Spring Intro 2023

16/02/2023

Why Important?

• Requirement for all new MAs (from July 2012) CP/DCP/MRP • NCAs can request an RMP when concerned about B/R (nationally approved products) • Legacy products may not have RMPs – need may be triggered by safety concerns or significant change to MA • The RMP = live document - continually modified and updated throughout lifetime as new information becomes available

29

Considerations

Updates generally triggered by: ● Significant/clinically important change to the safety profile or indication ● New dosage form, route of administration, manufacturing process of biotech-derived product ● At request of EMA/NCAs or proactively by MAH – concern about  risk or  benefit impacting risk/benefit balance ● Submission of final study results (studies listed in RMP) ● Renewals ● Consequential to a variation that impacts RMP

PSUR - only where changes to the RMP are a direct result of data presented

30