Approval Letter following Variation

During handling of variations in which cases do you receive a “Validation Letter”, in which cases an “Approval Letter”?

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. If applicable the final national texts (FI, GI, KE) will be sent via e-mail and uploaded in the finalised procedure in the eServices.

 

National Procedures

For national procedures you will receive a “Validation Letter” as well as an “Approval Letter”. Should the validation of a variation be done simultaneously to the approval of the procedure you only receive an “Approval Letter” as the closing of the procedure includes positive validation. “Validation Letter” as well as “Approval Letter” and if applicable the product information (SmPC, PL and Labelling) will be sent via e-mail. 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.

 

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