Module232025

07/05/2025

Article 2

Introductory provisions

• Definitions of: • Paediatric population • Paediatric investigation plan (PIP) • Medicinal product authorised for a paediatric indication • Paediatric Use Marketing Authorisation (PUMA)

The Organisation for Professionals in Regulatory Affairs

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Articles 3 & 4

Introductory provisions

• Establishment of the Paediatric Committee (PDCO) and supporting secretariat • PDCO comprises: • 5 CHMP members (and alternates) • 1 member from each EU Member State (and alternate) • 3 members appointed by the European Commission representing health professionals (and alternates) • 3 members appointed by the European Commission representing patient associations (and alternates) • Members serve 3-year renewable terms

No provision for any members representing the interests of industry

The Organisation for Professionals in Regulatory Affairs

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