Spring Intro 2023

16/02/2023

Why Important?

Objective: to present risk-benefit balance of the product considering new or emerging information in the context of cumulative information on risks and benefits. • Tool for post-authorisation evaluation at defined time points in the lifecycle of a product. • Time points determined by the European Union Reference Dates (EURD) (first MAA approval for active/combination) • Typical schedule: – At least every 6 months for first 2 years – Annually for the next 2 years – Every 3 years thereafter Ultimately determined by EURD list published online and this list overrides the typical schedule

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Considerations & Tips

Cross-functional effort: Safety, Regulatory, Clinical and others Key Regulatory Input: ● Worldwide Marketing Status ● Actions taken for safety reasons during the reporting period ● Changes to Reference Safety Information (RSI) (usually Core Datasheet) ● Difference between RSI and EU PI Assessed by PRAC ● Endorsed by CHMP (CP)/CMDh (MRP/DCP) if regulatory action necessary Updates to the SmPC/PL may be proposed by MAH or requested by agency

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