I henhold til CHMPs retningslinjer om Risk Management- systemer for lægemidler til humant brug skal en opdateret 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, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).