Spring Intro 2023

16/02/2023

PAEDIATRICS – LIFECYCLE MAINTENANCE : •  PIP COMPLIANCE CHECK •  PIP ANNUAL REPORT •  PIP MODIFICATIONS •  STUDY RESULTS

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Compliance with PIP = reward ● Regulatory obligation to submit results compliant with agreed PIP OR an EMEA decision on waiver/deferral, at time of MAA, New Indication, Line extension ● Rewards – 6 months extension of the patent protection – 2 year extension for orphan-designated products – 10 years for paediatric medicines (PUMA) Why Important? • Annual reports: MAHs that have a deferral on a PIP are obliged to submit annual reports to the Agency: • Progress on PIP key measures • PIP modifications: If study is not continuing as planned a modification may be required to ensure compliance. • Article 46: Required to submit results of studies conducted in paediatrics within 6 months of study completion.

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