Module232025

07/05/2025

Article 36

Rewards and incentives

Completed PIP

Caveats

• For decentralised MAs, only if authorised in all 27 MS

No paediatric indication in MA

Paediatric indication in MA

• Not if 1 year of additional data protection has been claimed

• Not if the product has orphan status because…

6-month extension to SPC

The Organisation for Professionals in Regulatory Affairs

35

Article 37

Rewards and incentives

Completed PIP

No paediatric indication in MA

Paediatric indication in MA

2-year extension to orphan exclusivity

The Organisation for Professionals in Regulatory Affairs

36