Module232025

07/05/2025

Compliance check

If some studies deferred: Partial/interim compliance check – i.e., some studies will be conducted after initial MA If it is the final, deferred studies: Final compliance check If full waiver: No compliance check

Partial PDCO compliance check is reflected in a PDCO letter of compliance. Full PDCO compliance check results in a PDCO Opinion Compliance statement (included in MA) – NEEDED for the reward!

The Organisation for Professionals in Regulatory Affairs

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Compliance check

Compliance with the approved PIP is followed by EMA/PDCO for the duration of the Paediatric Development • Annual deferral reports (for authorised products)

• Non-fulfilment may lead to penalties, including: • Publication of non-compliance

• Financial penalties if deferred studies are noncompliant (Draft amendment of Commission Regulation (EC) 658/2007 concerning financial penalties for infringements by MAHs)

The Organisation for Professionals in Regulatory Affairs

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