CRED ERP 25

01/07/2025

Paediatric Investigation Plan (2/2)

⚫ Submission of results of studies on authorised medicines conducted in children to EMA/NCAs ⚫ In case of compliance with agreed PIP, information in SmPC and if a MA is granted in all Member States: 6-month extension of the patent protection (= Supplementary Protection Certificate = SPC)

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The Organisation for Professionals in Regulatory Affairs

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Paediatric Use Marketing Authorisation (PUMA)

⚫ Introduced by the Paediatric Regulation for medicines that are:

- Already authorised;

- No longer covered by a supplementary protection certificate (SPC) or a patent that qualifies as a SPC;

- To be exclusively developed for use in children.

⚫ The development of a PUMA must follow a paediatric investigation plan (PIP), to be agreed by the Paediatric Committee (PDCO).

Example: Buccolam (Oromucosal use, for treatment of prolonged, acute, convulsive seizures in infants from 3 months to adults)

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