Module 1 2021

01/07/2021

• Deferred” means Marketing Authorization Application for adults is possible before initiation/completion of one or more measures in the PIP • Given by study/measure • For initiation and/or completion of study/measures; completion of a clinical trial may be deferred, but initiation may not be! • Completion dates are included in the opinion of the PIP (key binding element) • If a measure is NOT deferred: it should be done BEFORE Marketing authorization application (or relevant procedure) • Deferrals: granted only on scientific/technical/safety grounds (not for economic reasons) Deferrals; Instrument to avoid delaying marketing authorization in adults

The Organisation for Professionals in Regulatory Affairs

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Modifications

• Most PIP’s are need to be modified after approval • A modification procedure has a 60 day time-line

The Organisation for Professionals in Regulatory Affairs

26

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