Module232025

07/05/2025

Articles 47 & 49

Other selected highlights

Article 47 • Applications to PDCO are free of charge

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Article 49 • Provides for penalties for infringement of the paediatric legislation… • …but no scale of fines has been published so there are currently no financial penalties in effect

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The Organisation for Professionals in Regulatory Affairs

41

Practical realities

• You need to understand very early in development whether a PIP (or PIP waiver) is required • Part of this means knowing the legal basis for MAA years in advance • Must define and commit to “what, why, when & how” very early on • Defining the appropriate “PIP condition” can be tricky • Elaborating full development plans before you even know about the effect size in adults is required… • …but not realistic

The Organisation for Professionals in Regulatory Affairs

42