Spring Intro 2023

30/03/2023

Additional protection Orphan Products (Regulation 141/2000)

10 year ‘Orphan Market Exclusivity’ • Different from non-orphan market exclusivity • Regulators cannot accept MAA/indication application for the same indication as an approved similar medicinal product • Market exclusivity only in orphan indication

The Organisation for Professionals in Regulatory Affairs

91

Additional protection Paediatrics

Non-orphan products • 6 months SPC extension

• If paediatric program completed

Orphan products • 2 year extension of ‘orphan’ market exclusivity

The Organisation for Professionals in Regulatory Affairs

92