Spring Intro 2023

16/02/2023

RISK/BENEFIT ASSESSMENT: - POST APPROVAL MEASURES

CP Post-approval Measures: • LEG: Legally binding measures • REC: Recommendation • MEA: Additional PhV activity in RMP • ANX: Obligation in Annex II • SOB: Specific obligation

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Schematic overview of decision tree for classification of PAMs

Link to schematic : European Medicines Agency post authorisation procedural advice for users of the centralised procedure (europa.eu)

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