 2011).
1) Since March 2010, the FAMHP’s local Eudravigilance program is not able to receive your electronic messages directly in its system. Therefore, the FAMHP has decided to transfer its “AFIGP” organization from gateway trader to webtrader.
This change was essential at that time in order to be able to comply with the actual legislation, namely sending the acknowledgements (acks) to our electronic reporting partners and transferring the reported cases to the European Medicines Agency (EMA).
- This change has important consequences on the daily process of transfer and evaluation of ICSRs (Individual Case Safety Reports) within the FAMHP;
- All reports, electronically sent to the FAMHP in the E2B format, are received in the Eudravigilance Webtrader (EVWEB) application of the EMA;
- Acknowledgements on reports (acks), normally sent out automatically by our system, now need to be created manually in the EMA’s EVWEB application;
- All received reports need to be loaded manually in the local Eudravigilance system for further evaluation.
Because of the impact (human resources) of the previous steps on the daily working process, new partners cannot be accepted for electronic reporting for the moment.
In the context of the total migration project of the ICT infrastructure within the FAMHP, the “Eudravigilance” project to resolve the problems with our local Eudravigilance program is currently under discussion. You will be informed as soon as possible about the new process to follow for electronic reporting.
In the meantime, the current process will be continued. This means that the new business rules that will come into force on the 7th of February 2011, will be applied at the Belgian level. The future reporting, applying the new process (currently in development – you will be informed about this in 2011), will need to comply with the new business rules.
2) The FAMHP is closed during the Christmas Holidays (25th of December 2010 until 2nd of January 2011 incl.). Nevertheless, the electronic reporting process will be followed up. This means that acks for 24/12 until 27/12 incl. will be sent out on Tuesday 28/12; acks for 28/12 until 30/12 incl. will be sent out on the 31/12. As of 3/01/2011, the normal process will be resumed.