CRED ERP 25

10. Mutual Recognition Repeat Use

MRP is a “repeat use procedure” meaning that once approved in one Member State or some other EU MSs, the same process can be used for subsequent Member States. Each of these subsequent Member States is designated as the Concerned Member State.

There are a couple conditions:

• The application is submitted to a new Concerned Member State that was not involved in the first process • When resubmitted to a Concerned Member State, all on-going procedures must be finalised, i.e. variations, renewals, updating SmPC, etc. The updated application is submitted first to the Reference Member State.

It should be noted that no additional updates can be proposed to the approved dossier as part of the repeat-use in MRP.

When to use Repeat Use MRP: