CRED ERP 25

01/07/2025

Proposal incentives (consensus reached in Council but further discussions expected)

+2 year possible if medicine launched in all 27 MS within 2 years from EU authorisation and continuously supplied

The Organisation for Professionals in Regulatory Affairs 39

39

⚫ Orphan Regulations

Reg. (EC) No 141/2000 Reg. (EC) No 847/2000

NB: amended in 2019 via REGULATION (EU) 2019/1243 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019

The Organisation for Professionals in Regulatory Affairs 40

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