Module232025

07/05/2025

Article 13

Waivers

• Article 13 • Provides for applicants to request a product-specific waiver • 60-day procedure

Very interesting In practice, there are no clock-stops in a waiver procedure

The Organisation for Professionals in Regulatory Affairs

15

Article 14

Waivers

• Article 14 • Requires EMA to keep a list of all waivers • Allows PDCO to advocate review of a granted waiver • Sets out how to deal with changes to waivers by reference to other articles

• Covers both class waivers and product-specific waivers

The Organisation for Professionals in Regulatory Affairs

16