Is the Icelandic Medicines Control Agency ready for the production phase?

Yes, see EudraVigilance

Is a testing phase mandatory?

No. When a MAH has completed a testphase with EMEA further testing is not required with IMCA.

Is submission of paper/fax copies necessary in parallel with electronic reporting?

No, but Icelandic representatives of MAHs are required to send a copy to IMCA when they send a report to their Qualified Person. This is for regulatory purposes and to avoid duplicate submission.

How do MAHs receive ICSRs from IMCA?

Electronic transmission is a two way communication. The MAHs are required to send all ICSRs electronically (to ADALIMCA01), as described above. Likewise, all transmissions of ICSRs from IMCA to MAHs can be sent via the same EudraVigilance-gateway. If a MAH wishes to enter into such communication with IMCA please send a request to imca@imca.is or via the Icelandic representative. Currently IMCA sends a paper-copy of the report the Icelandic representatives of MAHs. All ICSRs sent to the MAHs are also transmitted to  EMEA. We use the acknowledgment files from  EMEA to validate the correctness of the reports according to  EMEA business rules. If the report is considered valid and correct by  EMEA, we consider it to be valid also towards the MAHs.

What causality assessments does  IMCA use when evaluating reports.

 IMCA uses the WHO causality assessment of suspected adverse reactions

Does  IMCA receive consumer reports?

Yes,  IMCA has started a trial project for receiving consumer reports. The reports do not have to be medically confirmed.