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).
Vastavalt CHMP Inimestel kasutatavate ravimite riskijuhtimise juhendile, tuleb värskendatud RMP esitada Regulaarse ohutuse ajakohastamise raportiga (PSUR) üheaegselt.