Ifølge CHMP’ s Guideline for Risk Management systemer for humane lægemidler skal den opdaterede RMP indsendes sammen med den næste Periodiske Sikkerhedsopdateringsrapport (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).