CRED 8 Presentations

01/07/2024

Proposal incentives

+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 37

37

 Orphan Regulations

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

NB: Revision of orphan regulation ongoing

The Organisation for Professionals in Regulatory Affairs 38

38