Module232025

07/05/2025

Article 11

Waivers

Drug is likely to be ineffective or is unsafe

Condition does not occur

Drug offers no significant benefit over existing treatments

Waivers can apply to all or part of the paediatric population

The Organisation for Professionals in Regulatory Affairs

13

Article 12

Waivers

There is a list of class (automatic) waivers for which no application to PDCO is required

PDCO has the right to impose a waiver

The Organisation for Professionals in Regulatory Affairs

14