A Marketing Authorization Holder (MAH) can use the Mutual Recognition Procedure (MRP) for the same authorization more than once after completion of a first MRP or a Decentralized Procedure (DCP) for the recognition of a marketing authorisation by other Member States (MS). This procedure is known as “Repeat Use” (RuP).
This procedure can be used in the following situations: • either by application to new Concerned Member States (CMS) not involved in the first MRP or DCP, or by reapplication to CMS withdrawn from the first procedure.
The MAH should send a written request for Repeat Use procedure to the RMS. In case IS is RMS the request should be sent to [email protected]. CMDh has introduced a Request Form and annex which should be filled out requesting the RuP.
- The RuP can be initiated 30 days post last round of the MR or DC procedure but MA only needs to be issued in the RMS before this next round of. Any additional changes to the dossier including product information requiring a Mutual Recognition variation, should be completed before the start of the Repeat Use procedure. The first MRP or DCP needs to be completed before submitting such a variation.
- The new CMS(s) must recognize the MA of the product with the same, identical SmPC, labelling and package leaflet that were approved in the earlier MRP or DCP. The package leaflet should however be updated at the end of the Repeat Use procedure to include the product names in the new CMS(s) in section 6. The applicant will inform the ‘old’ CMS(s) of this change at the time of the next variation/notification affecting the package leaflet.
- If the original dossier is structured according to the “old” EU format, when starting a Repeat Use procedure, it is required to submit Modules 1, 2 and 3 in the CTD structure. There is no need to reformat non-clinical and clinical data submitted with the original dossier to CTD structure. It should be stated however that Part III corresponds to Module 4 and Part IV to Module 5. Overviews and summaries of non-clinical and clinical data in Module 2 can be replaced by expert statements with reference to the corresponding expert reports in the “old” EU format. Any new preclinical or clinical data submitted to update the dossier e.g. in support of a variation, must be submitted using the CTD format. It is also necessary to provide new CTD-format summaries and overviews to cover any new information or data provided in support of the application
CMDh has introduced procedural guidance on application for MA via MRP and RuP.