Module 1 2021

30/06/2021

Incentives

Protocol assistance:

Fee reduction / exemption at Marketing Authorisation Stage (annually reviewed)

Scientific Advice with significant fee reductions

Extended incentives for small and medium sized enterprises (SMEs)

Market exclusivity (10 yrs) (+2yrs if paediatric indication; completion investigation plan)

Priority Access to Parallel Scientific Advice with FDA

Automatic access to EU wide marketing authorization (CP)

EU funded research

The Organisation for Professionals in Regulatory Affairs

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Market exclusivity EC 141/00 (art 8)

10 years market exclusivity

• No MAA will be accepted for the same therapeutic indication for a “similar medicinal product” • Reduced exclusivity to 6 years if criteria at the end of the 5th year are not met

The Organisation for Professionals in Regulatory Affairs

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