Spring Intro 2023

16/02/2023

Top Tips

● Need for updated RMP to be discussed with agency as appropriate ● How to handle parallel updates? ● Annotated RMP in working documents ● Procedure-specific RMP versions provided in eCTD closeout ● PASS dates in RMP –as broad as possible (year only, or Q3 YYYY rather than MM/YYYY) ● How to submit ? ● Stand-alone (no fee) vs variation (fee)

● Consider timing/when to incorporate minor updates ● Other impacts submission of annex I, RMP summary

● NOTE : Summary RMP used to be part of EPAR : New guidance (2022) : Full RMP and Annexes 4 and 6 now released

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Risk minimisation activities

Routine

Additional

• Summary of product characteristics (SmPC, Annex I) • Package leaflet (PL, Annex IIIb) • Labelling (Annex IIIa) • Pack size and design • Legal (prescription) status of the product

• Educational tools • targeting HCPs • targeting patients (including patient alert cards) • Controlled access programme • Prevention programmes (e.g. pregnancy prevention programme) • DHPC

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