CRED NPM

05/11/2024

Data Package

• Switch Application to follow the ‘European Switch Guideline’

The Organisation for Professionals in Regulatory Affairs

19

Data Package

• Expert reports (non-clinical, clinical) - All switch criteria of the ‘European Switch Guideline’ to be reflected • Safety - Summary of animal and/or human studies - Experience of patient exposure (Post Marketing Surveillance data) - Information on adverse reactions - Summary of safety profile according to EU guidelines - Potential for drug interactions and consequences - Potential misuse / overdose - Consequences of incorrect assessment of symptoms - Consequences of incorrect or delayed diagnosis due to self medication

The Organisation for Professionals in Regulatory Affairs

20

10