Spring Intro 2023

30/03/2023

How and Where ? Defined process and timelines for: Initial submission

Timetable Graphics

Modification

The Organisation for Professionals in Regulatory Affairs

How and Where ?

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Key point to remember

The Key Elements of a PIP are legally binding – it is important to ensure that all teams are aware of this.

• Ensure Key Elements do not impact filing of MAA or post approval line extensions • If you have a binding element with an initiation or completion date immediately prior to filing you will need to demonstrate PIP compliance prior to filing via a formal “compliance check” procedure • You can request that Key Elements are changed after initial PIP approval (PIP modification) • No guarantee

The Organisation for Professionals in Regulatory Affairs

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