CRED ERP 25

01/07/2025

PIP related obligations vs. incentives

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The Organisation for Professionals in Regulatory Affairs

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Conditions for paediatric rewards

• Development is compliant with the agreed PIP

• Results of studies included in Product information

• Product is authorised in all MSs (except for PUMA)

• Compliance statement included in the MA

The Organisation for Professionals in Regulatory Affairs 54

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