AT=RMS

If all validation issues are clarified and the application has been checked and accepted, you receive a “Start of Procedure”-e-mail in the case of Type IB and Type II Variations which corresponds to the “Validation letter” for national variations. At the closure of the procedure an “End of Procedure Letter” (corresponding to “Acceptance Notification”, “Approval Letter”) and if applicable the final common texts (SmPC, PL, Lab) will be forwarded via e-mail. The final national texts (FI, GI, KE) will be uploaded in the finalised procedure and displayed in eService once the process is complete.

National Procedures

For national procedures you will receive for Type IB- or Typ II- a “Validation Letter” as well and for all other changes as an “Approval Letter”. Should the validation of a variation be done simultaneously to the approval of the procedure in this case you only receive an “Approval Letter”. After closing of the procedure the “Approval Letter” and the product information is available on eServices in the finalised procedure.

AT=CMS

You neither receive a “Start of Procedure”-e-mail nor an “End of Procedure Letter”. If applicable, the final national SmPC, PIL and Labelling (FI/GI/KE) are shown in the finalised procedure on e-Service, there will be no separate e-mail. However, you will receive an automated e-mail after closure of the procedure, indicating that the procedure including the final product information can be found on eServices.