null How to proceed if a duplicate report is suspected locally?
How to proceed if a duplicate report is suspected locally?In order to identify a duplicate the MAH may, if necessary, contact Fimea (FIMEA.EV@fimea.fi). Likewise, Fimea may contact the MAH if it suspects the existence of a duplicate report. If existence of a duplicate report is confirmed, it will be agreed between the parties which one will send the information to the EMA (firstname.lastname@example.org) and the EMA will create a ‘master case’ to the EudraVigilance database.
24 Jan 2018