Module232025

07/05/2025

Articles 5 & 6

Introductory provisions

• PDCO should use best endeavours to reach consensus

Key PDCO tasks: • Assessment PIPs, waivers and deferrals and give an opinion • Perform compliance checks

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• Several other tasks are set out but have less importance

The Organisation for Professionals in Regulatory Affairs

7

Article 7

General authorisation requirements

An MAA for a new drug cannot be validated unless: You are in compliance with an agreed PIP OR You have a waiver and/or deferral !

The Organisation for Professionals in Regulatory Affairs

8