Ifølge CHMP´s retningslinjer for Risk Management Systemer for medicinske produkter til human brug, skal den opdaterede RMP indsendes sammen med den næste Periodisk sikkerhedsopdatering (PSUR).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).