• Når ny information modtages, som kan have betydning for den gældende Safety Specification, Pharmacovigilance Plan eller aktiviteterne vedrørende risikominimering. • Senest 60 dage før en vigtig milepæl nås (vedr. pharmacovigilance eller risikominimering). • Efter anmodning fra EMEA.
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