Opdateret RMP skal tillige indsendes: • Ved ny information, der kan have indflydelse på sikkerhedsspecifikation, Pharmacovigilance Plan eller risk minimisation activities • Inden for 60 dage efter en vigtig (pharmacovigilance eller risk minimisation) milepæl nås • På EMEA’ s anmodning
In addition, an updated RMP should be submitted: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.