Ifølge CHMP’ s retningslinier for risk management- systemer for lægemidler til humant brug skal den opdaterede RMP indsendes samtidig med den næste Periodic Safety Update Report (PSUR).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).