I henhold til CHMPs retningslinjer “ Guideline on Risk Management Systems for medicinal products for human use ” bør den næste opdatering af RMP indsendes på samme tid som den næste Periodiske sikkerhedsopdatering “ 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).