Spring Intro 2023

16/02/2023

SAFETY: - SAFETY VARIATIONS

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Pharmacovigilance Risk Assessment Committee (PRAC)

• Established in 2012 with pharmacovigilance legislation • Important committee involved in all aspects of risk management for medicines licensed in EU • 1 x Chair + reps from each MS + 6 x experts + 1 x HCP rep & 1 x EU patient Rep Scope: MRP/DCP Urgent EU procedures, PSURs, PASS protocols/results, safety signals, GVP inspections Article 20 referrals, RMPs, renewals, annual reassessments Article 31 referrals Type II safety variations where requested by CHMP RMP, renewals, type II safety variations as requested by CMDh Centralised

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