En opdateret RMP skal fremsendes samtidig med den næste periodiske sikkerhedsopdatering (Periodic Safety Update Report, PSUR), som beskrevet i CHMP Guideline on Risk Management Systems for medicinal products for human use.
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).