Module232025

07/05/2025

Compliance check

• EMA/PDCO check that all PIP studies have been conducted exactly as promised • Compliance check at Marketing Authorisation Application (MAA) submission:

• NO compliance = NO Marketing Authorisation

• No validation of a MAA without results of all studies performed in agreement with the PIP

The Organisation for Professionals in Regulatory Affairs

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Compliance check 60 day procedure, but PDCO aims at doing it in 30 days. For all centralised procedure applications, the EMA/PDCO conducts the compliance check. EMA holds up PIP Decision against the FINAL study report (“ticking a check-list”).

The Organisation for Professionals in Regulatory Affairs

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