CRED 8 Presentations

01/07/2024

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 52

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