I henhold til CHMP Guideline for Risk Management Systemet for lægemidler til human brug bør den opdaterede RMP indsendes samtidig med den næste 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).