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).
Riskide ohjamise plaanis (Risk Management Plan, RMP) ning kõigis järgnevates kaasajastatud RMPdes kooskõlastatuna Euroopa Ravimiameti Inimravimite Komiteega.