Ifølge CHMP guideline om Risk Management System for lægemidler til human brug, bør de opdaterede RMP indsendes samtidig med den næste sikkerhedsopdateringsrapporter (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).