Spring Intro 2023

16/02/2023

Considerations

● Oversight: EMA (CP), NCA (MRP/DCP/National) ● How is this monitored? – Product communications - Notify EMA/NCA: – Upon placing on market

– Planned cessations (temp/perm) – CP: Marketing status report –

To be done via IRIS as of April 2022

– Renewals – PSURs – Inspections

• CP only - Agency notifies the Commission when a three consecutive year period without marketing has elapsed • Interpretation /enforcement of clause at NCA level varies widely

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GXP INSPECTIONS  GVP –Pharmacovigilance  GMP – Manufacturing  GCP – Clinical

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