CRED 8 Presentations

01/07/2024

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)

49

The Organisation for Professionals in Regulatory Affairs

49

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).

The Organisation for Professionals in Regulatory Affairs 50

50