CRED 8 Presentations

01/07/2024

ACCESS TO PROCEDURES

The Organisation for Professionals in Regulatory Affairs

7

Access to procedures

Consider • Options available according to • Indication • Product type • Strength of data • Company size – SME or not • Desired geography • Internal & external factors

•

EU / EEA • Centralised Procedure • Decentralised Procedure • Mutual Recognition Procedure • National Procedure

•

UK • National Procedure

•

• Other: Reliance Procedure / Access Consortium / Project Optimus

The Organisation for Professionals in Regulatory Affairs

8