CRED NPM

05/11/2024

Switch criteria

New substance

•

Market experience in the general population / real conditions is a MUST

Activity and/or side-effects of substance contained in the medicinal product not yet well-known < New medicinal product on the market < Limited sales Modification to existing products (e.g. new strength, dose, route of administration, indication, new age group or combination of substances) must be evaluated

New substance

The Organisation for Professionals in Regulatory Affairs

11

Switch criteria

Injectable Additional risks and complexity of the route of administration

Injectable

The Organisation for Professionals in Regulatory Affairs

12

6